Children's Interstitial and Diffuse Lung Disease. Progress and Future Horizons.

PubMed

Deterding, Robin R

2015-10-01

Children's interstitial and diffuse lung disease (chILD) is a term that encompasses a large and diverse group of rare pediatric diseases and disorders. Significant progress has been made over the last 2 decades in classification, clinical care, research, and organizational structure to enhance the care of children with these high-morbidity and -mortality diseases. New diseases have been defined clinically and genetically, classification systems developed and applied, organizations formed such as the chILD Research Network (chILDRN) and chILD Foundation, and basic and translational science expanded to focus on chILD diseases. Multidisciplinary collaborations and efforts to advance understanding and treatment of chILD have been extended worldwide. The future horizon holds great promise to expand scientific discoveries, collaborate more broadly, and bring new treatment to these children. An overview of key historical past developments, major clinical and research updates, and opportunities for the future in chILD is reviewed in this Perspective.

Data Quality Monitoring in Clinical Trials: Has It Been Worth It? An Evaluation and Prediction of the Future by All Stakeholders

PubMed Central

Kalali, Amir; West, Mark; Walling, David; Hilt, Dana; Engelhardt, Nina; Alphs, Larry; Loebel, Antony; Vanover, Kim; Atkinson, Sarah; Opler, Mark; Sachs, Gary; Nations, Kari; Brady, Chris

2016-01-01

This paper summarizes the results of the CNS Summit Data Quality Monitoring Workgroup analysis of current data quality monitoring techniques used in central nervous system (CNS) clinical trials. Based on audience polls conducted at the CNS Summit 2014, the panel determined that current techniques used to monitor data and quality in clinical trials are broad, uncontrolled, and lack independent verification. The majority of those polled endorse the value of monitoring data. Case examples of current data quality methodology are presented and discussed. Perspectives of pharmaceutical companies and trial sites regarding data quality monitoring are presented. Potential future developments in CNS data quality monitoring are described. Increased utilization of biomarkers as objective outcomes and for patient selection is considered to be the most impactful development in data quality monitoring over the next 10 years. Additional future outcome measures and patient selection approaches are discussed. PMID:27413584

Clinical case definition for the diagnosis of acute intussusception.

PubMed

Bines, Julie E; Ivanoff, Bernard; Justice, Frances; Mulholland, Kim

2004-11-01

Because of the reported association between intussusception and a rotavirus vaccine, future clinical trials of rotavirus vaccines will need to include intussusception surveillance in the evaluation of vaccine safety. The aim of this study is to develop and validate a clinical case definition for the diagnosis of acute intussusception. A clinical case definition for the diagnosis of acute intussusception was developed by analysis of an extensive literature review that defined the clinical presentation of intussusception in 70 developed and developing countries. The clinical case definition was then assessed for sensitivity and specificity using a retrospective chart review of hospital admissions. Sensitivity of the clinical case definition was assessed in children diagnosed with intussusception over a 6.5-year period. Specificity was assessed in patients aged <2 years admitted with bowel obstruction and in patients aged <19 years presenting with symptoms that may occur in intussusception. The clinical case definition accurately identified 185 of 191 assessable cases as "probable" intussusception and six cases as "possible" intussusception (sensitivity, 97%). No case of radiologic or surgically proven intussusception failed to be identified by the clinical case definition. The specificity of the definition in correctly identifying patients who did not have intussusception ranged from 87% to 91%. The clinical case definition for intussusception may assist in the prompt identification of patients with intussusception and may provide an important tool for the future trials of enteric vaccines.

Nano-technology contributions towards the development of high performance radioisotope generators: The future promise to meet the continuing clinical demand.

PubMed

Sakr, Tamer M; Nawar, Mohamed F; Fasih, T W; El-Bayoumy, S; Abd El-Rehim, H A

2017-11-01

Nanostructured materials attracted considerable attention because of its high surface area to volume ratio resulting from their nano-scale dimensions. This class of sorbents is expected to have a potential impact on enhancement the efficacy of radioisotope generators for diagnostic and therapeutic applications in nuclear medicine. This review provides a summary on the importance of nanostructured materials as effective sorbents for the development of clinical-scale radioisotope generators and outlining the assessment of recent developments, key challenges and promising access to the near future. Copyright © 2017 Elsevier Ltd. All rights reserved.

Pathogenesis and prevention of rheumatic disease: focus on preclinical RA and SLE

PubMed Central

and, Kevin D. Deane; El-Gabalawy, Hani

2014-01-01

Established and emerging data demonstrate that a ‘preclinical’ period of disease precedes the onset of clinical rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE), as well as other autoimmune rheumatic diseases (ARDs).This preclinical stage of development of disease is characterized by abnormalities in disease-related biomarkers before the onset of the clinically apparent signs and symptoms. Numerous genetic and environmental risk factors for ARDs have also been identified, and many of these factors are likely to act before the clinical appearance of tissue injury to initiate and/or propagate autoimmunity and autoimmune disease. Thus, biomarkers representative of these autoimmune processes could potentially be used in conjunction with other clinical parameters during the preclinical period of ARDs to predict the future development of clinically apparent disease. This Review focuses on the preclinical stages of RA and SLE, as our current understanding of these diseases can be used to present an overall model of the development of ARDs that might ultimately be used to develop screening programmes and preventive strategies. Important considerations for the future development of such approaches, in particular, the issues that require additional research and how they might be addressed, are also discussed. PMID:24514912

What are the priorities for future success in critical care research in the UK? Report from a national stakeholder meeting.

PubMed

Walsh, Tim; Brett, Stephen J

2015-11-01

Critical care in the United Kingdom is now well-established in terms of professional status, standards of clinical practice and training, and national audit through professional bodies and government representation. Research is fundamental to the further development and maturation of the specialty, to develop new therapies and technologies, more efficient and effective service organisation, and to improve patient and family experience and outcomes. Critical care research has expanded rapidly in the UK, and now has established organisations and infrastructure to share and develop ideas, through the UK Critical Care Research Forum and similar meetings. In September 2014, the Intensive Care Foundation and Critical Care Leadership Forum hosted a research colloquium to reflect, in part, on achievements, but more importantly plan for the future. With an invited list of participants the meeting explored firstly - the practical delivery of clinical research and secondly - the future financing landscape, from both academic funders' and commercial developers' perspectives. The following article summarises the important 'take home' messages from this meeting and suggests key issues for future strategy.

The face, the future, and dental practice: how research in craniofacial biology will influence patient care.

PubMed

Townsend, G C; Brook, A H

2014-06-01

It has been a privilege to assemble a group of Australian and international researchers to produce a special issue of the Australian Dental Journal that reflects the cutting edge of research in different aspects of craniofacial biology, and also considers how these advances will influence future education and practice within dentistry. The aim of this special issue is to provide a collection of concept papers and critical reviews on key topics that cover both fundamental and applied research in craniofacial biology and to consider the clinical implications. To do this, four questions have been addressed that lead to the four sections of this issue. These are: How have we come to the present exciting position in craniofacial biology with breakthroughs over the past 50 years? What are current fundamental research topics that are helping us to understand more about craniofacial and general development, possibly leading to future clinical developments? What are the current applied research topics that will influence future clinical practice? Looking forward, what new developments in craniofacial biology may come about that will change the face of dental education and practice? The refereed papers in this special issue are grouped into the four sections that seek to respond to these demanding questions. © 2014 Australian Dental Association.

Amnesia and future thinking: Exploring the role of memory in the quantity and quality of episodic future thoughts.

PubMed

Cole, Scott N; Morrison, Catriona M; Barak, Ohr; Pauly-Takacs, Katalin; Conway, Martin A

2016-06-01

To examine the impact of memory accessibility on episodic future thinking. Single-case study of neurological patient HCM and an age-matched comparison group of neurologically Healthy Controls. We administered a full battery of tests assessing general intelligence, memory, and executive functioning. To assess autobiographical memory, the Autobiographical Memory Interview (Kopelman, Wilson, & Baddeley, 1990. The Autobiographical Memory Interview. Bury St. Edmunds, UK: Thames Valley Test Company) was administered. The Past Episodic and Future Episodic sections of Dalla Barba's Confabulation Battery (Dalla Barba, 1993, Cogn. Neuropsychol., 1, 1) and a specifically tailored Mental Time Travel Questionnaire were administered to assess future thinking in HCM and age-matched controls. HCM presented with a deficit in forming new memories (anterograde amnesia) and recalling events from before the onset of neurological impairment (retrograde amnesia). HCM's autobiographical memory impairments are characterized by a paucity of memories from Recent Life. In comparison with controls, two features of his future thoughts are apparent: Reduced episodic future thinking and outdated content of his episodic future thoughts. This article suggests neuropsychologists should look beyond popular conceptualizations of the past-future relation in amnesia via focussing on reduced future thinking. Investigating both the quantity and quality of future thoughts produced by amnesic patients may lead to developments in understanding the complex nature of future thinking disorders resulting from memory impairments. We highlight the clinical importance of examining the content of future thoughts in amnesic patients, rather than only its quantitative reduction. We propose an explanation of how quantitative and qualitative aspects of future thinking could be affected by amnesia. This could provide a useful approach to understand clinical cases of impaired prospection. Systematic group investigations are required to fully examine our hypothesis. Although the current study utilized typical future thinking measures, these may be limited and we highlight the need to develop clinically relevant measures of prospection. © 2015 The British Psychological Society.

Leveraging Big Data in Pediatric Development Programs: Proceedings From the 2016 American College of Clinical Pharmacology Annual Meeting Symposium.

PubMed

Mulugeta, Lily Yeruk; Yao, Lynne; Mould, Diane; Jacobs, Brian; Florian, Jeffrey; Smith, Brian; Sinha, Vikram; Barrett, Jeffrey S

2018-01-10

This article discusses the use of big data in pediatric drug development. The article covers key topics discussed at the ACCP annual meeting symposium in 2016 including the extent to which big data or real-world data can inform clinical trial design and substitute for efficacy and safety data typically obtained in clinical trials. The current states of use, opportunities, and challenges with the use of big data in future pediatric drug development are discussed. © 2018 American Society for Clinical Pharmacology and Therapeutics.

Bedside to Bench: Integrating Quantitative Clinical Pharmacology and Reverse Translation to Optimize Drug Development.

PubMed

Gibbs, John P; Menon, Rajeev; Kasichayanula, Sreeneeranj

2018-02-01

With so much emphasis on reducing attrition and becoming more efficient in the delivery of healthcare, there are many opportunities to leverage existing clinical data in drug development and to foster the practice of reverse translation. The application of quantitative approaches to convert clinical trial and real-world data to knowledge will continue to drive innovation. Herein we discuss recent examples of reverse translation and consider future opportunities to capture critical clinical knowledge to inform decision-making in drug development. © 2017 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

Clinical skills development in student-run free clinic volunteers: a multi-trait, multi-measure study.

PubMed

Nakamura, Mio; Altshuler, David; Chadwell, Margit; Binienda, Juliann

2014-12-12

At Wayne State University School of Medicine (WSU SOM), the Robert R. Frank Student Run Free Clinic (SRFC) is one place preclinical students can gain clinical experience. There have been no published studies to date measuring the impact of student-run free clinic (SRFC) volunteerism on clinical skills development in preclinical medical students. Surveys were given to first year medical students at WSU SOM at the beginning and end of Year 1 to assess perception of clinical skills, including self-confidence, self-reflection, and professionalism. Scores of the Year 1 Objective Structured Clinical Exam (OSCE) were compared between SRFC volunteers and non-volunteers. There were a total of 206 (68.2%) and 80 (26.5%) survey responses at the beginning and end of Year 1, respectively. Of the 80 students, 31 (38.7%) volunteered at SRFC during Year 1. Statistically significant differences were found between time points in self-confidence (p < 0.001) in both groups. When looking at self-confidence in skills pertaining to SRFC, the difference between groups was statistically significant (p = 0.032) at both time points. A total of 302 students participated in the Year 1 OSCE, 27 (9%) of which were SRFC volunteers. No statistically significant differences were found between groups for mean score (p = 0.888) and established level of rapport (p = 0.394). While this study indicated no significant differences in clinical skills in students who volunteer at the SRFC, it is a first step in attempting to measure clinical skill development outside of the structured medical school setting. The findings lend themselves to development of research designs, clinical surveys, and future studies to measure the impact of clinical volunteer opportunities on clinical skills development in future physicians.

Overview: What's Worked and What Hasn't as a Guide towards Predictive Admissions Tool Development

ERIC Educational Resources Information Center

Siu, Eric; Reiter, Harold I.

2009-01-01

Admissions committees and researchers around the globe have used diligence and imagination to develop and implement various screening measures with the ultimate goal of predicting future clinical and professional performance. What works for predicting future job performance in the human resources world and in most of the academic world may not,…

TH-D-BRC-01: Panel Member

DOE Office of Scientific and Technical Information (OSTI.GOV)

Aydogan, B.

Interest in proton therapy has increased dramatically in the past couple of years, especially in the United States. There certainly is an important place for proton therapy in the arsenal of cancer treatments. Its dosimetric advantage and potential for low toxicity makes it the perfect partner for photons and other cancer treatment modalities. Often there is a belief that the new technology ought to be better but many believe that they should be widely adopted in the clinic only after evidence has shown that they are at least as safe and efficacious as existing technologies, which are often less expensive.more » This is the case for proton radiotherapy. This session being both educational and debate will provide a good review of basics and technological advancement as well as a comprehensive clinical update for both proton and photon therapy. Future technology developments and how they will impact the potential dosimetric advantage of proton therapy will be discussed. Particularly the debate will focus on whether these developments will close or widen the gap between photon and proton therapy. Learning Objectives: To review challenges, limitations, and recent and future developments in proton therapy. To review challenges, limitations, recent and future developments in photon radiotherapy. To review current clinical trials and challenging clinical cases. C. Yu, No company or organization that my presentation mentions provided me with financial support. I am the Founder and CEO of Xcision Medical Systems, LLC. However, my presentation will not mention any product or technology developed by Xcision.« less

TH-D-BRC-02: Panel Member

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hahn, S.

Interest in proton therapy has increased dramatically in the past couple of years, especially in the United States. There certainly is an important place for proton therapy in the arsenal of cancer treatments. Its dosimetric advantage and potential for low toxicity makes it the perfect partner for photons and other cancer treatment modalities. Often there is a belief that the new technology ought to be better but many believe that they should be widely adopted in the clinic only after evidence has shown that they are at least as safe and efficacious as existing technologies, which are often less expensive.more » This is the case for proton radiotherapy. This session being both educational and debate will provide a good review of basics and technological advancement as well as a comprehensive clinical update for both proton and photon therapy. Future technology developments and how they will impact the potential dosimetric advantage of proton therapy will be discussed. Particularly the debate will focus on whether these developments will close or widen the gap between photon and proton therapy. Learning Objectives: To review challenges, limitations, and recent and future developments in proton therapy. To review challenges, limitations, recent and future developments in photon radiotherapy. To review current clinical trials and challenging clinical cases. C. Yu, No company or organization that my presentation mentions provided me with financial support. I am the Founder and CEO of Xcision Medical Systems, LLC. However, my presentation will not mention any product or technology developed by Xcision.« less

TH-D-BRC-04: Panel Member

DOE Office of Scientific and Technical Information (OSTI.GOV)

Yu, C.

Interest in proton therapy has increased dramatically in the past couple of years, especially in the United States. There certainly is an important place for proton therapy in the arsenal of cancer treatments. Its dosimetric advantage and potential for low toxicity makes it the perfect partner for photons and other cancer treatment modalities. Often there is a belief that the new technology ought to be better but many believe that they should be widely adopted in the clinic only after evidence has shown that they are at least as safe and efficacious as existing technologies, which are often less expensive.more » This is the case for proton radiotherapy. This session being both educational and debate will provide a good review of basics and technological advancement as well as a comprehensive clinical update for both proton and photon therapy. Future technology developments and how they will impact the potential dosimetric advantage of proton therapy will be discussed. Particularly the debate will focus on whether these developments will close or widen the gap between photon and proton therapy. Learning Objectives: To review challenges, limitations, and recent and future developments in proton therapy. To review challenges, limitations, recent and future developments in photon radiotherapy. To review current clinical trials and challenging clinical cases. C. Yu, No company or organization that my presentation mentions provided me with financial support. I am the Founder and CEO of Xcision Medical Systems, LLC. However, my presentation will not mention any product or technology developed by Xcision.« less

TH-D-BRC-03: Panel Member

DOE Office of Scientific and Technical Information (OSTI.GOV)

Paganetti, H.

Interest in proton therapy has increased dramatically in the past couple of years, especially in the United States. There certainly is an important place for proton therapy in the arsenal of cancer treatments. Its dosimetric advantage and potential for low toxicity makes it the perfect partner for photons and other cancer treatment modalities. Often there is a belief that the new technology ought to be better but many believe that they should be widely adopted in the clinic only after evidence has shown that they are at least as safe and efficacious as existing technologies, which are often less expensive.more » This is the case for proton radiotherapy. This session being both educational and debate will provide a good review of basics and technological advancement as well as a comprehensive clinical update for both proton and photon therapy. Future technology developments and how they will impact the potential dosimetric advantage of proton therapy will be discussed. Particularly the debate will focus on whether these developments will close or widen the gap between photon and proton therapy. Learning Objectives: To review challenges, limitations, and recent and future developments in proton therapy. To review challenges, limitations, recent and future developments in photon radiotherapy. To review current clinical trials and challenging clinical cases. C. Yu, No company or organization that my presentation mentions provided me with financial support. I am the Founder and CEO of Xcision Medical Systems, LLC. However, my presentation will not mention any product or technology developed by Xcision.« less

Thymoquinone, as an anticancer molecule: from basic research to clinical investigation

PubMed Central

Asaduzzaman Khan, Md.; Tania, Mousumi; Fu, Shangyi; Fu, Junjiang

2017-01-01

Thymoquinone is an anticancer phytochemical commonly found in black cumin. In this review, we discuss the potential of thymoquinone as anticancer molecule, its mechanism of action and future usage in clinical applications. Thymoquinone exhibits anticancer activity via numerous mechanisms of action, specifically by showing selective antioxidant and oxidant activity, interfering with DNA structure, affecting carcinogenic signaling molecules/pathways and immunomodulation. In vitro activity of thymoquinone has been further implicated in animal models of cancer; however, no clinical application has been proven yet. This is the optimum time to focus on clinical trials for developing thymoquinone as a future drug in cancer therapeutics. PMID:28881699

Thymoquinone, as an anticancer molecule: from basic research to clinical investigation.

PubMed

Asaduzzaman Khan, Md; Tania, Mousumi; Fu, Shangyi; Fu, Junjiang

2017-08-01

Thymoquinone is an anticancer phytochemical commonly found in black cumin. In this review, we discuss the potential of thymoquinone as anticancer molecule, its mechanism of action and future usage in clinical applications. Thymoquinone exhibits anticancer activity via numerous mechanisms of action, specifically by showing selective antioxidant and oxidant activity, interfering with DNA structure, affecting carcinogenic signaling molecules/pathways and immunomodulation. In vitro activity of thymoquinone has been further implicated in animal models of cancer; however, no clinical application has been proven yet. This is the optimum time to focus on clinical trials for developing thymoquinone as a future drug in cancer therapeutics.

Severity in irritable bowel syndrome: a Rome Foundation Working Team report.

PubMed

Drossman, Douglas A; Chang, L; Bellamy, N; Gallo-Torres, H E; Lembo, A; Mearin, F; Norton, N J; Whorwell, P

2011-10-01

The concept of severity in irritable bowel syndrome (IBS) is clinically recognized and operative in diagnostic decision making and treatment planning. Yet, there is no consensus on its definition, and there are limited data on the prevalence of severity subgroups, its medical and psychosocial determinants, and its association with other health status measures. The aims of the Rome Foundation Working Team Committee were to summarize current research, to develop a consensus of understanding on this concept, and to make recommendations for its use in research and clinical care. In 2006, a multinational committee of clinical investigators with expertise in IBS and/or psychometric research methods undertook a systematic review of the literature relating to severity in IBS. Owing to limited data, the Foundation commissioned three clinical studies to better characterize the concept of severity in IBS, and summary information and recommendations for future research and clinical care were developed. The main findings were: (i) severity in IBS is defined as a biopsychosocial composite of patient-reported gastrointestinal and extraintestinal symptoms, degree of disability, and illness-related perceptions and behaviors; (ii) both visceral and central nervous system physiological factors affect severity; as severity increases, the central nervous system provides a greater contribution; (iii) severity is related to and influences health-related quality of life and health behaviors and also guides diagnostic and therapeutic clinical decision making; (iv) severity can be subcategorized into clinically meaningful subgroups as mild (∼40%), moderate (∼35%), and severe (∼25%), and this provides a working model for use in future research and clinical care. Future work is required to understand more precisely the factors contributing to severity and to develop a valid patient-reported instrument to measure severity in IBS.

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.

Standards for Clinical Grade Genomic Databases.

PubMed

Yohe, Sophia L; Carter, Alexis B; Pfeifer, John D; Crawford, James M; Cushman-Vokoun, Allison; Caughron, Samuel; Leonard, Debra G B

2015-11-01

Next-generation sequencing performed in a clinical environment must meet clinical standards, which requires reproducibility of all aspects of the testing. Clinical-grade genomic databases (CGGDs) are required to classify a variant and to assist in the professional interpretation of clinical next-generation sequencing. Applying quality laboratory standards to the reference databases used for sequence-variant interpretation presents a new challenge for validation and curation. To define CGGD and the categories of information contained in CGGDs and to frame recommendations for the structure and use of these databases in clinical patient care. Members of the College of American Pathologists Personalized Health Care Committee reviewed the literature and existing state of genomic databases and developed a framework for guiding CGGD development in the future. Clinical-grade genomic databases may provide different types of information. This work group defined 3 layers of information in CGGDs: clinical genomic variant repositories, genomic medical data repositories, and genomic medicine evidence databases. The layers are differentiated by the types of genomic and medical information contained and the utility in assisting with clinical interpretation of genomic variants. Clinical-grade genomic databases must meet specific standards regarding submission, curation, and retrieval of data, as well as the maintenance of privacy and security. These organizing principles for CGGDs should serve as a foundation for future development of specific standards that support the use of such databases for patient care.

'Maternity clinic on the net service' and its introduction into practice: experiences of maternity-care professionals.

PubMed

Kouri, Pirkko; Turunen, Hannele; Palomäki, Tuula

2005-06-01

To describe the experiences of maternity-care professionals using an Internet-based network service, called Net Clinic, and the opportunities and obstacles they encountered in Net Clinic while organising their work and developing their know-how. Qualitative information gathered from semi-structured thematic interviews. Four maternity care units in Eastern Finland (one antenatal ward in a university hospital, one antenatal ward in a central hospital, two maternity clinics in the community). Five midwives, two public health nurses and three doctors. All participants considered adequate privacy protection a prerequisite for development. They anticipated that because of their computer skills, young people would be able to use information and communication technology (ICT) as part of maternity-care services naturally. Managerial support, such as allocation of time and equipment, was extremely important during the introductory phase. The participants were divided into three groups based on their experiences of implementing Net Clinic: (1) 'doubters' did not believe in their own ICT competence and were afraid of using Net Clinic. They also showed resistance to Net Clinic. Doubters wanted versatile and personal guidance in ICT skills; (2) 'accepters' agreed that progress in ICT would inevitably affect their work. Development was considered difficult without awareness of the benefits of ICT, and Net Clinic was expected to increase their workload. Accepters preferred to have one-to-one ICT training; (3) 'future confidents' saw ICT as a useful tool for developing maternity care. They recognised the opportunities implicit in network collaboration and wanted versatile user training in ICT. They wanted successful network service models and were eager to develop them. IMPLICATIONS FOR THE FUTURE: Families will increase their knowledge levels, as those who will be future parents are learning to use public network services at school. The increasing diversity of family structure will be a challenge to maternity care. Changes in maternity services can be accomplished with new e-Working models developed through diversified co-operation and with managerial support. The crucial question will be the attitude of maternity-care professionals towards Internet-based network service in their work.

Simulated Surgery-an exam for our time? Summary of the current status and development of the MRCGP Simulated Surgery module.

PubMed

Hawthorne, Kamila; Denney, Mei Ling; Bewick, Mike; Wakeford, Richard

2006-01-01

WHAT IS ALREADY KNOWN IN THIS AREA • The Simulated Surgery module of the MRCGP examination has been shown to be a valid and reliable assessment of clinical consulting skills. WHAT THIS WORK ADDS • This paper describes the further development of the methodology of the Simulated Surgery; showing the type of data analysis currently used to assure its quality and reliability. The measures taken to tighten up case quality are discussed. SUGGESTIONS FOR FUTURE RESEARCH The future development of clinical skills assessments in general practice is discussed. More work is needed on the effectiveness and reliability of lay assessors in complex integrated clinical cases. New methods to test areas that are difficult to reproduces in a simulated environment (such as acute emergencies and cases with the very young or very old) are also needed.

Integrative tobacco cessation: A survey assessing past quit strategies and future interest.

PubMed

Howerter, Amy; Floden, Lysbeth; Matthews, Eva; Muramoto, Myra L

2016-04-01

Tobacco cessation remains a public health priority. Unassisted quits are most common despite evidence for a combination of guideline-recommended strategies. This paper reports findings from a pilot study designed to assess past quit strategies and tobacco users' receptiveness to using an integrative clinic that offers both conventional and alternative treatments for future cessation attempts. Participants were recruited from a pool of individuals reporting for jury duty. Paper-pencil surveys assessed smoking, past cessation behaviors, and interest in use of the integrative clinic which offers both conventional and alternative treatments. Current and former smokers (n=304) returned surveys. Using multivariate logistic regression, past physiological quit strategies, past behavioral quit strategies, and use of multiple quit strategies increased agreement with interest in future use of an integrative clinic option. Additionally, there is support for the notion that if such a clinic were offered, smokers may be inclined to use this resource for a future quit attempt. An integrative clinic option for tobacco cessation may encourage smokers to try to quit, especially for those who have used varied cessation strategies in the past. Motivating smokers to use a combined approach for tobacco cessation is a potential future direction for tobacco cessation treatment. Developing and testing an integrative approach may support this effort.

Clinical linguistics: its past, present and future.

PubMed

Perkins, Michael R

2011-11-01

Historiography is a growing area of research within the discipline of linguistics, but so far the subfield of clinical linguistics has received virtually no systematic attention. This article attempts to rectify this by tracing the development of the discipline from its pre-scientific days up to the present time. As part of this, I include the results of a survey of articles published in Clinical Linguistics & Phonetics between 1987 and 2008 which shows, for example, a consistent primary focus on phonetics and phonology at the expense of grammar, semantics and pragmatics. I also trace the gradual broadening of the discipline from its roots in structural linguistics to its current reciprocal relationship with speech and language pathology and a range of other academic disciplines. Finally, I consider the scope of clinical linguistic research in 2011 and assess how the discipline seems likely develop in the future.

Current status and future prospects of the development of clinical Pharmacy in China: A SWOT analysis.

PubMed

Rao, Yuefeng; Zhao, Qingwei; Zhang, Xiangyi; Yang, Hongyu; Lou, Yan; Zhang, Xingguo

2016-03-01

In many industrialized countries, clinical pharmacy has developed into a separate discipline and become a vital part of inpatient care in hospitals. However, as compared to many established branches of medicine, clinical pharmacy is still in its infancy, with much room for growth, improvement, and recognition by both the medical community and patients. In this study, a widely-recognized development strategy analysis tool, Strength, Weakness, Opportunity and Threat (SWOT), was used to systematically address several key issues to the development of clinical pharmacy in China. This analysis aims to provide feasible recommendations for the development of clinical pharmacy in China by identifying current problems and growth opportunities. Full development of clinical pharmacy as a mature clinical discipline will help promote the rational use of drugs by both clinicians and patients and lead to enhanced drug efficacy and safety.

[Nursing education in Taiwan: the current situation and prospects for the future].

PubMed

Lu, Meei-Shiow

2004-08-01

Two factors which have a close bearing on nursing education are social and technological change. How nursing education meets social needs and how nursing students are best equipped with professional knowledge, attitudes, and skills in a rapidly changing society have become important issues. The purposes of this paper are to describe the current state of nursing education and to identify problems that need to be solved, including the complexity of the educational system, the quality and quantity of nursing manpower, the degree of compatibility between the aims of education and future social needs, the quality of nursing educators, courses and course delivery, and the clinical competence of nursing graduates. Based on the paradigm shifts of International Medical Care and higher education described by McBride, several suggestions for future educational reform are proposed, including simplifying the educational system, improving the development of both the quality and quantity of nursing manpower, matching educational aims with future social needs, bridging the gap between theory and clinical practice, promoting both instructional and clinical skills among nursing educators and enhancing the ability of graduates to deal with a contingency strain. It is expected that in order to meet the challenges presented by a rapidly changing society, nursing educators will have to develop a mixed role including clinical proficiency, outstanding research skills, and excellent leadership skills.

Community-based dental education: history, current status, and future.

PubMed

Formicola, Allan J; Bailit, Howard L

2012-01-01

This article examines the history, current status, and future direction of community-based dental education (CBDE). The key issues addressed include the reasons that dentistry developed a different clinical education model than the other health professions; how government programs, private medical foundations, and early adopter schools influenced the development of CBDE; the societal and financial factors that are leading more schools to increase the time that senior dental students spend in community programs; the impact of CBDE on school finances and faculty and student perceptions; and the reasons that CBDE is likely to become a core part of the clinical education of all dental graduates.

From a Parkinson's disease expert: Rasagiline and the Future of Therapy

PubMed Central

Lakhan, Shaheen E

2007-01-01

John Finberg is a professor of pharmacology at the Faculty of Medicine, Technion – Israel Institute of Technology, home of Israel's two Nobel laureates. He and his colleague Prof. Moussa Youdim were instrumental in the early clinical development of the anti-Parkinson drug rasagiline, which gained UK- and EU-marketing authorization in 2005 and US FDA approval in 2006. In our interview, Finberg reflects on his clinical research to develop rasagiline as a commercial drug and its proposed pharmacological mechanisms of action. Moreover, he elucidates the current state of anti-Parkinson drug discovery and offers direction for future research. PMID:17617893

Development and future perspectives of behavioral medicine in Japan.

PubMed

Nomura, Shinobu

2016-01-01

Development and Future Perspectives of Behavioral Medicine in Japan The study of the "Type A behavior pattern and myocardial infarction" was one of the main themes in the early stage of Behavioral Medicine. After that, behavior modification came to be widely applied to the treatment of various kinds of chronic diseases, and a general concept of Behavioral Medicine was subsequently formed. The Japanese Society of Behavioral Medicine was established in 1992 and is comprised of researchers in the fields of clinical medicine, social medicine, and psycho-behavioral science. Recently, we devised a core curriculum for behavioral science and behavioral medicine and have published a Japanese version of the "Textbook of Behavioral Medicine" in conformity with it. It is a primer that includes all of the basics and clinical applications of Behavioral Medicine and is edited as a manual that can be utilized in clinical practice. We hope this book will contribute to the development of Behavioral Medicine in Japan, to a more healthy life for our people, and to the improvement of the QOL of our patients. In this paper, I discuss the future perspectives from my personal opinion while looking back on the history of Behavioral Medicine in Japan.

Survey of Irish general practitioners' preferences for continuing professional development.

PubMed

Maher, B; O'Neill, R; Faruqui, A; Bergin, C; Horgan, M; Bennett, D; O'Tuathaigh, C M P

2018-01-01

Doctors' continuing professional development (CPD) training needs are known to be strongly influenced by national and local contextual characteristics. Given the changing national demographic profile and government-mandated changes to primary care health care provision, this study aimed to investigate Irish General Practitioners' (GPs) perceptions of, and preferences for, current and future CPD programmes. A cross-sectional questionnaire, using closed- and open-ended questions, was administered to Irish GPs, focusing on training needs analysis; CPD course content; preferred format and the learning environment. The response rate was 719/1000 (71.9%). GPs identified doctor-patient communication as the most important and best-performed GP skill. Discrepancies between perceived importance (high) and current performance (low) emerged for time/workload management, practice finance and business skills. GPs identified clinically-relevant primary care topics and non-clinical topics (stress management, business skills, practice management) as preferences for future CPD. Flexible methods for CPD delivery were important. Gender and practice location (urban or rural) significantly influenced CPD participation and future course preference. The increasing diversity of services offered in the Irish primary care setting, in both clinical and non-clinical areas, should be tailored based to include GP practice location and structure.

Developing evidence-based physical therapy clinical practice guidelines.

PubMed

Kaplan, Sandra L; Coulter, Colleen; Fetters, Linda

2013-01-01

Recommended strategies for developing evidence-based clinical practice guidelines (CPGs) are provided. The intent is that future CPGs developed with the support of the Section on Pediatrics of the American Physical Therapy Association would consistently follow similar developmental processes to yield consistent quality and presentation. Steps in the process of developing CPGs are outlined and resources are provided to assist CPG developers in carrying out their task. These recommended processes may also be useful to CPG developers representing organizations with similar structures, objectives, and resources.

[Effects of practical training to increase motivation for learning and related factors].

PubMed

Yamaguchi, Takumi; Akiyama, Shinji; Sagara, Hidenori; Tanaka, Akihiro; Miyauchi, Yoshirou; Araki, Hiroaki; Shibata, Kazuhiko; Izushi, Fumio; Namba, Hiroyuki

2014-01-01

Under the six-year pharmaceutical education system that was initiated in April 2006, students who had completed the course in March 2012 became the first graduates. The six-year system encourages students to develop a well-rounded personality, a deep sense of ethics, knowledge required for health care professionals, abilities to identify and solve problems, and practical skills required in clinical settings, as well as basic knowledge and skills. Under the new education system based on the "pharmaceutical education model core curriculums" and "practical training model core curriculums", general pharmaceutical education is implemented in each college, and five-month practical training is conducted in clinical settings. Clinical tasks experienced by students for the first time are expected to significantly influence their motivation to learn and future prospects. In the present survey research, students who had completed practical training evaluated the training program, and correspondence and logistic regression analyses of the results were conducted to examine the future effects and influences of the training on the students. The results suggest that the students viewed the practical training program positively. In addition, clinical experience during the training sessions not only influenced their decisions on future careers, but also significantly increased their motivation to learn. Furthermore, their motivation for learning was increased most by the enthusiasm of pharmacists who advised them in clinical settings, rather than the training program itself. To improve pharmaceutical clinical learning, it is important to develop teaching and working environments for pharmacists in charge of advising students in clinical training.

TH-D-BRC-00: Educational Point Counter/Point: Has Photon RT Hit the Limits?

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

Interest in proton therapy has increased dramatically in the past couple of years, especially in the United States. There certainly is an important place for proton therapy in the arsenal of cancer treatments. Its dosimetric advantage and potential for low toxicity makes it the perfect partner for photons and other cancer treatment modalities. Often there is a belief that the new technology ought to be better but many believe that they should be widely adopted in the clinic only after evidence has shown that they are at least as safe and efficacious as existing technologies, which are often less expensive.more » This is the case for proton radiotherapy. This session being both educational and debate will provide a good review of basics and technological advancement as well as a comprehensive clinical update for both proton and photon therapy. Future technology developments and how they will impact the potential dosimetric advantage of proton therapy will be discussed. Particularly the debate will focus on whether these developments will close or widen the gap between photon and proton therapy. Learning Objectives: To review challenges, limitations, and recent and future developments in proton therapy. To review challenges, limitations, recent and future developments in photon radiotherapy. To review current clinical trials and challenging clinical cases. C. Yu, No company or organization that my presentation mentions provided me with financial support. I am the Founder and CEO of Xcision Medical Systems, LLC. However, my presentation will not mention any product or technology developed by Xcision.« less

76 FR 22404 - Analgesic Clinical Trials Innovation, Opportunities, and Networks (ACTION) Initiative

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-21

..., but not limited to, specific research designs and methodological features so as to inform the future... clinical trials. Many experts in analgesic drug development believe that it is the design of the clinical trials that is at fault in this situation and that better trial designs will yield more successful...

Electronic decision protocols for ART patient triaging to expand access to HIV treatment in South Africa: a cross sectional study for development and validation.

PubMed

Mitchell, Marc; Hedt, Bethany L; Eshun-Wilson, Ingrid; Fraser, Hamish; John, Melanie-Anne; Menezes, Colin; Grobusch, Martin P; Jackson, Jonathan; Taljaard, Jantjie; Lesh, Neal

2012-03-01

The shortage of doctors and nurses, along with future expansion into rural clinics, will require that the majority of clinic visits by HIV infected patients on antiretroviral therapy (ART) are managed by non-doctors. The goal of this study was to develop and evaluate a screening protocol to determine which patients needed a full clinical assessment and which patients were stable enough to receive their medications without a doctor's consultation. For this study, we developed an electronic, handheld tool to guide non-physician counselors through screening questions. Patients visiting two ART clinics in South Africa for routine follow-up visits between March 2007 and April 2008 were included in our study. Each patient was screened by non-physician counselors using the handheld device and then received a full clinical assessment. Clinicians' report on whether full clinical assessment had been necessary was used as the gold standard for determining "required referral". Observations were randomly divided into two datasets--989 for developing a referral protocol and 200 for validating protocol performance. A third of patients had at least one physical complaint, and 16% had five or more physical complaints. 38% of patients required referral for full clinical assessment. We identify a subset of questions which are 87% sensitive and 47% specific for recommended patient referral. The final screening protocol is highly sensitive and could reduce burden on ART clinicians by 30%. The uptake and acceptance of the handheld tool to support implementation of the protocol was high. Further examination of the data reveals several important questions to include in future referral algorithms to improve sensitivity and specificity. Based on these results, we identify a refined algorithm to explore in future evaluations. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Impact of reconstructive transplantation on the future of plastic and reconstructive surgery.

PubMed

Siemionow, Maria

2012-10-01

This article summarizes the current knowledge on the new developing field of reconstructive transplantation. A brief outline of vascularized composite allografts (VCA) such as human hand, face, larynx, and abdominal wall transplants is provided. The clinical applications and indications for these new reconstructive transplantation procedures are outlined. The advantages, disadvantages, and complications and concerns surrounding clinical VCA are discussed. Finally, the impact of reconstructive transplantation on the future of plastic and reconstructive surgery is presented. Copyright © 2012 Elsevier Inc. All rights reserved.

Developing technology for surgery in the UK: a multidisciplinary meeting of engineers and surgeons.

PubMed

Taylor, G W

2007-03-01

There is an increasing necessity for surgeons and engineers to work together in order to target future technological developments at clinical need and cost-effectiveness. This is a report of two linked meetings with these objectives, held at the Institute of Mechanical Engineers, London, UK. The two meetings were organized by the same faculty members and held on consecutive days. Delegates included surgeons, academic mechanical engineers, researchers and industrial representatives. The programme was made up of varied presentations by surgeons and engineers as well as open discussion of the topics covered. Delegates were updated on the current state of surgical robotics in the UK in four surgical specialties; urology, neurosurgery, orthopaedics and ENT. This included clinical and experimental evidence, together with discussion of future advances. Minimally invasive surgery, real-time imaging and the development of more compact and cost effective surgical robots were identified as key areas for future research. Copyright 2006 John Wiley & Sons, Ltd.

Clinical Space Medicine Products as Developed by the Medical Operations Support Team (MOST)

NASA Technical Reports Server (NTRS)

Polk, James D.; Doerr, Harold K.; Hurst, Victor W., IV; Schmid, Josef

2007-01-01

Medical Operations Support Team (MOST) is introducing/integrating teaching practices associated with high fidelity human patient simulation into the NASA culture, in particular, into medical training sessions and medical procedure evaluations. Current/Future Products iclude: a) Development of Sub-optimal Airway Protocols for the International Space Station (ISS) using the ILMA; b) Clinical Core Competency Training for NASA Flight Surgeons (FS); c) Post-Soyuz Landing Clinical Training for NASA FS; d) Experimental Integrated Training for Astronaut Crew Medical Officers and NASA FS; and e) Private Clinical Refresher Training.

Template protocol for clinical trials investigating vaccines—Focus on safety elements☆

PubMed Central

Bonhoeffer, Jan; Imoukhuede, Egeruan B.; Aldrovandi, Grace; Bachtiar, Novilia S.; Chan, Eng-Soon; Chang, Soju; Chen, Robert T.; Fernandopulle, Rohini; Goldenthal, Karen L.; Heffelfinger, James D.; Hossain, Shah; Jevaji, Indira; Khamesipour, Ali; Kochhar, Sonali; Makhene, Mamodikoe; Malkin, Elissa; Nalin, David; Prevots, Rebecca; Ramasamy, Ranjan; Sellers, Sarah; Vekemans, Johan; Walker, Kenneth B.; Wilson, Pam; Wong, Virginia; Zaman, Khalequz; Heininger, Ulrich

2015-01-01

This document is intended as a guide to the protocol development for trials of prophylactic vaccines. The template may serve phases I–IV clinical trials protocol development to include safety relevant information as required by the regulatory authorities and as deemed useful by the investigators. This document may also be helpful for future site strengthening efforts. PMID:23499603

Return to contingency: developing a coherent strategy for future R2E/R3 land medical capabilities.

PubMed

Ingram, Mike; Mahan, J

2015-03-01

Key to deploying forces in the future will be the provision of a rapidly deployable Deployed Hospital Capability. Developing this capability has been the focus of 34 Field Hospital and 2nd Medical Brigade over the last 18 months and this paper describes a personal account of this development work to date. Future contingent Deployed Hospital Capability must meet the requirements of Defence; that is to be rapidly deployable delivering a hospital standard of care. The excellence seen in clinical delivery on recent operations is intensive; in personnel, equipment, infrastructure and sustainment. The challenge in developing a coherent capability has been in balancing the clinical capability and capacity against strategic load in light of recent advances in battlefield medicine. This paper explores the issues encountered and solutions found to date in reconstituting a Very High Readiness Deployed Hospital Capability. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

New evidence-based adaptive clinical trial methods for optimally integrating predictive biomarkers into oncology clinical development programs

PubMed Central

Beckman, Robert A.; Chen, Cong

2013-01-01

Predictive biomarkers are important to the future of oncology; they can be used to identify patient populations who will benefit from therapy, increase the value of cancer medicines, and decrease the size and cost of clinical trials while increasing their chance of success. But predictive biomarkers do not always work. When unsuccessful, they add cost, complexity, and time to drug development. This perspective describes phases 2 and 3 development methods that efficiently and adaptively check the ability of a biomarker to predict clinical outcomes. In the end, the biomarker is emphasized to the extent that it can actually predict. PMID:23489587

NCI Director Norman Sharpless’s ASCO 2018 Remarks

Cancer.gov

In this video, NCI Director Dr. Norman E. Sharpless discusses the future of cancer research at the 2018 American Society of Clinical Oncology (ASCO) annual meeting in Chicago. Learn more about his focus on basic science, workforce development, big data, and clinical trials.

Recommendations for the Integration of Genomics into Clinical Practice

PubMed Central

Bowdin, Sarah; Gilbert, Adel; Bedoukian, Emma; Carew, Christopher; Adam, Margaret P; Belmont, John; Bernhardt, Barbara; Biesecker, Leslie; Bjornsson, Hans T.; Blitzer, Miriam; D’Alessandro, Lisa C. A.; Deardorff, Matthew A.; Demmer, Laurie; Elliott, Alison; Feldman, Gerald L.; Glass, Ian A.; Herman, Gail; Hindorff, Lucia; Hisama, Fuki; Hudgins, Louanne; Innes, A. Micheil; Jackson, Laird; Jarvik, Gail; Kim, Raymond; Korf, Bruce; Ledbetter, David H.; Li, Mindy; Liston, Eriskay; Marshall, Christian; Medne, Livija; Meyn, M. Stephen; Monfared, Nasim; Morton, Cynthia; Mulvihill, John J.; Plon, Sharon E.; Rehm, Heidi; Roberts, Amy; Shuman, Cheryl; Spinner, Nancy B.; Stavropoulos, D. James; Valverde, Kathleen; Waggoner, Darrel J.; Wilkens, Alisha; Cohn, Ronald D.; Krantz, Ian D.

2017-01-01

The introduction of diagnostic clinical genome and exome sequencing (CGES) is changing the scope of practice for clinical geneticists. Many large institutions are making a significant investment in infrastructure and technology, allowing clinicians to access CGES especially as health care coverage begins to extend to clinically indicated genomic sequencing-based tests. Translating and realizing the comprehensive clinical benefits of genomic medicine remains a key challenge for the current and future care of patients. With the increasing application of CGES, it is necessary for geneticists and other health care providers to understand its benefits and limitations, in order to interpret the clinical relevance of genomic variants identified in the context of health and disease. Establishing new, collaborative working relationships with specialists across diverse disciplines (e.g., clinicians, laboratorians, bioinformaticians) will undoubtedly be key attributes of the future practice of clinical genetics and may serve as an example for other specialties in medicine. These new skills and relationships will also inform the development of the future model of clinical genetics training curricula. To address the evolving role of the clinical geneticist in the rapidly changing climate of genomic medicine, two Clinical Genetics Think Tank meetings were held which brought together physicians, laboratorians, scientists, genetic counselors, trainees and patients with experience in clinical genetics, genetic diagnostics, and genetics education. This paper provides recommendations that will guide the integration of genomics into clinical practice. PMID:27171546

What can HIV vaccine trials teach us about future HIV vaccine dissemination?

PubMed Central

Newman, Peter A.; Duan, Naihua; Kakinami, Lisa; Roberts, Kathleen

2008-01-01

Summary This investigation explored commonalities and differences in barriers and motivators to HIV vaccine trial participation and acceptability of future U.S. Food and Drug Administration (FDA)-approved HIV vaccines in order to identify implications of clinical trials for future HIV vaccine dissemination. Fifteen focus groups were conducted with 157 predominately ethnic minority and low income participants recruited using venue-based sampling in Los Angeles. Data were analyzed using narrative thematic analysis. Barriers and motivators in common across willingness to participate (WTP) in HIV vaccine trials and future HIV vaccine acceptability (e.g., concerns about vaccine-induced infection, false-positives, side effects, efficacy, mistrust and stigma) suggest clinical trials present significant opportunities to develop and evaluate empirically based interventions to support future HIV vaccine dissemination. Barriers specific to HIV vaccine acceptability (e.g., concerns about duration of protection, cross-clade protection, cost and access) also indicate the need for formative research focused specifically on future dissemination. Protection motivation, common to WTP and acceptability, highlights the need to provide and evaluate prevention counseling and education in clinical trials, which may form the basis of evidence-informed preventive interventions to be launched in tandem with dissemination of partial efficacy HIV vaccines. PMID:18420313

Transforming Medical Assessment: Integrating Uncertainty Into the Evaluation of Clinical Reasoning in Medical Education.

PubMed

Cooke, Suzette; Lemay, Jean-Francois

2017-06-01

In an age where practicing physicians have access to an overwhelming volume of clinical information and are faced with increasingly complex medical decisions, the ability to execute sound clinical reasoning is essential to optimal patient care. The authors propose two concepts that are philosophically paramount to the future assessment of clinical reasoning in medicine: assessment in the context of "uncertainty" (when, despite all of the information that is available, there is still significant doubt as to the best diagnosis, investigation, or treatment), and acknowledging that it is entirely possible (and reasonable) to have more than "one correct answer." The purpose of this article is to highlight key elements related to these two core concepts and discuss genuine barriers that currently exist on the pathway to creating such assessments. These include acknowledging situations of uncertainty, creating clear frameworks that define progressive levels of clinical reasoning skills, providing validity evidence to increase the defensibility of such assessments, considering the comparative feasibility with other forms of assessment, and developing strategies to evaluate the impact of these assessment methods on future learning and practice. The authors recommend that concerted efforts be directed toward these key areas to help advance the field of clinical reasoning assessment, improve the clinical care decisions made by current and future physicians, and have positive outcomes for patients. It is anticipated that these and subsequent efforts will aid in reaching the goal of making future assessment in medical education more representative of current-day clinical reasoning and decision making.

Innovative regenerative medicines in the EU: a better future in evidence?

PubMed

Corbett, Mark S; Webster, Andrew; Hawkins, Robert; Woolacott, Nerys

2017-03-08

Despite a steady stream of headlines suggesting they will transform the future of healthcare, high-tech regenerative medicines have, to date, been quite inaccessible to patients, with only eight having been granted an EU marketing licence in the last 7 years. Here, we outline some of the historical reasons for this paucity of licensed innovative regenerative medicines. We discuss the challenges to be overcome to expedite the development of this complex and rapidly changing area of medicine, together with possible reasons to be more optimistic for the future. Several factors have contributed to the scarcity of cutting-edge regenerative medicines in clinical practice. These include the great expense and difficulties involved in planning how individual therapies will be developed, manufactured to commercial levels and ultimately successfully delivered to patients. Specific challenges also exist when evaluating the safety, efficacy and cost-effectiveness of these therapies. Furthermore, many treatments are used without a licence from the European Medicines Agency, under "Hospital Exemption" from the EC legislation. For products which are licensed, alternative financing approaches by healthcare providers may be needed, since many therapies will have significant up-front costs but uncertain benefits and harms in the long-term. However, increasing political interest and more flexible mechanisms for licensing and financing of therapies are now evident; these could be key to the future growth and development of regenerative medicine in clinical practice. Recent developments in regulatory processes, coupled with increasing political interest, may offer some hope for improvements to the long and often difficult routes from laboratory to marketplace for leading-edge cell or tissue therapies. Collaboration between publicly-funded researchers and the pharmaceutical industry could be key to the future development of regenerative medicine in clinical practice; such collaborations might also offer a possible antidote to the innovation crisis in the pharmaceutical industry.

CIS: where are we going and what should we demand from industry?

PubMed

Frassica, Joseph J

2004-12-01

Clinical information systems designed for use in the critical care setting have been available for many years. Yet, despite significant evidence that these systems contribute to patient safety and efficiency of care, they have not achieved widespread use. This paper examines some of the factors responsible for the slow growth in use of clinical information systems in the intensive care unit. We further examine the elements that will be necessary to support widespread adoption of future clinical information systems. We give an outline of functionalities, processes, and standards that users will demand from industry as they develop the information systems of the future.

A Time for Reflection: Should We Reconsider the Direct Supervision Standard in Clinical Education?

ERIC Educational Resources Information Center

Mazerolle, Stephanie M.; Bowman, Thomas G.

2017-01-01

Context: Educational reform is occurring again in athletic training. The profession, at this time, should reflect on the structure of clinical education, particularly with direct supervision. Clinical education plays a critical role in the development of future practitioners and should provide students with a chance to gain autonomous experience,…

Developing professional status: an investigation into the working patterns, working relationships and vision for the future of UK clinical dental technicians.

PubMed

Leyssen, W; Clark, R K F; Gallagher, J E; Radford, D R

2013-01-01

To investigate the working patterns and patient base of registered clinical dental technicians (CDTs); their relationships with dentists and other professionals in the dental team; their willingness to work within the NHS and their expectations for the future as a new professional group. Face-to-face qualitative interviews of registered CDTs, selected because of their geographic representation and mode of working, informed the development of a postal questionnaire survey of all early registrants with the General Dental Council (GDC). The majority of CDTs reported working part-time, often combining clinical practice with their role as a dental technician. They reported both positive and negative working relationships with dentists and dental technicians, demonstrating collaboration and/or competition depending on whether the scope of CDTs was respected and patient care was shared or lost. CDTs role in the NHS was limited because they did not have the status of becoming a recognised provider of dental care. There was a desire to expand their scope of practice in future. CDTs are embracing their new status as an occupational group within dentistry. Core features of becoming a professional group were exhibited including the importance of social and financial status and the need to negotiate their current and future roles in the healthcare system.

Occupational rehabilitation in Hong Kong: current status and future needs.

PubMed

Kwok, H K H; Szeto, G P Y; Cheng, A S K; Siu, H; Chan, C C H

2011-03-01

This paper reviews the development of occupational rehabilitation in Hong Kong, both in terms of the science as well as the service for injured workers. Besides, it also reviews the existing Employees' Compensation Ordinance for work injury to illustrate how the policy could influence the success and development of the discipline. Five experienced occupational rehabilitation providers, including 1 occupational medicine specialist, 3 occupational therapists, and 1 physiotherapist critically reviewed the past and current development of occupational rehabilitation in Hong Kong as well as the local contextual factors, which could influence its future development. Since the enactment of the Employees' Compensation Ordinance in the 1950s, there have been progressive improvements in the field of occupational rehabilitation in Hong Kong. Services in the early years were mostly based on the biomedical model, where doctors and patients tended to focus on clinical symptoms and physical pathology when making clinical decisions. Since then, remarkable academic achievements have been made in the field locally, from the validation of clinical instruments for assessment of work capacity, assessment of employment readiness to the evaluation of efficacy of interventional programs for injured workers focusing on work related outcomes. However, there has been a relatively lack of progress in the development of related policies and implementation of related programs for occupational rehabilitation. There is no built in linkage between rehabilitation, compensation and prevention in the current system in Hong Kong, and there is no rehabilitation policy specific to those workers with occupational diseases and injuries. There are still deficiencies in the development and provision of occupational rehabilitation services in Hong Kong. Incorporation of requirements for occupational rehabilitation at the legislation and policy levels should be seriously considered in the future. Besides, the development of the Occupational Medicine subspecialty in the public hospital system in Hong Kong is considered a facilitator to the future development of occupational rehabilitation in Hong Kong.

Radioprotective Agents: Strategies and Translational Advances.

PubMed

Kamran, Mohammad Zahid; Ranjan, Atul; Kaur, Navrinder; Sur, Souvik; Tandon, Vibha

2016-05-01

Radioprotectors are agents required to protect biological system exposed to radiation, either naturally or through radiation leakage, and they protect normal cells from radiation injury in cancer patients undergoing radiotherapy. It is imperative to study radioprotectors and their mechanism of action comprehensively, looking at their potential therapeutic applications. This review intimately chronicles the rich intellectual, pharmacological story of natural and synthetic radioprotectors. A continuous effort is going on by researchers to develop clinically promising radioprotective agents. In this article, for the first time we have discussed the impact of radioprotectors on different signaling pathways in cells, which will create a basis for scientific community working in this area to develop novel molecules with better therapeutic efficacy. The bright future of exceptionally noncytotoxic derivatives of bisbenzimidazoles is also described as radiomodulators. Amifostine, an effective radioprotectant, has been approved by the FDA for limited clinical use. However, due to its adverse side effects, it is not routinely used clinically. Recently, CBLB502 and several analog of a peptide are under clinical trial and showed high success against radiotherapy in cancer. This article reviews the different types of radioprotective agents with emphasis on the strategies for the development of novel radioprotectors for drug development. In addition, direction for future strategies relevant to the development of radioprotectors is also addressed. © 2016 Wiley Periodicals, Inc.

More than just teaching procedural skills: How RN clinical tutors perceive they contribute to medical students' professional identity development.

PubMed

McLean, Michelle; Johnson, Patricia; Sargeant, Sally; Green, Patricia

2015-01-01

On their journey to "becoming" doctors, medical students encounter a range of health professionals who contribute to their socialisation into clinical practice. Amongst these individuals are registered nurses (RNs) in clinical practice who are often employed by medical schools as clinical tutors. These RNs will encounter medical students on campus and later in the clinical setting. This qualitative study explored RNs' perceptions of their contribution to medical students' developing professional identities in order to provide a greater understanding of this process and ultimately inform future curriculum. This qualitative study took place in 2012 at one Australian medical school as part of a broader study exploring medical students' professional identity development from the perspectives of their teachers and trainers. Eight of the nine RNs involved in teaching procedural skills were interviewed. Recorded interviews were transcribed verbatim. Data were analysed inductively by the research team. Two major themes emerged: RNs as change agents and RNs as facilitators of medical students' transition to the clinical environment. RNs as change agents related to their role modelling good practice, being patient-centred, and by emphasising factors contributing to good teamwork such as recognising and respecting individual professional roles. They facilitated students' transition to the clinical environment often through personal narratives, by offering advice on how to behave and work with members of the healthcare team, and by being a point of contact in the hospital. Based on their descriptions of how they role modelled good practice and how they facilitated students' transition to clinical practice, we believe that RN clinical tutors do have the experience and expertise in clinical practice and a professional approach to patients to contribute to medical students' developing professional identities as future doctors.

Medical service plans in academic medical centers.

PubMed

Siegel, B

1978-10-01

Medical service plans are of major importance to academic medical centers and are becoming increasingly so each year as evidenced by growing dependence of medical schools on resulting funds. How these funds are generated and used varies among schools. The procedures may affect the governance of the institution, modifying the authority of the central administration or the clinical departments. Recent developments in federal legislation, such as health maintenance organizations and amendments (Section 227) to the Social Security Act, and the future development of national health insurance will certainly have an effect on how academic medical centers organize their clinical activities. How successfully various medical schools deal with the dynamic problem may well determine their future survival.

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

PubMed

Chi, Donald L

2017-07-01

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

Evidence-based medicine in the treatment of peritoneal carcinomatosis: Past, present, and future.

PubMed

Nissan, Aviram; Stojadinovic, Alexander; Garofalo, Alfredo; Esquivel, Jesus; Piso, Pompiliu

2009-09-15

The current treatment of peritoneal surface malignancies (PSMs) is moving from a nihilistic approach, into a combined modality approach offering selected patients long-term survival. As primary PSM are rare, extrapolation of data from clinical trials of related disease is necessary to develop treatment guidelines. Secondary PSM are more common, and therefore, treatment guidelines should be developed based on prospective clinical trials. We reviewed the published and ongoing clinical trials studying the treatment of PSM. (c) 2009 Wiley-Liss, Inc.

Stents for colorectal obstruction: Past, present, and future

PubMed Central

Kim, Eui Joo; Kim, Yoon Jae

2016-01-01

Since the development of uncovered self-expanding metal stents (SEMS) in the 1990s, endoscopic stents have evolved dramatically. Application of new materials and new designs has expanded the indications for enteral SEMS. At present, enteral stents are considered the first-line modality for palliative care, and numerous types of enteral stents are under development for extended clinical usage, beyond a merely palliative purpose. Herein, we will discuss the current status and the future development of lower enteral stents. PMID:26811630

Applications for detection of acute kidney injury using electronic medical records and clinical information systems: workgroup statements from the 15(th) ADQI Consensus Conference.

PubMed

James, Matthew T; Hobson, Charles E; Darmon, Michael; Mohan, Sumit; Hudson, Darren; Goldstein, Stuart L; Ronco, Claudio; Kellum, John A; Bagshaw, Sean M

2016-01-01

Electronic medical records and clinical information systems are increasingly used in hospitals and can be leveraged to improve recognition and care for acute kidney injury. This Acute Dialysis Quality Initiative (ADQI) workgroup was convened to develop consensus around principles for the design of automated AKI detection systems to produce real-time AKI alerts using electronic systems. AKI alerts were recognized by the workgroup as an opportunity to prompt earlier clinical evaluation, further testing and ultimately intervention, rather than as a diagnostic label. Workgroup members agreed with designing AKI alert systems to align with the existing KDIGO classification system, but recommended future work to further refine the appropriateness of AKI alerts and to link these alerts to actionable recommendations for AKI care. The consensus statements developed in this review can be used as a roadmap for development of future electronic applications for automated detection and reporting of AKI.

Contemporary challenges for specialist nursing in interstitial lung disease

PubMed Central

Russell, Anne Marie; Olive, Sandra; Lines, Sarah; Murphy, Anna; Hocking, Julie; Newell, Karen; Morris, Helen; Harris, Emma; Dixon, Catherine; Agnew, Sarah; Burge, Geraldine

2018-01-01

The role of clinical nurse specialists (CNSs) in interstitial lung disease (ILD) is evolving in response to clinical guidelines and the growth of clinical research. The role is well established in the UK, although more ILD posts are needed to ensure supply meets clinical demand. This phenomenon is also happening across Europe. An appreciation of the similarities and differences between CNS and advanced nurse practitioners is important given the challenges in defining, developing and supporting this nursing specialisation. Globally, different models exist. In some countries charitable organisations take a leading role in supporting patients. Many European centres look to the National Institute for Health and Care Excellence guidelines and quality standards as a template to develop and evaluate the role of the ILD CNS. We present a UK perspective in the context of a government subsidised healthcare system to promote professional discussion and debate regarding the future of nursing practice in the ILD specialty. Key points ILDs are often complex and associated with significant mortality, morbidity and co-morbid conditions that require a technical healthcare skill set There is worldwide shortage of nurses, low retention rates and retirement of many skilled nurses Collaboration across the ILD interdisciplinary community is needed to safeguard the future of our professions and high-quality patient care The ILD interdisciplinary and nurse network has identified key priorities to help secure the future of the ILD clinical and academic nurse specialism Educational aims To explain the similarities and differences between clinical nurse specialists (CNSs) and advanced nurse practitioners (ANPs) in the context of ILD specialism To review contemporary nursing specialism in the UK’s government subsidised healthcare system To stimulate discussion and debate across the European/international respiratory community regarding the clinical and academic development of the ILD CNS To identify key priorities that will support collaboration across the ILD interdisciplinary workforce in clinical practice and research PMID:29515666

Contemporary challenges for specialist nursing in interstitial lung disease.

PubMed

Russell, Anne Marie; Olive, Sandra; Lines, Sarah; Murphy, Anna; Hocking, Julie; Newell, Karen; Morris, Helen; Harris, Emma; Dixon, Catherine; Agnew, Sarah; Burge, Geraldine

2018-03-01

The role of clinical nurse specialists (CNSs) in interstitial lung disease (ILD) is evolving in response to clinical guidelines and the growth of clinical research. The role is well established in the UK, although more ILD posts are needed to ensure supply meets clinical demand. This phenomenon is also happening across Europe. An appreciation of the similarities and differences between CNS and advanced nurse practitioners is important given the challenges in defining, developing and supporting this nursing specialisation. Globally, different models exist. In some countries charitable organisations take a leading role in supporting patients. Many European centres look to the National Institute for Health and Care Excellence guidelines and quality standards as a template to develop and evaluate the role of the ILD CNS. We present a UK perspective in the context of a government subsidised healthcare system to promote professional discussion and debate regarding the future of nursing practice in the ILD specialty. ILDs are often complex and associated with significant mortality, morbidity and co-morbid conditions that require a technical healthcare skill setThere is worldwide shortage of nurses, low retention rates and retirement of many skilled nursesCollaboration across the ILD interdisciplinary community is needed to safeguard the future of our professions and high-quality patient careThe ILD interdisciplinary and nurse network has identified key priorities to help secure the future of the ILD clinical and academic nurse specialism. To explain the similarities and differences between clinical nurse specialists (CNSs) and advanced nurse practitioners (ANPs) in the context of ILD specialismTo review contemporary nursing specialism in the UK's government subsidised healthcare systemTo stimulate discussion and debate across the European/international respiratory community regarding the clinical and academic development of the ILD CNSTo identify key priorities that will support collaboration across the ILD interdisciplinary workforce in clinical practice and research.

Design principles for simulation games for learning clinical reasoning: A design-based research approach.

PubMed

Koivisto, J-M; Haavisto, E; Niemi, H; Haho, P; Nylund, S; Multisilta, J

2018-01-01

Nurses sometimes lack the competence needed for recognising deterioration in patient conditions and this is often due to poor clinical reasoning. There is a need to develop new possibilities for learning this crucial competence area. In addition, educators need to be future oriented; they need to be able to design and adopt new pedagogical innovations. The purpose of the study is to describe the development process and to generate principles for the design of nursing simulation games. A design-based research methodology is applied in this study. Iterative cycles of analysis, design, development, testing and refinement were conducted via collaboration among researchers, educators, students, and game designers. The study facilitated the generation of reusable design principles for simulation games to guide future designers when designing and developing simulation games for learning clinical reasoning. This study makes a major contribution to research on simulation game development in the field of nursing education. The results of this study provide important insights into the significance of involving nurse educators in the design and development process of educational simulation games for the purpose of nursing education. Copyright © 2017 Elsevier Ltd. All rights reserved.

Clinical leadership for high-quality care: developing future ward leaders.

PubMed

Enterkin, Judith; Robb, Elizabeth; McLaren, Susan

2013-03-01

This paper reports upon the development, delivery and evaluation of a leadership programme for aspiring Ward Leaders in one National Health Service Trust in England. The ward sister role is fundamental to quality patient care and clinical leadership, however the role is increasingly difficult to recruit to. A lack of formal preparation and skills development for the role has been widely acknowledged. An evaluation of a programme of education for leadership. Three cohorts (n = 60) completed the programme. Semi-structured questionnaires were completed by participants (n = 36: 60%) at the conclusion of the programme. Qualitative data from questionnaires was analysed using a thematic approach. Participants reported increased political, organizational and self-awareness, increased confidence, feelings of empowerment and the ability to empower others. Opportunities for networking with peers were valued within the action learning approach. For some participants, career intentions were clarified through reflection. The majority of participants had benefited from the leadership programme and valued this development as an empowering preparation for future careers. Investment in leadership preparation for future ward sister roles is strongly recommended as part of a strategy designed to enhance quality improvement, career path development, workforce empowerment and retention. © 2012 Blackwell Publishing Ltd.

Experience with the Implementation of Clinical Pharmacy Services and Processes in a University Hospital in Belgium.

PubMed

Somers, Annemie; Claus, Barbara; Vandewoude, Koen; Petrovic, Mirko

2016-03-01

This article summarizes the experience with the development of clinical pharmacy services in the Ghent University Hospital in Belgium. Implementation of clinical pharmacy services in Belgian hospitals has not been evident because these activities were initially not structurally financed. The aim is to describe the strengths and weaknesses of the clinical pharmacy development process, and the milestones that enhanced the progress. Furthermore, the organisation of clinical pharmacy in the Ghent University Hospital is explained, including back- and front-office activities, seamless pharmaceutical care and medication safety improvement. Some working methods, procedures and tools are explained for different clinical pharmacy services. In particular, the clinical pharmacy projects for geriatric patients as well as the preparation of clinical pharmacy services for the accreditation process are explained. We also reflect on the organisation model and the future development of clinical pharmacy, taking into consideration facilitators and potential barriers.

Template protocol for clinical trials investigating vaccines--focus on safety elements.

PubMed

Bonhoeffer, Jan; Imoukhuede, Egeruan B; Aldrovandi, Grace; Bachtiar, Novilia S; Chan, Eng-Soon; Chang, Soju; Chen, Robert T; Fernandopulle, Rohini; Goldenthal, Karen L; Heffelfinger, James D; Hossain, Shah; Jevaji, Indira; Khamesipour, Ali; Kochhar, Sonali; Makhene, Mamodikoe; Malkin, Elissa; Nalin, David; Prevots, Rebecca; Ramasamy, Ranjan; Sellers, Sarah; Vekemans, Johan; Walker, Kenneth B; Wilson, Pam; Wong, Virginia; Zaman, Khalequz; Heininger, Ulrich

2013-11-12

This document is intended as a guide to the protocol development for trials of prophylactic vaccines. The template may serve phases I-IV clinical trials protocol development to include safety relevant information as required by the regulatory authorities and as deemed useful by the investigators. This document may also be helpful for future site strengthening efforts. Copyright © 2013 Elsevier Ltd. All rights reserved.

Qualitative analysis of student beliefs and attitudes after an objective structured clinical evaluation: implications for affective domain learning in undergraduate nursing education.

PubMed

Cazzell, Mary; Rodriguez, Amber

2011-12-01

This qualitative study explored the feelings, beliefs, and attitudes of senior-level undergraduate pediatric nursing students upon completion of a medication administration Objective Structured Clinical Evaluation (OSCE). The affective domain is the most neglected domain in higher education, although it is deemed the "gateway to learning." Quantitative assessments of clinical skills performed during OSCEs usually address two of the three domains of learning: cognitive (knowledge) and psychomotor skills. Twenty students volunteered to participate in focus groups (10 per group) and were asked three questions relevant to their feelings, beliefs, and attitudes about their OSCE experiences. Students integrated the attitude of safety first into future practice but felt that anxiety, loss of control, reaction under pressure, and no feedback affected their ability to connect the OSCE performance with future clinical practice. The findings affect future affective domain considerations in the development, modification, and assessment of OSCEs across the undergraduate nursing curriculum.

Ex vivo lung perfusion: a comprehensive review of the development and exploration of future trends.

PubMed

Roman, Marius A; Nair, Sukumaran; Tsui, Steven; Dunning, John; Parmar, Jasvir S

2013-09-01

There is a critical mismatch between the number of donor lungs available and the demand for lungs for transplantation. This has created unacceptably high waiting-list mortality for lung transplant recipients. Currently (2012) in the United Kingdom, there are 216 patients on the lung transplant waiting list and 17 on heart and lung transplant list. The waiting times for suitable lungs average 412 days, with an increasing mortality and morbidity among the patients on the lung transplant list. Ex vivo lung perfusion (EVLP) has emerged as a technique for the assessment, resuscitation, and potential repair of suboptimal donor lungs. This is a rapidly developing field with significant clinical implications. In this review article, we critically appraise the background developments that have led to our current clinical practice. In particular, we focus on the human and animal experience, the different perfusion-ventilation strategies, and the impact of different perfusates and leukocyte filters. Finally, we examine EVLP as a potential research tool. This will provide insight into EVLP and its future development in the field of clinical lung transplantation.

Can transcranial electrical stimulation improve learning difficulties in atypical brain development? A future possibility for cognitive training☆

PubMed Central

Krause, Beatrix; Cohen Kadosh, Roi

2013-01-01

Learning difficulties in atypical brain development represent serious obstacles to an individual's future achievements and can have broad societal consequences. Cognitive training can improve learning impairments only to a certain degree. Recent evidence from normal and clinical adult populations suggests that transcranial electrical stimulation (TES), a portable, painless, inexpensive, and relatively safe neuroenhancement tool, applied in conjunction with cognitive training can enhance cognitive intervention outcomes. This includes, for instance, numerical processing, language skills and response inhibition deficits commonly associated with profound learning difficulties and attention-deficit hyperactivity disorder (ADHD). The current review introduces the functional principles, current applications and promising results, and potential pitfalls of TES. Unfortunately, research in child populations is limited at present. We suggest that TES has considerable promise as a tool for increasing neuroplasticity in atypically developing children and may be an effective adjunct to cognitive training in clinical settings if it proves safe. The efficacy and both short- and long-term effects of TES on the developing brain need to be critically assessed before it can be recommended for clinical settings. PMID:23770059

Future clinical challenges in multiple sclerosis: Relevance to sphingosine 1-phosphate receptor modulator therapy.

PubMed

Hohlfeld, Reinhard; Barkhof, Frederik; Polman, Chris

2011-02-22

The limitations of established therapies for multiple sclerosis (MS) are well-known and include the need for injections, treatment adherence and convenience issues, partial efficacy, and, in some cases, a risk of potentially life-threatening adverse events, such as progressive multifocal leukoencephalopathy. Recently, attention has focused on developing more effective therapies that are administered orally and target neurodegeneration as well as inflammation. In this review, we provide an outlook on the future clinical challenges for MS treatment and management, and focus specifically on the emerging sphingosine 1-phosphate receptor (S1PR) modulators. We highlight the importance of improving our understanding of the neurobiological basis of MS to develop well-tolerated targeted therapies and the need to include advanced MRI assessments that quantify neurodegeneration in interventional studies in MS. As more treatments become available, often with complex pharmacodynamic actions, objective assessment of benefit-to-risk profiles becomes increasingly important to ensure that patients receive appropriate care. Pharmacovigilance and immune monitoring will become important aspects of patient treatment and management in the future. With respect to S1PR modulation, we review the experimental agents that are in clinical development for MS and summarize the steps taken in postmarketing surveillance to ensure that fingolimod (FTY720) has a well-characterized safety profile.

Radiochemistry Research and Training, UC Davis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sutcliffe, Julie

2012-08-01

The report contains a summary of the accomplishments made during the R2@UCDavis proposal. In brief we proposed to develop new and highly innovative radiotracer methods and to enhance training opportunities to ensure the future availability of human resources for highly specialized fields of radiotracer development chemistry and clinical nuclear medicine research and allied disciplines. The overall scientific objectives of this proposal were to utilize “click” chemistry to facilitate fast and site-specific radiolabeling. Progress was made on all initial goals presented. This funding has to date resulted in publications in high impact journals such as Acta Biomaterialia, Molecular Imaging and Biology,more » Nuclear Medicine and Biology and most recently Environmental Science and technology, and it is anticipated that through the collaborations established during the time course of this funding that future research will be published in clinically relevant journals such as Science Translational Medicine and the Journal of Nuclear Medicine. Trainees involved in this proposal have gone on to further their careers in both academia, industry and the private sector. The collaborative forums established during the time course of this funding will ensure the future availability of human resources for highly specialized fields of radiotracer development chemistry and clinical nuclear medicine research and allied disciplines.« less

Experiences from an interprofessional student-assisted chronic disease clinic.

PubMed

Frakes, Kerrie-Anne; Brownie, Sharon; Davies, Lauren; Thomas, Janelle; Miller, Mary-Ellen; Tyack, Zephanie

2014-11-01

Faced with significant health and workforce challenges in the region, the Central Queensland Health Service District (CQHSD) commenced a student-assisted clinical service. The Capricornia Allied Health Partnership (CAHP) is an interprofessional clinical placement program in which pre-entry students from exercise physiology, nutrition and dietetics, occupational therapy, pharmacy, podiatry and social work are embedded in a collaborative chronic disease service delivery model. The model coordinates multiple student clinical placements to: address service delivery gaps for previously underserved people with chronic disease in need of early intervention and management; provide an attractive clinical placement opportunity for students that will potentially lead to future recruitment success, and demonstrate leadership in developing future health workforce trainees to attain appropriate levels of interprofessional capacity. The CAHP clinic commenced student placements and client services in February 2010. This report provides early evaluative information regarding student experiences included self-reported changes in practice.

Clinical proteomics-driven precision medicine for targeted cancer therapy: current overview and future perspectives.

PubMed

Zhou, Li; Wang, Kui; Li, Qifu; Nice, Edouard C; Zhang, Haiyuan; Huang, Canhua

2016-01-01

Cancer is a common disease that is a leading cause of death worldwide. Currently, early detection and novel therapeutic strategies are urgently needed for more effective management of cancer. Importantly, protein profiling using clinical proteomic strategies, with spectacular sensitivity and precision, offer excellent promise for the identification of potential biomarkers that would direct the development of targeted therapeutic anticancer drugs for precision medicine. In particular, clinical sample sources, including tumor tissues and body fluids (blood, feces, urine and saliva), have been widely investigated using modern high-throughput mass spectrometry-based proteomic approaches combined with bioinformatic analysis, to pursue the possibilities of precision medicine for targeted cancer therapy. Discussed in this review are the current advantages and limitations of clinical proteomics, the available strategies of clinical proteomics for the management of precision medicine, as well as the challenges and future perspectives of clinical proteomics-driven precision medicine for targeted cancer therapy.

The ongoing search for best practice in clinical teaching and learning: a model of nursing students' evolution to proficient novice registered nurses.

PubMed

Edgecombe, Kay; Bowden, Margaret

2009-03-01

This article describes the development of a model of nursing students as evolving registered nurses (RNs). It aims to generate critical debate about innovations in nursing teaching and learning. The model is the outcome of research conducted with undergraduate nursing students (n=111) from Flinders University, Adelaide, South Australia. It identifies the positive and negative intrinsic and extrinsic factors that impact on nursing students' clinical learning development and progression from students to proficient novice RNs. This model has implications for future curriculum development, staff development, placement approaches and research in relation to clinical teaching and learning.

The clinical development of p53-reactivating drugs in sarcomas - charting future therapeutic approaches and understanding the clinical molecular toxicology of Nutlins.

PubMed

Biswas, Swethajit; Killick, Emma; Jochemsen, Aart G; Lunec, John

2014-05-01

The majority of human sarcomas, particularly soft tissue sarcomas, are relatively resistant to traditional cytotoxic therapies. The proof-of-concept study by Ray-Coquard et al., using the Nutlin human double minute (HDM)2-binding antagonist RG7112, has recently opened a new chapter in the molecular targeting of human sarcomas. In this review, the authors discuss the challenges and prospective remedies for minimizing the significant haematological toxicities of the cis-imidazole Nutlin HDM2-binding antagonists. Furthermore, they also chart the future direction of the development of p53-reactivating (p53-RA) drugs in 12q13-15 amplicon sarcomas and as potential chemopreventative therapies against sarcomagenesis in germ line mutated TP53 carriers. Drawing lessons from the therapeutic use of Imatinib in gastrointestinal tumours, the authors predict the potential pitfalls, which may lie in ahead for the future clinical development of p53-RA agents, as well as discussing potential non-invasive methods to identify the development of drug resistance. Medicinal chemistry strategies, based on structure-based drug design, are required to re-engineer cis-imidazoline Nutlin HDM2-binding antagonists into less haematologically toxic drugs. In silico modelling is also required to predict toxicities of other p53-RA drugs at a much earlier stage in drug development. Whether p53-RA drugs will be therapeutically effective as a monotherapy remains to be determined.

MMP Inhibitors: Past, present and future.

PubMed

Cathcart, Jillian M; Cao, Jian

2015-06-01

  Development of inhibitors of matrix metalloproteinases (MMPs) has been fraught with challenges. Early compounds largely failed due to poor selectivity and bioavailability. Dose-limiting side effects, off-target interactions, and improperly designed clinical trials significantly impeded clinical success. As information becomes available and technology evolves, tools to combat these obstacles have been developed. Improved methods for high throughput screening and drug design have led to identification of compounds exhibiting high potency, binding affinity, and favorable pharmacokinetic profiles. Current research into MMP inhibitors employs innovative approaches for drug delivery methods and allosteric inhibitors. Such innovation is key for development of clinically successful compounds.

Clinical Trials with Oncolytic Measles Virus: Current Status and Future Prospects.

PubMed

Msaouel, Pavlos; Opyrchal, Mateusz; Dispenzieri, Angela; Peng, Kah Whye; Federspiel, Mark J; Russell, Stephen J; Galanis, Evanthia

2018-01-01

Attenuated Edmonston lineage measles virus (MV-Edm) vaccine strains can preferentially infect and lyse a wide variety of cancer cells. Oncolytic MV-Edm derivatives are genetically engineered to express the human carcinoembryonic antigen (MV-CEA virus) or the human sodium iodide symporter (MV-NIS virus) and are currently being tested in clinical trials against ovarian cancer, glioblastoma multiforme, multiple myeloma, mesothelioma, head and neck cancer, breast cancer and malignant peripheral nerve sheath tumors. This review describes the basic and preclinical data that facilitated the clinical translation of MV-Edm strains, and summarizes the clinical results of this oncolytic platform to date. Furthermore, we discuss the latest clinically relevant MV-Edm vector developments and creative strategies for future translational steps. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Clinical development of new prophylactic antimalarial drugs after the 5th Amendment to the Declaration of Helsinki

PubMed Central

Dow, Geoffrey S; Magill, Alan J; Ohrt, Colin

2008-01-01

Malaria is of continuing concern in nonimmune traveling populations. Traditionally, antimalarial drugs have been developed as agents for dual indications (treatment and prophylaxis). However, since 2000, when the 5th Amendment to the Declaration of Helsinki (DH2000) was adopted, development of new malaria prophylaxis drugs in this manner has ceased. As a consequence, there may not be any new drugs licensed for this indication in the foreseeable future. Major pharmaceutical companies have interpreted DH2000 to mean that the traditional development paradigm may be considered unethical because of doubt over the likelihood of benefit to endemic populations participating in clinical studies, the use of placebo, and the sustainability of post-trial access to study medications. In this article, we explore the basis of these concerns and suggest that the traditional development paradigm remains ethical under certain circumstances. We also consider alternative approaches that may be more attractive to sponsors as they either do not use placebo, or utilize populations in endemic countries who may unambiguously benefit. These approaches represent the way forward in the future, but are at present unproven in clinical practice, and face numerous regulatory, logistical and technical challenges. Consequently, in the short term, we argue that the traditional clinical development paradigm remains the most feasible approach and is ethical and consistent with the spirit of DH2000 under the appropriate circumstances. PMID:19209263

NCI Director Norman Sharpless’s ASCO 2018 Remarks-The Power and Promise of Cancer Research

Cancer.gov

NCI Director Dr. Norman E. Sharpless discusses the future of cancer research at the 2018 American Society of Clinical Oncology (ASCO) annual meeting in Chicago. Learn more about his focus on basic science, workforce development, big data, and clinical trials.

Designing a placebo device: involving service users in clinical trial design.

PubMed

Gooberman-Hill, Rachael; Jinks, Clare; Bouças, Sofia Barbosa; Hislop, Kelly; Dziedzic, Krysia S; Rhodes, Carol; Burston, Amanda; Adams, Jo

2013-12-01

Service users are increasingly involved in the design of clinical trials and in product and device development. Service user involvement in placebo development is crucial to a credible and acceptable placebo for clinical trials, but such involvement has not yet been reported. To enhance the design of a future clinical trial of hand splints for thumb-base osteoarthritis (OA), service users were involved in splint selection and design of a placebo splint. This article describes and reflects on this process. Two fora of service users were convened in 2011. Service users who had been prescribed a thumb splint for thumb-base OA were approached about involvement by Occupational Therapy (OT) practitioners. A total of eight service users took part in the fora. Service users discussed their experience of OA and their own splints and then tried a variety of alternative splints. Through this they identified the active features of splints alongside acceptable and unacceptable design features. Service users focused on wearability and support with or without immobilization. Fora discussed whether a placebo group ('arm') was an acceptable feature of a future trial, and service users developed a potential design for a placebo splint. This is the first project that to involve service users in placebo design. Service users are increasingly involved in product and device design and are ideally placed to identify features to make a placebo credible yet lacking key active ingredients. The future trial will include research into its acceptability. © 2013 John Wiley & Sons Ltd.

Hidden benefits of a peer-mentored 'Hospital Orientation Day': first-year medical students' perspectives.

PubMed

Barker, Thomas A; Ngwenya, Nothando; Morley, David; Jones, Ellen; Thomas, Cathryn P; Coleman, Jamie J

2012-01-01

Entering the clinical environment is potentially stressful for junior medical students. We evaluated first-year medical student feedback on a peer-mentored 'Hospital Orientation Day' designed to provide insight into future clinical training. Using a mixed methodology approach data were collected from first-year medical students. Responses to a questionnaire were used to develop a topic guide for focus groups held the next academic year. The questionnaire was completed by 230 first-year students and 32 second years participated in the interviews. Thematic analysis was used to draw conclusions. Analysis of questionnaire responses indicated that students gained insight into future learning. Focus groups then generated five themes: (1) entering the hospital without fear, (2) linking the present with the future, (3) understanding the culture of learning in the clinical years, (4) a 'Backstage Pass' to the clinical world and (5) peer mentors make or break the day. Using peer mentors during the Hospital Orientation Day allowed insight into future learning. We highlight the importance of student Mentors in the success of hospital orientation. To maximise the benefits for first years, we recommend a mentor selection procedure, mentor training opportunities and incentives to optimise mentor performance.

Clinical Practice Guidelines for Delirium Management: Potential Application in Palliative Care

PubMed Central

Bush, Shirley H.; Bruera, Eduardo; Lawlor, Peter G.; Kanji, Salmaan; Davis, Daniel H.J.; Agar, Meera; Wright, David; Hartwick, Michael; Currow, David C.; Gagnon, Bruno; Simon, Jessica; Pereira, José L.

2014-01-01

Context Delirium occurs in patients across a wide array of health care settings. The extent to which formal management guidelines exist or are adaptable to palliative care is unclear. Objectives This review aims to 1) source published delirium management guidelines with potential relevance to palliative care settings, 2) discuss the process of guideline development, 3) appraise their clinical utility, and 4) outline the processes of their implementation and evaluation and make recommendations for future guideline development. Methods We searched PubMed (1990–2013), Scopus, U.S. National Guideline Clearinghouse, Google, and relevant reference lists to identify published guidelines for the management of delirium. This was supplemented with multidisciplinary input from delirium researchers and other relevant stakeholders at an international delirium study planning meeting. Results There is a paucity of high-level evidence for pharmacological and non-pharmacological interventions in the management of delirium in palliative care. However, multiple delirium guidelines for clinical practice have been developed, with recommendations derived from “expert opinion” for areas where research evidence is lacking. In addition to their potential benefits, limitations of clinical guidelines warrant consideration. Guidelines should be appraised and then adapted for use in a particular setting before implementation. Further research is needed on the evaluation of guidelines, as disseminated and implemented in a clinical setting, focusing on measurable outcomes in addition to their impact on quality of care. Conclusion Delirium clinical guidelines are available but the level of evidence is limited. More robust evidence is required for future guideline development. PMID:24766743

Integrating Health and Mental Health Services: A Past and Future History.

PubMed

Druss, Benjamin G; Goldman, Howard H

2018-04-25

The authors trace the modern history, current landscape, and future prospects for integration between mental health and general medical care in the United States. Research and new treatment models developed in the 1980s and early 1990s helped inform federal legislation, including the 2008 Mental Health Parity and Addiction Equity Act and the 2010 Affordable Care Act, which in turn are creating new opportunities to further integrate services. Future efforts should build on this foundation to develop clinical, service-level, and public health approaches that more fully integrate mental, medical, substance use, and social services.

Assessing Violence Risk: A Review and Clinical Recommendations

ERIC Educational Resources Information Center

Haggard-Grann, Ulrika

2007-01-01

Guidance to identify and manage clients with a perceived high risk for future violence is of great importance for mental health professionals. In the past decade, several structured instruments have been developed to assess risk of future violence. Awareness of the limits and abilities of such instruments is required. This article reviews the most…

The first competency-based higher education programme for midwives in the South Asian region--Pakistan.

PubMed

Jan, Rafat; Lakhani, Arusa; Kaufman, Karyn; Karimi, Sadia

2016-02-01

Midwives in Pakistan and the South Asian region who complete a diploma program face many challenges for career growth and development. The absence of higher education in professional midwifery in the region has contributed to general non-acceptance and invisibility of midwifery. In response to the interest, Aga Khan University (AKU) developed bachelors program in midwifery based on the Global Standards for Midwifery Education developed by the International Confederation of Midwives (ICM) with the vision to equip midwives to provide full-scope practice, develop confidence to practice midwifery independently, become clinical leaders and contribute to the future of midwifery. The final curriculum had a balance of theory and clinical practice in order to develop a high level of clinical competence that would meet the ICM standards and guidelines. The two year bachelors program is currently in progress. The first cohort of 21 midwives graduated in 2014 and a second cohort was enrolled in 2015. There is a planning for a future graduate program in midwifery to prepare individuals for leadership roles in practice, teaching, maternal-child health provision and policy making through a master's degree in midwifery. Copyright © 2015 Elsevier Ltd. All rights reserved.

Healthcare provider education to support integration of pharmacogenomics in practice: the eMERGE Network experience

PubMed Central

Rohrer Vitek, Carolyn R; Abul-Husn, Noura S; Connolly, John J; Hartzler, Andrea L; Kitchner, Terrie; Peterson, Josh F; Rasmussen, Luke V; Smith, Maureen E; Stallings, Sarah; Williams, Marc S; Wolf, Wendy A; Prows, Cynthia A

2017-01-01

Ten organizations within the Electronic Medical Records and Genomics Network developed programs to implement pharmacogenomic sequencing and clinical decision support into clinical settings. Recognizing the importance of informed prescribers, a variety of strategies were used to incorporate provider education to support implementation. Education experiences with pharmacogenomics are described within the context of each organization's prior involvement, including the scope and scale of implementation specific to their Electronic Medical Records and Genomics projects. We describe common and distinct education strategies, provide exemplars and share challenges. Lessons learned inform future perspectives. Future pharmacogenomics clinical implementation initiatives need to include funding toward implementing provider education and evaluating outcomes. PMID:28639489

Optical Tecnology Developments in Biomedicine: History, Current and Future

PubMed Central

Nioka, Shoko; Chen, Yu

2011-01-01

Biomedical optics is a rapidly emerging field for medical imaging and diagnostics. This paper reviews several biomedical optical technologies that have been developed and translated for either clinical or pre-clinical applications. Specifically, we focus on the following technologies: 1) near-infrared spectroscopy and tomography, 2) optical coherence tomography, 3) fluorescence spectroscopy and imaging, and 4) optical molecular imaging. There representative biomedical applications are also discussed here. PMID:23905030

Training the next generation of physician-executives: an innovative residency pathway in management and leadership.

PubMed

Ackerly, D Clay; Sangvai, Devdutta G; Udayakumar, Krishna; Shah, Bimal R; Kalman, Noah S; Cho, Alex H; Schulman, Kevin A; Fulkerson, William J; Dzau, Victor J

2011-05-01

The rapidly changing field of medicine demands that future physician-leaders excel not only in clinical medicine but also in the management of complex health care enterprises. However, many physicians have become leaders "by accident," and the active cultivation of future leaders is required. Addressing this need will require multiple approaches, targeting trainees at various stages of their careers, such as degree-granting programs, residency and fellowship training, and career and leadership development programs. Here, the authors describe a first-of-its-kind graduate medical education pathway at Duke Medicine, the Management and Leadership Pathway for Residents (MLPR). This program was developed for residents with both a medical degree and management training. Created in 2009, with its first cohort enrolled in the summer of 2010, the MLPR is intended to help catalyze the emergence of a new generation of physician-leaders. The program will provide physicians-in-training with rigorous clinical exposure along with mentorship and rotational opportunities in management to accelerate the development of critical leadership and management skills in all facets of medicine, including care delivery, research, and education. To achieve this, the MLPR includes 15 to 18 months of project-based rotations under the guidance of senior leaders in many disciplines including finance, patient safety, health system operations, strategy, and others. Developing both clinical and management skill sets during graduate medical education holds the promise of engaging future leaders of health care at an early career stage, keeping more MD-MBA graduates within health care, and creating a bench of talented future physician-executives. Copyright © by the Association of American medical Colleges.

Preparing Current and Future Practitioners to Integrate Research in Real Practice Settings

ERIC Educational Resources Information Center

Thyer, Bruce A.

2015-01-01

Past efforts aimed at promoting a better integration between research and practice are reviewed. These include the empirical clinical practice movement (ECP), originating within social work; the empirically supported treatment (EST) initiative of clinical psychology; and the evidence-based practice (EBP) model developed within medicine. The…

Development of Clinical Pharmacology in the Russian Federation.

PubMed

Petrov, V I; Kagramanyan, I N; Khokhlov, A L; Frolov, M U; Lileeva, E G

2016-05-01

The article aims to provide the history, organization, and approaches to clinical pharmacology in the Russian Federation. This article is based on major international and Russian documents, along with groundbreaking historical facts and scientific articles related to the development of modern clinical pharmacology the Russian Federation. Improving the quality of drug therapy is the main goal of clinical pharmacology in the Russian Federation. Decisions of the World Health Organization, scientific achievements, and the work of well-known scientists among the world community and in the Russian Federation have strongly influenced the development of clinical pharmacology the Russian Federation. Clinical pharmacology in the Russian Federation addresses a wide range of problems; it actively engages in modern scientific research, education; and clinical practice. Clinical pharmacologists participate in studies of new drugs and often have a specific area of expertise. The future development of clinical pharmacology in the Russian Federation will be related to improvements in training, refinement of the framework that regulates clinical pharmacologists, and the creation of clinical pharmacology laboratories with modern equipment. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

Implementation of interprofessional learning activities in a professional practicum: The emerging role of technology.

PubMed

Brault, Isabelle; Therriault, Pierre-Yves; St-Denis, Louise; Lebel, Paule

2015-01-01

To prepare future healthcare professionals to collaborate effectively, many universities have developed interprofessional education programs (IPE). Till date, these programs have been mostly courses or clinical simulation experiences. Few attempts have been made to pursue IPE in healthcare clinical settings. This article presents the results of a pilot project in which interprofessional learning activities (ILAs) were implemented during students' professional practicum and discusses the actual and potential use of informatics in the ILA implementation. We conducted a pilot study in four healthcare settings. Our analysis is based on focus group interviews with trainees, clinical supervisors, ILA coordinators, and education managers. Overall, ILAs led to better clarification of roles and understanding of each professional's specific expertise. Informatics was helpful for developing a common language about IPE between trainees and healthcare professionals; opportunities for future application of informatics were noted. Our results support the relevance of ILAs and the value of promoting professional exchanges between students of different professions, both in academia and in the clinical setting. Informatics appears to offer opportunities for networking among students from different professions and for team members' professional development. The use of technology facilitated communication among the participants.

CRISPR-mediated Ophthalmic Genome Surgery.

PubMed

Cho, Galaxy Y; Abdulla, Yazeed; Sengillo, Jesse D; Justus, Sally; Schaefer, Kellie A; Bassuk, Alexander G; Tsang, Stephen H; Mahajan, Vinit B

2017-09-01

Clustered regularly interspaced short palindromic repeats (CRISPR) is a genome engineering system with great potential for clinical applications due to its versatility and programmability. This review highlights the development and use of CRISPR-mediated ophthalmic genome surgery in recent years. Diverse CRISPR techniques are in development to target a wide array of ophthalmic conditions, including inherited and acquired conditions. Preclinical disease modeling and recent successes in gene editing suggest potential efficacy of CRISPR as a therapeutic for inherited conditions. In particular, the treatment of Leber congenital amaurosis with CRISPR-mediated genome surgery is expected to reach clinical trials in the near future. Treatment options for inherited retinal dystrophies are currently limited. CRISPR-mediated genome surgery methods may be able to address this unmet need in the future.

Recent advances and future challenges in cancer immunotherapy.

PubMed

Okuyama, Namiko; Tamada, Koji; Tamura, Hideto

2016-01-01

Remarkable advances have been made in cancer immunotherapy. Recent treatment strategies, especially chimeric antigen receptor-T (CAR-T) cell therapy and immune checkpoint inhibitors, reportedly achieve higher objective responses and better survival rates than previous immunotherapies for patients with treatment-resistant malignancies, creating a paradigm shift in cancer treatment. Several clinical trials of cancer immunotherapy for patients with various malignancies are ongoing. However, those with certain malignancies, such as low-immunogenic cancers, cannot be successfully treated with T-cell immunotherapy, and subsets of immunotherapy-treated patients relapse, meaning that more effective immunotherapeutic strategies are needed for such patients. Furthermore, the safety, convenience, and cost of cancer immunotherapy need to be improved in the near future. Herein, we discuss recent advances and future challenges in cancer immunotherapy, i.e., the identification of neoantigens for the development of individualized immunotherapies, the development of new CAR-T cell therapies, including so-called armored CAR-T cells that can induce greater clinical effects and thereby achieve longer survival, the development of off-the-shelf treatment regimens using non-self cells or cell lines, and effective cancer immunotherapy combinations.

Inhaled antibiotics in the treatment of non-cystic fibrosis bronchiectasis: clinical and drug delivery perspectives.

PubMed

Sugianto, Tiffanie Daisy; Chan, Hak-Kim

2016-01-01

Non-cystic fibrosis bronchiectasis (NCFB) is a chronic, progressive, suppurative lung disease characterized by permanent dilatation of bronchial subdivisions, which further causes accumulation of sputum and bacterial infections. The advent of inhaled antibiotics over the past two decades has been expected to effectively attenuate the problem of chronic bacterial infections in CF and NCFB subjects with higher, local drug concentrations and minimal systemic side effects. This review summarizes and evaluates current clinical evidence of efficacy and adverse effects of inhaled antibiotics in NCFB, as well as ongoing preclinical and clinical studies, followed by a discussion of issues and challenges in clinical practice and drug delivery strategies, together with future research directions. The evidence base of the clinical efficacy of inhaled antibiotics in NCFB is limited and the degrees of reported clinical benefits have been modest and conflicting. Challenges surrounding inhaled antibiotics application and development include the lack of knowledge of disease factors and optimum management strategies, unreceptive lung pathophysiology and the lack of factors that support compliance and tolerability. Nonetheless, research continues to give birth to new clinical findings and novel formulations such as combination antibiotics and sustained-release formulations, which add great value to the development of efficacious, safe and convenient inhalable antibiotics of the future.

[Holistic integrative medicine: the road to the future of the development of burn medicine].

PubMed

Fan, D M

2017-01-20

Holistic integrative medicine is the road to the future of the development of burn medicine. Not only burn medicine, but also human medicine gradually enters the era of holistic integrative medicine. Holistic integrative medicine is different from translational medicine, evidence-based medicine or precision medicine, which integrates the most advanced knowledge and theories in medicine fields with the most effective practices and experiences in clinical specialties to form a new medical system.

One vendor's experience: preliminary development of a reminder system based on the Arden Syntax.

PubMed

Spates, R P; Aller, K C

1994-09-01

This article reviews the efforts of HBO & Company in the production of a first phase clinical alerting system based on the Arden Syntax. The alerting system was integrated with a clinical data repository and clinical workstation to process returning laboratory results. Investigations with expert systems resulted in a C language alerting system. GUI prototyping of an authoring environment led to a Smalltalk language authoring system. Future development is expected to broaden the system scope and address the evolution of the Arden Syntax.

Human germline gene editing: Recommendations of ESHG and ESHRE.

PubMed

de Wert, Guido; Pennings, Guido; Clarke, Angus; Eichenlaub-Ritter, Ursula; van El, Carla G; Forzano, Francesca; Goddijn, Mariëtte; Heindryckx, Björn; Howard, Heidi C; Radojkovic, Dragica; Rial-Sebbag, Emmanuelle; Tarlatzis, Basil C; Cornel, Martina C

2018-04-01

Technological developments in gene editing raise high expectations for clinical applications, first of all for somatic gene editing but in theory also for germline gene editing (GLGE). GLGE is currently not allowed in many countries. This makes clinical applications in these countries impossible now, even if GLGE would become safe and effective. What were the arguments behind this legislation, and are they still convincing? If a technique can help to avoid serious genetic disorders, in a safe and effective way, would this be a reason to reconsider earlier standpoints? The European Society of Human Reproduction and Embryology (ESHRE) and the European Society of Human Genetics (ESHG) together developed a Background document and Recommendations to inform and stimulate ongoing societal debates. After consulting its membership and experts, this final version of the Recommendations was endorsed by the Executive Committee and the Board of the respective Societies in May 2017. Taking account of ethical arguments, we argue that both basic and pre-clinical research regarding GLGE can be justified, with conditions. Furthermore, while clinical GLGE would be totally premature, it might become a responsible intervention in the future, but only after adequate pre-clinical research. Safety of the child and future generations is a major concern. Future discussions must also address priorities among reproductive and potential non-reproductive alternatives, such as PGD and somatic editing, if that would be safe and successful. The prohibition of human germline modification, however, needs renewed discussion among relevant stakeholders, including the general public and legislators.

Assessing cognitive function in clinical trials: latest developments and future directions.

PubMed

Wesnes, Keith

2002-01-01

Properly developed automated test systems are of value for assessing changes in cognitive function in clinical trials. Besides the other advantages that automation brings to trials, such as increased reliability and utility, it is shown that such systems are also more sensitive to change in cognitive function than traditional nonautomated procedures. Data from a variety of topical areas in drug development are presented to illustrate the added value such techniques have brought. The latest developments in automation include remote testing via the Internet and telephone.

Neurostimulation as a promising epilepsy therapy.

PubMed

Lin, Yicong; Wang, Yuping

2017-12-01

The revolution in theory, swift technological developments, and invention of new devices have driven tremendous progress in neurostimulation as a third-line treatment for epilepsy. Over the past decades, neurostimulation took its place in the field of epilepsy as an advanced treatment technique and opened up a new world. Numerous animal studies have proven the physical efficacy of stimulation of the brain and peripheral nerves. Based on this optimistic fundamental research, new advanced techniques are being explored in clinical practice. Over the past century, drawing on the benefits brought about by vagus nerve stimulation for the treatment of epilepsy, various new neurostimulation modalities have been developed to control seizures. Clinical studies including case reports, case series, and clinical trials have been booming in the past several years. This article gives a comprehensive review of most of these clinical studies. In addition to highlighting the advantages of neurostimulation for the treatment of epilepsy, concerns with this modality and future development directions are also discussed. The biggest advantage of neurostimulation over pharmacological treatments for epilepsy is the modulation of the epilepsy network by delivering stimuli at a specific target or the "hub." Conversely, however, a lack of knowledge of epilepsy networks and the mechanisms of neurostimulation may hinder further development. Therefore, theoretical research on the mechanism of epileptogenesis and epilepsy networks is needed in the future. Within the multiple modalities of neuromodulation, the final choice should be made after full discussion with a multidisciplinary team at a presurgical conference. Furthermore, the establishment of a neurostimulation system with standardized parameters and rigorous guidelines is another important issue. To achieve this goal, a worldwide collaboration of epilepsy centers is also suggested in the future.

Engineering stem cells for future medicine.

PubMed

Ricotti, Leonardo; Menciassi, Arianna

2013-03-01

Despite their great potential in regenerative medicine applications, stem cells (especially pluripotent ones) currently show a limited clinical success, partly due to a lack of biological knowledge, but also due to a lack of specific and advanced technological instruments able to overcome the current boundaries of stem cell functional maturation and safe/effective therapeutic delivery. This paper aims at describing recent insights, current limitations, and future horizons related to therapeutic stem cells, by analyzing the potential of different bioengineering disciplines in bringing stem cells toward a safe clinical use. First, we clarify how and why stem cells should be properly engineered and which could be in a near future the challenges and the benefits connected with this process. Second, we identify different routes toward stem cell differentiation and functional maturation, relying on chemical, mechanical, topographical, and direct/indirect physical stimulation. Third, we highlight how multiscale modeling could strongly support and optimize stem cell engineering. Finally, we focus on future robotic tools that could provide an added value to the extent of translating basic biological knowledge into clinical applications, by developing ad hoc enabling technologies for stem cell delivery and control.

Pediatric hospital medicine: a strategic planning roundtable to chart the future.

PubMed

Rauch, Daniel A; Lye, Patricia S; Carlson, Douglas; Daru, Jennifer A; Narang, Steve; Srivastava, Rajendu; Melzer, Sanford; Conway, Patrick H

2012-04-01

Given the growing field of Pediatric Hospital Medicine (PHM) and the need to define strategic direction, the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association sponsored a roundtable to discuss the future of the field. Twenty-one leaders were invited plus a facilitator utilizing established health care strategic planning methods. A "vision statement" was developed. Specific initiatives in 4 domains (clinical practice, quality of care, research, and workforce) were identified that would advance PHM with a plan to complete each initiative. Review of the current issues demonstrated gaps between the current state of affairs and the full vision of the potential impact of PHM. Clinical initiatives were to develop an educational plan supporting the PHM Core Competencies and a clinical practice monitoring dashboard template. Quality initiatives included an environmental assessment of PHM participation on key committees, societies, and agencies to ensure appropriate PHM representation. Three QI collaboratives are underway. A Research Leadership Task Force was created and the Pediatric Research in Inpatient Settings (PRIS) network was refocused, defining a strategic framework for PRIS, and developing a funding strategy. Workforce initiatives were to develop a descriptive statement that can be used by any PHM physician, a communications tool describing "value added" of PHM; and a tool to assess career satisfaction among PHM physicians. We believe the Roundtable was successful in describing the current state of PHM and laying a course for the near future. Copyright © 2011 Society of Hospital Medicine.

The future of laboratory medicine - a 2014 perspective.

PubMed

Kricka, Larry J; Polsky, Tracey G; Park, Jason Y; Fortina, Paolo

2015-01-01

Predicting the future is a difficult task. Not surprisingly, there are many examples and assumptions that have proved to be wrong. This review surveys the many predictions, beginning in 1887, about the future of laboratory medicine and its sub-specialties such as clinical chemistry and molecular pathology. It provides a commentary on the accuracy of the predictions and offers opinions on emerging technologies, economic factors and social developments that may play a role in shaping the future of laboratory medicine. Copyright © 2014 Elsevier B.V. All rights reserved.

[Standard Cancer Therapy Are Established by the Investigator-Initiated Post-Marketing Clinical Trials, Not by the Indication-Directed Clinical Trials].

PubMed

Shimada, Yasuhiro

2016-04-01

The financial supports for investigator-initiated post-marketing clinical trial in clinical oncology are reduced after scandals related to the other fields of clinical trials in Japan. These clinical trials are the essential final steps of clinical development in newer cancer therapy, which should be conducted in the investigator-initiated clinical trial groups with well-organized infrastructure and continuous financial supports. The present problems are discussed and summarized. Future perspectives with the national viewpoints needed to be included the idea of "health technology assessment".

Developing Medications Targeting Glutamatergic Dysfunction in Autism: Progress to Date

PubMed Central

Fung, Lawrence K.; Hardan, Antonio Y.

2015-01-01

Pharmacologic treatments targeting specific molecular mechanisms relevant for autism spectrum disorder (ASD) are beginning to emerge in early drug development. This article reviews the evidence for the disruption of glutamatergic neurotransmission in animal models of social deficits and summarizes key pre-clinical and clinical efforts in developing pharmacologic interventions based on modulation of glutamatergic systems in individuals with ASD. Understanding the pathobiology of the glutamatergic system has led to the development of new investigational treatments for individuals with ASD. Specific examples of medications that modulate the glutamatergic system in preclinical and clinical studies are described. Finally, we will discuss the limitations of current strategies and future opportunities in developing medications targeting the glutamatergic system for treating individuals with ASD. PMID:26104862

Vaccines for Drug Abuse

PubMed Central

Shen, Xiaoyun; Orson, Frank M.; Kosten, Thomas R.

2012-01-01

Current medications for drug abuse have had only limited success. Anti-addiction vaccines to elicit antibodies that block the pharmacological effects of drugs have great potential for treating drug abuse. We review the status for two vaccines that are undergoing clinical trials (cocaine and nicotine) and two that are still in pre-clinical development (methamphetamine and heroin). We also outline the challenges and ethical concerns for anti-addiction vaccine development and their use as future therapeutics. PMID:22130115

Clinical development of Ebola vaccines

PubMed Central

Sridhar, Saranya

2015-01-01

The ongoing outbreak of Ebola virus disease in West Africa highlighted the lack of a licensed drug or vaccine to combat the disease and has renewed the urgency to develop a pipeline of Ebola vaccines. A number of different vaccine platforms are being developed by assessing preclinical efficacy in animal models and expediting clinical development. Over 15 different vaccines are in preclinical development and 8 vaccines are now in different stages of clinical evaluation. These vaccines include DNA vaccines, virus-like particles and viral vectors such as live replicating vesicular stomatitis virus (rVSV), human and chimpanzee adenovirus, and vaccinia virus. Recently, in preliminary results reported from the first phase III trial of an Ebola vaccine, the rVSV-vectored vaccine showed promising efficacy. This review charts this rapidly advancing area of research focusing on vaccines in clinical development and discusses the future opportunities and challenges faced in the licensure and deployment of Ebola vaccines. PMID:26668751

European Vaccine Initiative: lessons from developing malaria vaccines.

PubMed

Geels, Mark J; Imoukhuede, Egeruan B; Imbault, Nathalie; van Schooten, Harry; McWade, Terry; Troye-Blomberg, Marita; Dobbelaer, Roland; Craig, Alister G; Leroy, Odile

2011-12-01

For over 10 years, the European Vaccine Initiative (EVI; European Malaria Vaccine Initiative until 2009) has contributed to the development of 24 malaria candidate vaccine antigens with 13 vaccine candidates being advanced into Phase I clinical trials, two of which have been transitioned for further clinical development in sub-Saharan Africa. Since its inception the EVI organization has operated as a funding agency, but with a clear service-oriented strategy. The scientific successes and difficulties encountered during these years and how these efforts have led to standardization and harmonization in vaccine development through large-scale European consortia are discussed. In the future, the EVI will remain instrumental in the pharmaceutical and clinical development of vaccines against 'diseases of poverty' with a continued focus on malaria. EVI will continue to focus on funding and managing preclinical evaluation up to Phase I/II clinical trials and strengthening the vaccine-development infrastructure in Europe, albeit with a global orientation.

Digital technologies for cognitive assessment to accelerate drug development in Alzheimer's disease.

PubMed

Leurent, C; Ehlers, M D

2015-11-01

For many neurological and psychiatric diseases, novel therapeutics have been elusive for decades. By focusing on attention interference in Alzheimer's disease (AD), we provide a future vision on how emerging mobile, computer, and device-based cognitive tools are converting classically noisy, subjective, data-poor clinical endpoints associated with neuropsychiatric disease assessment into a richer, scalable, and objective set of measurements. Incorporation of such endpoints into clinical drug trials holds promise for more quickly and efficiently developing new medicines. © 2015 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of The American Society for Clinical Pharmacology and Therapeutics.

Assessing and managing breast cancer risk: clinicians' current practice and future needs.

PubMed

Collins, Ian M; Steel, Emma; Mann, G Bruce; Emery, Jon D; Bickerstaffe, Adrian; Trainer, Alison; Butow, Phyllis; Pirotta, Marie; Antoniou, Antonis C; Cuzick, Jack; Hopper, John; Phillips, Kelly-Anne; Keogh, Louise A

2014-10-01

Decision support tools for the assessment and management of breast cancer risk may improve uptake of prevention strategies. End-user input in the design of such tools is critical to increase clinical use. Before developing such a computerized tool, we examined clinicians' practice and future needs. Twelve breast surgeons, 12 primary care physicians and 5 practice nurses participated in 4 focus groups. These were recorded, coded, and analyzed to identify key themes. Participants identified difficulties assessing risk, including a lack of available tools to standardize practice. Most expressed confidence identifying women at potentially high risk, but not moderate risk. Participants felt a tool could especially reassure young women at average risk. Desirable features included: evidence-based, accessible (e.g. web-based), and displaying absolute (not relative) risks in multiple formats. The potential to create anxiety was a concern. Development of future tools should address these issues to optimize translation of knowledge into clinical practice. Copyright © 2014 Elsevier Ltd. All rights reserved.

Crizotinib for the Treatment of ALK-Rearranged Non-Small Cell Lung Cancer: A Success Story to Usher in the Second Decade of Molecular Targeted Therapy in Oncology

PubMed Central

Bartlett, Cynthia Huang; Mino-Kenudson, Mari; Cui, Jean; Iafrate, A. John

2012-01-01

Crizotinib, an ALK/MET/ROS1 inhibitor, was approved by the U.S. Food and Drug Administration for the treatment of anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer (NSCLC) in August 2011, merely 4 years after the first publication of ALK-rearranged NSCLC. The crizotinib approval was accompanied by the simultaneous approval of an ALK companion diagnostic fluorescent in situ hybridization assay for the detection of ALK-rearranged NSCLC. Crizotinib continued to be developed as an ALK and MET inhibitor in other tumor types driven by alteration in ALK and MET. Crizotinib has recently been shown to be an effective ROS1 inhibitor in ROS1-rearranged NSCLC, with potential future clinical applications in ROS1-rearranged tumors. Here we summarize the heterogeneity within the ALK- and ROS1-rearranged molecular subtypes of NSCLC. We review the past and future clinical development of crizotinib for ALK-rearranged NSCLC and the diagnostic assays to detect ALK-rearranged NSCLC. We highlight how the success of crizotinib has changed the paradigm of future drug development for targeted therapies by targeting a molecular-defined subtype of NSCLC despite its rarity and affected the practice of personalized medicine in oncology, emphasizing close collaboration between clinical oncologists, pathologists, and translational scientists. PMID:22989574

Clinical audit in the final year of undergraduate medical education: towards better care of future generations.

PubMed

Mak, Donna B; Miflin, Barbara

2012-01-01

In Australia, in an environment undergoing rapidly changing requirements for health services, there is an urgent need for future practitioners to be knowledgeable, skilful and self-motivated in ensuring the quality and safety of their practice. Postgraduate medical education and vocational programs have responded by incorporating training in quality improvement into continuing professional development requirements, but undergraduate medical education has been slower to respond. This article describes the clinical audit programme undertaken by all students in the final year of the medical course at the University of Notre Dame, Fremantle, Australia, and examines the educational worth of this approach. Data were obtained from curricular documents, including the clinical audit handbook, and from evaluation questionnaires administered to students and supervisors. The clinical audit programme is based on sound educational principles, including situated and participatory learning and reflective practice. It has demonstrated multi-dimensional benefits for students in terms of learning the complexities of conducting an effective audit in professional practice, and for health services in terms of facilitating quality improvement. Although this programme was developed in a medical course, the concept is readily transferable to a variety of other health professional curricula in which students undertake clinical placements.

Stem cell roadmap - The industrial point of view.

PubMed

Elzaabi, Mazen; Thevenin, Agnès; Lirsac, Pierre-Noël

2017-01-01

CELLforCURE is a French Contract Development and Manufacturing Organization (CDMO) dedicated to industrialization and process development for routine manufacturing, GMP manufacturing for clinical and commercial batches and regulatory services and associated logistics. CELLforCURE is a subsidiary of LFB Group.Stem cells fields of application gather cell and gene therapy as well as tissue engineering. According to VisionGain survey, cell therapy medicinal products will remain predominant in the future.Clinical trials are sponsored either by universities or private companies. Most of clinical trials are performed in oncology (53%). More than 100 clinical trials are currently performed in France, involving 36 products in clinical phases II or II/III.Tomorrow's regenerative medicine will be organ reconstruction using scaffolds and bioprinting technologies. The expected applications in the near future could be skin, cornea, blood vessels, retina, urethra and trachea. There are still important issues to overcome: create the vasculature and neuron connection.Solutions are expected regarding I) fundamental biology, in particular better understanding of IPS behavior and metabolism, precursor differentiation conditions, sustainability of induced genetic changes, II) technical approaches which involves injectable preservation medium, high density cells and centrifugation system.

77 FR 41431 - Proposed Collection; Comment Request: Impact of Clinical Research Training and Medical Education...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-13

... promotes (a) Patient safety; (b) research productivity and independence; and (c) future career development... Careers in Academia and Clinical Research SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data...

Orbital atherectomy: device evolution and clinical data.

PubMed

Staniloae, Cezar S; Korabathina, Ravikiran

2014-05-01

A number of atherectomy devices were developed in the last few years. Among them, the DiamondBack 360° Peripheral Orbital Atherectomy System (Cardiovascular Systems, Inc) was specifically designed to work in severely calcified plaque. This article reviews the history, mechanism of action, evolution, clinical data, and future applications of this particular atherectomy device.

Clinical Linguistics: Its Past, Present and Future

ERIC Educational Resources Information Center

Perkins, Michael R.

2011-01-01

Historiography is a growing area of research within the discipline of linguistics, but so far the subfield of clinical linguistics has received virtually no systematic attention. This article attempts to rectify this by tracing the development of the discipline from its pre-scientific days up to the present time. As part of this, I include the…

Gateway to the Future. Skill Standards for the Bioscience Industry for Technical Workers in Pharmaceutical Companies, Biotechnology Companies, and Clinical Laboratories.

ERIC Educational Resources Information Center

Education Development Center, Inc., Newton, MA.

The Bioscience Industry Skills Standards Project (BISSP) is developing national, voluntary skill standards for technical jobs in biotechnology and pharmaceutical companies and clinical laboratories in hospitals, universities, government, and independent settings. Research with employees and educators has pinpointed three issues underscoring the…

Clinical Diabetes Centers of Excellence: A Model for Future Adult Diabetes Care.

PubMed

Draznin, Boris; Kahn, Peter A; Wagner, Nicole; Hirsch, Irl B; Korytkowski, Mary; Harlan, David M; McDonnell, Marie E; Gabbay, Robert A

2018-03-01

Although diabetes research centers are well defined by National Institutes of Health, there is no clear definition for clinical Diabetes Centers of Excellence (DCOEs). There are multiple clinical diabetes centers across the United States, some established with philanthropic funding; however, it is not clear what defines a DCOE from a clinical perspective and what the future will be for these centers. In this Perspective we propose a framework to guide advancement for DCOEs. With the shift toward value-based purchasing and reimbursement and away from fee for service, defining the procedures for broader implementation of DCOEs as a way to improve population health and patient care experience (including quality and satisfaction) and reduce health care costs becomes critically important. It is prudent to implement new financial systems for compensating diabetes care that may not be provided by fiscally constrained private and academic medical centers. We envision that future clinical DCOEs would be composed of a well-defined infrastructure and six domains or pillars serving as the general guiding principles for developing expertise in diabetes care that can be readily demonstrated to stakeholders, including health care providers, patients, payers, and government agencies.

Introduction to current and future protein therapeutics: a protein engineering perspective.

PubMed

Carter, Paul J

2011-05-15

Protein therapeutics and its enabling sister discipline, protein engineering, have emerged since the early 1980s. The first protein therapeutics were recombinant versions of natural proteins. Proteins purposefully modified to increase their clinical potential soon followed with enhancements derived from protein or glycoengineering, Fc fusion or conjugation to polyethylene glycol. Antibody-based drugs subsequently arose as the largest and fastest growing class of protein therapeutics. The rationale for developing better protein therapeutics with enhanced efficacy, greater safety, reduced immunogenicity or improved delivery comes from the convergence of clinical, scientific, technological and commercial drivers that have identified unmet needs and provided strategies to address them. Future protein drugs seem likely to be more extensively engineered to improve their performance, e.g., antibodies and Fc fusion proteins with enhanced effector functions or extended half-life. Two old concepts for improving antibodies, namely antibody-drug conjugates and bispecific antibodies, have advanced to the cusp of clinical success. As for newer protein therapeutic platform technologies, several engineered protein scaffolds are in early clinical development and offer differences and some potential advantages over antibodies. Copyright © 2011 Elsevier Inc. All rights reserved.

Introduction to current and future protein therapeutics: A protein engineering perspective

DOE Office of Scientific and Technical Information (OSTI.GOV)

Carter, Paul J., E-mail: pjc@gene.com

2011-05-15

Protein therapeutics and its enabling sister discipline, protein engineering, have emerged since the early 1980s. The first protein therapeutics were recombinant versions of natural proteins. Proteins purposefully modified to increase their clinical potential soon followed with enhancements derived from protein or glycoengineering, Fc fusion or conjugation to polyethylene glycol. Antibody-based drugs subsequently arose as the largest and fastest growing class of protein therapeutics. The rationale for developing better protein therapeutics with enhanced efficacy, greater safety, reduced immunogenicity or improved delivery comes from the convergence of clinical, scientific, technological and commercial drivers that have identified unmet needs and provided strategies tomore » address them. Future protein drugs seem likely to be more extensively engineered to improve their performance, e.g., antibodies and Fc fusion proteins with enhanced effector functions or extended half-life. Two old concepts for improving antibodies, namely antibody-drug conjugates and bispecific antibodies, have advanced to the cusp of clinical success. As for newer protein therapeutic platform technologies, several engineered protein scaffolds are in early clinical development and offer differences and some potential advantages over antibodies.« less

Steroid Sulfatase Inhibition by Aryl Sulfamates: Clinical Progress, Mechanism and Future Prospects.

PubMed

Potter, Barry V L

2018-04-04

Steroid sulfatase is an emerging drug target for the endocrine therapy of hormone-dependent diseases, catalyzing estrogen sulfate hydrolysis to estrogen. Drug discovery, developing the core aryl O-sulfamate pharmacophore, has led to steroidal and non-steroidal drugs entering numerous clinical trials, with promising results in oncology and women's health. Steroidal estrogen sulfamate derivatives were the first irreversible active-site-directed inhibitors and one was developed clinically as an oral estradiol pro-drug and for endometriosis applications. This review summarizes work leading to the therapeutic concept of sulfatase inhibition, clinical trials executed to date and new insights into the mechanism of inhibition of steroid sulfatase. To date the non-steroidal sulfatase inhibitor Irosustat has been evaluated clinically in breast cancer, alone and in combination, in endometrial cancer and in prostate cancer. The versatile core pharmacophore both imbues attractive pharmaceutical properties and functions via three distinct mechanisms of action, as a pro-drug, an enzyme active site-modifying motif, likely through direct sulfamoyl group transfer, and as a structural component augmenting activity, for example by enhancing interactions at the colchicine binding site of tubulin. Preliminary new structural data on the Pseudomonas aeruginosa arylsulfatase enzyme suggest two possible sulfamate-based adducts with active site hydrated formylglycine as candidates for the inhibition end product via sulfamoyl group transfer, and a speculative choice is suggested. The clinical status of sulfatase inhibition is surveyed and how it might develop in the future. Also discussed are dual-targeting approaches, development of 2-substituted steroidal sulfamates and nonsteroidal derivatives as multi-targeting agents for hormone-independent tumours with other emerging directions.

Clinical practice guidelines for delirium management: potential application in palliative care.

PubMed

Bush, Shirley H; Bruera, Eduardo; Lawlor, Peter G; Kanji, Salmaan; Davis, Daniel H J; Agar, Meera; Wright, David Kenneth; Hartwick, Michael; Currow, David C; Gagnon, Bruno; Simon, Jessica; Pereira, José L

2014-08-01

Delirium occurs in patients across a wide array of health care settings. The extent to which formal management guidelines exist or are adaptable to palliative care is unclear. This review aims to 1) source published delirium management guidelines with potential relevance to palliative care settings, 2) discuss the process of guideline development, 3) appraise their clinical utility, and 4) outline the processes of their implementation and evaluation and make recommendations for future guideline development. We searched PubMed (1990-2013), Scopus, U.S. National Guideline Clearinghouse, Google, and relevant reference lists to identify published guidelines for the management of delirium. This was supplemented with multidisciplinary input from delirium researchers and other relevant stakeholders at an international delirium study planning meeting. There is a paucity of high-level evidence for pharmacological and non-pharmacological interventions in the management of delirium in palliative care. However, multiple delirium guidelines for clinical practice have been developed, with recommendations derived from "expert opinion" for areas where research evidence is lacking. In addition to their potential benefits, limitations of clinical guidelines warrant consideration. Guidelines should be appraised and then adapted for use in a particular setting before implementation. Further research is needed on the evaluation of guidelines, as disseminated and implemented in a clinical setting, focusing on measurable outcomes in addition to their impact on quality of care. Delirium clinical guidelines are available but the level of evidence is limited. More robust evidence is required for future guideline development. Copyright © 2014 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Addressing challenges of training a new generation of clinician-innovators through an interdisciplinary medical technology design program: Bench-to-Bedside.

PubMed

Loftus, Patrick D; Elder, Craig T; D'Ambrosio, Troy; Langell, John T

2015-01-01

Graduate medical education has traditionally focused on training future physicians to be outstanding clinicians with basic and clinical science research skills. This focus has resulted in substantial knowledge gains, but a modest return on investment based on direct improvements in clinical care. In today's shifting healthcare landscape, a number of important challenges must be overcome to not only improve the delivery of healthcare, but to prepare future physicians to think outside the box, focus on and create healthcare innovations, and navigate the complex legal, business and regulatory hurdles of bringing innovation to the bedside. We created an interdisciplinary and experiential medical technology design competition to address these challenges and train medical students interested in moving new and innovative clinical solutions to the forefront of medicine. Medical students were partnered with business, law, design and engineering students to form interdisciplinary teams focused on developing solutions to unmet clinical needs. Over the course of six months teams were provided access to clinical and industry mentors, $500 prototyping funds, development facilities, and non-mandatory didactic lectures in ideation, design, intellectual property, FDA regulatory requirements, prototyping, market analysis, business plan development and capital acquisition. After four years of implementation, the program has supported 396 participants, seen the development of 91 novel medical devices, and launched the formation of 24 new companies. From our perspective, medical education programs that develop innovation training programs and shift incentives from purely traditional basic and clinical science research to also include high-risk innovation will see increased student engagement in improving healthcare delivery and an increase in the quality and quantity of innovative solutions to medical problems being brought to market.

The current status of immunotherapy in peritoneal carcinomatosis.

PubMed

Ströhlein, Michael Alfred; Heiss, Markus Maria; Jauch, Karl-Walter

2016-10-01

Peritoneal carcinomatosis (PC) is a cancer disease with an urgent need for effective treatment. Conventional chemotherapy failed to show acceptable results. Cytoreductive surgery and hyperthermic chemoperfusion (HIPEC) are only beneficial in few patients with resectable peritoneal metastasis. Immunotherapy could be attractive against PC, as all requirements for immunotherapy are available in the peritoneal cavity. This review analyzes the present literature for immunotherapy of PC. Advances from immune stimulators, radionucleotide-conjugated- and bispecific antibodies to future developments like adoptive engineered T-cells with chimeric receptors are discussed. The clinical development of catumaxomab, which was the first intraperitoneal immunotherapy to be approved for clinical treatment, is discussed. The requirements for future developments are illustrated. Expert commentary: Immunotherapy of peritoneal carcinomatosis is manageable, showing striking cancer cell killing. Improved profiles of adverse events by therapy-induced cytokine release, enhanced specific killing and optimal treatment schedules within multimodal treatment will be key factors.

Can transcranial electrical stimulation improve learning difficulties in atypical brain development? A future possibility for cognitive training.

PubMed

Krause, Beatrix; Cohen Kadosh, Roi

2013-10-01

Learning difficulties in atypical brain development represent serious obstacles to an individual's future achievements and can have broad societal consequences. Cognitive training can improve learning impairments only to a certain degree. Recent evidence from normal and clinical adult populations suggests that transcranial electrical stimulation (TES), a portable, painless, inexpensive, and relatively safe neuroenhancement tool, applied in conjunction with cognitive training can enhance cognitive intervention outcomes. This includes, for instance, numerical processing, language skills and response inhibition deficits commonly associated with profound learning difficulties and attention-deficit hyperactivity disorder (ADHD). The current review introduces the functional principles, current applications and promising results, and potential pitfalls of TES. Unfortunately, research in child populations is limited at present. We suggest that TES has considerable promise as a tool for increasing neuroplasticity in atypically developing children and may be an effective adjunct to cognitive training in clinical settings if it proves safe. The efficacy and both short- and long-term effects of TES on the developing brain need to be critically assessed before it can be recommended for clinical settings. Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

New natural products of interest under development at the National Cancer Institute.

PubMed

Douros, J; Suffness, M

1978-01-01

Fourteen new agents of natural products origin which are under development as antitumor agents at the National Cancer Institute are discussed with reference to their sources, structures, antitumor activity, current status, and future prospects as clinically effective agents.

Clinical Utility and Future Applications of PET/CT and PET/CMR in Cardiology

PubMed Central

Pan, Jonathan A.; Salerno, Michael

2016-01-01

Over the past several years, there have been major advances in cardiovascular positron emission tomography (PET) in combination with either computed tomography (CT) or, more recently, cardiovascular magnetic resonance (CMR). These multi-modality approaches have significant potential to leverage the strengths of each modality to improve the characterization of a variety of cardiovascular diseases and to predict clinical outcomes. This review will discuss current developments and potential future uses of PET/CT and PET/CMR for cardiovascular applications, which promise to add significant incremental benefits to the data provided by each modality alone. PMID:27598207

The cost of clinical mastitis in the first 30 days of lactation: An economic modeling tool.

PubMed

Rollin, E; Dhuyvetter, K C; Overton, M W

2015-12-01

Clinical mastitis results in considerable economic losses for dairy producers and is most commonly diagnosed in early lactation. The objective of this research was to estimate the economic impact of clinical mastitis occurring during the first 30 days of lactation for a representative US dairy. A deterministic partial budget model was created to estimate direct and indirect costs per case of clinical mastitis occurring during the first 30 days of lactation. Model inputs were selected from the available literature, or when none were available, from herd data. The average case of clinical mastitis resulted in a total economic cost of $444, including $128 in direct costs and $316 in indirect costs. Direct costs included diagnostics ($10), therapeutics ($36), non-saleable milk ($25), veterinary service ($4), labor ($21), and death loss ($32). Indirect costs included future milk production loss ($125), premature culling and replacement loss ($182), and future reproductive loss ($9). Accurate decision making regarding mastitis control relies on understanding the economic impacts of clinical mastitis, especially the longer term indirect costs that represent 71% of the total cost per case of mastitis. Future milk production loss represents 28% of total cost, and future culling and replacement loss represents 41% of the total cost of a case of clinical mastitis. In contrast to older estimates, these values represent the current dairy economic climate, including milk price ($0.461/kg), feed price ($0.279/kg DM (dry matter)), and replacement costs ($2,094/head), along with the latest published estimates on the production and culling effects of clinical mastitis. This economic model is designed to be customized for specific dairy producers and their herd characteristics to better aid them in developing mastitis control strategies. Copyright © 2015 The Authors. Published by Elsevier B.V. All rights reserved.

Transforming the practice of medicine using genomics

PubMed Central

Ginsburg, Geoffrey S.; Ginsburg, Geoffrey S.; J. McCarthy, Jeanette

2009-01-01

Recent studies have demonstrated the use of genomic data, particularly gene expression signatures, as clinical prognostic factors in complex diseases. Such studies herald the future for genomic medicine and the opportunity for personalized prognosis in a variety of clinical contexts that utilize genomescale molecular information. Several key areas represent logical and critical next steps in the use of complex genomic profiling data towards the goal of personalized medicine. First, analyses should be geared toward the development of molecular profiles that predict future events – such as major clinical events or the response, resistance, or adverse reaction to therapy. Secondly, these must move into actual clinical practice by forming the basis for the next generation of clinical trials that will employ these methodologies to stratify patients. Lastly, there remain formidable challenges is in the translation of genomic technologies into clinical medicine that will need to be addressed: professional and public education, health outcomes research, reimbursement, regulatory oversight and privacy protection. PMID:22461094

Heat shock protein 90 inhibitors in the treatment of cancer: current status and future directions.

PubMed

Jhaveri, Komal; Ochiana, Stefan O; Dunphy, Mark Ps; Gerecitano, John F; Corben, Adriana D; Peter, Radu I; Janjigian, Yelena Y; Gomes-DaGama, Erica M; Koren, John; Modi, Shanu; Chiosis, Gabriela

2014-05-01

Heat shock protein 90 (HSP90) serves as a critical facilitator for oncogene addiction. There has been augmenting enthusiasm in pursuing HSP90 as an anticancer strategy. In fact, since the initial serendipitous discovery that geldanamycin (GM) inhibits HSP90, the field has rapidly moved from proof-of-concept clinical studies with GM derivatives to novel second-generation inhibitors. The authors highlight the current status of the second-generation HSP90 inhibitors in clinical development. Herein, the authors note the lessons learned from the completed clinical trials of first- and second-generation inhibitors and describe various assays attempting to serve for a more rational implementation of these agents to cancer treatment. Finally, the authors discuss the future perspectives for this promising class of agents. The knowledge gained thus far provides perhaps only a glimpse at the potential of HSP90 for which there is still much work to be done. Lessons from the clinical trials suggest that HSP90 therapy would advance at a faster pace if patient selection and tumor pharmacokinetics of these drugs were better understood and applied to their clinical development. It is also evident that combining HSP90 inhibitors with other potent anticancer therapies holds great promise not only due to synergistic antitumor activity but also due to the potential of prolonging or preventing the development of drug resistance.

Visualizing the Future: Technology Competency Development in Clinical Medicine, and Implications for Medical Education

ERIC Educational Resources Information Center

Srinivasan, Malathi; Keenan, Craig R.; Yager, Joel

2006-01-01

Objective: In this article, the authors ask three questions. First, what will physicians need to know in order to be effective in the future? Second, what role will technology play in achieving that high level of effectiveness? Third, what specific skill sets will physicians need to master in order to become effective? Method: Through three case…

Clinical Pharmacology & Therapeutics: Past, Present, and Future.

PubMed

Waldman, S A; Terzic, A

2017-03-01

Clinical Pharmacology & Therapeutics (CPT), the definitive and timely source for advances in human therapeutics, transcends the drug discovery, development, regulation, and utilization continuum to catalyze, evolve, and disseminate discipline-transformative knowledge. Prioritized themes and multidisciplinary content drive the science and practice of clinical pharmacology, offering a trusted point of reference. An authoritative herald across global communities, CPT is a timeless information vehicle at the vanguard of discovery, translation, and application ushering therapeutic innovation into modern healthcare. © 2017 American Society for Clinical Pharmacology and Therapeutics.

A Restorative Justice Approach to Empathy Development in Sex Offenders: An Exploratory Study

ERIC Educational Resources Information Center

Roseman, Christopher P.; Ritchie, Martin; Laux, John M.

2009-01-01

The authors describe an exploratory study in sex offender treatment using a restorative justice approach to examine the shame, guilt, and empathy development of convicted sexual offenders. Implications for clinical practice and future research are highlighted. (Contains 3 tables.)

What do doctors and nurses think about development of clinical leadership?

PubMed

Lo, David; Till, Alex; McKimm, Judy

2017-09-02

Leadership development for health-care professionals is a priority within the NHS. Training is generally targeted at individual staff groups in isolation, even though contemporary leadership thinking recognizes the benefits of collaborative leadership between different clinical disciplines. Focussing on the attitudes and perceived training needs of undergraduate and qualified medical and nursing professionals, this article highlights the similarities and differences and will help to inform the design of existing and future leadership programmes.

Resistance to EGFR inhibitors in non-small cell lung cancer: Clinical management and future perspectives.

PubMed

Tomasello, Chiara; Baldessari, Cinzia; Napolitano, Martina; Orsi, Giulia; Grizzi, Giulia; Bertolini, Federica; Barbieri, Fausto; Cascinu, Stefano

2018-03-01

In the last few years, the development of targeted therapies for non-small cell lung cancer (NSCLC) expressing oncogenic driver mutations (e.g. EGFR) has changed the clinical management and the survival outcomes of this specific minority of patients. Several phase III trials demonstrated the superiority of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs) over chemotherapy in EGFR-mutant NSCLC patients. However, in the vast majority of cases EGFR TKIs lose their clinical activity within 8-12 months. Many genetic aberrations have been described as possible mechanisms of EGFR TKIs acquired resistance and can be clustered in four main sub-groups: 1. Development of secondary EGFR mutations; 2. Activation of parallel signaling pathways; 3. Histological transformation; 4. Activation of downstream signaling pathways. In this review we will describe the molecular alterations underlying each of these EGFR TKIs resistance mechanisms, focusing on the currently available and future therapeutic strategies to overcome these phenomena. Copyright © 2018 Elsevier B.V. All rights reserved.

Nanomedicine applied to translational oncology: A future perspective on cancer treatment.

PubMed

Bregoli, Lisa; Movia, Dania; Gavigan-Imedio, James D; Lysaght, Joanne; Reynolds, John; Prina-Mello, Adriele

2016-01-01

The high global incidence of cancer is associated with high rates of mortality and morbidity worldwide. By taking advantage of the properties of matter at the nanoscale, nanomedicine promises to develop innovative drugs with greater efficacy and less side effects than standard therapies. Here, we discuss both clinically available anti-cancer nanomedicines and those en route to future clinical application. The properties, therapeutic value, advantages and limitations of these nanomedicine products are highlighted, with a focus on their increased performance versus conventional molecular anticancer therapies. The main regulatory challenges toward the translation of innovative, clinically effective nanotherapeutics are discussed, with a view to improving current approaches to the clinical management of cancer. Ultimately, it becomes clear that the critical steps for clinical translation of nanotherapeutics require further interdisciplinary and international effort, where the whole stakeholder community is involved from bench to bedside. From the Clinical Editor: Cancer is a leading cause of mortality worldwide and finding a cure remains the holy-grail for many researchers and clinicians. The advance in nanotechnology has enabled novel strategies to develop in terms of cancer diagnosis and therapy. In this concise review article, the authors described current capabilities in this field and outlined comparisons with existing drugs. The difficulties in bringing new drugs to the clinics were also discussed. Copyright © 2015 Elsevier Inc. All rights reserved.

Protocol for the development of a Core Outcome Set (COS) for hemorrhoidal disease: an international Delphi study.

PubMed

van Tol, R R; Melenhorst, J; Dirksen, C D; Stassen, L P S; Breukink, S O

2017-07-01

Over the last decade, many studies were performed regarding treatment options for hemorrhoidal disease. Randomised controlled trials (RCTs) should have well-defined primary and secondary outcomes. However, the reported outcome measures are numerous and diverse. The heterogeneity of outcome definition in clinical trials limits transparency and paves the way for bias. The development of a core outcome set (COS) helps minimizing this problem. A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease. The aim of this project is to generate a COS regarding the outcome of treatment after hemorrhoidal disease. A Delphi study will be performed by an international steering group healthcare professionals and patients with the intention to create a standard outcome set for future clinical trials for the treatment of hemorrhoidal disease. First, a literature review will be conducted to establish which outcomes are used in clinical trials for hemorrhoidal disease. Secondly, both healthcare professionals and patients will participate in several consecutive rounds of online questionnaires and a face-to-face meeting to refine the content of the COS. Development of a COS for hemorrhoidal disease defines a minimum outcome-reporting standard and will improve the quality of research in the future.

A Human-Centered Approach to Medical Informatics for Medical Students, Residents, and Practicing Clinicians.

ERIC Educational Resources Information Center

Stahlhut, Richard W.; Gosbee, John W.; Gardner-Bonneau, Daryle J.

1997-01-01

Describes development of a curriculum in medical information science that focuses on practical problems in clinical medicine rather than details of information technology. Design was guided by identification of six key clinical challenges that must be addressed by practitioners in the near future and by examination of past failures of informatics…

Pharmacological interventions to improve cognition and adaptive functioning in Down syndrome: Strides to date.

PubMed

Hart, Sarah J; Visootsak, Jeannie; Tamburri, Paul; Phuong, Patrick; Baumer, Nicole; Hernandez, Maria-Clemencia; Skotko, Brian G; Ochoa-Lubinoff, Cesar; Liogier D'Ardhuy, Xavier; Kishnani, Priya S; Spiridigliozzi, Gail A

2017-11-01

Although an increasing number of clinical trials have been developed for cognition in Down syndrome, there has been limited success to date in identifying effective interventions. This review describes the progression from pre-clinical studies with mouse models to human clinical trials research using pharmacological interventions to improve cognition and adaptive functioning in Down syndrome. We also provide considerations for investigators when conducting human clinical trials and describe strategies for the pharmaceutical industry to advance the field in drug discovery for Down syndrome. Future research focusing on earlier pharmaceutical interventions, development of appropriate outcome measures, and greater collaboration between industry, academia, advocacy, and regulatory groups will be important for addressing limitations from prior studies and developing potential effective interventions for cognition in Down syndrome. © 2017 Wiley Periodicals, Inc.

The future of interventional and neurointerventional radiology: learning lessons from the past.

PubMed

Maingard, Julian; Kok, Hong Kuan; Ranatunga, Dinesh; Brooks, Duncan Mark; Chandra, Ronil V; Lee, Michael J; Asadi, Hamed

2017-12-01

The rapid progression of medical imaging technology and the ability to leverage knowledge from non-invasive imaging means that Interventional Radiologists (IRs) and Interventional Neuroradiologists are optimally placed to incorporate minimally invasive interventional paradigms into clinical management to advance patient care. There is ample opportunity to radically change the management options for patients with a variety of diseases through the use of minimally invasive interventional procedures. However, this will need to be accompanied by an increased clinical role of IRs to become active partners in the clinical management of patients. Unfortunately, the development of IR clinical presence has lagged behind and is reflected by declining rates of IR involvement in certain areas of practice such as vascular interventions. Current and future IRs must be willing to take on clinical responsibilities; reviewing patients in clinic to determine suitability for a procedure and potential contraindications, rounding on hospital inpatients and be willing to manage procedure related complications, which are all important parts of a successful IR practice. Increasing our clinical presence has several advantages over the procedure-driven model including enhanced patient knowledge and informed consent for IR procedures, improved rapport with patients and other clinical colleagues through active participation and engagement in patient care, visibility as a means to facilitate referrals and consistency of follow-up with opportunities for further learning. Many of the solutions to these problems are already in progress and the use of IR as a "hired gun" or "technician" is a concept that should be relegated to the past, and replaced with recognition of IRs as clinicians and partners in delivering modern high quality multidisciplinary team-based patient care. The following article will review the history of IR, the challenges facing this rapidly evolving profession and discuss recent developments occurring globally that are essential in maintaining expertise, securing future growth and improving patient outcomes in the modern multidisciplinary practice of medicine.

Clinical Utility of Epstein-Barr Virus DNA Testing in the Treatment of Nasopharyngeal Carcinoma Patients.

PubMed

Kim, Kelly Y; Le, Quynh-Thu; Yom, Sue S; Ng, Raymond H W; Chan, K C Allen; Bratman, Scott V; Welch, John J; Divi, Rao L; Petryshyn, Raymond A; Conley, Barbara A

2017-08-01

Epstein-Barr virus (EBV) DNA analysis has been shown to be useful for early detection, prognostication, and monitoring of treatment response of nasopharyngeal carcinoma (NPC), and the recent literature provides growing evidence of the clinical utility of EBV DNA testing, particularly to inform treatment decisions for NPC patients. Despite the fact that NPC is a rare disease, the NRG Oncology cooperative group has successfully activated a phase 2/3 randomized clinical trial for NPC with international partners and in that process has discovered that the development of a harmonized EBV DNA test is absolutely critical for integration into clinical trials and for future deployment in clinical and central laboratories. In November 2015, the National Cancer Institute (NCI) convened a workshop of international experts in the treatment of NPC and EBV testing to provide a forum for discussing the state of EBV DNA testing and its clinical utility, and to stimulate consideration of future studies and clinical practice guidelines for EBV DNA. This review provides a summary of that discussion. Published by Elsevier Inc.

Facilitative Leadership: A Framework for the Creative Arts Therapies

ERIC Educational Resources Information Center

Kaimal, Girija; Metzl, Einat; Millrod, Eri

2017-01-01

We propose a leadership framework for the creative art therapies (CATs) as a means to affect the sociopolitical contexts of our clinical and scholarly practices. The new model of facilitative leadership includes 3 aspects: developing the self, developing others, and envisioning a creative and just future.

A conceptual model for the development process of confirmatory adaptive clinical trials within an emergency research network.

PubMed

Mawocha, Samkeliso C; Fetters, Michael D; Legocki, Laurie J; Guetterman, Timothy C; Frederiksen, Shirley; Barsan, William G; Lewis, Roger J; Berry, Donald A; Meurer, William J

2017-06-01

Adaptive clinical trials use accumulating data from enrolled subjects to alter trial conduct in pre-specified ways based on quantitative decision rules. In this research, we sought to characterize the perspectives of key stakeholders during the development process of confirmatory-phase adaptive clinical trials within an emergency clinical trials network and to build a model to guide future development of adaptive clinical trials. We used an ethnographic, qualitative approach to evaluate key stakeholders' views about the adaptive clinical trial development process. Stakeholders participated in a series of multidisciplinary meetings during the development of five adaptive clinical trials and completed a Strengths-Weaknesses-Opportunities-Threats questionnaire. In the analysis, we elucidated overarching themes across the stakeholders' responses to develop a conceptual model. Four major overarching themes emerged during the analysis of stakeholders' responses to questioning: the perceived statistical complexity of adaptive clinical trials and the roles of collaboration, communication, and time during the development process. Frequent and open communication and collaboration were viewed by stakeholders as critical during the development process, as were the careful management of time and logistical issues related to the complexity of planning adaptive clinical trials. The Adaptive Design Development Model illustrates how statistical complexity, time, communication, and collaboration are moderating factors in the adaptive design development process. The intensity and iterative nature of this process underscores the need for funding mechanisms for the development of novel trial proposals in academic settings.

Barriers for integrating personalized medicine into clinical practice: a qualitative analysis.

PubMed

Najafzadeh, Mehdi; Davis, Jennifer C; Joshi, Pamela; Marra, Carlo

2013-04-01

Personalized medicine-tailoring interventions based on individual's genetic information-will likely change routine clinical practice in the future. Yet, how practitioners plan to apply genetic information to inform medical decision making remains unclear. We aimed to investigate physician's perception about the future role of personalized medicine, and to identify the factors that influence their decision in using genetic testing in their practice. We conducted three semi-structured focus groups in three health regions (Fraser, Vancouver coastal, and Interior) in British Columbia, Canada. In the focus groups, participants discussed four topics on personalized medicine: (i) physicians' general understanding, (ii) advantages and disadvantages, (iii) potential impact and role in future clinical practice, and (iv) perceived barriers to integrating personalized medicine into clinical practice. Approximately 36% (n = 9) of physicians self-reported that they were not familiar with the concept of personalized medicine. After introducing the concept, the majority of physicians (68%, n = 19 of 28) were interested in incorporating personalized medicine in their practice, provided they have access to the necessary knowledge and tools. Participants mostly believed that genetic developments will directly affect their practice in the future. The key concerns highlighted were physician's access to clinical guidelines and training opportunities for the use of genetic testing and data interpretation. Despite the challenges that personalized medicine can create, in general, physicians in the focus groups expressed strong interest in using genetic information in their practice if they have access to the necessary knowledge and tools. Copyright © 2013 Wiley Periodicals, Inc.

Combining a clinical ladder and performance appraisal system as a reward strategy: the EXCEL clinical ladder program.

PubMed

Moe, J K; Lonowski, L R; Yancer, D A

1994-09-01

In response to the dramatic changes occurring in health care today and a desire to reward professional nurses for clinical behaviors that would be valued in the future, Bergan Mercy Medical Center (BMMC) has developed an innovative clinical ladder/performance appraisal system. The BMMC EXCEL Clinical Ladder program, which is based on the developmental model of Patricia Benner, is a competency-based system that uniquely combines a clinical ladder and performance appraisal system. The program is clinically focused and contains optional components in which registered nurses (RNs) can receive additional credit for participation in professional growth and leadership activities. Nurses document examples of their practice through nursing narratives that describe actual clinical situations. The development and implementation processes, challenges encountered, and recommendations for alternative approaches to the implementation of such a unique system are discussed.

Impact and User Satisfaction of a Clinical Information Portal Embedded in an Electronic Health Record

PubMed Central

Tannery, Nancy H; Epstein, Barbara A; Wessel, Charles B; Yarger, Frances; LaDue, John; Klem, Mary Lou

2011-01-01

In 2008, a clinical information tool was developed and embedded in the electronic health record system of an academic medical center. In 2009, the initial information tool, Clinical-e, was superseded by a portal called Clinical Focus, with a single search box enabling a federated search of selected online information resources. To measure the usefulness and impact of Clinical Focus, a survey was used to gather feedback about users' experience with this clinical resource. The survey determined what type of clinicians were using this tool and assessed user satisfaction and perceived impact on patient care decision making. Initial survey results suggest the majority of respondents found Clinical Focus easy to navigate, the content easy to read, and the retrieved information relevant and complete. The majority would recommend Clinical Focus to their colleagues. Results indicate that this tool is a promising area for future development. PMID:22016670

The National Cancer Institute-American Society of Clinical Oncology Cancer Trial Accrual Symposium: summary and recommendations.

PubMed

Denicoff, Andrea M; McCaskill-Stevens, Worta; Grubbs, Stephen S; Bruinooge, Suanna S; Comis, Robert L; Devine, Peggy; Dilts, David M; Duff, Michelle E; Ford, Jean G; Joffe, Steven; Schapira, Lidia; Weinfurt, Kevin P; Michaels, Margo; Raghavan, Derek; Richmond, Ellen S; Zon, Robin; Albrecht, Terrance L; Bookman, Michael A; Dowlati, Afshin; Enos, Rebecca A; Fouad, Mona N; Good, Marjorie; Hicks, William J; Loehrer, Patrick J; Lyss, Alan P; Wolff, Steven N; Wujcik, Debra M; Meropol, Neal J

2013-11-01

Many challenges to clinical trial accrual exist, resulting in studies with inadequate enrollment and potentially delaying answers to important scientific and clinical questions. The National Cancer Institute (NCI) and the American Society of Clinical Oncology (ASCO) cosponsored the Cancer Trial Accrual Symposium: Science and Solutions on April 29-30, 2010 to examine the state of accrual science related to patient/community, physician/provider, and site/organizational influences, and identify new interventions to facilitate clinical trial enrollment. The symposium featured breakout sessions, plenary sessions, and a poster session including 100 abstracts. Among the 358 attendees were clinical investigators, researchers of accrual strategies, research administrators, nurses, research coordinators, patient advocates, and educators. A bibliography of the accrual literature in these three major areas was provided to participants in advance of the meeting. After the symposium, the literature in these areas was revisited to determine if the symposium recommendations remained relevant within the context of the current literature. Few rigorously conducted studies have tested interventions to address challenges to clinical trials accrual. Attendees developed recommendations for improving accrual and identified priority areas for future accrual research at the patient/community, physician/provider, and site/organizational levels. Current literature continues to support the symposium recommendations. A combination of approaches addressing both the multifactorial nature of accrual challenges and the characteristics of the target population may be needed to improve accrual to cancer clinical trials. Recommendations for best practices and for future research developed from the symposium are provided.

Making sausage--effective management of enterprise-wide clinical IT projects.

PubMed

Smaltz, Detlev H; Callander, Rhonda; Turner, Melanie; Kennamer, Gretchen; Wurtz, Heidi; Bowen, Alan; Waldrum, Mike R

2005-01-01

Unlike most other industries in which company employees are, well, company employees, U.S. hospitals are typically run by both employees (nurses, technicians, and administrative staff) and independent entrepreneurs (physicians and nurse practitioners). Therefore, major enterprise-wide clinical IT projects can never simply be implemented by mandate. Project management processes in these environments must rely on methods that influence adoption rather than presume adoption will occur. "Build it and they will come" does not work in a hospital setting. This paper outlines a large academic medical center's experiences in managing an enterprise-wide project to replace its core clinical systems functionality. Best practices include developing a cogent optimal future-state vision, communications planning and execution, vendor validation against the optimal future-state vision, and benefits realization assessment.

Capacity building for assessing new technologies: approaches to examining personalized medicine in practice

PubMed Central

Van Bebber, Stephanie L; Trosman, Julia R; Liang, Su-Ying; Wang, Grace; Marshall, Deborah A; Knight, Sara; Phillips, Kathryn A

2011-01-01

This article focuses on the overarching question: how can we use existing data to develop the capacity to improve the evidence base on personalized medicine technologies and particularly regarding their utilization and clinical utility? We focus on data from health payers who are key stakeholders in capacity building, as they need data to guide decisions and they develop data as part of operations. Broadly defined, health payers include insurance carriers, third party payers, health-plan sponsors and organized delivery systems. Data from health payers have not yet been widely used to assess personalized medicine. Now, with an increasing number of personalized technologies covered and reimbursed by health payers, and an increasing number of emerging technologies that will require policy decisions, there is a great opportunity to develop the evidence base using payer data and by engaging with these stakeholders. Here, we describe data that are available from, and are being developed by, health payers and assess how these data can be further developed to increase the capacity for future research, using three examples. The examples suggest that payer data can be used to examine clinical utility and approaches can be developed that simultaneously address the characteristics of personalized medicine, real world data and organizations. These examples can now help us to elucidate how to best examine clinical utility in actual practice and build evaluation approaches that can be applied to future technologies. PMID:21857867

Developing future clinical leaders for quality improvement: experience from a London children's hospital.

PubMed

Runnacles, Jane; Moult, Beki; Lachman, Peter

2013-11-01

Medical training does not necessarily prepare graduates for the real world of healthcare in which continual improvement is required. Doctors in postgraduate training (DrPGT) rarely have the opportunity to develop skills to implement changes where they work. Paradoxically they are often best placed to identify safety and quality concerns and can innovate across organisational boundaries. In order to address this, educational programmes require a supportive educational environment and should include experiential learning on a safety and quality project, alongside teaching of quality improvement (QI) knowledge and systems theory. Enabling Doctors in Quality Improvement and Patient Safety (EQuIP) has been designed for DrPGT at a London children's hospital. The aim is to prepare trainees for the future of continual improvement to ensure safe and effective services are developed through effective clinical microsystems. This paper describes the rationale and design of EQuIP with evaluation built in the evolving programme. EQuIP supports DrPGTs through a QI project within their department, aligned to the Great Ormond Street NHS Foundation Trust's objectives. This changes the way DrPGTs view healthcare as they become quality champions for their department. A three-level approach to the programme is described. The innovation involves a peer-designed programme while being work-based, delivering organisational strategies. Results of the preprogramme and postprogramme evaluations demonstrate an improvement in knowledge, skills and attitudes. Benefits to both the DrPGTs and the organisation are emphasised and key factors to achieve success and barriers identified by the participants. The design and evaluation of EQuIP may inform similar educational programmes in other organisations. This capacity building is crucial to ensure that future clinical leaders have the skills and motivation to improve the effectiveness of clinical microsystems.

Development of biosimilars in an era of oncologic drug shortages

PubMed Central

Li, Edward; Subramanian, Janakiraman; Anderson, Scott; Thomas, Dolca; McKinley, Jason; Jacobs, Ira A

2015-01-01

Acute and chronic shortages of various pharmaceuticals and particularly of sterile injectable products are being reported on a global scale, prompting evaluation of more effective strategies to manage current shortages and development of new, high-quality pharmaceutical products to mitigate the risk of potential future shortages. Oncology drugs such as liposomal doxorubicin and 5-fluorouracil represent examples of first-choice drugs critically affected by shortages. Survey results indicate that the majority of hospitals and practicing oncologists have experienced drug shortages, which may have compromised patient safety and clinical outcomes, and increased health care costs, due to delays or changes in treatment regimens. Clinical trials evaluating novel agents in combination with standard-of-care drugs are also being affected by drug shortages. Clinical and ethical considerations on treatment objectives, drug indication, and availability of alternative options may help in prioritizing cancer patients involved in active drug shortages. The United States Food and Drug Administration and the European Medicines Agency have identified manufacturing problems, delays in supply, and lack of available active ingredients as the most frequent causes of recent or ongoing drug shortages, and have released specific guidance to monitor, manage, and reduce the risk of shortages. The upcoming loss of exclusivity for a number of anticancer biologics, together with the introduction of an abbreviated approval pathway for biosimilars, raises the question of whether these products will be vulnerable to shortages. Future supply by reliable manufacturers of well characterized biosimilar monoclonal antibodies, developed in compliance with regulatory and manufacturing guidelines and with substantial investments, may contribute to prevent future biologics shortages and ensure access to effective and safe treatment options for patients with cancer. Preclinical and clinical characterization is ongoing for potential biosimilars of trastuzumab, rituximab, and bevacizumab, with promising results. PMID:26150698

Update on B-cell targeted therapies for systemic lupus erythematosus.

PubMed

Mok, Chi Chiu

2014-06-01

Systemic lupus erythematosus (SLE) is a systemic autoimmune disease characterized by flares and remission, leading to accrual of organ damage over time as a result of persistent tissue inflammation and treatment-related complications. Novel therapies aiming at better treatment response and fewer adverse effects are being tested in the pipeline. This review summarizes the B-cell abnormalities observed in patients with SLE, and updates recent data on the efficacy and safety of B-cell targeted therapies in the treatment of SLE. The pitfalls of clinical trial design and future directions of the development of SLE therapeutics are discussed. The variability of clinical response to treatment in SLE reflects the clinical and immunological heterogeneity of the disease. The treatment plan for patients with SLE should be individualized with the aim of eradicating disease activity, preventing flares and minimizing treatment-related complications. Despite the disappointment of recent clinical trials, B-cell remains the promising target of future SLE therapies. Results from ongoing clinical trials on B-cell targeted biological agents are eagerly awaited.

Robotics and neurosurgery.

PubMed

Nathoo, Narendra; Pesek, Todd; Barnett, Gene H

2003-12-01

Ultimately, neurosurgery performed via a robotic interface will serve to improve the standard of a neurosurgeon's skills, thus making a good surgeon a better surgeon. In fact, computer and robotic instrumentation will become allies to the neurosurgeon through the use of these technologies in training, diagnostic, and surgical events. Nonetheless, these technologies are still in an early stage of development, and each device developed will entail its own set of challenges and limitations for use in clinical settings. The future operating room should be regarded as an integrated information system incorporating robotic surgical navigators and telecontrolled micromanipulators, with the capabilities of all principal neurosurgical concepts, sharing information, and under the control of a single person, the neurosurgeon. The eventual integration of robotic technology into mainstream clinical neurosurgery offers the promise of a future of safer, more accurate, and less invasive surgery that will result in improved patient outcome.

Metastatic melanoma - a review of current and future drugs.

PubMed

Velho, Tiago Rodrigues

2012-11-19

Melanoma is one of the most aggressive cancers, and it is estimated that 76,250 men and women will be diagnosed with melanoma of the skin in the USA in 2012. Over the last few decades many drugs have been developed but only in 2011 have new drugs demonstrated an impact on survival in metastatic melanoma. A systematic search of literature was conducted, and studies providing data on the effectiveness of current and/or future drugs used in the treatment of metastatic melanoma were selected for review. This review discusses the advantages and limitations of these agents, evaluating past, current and future clinical trials designed to overcome such limitations. To date, there are four drugs approved by the Food and Drug Administration for melanoma (dacarbazine, interleukin-2, ipilimumab and vemurafenib). Despite efforts to develop new drugs, few of them have demonstrated any clinical benefits. Approved in 1975, dacarbazine remains the gold standard in chemotherapy, although ipilimumab and vemurafenib have raised many hopes in the last few years. Combining dacarbazine or other chemotherapy agents with new pharmacological agents may be a new way to achieve better clinical responses in patients with metastatic melanoma. Advances in the molecular knowledge of melanoma have led to major improvements in the treatment of patients with metastatic melanoma, providing new targets and insights. However, heterogeneity amongst study populations, different approaches to treatment and the different melanoma types and localisations included in the trials makes their comparison difficult. New studies focusing on drugs developed in recent decades are warranted.

The future of practical skills in undergraduate medical education – an explorative Delphi-Study

PubMed Central

Dannenberg, Katja Anne; Stroben, Fabian; Schröder, Therese; Thomas, Anke; Hautz, Wolf E.

2016-01-01

Background: 64% of young medical professionals in Germany do not feel adequately prepared for the practical requirements of the medical profession. The goal of “outcome-orientated training” is to structure medical curricula based on the skills needed when entering the workforce after completing undergraduate medical education, and thus to bridge the gap between the skills graduates have attained and those necessary for a career in the medical profession. Outcome frameworks (OFs) are used for this purpose. In preparation for developing the National Competence-Based Catalogue of Learning Objectives for Medicine (NKLM) – the German OF – the “Consensus Statement of Practical Skills in Undergraduate Medical Education” (which structures the teaching and acquisition of practical skills in Germany and which strongly influenced the “Clinical-Practical Skills” chapter of the NKLM) was published in 2011. It is not uncommon for at least a decade to elapse between the definition and implementation of an OF and the students’ graduation, which can further increase the gap between necessary and acquired skills. Thus, the purpose of this paper is to posit theses for future development in healthcare and to apply these theses to a current OF. Methodology: Partially structured interviews with experts were used to generate theses pertaining to general, future development in healthcare. These theses were assessed by physician experts based on the likelihood of implementation by the year 2025. The 288 learning goals of the consensus statement were assessed for their relevance for medical education in the interim. Results: 11 theses were generated for the development of medicine, and these theses were assessed and discussed by 738 experts. These theses include the increase in diseases associated with old age, the increasing significance of interprofessional cooperation, and the growing prevalence of telemedicine applications. Of the 288 learning goals of the consensus statement, 231 of the goals were assessed as relevant, and 57 were deemed irrelevant for the short-term future. Discussion: The theses on the future of healthcare, which were generated in this study and which were validated by numerous experts, provide indications of future developments of overall requirements for medical school graduates. For example, when applied to the content of the “Clinical-Practical Skills” NKLM chapter, they largely validate the future relevance of developing practical skills while also providing indications for their further development as applied to the consensus statement. PMID:27579362

The future of practical skills in undergraduate medical education - an explorative Delphi-Study.

PubMed

Dannenberg, Katja Anne; Stroben, Fabian; Schröder, Therese; Thomas, Anke; Hautz, Wolf E

2016-01-01

64% of young medical professionals in Germany do not feel adequately prepared for the practical requirements of the medical profession. The goal of "outcome-orientated training" is to structure medical curricula based on the skills needed when entering the workforce after completing undergraduate medical education, and thus to bridge the gap between the skills graduates have attained and those necessary for a career in the medical profession. Outcome frameworks (OFs) are used for this purpose. In preparation for developing the National Competence-Based Catalogue of Learning Objectives for Medicine (NKLM) - the German OF - the "Consensus Statement of Practical Skills in Undergraduate Medical Education" (which structures the teaching and acquisition of practical skills in Germany and which strongly influenced the "Clinical-Practical Skills" chapter of the NKLM) was published in 2011. It is not uncommon for at least a decade to elapse between the definition and implementation of an OF and the students' graduation, which can further increase the gap between necessary and acquired skills. Thus, the purpose of this paper is to posit theses for future development in healthcare and to apply these theses to a current OF. Partially structured interviews with experts were used to generate theses pertaining to general, future development in healthcare. These theses were assessed by physician experts based on the likelihood of implementation by the year 2025. The 288 learning goals of the consensus statement were assessed for their relevance for medical education in the interim. 11 theses were generated for the development of medicine, and these theses were assessed and discussed by 738 experts. These theses include the increase in diseases associated with old age, the increasing significance of interprofessional cooperation, and the growing prevalence of telemedicine applications. Of the 288 learning goals of the consensus statement, 231 of the goals were assessed as relevant, and 57 were deemed irrelevant for the short-term future. The theses on the future of healthcare, which were generated in this study and which were validated by numerous experts, provide indications of future developments of overall requirements for medical school graduates. For example, when applied to the content of the "Clinical-Practical Skills" NKLM chapter, they largely validate the future relevance of developing practical skills while also providing indications for their further development as applied to the consensus statement.

The Future of Clinical Education: Using Futuristic Scenarios to Explore Allied Health Deans' Perspectives on Clinical Education.

PubMed

Romig, Barbara D; Tucker, Ann W; Hewitt, Anne M; O'Sullivan Maillet, Julie

2017-01-01

There is limited information and consensus on the future of clinical education. The Delphi technique was selected to identify agreement among Association of Schools of Allied Health Professions' (ASAHP) allied health deans on the future (2018-2023) of allied health (AH) clinical education. Sixty-one AH deans, 54.9% (61 of 111) of the ASAHP membership, expressed opinions about clinical education through a three-round Delphi study. In conjunction with a conceptual model, four futuristic scenarios were used to encourage deans' feedback on the key factors impacting the future of clinical education. The responses to the four scenarios showed ways the external environment influences which activities the deans recommend. The results presented, by individual scenario and in totality, provide relevant and timely information on the importance and transformation of AH clinical education and its future. Futuristic scenarios, in combination with the Delphi technique, generated information where little exists specific to AH deans' perspectives on AH clinical education. The results offer deans opportunities for future strategic improvements. The use of the futuristic scenarios was suitable for guiding deans' responses and reaching agreement on the future of AH clinical education. These contributions reflect the imminent conditions and healthcare environment identified in the various scenarios and provide additional insight on key factors impacting the future for AH clinical education.

Establishing Correlates of Protection for Vaccine Development: Considerations for the Respiratory Syncytial Virus Vaccine Field.

PubMed

Kulkarni, Prasad S; Hurwitz, Julia L; Simões, Eric A F; Piedra, Pedro A

2018-03-01

Correlates of protection (CoPs) can play a significant role in vaccine development by assisting the selection of vaccine candidates for clinical trials, supporting clinical trial design and implementation, and simplifying tests of vaccine modifications. Because of this important role in vaccine development, it is essential that CoPs be defined by well-designed immunogenicity and efficacy studies, with attention paid to benefits and limitations. The respiratory syncytial virus (RSV) field is unique in that a great deal of information about the humoral response is available from basic research and clinical studies. Polyclonal and monoclonal antibodies have been used routinely in the clinic to protect vulnerable infants from infection, providing a wealth of information about correlations between neutralizing antibodies and disease prevention. Considerations for the establishment of future CoPs to support RSV vaccine development in different populations are therefore discussed.

Challenges of assessing the clinical efficacy of asexual blood-stage Plasmodium falciparum malaria vaccines.

PubMed

Sheehy, Susanne H; Douglas, Alexander D; Draper, Simon J

2013-09-01

In the absence of any highly effective vaccine candidate against Plasmodium falciparum malaria, it remains imperative for the field to pursue all avenues that may lead to the successful development of such a formulation. The development of a subunit vaccine targeting the asexual blood-stage of Plasmodium falciparum malaria infection has proven particularly challenging with only limited success to date in clinical trials. However, only a fraction of potential blood-stage vaccine antigens have been evaluated as targets, and a number of new promising candidate antigen formulations and delivery platforms are approaching clinical development. It is therefore essential that reliable and sensitive methods of detecting, or ruling out, even modest efficacy of blood-stage vaccines in small clinical trials be established. In this article we evaluate the challenges facing blood-stage vaccine developers, assess the appropriateness and limitations of various in vivo approaches for efficacy assessment and suggest future directions for the field.

Scientific ways to study intercessory prayer as an intervention in clinical research.

PubMed

Rath, Linda L

2009-01-01

The purpose of this article is to share a "research journey" to study the somewhat controversial subject of Christian intercessory prayer (CIP) utilized as a clinical intervention, and the knowledge gained along the way. This article will explore the steps in the development and implementation of clinical research to scientifically examine a phenomenon that many say cannot--and should not--be studied. The sequential steps in developing this area of study are detailed and explained from the conception of the initial idea through utilization of concept analysis and literature review to develop the researchable topic. The subsequent development of both qualitative and quantitative pilot studies to investigate CIP in depth is presented to illustrate how the intervention of CIP can successfully be incorporated into clinical research. This article provides guidelines for future researchers who may want to utilize CIP as an intervention.

Appraising the methodological quality of the clinical practice guideline for diabetes mellitus using the AGREE II instrument: a methodological evaluation.

PubMed

Radwan, Mahmoud; Akbari Sari, Ali; Rashidian, Arash; Takian, Amirhossein; Abou-Dagga, Sanaa; Elsous, Aymen

2017-02-01

To evaluate the methodological quality of the Palestinian Clinical Practice Guideline for Diabetes Mellitus using the Translated Arabic Version of the AGREE II. Methodological evaluation. A cross-cultural adaptation framework was followed to translate and develop a standardised Translated Arabic Version of the AGREE II. Palestinian Primary Healthcare Centres. Sixteen appraisers independently evaluated the Clinical Practice Guideline for Diabetes Mellitus using the Translated Arabic Version of the AGREE II. Methodological quality of diabetic guideline. The Translated Arabic Version of the AGREE II showed an acceptable reliability and validity. Internal consistency ranged between 0.67 and 0.88 (Cronbach's α). Intra-class coefficient among appraisers ranged between 0.56 and 0.88. The quality of this guideline is low. Both domains 'Scope and Purpose' and 'Clarity of Presentation' had the highest quality scores (66.7% and 61.5%, respectively), whereas the scores for 'Applicability', 'Stakeholder Involvement', 'Rigour of Development' and 'Editorial Independence' were the lowest (27%, 35%, 36.5%, and 40%, respectively). The findings suggest that the quality of this Clinical Practice Guideline is disappointingly low. To improve the quality of current and future guidelines, the AGREE II instrument is extremely recommended to be incorporated as a gold standard for developing, evaluating or updating the Palestinian Clinical Practice Guidelines. Future guidelines can be improved by setting specific strategies to overcome implementation barriers with respect to economic considerations, engaging of all relevant end-users and patients, ensuring a rigorous methodology for searching, selecting and synthesising the evidences and recommendations, and addressing potential conflict of interests within the development group.

Trailblazing Partnerships: Professional Development Schools in Partnership with Emporia State University

ERIC Educational Resources Information Center

Jones, Jill; Schwerdtfeger, Sara; Roop, Teddy; Long, Jennie L.

2016-01-01

Emporia State University is committed to preparing future elementary education teachers through the collaborative efforts and ongoing reflective practice between the university and school districts. The Professional Development School is the vehicle behind the structured involvement in the process of immersing student-teacher in a clinical model…

Exogenous near-infrared fluorophores and their applications in cancer diagnosis: biological and clinical perspectives.

PubMed

Zhang, Hua; Uselman, Ryan R; Yee, Douglas

2011-05-01

Near-infrared fluorescent (NIRF) imaging is a rapidly growing research field which has the potential to be an important imaging modality in cancer diagnosis. Various exogenous NIR fluorophores have been developed for the technique, including small molecule fluorophores and nanoparticles. NIRF imaging has been used in animal models for the detection of cancer overthe last twenty years and has in recent years been used in human clinical trials. This article describes the types and characteristics of exogenous fluorophores available for in vivo fluorescent cancer imaging. The article also discusses the progression of NIRF cancer imaging over recent years and its future challenges, from both a biological and clinical perspective. in The review also looks at its application for lymph node mapping, tumor targeting and characterization, and tumor margin definition for surgical guidance. NIRF imaging is not in routine clinical cancer practice; yet, the authors predict that techniques using NIR fluorophores for tumor margin definition and lymph node mapping will enter clinical practice in the near future. The authors also anticipate that NIRF imaging research will lead to the development of flurophores with 'high brightness' that will overcome the limited penetration of this modality and be better suited for non invasive tumor targeting.

Re-thinking the role of radiometal isotopes: Towards a future concept for theranostic radiopharmaceuticals.

PubMed

Notni, Johannes; Wester, Hans-Jürgen

2018-03-01

The potential and future role of certain metal radionuclides, for example, 44 Sc, 89 Zr, 86 Y, 64 Cu, 68 Ga, 177 Lu, 225 Ac, and 213 Bi, and several terbium isotopes has been controversially discussed in the past decades. Furthermore, the possible benefits of "matched pairs" of isotopes for tandem applications of diagnostics and therapeutics (theranostics) have been emphasized, while such approaches still have not made their way into routine clinical practice. Analysis of bibliographical data illustrates how popularity of certain nuclides has been promoted by cycles of availability and applications. We furthermore discuss the different practical requirements for diagnostic and therapeutic radiopharmaceuticals and the resulting consequences for efficient development of clinically useful pairs of radionuclide theranostics, with particular emphasis on the underlying economical factors. Based on an exemplary assessment of overall production costs for 68 Ga and 18 F radiopharmaceuticals, we venture a look into the future of theranostics and predict that high-throughput PET applications, that is, diagnosis of frequent conditions, will ultimately rely on 18 F tracers. PET radiometals will occupy a niche in the clinical low-throughput sector (diagnosis of rare diseases), but above all, dominate preclinical research and clinical translation. Matched isotope pairs will be of lesser relevance for theranostics but may become important for future PET-based therapeutic dosimetry. Copyright © 2017 John Wiley & Sons, Ltd.

Bruton's tyrosine kinase inhibitors in B-cell lymphoma: current experience and future perspectives.

PubMed

Seiler, T; Dreyling, M

2017-08-01

The Bruton tyrosine kinase (BTK) is a central hub in the B cell receptor (BCR) pathway and strongly influences B cell maturation, differentiation and proliferation. Not surprisingly, BTK plays an essential role in the pathogenesis of various B cell lymphomas. Inhibitors of BTK have broadened our therapeutic options in several B cell lymphomas and already are an integral element in the treatment of Mantle Cell Lymphoma (MCL), chronic lymphocytic leukemia (CLL) and Waldenström's marcoglobulinemia. Several second generation BTK inhibitors are in clinical development and might further improve tolerability and efficacy of therapy in advanced stage CLL and MCL. Areas covered: This review illustrates the mechanism of action of BTK inhibitors and provides a comprehensive summary of key clinical trials in the development of BTK inhibitors. Characteristics of second generation BTK-inhibitors are described. Expert opinion: With accumulation of clinical experience after drug approval, longer patient follow-up and larger numbers of treated patients, future development will focus on the identification of intelligent treatment combinations. Individual selection of patients with distinct biologically properties might guide treatment decisions. While BTK inhibitors are moving to earlier treatment lines, the incorporation of these drugs into a comprehensive therapeutic strategy is still difficult to date.

Use of clinical simulations for patient education: targeting an untapped audience.

PubMed

Siwe, Karin; Berterö, Carina; Pugh, Carla; Wijma, Barbro

2009-01-01

In most cases, the health professional has been the target for simulation based learning curricula. We have developed a simulation based curriculum for patient education. In our curriculum lay-women learn how to perform the clinical female pelvic examination using a manikin-based trainer. Learner assessments show that prior negative expectations turned into positive expectations regarding future pelvic examinations.

Biosimilar Monoclonal Antibodies for Inflammatory Bowel Disease: Current Comfort and Future Prospects.

PubMed

Gecse, Krisztina B; Lakatos, Péter L

2016-10-01

Biosimilars are biologic medicines that enter the market after a patent for an original reference product expires. The European Medicines Agency (EMA) developed a stringent legislation process for biosimilar monoclonal antibodies, whereby similarity to the reference medicinal product in terms of quality characteristics, biological activity, clinical safety and efficacy must be demonstrated. Biosimilar infliximab CT-P13 was the first biosimilar monoclonal antibody to receive EMA marketing authorization, and further biosimilar molecules are being developed. The phase I and III clinical trials were conducted in ankylosing spondylitis and rheumatoid arthritis, and the use of CT-P13 in inflammatory bowel disease (IBD) was extrapolated on the results of these trials. Medical professionals were initially concerned about the reversed engineering process, the novel legal framework and the lack of clinical data in IBD. Emerging real-world data have confirmed the similarities between CT-P13 and the reference product in terms of efficacy, safety and immunogenicity in IBD. The cost reduction represented by biosimilars promotes industry competition and improves treatment access with sustained quality of care. This article reviews the existing and emerging clinical data for CT-P13 and a future perspective on biosimilar use in IBD.

The Bobath concept in contemporary clinical practice.

PubMed

Graham, Julie Vaughan; Eustace, Catherine; Brock, Kim; Swain, Elizabeth; Irwin-Carruthers, Sheena

2009-01-01

Future development in neurorehabilitation depends upon bringing together the endeavors of basic science and clinical practice. The Bobath concept is widely utilized in rehabilitation following stroke and other neurological conditions. This concept was first developed in the 1950s, based on the neuroscience knowledge of those times. The theoretical basis of the Bobath concept is redefined based on contemporary neuroscience and rehabilitation science. The framework utilized in the Bobath concept for the analysis of movement and movement dysfunction is described. This framework focuses on postural control for task performance, the ability to move selectively, the ability to produce coordinated sequences of movement and vary movement patterns to fit a task, and the role of sensory input in motor behaviour and learning. The article describes aspects of clinical practice that differentiate this approach from other models of practice. Contemporary practice in the Bobath concept utilizes a problem-solving approach to the individual's clinical presentation and personal goals. Treatment is focused toward remediation, where possible, and guiding the individual towards efficient movement strategies for task performance. The aim of this article is to provide a theoretical framework on which future research into the Bobath concept can be based.

Leveraging Epidemiology and Clinical Studies of Cancer Outcomes: Recommendations and Opportunities for Translational Research

PubMed Central

2013-01-01

As the number of cancer survivors continues to grow, research investigating the factors that affect cancer outcomes, such as disease recurrence, risk of second malignant neoplasms, and the late effects of cancer treatments, becomes ever more important. Numerous epidemiologic studies have investigated factors that affect cancer risk, but far fewer have addressed the extent to which demographic, lifestyle, genomic, clinical, and psychosocial factors influence cancer outcomes. To identify research priorities as well as resources and infrastructure needed to advance the field of cancer outcomes and survivorship research, the National Cancer Institute sponsored a workshop titled “Utilizing Data from Cancer Survivor Cohorts: Understanding the Current State of Knowledge and Developing Future Research Priorities” on November 3, 2011, in Washington, DC. This commentary highlights recent findings presented at the workshop, opportunities to leverage existing data, and recommendations for future research, data, and infrastructure needed to address high priority clinical and research questions. Multidisciplinary teams that include epidemiologists, clinicians, biostatisticians, and bioinformaticists will be essential to facilitate future cancer outcome studies focused on improving clinical care of cancer patients, identifying those at high risk of poor outcomes, and implementing effective interventions to ultimately improve the quality and duration of survival. PMID:23197494

Clinical protein science developments for patient monitoring in hospital central laboratories.

PubMed

Malm, Johan; Marko-Varga, György

2016-12-01

Patient care relies heavily on standardized tests performed in hospital laboratories, typically including clinical chemistry, pathology and microbiology. With the introduction of personalized medicine tremendous efforts have been made to identify new biomarkers of disease with various omics technologies, often including mass spectrometry. In order to validate new biomarkers and perform clinical studies high quality biobank samples are of key importance. In this editorial different aspects of mass spectrometry in future personalized medicine are discussed.

Clinical Pharmacology & Therapeutics: Past, Present and Future

PubMed Central

Waldman, SA; Terzic, A

2016-01-01

Clinical Pharmacology & Therapeutics (CPT), the definitive and timely source for advances in human therapeutics, transcends the drug discovery, development, regulation and utilization continuum to catalyze, evolve and disseminate discipline-transformative knowledge. Prioritized themes and multidisciplinary content drive the science and practice of clinical pharmacology, offering a trusted point of reference. An authoritative herald across global communities, CPT is a timeless information vehicle at the vanguard of discovery, translation and application ushering therapeutic innovation into modern health care. PMID:28194770

Recommendations for future development of contractility and obstruction nomograms for women. ICI-RS 2014.

PubMed

Rademakers, Kevin; Apostolidis, Apostolos; Constantinou, Christos; Fry, Christopher; Kirschner-Hermanns, Ruth; Oelke, Matthias; Parsons, Brian; Nelson, Pierre; Valentini, Françoise; Gammie, Andrew

2016-02-01

At present, existing bladder outlet obstruction (BOO) nomograms for women are still not universally accepted. Moreover, only limited information is available regarding bladder contractility in women. The aim is to present the discussions and recommendations from the think tank session "Can we construct and validate contractility and obstruction nomograms for women?" held at the 2014 International Consultation on Incontinence-Research Society (ICI-RS) meeting in Bristol, UK. An overview of clinical significance, bladder mechanics and modelling, lack of existing nomograms for women, and development of new nomograms were presented and discussed in a multidisciplinary think tank session. This think tank session was based on a collaboration between physicians, engineers, and researchers and consensus was achieved on future research initiatives. Based on the think tank discussion, the ICI-RS panel put forward the following recommendations: the need to acquire normative age-matched data in women to define "normal" and "pathological" values of urodynamic parameters; the inclusion of additional clinical data in new nomograms and the use of this extra dimension to develop clinically applicable nomograms for female BOO and contractility; and finally, the need to take into account the variability of BOO in women when developing female bladder contractility nomograms. © 2016 Wiley Periodicals, Inc.

Rhinology Future Debates, an EUFOREA Report.

PubMed

Fokkens, W J; Bachert, C; Bernal-Sprekelsen, M; Bousquet, J; Djandji, M; Dorenbaum, A; Hakimi-Mehr, D; Hendry, S; Hopkins, C; Leunig, A; Mannent, L; Mucha, D; Onerci, M; Pugin, B; Toppila-Salmi, S; Rowe, P; Seys, S F; Stimson, S; Strzembosz, A; Hellings, P W

2017-12-01

The first Rhinology Future Debates was held in Brussels in December 2016, organized by EUFOREA (European Forum for Research and Education in Allergy and Airways diseases). The purpose of these debates is to bring novel developments in the field of Rhinology to the attention of the medical, paramedical and patient community, in a highly credible and balanced context. For the first time in Rhinology, a peer to peer scientific exchange with key experts in the field of rhinology and key medical colleagues from leading industries let to a brainstorming and discussion event on a number of hot issues in Rhinology. Novel developments are presented by key experts from industry and/or key thought leaders in Rhinology, and then followed by a lively debate on the potential positioning of new developments in care pathways, the strengths and weaknesses of the novel development(s), and comparisons with existing and/or competing products, devices, and/or molecules. As all debates are recorded and distributed on-line with limited editing (www.rhinology-future.com), EUFOREA aims at maximizing the education of the target groups on novel developments, allowing a critical appraisal of the future and a more rapid implementation of promising novel tools, techniques and/or molecules in clinical practise in Europe. The next Rhinology Future debate will be held in Brussels in December 2017.

[Influence of new technologies in modern microbiology].

PubMed

Pumarola, Tomás

2010-10-01

The influence of new technologies in modern microbiology is directly related to their automation, the real driving force of change. Automation has occurred since the beginning of clinical microbiology, but from the 1980s has experienced huge development, which is being projected through the immediate future to all areas of the speciality. Automation has become a prime organizational tool. However, its main disadvantage is that it has no limits, which in association with the current economicallyoriented criteria, is encouraging initiatives to integrate the various laboratory specialities into one production center and, eventually, to outsource its activity. This process could significantly reduce the quality of clinical microbiology and the training of future specialists, or even worst, lead to the eventual disappearance of the speciality, at least as it is known today. The future development of highly automated and integrated laboratories is an irreversible process. To preserve the quality of the speciality and of specialist training, rather than fight directly against this process, we must, as microbiologists, actively participate with creativity and leadership. Copyright © 2010 Elsevier España S.L. All rights reserved.

Advances in Monitoring Cell-Based Therapies with Magnetic Resonance Imaging: Future Perspectives

PubMed Central

Ngen, Ethel J.; Artemov, Dmitri

2017-01-01

Cell-based therapies are currently being developed for applications in both regenerative medicine and in oncology. Preclinical, translational, and clinical research on cell-based therapies will benefit tremendously from novel imaging approaches that enable the effective monitoring of the delivery, survival, migration, biodistribution, and integration of transplanted cells. Magnetic resonance imaging (MRI) offers several advantages over other imaging modalities for elucidating the fate of transplanted cells both preclinically and clinically. These advantages include the ability to image transplanted cells longitudinally at high spatial resolution without exposure to ionizing radiation, and the possibility to co-register anatomical structures with molecular processes and functional changes. However, since cellular MRI is still in its infancy, it currently faces a number of challenges, which provide avenues for future research and development. In this review, we describe the basic principle of cell-tracking with MRI; explain the different approaches currently used to monitor cell-based therapies; describe currently available MRI contrast generation mechanisms and strategies for monitoring transplanted cells; discuss some of the challenges in tracking transplanted cells; and suggest future research directions. PMID:28106829

Personality: individual differences and clinical assessment.

PubMed

Butcher, J N; Rouse, S V

1996-01-01

Research in clinical personality assessment continues to be produced at a high rate. The MMPI/MMPI-2 remains the most popular instrument for both clinical application and psychopathology research. Two other clinical personality instruments, the Rorschach and TAT, continue to find a place in research and clinical assessment. Some new instruments have surfaced recently to deal with areas, such as personality disorders, that have been considered inadequately addressed. There is a growing recognition that the Five-Factor Model is too superficial for clinical assessment that requires more refined and broadened patient information. Clinical personality assessment has successfully survived a number of past challenges. The newest challenge stems from the health-care revolution, in which managed-care providers are reluctant to pay for assessment because of shrinking funds. Psychologists need to develop models for incorporating assessment information into the treatment process. The future is likely to see more extensive research and theoretical development in this endeavor.

Clinical simulation: a sine qua non of nurse education or a white elephant?

PubMed

Stayt, Louise C

2012-07-01

An emphasis has been placed on clinical skill development in nurse education curricula due to the expressed concern about nursing students' clinical competence at the point of registration. Hence, the use of clinical simulation as an educational tool has become increasingly popular. The aim of this article is to examine the learning theory that underpins clinical simulation by utilising Carper's patterns of knowing (1978) as a theoretical framework. It is revealed that there is a philosophical conflict between the different learning approaches required to meet all the expected learning outcomes. It would also appear that due to a paucity of the current evidence base that the cost benefits of clinical simulation are largely unknown. The implications of these limitations may in part be overcome by future research endeavours, judicious curriculum development and a pluralistic approach to the facilitation of clinical simulation. Copyright © 2011 Elsevier Ltd. All rights reserved.

PODCAST: From Lost in Translation to Paradise Found: Enabling Protein Biomarker Method Transfer by Mass Spectrometry | Office of Cancer Clinical Proteomics Research

Cancer.gov

Translation of novel biomarkers into clinical care for the evaluation of therapeutic safety and efficacy has been slow, partly attributable to the cost and complexity of immunoassay development.  The potential for liquid chromatography-tandem mass spectrometry (LC-MS/MS) to streamline the translation of novel protein biomarkers is profound.  Drs. Henry Rodriguez and Andrew Hoofnagle discuss what the future may be for clinical proteomics. This is an American Association for Clinical Chemistry (AACC) podcast.

The Importance of Considering Clinical Utility in the Construction of a Diagnostic Manual.

PubMed

Mullins-Sweatt, Stephanie N; Lengel, Gregory J; DeShong, Hilary L

2016-01-01

The development of major diagnostic manuals primarily has been guided by construct validity rather than clinical utility. The purpose of this article is to summarize recent research and theory examining the importance of clinical utility when constructing and evaluating a diagnostic manual. We suggest that construct validity is a necessary but not sufficient criterion for diagnostic constructs. This article discusses components of clinical utility and how these have applied to the current and forthcoming diagnostic manuals. Implications and suggestions for future research are provided.

Childhood Ataxia: Clinical Features, Pathogenesis, Key Unanswered Questions, and Future Directions

PubMed Central

Ashley, Claire N.; Hoang, Kelly D.; Lynch, David R.; Perlman, Susan L.; Maria, Bernard L.

2013-01-01

Childhood ataxia is characterized by impaired balance and coordination primarily due to cerebellar dysfunction. Friedreich ataxia, a form of childhood ataxia, is the most common multisystem autosomal recessive disease. Most of these patients are homozygous for the GAA repeat expansion located on the first intron of the frataxin gene on chromosome 9. Mutations in the frataxin gene impair mitochondrial function, increase reactive oxygen species, and trigger redistribution of iron in the mitochondria and cytosol. Targeted therapies for Friedreich ataxia are undergoing testing. In addition, a centralized database, patient registry, and natural history study have been launched to support clinical trials in Friedreich ataxia. The 2011 Neurobiology of Disease in Children symposium, held in conjunction with the 40th annual Child Neurology Society meeting, aimed to (1) describe clinical features surrounding Friedreich ataxia, including cardiomyopathy and genetics; (2) discuss recent advances in the understanding of the pathogenesis of Friedreich ataxia and developments of clinical trials; (3) review new investigations of characteristic symptoms; (4) establish clinical and biochemical overlaps in neurodegenerative diseases and possible directions for future basic, translational, and clinical studies. PMID:22859693

[Level of Development of Clinical Ethics Consultation in Psychiatry - Results of a Survey Among Psychiatric Acute Clinics and Forensic Psychiatric Hospitals].

PubMed

Gather, Jakov; Kaufmann, Sarah; Otte, Ina; Juckel, Georg; Schildmann, Jan; Vollmann, Jochen

2018-04-17

The aim of this article is to assess the level of development of clinical ethics consultation in psychiatric institutions in North Rhine-Westphalia. Survey among medical directors, directors of nursing and administrative directors of all psychiatric acute clinics and forensic psychiatric hospitals in North Rhine-Westphalia. 113 persons working in psychiatric acute clinics responded (reponse rate: 48 %) and 13 persons working in forensic psychiatric hospitals (response rate 54 %). We received at least one response from 89 % of all psychiatric acute clinics and from 100 % of all forensic psychiatric hospitals. 90 % of the responding psychiatric acute clinics and 29 % of the responding forensic psychiatric hospitals have already implemented clinical ethics consultation. Clinical ethics consultation is more widespread in psychiatric institutions than was hitherto assumed. Future medical ethics research should therefore give greater attention to the methodology and the quality of clinical ethics consultation in psychiatric practice. © Georg Thieme Verlag KG Stuttgart · New York.

NeuroMind: Past, present, and future.

PubMed

Kubben, Pieter L

2017-01-01

This narrative report describes the underlying rationale and technical developments of NeuroMind, a mobile clinical decision support system for neurosurgery. From the perspective of a neurosurgeon - (app) developer it explains how technical progress has shaped the world's "most rated and highest rated" neurosurgical mobile application, with particular attention for operating system diversity on mobile hardware, cookbook medicine, regulatory affairs (in particular regarding software as a medical device), and new developments in the field of clinical data science, machine learning, and predictive analytics. Finally, the concept of "computational neurosurgery" is introduced as a vehicle to reach new horizons in neurosurgery.

NeuroMind: Past, present, and future

PubMed Central

Kubben, Pieter L.

2017-01-01

This narrative report describes the underlying rationale and technical developments of NeuroMind, a mobile clinical decision support system for neurosurgery. From the perspective of a neurosurgeon – (app) developer it explains how technical progress has shaped the world's “most rated and highest rated” neurosurgical mobile application, with particular attention for operating system diversity on mobile hardware, cookbook medicine, regulatory affairs (in particular regarding software as a medical device), and new developments in the field of clinical data science, machine learning, and predictive analytics. Finally, the concept of “computational neurosurgery” is introduced as a vehicle to reach new horizons in neurosurgery. PMID:28966822

Publish or perish: writing clinical manuscripts suitable for publication.

PubMed

Batcheller, Joyce; Kirksey, Kenn M; VanDyke, Yvonne; Armstrong, Myrna L

2012-01-01

A successful hospital network and university faculty collaboration offered 21 staff nurses and nurse leaders opportunities to develop clinical manuscripts that would be suitable for publishing their innovative ideas. This process prepared them to synthesize relevant literature and develop their ideas into manuscripts. Ten nurses submitted their final manuscripts to refereed journals, and nine individuals or team members had their articles accepted. These accepted publications provided a boost to individual career development and stimulated further valuable professional dissemination goals. One major challenge was to seek further ways to find time to write while working in today's health care arena. Suggestions for future manuscript development are provided. Copyright 2012, SLACK Incorporated.

Malformations of Cortical Development and Epilepsy

PubMed Central

Barkovich, A. James; Dobyns, William B.; Guerrini, Renzo

2015-01-01

Malformations of cortical development (MCDs) are an important cause of epilepsy and an extremely interesting group of disorders from the perspective of brain development and its perturbations. Many new MCDs have been described in recent years as a result of improvements in imaging, genetic testing, and understanding of the effects of mutations on the ability of their protein products to correctly function within the molecular pathways by which the brain functions. In this review, most of the major MCDs are reviewed from a clinical, embryological, and genetic perspective. The most recent literature regarding clinical diagnosis, mechanisms of development, and future paths of research are discussed. PMID:25934463

Prospects and perspectives for development of a vaccine against herpes simplex virus infections.

PubMed

McAllister, Shane C; Schleiss, Mark R

2014-11-01

Herpes simplex viruses 1 and 2 are human pathogens that lead to significant morbidity and mortality in certain clinical settings. The development of effective antiviral medications, however, has had little discernible impact on the epidemiology of these pathogens, largely because the majority of infections are clinically silent. Decades of work have gone into various candidate HSV vaccines, but to date none has demonstrated sufficient efficacy to warrant licensure. This review examines developments in HSV immunology and vaccine development published since 2010, and assesses the prospects for improved immunization strategies that may result in an effective, licensed vaccine in the near future.

Prospects and Perspectives for Development of a Vaccine Against Herpes Simplex Virus Infections

PubMed Central

McAllister, Shane C.; Schleiss, Mark R.

2014-01-01

Herpes simplex viruses 1 and -2 are human pathogens that lead to significant morbidity and mortality in certain clinical settings. The development of effective antiviral medications, however, has had little discernible impact on the epidemiology of these pathogens, largely because the majority of infections are clinically silent. Decades of work have gone into various candidate HSV vaccines, but to date none has demonstrated sufficient efficacy to warrant licensure. This review examines developments in HSV immunology and vaccine development published since 2010, and assesses the prospects for improved immunization strategies that may result in an effective, licensed vaccine in the near future. PMID:25077372

Viewing clinical research career development through the lens of social cognitive career theory.

PubMed

Bakken, Lori L; Byars-Winston, Angela; Wang, Min-Fen

2006-02-01

Issues such as, over commitment, insufficient time, and lack of funding, threaten physicians' entry and sustainability in a research career pathway. Social cognitive career theory is presented as a conceptual framework to critically examine the limitations of the National Institutes of Health's (NIH) efforts to promote the career development of physician-scientists. Special attention is given to the unique challenges of promoting this career pathway for women and underrepresented minorities. The authors propose enhanced recommendations for the career development of physician-scientists and research questions for future studies and program development aimed at advancing the nation's efforts to promote clinical research.

A historical overview of magnetic resonance imaging, focusing on technological innovations.

PubMed

Ai, Tao; Morelli, John N; Hu, Xuemei; Hao, Dapeng; Goerner, Frank L; Ager, Bryan; Runge, Val M

2012-12-01

Magnetic resonance imaging (MRI) has now been used clinically for more than 30 years. Today, MRI serves as the primary diagnostic modality for many clinical problems. In this article, historical developments in the field of MRI will be discussed with a focus on technological innovations. Topics include the initial discoveries in nuclear magnetic resonance that allowed for the advent of MRI as well as the development of whole-body, high field strength, and open MRI systems. Dedicated imaging coils, basic pulse sequences, contrast-enhanced, and functional imaging techniques will also be discussed in a historical context. This article describes important technological innovations in the field of MRI, together with their clinical applicability today, providing critical insights into future developments.

Detrusor underactivity: Pathophysiological considerations, models and proposals for future research. ICI-RS 2013.

PubMed

van Koeveringe, Gommert A; Rademakers, Kevin L J; Birder, Lori A; Korstanje, Cees; Daneshgari, Firouz; Ruggieri, Michael R; Igawa, Yasuhiko; Fry, Christopher; Wagg, Adrian

2014-06-01

Detrusor underactivity, resulting in either prolonged or inefficient voiding, is a common clinical problem for which treatment options are currently limited. The aim of this report is to summarize current understanding of the clinical observation and its underlying pathophysiological entities. This report results from presentations and subsequent discussion at the International Consultation on Incontinence Research Society (ICI-RS) in Bristol, 2013. The recommendations made by the ICI-RS panel include: Development of study tools based on a system's pathophysiological approach, correlation of in vitro and in vivo data in experimental animals and humans, and development of more comprehensive translational animal models. In addition, there is a need for longitudinal patient data to define risk groups and for the development of screening tools. In the near-future these recommendations should lead to a better understanding of detrusor underactivity and its pathophysiological background. Neurourol. Urodynam. 33:591-596, 2014. © 2014 Wiley Periodicals, Inc. © 2014 Wiley Periodicals, Inc.

Independent data monitoring committees: Preparing a path for the future

PubMed Central

Hess, Connie N.; Roe, Matthew T.; Gibson, C. Michael; Temple, Robert J.; Pencina, Michael J.; Zarin, Deborah A.; Anstrom, Kevin J.; Alexander, John H.; Sherman, Rachel E.; Fiedorek, Fred T.; Mahaffey, Kenneth W.; Lee, Kerry L.; Chow, Shein-Chung; Armstrong, Paul W.; Califf, Robert M.

2014-01-01

Independent data monitoring committees (IDMCs) were introduced to monitor patient safety and study conduct in randomized clinical trials (RCTs), but certain challenges regarding the utilization of IDMCs have developed. First, the roles and responsibilities of IDMCs are expanding, perhaps due to increasing trial complexity and heterogeneity regarding medical, ethical, legal, regulatory, and financial issues. Second, no standard for IDMC operating procedures exists, and there is uncertainty about who should determine standards and whether standards should vary with trial size and design. Third, considerable variability in communication pathways exist across IDMC interfaces with regulatory agencies, academic coordinating centers, and sponsors. Finally, there has been a substantial increase in the number of RCTs using IDMCs, yet there is no set of qualifications to help guide the training and development of the next generation of IDMC members. Recently, an expert panel of representatives from government, industry, and academia assembled at the Duke Clinical Research Institute to address these challenges and to develop recommendations for the future utilization of IDMCs in RCTs. PMID:25066551

The Use of Plant-Derived Ribosome Inactivating Proteins in Immunotoxin Development: Past, Present and Future Generations

PubMed Central

Rust, Aleksander; Partridge, Lynda J.; Davletov, Bazbek

2017-01-01

Ribosome inactivating proteins (RIPs) form a class of toxins that was identified over a century ago. They continue to fascinate scientists and the public due to their very high activity and long-term stability which might find useful applications in the therapeutic killing of unwanted cells but can also be used in acts of terror. We will focus our review on the canonical plant-derived RIPs which display ribosomal RNA N-glycosidase activity and irreversibly inhibit protein synthesis by cleaving the 28S ribosomal RNA of the large 60S subunit of eukaryotic ribosomes. We will place particular emphasis on therapeutic applications and the generation of immunotoxins by coupling antibodies to RIPs in an attempt to target specific cells. Several generations of immunotoxins have been developed and we will review their optimisation as well as their use and limitations in pre-clinical and clinical trials. Finally, we endeavour to provide a perspective on potential future developments for the therapeutic use of immunotoxins. PMID:29076988

Status of knowledge on student-learning environments in nursing homes: A mixed-method systematic review.

PubMed

Husebø, Anne Marie Lunde; Storm, Marianne; Våga, Bodil Bø; Rosenberg, Adriana; Akerjordet, Kristin

2018-04-01

To give an overview of empirical studies investigating nursing homes as a learning environment during nursing students' clinical practice. A supportive clinical learning environment is crucial to students' learning and for their development into reflective and capable practitioners. Nursing students' experience with clinical practice can be decisive in future workplace choices. A competent workforce is needed for the future care of older people. Opportunities for maximum learning among nursing students during clinical practice studies in nursing homes should therefore be explored. Mixed-method systematic review using PRISMA guidelines, on learning environments in nursing homes, published in English between 2005-2015. Search of CINAHL with Full Text, Academic Search Premier, MEDLINE and SocINDEX with Full Text, in combination with journal hand searches. Three hundred and thirty-six titles were identified. Twenty studies met the review inclusion criteria. Assessment of methodological quality was based on the Mixed Methods Appraisal Tool. Data were extracted and synthesised using a data analysis method for integrative reviews. Twenty articles were included. The majority of the studies showed moderately high methodological quality. Four main themes emerged from data synthesis: "Student characteristic and earlier experience"; "Nursing home ward environment"; "Quality of mentoring relationship and learning methods"; and "Students' achieved nursing competencies." Nursing home learning environments may be optimised by a well-prepared academic-clinical partnership, supervision by encouraging mentors and high-quality nursing care of older people. Positive learning experiences may increase students' professional development through achievement of basic nursing skills and competencies and motivate them to choose the nursing home as their future workplace. An optimal learning environment can be ensured by thorough preplacement preparations in academia and in nursing home wards, continuous supervision and facilitation of team learning. © 2018 John Wiley & Sons Ltd.

Effectiveness guidance document (EGD) for Chinese medicine trials: a consensus document

PubMed Central

2014-01-01

Background There is a need for more Comparative Effectiveness Research (CER) on Chinese medicine (CM) to inform clinical and policy decision-making. This document aims to provide consensus advice for the design of CER trials on CM for researchers. It broadly aims to ensure more adequate design and optimal use of resources in generating evidence for CM to inform stakeholder decision-making. Methods The Effectiveness Guidance Document (EGD) development was based on multiple consensus procedures (survey, written Delphi rounds, interactive consensus workshop, international expert review). To balance aspects of internal and external validity, multiple stakeholders, including patients, clinicians, researchers and payers were involved in creating this document. Results Recommendations were developed for “using available data” and “future clinical studies”. The recommendations for future trials focus on randomized trials and cover the following areas: designing CER studies, treatments, expertise and setting, outcomes, study design and statistical analyses, economic evaluation, and publication. Conclusion The present EGD provides the first systematic methodological guidance for future CER trials on CM and can be applied to single or multi-component treatments. While CONSORT statements provide guidelines for reporting studies, EGDs provide recommendations for the design of future studies and can contribute to a more strategic use of limited research resources, as well as greater consistency in trial design. PMID:24885146

Clinical application of high throughput molecular screening techniques for pharmacogenomics

PubMed Central

Wiita, Arun P; Schrijver, Iris

2011-01-01

Genetic analysis is one of the fastest-growing areas of clinical diagnostics. Fortunately, as our knowledge of clinically relevant genetic variants rapidly expands, so does our ability to detect these variants in patient samples. Increasing demand for genetic information may necessitate the use of high throughput diagnostic methods as part of clinically validated testing. Here we provide a general overview of our current and near-future abilities to perform large-scale genetic testing in the clinical laboratory. First we review in detail molecular methods used for high throughput mutation detection, including techniques able to monitor thousands of genetic variants for a single patient or to genotype a single genetic variant for thousands of patients simultaneously. These methods are analyzed in the context of pharmacogenomic testing in the clinical laboratories, with a focus on tests that are currently validated as well as those that hold strong promise for widespread clinical application in the near future. We further discuss the unique economic and clinical challenges posed by pharmacogenomic markers. Our ability to detect genetic variants frequently outstrips our ability to accurately interpret them in a clinical context, carrying implications both for test development and introduction into patient management algorithms. These complexities must be taken into account prior to the introduction of any pharmacogenomic biomarker into routine clinical testing. PMID:23226057

Doctoral programs to train future leaders in clinical and translational science.

PubMed

Switzer, Galen E; Robinson, Georgeanna F W B; Rubio, Doris M; Fowler, Nicole R; Kapoor, Wishwa N

2013-09-01

Although the National Institutes of Health (NIH) has made extensive investments in educational programs related to clinical and translational science (CTS), there has been no systematic investigation of the number and characteristics of PhD programs providing training to future leaders in CTS. The authors undertook to determine the number of institutions that, having had received NIH-funded Clinical and Translational Science Awards (CTSAs), currently had or were developing PhD programs in CTS; to examine differences between programs developed before and after CTSA funding; and to provide detailed characteristics of new programs. In 2012, CTS program leaders at the 60 CTSA-funded institutions completed a cross-sectional survey focusing on four key domains related to PhD programs in CTS: program development and oversight; students; curriculum and research; and milestones. Twenty-two institutions had fully developed PhD programs in CTS, and 268 students were earning PhDs in this new field; 13 institutions were planning PhD programs. New programs were more likely to have fully developed PhD competencies and more likely to include students in medical school, students working only on their PhD, students working on a first doctoral degree, and students working in T1 translational research. They were less likely to include physicians and students working in clinical or T2 research. Although CTS PhD programs have similarities, they also vary in their characteristics and management of students. This may be due to diversity in translational science itself or to the relative infancy of CTS as a discipline.

Doctoral Programs to Train Future Leaders in Clinical and Translational Science

PubMed Central

Switzer, Galen E.; Robinson, Georgeanna F.W.B.; Rubio, Doris M.; Fowler, Nicole R.; Kapoor, Wishwa N.

2013-01-01

Purpose Although the National Institutes of Health (NIH) has made extensive investments in educational programs related to clinical and translational science (CTS), there has been no systematic investigation of the number and characteristics of PhD programs providing training to future leaders in CTS. The authors undertook to determine the number of institutions that, having had received NIH-funded Clinical and Translational Science Awards (CTSAs), currently had or were developing PhD programs in CTS; to examine differences between programs developed before and after CTSA funding; and to provide detailed characteristics of new programs. Method In 2012, CTS program leaders at the 60 CTSA-funded institutions completed a cross-sectional survey focusing on four key domains related to PhD programs in CTS: program development and oversight; students; curriculum and research; and milestones. Results Twenty-two institutions had fully developed PhD programs in CTS, and 268 students were earning a PhD in this new field; 13 institutions were planning a PhD program. New programs were more likely to have fully developed PhD competencies and more likely to include students in medical school, students working only on their PhD, students working on a first doctoral degree, and students working in T1 translational research. They were less likely to include physicians and students working in clinical or T2 research. Conclusions Although CTS PhD programs have similarities, they also vary in their characteristics and management of students. This may be due to diversity in translational science itself or to the relative infancy of CTS as a discipline. PMID:23899901

Reward-related neural activity and structure predict future substance use in dysregulated youth.

PubMed

Bertocci, M A; Bebko, G; Versace, A; Iyengar, S; Bonar, L; Forbes, E E; Almeida, J R C; Perlman, S B; Schirda, C; Travis, M J; Gill, M K; Diwadkar, V A; Sunshine, J L; Holland, S K; Kowatch, R A; Birmaher, B; Axelson, D A; Frazier, T W; Arnold, L E; Fristad, M A; Youngstrom, E A; Horwitz, S M; Findling, R L; Phillips, M L

2017-06-01

Identifying youth who may engage in future substance use could facilitate early identification of substance use disorder vulnerability. We aimed to identify biomarkers that predicted future substance use in psychiatrically un-well youth. LASSO regression for variable selection was used to predict substance use 24.3 months after neuroimaging assessment in 73 behaviorally and emotionally dysregulated youth aged 13.9 (s.d. = 2.0) years, 30 female, from three clinical sites in the Longitudinal Assessment of Manic Symptoms (LAMS) study. Predictor variables included neural activity during a reward task, cortical thickness, and clinical and demographic variables. Future substance use was associated with higher left middle prefrontal cortex activity, lower left ventral anterior insula activity, thicker caudal anterior cingulate cortex, higher depression and lower mania scores, not using antipsychotic medication, more parental stress, older age. This combination of variables explained 60.4% of the variance in future substance use, and accurately classified 83.6%. These variables explained a large proportion of the variance, were useful classifiers of future substance use, and showed the value of combining multiple domains to provide a comprehensive understanding of substance use development. This may be a step toward identifying neural measures that can identify future substance use disorder risk, and act as targets for therapeutic interventions.

Reproduction in the Noughties: will the scientists have all the fun?

PubMed Central

JOHNSON, MARTIN H.

2001-01-01

The past 20–30 years have seen major advances in our understanding of human reproduction and in our ability to manipulate it, as well as major social changes in human reproductive and sexual attitudes. Many of these advances and changes developed out of the first successful in vitro fertilisation (IVF) of the human oocyte. It is also the case that 30 years ago few foresaw what was to come, and many were at best doubtful and often were very critical of the scientific work which led to human IVF and to many of the subsequent developments. This lack of foresight provides us with a lesson about the dangers that we face in looking forward and attempting to predict the future. This review will try to convey, not comprehensively but through examples, the flavour of current activities in Assisted Reproduction clinics and research laboratories around the world and what is being talked about for the future in respect of emergent patient demands and anticipated clinical needs. This clinically driven approach will form the basis for consideration of some underlying scientific aspects of reproductive research, some of the ethicolegal issues that may arise, and the implications of this anticipated future for our current approaches to medical education. The future will be considered not simply in terms of the New Reproduction itself but also in its interaction with the opportunities and challenges presented by the New Genetics. It is perhaps in the interaction between these two fields of endeavour that some of the most difficult challenges ahead lie. PMID:11327201

Current status and future perspectives in laparoendoscopic single-site and natural orifice transluminal endoscopic urological surgery.

PubMed

Autorino, Riccardo; Stein, Robert J; Lima, Estevão; Damiano, Rocco; Khanna, Rakesh; Haber, Georges-Pascal; White, Michael A; Kaouk, Jihad H

2010-05-01

Objective of this study is to provide an evidence-based analysis of the current status and future perspectives of scarless urological surgery. A PubMed search has been performed for all relevant urological literature regarding natural orifice transluminal endoscopic surgery (NOTES) and laparoendoscopic single-site surgery (LESS). In addition, experience with LESS and NOTES at our own institution has been considered. All clinical and investigative reports for LESS and NOTES procedures in the urological literature have been considered. A wide variety of clinical procedures in urology have been successfully completed by using LESS techniques. Thus far, experience with NOTES has largely been investigational, although early clinical reports are emerging. Further development of instrumentation and platforms is necessary for both techniques to become more widely adopted throughout the urological community.

Using ballistocardiography to measure cardiac performance: a brief review of its history and future significance.

PubMed

Vogt, Emelie; MacQuarrie, David; Neary, John Patrick

2012-11-01

Ballistocardiography (BCG) is a non-invasive technology that has been used to record ultra-low-frequency vibrations of the heart allowing for the measurement of cardiac cycle events including timing and amplitudes of contraction. Recent developments in BCG have made this technology simple to use, as well as time- and cost-efficient in comparison with other more complicated and invasive techniques used to evaluate cardiac performance. Recent technological advances are considerably greater since the advent of microprocessors and laptop computers. Along with the history of BCG, this paper reviews the present and future potential benefits of using BCG to measure cardiac cycle events and its application to clinical and applied research. © 2012 The Authors Clinical Physiology and Functional Imaging © 2012 Scandinavian Society of Clinical Physiology and Nuclear Medicine.

Epidermolysis bullosa care in Germany.

PubMed

Bruckner-Tuderman, Leena

2010-04-01

Until 2003, no structures existed in Germany for special care of patients with rare diseases, such as epidermolysis bullosa (EB). At that point, the Federal Ministry of Education and Research announced a clinical research program-networks for rare diseases. The Network Epidermolysis Bullosa (EB Network), coordinated from the Department of Dermatology, University Medical Center Freiburg, has operated since October 2003 with the goal of improving diagnostics and clinical management, elucidating disease mechanisms, and development of novel therapies for EB (www.netzwerk-eb.de). Future goals of the EB Network include securing the clinical-diagnostic and IT structures established with grant support and focusing research on molecular disease mechanisms in EB and novel biologically valid therapies. Intensive collaborations with other networks for rare genetic diseases will generate durable structures in Germany and form a basis for future international consortia. Copyright 2010 Elsevier Inc. All rights reserved.

Past, Present, and Future Trends in Teaching Clinical Skills through Web-Based Learning Environments

ERIC Educational Resources Information Center

Coe Regan, Jo Ann R.; Youn, Eric J.

2008-01-01

Distance education in social work has grown significantly due to the use of interactive television and computer networks. Given the recent developments in delivering distance education utilizing Web-based technology, this article presents a literature review focused on identifying generational trends in the development of Web-based learning…

Do Clinical Practice Guidelines Improve Quality?

PubMed

Baldassari, Cristina M

2017-07-01

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

Interleukin-5 Inhibitors for Severe Asthma: Rationale and Future Outlook.

PubMed

Shrimanker, Rahul; Pavord, Ian D

2017-04-01

In this review, we outline the pathophysiology of severe asthma and discuss the role of anti-interleukin (IL)-5 inhibitors for the treatment of asthma. Anti-IL-5 treatments have shown efficacy in reducing the rate of severe asthma attacks in eosinophilic asthma. We review the history of the development of these agents, lessons learnt about severe asthma along the way and key clinical trials supporting efficacy of the three anti-IL-5 treatments that are clinically available or undergoing clinical trials in asthma.

Recent developments in neurofibromatoses and RASopathies: management, diagnosis and current and future therapeutic avenues.

PubMed

Rauen, Katherine A; Huson, Susan M; Burkitt-Wright, Emma; Evans, D Gareth; Farschtschi, Said; Ferner, Rosalie E; Gutmann, David H; Hanemann, C Oliver; Kerr, Bronwyn; Legius, Eric; Parada, Luis F; Patton, Michael; Peltonen, Juha; Ratner, Nancy; Riccardi, Vincent M; van der Vaart, Thijs; Vikkula, Miikka; Viskochil, David H; Zenker, Martin; Upadhyaya, Meena

2015-01-01

Neurofibromatosis type 1 (NF1) was the first RASopathy and is now one of many RASopathies that are caused by germline mutations in genes that encode components of the Ras/mitogen-activated protein kinase (MAPK) pathway. Their common underlying pathogenetic etiology causes significant overlap in phenotypic features which includes craniofacial dysmorphology, cardiac, cutaneous, musculoskeletal, GI and ocular abnormalities, and a predisposition to cancer. The proceedings from the symposium "Recent Developments in Neurofibromatoses (NF) and RASopathies: Management, Diagnosis and Current and Future Therapeutic Avenues" chronicle this timely and topical clinical translational research symposium. The overarching goal was to bring together clinicians, basic scientists, physician-scientists, advocate leaders, trainees, students and individuals with Ras pathway syndromes to discuss the most state-of-the-art basic science and clinical issues in an effort to spark collaborations directed towards the best practices and therapies for individuals with RASopathies. © 2014 Wiley Periodicals, Inc.

Recent Developments in Neurofibromatoses and RASopathies: Management, Diagnosis and Current and Future Therapeutic Avenues

PubMed Central

Rauen, Katherine A.; Huson, Susan M.; Burkitt-Wright, Emma; Evans, D Gareth; Farschtschi, Said; Ferner, Rosalie E; Gutmann, David H.; Hanemann, C Oliver; Kerr, Bronwyn; Legius, Eric; Parada, Luis F; Patton, Michael; Peltonen, Juha; Ratner, Nancy; Riccardi, Vincent M.; van der Vaart, Thijs; Vikkula, Miikka; Viskochil, David H.; Zenker, Martin; Upadhyaya, Meena

2014-01-01

Neurofibromatosis type 1 was the first RASopathy and is now one of many RASopathies that are caused by germline mutations in genes that encode components of the Ras/mitogen-activated protein kinase (MAPK) pathway. Their common underlying pathogenetic etiology causes significant overlap in phenotypic features which includes craniofacial dysmorphology, cardiac, cutaneous, musculoskeletal, GI and ocular abnormalities, and a predisposition to cancer. The proceedings from the symposium “Recent Developments in Neurofibromatoses and RASopathies: Management, Diagnosis and Current and Future Therapeutic Avenues” chronicle this timely and topical clinical translational research symposium. The overarching goal was to bring together clinicians, basic scientists, physician-scientists, advocate leaders, trainees, students and individuals with Ras pathway syndromes to discuss the most state-of-the-art basic science and clinical issues in an effort to spark collaborations directed towards the best practices and therapies for individuals with RASopathies. PMID:25393061

Child neurology practice guidelines: past, present, and future.

PubMed

Hurwitz, Benjamin A; Hurwitz, Kathleen Bretzius; Ashwal, Stephen

2015-03-01

Practice guidelines have been developed in child neurology during the last fifteen years to address important clinical questions and provide evidence-based recommendations for patient care. This review describes the guideline development process and how it has evolved to meet the needs of child neurologists. Several current child neurology guidelines are reviewed and the advantages and disadvantages of guidelines, as well as the legal consequences of using them to determine a standard of care are discussed. The future of guidelines and of their influence on integrated support systems also is considered. Child neurology practice guidelines are a helpful resource for clinicians, families and institutions as they provide evidence-based recommendations concerning the diagnosis and management of common neurological conditions affecting children. Incorporating consensus processes has allowed expansion of clinically relevant recommendations that has increased the utility of guidelines. Copyright © 2015 Elsevier Inc. All rights reserved.

Neuropsychiatry: Where Are We And Where Do We Go From Here?

PubMed Central

Sachdev, Perminder S.; Mohan, Adith

2013-01-01

Introduction: Neuropsychiatry has generally been regarded as a hybrid discipline that lies in the borderland between the disciplines of psychiatry and neurology. There is much debate on its current and future identity and status as a discipline. Materials and Methods: Taking a historical perspective, the future of neuropsychiatry is placed within the context of recent developments in clinical neuroscience. Results: The authors argue that with the maturation of the discipline, it must define its own identity that is not dependent entirely upon the parent disciplines. The requirements for this are the claiming of neuropsychiatric territory, a strong training agenda, an emphasis on treatments that are uniquely neuropsychiatric, and a bold embrace of new developments in clinical neuroscience. Conclusion: The exponential growth in neuroscientific knowledge places neuropsychiatry in an excellent position to carve out a strong identity. It is imperative that the leaders of the discipline seize the moment. PMID:23678234

A critical evaluation of the validity of episodic future thinking: A clinical neuropsychology perspective.

PubMed

Ward, Amanda M

2016-11-01

Episodic future thinking is defined as the ability to mentally simulate a future event. Although episodic future thinking has been studied extensively in neuroscience, this construct has not been explored in depth from the perspective of clinical neuropsychology. The aim of this critical narrative review is to assess the validity and clinical implications of episodic future thinking. A systematic review of episodic future thinking literature was conducted. PubMed and PsycInfo were searched through July 2015 for review and empirical articles with the following search terms: "episodic future thinking," "future mental simulation," "imagining the future," "imagining new experiences," "future mental time travel," "future autobiographical experience," and "prospection." The review discusses evidence that episodic future thinking is important for adaptive functioning, which has implications for neurological populations. To determine the validity of episodic future thinking, the construct is evaluated with respect to related constructs, such as imagination, episodic memory, autobiographical memory, prospective memory, narrative construction, and working memory. Although it has been minimally investigated, there is evidence of convergent and discriminant validity for episodic future thinking. Research has not addressed the incremental validity of episodic future thinking. Practical considerations of episodic future thinking tasks and related constructs in a clinical neuropsychological setting are considered. The utility of episodic future thinking is currently unknown due to the lack of research investigating the validity of episodic future thinking. Future work is discussed, which could determine whether episodic future thinking is an important missing piece in standard clinical neuropsychological assessment. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Targeting the DNA damage response in oncology: past, present and future perspectives.

PubMed

Basu, Bristi; Yap, Timothy A; Molife, L Rhoda; de Bono, Johann S

2012-05-01

The success of poly(ADP-ribose) polymerase inhibition in BRCA1 or BRCA2 deficient tumors as an anticancer strategy provided proof-of-concept for a synthetic lethality approach in oncology. There is therefore now active interest in expanding this approach to include other agents targeting the DNA damage response (DDR). We review lessons learnt from the development of inhibitors against DNA damage response mechanisms and envision the future of DNA repair inhibition in oncology. Preclinical synthetic lethality screens may potentially identify the best combinations of DNA-damaging drugs with inhibitors of DNA repair and the DDR or two agents acting within the DDR. Efforts are currently being made to establish robust and cost-effective assays that may be implemented within appropriate time-scales in parallel with future clinical studies. Detection of relevant mutations in a high-throughput manner, such as with next-generation sequencing for genes implicated in homologous recombination, including BRCA1, BRCA2, and ataxia telangiectasia mutated is anticipated. Novel approaches targeting the DDR are currently being evaluated and inhibitors of ATM, RAD51 and DNA-dependent protein kinase are now in early drug discovery and development. There remains great enthusiasm in oncology practice for pursuing the strategy of synthetic lethality. The future development of antitumor agents targeting the DDR should include detailed correlative biomarker work within early phase clinical studies wherever possible, with clear attempts to identify doses at which robust target modulation is observed.

Design participation as an insurance: risk-management and end-user participation in the development of information systems in healthcare organizations.

PubMed

Vimarlund, V; Timpka, T

2002-01-01

The aim of this paper is to build a theoretical framework for analysis of when decision-makers should use end-user participation as a form of insurance for unforeseen consequences of implementing information systems in healthcare organizations. Data were collected in a case study of an information system development project in a small clinical setting. During the initial phase, the future end-users of the system were allowed to actively influence the system design and test every new tool that was considered for implementation. The results of the case study suggest that when time and effort are invested in allowing healthcare staff to participate in information system development processes, the benefits can well exceed the costs throughout the life cycle of the project. Risk-averse decision-makers fearing negative secondary consequences of a HIS, with regard to clinical work flow, will always adopt measures to prevent future failures, if they can find a possibility of shifting these risks. Therefore, they calculate the present discounted value of the effects accrued over time to the unit and predict the amount of resources they are willing to pay to acquire on insurance (such as design participation) that will protect the organization from future losses. End-user participation in the design process can be the key positive influence on the quality of the service and, thereby, organizational effectiveness. Investments in broad design participation can, consequently, be a productive activity that transforms potential current income into future benefits.

Clinical Needs and Outcomes of Adults with Intellectual Disabilities Accessing an Inpatient Assessment and Treatment Service and the Implication for Development of Community Services

ERIC Educational Resources Information Center

Sandhu, Daljit; Tomlins, Rose

2017-01-01

The role and future of assessment and treatment units for people with intellectual disabilities is once again the focus of debate and government policy. Reviewing the admissions to inpatient services can provide useful information about the characteristics, needs and clinical outcomes of clients. Data were collected retrospectively for all 36…

Development of a Mobile Clinical Prediction Tool to Estimate Future Depression Severity and Guide Treatment in Primary Care: User-Centered Design

PubMed Central

2018-01-01

Background Around the world, depression is both under- and overtreated. The diamond clinical prediction tool was developed to assist with appropriate treatment allocation by estimating the 3-month prognosis among people with current depressive symptoms. Delivering clinical prediction tools in a way that will enhance their uptake in routine clinical practice remains challenging; however, mobile apps show promise in this respect. To increase the likelihood that an app-delivered clinical prediction tool can be successfully incorporated into clinical practice, it is important to involve end users in the app design process. Objective The aim of the study was to maximize patient engagement in an app designed to improve treatment allocation for depression. Methods An iterative, user-centered design process was employed. Qualitative data were collected via 2 focus groups with a community sample (n=17) and 7 semistructured interviews with people with depressive symptoms. The results of the focus groups and interviews were used by the computer engineering team to modify subsequent protoypes of the app. Results Iterative development resulted in 3 prototypes and a final app. The areas requiring the most substantial changes following end-user input were related to the iconography used and the way that feedback was provided. In particular, communicating risk of future depressive symptoms proved difficult; these messages were consistently misinterpreted and negatively viewed and were ultimately removed. All participants felt positively about seeing their results summarized after completion of the clinical prediction tool, but there was a need for a personalized treatment recommendation made in conjunction with a consultation with a health professional. Conclusions User-centered design led to valuable improvements in the content and design of an app designed to improve allocation of and engagement in depression treatment. Iterative design allowed us to develop a tool that allows users to feel hope, engage in self-reflection, and motivate them to treatment. The tool is currently being evaluated in a randomized controlled trial. PMID:29685864

Twenty years of the Journal of Clinical Psychology in Medical Settings: we hope you will enjoy the show.

PubMed

Rozensky, Ronald H; Tovian, Steven M; Sweet, Jerry J

2014-03-01

The 20th anniversary of the Journal of Clinical Psychology in Medical Settings is celebrated by highlighting the scientist-practitioner philosophy on which it was founded. The goal of the Journal-to provide an outlet for evidence-based approaches to healthcare that underscore the important scientific and clinical contributions of psychology in medical settings-is discussed. The contemporary relevance of this approach is related to the current implementation of the Patient Protection and Affordable Care and its focus on accountability and the development of an interprofessional healthcare workforce; both of which have been foci of the Journal throughout its history and will continue to be so into the future. Several recommendations of future topic areas for the Journal to highlight regarding scientific, practice, policy, and education and training in professional health service psychology are offered. Successfully addressing these topics will support the growth of the field of psychology in the ever evolving healthcare system of the future and continue ensure that the Journal is a key source of professional information in health service psychology.

The National Cancer Institute–American Society of Clinical Oncology Cancer Trial Accrual Symposium: Summary and Recommendations

PubMed Central

Denicoff, Andrea M.; McCaskill-Stevens, Worta; Grubbs, Stephen S.; Bruinooge, Suanna S.; Comis, Robert L.; Devine, Peggy; Dilts, David M.; Duff, Michelle E.; Ford, Jean G.; Joffe, Steven; Schapira, Lidia; Weinfurt, Kevin P.; Michaels, Margo; Raghavan, Derek; Richmond, Ellen S.; Zon, Robin; Albrecht, Terrance L.; Bookman, Michael A.; Dowlati, Afshin; Enos, Rebecca A.; Fouad, Mona N.; Good, Marjorie; Hicks, William J.; Loehrer, Patrick J.; Lyss, Alan P.; Wolff, Steven N.; Wujcik, Debra M.; Meropol, Neal J.

2013-01-01

Introduction: Many challenges to clinical trial accrual exist, resulting in studies with inadequate enrollment and potentially delaying answers to important scientific and clinical questions. Methods: The National Cancer Institute (NCI) and the American Society of Clinical Oncology (ASCO) cosponsored the Cancer Trial Accrual Symposium: Science and Solutions on April 29-30, 2010 to examine the state of accrual science related to patient/community, physician/provider, and site/organizational influences, and identify new interventions to facilitate clinical trial enrollment. The symposium featured breakout sessions, plenary sessions, and a poster session including 100 abstracts. Among the 358 attendees were clinical investigators, researchers of accrual strategies, research administrators, nurses, research coordinators, patient advocates, and educators. A bibliography of the accrual literature in these three major areas was provided to participants in advance of the meeting. After the symposium, the literature in these areas was revisited to determine if the symposium recommendations remained relevant within the context of the current literature. Results: Few rigorously conducted studies have tested interventions to address challenges to clinical trials accrual. Attendees developed recommendations for improving accrual and identified priority areas for future accrual research at the patient/community, physician/provider, and site/organizational levels. Current literature continues to support the symposium recommendations. Conclusions: A combination of approaches addressing both the multifactorial nature of accrual challenges and the characteristics of the target population may be needed to improve accrual to cancer clinical trials. Recommendations for best practices and for future research developed from the symposium are provided. PMID:24130252

"I understood…but some parts were confusing and hard to grasp": Patients' perception of informed consent forms and clinical trials in Eldoret, Kenya.

PubMed

Naanyu, Violet; Some, Fatma F; Siika, Abraham M

2014-01-01

A signed informed consent (IC) form proves voluntary participation in a study. Yet the development of accessible and understandable IC forms comes with its own set of challenges, particularly when conducting international research. This study explores understanding by participants in an Eldoret-based clinical trial of IC and its implications as well as whether they will volunteer for future trials. In mid-2010, in-depth interviews with trial participants were recorded in audio format. Content analysis provides a description of trial participants' experiences and thoughts. All participants were informed about the trial and its voluntariness and they consented. However, some were too ill to scrutinize trial details. Thus, they relied on their health care provider's advice, or on their guardians. In general, participants understood their role and were happy to volunteer or invite others to participate in future trials. They also emphasised the importance of an open on-going dialogue in order for participants to be able to ask questions. Clinical trial participants in Eldoret seem to understand their role, but rely on providers and guardians when consenting. They are very willing to participate in future trials. Evaluation of research participants' opinions may improve trial protocols, increase comprehension and guard against manipulation of study participants. In addition, this research focus should guide development of consent forms and process that facilitates a truly IC.

Immunotherapy in prostate cancer: challenges and opportunities.

PubMed

Noguchi, Masanori; Koga, Noriko; Moriya, Fukuko; Itoh, Kyogo

2016-01-01

Although treatment options for castration-resistant prostate cancer (CRPC) have increased over the last decade, there remains a need for strategies that can provide durable disease control and long-term benefit. Recently, immunotherapy has emerged as a viable and attractive strategy for the treatment of CRPC. To date, there are multiple strategies to target the immune system, and several approaches including therapeutic cancer vaccines and immune checkpoint inhibitors have been most successful in clinical trials. With regard to this, we report the results of the most recent clinical trials investigating immunotherapy in CRPC and discuss the future development of immunotherapy for CRPC, as well as the potential importance of biomarkers in the future progress of this field.

RNA-targeted therapeutics in cancer clinical trials: Current status and future directions.

PubMed

Barata, Pedro; Sood, Anil K; Hong, David S

2016-11-01

Recent advances in RNA delivery and target selection provide unprecedented opportunities for cancer treatment, especially for cancers that are particularly hard to treat with existing drugs. Small interfering RNAs, microRNAs, and antisense oligonucleotides are the most widely used strategies for silencing gene expression. In this review, we summarize how these approaches were used to develop drugs targeting RNA in human cells. Then, we review the current state of clinical trials of these agents for different types of cancer and outcomes from published data. Finally, we discuss lessons learned from completed studies and future directions for this class of drugs. Copyright © 2016 Elsevier Ltd. All rights reserved.

Development of a Self-Management Theory-Guided Discharge Intervention for Parents of Hospitalized Children.

PubMed

Sawin, Kathleen J; Weiss, Marianne E; Johnson, Norah; Gralton, Karen; Malin, Shelly; Klingbeil, Carol; Lerret, Stacee M; Thompson, Jamie J; Zimmanck, Kim; Kaul, Molly; Schiffman, Rachel F

2017-03-01

Parents of hospitalized children, especially parents of children with complex and chronic health conditions, report not being adequately prepared for self-management of their child's care at home after discharge. No theory-based discharge intervention exists to guide pediatric nurses' preparation of parents for discharge. To develop a theory-based conversation guide to optimize nurses' preparation of parents for discharge and self-management of their child at home following hospitalization. Two frameworks and one method influenced the development of the intervention: the Individual and Family Self-Management Theory, Tanner's Model of Clinical Judgment, and the Teach-Back method. A team of nurse scientists, nursing leaders, nurse administrators, and clinical nurses developed and field tested the electronic version of a nine-domain conversation guide for use in acute care pediatric hospitals. The theory-based intervention operationalized self-management concepts, added components of nursing clinical judgment, and integrated the Teach-Back method. Development of a theory-based intervention, the translation of theoretical knowledge to clinical innovation, is an important step toward testing the effectiveness of the theory in guiding clinical practice. Clinical nurses will establish the practice relevance through future use and refinement of the intervention. © 2017 Sigma Theta Tau International.

Quantitative assessment of barriers to the clinical development and adoption of cellular therapies: A pilot study

PubMed Central

Rikabi, Sarah; French, Anna; Pinedo-Villanueva, Rafael; Morrey, Mark E; Wartolowska, Karolina; Judge, Andrew; MacLaren, Robert E; Mathur, Anthony; Williams, David J; Wall, Ivan; Birchall, Martin; Reeve, Brock; Atala, Anthony; Barker, Richard W; Cui, Zhanfeng; Furniss, Dominic; Bure, Kim; Snyder, Evan Y; Karp, Jeffrey M; Price, Andrew; Carr, Andrew; Brindley, David A

2014-01-01

There has been a large increase in basic science activity in cell therapy and a growing portfolio of cell therapy trials. However, the number of industry products available for widespread clinical use does not match this magnitude of activity. We hypothesize that the paucity of engagement with the clinical community is a key contributor to the lack of commercially successful cell therapy products. To investigate this, we launched a pilot study to survey clinicians from five specialities and to determine what they believe to be the most significant barriers to cellular therapy clinical development and adoption. Our study shows that the main concerns among this group are cost-effectiveness, efficacy, reimbursement, and regulation. Addressing these concerns can best be achieved by ensuring that future clinical trials are conducted to adequately answer the questions of both regulators and the broader clinical community. PMID:25383173

Quantitative assessment of barriers to the clinical development and adoption of cellular therapies: A pilot study.

PubMed

Davies, Benjamin M; Rikabi, Sarah; French, Anna; Pinedo-Villanueva, Rafael; Morrey, Mark E; Wartolowska, Karolina; Judge, Andrew; MacLaren, Robert E; Mathur, Anthony; Williams, David J; Wall, Ivan; Birchall, Martin; Reeve, Brock; Atala, Anthony; Barker, Richard W; Cui, Zhanfeng; Furniss, Dominic; Bure, Kim; Snyder, Evan Y; Karp, Jeffrey M; Price, Andrew; Carr, Andrew; Brindley, David A

2014-01-01

There has been a large increase in basic science activity in cell therapy and a growing portfolio of cell therapy trials. However, the number of industry products available for widespread clinical use does not match this magnitude of activity. We hypothesize that the paucity of engagement with the clinical community is a key contributor to the lack of commercially successful cell therapy products. To investigate this, we launched a pilot study to survey clinicians from five specialities and to determine what they believe to be the most significant barriers to cellular therapy clinical development and adoption. Our study shows that the main concerns among this group are cost-effectiveness, efficacy, reimbursement, and regulation. Addressing these concerns can best be achieved by ensuring that future clinical trials are conducted to adequately answer the questions of both regulators and the broader clinical community.

Using health technology assessment to identify gaps in evidence and inform study design for comparative effectiveness research.

PubMed

Tunis, Sean R; Turkelson, Charles

2012-12-01

Health technology assessment (HTA) is primarily used as a tool to ensure that clinical and policy decisions are made with the benefit of a systematic analysis of all completed research. This article describes the progress and potential for HTA reports to improve the quality and relevance of future research and to better serve the information needs of patients, clinicians, payers, and other decision makers. We conducted a review of the current published literature and working papers describing past, ongoing, and future initiatives that rely on HTA reports to identify gaps in evidence and improve the design of future research. Although still in a developmental stage, significant progress is under way to improve methods for using HTA reports for the systematic identification of research gaps, prioritization of future research, and improvement of study designs. Several well-defined frameworks have been developed to assist those who produce HTA to become more effective in these additional domains of work. A recurring element of this work is the importance of meaningfully involving stakeholders in the process of defining future research needs and designing studies to address them. Patients, clinicians, and payers are important audiences for completed research and are now recognized as serving an important role in determining what future research is needed. There are substantial opportunities to improve the quality, relevance, and efficiency of clinical research. Recent efforts are beginning to demonstrate the potential to build on the work invested in developing HTA reports to provide a roadmap toward these objectives.

Better informed in clinical practice - a brief overview of dental informatics.

PubMed

Reynolds, P A; Harper, J; Dunne, S

2008-03-22

Uptake of dental informatics has been hampered by technical and user issues. Innovative systems have been developed, but usability issues have affected many. Advances in technology and artificial intelligence are now producing clinically useful systems, although issues still remain with adapting computer interfaces to the dental practice working environment. A dental electronic health record has become a priority in many countries, including the UK. However, experience shows that any dental electronic health record (EHR) system cannot be subordinate to, or a subset of, a medical record. Such a future dental EHR is likely to incorporate integrated care pathways. Future best dental practice will increasingly depend on computer-based support tools, although disagreement remains about the effectiveness of current support tools. Over the longer term, future dental informatics tools will incorporate dynamic, online evidence-based medicine (EBM) tools, and promise more adaptive, patient-focused and efficient dental care with educational advantages in training.

Representational Approach: A Conceptual Framework to Guide Patient Education Research and Practice.

PubMed

Arida, Janet A; Sherwood, Paula R; Flannery, Marie; Donovan, Heidi S

2016-11-01

Illness representations are cognitive structures that individuals rely on to understand and explain their illnesses and associated symptoms. The Representational Approach (RA) to patient education offers a theoretically based, clinically useful model that can support oncology nurses to develop a shared understanding of patients' illness representations to collaboratively develop highly personalized plans for symptom management and other important self-management behaviors. This article discusses theoretical underpinnings, practical applications, challenges, and future directions for incorporating illness representations and the RA in clinical and research endeavors.

Transcriptomics in cancer diagnostics: developments in technology, clinical research and commercialization.

PubMed

Sager, Monica; Yeat, Nai Chien; Pajaro-Van der Stadt, Stefan; Lin, Charlotte; Ren, Qiuyin; Lin, Jimmy

2015-01-01

Transcriptomic technologies are evolving to diagnose cancer earlier and more accurately to provide greater predictive and prognostic utility to oncologists and patients. Digital techniques such as RNA sequencing are replacing still-imaging techniques to provide more detailed analysis of the transcriptome and aberrant expression that causes oncogenesis, while companion diagnostics are developing to determine the likely effectiveness of targeted treatments. This article examines recent advancements in molecular profiling research and technology as applied to cancer diagnosis, clinical applications and predictions for the future of personalized medicine in oncology.

Immunotherapy for Ovarian Cancer: What's Next?

PubMed Central

Kandalaft, Lana E.; Powell, Daniel J.; Singh, Nathan; Coukos, George

2011-01-01

In the past decade, we have witnessed important gains in the treatment of ovarian cancer; however, additional advances are required to reduce mortality. With compelling evidence that ovarian cancers are immunogenic tumors, immunotherapy should be further pursued and optimized. The dramatic advances in laboratory and clinical procedures in cellular immunotherapy, along with the development of powerful immunomodulatory antibodies, create new opportunities in ovarian cancer therapeutics. Herein, we review current progress and future prospects in vaccine and adoptive T-cell therapy development as well as immunomodulatory therapy tools available for immediate clinical testing. PMID:21079136

Five-grass pollen immunotherapy tablet: an update on the latest findings from clinical trials: an interview with Olivier de Beaumont.

PubMed

de Beaumont, Olivier; Wilkinson, Jonathan

2014-01-01

Interview by Jonathan Wilkinson (Managing Commissioning Editor, Future Science Group). Olivier de Beaumont became Doctor of Medicine at the University of Paris Descartes in 1993. In the same year, he also took a Master of Health Economics degree at Paris Dauphine University. He is also a Master of Business Administration, ESCP Paris, 1999. At Stallergenes, he has been serving as Vice President/Head of Corporate Clinical Development since 2005, responsible for the clinical development plan, clinical operations, biometry and pharmacovigilance. In 2011, he took the responsibility of Senior Vice President Global Medical Affairs responsible for medical information and education, medical communication and nonregistration clinical studies. In 2014 he became Senior Vice President Global Scientific and Medical Affairs. From 2002 to 2005 he led the European business development of the world's leading clinical research organization Quintiles, developing Phase I-IV clinical trial programs for pharmaceutical companies. Previous roles included: Chief Scientific Officer and cofounder of Direct Medica (2000-2002), product champion and lifecycle management at Aventis (1998-2000), medical affairs manager in oncology and respiratory diseases at corporate Rhone-Poulenc Rorer (1993-1998).

The core content of clinical ultrasonography fellowship training.

PubMed

Lewiss, Resa E; Tayal, Vivek S; Hoffmann, Beatrice; Kendall, John; Liteplo, Andrew S; Moak, James H; Panebianco, Nova; Noble, Vicki E

2014-04-01

The purpose of developing a core content for subspecialty training in clinical ultrasonography (US) is to standardize the education and qualifications required to provide oversight of US training, clinical use, and administration to improve patient care. This core content would be mastered by a fellow as a separate and unique postgraduate training, beyond that obtained during an emergency medicine (EM) residency or during medical school. The core content defines the training parameters, resources, and knowledge of clinical US necessary to direct clinical US divisions within medical specialties. Additionally, it is intended to inform fellowship directors and candidates for certification of the full range of content that might appear in future examinations. This article describes the development of the core content and presents the core content in its entirety. © 2014 by the Society for Academic Emergency Medicine.

Recent developments of cyclotron produced radionuclides for nuclear cardiology

NASA Astrophysics Data System (ADS)

Kulkarni, P. V.; Jansen, D. E.; Corbett, J. R.

1987-04-01

For over a decade myocardial perfusion imaging with thallium-201, a cyclotron product, has been routinely used in clinical medicine. Recent advances have allowed the efficient production of very high purity (> 99.8%) iodine-123. New metabolically active 123I labeled radiopharmaceuticals, including alkyl and phenyl fatty acids, and norepinephrine analogs, have been developed and are undergoing clinical trials. Fab' fragments of monoclonal antibodies to cardiac myosin have been labeled with indium-111 ( 111In) and are undergoing clinical evaluation for imaging myocardial infarcts. Monoclonal antibodies to platelets, fibrin, and the thrombolytic agent, tissue plasminogen activator (TPA), have recently been labeled with 111In. Together these developments in radiotracers and instrumentation should have a significant impact on the future of cardiovascular nuclear medicine. This manuscript will discuss developments in single photon emitting radiotracers for myocardial imaging.

Clinical associations of maternal thyroid function with foetal brain development: Epidemiological interpretation and overview of available evidence.

PubMed

Korevaar, Tim I M; Tiemeier, Henning; Peeters, Robin P

2018-04-24

Thyroid hormone is an important regulator of early brain development, particularly during early stages of gestation during which foetal thyroid hormone availability depends on the maternal transfer of thyroid hormones. There is a wide range of experimental studies showing that low maternal thyroid hormone availability is associated with suboptimal brain development parameters. While few clinical studies have shown that overt maternal hypothyroidism is associated with lower child IQ, the question whether more subclinical changes in maternal thyroid function could also lead to suboptimal foetal brain development. In this review, we put the latter studies in perspective and discuss their interpretation from an epidemiological and clinical perspective. Furthermore, we extend this discussion to also include future perspective and identify important knowledge gaps in the field. © 2018 John Wiley & Sons Ltd.

[First SIBEN clinical consensus: diagnostic and therapeutic approach to patent ductus arteriosus in premature newborns].

PubMed

Golombek, S G; Sola, A; Baquero, H; Borbonet, D; Cabañas, F; Fajardo, C; Goldsmit, G; Lemus, L; Miura, E; Pellicer, A; Pérez, J M; Rogido, M; Zambosco, G; van Overmeire, B

2008-11-01

To report the process and results of the first neonatal clinical consensus of the Ibero-American region. Two recognized experts in the field (Clyman and Van Overmeire) and 45 neonatologists from 23 countries were invited for active participation and collaboration. We developed 46 questions of clinical-physiological relevance in all aspects of patent ductus arteriosus (PDA). Guidelines for consensus process, literature search and future preparation of educational material and authorship were developed, reviewed and agreed by all. Participants from different countries were distributed in groups, and assigned to interact and work together to answer 3-5 questions, reviewing all global literature and local factors. Answers and summaries were received, collated and reviewed by 2 coordinators and the 2 experts. Participants and experts met in Granada, Spain for 4.5 h (lectures by experts, presentations by groups, discussion, all literature available). 31 neonatologists from 16 countries agreed to participate. Presentations by each group and general discussion were used to develop a consensus regarding: general management, availability of drugs (indomethacin vs. ibuprofen), costs, indications for echo/surgery, etc. Many steps were learnt by all present in a collaborative forum. This first consensus group of Ibero-American neonatologists SIBEN led to active and collaborative participation of neonatologists of 16 countries, improved education of all participants and ended with consensus development on clinical approaches to PDA. Furthermore, it provides recommendations for clinical care reached by consensus. Additionally, it will serve as a useful foundation for future SIBEN Consensus on other topics and it could become valuable as a model to decrease disparity in care and improve outcomes in this and other regions.

Emerging pathways and future targets for the molecular therapy of pancreatic cancer.

PubMed

Vaccaro, Vanja; Melisi, Davide; Bria, Emilio; Cuppone, Federica; Ciuffreda, Ludovica; Pino, Maria Simona; Gelibter, Alain; Tortora, Giampaolo; Cognetti, Francesco; Milella, Michele

2011-10-01

Pancreatic cancer treatment remains a challenge for clinicians and researchers. Despite undisputable advances in the comprehension of the molecular mechanisms underlying cancer development and progression, early disease detection and clinical management of patients has made little, if any, progress in the past 20 years. Clinical development of targeted agents directed against validated pathways, such as the EGF/EGF receptor axis, the mutant KRAS protein, MMPs, and VEGF-mediated angiogenesis, alone or in combination with gemcitabine-based standard chemotherapy, has been disappointing. This review explores the preclinical rationale for clinical approaches aimed at targeting the TGF-β, IGF, Hedgehog, Notch and NF-κB signaling pathways, to develop innovative therapeutic strategies for pancreatic cancer. Although some of the already clinically explored approaches (particularly EGFR and KRAS targeting) deserve further clinical consideration, by employing more innovative and creative clinical trial designs than the gemcitabine-targeted agent paradigm that has thus far invariably failed, the targeting of emerging and relatively unexplored signaling pathways holds great promise to increase our understanding of the complex molecular biology and to advance the clinical management of pancreatic cancer.

Adaptation and development of software simulation methodologies for cardiovascular engineering: present and future challenges from an end-user perspective

PubMed Central

Díaz-Zuccarini, V.; Narracott, A.J.; Burriesci, G.; Zervides, C.; Rafiroiu, D.; Jones, D.; Hose, D.R.; Lawford, P.V.

2009-01-01

This paper describes the use of diverse software tools in cardiovascular applications. These tools were primarily developed in the field of engineering and the applications presented push the boundaries of the software to address events related to venous and arterial valve closure, exploration of dynamic boundary conditions or the inclusion of multi-scale boundary conditions from protein to organ levels. The future of cardiovascular research and the challenges that modellers and clinicians face from validation to clinical uptake are discussed from an end-user perspective. PMID:19487202

Adaptation and development of software simulation methodologies for cardiovascular engineering: present and future challenges from an end-user perspective.

PubMed

Díaz-Zuccarini, V; Narracott, A J; Burriesci, G; Zervides, C; Rafiroiu, D; Jones, D; Hose, D R; Lawford, P V

2009-07-13

This paper describes the use of diverse software tools in cardiovascular applications. These tools were primarily developed in the field of engineering and the applications presented push the boundaries of the software to address events related to venous and arterial valve closure, exploration of dynamic boundary conditions or the inclusion of multi-scale boundary conditions from protein to organ levels. The future of cardiovascular research and the challenges that modellers and clinicians face from validation to clinical uptake are discussed from an end-user perspective.

Development and Evaluation of a Clinical Note Section Header Terminology

PubMed Central

Denny, Joshua C.; Miller, Randolph A.; Johnson, Kevin B.; Spickard, Anderson

2008-01-01

Clinical documentation is often expressed in natural language text, yet providers often use common organizations that segment these notes in sections, such as “history of present illness” or “physical examination.” We developed a hierarchical section header terminology, supporting mappings to LOINC and other vocabularies; it contained 1109 concepts and 4332 synonyms. Physicians evaluated it compared to LOINC and the Evaluation and Management billing schema using a randomly selected corpus of history and physical notes. Evaluated documents contained a median of 54 sections and 27 “major sections.” There were 16,196 total sections in the evaluation note corpus. The terminology contained 99.9% of the clinical sections; LOINC matched 77% of section header concepts and 20% of section header strings in those documents. The section terminology may enable better clinical note understanding and interoperability. Future development and integration into natural language processing systems is needed. PMID:18999303

Black raspberries in cancer clinical trials: Past, present and future.

PubMed

Kresty, Laura A; Mallery, Susan R; Stoner, Gary D

Black raspberries (BRB) inhibit a broad range of cancers in preclinical models, including in vivo models of oral, esophageal, colon, breast and skin cancer. Promising preclinical results have led to clinical evaluations in cancer patients or patients at increased risk for cancer development. To summarize clinical investigations targeting cancer or precancerous lesions with BRB and discuss future directions. A thorough literature search was conducted through December 1, 2015 to identify all published studies evaluating BRB in cancer focused clinical trials. Research investigating BRB in clinical settings report positive effects on preneoplastic lesions or cancers of the oral cavity, esophagus and colon. BRB treatment resulted in: histologic regression of oral intraepithelial neoplasia associated with improved histologic grade and significantly reduced loss of heterozygosity at tumor suppressor gene loci, modulated genes linked to RNA processing and growth factor recycling; in the colon, BRB inhibited FAP-associated polyp progression, demethylated tumor suppressor genes and improved plasma cytokine profiles; in Barrett's patients, BRB consumption increased tissue levels of GST-pi and decreased 8-isoprostane, a marker of lipid peroxidation/oxidative stress. The precise dose, duration and optimum mode of BRB delivery for cancer inhibition remains to be fully elucidated. Common themes across studies support that BRB are anti-proliferative, anti- inflammatory, reduce oxidative stress and restore tumor suppressive activity. Future directions are included in the conclusions section.

Breakthrough Invasive Mold Infections in the Hematology Patient: Current Concepts and Future Directions.

PubMed

Lionakis, Michail S; Lewis, Russell E; Kontoyiannis, Dimitrios P

2018-05-31

Although the widespread use of mold-active agents (especially the new-generation of triazoles) has resulted in reductions of documented invasive mold infections (IMIs) in patients with hematological malignancies and allogeneic hematopoietic stem cell transplantation (HSCT), a subset of such patients still develop breakthrough IMIs (bIMIs). There are no data from prospective randomized clinical trials to guide therapeutic decisions in the different scenarios of bIMIs. In this viewpoint, we present the current status of our understanding of the clinical, diagnostic and treatment challenges of bIMIs in high-risk adult patients with hematological cancer and/or HSCT receiving mold-active antifungals and outline common clinical scenarios. As a rule, managing bIMIs demands an individualized treatment plan that takes into account the host, including co-morbidities, certainty of diagnosis and site of bIMIs, local epidemiology, considerations for fungal resistance, and antifungal pharmacological properties. Finally, we highlight areas that require future investigation in this complex area of clinical mycology.

Challenges of advanced hepatocellular carcinoma

PubMed Central

Colagrande, Stefano; Inghilesi, Andrea L; Aburas, Sami; Taliani, Gian G; Nardi, Cosimo; Marra, Fabio

2016-01-01

Hepatocellular carcinoma (HCC) is an aggressive malignancy, resulting as the third cause of death by cancer each year. The management of patients with HCC is complex, as both the tumour stage and any underlying liver disease must be considered conjointly. Although surveillance by imaging, clinical and biochemical parameters is routinely performed, a lot of patients suffering from cirrhosis have an advanced stage HCC at the first diagnosis. Advanced stage HCC includes heterogeneous groups of patients with different clinical condition and radiological features and sorafenib is the only approved treatment according to Barcelona Clinic Liver Cancer. Since the introduction of sorafenib in clinical practice, several phase III clinical trials have failed to demonstrate any superiority over sorafenib in the frontline setting. Loco-regional therapies have also been tested as first line treatment, but their role in advanced HCC is still matter of debate. No single agent or combination therapies have been shown to impact outcomes after sorafenib failure. Therefore this review will focus on the range of experimental therapeutics for patients with advanced HCC and highlights the successes and failures of these treatments as well as areas for future development. Specifics such as dose limiting toxicity and safety profile in patients with liver dysfunction related to the underlying chronic liver disease should be considered when developing therapies in HCC. Finally, robust validated and reproducible surrogate end-points as well as predictive biomarkers should be defined in future randomized trials. PMID:27678348

Ongoing Use of Data and Specimens from NCI Sponsored Cancer Prevention Clinical Trials in the Community Clinical Oncology Program

PubMed Central

Minasian, Lori; Tangen, Catherine M.; Wickerham, D. Lawrence

2015-01-01

Large cancer prevention trials provide opportunities to collect a wide array of data and biospecimens at study entry and longitudinally, for a healthy, aging population without cancer. This provides an opportunity to use pre-diagnostic data and specimens to evaluate hypotheses about the initial development of cancer. This paper reports on strides made by, and future possibilities for, the use of accessible biorepositories developed from precisely annotated samples obtained through large-scale National Cancer Institute (NCI)-sponsored cancer prevention clinical trials conducted by the NCI Cooperative Groups. These large cancer prevention studies, which have enrolled over 80,000 volunteers, continue to contribute to our understanding of cancer development more than 10 years after they were closed. PMID:26433556

Checkpoint inhibitors in advanced melanoma: effect on the field of immunotherapy.

PubMed

O'reilly, Aine; Larkin, James

2017-07-01

The success of the immune checkpoint inhibitors in melanoma has reinvigorated the field of immunotherapy. Immune checkpoint inhibitors are now the standard of care in multiple cancer types including lung cancer, head and neck cancer, urothelial cancer and renal cell cancer. The field of immunotherapy is currently expanding rapidly and will be a focus of research and development for decades to come. Areas covered: This review covers the early development of immune checkpoint inhibitors and the changes that occurred in the drug development paradigm to facilitate the development of immunotherapy. The review will summarise the areas into which immune checkpoint inhibitors have been adopted and will review the data that supported this. Furthermore, we will discuss future developments in immunotherapy and the current landscape regarding maximising the potential of immunotherapy in clinical practice. Expert commentary: In the author's opinion, the potential of immunotherapy is vast. To date immune checkpoint inhibition has already delivered durable responses in a proportion of patients with cancer types which were previously universally lethal. The future of immunotherapy will rely upon the intelligent application of translational research to clinical practice, such that immunotherapy can be effective for a wider population and maintain its current growth.

Developing genomic knowledge bases and databases to support clinical management: current perspectives.

PubMed

Huser, Vojtech; Sincan, Murat; Cimino, James J

2014-01-01

Personalized medicine, the ability to tailor diagnostic and treatment decisions for individual patients, is seen as the evolution of modern medicine. We characterize here the informatics resources available today or envisioned in the near future that can support clinical interpretation of genomic test results. We assume a clinical sequencing scenario (germline whole-exome sequencing) in which a clinical specialist, such as an endocrinologist, needs to tailor patient management decisions within his or her specialty (targeted findings) but relies on a genetic counselor to interpret off-target incidental findings. We characterize the genomic input data and list various types of knowledge bases that provide genomic knowledge for generating clinical decision support. We highlight the need for patient-level databases with detailed lifelong phenotype content in addition to genotype data and provide a list of recommendations for personalized medicine knowledge bases and databases. We conclude that no single knowledge base can currently support all aspects of personalized recommendations and that consolidation of several current resources into larger, more dynamic and collaborative knowledge bases may offer a future path forward.

Building a sustainable clinical academic workforce to meet the future healthcare needs of Australia and New Zealand: report from the first summit meeting.

PubMed

Windsor, J; Searle, J; Hanney, R; Chapman, A; Grigg, M; Choong, P; Mackay, A; Smithers, B M; Churchill, J A; Carney, S; Smith, J A; Wainer, Z; Talley, N J; Gladman, M A

2015-09-01

The delivery of healthcare that meets the requirements for quality, safety and cost-effectiveness relies on a well-trained medical workforce, including clinical academics whose career includes a specific commitment to research, education and/or leadership. In 2011, the Medical Deans of Australia and New Zealand published a review on the clinical academic workforce and recommended the development of an integrated training pathway for clinical academics. A bi-national Summit on Clinical Academic Training was recently convened to bring together all relevant stakeholders to determine how best to do this. An important part understood the lessons learnt from the UK experience after 10 years since the introduction of an integrated training pathway. The outcome of the summit was to endorse strongly the recommendations of the medical deans. A steering committee has been established to identify further stakeholders, solicit more information from stakeholder organisations, convene a follow-up summit meeting in late 2015, recruit pilot host institutions and engage the government and future funders. © 2015 Royal Australasian College of Physicians.

Developing genomic knowledge bases and databases to support clinical management: current perspectives

PubMed Central

Huser, Vojtech; Sincan, Murat; Cimino, James J

2014-01-01

Personalized medicine, the ability to tailor diagnostic and treatment decisions for individual patients, is seen as the evolution of modern medicine. We characterize here the informatics resources available today or envisioned in the near future that can support clinical interpretation of genomic test results. We assume a clinical sequencing scenario (germline whole-exome sequencing) in which a clinical specialist, such as an endocrinologist, needs to tailor patient management decisions within his or her specialty (targeted findings) but relies on a genetic counselor to interpret off-target incidental findings. We characterize the genomic input data and list various types of knowledge bases that provide genomic knowledge for generating clinical decision support. We highlight the need for patient-level databases with detailed lifelong phenotype content in addition to genotype data and provide a list of recommendations for personalized medicine knowledge bases and databases. We conclude that no single knowledge base can currently support all aspects of personalized recommendations and that consolidation of several current resources into larger, more dynamic and collaborative knowledge bases may offer a future path forward. PMID:25276091

Considerations and caveats in anti-virulence drug development

PubMed Central

Maura, Damien; Ballok, Alicia E.; Rahme, Laurence G.

2016-01-01

As antibiotic resistance remains a major public health threat, anti-virulence therapy research is gaining interest. Hundreds of potential anti-virulence compounds have been examined, but very few have made it to clinical trials and none have been approved. This review surveys the current anti-virulence research field with a focus on the highly resistant and deadly ESKAPE pathogens, especially Pseudomonas aeruginosa. We discuss timely considerations and caveats in anti-virulence drug development, including target identification, administration, preclinical development, and metrics for success in clinical trials. Development of a defined pipeline for anti-virulence agents, which differs in important ways from conventional antibiotics, is imperative for the future success of these critically needed drugs. PMID:27318551

Intracranial cavernous angioma: a practical review of clinical and biological aspects.

PubMed

Raychaudhuri, Ratul; Batjer, H Huntington; Awad, Issam A

2005-04-01

Cavernomas are an uncommon lesion seen in neurosurgical practice that can occasionally rupture. Recent developments in neurosurgical technique and microbiology have brought greater insight into the treatment and molecular pathogenesis of cavernoma. In this review, a historical overview of cavernous angioma, a current paradigm for treatment, promising new molecular biological developments, and suggestions for future directions in neurosurgical research are presented, with emphasis on practical clinical applications. A survey of the literature on cavernous angioma and consultation with the Department of Neurosurgery at Northwestern Memorial Hospital was conducted by the authors to gain greater insight regarding this lesion. Papers and consultation revealed the importance of careful evaluation of this lesion, new techniques such as functional magnetic resonance imaging and frameless stereotaxy that simplify clinical management of cavernomas, and potential mechanisms by which to tackle this lesion in the future. New basic knowledge on disease biology is summarized with practical applications in the clinical arena. There appear to be a number of controversies regarding management of this lesion. These include risk factors faced by the patient, controversy over the importance of resection, and modality through which the treatment should occur. An algorithm is presented to aid the neurosurgeon in management of these lesions. Exciting developments in neurosurgery and molecular biology will continue to have a major impact on clinical treatment of this disease. Unresolved issues regarding the importance of certain risk factors, the role for radiotherapy in treatments, and the underlying molecular abnormalities must be tackled to gain greater clarity in treatment of this lesion.

[Proposal for graduate school education in the future: from the viewpoint of the Department of clinical Laboratory in a university hospital].

PubMed

Ishii, Junichi

2009-08-01

Fujita Health University Hospital, located in Toyoake, is a large teaching hospital with 1,505 beds. The Department of Clinical Laboratory in our hospital, in which 136 medical technologists work, is one of the largest clinical laboratories in Japan. Medical technologists in our hospital are required not only to perform accurate laboratory examinations, but also to contribute to the medical care team. In addition, they must educate students and trainee medical technologists. Furthermore, they conduct research to develop and evaluate new laboratory methods. Thus, we hope that education in graduate schools of medical technology (Master's course), along with promoting the specialty of laboratory techniques, will develop students' clinical skills to examine patients and research skills to conduct studies.

Analyzing clinical phonological data using Phon

PubMed Central

McAllister Byun, Tara

2016-01-01

In this paper, we describe how Phon, a software program for the transcription and analysis of phonological data, can be applied to facilitate clinical phonological analyses. We begin with a summary of the types of analyses that are frequently used in the assessment and management of speech sound disorders. We then discuss challenges inherent to the transcription and analysis of clinical phonological data. For each challenge, we discuss solutions currently available within Phon, and offer an outlook on future methodological and technical developments in the area of clinical phonology. This paper includes a step-by-step introduction to Phon suitable for readers who lack previous experience with the software. We conclude with a discussion of data sharing and its vital role in advancing research and intervention practices in the area of speech development and disorders. PMID:27111269

From the RNA world to the clinic.

PubMed

Sullenger, Bruce A; Nair, Smita

2016-06-17

The study of RNA has continually emphasized the structural and functional versatility of RNA molecules. This versatility has inspired translational and clinical researchers to explore the utility of RNA-based therapeutic agents for a wide variety of medical applications. Several RNA therapeutics, with diverse modes of action, are being evaluated in large late-stage clinical trials, and many more are in early clinical development. Hundreds of patients are enrolled in large trials testing messenger RNAs to combat cancer, small interfering RNAs to treat renal and hepatic disorders, and aptamers to combat ocular and cardiovascular disease. Results from these studies are generating considerable interest among the biomedical community and the public and will be important for the future development of this emerging class of therapeutic agents. Copyright © 2016, American Association for the Advancement of Science.

The importance of academic literacy for undergraduate nursing students and its relationship to future professional clinical practice: A systematic review.

PubMed

Jefferies, Diana; McNally, Stephen; Roberts, Katriona; Wallace, Anna; Stunden, Annette; D'Souza, Suzanne; Glew, Paul

2018-01-01

This systematic review was designed to assess the importance of academic literacy for undergraduate nursing students and its relationship to future professional clinical practice. It aimed to explore the link between academic literacy and writing in an undergraduate nursing degree and the development of critical thinking skills for their future professional clinical practice. A systematic review of qualitative studies and expert opinion publications. A systematic literature search was undertaken of the following databases: ERIC, PubMed, CINAHL, MEDLINE and Scopus. All papers reviewed were from 2000 to 2016 and were written in English. We identified 981 studies and expert opinion papers from the selected databases. After reviewing key words and abstracts for the inclusion and exclusion criteria, 48 papers were selected for review. These were read and reread, with 22 papers, including one thesis, selected for quality appraisal. One paper was discarded due to the exclusion criteria. Three major themes were evident from this study. First, students need assistance to develop tertiary level academic literacy skills when they commence their undergraduate nursing degree. Second, that teaching practices need to be consistent in both designing assessments and in giving feedback to students, in order to assist improvement of academic literacy skills. And finally, academic literacy can facilitate critical thinking when students are assessed using discipline specific genres that relate to their future professional nursing practice. This review highlights the importance of critical thinking in clinical nursing practice and its strong relationship with academic writing skills. It has shown critical thinking is discipline specific and nursing students need to be taught discipline specific literacy genres in undergraduate nursing degrees. Nursing has a diverse educational and cultural mix of students, and educators should not assume academic literacy skills upon commencement of an undergraduate nursing programme. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

New Cancer Immunotherapy Agents in Development: a report from an associated program of the 31stAnnual Meeting of the Society for Immunotherapy of Cancer, 2016.

PubMed

Adusumilli, Prasad S; Cha, Edward; Cornfeld, Mark; Davis, Thomas; Diab, Adi; Dubensky, Thomas W; Evans, Elizabeth; Grogan, Jane L; Irving, Bryan A; Leidner, Rom S; Olwill, Shane A; Soon-Shiong, Patrick; Triebel, Frederic; Tuck, David; Bot, Adrian; Dansey, Roger D; Drake, Charles G; Freeman, Gordon J; Ibrahim, Ramy; Patel, Salil; Chen, Daniel S

2017-01-01

This report is a summary of 'New Cancer Immunotherapy Agents in Development' program, which took place in association with the 31st Annual Meeting of the Society for Immunotherapy of Cancer (SITC), on November 9, 2016 in National Harbor, Maryland. Presenters gave brief overviews of emerging clinical and pre-clinical immune-based agents and combinations, before participating in an extended panel discussion with multidisciplinary leaders, including members of the FDA, leading academic institutions and industrial drug developers, to consider topics relevant to the future of cancer immunotherapy.

Caregiver anticipatory grief: phenomenology, assessment and clinical interventions.

PubMed

Coelho, Alexandra; de Brito, Maja; Barbosa, António

2018-03-01

This review aims to synthesize recent findings on anticipatory grief in caregivers, referring to its phenomenology, assessment and clinical interventions. Recent literature illustrates the wide scope of the current use of the term anticipatory grief, reflecting caregivers' experiences in different end-of-life trajectories. The anticipation of death is the distinctive aspect of anticipatory grief in the predeath grief continuum, encompassing several progressive losses, past and future. Recently developed assessment instruments capture key aspects of this experience, such as separation anxiety, anticipation of death and future absence of the person, denial and relational losses. Recent findings on prevalence of clinically significant predeath symptoms in caregivers range from 12.5 to 38.5%. Beyond personal and relational factors, difficult circumstances of end-of-life care significantly interfere in adjustment to anticipatory grief. Useful therapeutic interventions were identified, such as validation of grief feelings, increased coping and self-care, anticipation of future losses and reframing roles. However, rigorous interventional studies are needed to create guidelines and the manualization of specific therapeutic approaches to caregiver anticipatory grief. Findings suggest that anticipatory grief dynamics in different end-of-life trajectories should be recognized and adequately assessed. Clinical interventions considered useful to support anticipatory grief caregivers are presented, but further research is needed to verify effectiveness.

NanoString, a novel digital color-coded barcode technology: current and future applications in molecular diagnostics.

PubMed

Tsang, Hin-Fung; Xue, Vivian Weiwen; Koh, Su-Pin; Chiu, Ya-Ming; Ng, Lawrence Po-Wah; Wong, Sze-Chuen Cesar

2017-01-01

Formalin-fixed, paraffin-embedded (FFPE) tissue sample is a gold mine of resources for molecular diagnosis and retrospective clinical studies. Although molecular technologies have expanded the range of mutations identified in FFPE samples, the applications of existing technologies are limited by the low nucleic acids yield and poor extraction quality. As a result, the routine clinical applications of molecular diagnosis using FFPE samples has been associated with many practical challenges. NanoString technologies utilize a novel digital color-coded barcode technology based on direct multiplexed measurement of gene expression and offer high levels of precision and sensitivity. Each color-coded barcode is attached to a single target-specific probe corresponding to a single gene which can be individually counted without amplification. Therefore, NanoString is especially useful for measuring gene expression in degraded clinical specimens. Areas covered: This article describes the applications of NanoString technologies in molecular diagnostics and challenges associated with its applications and the future development. Expert commentary: Although NanoString technology is still in the early stages of clinical use, it is expected that NanoString-based cancer expression panels would play more important roles in the future in classifying cancer patients and in predicting the response to therapy for better personal therapeutic care.

Distributed user interfaces for clinical ubiquitous computing applications.

PubMed

Bång, Magnus; Larsson, Anders; Berglund, Erik; Eriksson, Henrik

2005-08-01

Ubiquitous computing with multiple interaction devices requires new interface models that support user-specific modifications to applications and facilitate the fast development of active workspaces. We have developed NOSTOS, a computer-augmented work environment for clinical personnel to explore new user interface paradigms for ubiquitous computing. NOSTOS uses several devices such as digital pens, an active desk, and walk-up displays that allow the system to track documents and activities in the workplace. We present the distributed user interface (DUI) model that allows standalone applications to distribute their user interface components to several devices dynamically at run-time. This mechanism permit clinicians to develop their own user interfaces and forms to clinical information systems to match their specific needs. We discuss the underlying technical concepts of DUIs and show how service discovery, component distribution, events and layout management are dealt with in the NOSTOS system. Our results suggest that DUIs--and similar network-based user interfaces--will be a prerequisite of future mobile user interfaces and essential to develop clinical multi-device environments.

Glycosylated haemoglobin: measurement and clinical use.

PubMed

Peacock, I

1984-08-01

The discovery, biochemistry, laboratory determination, and clinical application of glycosylated haemoglobins are reviewed. Sources of error are discussed in detail. No single assay method is suitable for all purposes, and in the foreseeable future generally acceptable standards and reference ranges are unlikely to be agreed. Each laboratory must establish its own. Nevertheless, the development of glycosylated haemoglobin assays is an important advance. They offer the best available means of assessing diabetic control.

A Survey of U.S. Navy Medical Communications and Evacuations at Sea

DTIC Science & Technology

1984-07-05

specialized 0 sector of the health care system . The majority of these medical departments are headed by an independent duty corpsman who, unlike many...the U.S. Navy has focused increasing attention on the development and implementation of clinical algorithms and telemedicine systems to enhance...a computer assisted clinical algorithm system for use aboard submarines. 5- 7 Although initial work focused upon acute abdominal pain, future

Research and Its Relationship to Nurse Education: Focus and Capacity.

ERIC Educational Resources Information Center

Newell, Robert

2002-01-01

Examination of two British mental health journals and a government document on the future of nursing found a lack of focus on clinical research and little reference to the role of research and development in practice. The increasing importance of evidence-based practice demands a strategy for developing nurses' capacity to understand, undertake,…

Acute pancreatitis patient registry to examine novel therapies in clinical experience (APPRENTICE): an international, multicenter consortium for the study of acute pancreatitis.

PubMed

Papachristou, Georgios I; Machicado, Jorge D; Stevens, Tyler; Goenka, Mahesh Kumar; Ferreira, Miguel; Gutierrez, Silvia C; Singh, Vikesh K; Kamal, Ayesha; Gonzalez-Gonzalez, Jose A; Pelaez-Luna, Mario; Gulla, Aiste; Zarnescu, Narcis O; Triantafyllou, Konstantinos; Barbu, Sorin T; Easler, Jeffrey; Ocampo, Carlos; Capurso, Gabriele; Archibugi, Livia; Cote, Gregory A; Lambiase, Louis; Kochhar, Rakesh; Chua, Tiffany; Tiwari, Subhash Ch; Nawaz, Haq; Park, Walter G; de-Madaria, Enrique; Lee, Peter J; Wu, Bechien U; Greer, Phil J; Dugum, Mohannad; Koutroumpakis, Efstratios; Akshintala, Venkata; Gougol, Amir

2017-01-01

We have established a multicenter international consortium to better understand the natural history of acute pancreatitis (AP) worldwide and to develop a platform for future randomized clinical trials. The AP patient registry to examine novel therapies in clinical experience (APPRENTICE) was formed in July 2014. Detailed web-based questionnaires were then developed to prospectively capture information on demographics, etiology, pancreatitis history, comorbidities, risk factors, severity biomarkers, severity indices, health-care utilization, management strategies, and outcomes of AP patients. Between November 2015 and September 2016, a total of 20 sites (8 in the United States, 5 in Europe, 3 in South America, 2 in Mexico and 2 in India) prospectively enrolled 509 AP patients. All data were entered into the REDCap (Research Electronic Data Capture) database by participating centers and systematically reviewed by the coordinating site (University of Pittsburgh). The approaches and methodology are described in detail, along with an interim report on the demographic results. APPRENTICE, an international collaboration of tertiary AP centers throughout the world, has demonstrated the feasibility of building a large, prospective, multicenter patient registry to study AP. Analysis of the collected data may provide a greater understanding of AP and APPRENTICE will serve as a future platform for randomized clinical trials.

Coronary artery disease concomitant with chronic obstructive pulmonary disease.

PubMed

Roversi, Sara; Roversi, Pietro; Spadafora, Giuseppe; Rossi, Rosario; Fabbri, Leonardo M

2014-01-01

Numerous epidemiologic studies have linked the presence of chronic obstructive pulmonary disease (COPD) to coronary artery disease (CAD). However, prevalence, pathological processes, clinical manifestations and therapy are still debated, as progress towards uncovering the link between these two disorders has been hindered by the complex nature of multimorbidity. Articles targeting CAD in patients with COPD were identified from the searches of MEDLINE and EMBASE databases in July 2013. Three authors reviewed available evidence, focusing on the latest development on disease prevalence, pathogenesis, clinical manifestations and therapeutic strategies. Both clinical trial and previous reviews have been included in this work. The most accredited hypothesis asserts that the main common risk factors, that is, cigarette smoke and ageing, elicit a chronic low-grade systemic inflammatory response, which affects both cardiovascular endothelial cells and airways/lung parenchyma. The development of CAD in patients with COPD potentiates the morbidity of COPD, leading to increased hospitalizations, mortality and health costs. Moreover, correct diagnosis is challenging and therapies are not clearly defined. Evidence from recently published articles highlights the importance of multimorbidity in patient management and future research. Moreover, many authors emphasize the importance of low-grade systemic inflammation as a common pathological mechanism and a possible future therapeutic target. © 2013 Stichting European Society for Clinical Investigation Journal Foundation. Published by John Wiley & Sons Ltd.

The diagnosis of idiopathic pulmonary fibrosis: current and future approaches

PubMed Central

Martinez, Fernando J; Chisholm, Alison; Collard, Harold R; Flaherty, Kevin R; Myers, Jeffrey; Raghu, Ganesh; Walsh, Simon LF; White, Eric S; Richeldi, Luca

2017-01-01

With the recent development of two effective treatments for patients with idiopathic pulmonary fibrosis, an accurate diagnosis is crucial. The traditional approach to diagnosis emphasises the importance of thorough clinical and laboratory evaluations to exclude secondary causes of disease. High-resolution CT is a critical initial diagnostic test and acts as a tool to identify patients who should undergo surgical lung biopsy to secure a definitive histological diagnosis of usual interstitial pneumonia pattern. This diagnostic approach faces several challenges. Many patients with suspected idiopathic pulmonary fibrosis present with atypical high-resolution CT characteristics but are unfit for surgical lung biopsy, therefore preventing a confident diagnosis. The state of the art suggests an iterative, multidisciplinary process that incorporates available clinical, laboratory, imaging, and histological features. Recent research has explored genomic techniques to molecularly phenotype patients with interstitial lung disease. In the future, clinicians will probably use blood-specific or lung-specific molecular markers in combination with other clinical, physiological, and imaging features to enhance diagnostic efforts, refine prognostic recommendations, and influence the initial or subsequent treatment options. There is an urgent and increasing need for well designed, large, prospective studies measuring the effect of different diagnostic approaches. Ultimately, this will help to inform the development of guidelines and tailor clinical practice for the benefit of patients. PMID:27932290

Clinical Predictors of Severe Cetuximab-Induced Rash: Observations from 933 Patients Enrolled in North Central Cancer Treatment Group Study N0147

PubMed Central

Jatoi, Aminah; Green, Erin M.; Rowland, Jr., Kendrith M.; Sargent, Daniel J.; Alberts, Steven R.

2009-01-01

Objective Epidermal growth factor receptor inhibitors can result in a severe rash in 5–10% of patients and can detract from quality of life. The objective of this study was to identify clinical predictors of severe rash in the hope of utilizing such factors in the design of future rash palliative and prevention trials. Methods 933 cetuximab-treated patients enrolled on N0147, an adjuvant chemotherapy trial for colon cancer, were evaluated for clinical risk factors of severe rash. Results Within this cohort, 50 patients (5%) developed a severe rash (grade 3). More men compared to women developed such a rash: 34 (7%) versus 16 (3%) (multivariate odds ratio = 2.12; 95% confidence interval: 1.14–3.88; p = 0.017). A greater number of younger patients (<70 years of age) also developed a rash: 48 (6%) versus 2 (1%) (multivariate odds ratio = 0.21; 95% confidence interval: 0.05–0.88; p = 0.032). Race and performance score were not predictive. Conclusion Men and younger patients are at greater risk for a severe cetuximab-induced rash although overall the risk is low. These observations are particularly important in designing future rash prevention and palliation trials. PMID:19622902

Satisfaction with Healthcare Received at an Interprofessional Student-run Free Clinic: Invested in Training the Next Generation of Healthcare Professionals.

PubMed

Lu, Karen B; Thiel, Bryan; Atkins, Christopher A; Desai, Anand; Botwin, Ariel; Povlow, Michael R; Simms-Cendan, Judith; Pasarica, Magdalena

2018-03-07

Most medical schools in the United States have an associated student-run free clinic (SRFC) providing medical care to the underserved population around the campus. SRFCs provide students with opportunities to practice history-taking and diagnosis skills. There have been a few studies that have evaluated patient satisfaction within SRFCs; however, these studies report limited aspects of care within these clinics. This study hopes to determine the levels of satisfaction with clinical staff and operations and to ensure that the medical needs of patients are being met. Results showed that 91% of the patients were satisfied or very satisfied with their overall clinic experience. The highest scoring parameters were "courtesy/respect of staff", "availability of free or affordable medications", and "doctor's knowledge". Overall, the patients are satisfied with the staff, care, and availability of medicine provided by the Keeping Neighbors in Good Health Through Service (KNIGHTS) clinic. Most patients enjoy participating in the training and education of future physicians and would recommend this clinic to a friend or family member. The lowest satisfaction rates were associated with length of visit and wait time. In the future, SRFCs should work together to assess patient satisfaction in the clinics, identify problem areas, and develop generalizable interventions for improvement.

The opportunities and obstacles in developing a vascular birthmark database for clinical and research use.

PubMed

Sharma, Vishal K; Fraulin, Frankie Og; Harrop, A Robertson; McPhalen, Donald F

2011-01-01

Databases are useful tools in clinical settings. The authors review the benefits and challenges associated with the development and implementation of an efficient electronic database for the multidisciplinary Vascular Birthmark Clinic at the Alberta Children's Hospital, Calgary, Alberta. The content and structure of the database were designed using the technical expertise of a data analyst from the Calgary Health Region. Relevant clinical and demographic data fields were included with the goal of documenting ongoing care of individual patients, and facilitating future epidemiological studies of this patient population. After completion of this database, 10 challenges encountered during development were retrospectively identified. Practical solutions for these challenges are presented. THE CHALLENGES IDENTIFIED DURING THE DATABASE DEVELOPMENT PROCESS INCLUDED: identification of relevant data fields; balancing simplicity and user-friendliness with complexity and comprehensive data storage; database expertise versus clinical expertise; software platform selection; linkage of data from the previous spreadsheet to a new data management system; ethics approval for the development of the database and its utilization for research studies; ensuring privacy and limited access to the database; integration of digital photographs into the database; adoption of the database by support staff in the clinic; and maintaining up-to-date entries in the database. There are several challenges involved in the development of a useful and efficient clinical database. Awareness of these potential obstacles, in advance, may simplify the development of clinical databases by others in various surgical settings.

The past, present, and future of selective progesterone receptor modulators in the management of uterine fibroids.

PubMed

Singh, Sukhbir S; Belland, Liane; Leyland, Nicholas; von Riedemann, Sarah; Murji, Ally

2017-12-21

Uterine fibroids are common in women of reproductive age and can have a significant impact on quality of life and fertility. Although a number of international obstetrics/gynecology societies have issued evidence-based clinical practice guidelines for the management of symptomatic uterine fibroids, many of these guidelines do not yet reflect the most recent clinical evidence and approved indication for one of the key medical management options: the selective progesterone receptor modulator class. This article aims to share the clinical experience gained with selective progesterone receptor modulators in Europe and Canada by reviewing the historical development of selective progesterone receptor modulators, current best practices for selective progesterone receptor modulator use based on available data, and potential future uses for selective progesterone receptor modulators in uterine fibroids and other gynecologic conditions. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Neuroimaging of Pain: Human Evidence and Clinical Relevance of Central Nervous System Processes and Modulation.

PubMed

Martucci, Katherine T; Mackey, Sean C

2018-06-01

Neuroimaging research has demonstrated definitive involvement of the central nervous system in the development, maintenance, and experience of chronic pain. Structural and functional neuroimaging has helped elucidate central nervous system contributors to chronic pain in humans. Neuroimaging of pain has provided a tool for increasing our understanding of how pharmacologic and psychologic therapies improve chronic pain. To date, findings from neuroimaging pain research have benefitted clinical practice by providing clinicians with an educational framework to discuss the biopsychosocial nature of pain with patients. Future advances in neuroimaging-based therapeutics (e.g., transcranial magnetic stimulation, real-time functional magnetic resonance imaging neurofeedback) may provide additional benefits for clinical practice. In the future, with standardization and validation, brain imaging could provide objective biomarkers of chronic pain, and guide treatment for personalized pain management. Similarly, brain-based biomarkers may provide an additional predictor of perioperative prognoses.

Hybrid 2D-nanomaterials-based electrochemical immunosensing strategies for clinical biomarkers determination.

PubMed

Campuzano, S; Pedrero, M; Nikoleli, G-P; Pingarrón, J M; Nikolelis, D P

2017-03-15

Owing to the outstanding conductivity and biocompatibility as well as numerous other fascinating properties of two-dimensional (2D)-nanomaterials, 2D-based nanohybrids have shown unparalleled superiorities in the field of electrochemical biosensors. This review highlights latest advances in electrochemical immunosensors for clinical biomarkers based on different hybrid 2D-nanomaterials. Particular attention will be given to hybrid nanostructures involving graphene and other graphene-like 2D-layered nanomaterials (GLNs). Several recent strategies for using such 2D-nanomaterial heterostructures in the development of modern immunosensors, both for tagging or modifying electrode transducers, are summarized and discussed. These hybrid nanocomposites, quite superior than their rival materials, will undoubtedly have an important impact within the near future and not only in clinical areas. Current challenges and future perspectives in this rapidly growing field are also outlined. Copyright © 2016 Elsevier B.V. All rights reserved.

VTE Risk assessment - a prognostic Model: BATER Cohort Study of young women.

PubMed

Heinemann, Lothar Aj; Dominh, Thai; Assmann, Anita; Schramm, Wolfgang; Schürmann, Rolf; Hilpert, Jan; Spannagl, Michael

2005-04-18

BACKGROUND: Community-based cohort studies are not available that evaluated the predictive power of both clinical and genetic risk factors for venous thromboembolism (VTE). There is, however, clinical need to forecast the likelihood of future occurrence of VTE, at least qualitatively, to support decisions about intensity of diagnostic or preventive measures. MATERIALS AND METHODS: A 10-year observation period of the Bavarian Thromboembolic Risk (BATER) study, a cohort study of 4337 women (18-55 years), was used to develop a predictive model of VTE based on clinical and genetic variables at baseline (1993). The objective was to prepare a probabilistic scheme that discriminates women with virtually no VTE risk from those at higher levels of absolute VTE risk in the foreseeable future. A multivariate analysis determined which variables at baseline were the best predictors of a future VTE event, provided a ranking according to the predictive power, and permitted to design a simple graphic scheme to assess the individual VTE risk using five predictor variables. RESULTS: Thirty-four new confirmed VTEs occurred during the observation period of over 32,000 women-years (WYs). A model was developed mainly based on clinical information (personal history of previous VTE and family history of VTE, age, BMI) and one composite genetic risk markers (combining Factor V Leiden and Prothrombin G20210A Mutation). Four levels of increasing VTE risk were arbitrarily defined to map the prevalence in the study population: No/low risk of VTE (61.3%), moderate risk (21.1%), high risk (6.0%), very high risk of future VTE (0.9%). In 10.6% of the population the risk assessment was not possible due to lacking VTE cases. The average incidence rates for VTE in these four levels were: 4.1, 12.3, 47.2, and 170.5 per 104 WYs for no, moderate, high, and very high risk, respectively. CONCLUSION: Our prognostic tool - containing clinical information (and if available also genetic data) - seems to be worthwhile testing in medical practice in order to confirm or refute the positive findings of this study. Our cohort study will be continued to include more VTE cases and to increase predictive value of the model.

Clinical Findings and Pain Symptoms as Potential Risk Factors for Chronic TMD: Descriptive Data and Empirically Identified Domains from the OPPERA Case-Control Study

PubMed Central

Ohrbach, Richard; Fillingim, Roger B.; Mulkey, Flora; Gonzalez, Yoly; Gordon, Sharon; Gremillion, Henry; Lim, Pei-Feng; Ribeiro-Dasilva, Margarete; Greenspan, Joel D.; Knott, Charles; Maixner, William; Slade, Gary

2011-01-01

Clinical characteristics might be associated with temporomandibular disorders (TMD) because they are antecedent risk factors that increase the likelihood of a healthy person developing the condition or because they represent signs or symptoms of either subclinical or overt TMD. In this baseline case-control study of the multisite Orofacial Pain: Prospective Evaluation and Risk Assessment (OPPERA) project, 1,633 controls and 185 cases with chronic, painful TMD completed questionnaires and received clinical examinations. Odds ratios measuring association between each clinical factor and TMD were computed, with adjustment for study-site as well as age, sex, and race/ethnicity. Compared to controls, TMD cases reported more trauma, greater parafunction, more headaches and other pain disorders, more functional limitation in using the jaw, more nonpain symptoms in the facial area, more temporomandibular joint noises and jaw locking, more neural or sensory medical conditions, and worse overall medical status. They also exhibited on examination reduced jaw mobility, more joint noises, and a greater number of painful masticatory, cervical, and body muscles upon palpation. The results indicated that TMD cases differ substantially from controls across almost all variables assessed. Future analyses of follow-up data will determine whether these clinical characteristics predict increased risk for developing first-onset pain-related TMD Perspective Clinical findings from OPPERA’s baseline case-control study indicate significant differences between chronic TMD cases and controls with respect to trauma history, parafunction, other pain disorders, health status, and clinical examination data. Future analyses will examine their contribution to TMD onset. PMID:22074750

Measures of outcome for stimulant trials: ACTTION recommendations and research agenda.

PubMed

Kiluk, Brian D; Carroll, Kathleen M; Duhig, Amy; Falk, Daniel E; Kampman, Kyle; Lai, Shengan; Litten, Raye Z; McCann, David J; Montoya, Ivan D; Preston, Kenzie L; Skolnick, Phil; Weisner, Constance; Woody, George; Chandler, Redonna; Detke, Michael J; Dunn, Kelly; Dworkin, Robert H; Fertig, Joanne; Gewandter, Jennifer; Moeller, F Gerard; Ramey, Tatiana; Ryan, Megan; Silverman, Kenneth; Strain, Eric C

2016-01-01

The development and approval of an efficacious pharmacotherapy for stimulant use disorders has been limited by the lack of a meaningful indicator of treatment success, other than sustained abstinence. In March, 2015, a meeting sponsored by Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) was convened to discuss the current state of the evidence regarding meaningful outcome measures in clinical trials for stimulant use disorders. Attendees included members of academia, funding and regulatory agencies, pharmaceutical companies, and healthcare organizations. The goal was to establish a research agenda for the development of a meaningful outcome measure that may be used as an endpoint in clinical trials for stimulant use disorders. Based on guidelines for the selection of clinical trial endpoints, the lessons learned from prior addiction clinical trials, and the process that led to identification of a meaningful indicator of treatment success for alcohol use disorders, several recommendations for future research were generated. These include a focus on the validation of patient reported outcome measures of functioning, the exploration of patterns of stimulant abstinence that may be associated with physical and/or psychosocial benefits, the role of urine testing for validating self-reported measures of stimulant abstinence, and the operational definitions for reduction-based measures in terms of frequency rather than quantity of stimulant use. These recommendations may be useful for secondary analyses of clinical trial data, and in the design of future clinical trials that may help establish a meaningful indicator of treatment success. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Practitioner perspectives on extended clinical placement programs in optometry.

PubMed

Bentley, Sharon A; Cartledge, Amy; Guest, Daryl J; Cappuccio, Skye; Woods, Craig A

2016-05-01

Some universities are looking to provide a more diverse range of clinical learning experiences through extended clinical placement programs. This approach will potentially have a significant impact on practitioners. The aim of this study was to conduct a national survey of optometrists to ascertain their perspectives on participating in extended clinical placement programs. Members of Optometry Australia were invited to participate in a survey conducted during June and July 2014. A total of 268 practitioners participated (six per cent of registered Australian optometrists): 159 were predominantly employees or locums and 109 were owners or managers who identified as the key representative of a practice or organisation for the purpose of this survey. Almost two-thirds (65 per cent) of participants, who were employees or locums were supportive of extended clinical placement programs. Among this group, females were more likely to be supportive than males (p = 0.033). In comparison, just over one-third (34 per cent) of participants who were key decision-makers were supportive, with 30 per cent possibly supportive and 36 per cent not supportive. Among key decision-makers, males were more likely to be supportive (p = 0.009). The top three perceived advantages of supervising a student were: opportunity to mentor early career development, opportunity to give back to the profession and future recruitment. The top three perceived disadvantages were: burden on time, decrease in number of patients examined and burden on support staff. Suggested incentives for supervising students were credit for continuing professional development and financial remuneration. There appears to be moderate support for extended clinical placement programs; however, there are incentives that might engage a larger proportion of the profession in the future. These findings can inform the development of effective and sustainable clinical training programs for optometry students. Additionally, the findings might be used as evidence to seek Government support for clinical placement training in optometry. © 2016 Optometry Australia.

The development and psychometric testing of a theory-based instrument to evaluate nurses' perception of clinical reasoning competence.

PubMed

Liou, Shwu-Ru; Liu, Hsiu-Chen; Tsai, Hsiu-Min; Tsai, Ying-Huang; Lin, Yu-Ching; Chang, Chia-Hao; Cheng, Ching-Yu

2016-03-01

The purpose of the study was to develop and psychometrically test the Nurses Clinical Reasoning Scale. Clinical reasoning is an essential skill for providing safe and quality patient care. Identifying pre-graduates' and nurses' needs and designing training courses to improve their clinical reasoning competence becomes a critical task. However, there is no instrument focusing on clinical reasoning in the nursing profession. Cross-sectional design was used. This study included the development of the scale, a pilot study that preliminary tested the readability and reliability of the developed scale and a main study that implemented and tested the psychometric properties of the developed scale. The Nurses Clinical Reasoning Scale was developed based on the Clinical Reasoning Model. The scale includes 15 items using a Likert five-point scale. Data were collected from 2013-2014. Two hundred and fifty-one participants comprising clinical nurses and nursing pre-graduates completed and returned the questionnaires in the main study. The instrument was tested for internal consistency and test-retest reliability. Its validity was tested with content, construct and known-groups validity. One factor emerged from the factor analysis. The known-groups validity was confirmed. The Cronbach's alpha for the entire instrument was 0·9. The reliability and validity of the Nurses Clinical Reasoning Scale were supported. The scale is a useful tool and can be easily administered for the self-assessment of clinical reasoning competence of clinical nurses and future baccalaureate nursing graduates. Study limitations and further recommendations are discussed. © 2015 John Wiley & Sons Ltd.

Enhancing diversity in the public health research workforce: the research and mentorship program for future HIV vaccine scientists.

PubMed

Sopher, Carrie J; Adamson, Blythe Jane S; Andrasik, Michele P; Flood, Danna M; Wakefield, Steven F; Stoff, David M; Cook, Ryan S; Kublin, James G; Fuchs, Jonathan D

2015-04-01

We developed and evaluated a novel National Institutes of Health-sponsored Research and Mentorship Program for African American and Hispanic medical students embedded within the international, multisite HIV Vaccine Trials Network, and explored its impact on scientific knowledge, acquired skills, and future career plans. Scholars conducted social, behavioral, clinical, or laboratory-based research projects with HIV Vaccine Trials Network investigators over 8 to 16 weeks (track 1) or 9 to 12 months (track 2). We conducted an in-depth, mixed-methods evaluation of the first 2 cohorts (2011-2013) to identify program strengths, areas for improvement, and influence on professional development. A pre-post program assessment demonstrated increases in self-reported knowledge, professional skills, and interest in future HIV vaccine research. During in-depth interviews, scholars reported that a supportive, centrally administered program; available funding; and highly involved mentors and staff were keys to the program's early success. A multicomponent, mentored research experience that engages medical students from underrepresented communities and is organized within a clinical trials network may expand the pool of diverse public health scientists. Efforts to sustain scholar interest over time and track career trajectories are warranted.

Preclinical Alzheimer's Disease: Implications for Refinement of the Concept.

PubMed

Vos, Stephanie J B; Visser, Pieter Jelle

2018-05-23

Increasing interest in clinical trials and clinical research settings to identify Alzheimer's disease (AD) in the earliest stages of the disease has led to the concept of preclinical AD. Individuals with preclinical AD have AD pathology without clinical symptoms yet. Accumulating evidence has shown that biomarkers can identify preclinical AD and that preclinical AD is associated with a poor clinical outcome. Little is known yet about the role of vascular and lifestyle risk factors in the development of preclinical AD. In order to better understand preclinical AD pathology and clinical progression rates, there is a need to refine the concept of preclinical AD. This will be of great value for advancements in future research, clinical trials, and eventually clinical practice.

The feasibility, perceived satisfaction, and value of using synchronous webinars to educate clinical research professionals on reporting adverse events in clinical trials: a report from the Children's Oncology Group.

PubMed

Borgerson, Dawn; Dino, Jennifer

2012-01-01

Clinical research professionals are faced with decreased funding and increased workloads; innovative methods of professional development programs are necessary to accommodate these factors. This study evaluated the feasibility, perceived satisfaction, and value of using webinars to educate clinical research professionals on reporting adverse events commonly experienced in pediatric oncology clinical trials. The setting incorporated synchronous web-based educational technology. Constructivist learning provides the theoretical framework for this study. Participants evaluated the professional development program at 2 time points: (a) at the conclusion and (b) 4 to 6 weeks afterward, using survey method. Synchronous webinars were both economical and effective in educating clinical research professionals across institutional sites. Participants reported exceptionally high levels of satisfaction with the accessibility, scope, quality, and interactivity of the professional development program. The vast majority of participants reported that the education would assist with reporting adverse events in pediatric oncology clinical trials and this perception persisted into clinical practice. Although the results of this study were intended to guide future educational efforts of the Children's Oncology Group, they may also apply to other cooperative groups.

Big Data Mining and Adverse Event Pattern Analysis in Clinical Drug Trials

PubMed Central

Federer, Callie; Yoo, Minjae

2016-01-01

Abstract Drug adverse events (AEs) are a major health threat to patients seeking medical treatment and a significant barrier in drug discovery and development. AEs are now required to be submitted during clinical trials and can be extracted from ClinicalTrials.gov (https://clinicaltrials.gov/), a database of clinical studies around the world. By extracting drug and AE information from ClinicalTrials.gov and structuring it into a database, drug-AEs could be established for future drug development and repositioning. To our knowledge, current AE databases contain mainly U.S. Food and Drug Administration (FDA)-approved drugs. However, our database contains both FDA-approved and experimental compounds extracted from ClinicalTrials.gov. Our database contains 8,161 clinical trials of 3,102,675 patients and 713,103 reported AEs. We extracted the information from ClinicalTrials.gov using a set of python scripts, and then used regular expressions and a drug dictionary to process and structure relevant information into a relational database. We performed data mining and pattern analysis of drug-AEs in our database. Our database can serve as a tool to assist researchers to discover drug-AE relationships for developing, repositioning, and repurposing drugs. PMID:27631620

Big Data Mining and Adverse Event Pattern Analysis in Clinical Drug Trials.

PubMed

Federer, Callie; Yoo, Minjae; Tan, Aik Choon

2016-12-01

Drug adverse events (AEs) are a major health threat to patients seeking medical treatment and a significant barrier in drug discovery and development. AEs are now required to be submitted during clinical trials and can be extracted from ClinicalTrials.gov ( https://clinicaltrials.gov/ ), a database of clinical studies around the world. By extracting drug and AE information from ClinicalTrials.gov and structuring it into a database, drug-AEs could be established for future drug development and repositioning. To our knowledge, current AE databases contain mainly U.S. Food and Drug Administration (FDA)-approved drugs. However, our database contains both FDA-approved and experimental compounds extracted from ClinicalTrials.gov . Our database contains 8,161 clinical trials of 3,102,675 patients and 713,103 reported AEs. We extracted the information from ClinicalTrials.gov using a set of python scripts, and then used regular expressions and a drug dictionary to process and structure relevant information into a relational database. We performed data mining and pattern analysis of drug-AEs in our database. Our database can serve as a tool to assist researchers to discover drug-AE relationships for developing, repositioning, and repurposing drugs.

Web-based unfolding cases: a strategy to enhance and evaluate clinical reasoning skills.

PubMed

Johnson, Gail; Flagler, Susan

2013-10-01

Clinical reasoning involves the use of both analytical and nonanalytical intuitive cognitive processes. Fostering student development of clinical reasoning skills and evaluating student performance in this cognitive arena can challenge educators. The use of Web-based unfolding cases is proposed as a strategy to address these challenges. Unfolding cases mimic real-life clinical situations by presenting only partial clinical information in sequential segments. Students receive immediate feedback after submitting a response to a given segment. The student's comparison of the desired and submitted responses provides information to enhance the development of clinical reasoning skills. Each student's set of case responses are saved for the instructor in an individual-student electronic file, providing a record of the student's knowledge and thinking processes for faculty evaluation. For the example case given, the approaches used to evaluate individual components of clinical reasoning are provided. Possible future uses of Web-based unfolding cases are described. Copyright 2013, SLACK Incorporated.

Combat Wound Initiative program.

PubMed

Stojadinovic, Alexander; Elster, Eric; Potter, Benjamin K; Davis, Thomas A; Tadaki, Doug K; Brown, Trevor S; Ahlers, Stephen; Attinger, Christopher E; Andersen, Romney C; Burris, David; Centeno, Jose; Champion, Hunter; Crumbley, David R; Denobile, John; Duga, Michael; Dunne, James R; Eberhardt, John; Ennis, William J; Forsberg, Jonathan A; Hawksworth, Jason; Helling, Thomas S; Lazarus, Gerald S; Milner, Stephen M; Mullick, Florabel G; Owner, Christopher R; Pasquina, Paul F; Patel, Chirag R; Peoples, George E; Nissan, Aviram; Ring, Michael; Sandberg, Glenn D; Schaden, Wolfgang; Schultz, Gregory S; Scofield, Tom; Shawen, Scott B; Sheppard, Forest R; Stannard, James P; Weina, Peter J; Zenilman, Jonathan M

2010-07-01

The Combat Wound Initiative (CWI) program is a collaborative, multidisciplinary, and interservice public-private partnership that provides personalized, state-of-the-art, and complex wound care via targeted clinical and translational research. The CWI uses a bench-to-bedside approach to translational research, including the rapid development of a human extracorporeal shock wave therapy (ESWT) study in complex wounds after establishing the potential efficacy, biologic mechanisms, and safety of this treatment modality in a murine model. Additional clinical trials include the prospective use of clinical data, serum and wound biomarkers, and wound gene expression profiles to predict wound healing/failure and additional clinical patient outcomes following combat-related trauma. These clinical research data are analyzed using machine-based learning algorithms to develop predictive treatment models to guide clinical decision-making. Future CWI directions include additional clinical trials and study centers and the refinement and deployment of our genetically driven, personalized medicine initiative to provide patient-specific care across multiple medical disciplines, with an emphasis on combat casualty care.

Limitations in predicting the space radiation health risk for exploration astronauts.

PubMed

Chancellor, Jeffery C; Blue, Rebecca S; Cengel, Keith A; Auñón-Chancellor, Serena M; Rubins, Kathleen H; Katzgraber, Helmut G; Kennedy, Ann R

2018-01-01

Despite years of research, understanding of the space radiation environment and the risk it poses to long-duration astronauts remains limited. There is a disparity between research results and observed empirical effects seen in human astronaut crews, likely due to the numerous factors that limit terrestrial simulation of the complex space environment and extrapolation of human clinical consequences from varied animal models. Given the intended future of human spaceflight, with efforts now to rapidly expand capabilities for human missions to the moon and Mars, there is a pressing need to improve upon the understanding of the space radiation risk, predict likely clinical outcomes of interplanetary radiation exposure, and develop appropriate and effective mitigation strategies for future missions. To achieve this goal, the space radiation and aerospace community must recognize the historical limitations of radiation research and how such limitations could be addressed in future research endeavors. We have sought to highlight the numerous factors that limit understanding of the risk of space radiation for human crews and to identify ways in which these limitations could be addressed for improved understanding and appropriate risk posture regarding future human spaceflight.

Physiological effects of oral glucosamine on joint health: current status and consensus on future research priorities

PubMed Central

2013-01-01

The aim of this paper was to provide an overview of the current knowledge and understanding of the potential beneficial physiological effects of glucosamine (GlcN) on joint health. The objective was to reach a consensus on four critical questions and to provide recommendations for future research priorities. To this end, nine scientists from Europe and the United States were selected according to their expertise in this particular field and were invited to participate in the Hohenheim conference held in August 2011. Each expert was asked to address a question that had previously been posed by the chairman of the conference. Based on a systematic review of the literature and the collection of recent data, the experts documented the effects of GlcN on cartilage ageing, metabolic/kinetic and maintenance of joint health as well as reduction of risk of OA development. After extensive debate and discussion the expert panel addressed each question and a general consensus statement was developed, agreeing on the current state-of-the-art and future areas for basic and clinical studies. This paper summarizes the available evidence for beneficial effects of GlcN on joint health and proposes new insight into the design of future clinical trials aimed at identifying beneficial physiological effect of GlcN on joint tissues. PMID:23531101

Supraspinal Control Predicts Locomotor Function and Forecasts Responsiveness to Training after Spinal Cord Injury

PubMed Central

Field-Fote, Edelle C.; Yang, Jaynie F.; Basso, D. Michele; Gorassini, Monica A.

2017-01-01

Abstract Restoration of walking ability is an area of great interest in the rehabilitation of persons with spinal cord injury. Because many cortical, subcortical, and spinal neural centers contribute to locomotor function, it is important that intervention strategies be designed to target neural elements at all levels of the neuraxis that are important for walking ability. While to date most strategies have focused on activation of spinal circuits, more recent studies are investigating the value of engaging supraspinal circuits. Despite the apparent potential of pharmacological, biological, and genetic approaches, as yet none has proved more effective than physical therapeutic rehabilitation strategies. By making optimal use of the potential of the nervous system to respond to training, strategies can be developed that meet the unique needs of each person. To complement the development of optimal training interventions, it is valuable to have the ability to predict future walking function based on early clinical presentation, and to forecast responsiveness to training. A number of clinical prediction rules and association models based on common clinical measures have been developed with the intent, respectively, to predict future walking function based on early clinical presentation, and to delineate characteristics associated with responsiveness to training. Further, a number of variables that are correlated with walking function have been identified. Not surprisingly, most of these prediction rules, association models, and correlated variables incorporate measures of volitional lower extremity strength, illustrating the important influence of supraspinal centers in the production of walking behavior in humans. PMID:27673569

Knowledge as a Service at the Point of Care.

PubMed

Shellum, Jane L; Freimuth, Robert R; Peters, Steve G; Nishimura, Rick A; Chaudhry, Rajeev; Demuth, Steve J; Knopp, Amy L; Miksch, Timothy A; Milliner, Dawn S

2016-01-01

An electronic health record (EHR) can assist the delivery of high-quality patient care, in part by providing the capability for a broad range of clinical decision support, including contextual references (e.g., Infobuttons), alerts and reminders, order sets, and dashboards. All of these decision support tools are based on clinical knowledge; unfortunately, the mechanisms for managing rules, order sets, Infobuttons, and dashboards are often unrelated, making it difficult to coordinate the application of clinical knowledge to various components of the clinical workflow. Additional complexity is encountered when updating enterprise-wide knowledge bases and delivering the content through multiple modalities to different consumers. We present the experience of Mayo Clinic as a case study to examine the requirements and implementation challenges related to knowledge management across a large, multi-site medical center. The lessons learned through the development of our knowledge management and delivery platform will help inform the future development of interoperable knowledge resources.

Knowledge as a Service at the Point of Care

PubMed Central

Shellum, Jane L.; Freimuth, Robert R.; Peters, Steve G.; Nishimura, Rick A.; Chaudhry, Rajeev; Demuth, Steve J.; Knopp, Amy L.; Miksch, Timothy A.; Milliner, Dawn S.

2016-01-01

An electronic health record (EHR) can assist the delivery of high-quality patient care, in part by providing the capability for a broad range of clinical decision support, including contextual references (e.g., Infobuttons), alerts and reminders, order sets, and dashboards. All of these decision support tools are based on clinical knowledge; unfortunately, the mechanisms for managing rules, order sets, Infobuttons, and dashboards are often unrelated, making it difficult to coordinate the application of clinical knowledge to various components of the clinical workflow. Additional complexity is encountered when updating enterprise-wide knowledge bases and delivering the content through multiple modalities to different consumers. We present the experience of Mayo Clinic as a case study to examine the requirements and implementation challenges related to knowledge management across a large, multi-site medical center. The lessons learned through the development of our knowledge management and delivery platform will help inform the future development of interoperable knowledge resources. PMID:28269911

Foundational biomedical informatics research in the clinical and translational science era: a call to action.

PubMed

Payne, Philip R O; Embi, Peter J; Niland, Joyce

2010-01-01

Advances in clinical and translational science, along with related national-scale policy and funding mechanisms, have provided significant opportunities for the advancement of applied clinical research informatics (CRI) and translational bioinformatics (TBI). Such efforts are primarily oriented to application and infrastructure development and are critical to the conduct of clinical and translational research. However, they often come at the expense of the foundational CRI and TBI research needed to grow these important biomedical informatics subdisciplines and ensure future innovations. In light of this challenge, it is critical that a number of steps be taken, including the conduct of targeted advocacy campaigns, the development of community-accepted research agendas, and the continued creation of forums for collaboration and knowledge exchange. Such efforts are needed to ensure that the biomedical informatics community is able to advance CRI and TBI science in the context of the modern clinical and translational science era.

The Translational Science Benefits Model: A New Framework for Assessing the Health and Societal Benefits of Clinical and Translational Sciences

PubMed Central

Sarli, Cathy C.; Suiter, Amy M.; Carothers, Bobbi J.; Combs, Todd B.; Allen, Jae L.; Beers, Courtney E.; Evanoff, Bradley A.

2017-01-01

Abstract We report the development of the Translational Science Benefits Model (TSBM), a framework designed to support institutional assessment of clinical and translational research outcomes to measure clinical and community health impacts beyond bibliometric measures. The TSBM includes 30 specific and potentially measurable indicators that reflect benefits that accrue from clinical and translational science research such as products, system characteristics, or activities. Development of the TSBM was based on literature review, a modified Delphi method, and in‐house expert panel feedback. Three case studies illustrate the feasibility and face validity of the TSBM for identification of clinical and community health impacts that result from translational science activities. Future plans for the TSBM include further pilot testing and a resource library that will be freely available for evaluators, translational scientists, and academic institutions who wish to implement the TSBM framework in their own evaluation efforts. PMID:28887873

Newer influenza antivirals, biotherapeutics and combinations.

PubMed

Hayden, Frederick G

2013-01-01

This summary provides an overview of investigational antiviral agents for influenza and of future directions for development of influenza therapeutics. While progress in developing clinically useful antiviral agents for influenza has been generally slow, especially with respect to seriously ill and high-risk patients, important clinical studies of intravenous neuraminidase inhibitors, antibodies and drug combinations are currently in progress. The current decade offers the promise of developing small molecular weight inhibitors with novel mechanisms of action, including host-directed therapies, new biotherapeutics and drug combinations, that should provide more effective antiviral therapies and help mitigate the problem of antiviral resistance. Immunomodulatory interventions also offer promise but need to be based on better understanding of influenza pathogenesis, particularly in seriously ill patients. The development of combination interventions, immunomodulators and host-directed therapies presents unique clinical trial design and regulatory hurdles that remain to be addressed. © 2012 Blackwell Publishing Ltd.

Future directions in bladder cancer immunotherapy: towards adaptive immunity

PubMed Central

Smith, Sean G; Zaharoff, David A

2016-01-01

The clinical management of bladder cancer has not changed significantly in several decades. In particular, intravesical bacillus Calmette–Guérin (BCG) immunotherapy has been a mainstay for high-risk nonmuscle invasive bladder cancer since the late 1970s/early 1980s. This is despite the fact that bladder cancer has the highest recurrence rates of any cancer and BCG immunotherapy has not been shown to induce a tumor-specific immune response. We and others have hypothesized that immunotherapies capable of inducing tumor-specific adaptive immunity are needed to impact bladder cancer morbidity and mortality. This article summarizes the preclinical and clinical development of bladder cancer immunotherapies with an emphasis on the last 5 years. Expected progress in the near future is also discussed. PMID:26860539

Future directions in bladder cancer immunotherapy: towards adaptive immunity.

PubMed

Smith, Sean G; Zaharoff, David A

2016-01-01

The clinical management of bladder cancer has not changed significantly in several decades. In particular, intravesical bacillus Calmette-Guérin (BCG) immunotherapy has been a mainstay for high-risk nonmuscle invasive bladder cancer since the late 1970s/early 1980s. This is despite the fact that bladder cancer has the highest recurrence rates of any cancer and BCG immunotherapy has not been shown to induce a tumor-specific immune response. We and others have hypothesized that immunotherapies capable of inducing tumor-specific adaptive immunity are needed to impact bladder cancer morbidity and mortality. This article summarizes the preclinical and clinical development of bladder cancer immunotherapies with an emphasis on the last 5 years. Expected progress in the near future is also discussed.

Cell Therapy in Dermatology

PubMed Central

Petrof, Gabriela; Abdul-Wahab, Alya; McGrath, John A.

2014-01-01

Harnessing the regenerative capacity of keratinocytes and fibroblasts from human skin has created new opportunities to develop cell-based therapies for patients. Cultured cells and bioengineered skin products are being used to treat patients with inherited and acquired skin disorders associated with defective skin, and further clinical trials of new products are in progress. The capacity of extracutaneous sources of cells such as bone marrow is also being investigated for its plasticity in regenerating skin, and new strategies, such as the derivation of inducible pluripotent stem cells, also hold great promise for future cell therapies in dermatology. This article reviews some of the preclinical and clinical studies and future directions relating to cell therapy in dermatology, particularly for inherited skin diseases associated with fragile skin and poor wound healing. PMID:24890834

Mesenchymal stem cells and immunomodulation: current status and future prospects

PubMed Central

Gao, F; Chiu, S M; Motan, D A L; Zhang, Z; Chen, L; Ji, H-L; Tse, H-F; Fu, Q-L; Lian, Q

2016-01-01

The unique immunomodulatory properties of mesenchymal stem cells (MSCs) make them an invaluable cell type for the repair of tissue/ organ damage caused by chronic inflammation or autoimmune disorders. Although they hold great promise in the treatment of immune disorders such as graft versus host disease (GvHD) and allergic disorders, there remain many challenges to overcome before their widespread clinical application. An understanding of the biological properties of MSCs will clarify the mechanisms of MSC-based transplantation for immunomodulation. In this review, we summarize the preclinical and clinical studies of MSCs from different adult tissues, discuss the current hurdles to their use and propose the future development of pluripotent stem cell-derived MSCs as an approach to immunomodulation therapy. PMID:26794657

ESPEN guidelines on definitions and terminology of clinical nutrition.

PubMed

Cederholm, T; Barazzoni, R; Austin, P; Ballmer, P; Biolo, G; Bischoff, S C; Compher, C; Correia, I; Higashiguchi, T; Holst, M; Jensen, G L; Malone, A; Muscaritoli, M; Nyulasi, I; Pirlich, M; Rothenberg, E; Schindler, K; Schneider, S M; de van der Schueren, M A E; Sieber, C; Valentini, L; Yu, J C; Van Gossum, A; Singer, P

2017-02-01

A lack of agreement on definitions and terminology used for nutrition-related concepts and procedures limits the development of clinical nutrition practice and research. This initiative aimed to reach a consensus for terminology for core nutritional concepts and procedures. The European Society of Clinical Nutrition and Metabolism (ESPEN) appointed a consensus group of clinical scientists to perform a modified Delphi process that encompassed e-mail communication, face-to-face meetings, in-group ballots and an electronic ESPEN membership Delphi round. Five key areas related to clinical nutrition were identified: concepts; procedures; organisation; delivery; and products. One core concept of clinical nutrition is malnutrition/undernutrition, which includes disease-related malnutrition (DRM) with (eq. cachexia) and without inflammation, and malnutrition/undernutrition without disease, e.g. hunger-related malnutrition. Over-nutrition (overweight and obesity) is another core concept. Sarcopenia and frailty were agreed to be separate conditions often associated with malnutrition. Examples of nutritional procedures identified include screening for subjects at nutritional risk followed by a complete nutritional assessment. Hospital and care facility catering are the basic organizational forms for providing nutrition. Oral nutritional supplementation is the preferred way of nutrition therapy but if inadequate then other forms of medical nutrition therapy, i.e. enteral tube feeding and parenteral (intravenous) nutrition, becomes the major way of nutrient delivery. An agreement of basic nutritional terminology to be used in clinical practice, research, and the ESPEN guideline developments has been established. This terminology consensus may help to support future global consensus efforts and updates of classification systems such as the International Classification of Disease (ICD). The continuous growth of knowledge in all areas addressed in this statement will provide the foundation for future revisions. Copyright © 2016 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd.. All rights reserved.

Implementing guidelines: Proposed definitions of neuropsychology services in pediatric oncology.

PubMed

Baum, Katherine T; Powell, Stephanie K; Jacobson, Lisa A; Gragert, Marsha N; Janzen, Laura A; Paltin, Iris; Rey-Casserly, Celiane M; Wilkening, Greta N

2017-08-01

Several organizations have published guidelines for the neuropsychological care of survivors of childhood cancer. However, there is limited consensus in how these guidelines are applied. The model of neuropsychology service delivery is further complicated by the variable terminology used to describe recommended services. In an important first step to translate published guidelines into clinical practice, this paper proposes definitions for specific neuropsychological processes and services, with the goal of facilitating consistency across sites to foster future clinical program development and to clarify clinical practice guidelines. © 2017 Wiley Periodicals, Inc.

NASPGHAN Capsule Endoscopy Clinical Report.

PubMed

Friedlander, Joel A; Liu, Quin Y; Sahn, Benjamin; Kooros, Koorosh; Walsh, Catharine M; Kramer, Robert E; Lightdale, Jenifer R; Khlevner, Julie; McOmber, Mark; Kurowski, Jacob; Giefer, Matthew J; Pall, Harpreet; Troendle, David M; Utterson, Elizabeth C; Brill, Herbert; Zacur, George M; Lirio, Richard A; Lerner, Diana G; Reynolds, Carrie; Gibbons, Troy E; Wilsey, Michael; Liacouras, Chris A; Fishman, Douglas S

2017-03-01

Wireless capsule endoscopy (CE) was introduced in 2000 as a less invasive method to visualize the distal small bowel in adults. Because this technology has advanced it has been adapted for use in pediatric gastroenterology. Several studies have described its clinical use, utility, and various training methods but pediatric literature regarding CE is limited. This clinical report developed by the Endoscopic and Procedures Committee of the North American Society of Pediatric Gastroenterology, Hepatology and Nutrition outlines the current literature, and describes the recommended current role, use, training, and future areas of research for CE in pediatrics.

Mass spectrometry in the palm of your hand: future applications of in vivo tissue analysis.

PubMed

Fox, Simon A; Farah, Camile S

2018-05-21

Assessment and diagnosis of oral mucosal disorders continues to present clinical challenges with conventional methodologies being time consuming and hampered by subjectivity. These considerations also apply to surgical excision of malignant and potentially malignant lesions where accurate assessment of margins is critical to patient outcomes. These clinical needs are driving the development of new technologies which can enable rapid diagnosis based upon characteristic molecular profiles identified through clinical science. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Targeting oncogenic vulnerabilities in triple negative breast cancer: biological bases and ongoing clinical studies

PubMed Central

Ocana, Alberto; Pandiella, Atanasio

2017-01-01

Triple negative breast cancer (TNBC) is still an incurable disease despite the great scientific effort performed during the last years. The huge heterogeneity of this disease has motivated the evaluation of a great number of therapies against different molecular alterations. In this article, we review the biological bases of this entity and how the known molecular evidence supports the current preclinical and clinical development of new therapies. Special attention will be given to ongoing clinical studies and potential options for future drug combinations. PMID:28108739

Physics and engineering aspects of cell and tissue imaging systems: microscopic devices and computer assisted diagnosis.

PubMed

Chen, Xiaodong; Ren, Liqiang; Zheng, Bin; Liu, Hong

2013-01-01

The conventional optical microscopes have been used widely in scientific research and in clinical practice. The modern digital microscopic devices combine the power of optical imaging and computerized analysis, archiving and communication techniques. It has a great potential in pathological examinations for improving the efficiency and accuracy of clinical diagnosis. This chapter reviews the basic optical principles of conventional microscopes, fluorescence microscopes and electron microscopes. The recent developments and future clinical applications of advanced digital microscopic imaging methods and computer assisted diagnosis schemes are also discussed.

Molecular profiling of cancer--the future of personalized cancer medicine: a primer on cancer biology and the tools necessary to bring molecular testing to the clinic.

PubMed

Stricker, Thomas; Catenacci, Daniel V T; Seiwert, Tanguy Y

2011-04-01

Cancers arise as a result of an accumulation of genetic aberrations that are either acquired or inborn. Virtually every cancer has its unique set of molecular changes. Technologies have been developed to study cancers and derive molecular characteristics that increasingly have implications for clinical care. Indeed, the identification of key genetic aberrations (molecular drivers) may ultimately translate into dramatic benefit for patients through the development of highly targeted therapies. With the increasing availability of newer, more powerful, and cheaper technologies such as multiplex mutational screening, next generation sequencing, array-based approaches that can determine gene copy numbers, methylation, expression, and others, as well as more sophisticated interpretation of high-throughput molecular information using bioinformatics tools like signatures and predictive algorithms, cancers will routinely be characterized in the near future. This review examines the background information and technologies that clinicians and physician-scientists will need to interpret in order to develop better, personalized treatment strategies. Copyright © 2011 Elsevier Inc. All rights reserved.

Colonization by Pneumocystis jirovecii and Its Role in Disease

PubMed Central

Norris, Karen A.

2012-01-01

Summary: Although the incidence of Pneumocystis pneumonia (PCP) has decreased since the introduction of combination antiretroviral therapy, it remains an important cause of disease in both HIV-infected and non-HIV-infected immunosuppressed populations. The epidemiology of PCP has shifted over the course of the HIV epidemic both from changes in HIV and PCP treatment and prevention and from changes in critical care medicine. Although less common in non-HIV-infected immunosuppressed patients, PCP is now more frequently seen due to the increasing numbers of organ transplants and development of novel immunotherapies. New diagnostic and treatment modalities are under investigation. The immune response is critical in preventing this disease but also results in lung damage, and future work may offer potential areas for vaccine development or immunomodulatory therapy. Colonization with Pneumocystis is an area of increasing clinical and research interest and may be important in development of lung diseases such as chronic obstructive pulmonary disease. In this review, we discuss current clinical and research topics in the study of Pneumocystis and highlight areas for future research. PMID:22491773

Future European health care: cost containment, health care reform and scientific progress in drug research.

PubMed

Emilien, G

1997-01-01

The cost of the development of a new pharmaceutical product from its conception and synthesis through to the regulatory approval process has more than quadrupled in the last 20 years. Both clinical and total development times have increased substantially. To amortize the costs incurred, the pharmaceutical industry has taken an international dimension. The incentives for pharmaceutical firms to discover and develop new drugs depend on the length of the development and regulatory review process plus the potential market size. Recent regulatory, economic and political changes may have significant implications for the future of new drug developments in Europe. The European Union industrial policy felt that there is a need for convergence in the area of pricing. It is recommended that the policy should aim to contain growth in pharmaceutical expenses by means specific to reimbursement rather than direct price controls. By encouraging doctors to prescribe and customers to use generics, competition is enhanced to bring down drug prices. More emphasis is being laid by government in educating customers to cost-awareness and cost-benefit ratios with regard to pharmaceuticals. Concerning clinical trials, European harmonization has been achieved by significant developments: the rights and integrity of the trial subjects are protected; the credibility of the data is established; and the ethical, scientific and technical quality of the trials has improved. Future European health care forecasts a whole change in the pharmaceutical business. Important issues in cost and outcome measurement should be carefully planned and considered in drug development. Due to important mergers and acquisitions, the pharmaceutical sector will consist mainly of important multinational corporations. In this way, valuable new products may be brought to the market.

Developing future clinician scientists while supporting a research infrastructure.

PubMed

Holsti, Maija; Adelgais, Kathleen M; Willis, Leah; Jacobsen, Kammy; Clark, Edward B; Byington, Carrie L

2013-04-01

Supporting clinical research is a national priority. Clinician scientists are rare and clinical trials in academic medical centers (AMC) often fail to meet enrollment goals. Undergraduate students interested in biomedical careers often lack opportunities to perform clinical research. Describe an innovative undergraduate course that supports clinical research in an AMC. The course, Clinical Research Methods and Practice, offers undergraduate students the opportunity to learn clinical research through didactic and practical experiences. The students in turn support clinician scientists' conduct of clinical studies in an AMC. Clinician scientists receive research support and participate in mentoring sessions for students. Over seven semesters, 128 students have assisted in 21 clinical studies located in outpatient and inpatient units of two hospitals. Students identified and screened eligible patients, collected clinical data, assisted in obtaining informed consent, and transported specimens. Many of the clinician scientists have met their enrollment goals and several have been top-enrollers in multicenter clinical trials as a result of student support. The Clinical Research Methods and Practice class addresses barriers to clinical research in AMC. This may be a model for institutions committed to mentoring students early in their career and to developing infrastructures for clinical research. © 2013 Wiley Periodicals, Inc.

Developing Practice Guidelines for Psychoanalysis

PubMed Central

GRAY, SHEILA HAFTER

1996-01-01

Consensus-based practice guidelines codify clinical intelligence and the rich oral tradition in medicine. Because they reflect actual practice, they are readily accepted by clinicians as a basis for external review. This article illustrates the development of guidelines for a psychoanalytic approach to the large pool of patients who present with a depression. It suggests an integrated biopsychosocial approach to these individuals that is useful in current practice, and it offers propositions that may be tested in future research undertakings. Eventually, practice guidelines such as these may form the basis of economical systems of health care that avoid arbitrary, clinically untenable limitations on services. PMID:22700290

Quest for quality: department of laboratory medicine and pathology, Mayo Clinic.

PubMed

Arney, Kris R; Hopper, Mary H; Tran, Sheryl A; Ward, Melissa M; Hanson, Curtis A

2004-01-01

This article describes our journey for quality in the Department of Laboratory Medicine and Pathology (DLMP) at Mayo Clinic. It provides the background of the department and the process for the development and implementation of the quality program. In addition, a quality conference and the development of a quality school are outlined. Throughout the course of this process, valuable lessons were learned and are discussed. We are pleased with the success of the quality journey. However, we realize that the quest has just begun. We look forward to the future and the challenges that lie ahead.

Precision medicine in the age of big data: The present and future role of large-scale unbiased sequencing in drug discovery and development.

PubMed

Vicini, P; Fields, O; Lai, E; Litwack, E D; Martin, A-M; Morgan, T M; Pacanowski, M A; Papaluca, M; Perez, O D; Ringel, M S; Robson, M; Sakul, H; Vockley, J; Zaks, T; Dolsten, M; Søgaard, M

2016-02-01

High throughput molecular and functional profiling of patients is a key driver of precision medicine. DNA and RNA characterization has been enabled at unprecedented cost and scale through rapid, disruptive progress in sequencing technology, but challenges persist in data management and interpretation. We analyze the state-of-the-art of large-scale unbiased sequencing in drug discovery and development, including technology, application, ethical, regulatory, policy and commercial considerations, and discuss issues of LUS implementation in clinical and regulatory practice. © 2015 American Society for Clinical Pharmacology and Therapeutics.

Clinical application of antidepressant pharmacogenetics: considerations for the design of future studies.

PubMed

Fabbri, Chiara; Serretti, Alessandro

2018-06-12

A frustrating inertia has affected the development of clinical applications of antidepressant pharmacogenetics and personalized treatments of depression are still lacking 20 years after the first findings. Candidate gene studies provided replicated findings for some polymorphisms, but each of them shows at best a small effect on antidepressant efficacy and the cumulative effect of different polymorphisms is unclear. Further, no candidate was immune by at least some negative studies. These considerations give rise to some concerns about the clinical benefits of currently available pharmacogenetic tests since they are based on the results of candidate gene studies. Clinical guidelines in fact suggest that only polymorphisms that alter cytochrome 2D6 or 2C19 enzymatic activity probably provide useful clinical indications, while variants in genes involved in antidepressant pharmacodynamics have no recommended clinical applications. The present review discusses possible strategies to facilitate the identification of genetic biomarkers with clinical usefulness in guiding antidepressant treatments. These include analysis methods for the study of the polygenic/omnigenic nature of antidepressant response, the prioritization of polymorphisms on the basis of functional considerations, the incorporation of clinical-demographic predictors in pharmacogenetic studies (e.g. mixed polygenic and clinical risk scores), the application of methodological improvements to the design of future studies in order to maximize the comparability of results and improve power. Copyright © 2018. Published by Elsevier B.V.

Preparing medical students for future learning using basic science instruction.

PubMed

Mylopoulos, Maria; Woods, Nicole

2014-07-01

The construct of 'preparation for future learning' (PFL) is understood as the ability to learn new information from available resources, relate new learning to past experiences and demonstrate innovation and flexibility in problem solving. Preparation for future learning has been proposed as a key competence of adaptive expertise. There is a need for educators to ensure that opportunities are provided for students to develop PFL ability and that assessments accurately measure the development of this form of competence. The objective of this research was to compare the relative impacts of basic science instruction and clinically focused instruction on performance on a PFL assessment (PFLA). This study employed a 'double transfer' design. Fifty-one pre-clerkship students were randomly assigned to either basic science instruction or clinically focused instruction to learn four categories of disease. After completing an initial assessment on the learned material, all participants received clinically focused instruction for four novel diseases and completed a PFLA. The data from the initial assessment and the PFLA were submitted to independent-sample t-tests. Mean ± standard deviation [SD] scores on the diagnostic cases in the initial assessment were similar for participants in the basic science (0.65 ± 0.11) and clinical learning (0.62 ± 0.11) conditions. The difference was not significant (t[42] = 0.90, p = 0.37, d = 0.27). Analysis of the diagnostic cases on the PFLA revealed significantly higher mean ± SD scores for participants in the basic science learning condition (0.72 ± 0.14) compared with those in the clinical learning condition (0.63 ± 0.15) (t[42] = 2.02, p = 0.05, d = 0.62). Our results show that the inclusion of basic science instruction enhanced the learning of novel related content. We discuss this finding within the broader context of research on basic science instruction, development of adaptive expertise and assessment in medical education. © 2014 John Wiley & Sons Ltd.

Considering future pharmacotherapy for PTSD.

PubMed

Friedman, Matthew J; Bernardy, Nancy C

2017-05-10

Posttraumatic stress disorder (PTSD) is a prevalent, disabling, and often chronic condition that may develop following exposure to a traumatic event. Despite the immense social and economic ramifications of PTSD, there has been relatively little recent development of new pharmacotherapies. The majority of pharmacological randomized clinical trials (RCTs) that has been conducted are now dated. Existing treatments for PTSD primarily have come out of research that tested medications developed for other disorders such as antidepressants, anti-hypertensives, antipsychotics, anticonvulsants, and anxiolytics. With an improved understanding of the complex pathophysiology of PTSD, we consider why it has taken so long to identify important targets to advance the field by addressing the underlying pathophysiology in pharmacological interventions. Exciting developments include research into PTSD-related abnormalities associated with dysregulation of adrenergic, hypothalamic-pituitary-adrenocortical, monoaminergic, peptide, glutamatergic, GABAergic, cannabinoid, opioid, and other neurotransmitter and neuroendocrine systems. Yet, this is a broad list and there are many unanswered questions. Current research on biomarkers associated with different clinical phenotypes of PTSD should lead to novel and more specific pharmacotherapeutic strategies. In this brief review, we consider key questions regarding current knowledge on pharmacological treatments for PTSD and highlight evolving practices in future research. Copyright © 2016. Published by Elsevier B.V.

Ventilator-induced lung injury: the role of gene activation.

PubMed

Ngiam, Nicola; Kavanagh, Brian P

2012-02-01

Ventilator-induced lung injury (VILI) is a ubiquitous iatrogenic clinical problem in critical care. Aside from avoiding large tidal volumes, little progress has been made in identifying effective clinical strategies to minimize this injury. With recent rapid development in bioinformatics and high-throughput molecular technology, the genetic basis of lung injury has been intensively investigated. This review will describe recent insights and potential therapies developed in the field. Much progress has been made in delineating the possible genes and gene products involved in VILI through various mechanisms such as early induced genes, capillary leak, apoptosis, fibrin deposition, inflammatory cytokines, oxidative stress, disrupted angiogenesis, and neutrophil infiltration. Some studies have translated bench findings to the bedside in an attempt to identify clinically important genetic susceptibility, which could aid in the identification of at-risk individuals who might benefit from careful titration of mechanical ventilation. Genetic insights also provide candidate pharmaceutical approaches that may ameliorate VILI in the future. Much relevant information exists for investigators and clinicians interested in VILI. Future research will interlink evolving data to provide a more integrated picture of the molecular mechanisms involved in VILI enabling translation of the most promising candidate therapies.

Evidence-based clinical policy: case report of a reproducible process to encourage understanding and evaluation of evidence.

PubMed

Rikard-Bell, G; Waters, E; Ward, J

2006-07-01

We report within a case study a reproducible process to facilitate the explicit incorporation of evidence by a multidisciplinary group into clinical policy development. To support the decision-making of a multidisciplinary Intersectoral Advisory Group (IAG) convened by the Royal Australasian College of Physicians Health Policy Unit, a systematic review of randomized controlled trials about environmental tobacco smoke and smoking cessation interventions in paediatric settings was first undertaken. As reported in detail here, IAG members were then formally engaged in a transparent and replicable process to understand and interpret the synthesized evidence and to proffer their independent reactions regarding policy, practice and research. Our intention was to ensure that all IAG members were democratically engaged and made aware of the available evidence. As clinical policy must engage stakeholder representatives from diverse backgrounds, a process to equalize understanding of the evidence and 'democratize' judgment about its implications is needed. Future research must then examine the benefits of such explicit steps when guidelines, in turn, are implemented. We hypothesize that changes to future practice will be more likely if processes undertaken to develop guidelines are transparent to clinicians and other target groups.

[Exploration of Recent Mobile Technologies Applied in Nursing Education].

PubMed

Wu, Ting-Ting; Lu, Yi-Chen; Chang, Lei

2017-12-01

The development of science and technology has fundamentally changed people's lives and the way that medical systems function. Increasingly, mobile technologies are being introduced and integrated into classroom teaching and clinical applications, resulting in healthcare providers introducing innovative applications into health education. These applications enhance the clinical, education, and research expertise of medical staffs and nurses, while improving quality of care and providing new experiences for patients. In order to understand the current situation and trends in nursing education, the present study adopted literature analysis to explore the influence and effect of mobile technologies that have been introduced into nursing education from the school and clinical environments. The results found that students hold positive attitudes toward introducing these technologies into their curricula. Although these technologies may increase the work efficiency of nurses in the workplace, questions remain user perceptions and professional expression. Therefore, securing patient agreement and healthcare system approval were major turning points in the introduction of mobile technologies into nursing education. In the future, adapting mobile technologies for use in teaching materials and courses may be further developed. Moreover, empirical studies may be used in future research in order to facilitate the increasingly successful integration of relevant technologies into nursing education.

Genetics of liver disease: From pathophysiology to clinical practice.

PubMed

Karlsen, Tom H; Lammert, Frank; Thompson, Richard J

2015-04-01

Paralleling the first 30 years of the Journal of Hepatology we have witnessed huge advances in our understanding of liver disease and physiology. Genetic advances have played no small part in that. Initial studies in the 1970s and 1980s identified the strong major histocompatibility complex associations in autoimmune liver diseases. During the 1990 s, developments in genomic technologies drove the identification of genes responsible for Mendelian liver diseases. Over the last decade, genome-wide association studies have allowed for the dissection of the genetic susceptibility to complex liver disorders, in which also environmental co-factors play important roles. Findings have allowed the identification and elaboration of pathophysiological processes, have indicated the need for reclassification of liver diseases and have already pointed to new disease treatments. In the immediate future genetics will allow further stratification of liver diseases and contribute to personalized medicine. Challenges exist with regard to clinical implementation of rapidly developing technologies and interpretation of the wealth of accumulating genetic data. The historical perspective of genetics in liver diseases illustrates the opportunities for future research and clinical care of our patients. Copyright © 2015 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

Case Report: Activity Diagrams for Integrating Electronic Prescribing Tools into Clinical Workflow

PubMed Central

Johnson, Kevin B.; FitzHenry, Fern

2006-01-01

To facilitate the future implementation of an electronic prescribing system, this case study modeled prescription management processes in various primary care settings. The Vanderbilt e-prescribing design team conducted initial interviews with clinic managers, physicians and nurses, and then represented the sequences of steps carried out to complete prescriptions in activity diagrams. The diagrams covered outpatient prescribing for patients during a clinic visit and between clinic visits. Practice size, practice setting, and practice specialty type influenced the prescribing processes used. The model developed may be useful to others engaged in building or tailoring an e-prescribing system to meet the specific workflows of various clinic settings. PMID:16622168

Defining Quality in Cardiovascular Imaging: A Scientific Statement From the American Heart Association.

PubMed

Shaw, Leslee J; Blankstein, Ron; Jacobs, Jill E; Leipsic, Jonathon A; Kwong, Raymond Y; Taqueti, Viviany R; Beanlands, Rob S B; Mieres, Jennifer H; Flamm, Scott D; Gerber, Thomas C; Spertus, John; Di Carli, Marcelo F

2017-12-01

The aims of the current statement are to refine the definition of quality in cardiovascular imaging and to propose novel methodological approaches to inform the demonstration of quality in imaging in future clinical trials and registries. We propose defining quality in cardiovascular imaging using an analytical framework put forth by the Institute of Medicine whereby quality was defined as testing being safe, effective, patient-centered, timely, equitable, and efficient. The implications of each of these components of quality health care are as essential for cardiovascular imaging as they are for other areas within health care. Our proposed statement may serve as the foundation for integrating these quality indicators into establishing designations of quality laboratory practices and developing standards for value-based payment reform for imaging services. We also include recommendations for future clinical research to fulfill quality aims within cardiovascular imaging, including clinical hypotheses of improving patient outcomes, the importance of health status as an end point, and deferred testing options. Future research should evolve to define novel methods optimized for the role of cardiovascular imaging for detecting disease and guiding treatment and to demonstrate the role of cardiovascular imaging in facilitating healthcare quality. © 2017 American Heart Association, Inc.

Clinical Manifestations and Outcomes of West Nile Virus Infection

PubMed Central

Sejvar, James J.

2014-01-01

Since the emergence of West Nile virus (WNV) in North America in 1999, understanding of the clinical features, spectrum of illness and eventual functional outcomes of human illness has increased tremendously. Most human infections with WNV remain clinically silent. Among those persons developing symptomatic illness, most develop a self-limited febrile illness. More severe illness with WNV (West Nile neuroinvasive disease, WNND) is manifested as meningitis, encephalitis or an acute anterior (polio) myelitis. These manifestations are generally more prevalent in older persons or those with immunosuppression. In the future, a more thorough understanding of the long-term physical, cognitive and functional outcomes of persons recovering from WNV illness will be important in understanding the overall illness burden. PMID:24509812

Psychometric testing of the clinical nurse leader staff satisfaction instrument.

PubMed

Spiva, LeeAnna; Hart, Patricia L; Wesley, Mary Lou; Gallagher, Erin; McVay, Frank; Waggoner, Jessica; Jarrell, Nicole; Threatt, Jamie L

2014-01-01

Patient care is changing rapidly with increased complexity of care, patient volumes, and financial constraints with rising health care costs and limited reimbursements. In response, the clinical nurse leader (CNL) role was developed. No appropriate instrument exists to measure staff satisfaction with the CNL role. This study describes the development and testing of an instrument designed to measure staff satisfaction with implementation of the CNL role. The psychometric properties and factor structure of the Clinical Nurse Leader Staff Satisfaction (CNLSS) instrument was examined. A 2-factor solution was discovered for the CNLSS. Cronbach's alpha coefficients were acceptable for the subscales and instrument. The CNLSS is a valid and reliable instrument. Future research should focus on establishing test-retest reliability and construct validity.

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.

Tissue chips - innovative tools for drug development and disease modeling.

PubMed

Low, L A; Tagle, D A

2017-09-12

The high rate of failure during drug development is well-known, however recent advances in tissue engineering and microfabrication have contributed to the development of microphysiological systems (MPS), or 'organs-on-chips' that recapitulate the function of human organs. These 'tissue chips' could be utilized for drug screening and safety testing to potentially transform the early stages of the drug development process. They can also be used to model disease states, providing new tools for the understanding of disease mechanisms and pathologies, and assessing effectiveness of new therapies. In the future, they could be used to test new treatments and therapeutics in populations - via clinical trials-on-chips - and individuals, paving the way for precision medicine. Here we will discuss the wide-ranging and promising future of tissue chips, as well as challenges facing their development.

A psychological approach to providing self-management education for people with type 2 diabetes: the Diabetes Manual

PubMed Central

Sturt, Jackie; Taylor, Hafrun; Docherty, Andrea; Dale, Jeremy; Louise, Taylor

2006-01-01

Background The objectives of this study were twofold (i) to develop the Diabetes Manual, a self-management educational intervention aimed at improving biomedical and psychosocial outcomes (ii) to produce early phase evidence relating to validity and clinical feasibility to inform future research and systematic reviews. Methods Using the UK Medical Research Council's complex intervention framework, the Diabetes Manual and associated self management interventions were developed through pre-clinical, and phase I evaluation phases guided by adult-learning and self-efficacy theories, clinical feasibility and health policy protocols. A qualitative needs assessment and an RCT contributed data to the pre-clinical phase. Phase I incorporated intervention development informed by the pre-clinical phase and a feasibility survey. Results The pre-clinical and phase I studies resulted in the production in the Diabetes Manual programme for trial evaluation as delivered within routine primary care consultations. Conclusion This complex intervention shows early feasibility and face validity for both diabetes health professionals and people with diabetes. Randomised trial will determine effectiveness against clinical and psychological outcomes. Further study of some component parts, delivered in alternative combinations, is recommended. PMID:17129376

Optimizing clinical operations as part of a global emergency medicine initiative in Kumasi, Ghana: application of Lean manufacturing principals to low-resource health systems.

PubMed

Carter, Patrick M; Desmond, Jeffery S; Akanbobnaab, Christopher; Oteng, Rockefeller A; Rominski, Sarah D; Barsan, William G; Cunningham, Rebecca M

2012-03-01

Although many global health programs focus on providing clinical care or medical education, improving clinical operations can have a significant effect on patient care delivery, especially in developing health systems without high-level operations management. Lean manufacturing techniques have been effective in decreasing emergency department (ED) length of stay, patient waiting times, numbers of patients leaving without being seen, and door-to-balloon times for ST-elevation myocardial infarction in developed health systems, but use of Lean in low to middle income countries with developing emergency medicine (EM) systems has not been well characterized. To describe the application of Lean manufacturing techniques to improve clinical operations at Komfo Anokye Teaching Hospital (KATH) in Ghana and to identify key lessons learned to aid future global EM initiatives. A 3-week Lean improvement program focused on the hospital admissions process at KATH was completed by a 14-person team in six stages: problem definition, scope of project planning, value stream mapping, root cause analysis, future state planning, and implementation planning. The authors identified eight lessons learned during our use of Lean to optimize the operations of an ED in a global health setting: 1) the Lean process aided in building a partnership with Ghanaian colleagues; 2) obtaining and maintaining senior institutional support is necessary and challenging; 3) addressing power differences among the team to obtain feedback from all team members is critical to successful Lean analysis; 4) choosing a manageable initial project is critical to influence long-term Lean use in a new environment; 5) data intensive Lean tools can be adapted and are effective in a less resourced health system; 6) several Lean tools focused on team problem-solving techniques worked well in a low-resource system without modification; 7) using Lean highlighted that important changes do not require an influx of resources; and 8) despite different levels of resources, root causes of system inefficiencies are often similar across health care systems, but require unique solutions appropriate to the clinical setting. Lean manufacturing techniques can be successfully adapted for use in developing health systems. Lessons learned from this Lean project will aid future introduction of advanced operations management techniques in low- to middle-income countries. © 2012 by the Society for Academic Emergency Medicine.

Optimizing Clinical Operations as part of a Global Emergency Medicine Initiative in Kumasi, Ghana: Application of Lean Manufacturing Principals to Low Resource Health Systems

PubMed Central

Carter, Patrick M.; Desmond, Jeffery S.; Akanbobnaab, Christopher; Oteng, Rockefeller A.; Rominski, Sarah; Barsan, William G.; Cunningham, Rebecca

2012-01-01

Background Although many global health programs focus on providing clinical care or medical education, improving clinical operations can have a significant effect on patient care delivery, especially in developing health systems without high-level operations management. Lean manufacturing techniques have been effective in decreasing emergency department (ED) length of stay, patient waiting times, numbers of patients leaving without being seen, and door-to-balloon times for ST-elevation myocardial infarction in developed health systems; but use of Lean in low to middle income countries with developing emergency medicine systems has not been well characterized. Objectives To describe the application of Lean manufacturing techniques to improve clinical operations at Komfo Anokye Teaching Hospital in Ghana and to identify key lessons learned to aid future global EM initiatives. Methods A three-week Lean improvement program focused on the hospital admissions process at Komfo Anokye Teaching Hospital was completed by a 14-person team in six stages: problem definition, scope of project planning, value stream mapping, root cause analysis, future state planning, and implementation planning. Results The authors identified eight lessons learned during our use of Lean to optimize the operations of an ED in a global health setting: 1) the Lean process aided in building a partnership with Ghanaian colleagues; 2) obtaining and maintaining senior institutional support is necessary and challenging; 3) addressing power differences among the team to obtain feedback from all team members is critical to successful Lean analysis; 4) choosing a manageable initial project is critical to influence long-term Lean use in a new environment; 5) data intensive Lean tools can be adapted and are effective in a less resourced health system; 6) several Lean tools focused on team problem solving techniques worked well in a low resource system without modification; 7) using Lean highlighted that important changes do not require an influx of resources; 8) despite different levels of resources, root causes of system inefficiencies are often similar across health care systems, but require unique solutions appropriate to the clinical setting. Conclusions Lean manufacturing techniques can be successfully adapted for use in developing health systems. Lessons learned from this Lean project will aid future introduction of advanced operations management techniques in low to middle income countries. PMID:22435868

The Future of Clinical Education: Using the Delphi Technique to Study Allied Health Deans' Perspectives on Definitions and Goals.

PubMed

Romig, Barbara D; Tucker, Ann W; Hewitt, Anne M; O'Sullivan Maillet, Julie

2016-01-01

Allied health (AH) clinical education provides future health professionals with the experiences necessary to develop the healthcare competencies required for success in their individual fields. There is limited information and consensus on the purposes of clinical education, including its definition and goals, and its comprehensive role in AH clinical training. This study explored whether consensus could be achieved in the definition, goals, and factors impacting AH clinical education. An expert panel consisting of 61 AH deans (54.9% of the population) whose institutions were 2013 members of the Association of Schools of Allied Health Professions (ASAHP) participated in a three-round Delphi study. From July 2013 to March 2014, the deans expressed opinions about clinical education and its purposes. Responses were collected, summarized, and refined, and responses were accepted and re-rated until agreement was achieved or the study concluded. The hypothesis that AH deans would agree upon the definition and goals of clinical education was supported by this study's findings. Over 90% of deans "strongly agreed" or "agreed" on the definition of clinical education. A majority (90.2% to 92.7%) agreed with the goals. High agreement was achieved on the purposes of clinical education, resulting in a comprehensive definition of and goals for AH clinical education. The definition and goals of clinical education can be added in the healthcare literature and used in support of AH education.

A Behavior-Analytic Account of Cognitive Bias in Clinical Populations

PubMed Central

Wray, Alisha M; Freund, Rachel A; Dougher, Michael J

2009-01-01

Cognitive bias refers to a well-established finding that individuals who suffer from certain clinical problems (e.g., depression, anxiety, posttraumatic stress disorder, substance abuse, etc.) selectively attend to, remember, and interpret events relevant to their condition. Although a body of literature exists that has tried to examine this phenomenon, most existing explanations are mentalistic and mediational. In this paper we offer a behavior-analytic account of cognitive bias, its development, and how it may contribute to maintenance of clinical problems. This account is based on establishing operations or motivating events, verbal processes, and relational responding. Clinical and future research implications are also discussed. PMID:22478512

Combination of photodynamic therapy and immunomodulation — current status and future trends

PubMed Central

Qiang, Yong-Gang; Yow, Christine M.N.; Huang, Zheng

2008-01-01

Photodynamic therapy (PDT) has been used for the treatment of non-malignant and malignant diseases from head to toe. Over the last decade its clinical application has gained increasing acceptance around the world. Pre-clinical studies demonstrate that, in addition to the direct local cytotoxicity and vascular effects, PDT can induce various host immune responses. Recent clinical data also show that improved clinical outcomes are obtained through the combination of PDT and immunomodulation. This review will summarize and discuss recent progress in developing innovative regimen of PDT combined with immunomodulation for the treatment of both non-malignant and malignant diseases. PMID:18161883

Modulation of hepcidin to treat iron deregulation: potential clinical applications

PubMed Central

Blanchette, Nicole L.; Manz, David H.; Torti, Frank M.

2016-01-01

The secreted peptide hormone hepcidin regulates systemic and local iron homeostasis through degradation of the iron exporter ferroportin. Dysregulation of hepcidin leads to altered iron homeostasis and development of pathological disorders including hemochromatosis, and iron loading and iron restrictive anemias. Therapeutic modulation of hepcidin is a promising method to ameliorate these conditions. Several approaches have been taken to enhance or reduce the effects of hepcidin in vitro and in vivo. Based on these approaches, hepcidin modulating drugs have been developed and are undergoing clinical evaluation. In this article we review the rationale for development of these drugs, the data concerning their safety and efficacy, their therapeutic uses, and potential future prospects. PMID:26669208

The development of a gender identity psychosocial clinic: treatment issues, logistical considerations, interdisciplinary cooperation, and future initiatives.

PubMed

Leibowitz, Scott F; Spack, Norman P

2011-10-01

Few interdisciplinary treatment programs that tend to the needs of youth with gender nonconforming behaviors, expressions, and identities exist in academic medical centers with formal residency training programs. Despite this, the literature provides evidence that these youth have higher rates of poor psychosocial adjustment and suicide attempts. This article explores the logistical considerations involved in developing a specialized interdisciplinary service to these gender minority youth in accordance with the existing treatment guidelines.Demographic data will be presented and treatment issues will be explored. The impact that a specialized interdisciplinary treatment program has on clinical expansion, research development, education and training, and community outreach initiatives is discussed.

Intergenerational Effects of Incest on Parenting: Skills, Abilities, and Attitudes.

ERIC Educational Resources Information Center

Armsworth, Mary W.; Stronck, Karin

1999-01-01

Investigates women's perceptions of generational influences of incest on their skills, abilities, and attitudes toward parenting their own children. Overarching themes that emerged were classified as unbalanced development, disconnected lives, and disowned dramas. Implications for clinical intervention, parent training, and future research are…

The role of scripts in psychological maladjustment and psychotherapy.

PubMed

Demorest, Amy P

2013-12-01

This article considers the value of script theory for understanding psychological maladjustment and psychotherapy. Scripts are implicit expectations that individuals develop to understand and deal with emotionally significant life experiences. Script theory provides a way to understand the complex patterns of thinking, feeling, and behavior that characterize personal consistency, as well as a way to address personality development and change. As such it is a vital model for understanding both personality and clinical phenomena. The article begins by describing script theory and noting similar models in personality and clinical psychology. It then outlines both idiographic and nomothetic methods for assessing scripts and discusses the strengths and weaknesses of each. A survey of the author's program of research follows, using a nomothetic method to examine the role of interpersonal scripts in psychological maladjustment and psychotherapy. The article concludes by presenting a promising method for future research synthesizing idiographic and nomothetic approaches and raising important questions for future research on the role of scripts in psychological maladjustment and psychotherapy. © 2012 Wiley Periodicals, Inc.

Child neurology: Past, present, and future: part 1: history.

PubMed

Millichap, John J; Millichap, J Gordon

2009-08-18

The founding period of child neurology occurred in 3 phases: 1) early individual contributory phase, 2) organized training phase, and 3) expansion phase. In the late 19th and early 20th centuries, individuals in pediatrics, neurology, and psychiatry established clinics and made important contributions to the literature on childhood epilepsy, cerebral palsy, and pediatric neurology. The latter half of the 20th century saw the organization of training programs in pediatric neurology, with fellowships supported by the NIH. This development was followed by a rapid expansion in the number of trainees certified in child neurology and their appointment to divisions of neurology in children's hospitals. In recent years, referrals of children with neurologic disorders have increased, and disorders previously managed by pediatricians are often seen in neurology clinics. The era of subspecialization is embraced by the practicing physician. The present day status of pediatric neurology and suggestions for the future development of the specialty are subjects for further discussion.

Present and future molecular testing of lung carcinoma.

PubMed

Dacic, Sanja; Nikiforova, Marina N

2014-03-01

The rapid development of targeted therapies has tremendously changed clinical management of lung carcinoma patients and set the stage for similar developments in other tumor types. Many studies have been published in the past decade in search for the most acceptable method of assessment for predictors of response to targeted therapies in lung cancer. As a result, several guidelines for molecular testing have been published in a past couple of years. Because of accumulated evidence that targetable drugs show the best efficacy and improved progression survival rates in lung cancer patients whose tumors have a specific genotype, molecular testing for predictors of therapy response has became standard of care. Presently, testing for EGFR mutations and ALK rearrangements in lung adenocarcinoma has been standardized. The landscape of targetable genomic alterations in lung carcinoma is expanding, but none of other potentially targetable biomarkers have been standardized outside of clinical trials. This review will summarize current practice of molecular testing. Future methods in molecular testing of lung carcinoma will be briefly reviewed.

Update on the management of ulcerative colitis.

PubMed

Taba Taba Vakili, Sahar; Taher, Mohammad; Ebrahimi Daryani, Nasser

2012-01-01

The present treatment goals for inflammatory bowel diseases (IBD) especially ulcerative colitis (UC) include rapid induction of clinical remission, steroid-free maintenance of clinical remission, mucosal healing and improvement of quality of life in UC patients. Immunomodulators have been reserved for steroid- dependent or steroid- refractory UC patients. Among these agents, azathioprine/6-mercaptopurine should be used for maintenance of remission in quiescent UC. Calcineurin inhibitors can be prescribed as a short-term rescue therapy in steroid- refractory UC patients, but the long term efficacy of these agents remains unclear. According to retrospective studies, methotraxate is not recommended for inducing and maintaining remission in UC. Novel biological therapies targeting different specific immunological pathways continue to be developed and introduced for a variety of clinical scenarios in IBD. Infliximab is currently used for induction and maintenance therapy in patients who have moderately to severely active UC with an inadequate response to conventional agents such as aminosalicylates, corticosteroids, or immunomodulators. Other anti-TNF agents and biologic therapies are undergoing evaluation in clinical trials for their efficacy in IBD. Most patients who start biologics should continue treatment for the foreseeable future and potential consequences of discontinuation should be discussed with individual patients. Currently, data do not exist to administer biologics as first-line therapy in UC. Emerging data suggest that biologics may have the potential to prevent complications and limit disease progression. If such benefits are proven, biologics may be used in the future to modulate subclinical inflammation and to prevent the development of clinical disease.

Diagnostic imaging applications; Proceedings of the Meeting, Amsterdam, Netherlands, October 8, 9, 1984

NASA Technical Reports Server (NTRS)

Beckenbach, E. S. (Editor)

1984-01-01

It is more important than ever that engineers have an understanding of the future needs of clinical and research medicine, and that physicians know somthing about probable future developments in instrumentation capabilities. Only by maintaining such a dialog can the most effective application of technological advances to medicine be achieved. This workshop attempted to provide this kind of information transfer in the limited field of diagnostic imaging. Biomedical research at the Jet Propulsion Laboratory is discussed, taking into account imaging results from space exploration missions, as well as biomedical research tasks based in these technologies. Attention is also given to current and future indications for magnetic resonance in medicine, high speed quantitative digital microscopy, computer processing of radiographic images, computed tomography and its modern applications, position emission tomography, and developments related to medical ultrasound.

Development of a sustainable community-based dental education program.

PubMed

Piskorowski, Wilhelm A; Fitzgerald, Mark; Mastey, Jerry; Krell, Rachel E

2011-08-01

Increasing the use of community-based programs is an important trend in improving dental education to meet the needs of students and the public. To support this trend, understanding the history of programs that have established successful models for community-based education is valuable for the creation and development of new programs. The community-based education model of the University of Michigan School of Dentistry (UMSOD) offers a useful guide for understanding the essential steps and challenges involved in developing a successful program. Initial steps in program development were as follows: raising funds, selecting an outreach clinical model, and recruiting clinics to become partners. As the program developed, the challenges of creating a sustainable financial model with the highest educational value required the inclusion of new clinical settings and the creation of a unique revenue-sharing model. Since the beginning of the community-based program at UMSOD in 2000, the number of community partners has increased to twenty-seven clinics, and students have treated thousands of patients in need. Fourth-year students now spend a minimum of ten weeks in community-based clinical education. The community-based program at UMSOD demonstrates the value of service-based education and offers a sustainable model for the development of future programs.

Breast magnetic resonance elastography: a review of clinical work and future perspectives.

PubMed

Bohte, A E; Nelissen, J L; Runge, J H; Holub, O; Lambert, S A; de Graaf, L; Kolkman, S; van der Meij, S; Stoker, J; Strijkers, G J; Nederveen, A J; Sinkus, R

2018-05-30

This review on magnetic resonance elastography (MRE) of the breast provides an overview of available literature and describes current developments in the field of breast MRE, including new transducer technology for data acquisition and multi-frequency-derived power-law behaviour of tissue. Moreover, we discuss the future potential of breast MRE, which goes beyond its original application as an additional tool in differentiating benign from malignant breast lesions. These areas of ongoing and future research include MRE for pre-operative tumour delineation, staging, monitoring and predicting response to treatment, as well as prediction of the metastatic potential of primary tumours. Copyright © 2018 John Wiley & Sons, Ltd.

Helicase-primase inhibitors for herpes simplex virus: looking to the future of non-nucleoside inhibitors for treating herpes virus infections.

PubMed

Biswas, Subhajit; Sukla, Soumi; Field, Hugh J

2014-01-01

Helicase-primase inhibitors (HPIs) are the first new family of potent herpes virus (herpes simplex and varicella-zoster virus) inhibitors to go beyond the preliminary stages of investigation since the emergence of the original nucleoside analog inhibitors. To consider the clinical future of HPIs, this review puts the exciting new findings with two HPIs, amenamevir and pritelivir, into the historical context of antiviral development for the prevention and treatment of herpes simplex virus over the last century and, on this basis, the authors speculate on the potential evolution of these and other non-nucleoside inhibitors in the future.

Current and proposed molecular diagnostics in a genitourinary service line laboratory at a tertiary clinical institution.

PubMed

Udager, Aaron M; Alva, Ajjai; Mehra, Rohit

2014-01-01

The idea that detailed knowledge of molecular oncogenesis will drive diagnostic, prognostic, and therapeutic clinical decision making in an increasingly multidisciplinary practice of oncologic care has been anticipated for many years. With the recent rapid advancement in our understanding of the molecular underpinnings of genitourinary malignancies, this concept is now starting to take shape in the fields of prostate, kidney, bladder, testicular, and penile cancer. Such breakthroughs necessitate the development of robust clinical-grade assays that can be quickly made available for patients to facilitate diagnosis in challenging cases, risk-stratify patients for subsequent clinical management, select the appropriate targeted therapy from among increasingly diverse and numerous options, and enroll patients in advanced clinical trials. This rapid translation of basic and clinical cancer research requires a streamlined, multidisciplinary approach to clinical assay development, termed here the molecular diagnostics service line laboratory. In this review, we summarize the current state and explore the future of molecular diagnostics in genitourinary oncology to conceptualize a genitourinary service line laboratory at a tertiary clinical institution.

Diagnosis of borderline personality disorder in China: current status and future directions.

PubMed

Zhong, Jie; Leung, Freedom

2009-02-01

This paper reviews the current status and future directions of borderline personality disorder (BPD) research in China. Although the committee of the third version of the Chinese Classification of Mental Disorders (CCMD-3) rejected BPD as a valid diagnostic category and instead adopted the term impulsive personality disorder (IPD), our literature review on personality disorders from 1979 to 2008 in China indicated that BPD was the most popular research topic among researchers and clinicians. Available empiric evidence on BPD in China provided preliminary support for the construct validity and clinical utility of BPD in clinical and nonclinical Chinese samples. Future studies in the following areas are suggested: 1) developing reliable assessment instruments for measuring BPD pathology in China, 2) comparing the construct validity and phenomenology of CCMD IPD and DSM BPD among Chinese patients, 3) examining potential cultural differences in symptom expression of BPD pathology among the Chinese, and 4) exploring indigenous and imported methods for treating BPD patients in China.

Medical image computing for computer-supported diagnostics and therapy. Advances and perspectives.

PubMed

Handels, H; Ehrhardt, J

2009-01-01

Medical image computing has become one of the most challenging fields in medical informatics. In image-based diagnostics of the future software assistance will become more and more important, and image analysis systems integrating advanced image computing methods are needed to extract quantitative image parameters to characterize the state and changes of image structures of interest (e.g. tumors, organs, vessels, bones etc.) in a reproducible and objective way. Furthermore, in the field of software-assisted and navigated surgery medical image computing methods play a key role and have opened up new perspectives for patient treatment. However, further developments are needed to increase the grade of automation, accuracy, reproducibility and robustness. Moreover, the systems developed have to be integrated into the clinical workflow. For the development of advanced image computing systems methods of different scientific fields have to be adapted and used in combination. The principal methodologies in medical image computing are the following: image segmentation, image registration, image analysis for quantification and computer assisted image interpretation, modeling and simulation as well as visualization and virtual reality. Especially, model-based image computing techniques open up new perspectives for prediction of organ changes and risk analysis of patients and will gain importance in diagnostic and therapy of the future. From a methodical point of view the authors identify the following future trends and perspectives in medical image computing: development of optimized application-specific systems and integration into the clinical workflow, enhanced computational models for image analysis and virtual reality training systems, integration of different image computing methods, further integration of multimodal image data and biosignals and advanced methods for 4D medical image computing. The development of image analysis systems for diagnostic support or operation planning is a complex interdisciplinary process. Image computing methods enable new insights into the patient's image data and have the future potential to improve medical diagnostics and patient treatment.

Development of a Mobile Clinical Prediction Tool to Estimate Future Depression Severity and Guide Treatment in Primary Care: User-Centered Design.

PubMed

Wachtler, Caroline; Coe, Amy; Davidson, Sandra; Fletcher, Susan; Mendoza, Antonette; Sterling, Leon; Gunn, Jane

2018-04-23

Around the world, depression is both under- and overtreated. The diamond clinical prediction tool was developed to assist with appropriate treatment allocation by estimating the 3-month prognosis among people with current depressive symptoms. Delivering clinical prediction tools in a way that will enhance their uptake in routine clinical practice remains challenging; however, mobile apps show promise in this respect. To increase the likelihood that an app-delivered clinical prediction tool can be successfully incorporated into clinical practice, it is important to involve end users in the app design process. The aim of the study was to maximize patient engagement in an app designed to improve treatment allocation for depression. An iterative, user-centered design process was employed. Qualitative data were collected via 2 focus groups with a community sample (n=17) and 7 semistructured interviews with people with depressive symptoms. The results of the focus groups and interviews were used by the computer engineering team to modify subsequent protoypes of the app. Iterative development resulted in 3 prototypes and a final app. The areas requiring the most substantial changes following end-user input were related to the iconography used and the way that feedback was provided. In particular, communicating risk of future depressive symptoms proved difficult; these messages were consistently misinterpreted and negatively viewed and were ultimately removed. All participants felt positively about seeing their results summarized after completion of the clinical prediction tool, but there was a need for a personalized treatment recommendation made in conjunction with a consultation with a health professional. User-centered design led to valuable improvements in the content and design of an app designed to improve allocation of and engagement in depression treatment. Iterative design allowed us to develop a tool that allows users to feel hope, engage in self-reflection, and motivate them to treatment. The tool is currently being evaluated in a randomized controlled trial. ©Caroline Wachtler, Amy Coe, Sandra Davidson, Susan Fletcher, Antonette Mendoza, Leon Sterling, Jane Gunn. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 23.04.2018.

The Development of a Clinical Nurse Scholar in Baccalaureate Education.

PubMed

Beal, Judy A; Riley, Joan M

2015-01-01

The purpose of this national study was to explore the vision of chief academic officers for baccalaureate nursing education. We invited chief academic nursing officers, randomly selected from a representative sample of accredited baccalaureate nursing programs to participate in the study. Audiotaped interviews were conducted in focus groups at professional meetings or by telephone and were transcribed verbatim. Data collection continued until thematic saturation was reached (N = 29). Analysis of the findings revealed themes that described future vision for baccalaureate education that provides guidance to faculty as they develop curriculum. An overarching theme "We are all Stewards of the Profession" and three supporting themes emerged: "Learning Pathways are Varied," "Faculty Need to Grow," and "New Pedagogies Need to Focus on the Development of 'Who I Am' as a Clinical Scholar." Findings point to a future where diverse learning pathways are integrated throughout the curriculum. The curriculum of tomorrow will place greater emphasis on the development of professional identity as a nurse and calls for expanded stewardship for nursing education. Deans recommended that investing time and resources into well-designed faculty development programs will help all faculty, regardless of appointment, to adapt to changing student needs and rapidly evolving practice environments. Copyright © 2015 Elsevier Inc. All rights reserved.

Lestaurtinib, a multitargeted tyrosine kinase inhibitor: from bench to bedside.

PubMed

Shabbir, Munira; Stuart, Robert

2010-03-01

Internal tandem duplication of the fms-like tyrosine kinase 3 (FLT3) gene (FLT3-ITD) is a common recurring mutation in acute myeloid leukemia (AML) with normal karyotype, and the presence of FLT3-ITD confers a poor prognosis on this large subgroup of AML patients. Since the discovery of lestaurtinib as a potent FLT3 inhibitor, in 1985, there has been considerable interest in the development of this agent (CEP-701, Cephalon, Frazer, PA, USA) for treatment of this population. An extensive literature search was conducted that included published articles and abstracts on the preclinical and clinical development of this agent spanning the last decade. The review describes the historical development of this agent and reviews the available preclinical and clinical data on lestaurtinib and expands on potential future directions in development of this agent. Lestaurtinib is a multi targeted tyrosine kinase inhibitor which has been shown to potently inhibit FLT3 at nanomolar concentrations in preclinical studies, leading to its rapid development as a potential targeted agent for treatment of AML. Phase I studies have shown lestaturtinib to be an active agent particularly when used in combination with cytotoxic drugs. Currently, Phase II and Phase III studies are underway aiming to establish the future of this agent as a treatment option for patients with FLT3-ITD AML.

Intramuscular injection of AAV8 in mice and macaques is associated with substantial hepatic targeting and transgene expression.

PubMed

Greig, Jenny A; Peng, Hui; Ohlstein, Jason; Medina-Jaszek, C Angelica; Ahonkhai, Omua; Mentzinger, Anne; Grant, Rebecca L; Roy, Soumitra; Chen, Shu-Jen; Bell, Peter; Tretiakova, Anna P; Wilson, James M

2014-01-01

Intramuscular (IM) administration of adeno-associated viral (AAV) vectors has entered the early stages of clinical development with some success, including the first approved gene therapy product in the West called Glybera. In preparation for broader clinical development of IM AAV vector gene therapy, we conducted detailed pre-clinical studies in mice and macaques evaluating aspects of delivery that could affect performance. We found that following IM administration of AAV8 vectors in mice, a portion of the vector reached the liver and hepatic gene expression contributed significantly to total expression of secreted transgenes. The contribution from liver could be controlled by altering injection volume and by the use of traditional (promoter) and non-traditional (tissue-specific microRNA target sites) expression control elements. Hepatic distribution of vector following IM injection was also noted in rhesus macaques. These pre-clinical data on AAV delivery should inform safe and efficient development of future AAV products.

Internet and cardiovascular research: the present and its future potentials and limits.

PubMed

2002-03-01

The Internet and the World Wide Web have been proposed as tools to improve medical and cardiovascular research. These new technologies have been mainly applied to large-scale clinical trials, with the development of clinical-trial websites. They include tools for the management of some aspects of clinical trials, such as the dissemination of information on trial progress; randomisation and the monitoring processes; the distribution and accountability of study drugs; and remote data-entry. Several clinical-trial websites have been developed in the cardiovascular field over the last few years, but few have been designed to conduct trials fully online. Advantages of such systems include greater interaction between the coordinating centre and investigators, availability of a clean database in a short time, and cost reduction. Website developers need to take care of security issues and to use security tools (data encryption, firewalls, passwords and electronic signatures) in order to prevent unauthorised users from accessing the system and patient data.

The complexities of malaria disease manifestations with a focus on asymptomatic malaria

PubMed Central

2012-01-01

Malaria is a serious parasitic disease in the developing world, causing high morbidity and mortality. The pathogenesis of malaria is complex, and the clinical presentation of disease ranges from severe and complicated, to mild and uncomplicated, to asymptomatic malaria. Despite a wealth of studies on the clinical severity of disease, asymptomatic malaria infections are still poorly understood. Asymptomatic malaria remains a challenge for malaria control programs as it significantly influences transmission dynamics. A thorough understanding of the interaction between hosts and parasites in the development of different clinical outcomes is required. In this review, the problems and obstacles to the study and control of asymptomatic malaria are discussed. The human and parasite factors associated with differential clinical outcomes are described and the management and treatment strategies for the control of the disease are outlined. Further, the crucial gaps in the knowledge of asymptomatic malaria that should be the focus of future research towards development of more effective malaria control strategies are highlighted. PMID:22289302

Using Facebook to enhance commencing student confidence in clinical skill development: A phenomenological hermeneutic study.

PubMed

Watson, Bernadette; Cooke, Marie; Walker, Rachel

2016-01-01

The purpose of this study was to explore commencing nursing students' experience of Facebook as an adjunct to on-campus course delivery to determine its impact as a learning strategy for improving confidence in clinical skill development. Approaches supporting nursing students in the development of clinical skills have relied on 'real-life' clinical placements and simulated on-campus clinical laboratories. However students continue to report a lack of confidence in their clinical skills for practice. Social networking sites including Facebook are being used as a learning strategy to stimulate active and collaborative learning approaches. A hermeneutic phenomenological approach was used to provide an understanding of the experience of confidence in clinical skills development for nursing students. Data were collected through in-depth interviews with commencing students about their experience as learners using Facebook and their perceptions of the impact on their clinical skill development. Ten first-year student nurses at one university in south-east Queensland, Australia. Four themes emerged from the data including: 'We're all in this together'; 'I can do this'; 'This is about my future goals and success'; and, 'Real time is not fast enough!'. These themes provide new meaningful insights demonstrating students' sense of confidence in clinical skills was increased through engagement with a dedicated Facebook page. The findings of this study have relevance to academics in the design of learning strategies for clinical courses to further support student confidence and engagement through peer collaboration and active learning processes. Crown Copyright © 2015. Published by Elsevier Ltd. All rights reserved.

[Postgraduate training program in laboratory medicine at a clinical teaching hospital].

PubMed

Matsuo, Shuji

2003-04-01

The Tenri Hospital resident system was introduced in 1976 and the training program for laboratory medicine began in 1982. Thus, the author proposes goals for the the future on the basis of experience. It is appropriate that trainees study emergency tests, blood transfusion and microbiology(particularly Gram's stain and sputum culture) as practical matters, and in addition to these, learn how to reply to consultations from physicians, learn the laboratory flow(so-called laboratory system), and announce interpretations of laboratory data at reversed clinical pathological conference(R-CPC). The objectives of these training programs are to gain skills for appropriate laboratory utilization and interpretation, and develop communications and consultations with clinical pathologists and medical technologists. The key points of success in the training are close cooperation of the laboratory and teaching divisions. Particularly, cooperation with medical technologists is necessary, and it is essential medical practice for trainees because they will have to work with them in future. Finally it should be emphasized that there training has a limited effect because of the short duration. It is thus important to communicate and discuss clinical matters regularly in medicine.

50 years of pediatric immunology: progress and future, a clinical perspective.

PubMed

Singh, Surjit; Gupta, Anju; Rawat, Amit

2013-01-08

Rapidly evolving advances in the field of immunology over the last few decades have impacted the practice of clinical medicine in many ways. In fact, understanding the immunological basis of disease has been pivotal in deciphering the pathogenesis of several disease processes, infective or otherwise. As of today, there is hardly any specialty of medicine which is not influenced by immunology. Pediatric rheumatological disorders, vasculitides, Human Immunodeficiency Virus (HIV) infection, Primary Immunodeficiency Diseases (PIDs) and autoimmune disorders fall under the domain of clinical immunology. This specialty is poised to emerge as a major clinical specialty in our country. The gulf between bench and bedside is narrowing down as our understanding of the complex immunological mechanisms gets better. However, a lot still needs to be done in this field as the morbidity and mortality of some of these conditions is unacceptably high in the Indian setup. A number of medical schools and institutes in the country now have the resources and the wherewithal to develop into specialized centres of clinical immunology. We need to concentrate on training more physicians and pediatricians in this field. The future is bright and the prospects exciting.

Addressing neuropsychiatric disturbances during rehabilitation after traumatic brain injury: current and future methods

PubMed Central

Arciniegas, David B.

2011-01-01

Cognitive, emotional, behavioral, and sensorimotor disturbances are the principal clinical manifestations of traumatic brain injury (TBI) throughout the early postinjury period. These post-traumatic neuropsychiatric disturbances present substantial challenges to patients, their families, and clinicians providing their rehabilitative care, the optimal approaches to which remain incompletely developed. In this article, a neuropsychiairically informed, neurobiologically anchored approach to understanding and meeting challenges is described. The foundation for thai approach is laid, with a review of clinical case definitions of TBI and clarification of their intended referents. The differential diagnosis of event-related neuropsychiatric disturbances is considered next, after which the clinical and neurobiological heterogeneity within the diagnostic category of TBI are discussed. The clinical manifestations of biomechanical force-induced brain dysfunction are described as a state of post-traumatic encephalopathy (PTE) comprising several phenomenologically distinct stages, PTE is then used as a framework for understanding and clinically evaluating the neuropsychiatric sequelae of TBI encountered commonly during the early post-injury rehabilitation period, and for considering the types and timings of neurorehabilitative interventions. Finally, directions for future research that may address productively the challenges to TBI rehabilitation presented by neuropsychiatric disturbances are considered. PMID:22034400

Gene and cell therapy for pancreatic cancer.

PubMed

Singh, Hans Martin; Ungerechts, Guy; Tsimberidou, Apostolia M

2015-04-01

The clinical outcomes of patients with pancreatic cancer are poor, and the limited success of classical chemotherapy underscores the need for new, targeted approaches for this disease. The delivery of genetic material to cells allows for a variety of therapeutic concepts. Engineered agents based on synthetic biology are under clinical investigation in various cancers, including pancreatic cancer. This review focuses on Phase I - III clinical trials of gene and cell therapy for pancreatic cancer and on future implications of recent translational research. Trials available in the US National Library of Medicine (www.clinicaltrials.gov) until February 2014 were reviewed and relevant published results of preclinical and clinical studies were retrieved from www.pubmed.gov . In pancreatic cancer, gene and cell therapies are feasible and may have synergistic antitumor activity with standard treatment and/or immunotherapy. Challenges are related to application safety, manufacturing costs, and a new spectrum of adverse events. Further studies are needed to evaluate available agents in carefully designed protocols and combination regimens. Enabling personalized cancer therapy, insights from molecular diagnostic technologies will guide the development and selection of new gene-based drugs. The evolving preclinical and clinical data on gene-based therapies can lay the foundation for future avenues improving patient care in pancreatic cancer.

The next generation of sepsis clinical trial designs: what is next after the demise of recombinant human activated protein C?*.

PubMed

Opal, Steven M; Dellinger, R Phillip; Vincent, Jean-Louis; Masur, Henry; Angus, Derek C

2014-07-01

The developmental pipeline for novel therapeutics to treat sepsis has diminished to a trickle compared to previous years of sepsis research. While enormous strides have been made in understanding the basic molecular mechanisms that underlie the pathophysiology of sepsis, a long list of novel agents have now been tested in clinical trials without a single immunomodulating therapy showing consistent benefit. The only antisepsis agent to successfully complete a phase III clinical trial was human recumbent activated protein C. This drug was taken off the market after a follow-up placebo-controlled trial (human recombinant activated Protein C Worldwide Evaluation of Severe Sepsis and septic Shock [PROWESS SHOCK]) failed to replicate the favorable results of the initial registration trial performed ten years earlier. We must critically reevaluate our basic approach to the preclinical and clinical evaluation of new sepsis therapies. We selected the major clinical studies that investigated interventional trials with novel therapies to treat sepsis over the last 30 years. Phase II and phase III trials investigating new treatments for sepsis and editorials and critiques of these studies. Selected manuscripts and clinical study reports were analyzed from sepsis trials. Specific shortcomings and potential pit falls in preclinical evaluation and clinical study design and analysis were reviewed and synthesized. After review and discussion, a series of 12 recommendations were generated with suggestions to guide future studies with new treatments for sepsis. We need to improve our ability to define appropriate molecular targets for preclinical development and develop better methods to determine the clinical value of novel sepsis agents. Clinical trials must have realistic sample sizes and meaningful endpoints. Biomarker-driven studies should be considered to categorize specific "at risk" populations most likely to benefit from a new treatment. Innovations in clinical trial design such as parallel crossover design, alternative endpoints, or adaptive trials should be pursued to improve the outlook for future interventional trials in sepsis.

Defining the future of health technology: biomechatronics.

PubMed

Bushko, Renata G

2002-01-01

Future progress in healthcare and medicine depends on today's investment in research, development, and education. We cannot leave such urgent issues to determine themselves, but rather must actively collaborate to ensure a stable healthcare system. This chapter describes efforts made by leading experts in industry, government, and academia to better ascertain future healthcare management. Such collaboration has occurred during a series of Future Healthcare Technology Summits helping in planning investments in health technology. Deliberating and reviewing plans before taking action will accelerate progress as it will (1) save costs, (2) encourage compliance, (3) improve clinical outcomes, and (4) ensure greater patient satisfaction. What we must resolve is: How can we invest a couple billion dollars to save hundreds of billions and, most importantly, increase human health in the future. A new branch of science, Biomechatronics, with millions of Intelligent Caring Creatures- is the answer.

The Observed Longitudinal Relationship between Future Orientation and Substance Use Among a Cohort of Youth with Serious Criminal Offenses.

PubMed

Brooks, Merrian; Miller, Elizabeth; Abebe, Kaleab; Mulvey, Edward

2018-03-06

Future orientation (FO), an essential construct in youth development, encompassing goals, expectations for life, and ability to plan for the future. This study uses a multidimensional measure of future orientation to assess the relationship between change in future orientation and change in substance use over time. Data were from the Pathways to Desistence study. Justice involved youth (n = 1,354), ages 14 to 18 at time of recruitment, completed interviews every six months for three years. Multiple measures were chosen a priori as elements of future orientation. After evaluating the psychometrics of a new measure for future orientation, we ran mixed effects cross-lagged panel models to assess the relationship between changes in future orientation and substance use (tobacco, marijuana, hard drugs, and alcohol). There was a significant bidirectional relationship between future orientation and all substance use outcomes. Adjusted models accounted for different sites, sex, age, ethnicity, parental education, and proportion of time spent in a facility. In adjusted models, higher levels of future orientation resulted in smaller increases in substance use at future time points. Future orientation and substance use influence each other in this sample of adolescent offenders. Treating substance use disorders is also likely to increase future orientation, promoting positive youth development more generally. This study expands our understanding of the longitudinal relationship between changes in future orientation and changes in levels of substance use in a sample of justice involved youth with high levels of substance use, a group of considerable clinical and policy interest.

A nurse- and pharmacist-led treatment advice clinic for patients attending an HIV outpatient clinic.

PubMed

Griffiths, C; Miles, K; Aldam, D; Cornforth, D; Minton, J; Edwards, S; Williams, I

2007-05-01

This paper is a report of a study to map care pathways, examine the approach of different treatment advisors and explore the acceptability of a nurse- and pharmacist-led treatment advice clinic in order to aid decision-making for the future development and evaluation of the clinic. High levels of adherence to antiretroviral drugs are a prerequisite for a successful and durable virological and immunological response to HIV. Treatment guidelines acknowledge that adherence is a process, not a single event, and that adherence support must be integrated into clinical follow-up for all patients receiving these drugs. Data were collected between September 2004 and January 2005 through 17 consultation observations and 10 patient interviews in a specialist treatment advice clinic located within a central London HIV outpatient clinic providing care for over 2200 patients, of whom more than 1300 are taking highly active antiretroviral therapy. The nurses and pharmacist had similar consultation approaches, although follow-up care varied in extent. Benefits of the clinic approach included permitting patients to observe real tablets, tailoring regimens to lifestyles and telephone follow-up. These factors, particularly telephone support, were perceived by patients to assist with adherence. The role of telephone support, perceived to assist with initial adherence, requires further investigation. Future work is also needed to explore the health economics of this approach and to determine the actual impact of the clinic on clinical and adherence outcomes.

Use of clinical movement screening tests to predict injury in sport

PubMed Central

Chimera, Nicole J; Warren, Meghan

2016-01-01

Clinical movement screening tests are gaining popularity as a means to determine injury risk and to implement training programs to prevent sport injury. While these screens are being used readily in the clinical field, it is only recently that some of these have started to gain attention from a research perspective. This limits applicability and poses questions to the validity, and in some cases the reliability, of the clinical movement tests as they relate to injury prediction, intervention, and prevention. This editorial will review the following clinical movement screening tests: Functional Movement Screen™, Star Excursion Balance Test, Y Balance Test, Drop Jump Screening Test, Landing Error Scoring System, and the Tuck Jump Analysis in regards to test administration, reliability, validity, factors that affect test performance, intervention programs, and usefulness for injury prediction. It is important to review the aforementioned factors for each of these clinical screening tests as this may help clinicians interpret the current body of literature. While each of these screening tests were developed by clinicians based on what appears to be clinical practice, this paper brings to light that this is a need for collaboration between clinicians and researchers to ensure validity of clinically meaningful tests so that they are used appropriately in future clinical practice. Further, this editorial may help to identify where the research is lacking and, thus, drive future research questions in regards to applicability and appropriateness of clinical movement screening tools. PMID:27114928

Regulatory challenges in the review of data from global clinical trials: the PMDA perspective.

PubMed

Asano, K; Tanaka, A; Sato, T; Uyama, Y

2013-08-01

Regulatory agencies face challenges in reviewing data from global clinical trials (GCTs) in the era of globalization of drug development. One major challenge is consideration of ethnic factors in evaluating GCT data so as to extrapolate foreign population data to one's own national population. Here, we present the Pharmaceuticals and Medical Devices Agency (PMDA) perspective in reviewing GCT data in new drug applications (NDAs) and discuss future challenges for new drug approval.

Naval Medical Research and Development News. Volume 8, Issue 5, May 2016

DTIC Science & Technology

2016-09-09

dental clinic ,” said Leal. “Many of the interns want to become dentists and a few may even pursue dental research in the future. We...Eliminating Sexual Assault 10 High School Dental Interns Tour Military Dental Clinic with Navy Dentists 11 NMRC-Asia Scientists Join the Fight...exposure to Navy dentistry for the Judson dental interns . “In part-two, students will have the opportunity to meet Navy research dentists at

Opinions of sports clinical practice chiropractors, with sports specialty training and those without, about chiropractic research priorities in sports health care: a centering resonance analysis

PubMed Central

Lee, Alexander D; Szabo, Kaitlyn; McDowell, Kirstie; Granger, Sydney

2016-01-01

Introduction: A Canadian sports chiropractic research agenda has yet to be defined. The Delphi method can be utilized to achieve this purpose; however, the sample of experts who participate can influence the results. To better inform sample selection for future research agenda development, we set out to determine if differences in opinions about research priorities exist between chiropractors who have their sports specialty designation and those who do not. Methods: Fifteen sports clinical practice chiropractors who have their sports fellowship designation and fifteen without, were interviewed with a set of standardized questions about sports chiropractic research priorities. A centering resonance analysis and cluster analysis were conducted on the interview responses. Results: The two practitioner groups differed in their opinions about the type of research that they would like to see conducted, the research that would impact their clinical practice the most, and where they believed research was lacking. However, both groups were similar in their opinions about research collaborations. Conclusion: Sports clinical practice chiropractors, with their sports specialty designation and those without, differed in their opinions about sports chiropractic research priorities; however, they had similar opinions about research collaborations. These results suggest that it may be important to sample from both practitioner groups in future studies aimed at developing research agendas for chiropractic research in sport. PMID:28065995

Children's Mental Health in the Context of Terrorist Attacks, Ongoing Threats, and Possibilities of Future Terrorism.

PubMed

Comer, Jonathan S; Bry, Laura J; Poznanski, Bridget; Golik, Alejandra M

2016-09-01

Over the past two decades, the field has witnessed tremendous advances in our understanding of terrorism and its impacts on affected youth. It is now well established that a significant proportion of exposed youth show elevated PTSD symptoms in the months following a terrorist attack. In more recent years, research has expanded beyond confirming our understanding of the association between direct terrorism exposure and child PTSD symptoms by elucidating (a) links between terrorism exposure and non-PTSD clinical outcomes (e.g., externalizing problems, substance use), (b) individual differences associated with divergent patterns of risk and resilience, (c) the clinical correlates of media-based contact with terrorism, (d) clinical outcomes associated with exposure to recurrent terrorist attacks, and (e) exposure to extended contexts of uncertainty and the possibilities of future terrorism. Researchers studying the effects of terrorism and political violence on youth have increasingly examined a much broader range of regions in the world, affording needed opportunities to consider the generalizability of prior findings to youth living in different political contexts, in less developed regions of the world, and/or in regions with different rates of recurrent terrorism. In order to understand and, in turn, best meet the clinical needs of the majority of terrorism-affected youth across the globe, more targeted research on exposed youth is needed in developing regions of the world and regions enduring more recurrent terrorist attacks.

Acute pancreatitis patient registry to examine novel therapies in clinical experience (APPRENTICE): an international, multicenter consortium for the study of acute pancreatitis

PubMed Central

Papachristou, Georgios I.; Machicado, Jorge D.; Stevens, Tyler; Goenka, Mahesh Kumar; Ferreira, Miguel; Gutierrez, Silvia C.; Singh, Vikesh K.; Kamal, Ayesha; Gonzalez-Gonzalez, Jose A.; Pelaez-Luna, Mario; Gulla, Aiste; Zarnescu, Narcis O.; Triantafyllou, Konstantinos; Barbu, Sorin T.; Easler, Jeffrey; Ocampo, Carlos; Capurso, Gabriele; Archibugi, Livia; Cote, Gregory A.; Lambiase, Louis; Kochhar, Rakesh; Chua, Tiffany; Tiwari, Subhash Ch.; Nawaz, Haq; Park, Walter G.; de-Madaria, Enrique; Lee, Peter J.; Wu, Bechien U.; Greer, Phil J.; Dugum, Mohannad; Koutroumpakis, Efstratios; Akshintala, Venkata; Gougol, Amir

2017-01-01

Background We have established a multicenter international consortium to better understand the natural history of acute pancreatitis (AP) worldwide and to develop a platform for future randomized clinical trials. Methods The AP patient registry to examine novel therapies in clinical experience (APPRENTICE) was formed in July 2014. Detailed web-based questionnaires were then developed to prospectively capture information on demographics, etiology, pancreatitis history, comorbidities, risk factors, severity biomarkers, severity indices, health-care utilization, management strategies, and outcomes of AP patients. Results Between November 2015 and September 2016, a total of 20 sites (8 in the United States, 5 in Europe, 3 in South America, 2 in Mexico and 2 in India) prospectively enrolled 509 AP patients. All data were entered into the REDCap (Research Electronic Data Capture) database by participating centers and systematically reviewed by the coordinating site (University of Pittsburgh). The approaches and methodology are described in detail, along with an interim report on the demographic results. Conclusion APPRENTICE, an international collaboration of tertiary AP centers throughout the world, has demonstrated the feasibility of building a large, prospective, multicenter patient registry to study AP. Analysis of the collected data may provide a greater understanding of AP and APPRENTICE will serve as a future platform for randomized clinical trials. PMID:28042246

Miniaturization and globalization of clinical laboratory activities.

PubMed

Melo, Murilo R; Clark, Samantha; Barrio, Daniel

2011-04-01

Clinical laboratories provide an invaluable service to millions of people around the world in the form of quality diagnostic care. Within the clinical laboratory industry the impetus for change has come from technological development (miniaturization, nanotechnology, and their collective effect on point-of-care testing; POCT) and the increasingly global nature of laboratory services. Potential technological gains in POCT include: the development of bio-sensors, microarrays, genetics and proteomics testing, and enhanced web connectivity. In globalization, prospective opportunities lie in: medical tourism, the migration of healthcare workers, cross-border delivery of testing, and the establishment of accredited laboratories in previously unexplored markets. Accompanying these impressive opportunities are equally imposing challenges. Difficulty transitioning from research to clinical use, poor infrastructure in developing countries, cultural differences and national barriers to global trade are only a few examples. Dealing with the issues presented by globalization and the impact of developing technology on POCT, and on the clinical laboratory services industry in general, will be a daunting task. Despite such concerns, with appropriate countermeasures it will be possible to address the challenges posed. Future laboratory success will be largely dependent on one's ability to adapt in this perpetually shifting landscape.

MALDI-TOF MS in the Microbiology Laboratory: Current Trends.

PubMed

Schubert, Sören; Kostrzewa, Markus

2017-01-01

Within less than a decade matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) has become a gold standard for microbial identification in clinical microbiology laboratories. Besides identification of microorganisms the typing of single strains as well as the antibiotic and antimycotic resistance testing has come into focus in order to speed up the microbiological diagnostic. However, the full potential of MALDI-TOF MS has not been tapped yet and future technological advancements will certainly expedite this method towards novel applications and enhancement of current practice. So, the following chapter shall be rather a brainstorming and forecast of how MALDI-TOF MS will develop to influence clinical diagnostics and microbial research in the future. It shall open up the stage for further discussions and does not claim for overall validity.

Management of Nasopharyngeal Carcinoma: Current Practice and Future Perspective.

PubMed

Lee, Anne W M; Ma, Brigette B Y; Ng, Wai Tong; Chan, Anthony T C

2015-10-10

Nasopharyngeal carcinoma of the undifferentiated subtype is endemic to southern China, and patient prognosis has improved significantly over the past three decades because of advances in disease management, diagnostic imaging, radiotherapy technology, and broader application of systemic therapy. Despite the excellent local control with modern radiotherapy, distant failure remains a key challenge. Advances in molecular technology have helped to decipher the molecular pathogenesis of nasopharyngeal carcinoma as well as its etiologic association with the Epstein-Barr virus. This in turn has led to the discovery of novel biomarkers and drug targets, rendering this cancer site a current focus for new drug development. This article reviews and appraises the key literature on the current management of nasopharyngeal carcinoma and future directions in clinical research. © 2015 by American Society of Clinical Oncology.

To CRISPR and beyond: the evolution of genome editing in stem cells

PubMed Central

Chen, Kuang-Yui; Knoepfler, Paul S

2016-01-01

The goal of editing the genomes of stem cells to generate model organisms and cell lines for genetic and biological studies has been pursued for decades. There is also exciting potential for future clinical impact in humans. While recent, rapid advances in targeted nuclease technologies have led to unprecedented accessibility and ease of gene editing, biology has benefited from past directed gene modification via homologous recombination, gene traps and other transgenic methodologies. Here we review the history of genome editing in stem cells (including via zinc finger nucleases, transcription activator-like effector nucleases and CRISPR–Cas9), discuss recent developments leading to the implementation of stem cell gene therapies in clinical trials and consider the prospects for future advances in this rapidly evolving field. PMID:27905217

To CRISPR and beyond: the evolution of genome editing in stem cells.

PubMed

Chen, Kuang-Yui; Knoepfler, Paul S

2016-12-01

The goal of editing the genomes of stem cells to generate model organisms and cell lines for genetic and biological studies has been pursued for decades. There is also exciting potential for future clinical impact in humans. While recent, rapid advances in targeted nuclease technologies have led to unprecedented accessibility and ease of gene editing, biology has benefited from past directed gene modification via homologous recombination, gene traps and other transgenic methodologies. Here we review the history of genome editing in stem cells (including via zinc finger nucleases, transcription activator-like effector nucleases and CRISPR-Cas9), discuss recent developments leading to the implementation of stem cell gene therapies in clinical trials and consider the prospects for future advances in this rapidly evolving field.

Combination Pharmacotherapies for Stimulant Use Disorder: A Review of Clinical Findings and Recommendations for Future Research

PubMed Central

Stoops, William W.; Rush, Craig R.

2014-01-01

Despite concerted efforts to identify a pharmacotherapy for managing stimulant use disorders, no widely effective medications have been approved. Innovative strategies are necessary to develop successful pharmacotherapies for stimulant use disorders. This manuscript reviews human laboratory studies and clinical trials to determine whether one such strategy, use of combination pharmacotherapies, holds promise. The extant literature shows that combination pharmacotherapy produced results that were better than placebo treatment, especially with medications shown to have efficacy as monotherapies. However, many studies did not compare individual constituents to the combination treatment, making it impossible to determine whether combination treatment is more effective than monotherapy. Future research should systematically compare combined treatments with individual agents using medications showing some efficacy when tested alone. PMID:24716825

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

Feasibility of Extracting Key Elements from ClinicalTrials.gov to Support Clinicians' Patient Care Decisions.

PubMed

Kim, Heejun; Bian, Jiantao; Mostafa, Javed; Jonnalagadda, Siddhartha; Del Fiol, Guilherme

2016-01-01

Motivation: Clinicians need up-to-date evidence from high quality clinical trials to support clinical decisions. However, applying evidence from the primary literature requires significant effort. Objective: To examine the feasibility of automatically extracting key clinical trial information from ClinicalTrials.gov. Methods: We assessed the coverage of ClinicalTrials.gov for high quality clinical studies that are indexed in PubMed. Using 140 random ClinicalTrials.gov records, we developed and tested rules for the automatic extraction of key information. Results: The rate of high quality clinical trial registration in ClinicalTrials.gov increased from 0.2% in 2005 to 17% in 2015. Trials reporting results increased from 3% in 2005 to 19% in 2015. The accuracy of the automatic extraction algorithm for 10 trial attributes was 90% on average. Future research is needed to improve the algorithm accuracy and to design information displays to optimally present trial information to clinicians.

Yesterday and Today: A Few Words About the Development of Health Protection in Stalinabad

DTIC Science & Technology

1960-11-02

Medical Institute are enrolled more than two thousand students . Within the walls of the school future den- tists, obstetricians, pharmacists...18 X-ray and 12 physiotherapy departments, 12 clinical diagnostic units, and seven electrocardiographic units. Republic and city sanitation and

A meta-analysis and model of the relationship between sleep and depression in adolescents: recommendations for future research and clinical practice.

PubMed

Lovato, Nicole; Gradisar, Michael

2014-12-01

The purpose of this review was to quantify the strength of evidence for a directional relationship between sleep disturbance and depression in adolescents. A literature search was conducted to identify research investigating the relationship between sleep disturbance and depression in adolescent samples (12-20 y). Twenty-three studies were identified; 13 explored associations between depression and sleep disturbance; seven examined the prospective role of sleep disturbance in the development of depression; and three investigated the role of adolescent depression in the development of subsequent sleep disturbance. Average weighted mean differences in sleep/depression-related outcome variables were calculated between adolescents with depression, and non-clinical adolescents, or those in remission. Adolescents with depression experienced significantly more wakefulness in bed (sleep onset latency, wake after sleep onset, number of awakenings and sleep efficiency), lighter sleep (more stage 1), and reported more subjective sleep disturbance. Overall effect sizes from longitudinal and treatment studies suggest sleep disturbance acts as a precursor to the development of depression. At follow-up, depressed adolescents had significantly longer sleep onset, more wake after sleep onset, and lower sleep efficiency compared to adolescents who were non-clinical, or had undergone remission. Little support was found for a predictive role of depressive symptoms in the development of sleep disturbance. Based on these findings we propose a model to understand the development of depression from initial sleep disturbance, provide recommendations for clinicians and recommendations for future research. Copyright © 2014 Elsevier Ltd. All rights reserved.

AMS in drug development at GSK

NASA Astrophysics Data System (ADS)

Young, G. C.; Ellis, W. J.

2007-06-01

A history of the use of AMS in GSK studies spanning the last 8 years (1998-2005) is presented, including use in pilot studies through to clinical, animal and in vitro studies. A brief summary of the status of GSK's in-house AMS capability is outlined and views on the future of AMS in GSK are presented, including potential impact on drug development and potential advances in AMS technology.

Scenario drafting to anticipate future developments in technology assessment.

PubMed

Retèl, Valesca P; Joore, Manuela A; Linn, Sabine C; Rutgers, Emiel J T; van Harten, Wim H

2012-08-16

Health Technology Assessment (HTA) information, and in particular cost-effectiveness data is needed to guide decisions, preferably already in early stages of technological development. However, at that moment there is usually a high degree of uncertainty, because evidence is limited and different development paths are still possible. We developed a multi-parameter framework to assess dynamic aspects of a technology -still in development-, by means of scenario drafting to determine the effects, costs and cost-effectiveness of possible future diffusion patterns. Secondly, we explored the value of this method on the case of the clinical implementation of the 70-gene signature for breast cancer, a gene expression profile for selecting patients who will benefit most from chemotherapy. To incorporate process-uncertainty, ten possible scenarios regarding the introduction of the 70-gene signature were drafted with European experts. Out of 5 most likely scenarios, 3 drivers of diffusion (non-compliance, technical failure, and uptake) were quantitatively integrated in a decision-analytical model. For these scenarios, the cost-effectiveness of the 70-gene signature expressed in Incremental Cost-Effectiveness Ratios (ICERs) was compared to clinical guidelines, calculated from the past (2005) until the future (2020). In 2005 the ICER was €1,9 million/quality-adjusted-life-year (QALY), meaning that the 70-gene signature was not yet cost-effective compared to the current clinical guideline. The ICER for the 70-gene signature improved over time with a range of €1,9 million to €26,145 in 2010 and €1,9 million to €11,123/QALY in 2020 depending on the separate scenario used. From 2010, the 70-gene signature should be cost-effective, based on the combined scenario. The uptake-scenario had strongest influence on the cost-effectiveness. When optimal diffusion of a technology is sought, incorporating process-uncertainty by means of scenario drafting into a decision model may reveal unanticipated developments and can demonstrate a range of possible cost-effectiveness outcomes. The effect of scenarios give additional information on the speed with cost effectiveness might be reached and thus provide a more realistic picture for policy makers, opinion leaders and manufacturers.

Scenario drafting to anticipate future developments in technology assessment

PubMed Central

2012-01-01

Background Health Technology Assessment (HTA) information, and in particular cost-effectiveness data is needed to guide decisions, preferably already in early stages of technological development. However, at that moment there is usually a high degree of uncertainty, because evidence is limited and different development paths are still possible. We developed a multi-parameter framework to assess dynamic aspects of a technology -still in development-, by means of scenario drafting to determine the effects, costs and cost-effectiveness of possible future diffusion patterns. Secondly, we explored the value of this method on the case of the clinical implementation of the 70-gene signature for breast cancer, a gene expression profile for selecting patients who will benefit most from chemotherapy. Methods To incorporate process-uncertainty, ten possible scenarios regarding the introduction of the 70-gene signature were drafted with European experts. Out of 5 most likely scenarios, 3 drivers of diffusion (non-compliance, technical failure, and uptake) were quantitatively integrated in a decision-analytical model. For these scenarios, the cost-effectiveness of the 70-gene signature expressed in Incremental Cost-Effectiveness Ratios (ICERs) was compared to clinical guidelines, calculated from the past (2005) until the future (2020). Results In 2005 the ICER was €1,9 million/quality-adjusted-life-year (QALY), meaning that the 70-gene signature was not yet cost-effective compared to the current clinical guideline. The ICER for the 70-gene signature improved over time with a range of €1,9 million to €26,145 in 2010 and €1,9 million to €11,123/QALY in 2020 depending on the separate scenario used. From 2010, the 70-gene signature should be cost-effective, based on the combined scenario. The uptake-scenario had strongest influence on the cost-effectiveness. Conclusions When optimal diffusion of a technology is sought, incorporating process-uncertainty by means of scenario drafting into a decision model may reveal unanticipated developments and can demonstrate a range of possible cost-effectiveness outcomes. The effect of scenarios give additional information on the speed with cost effectiveness might be reached and thus provide a more realistic picture for policy makers, opinion leaders and manufacturers. PMID:22894140

Conceptualizing clinical nurse leader practice: an interpretive synthesis.

PubMed

Bender, Miriam

2016-01-01

The Institute of Medicine's Future of Nursing report identifies the clinical nurse leader as an innovative new role for meeting higher health-care quality standards. However, specific clinical nurse leader practices influencing documented quality outcomes remain unclear. Lack of practice clarity limits the ability to articulate, implement and measure clinical nurse leader-specific practice and quality outcomes. Interpretive synthesis design and grounded theory analysis were used to develop a theoretical understanding of clinical nurse leader practice that can facilitate systematic and replicable implementation across health-care settings. The core phenomenon of clinical nurse leader practice is continuous clinical leadership, which involves four fundamental activities: facilitating effective ongoing communication; strengthening intra and interprofessional relationships; building and sustaining teams; and supporting staff engagement. Clinical nurse leaders continuously communicate and develop relationships within and across professions to promote and sustain information exchange, engagement, teamwork and effective care processes at the microsystem level. Clinical nurse leader-integrated care delivery systems highlight the benefits of nurse-led models of care for transforming health-care quality. Managers can use this study's findings to frame an implementation strategy that addresses theoretical domains of clinical nurse leader practice to help ensure practice success. © 2015 John Wiley & Sons Ltd.

Competencies to enable learning-focused clinical supervision: a thematic analysis of the literature.

PubMed

Pront, Leeanne; Gillham, David; Schuwirth, Lambert W T

2016-04-01

Clinical supervision is essential for development of health professional students and widely recognised as a significant factor influencing student learning. Although considered important, delivery is often founded on personal experience or a series of predetermined steps that offer standardised behavioural approaches. Such a view may limit the capacity to promote individualised student learning in complex clinical environments. The objective of this review was to develop a comprehensive understanding of what is considered 'good' clinical supervision, within health student education. The literature provides many perspectives, so collation and interpretation were needed to aid development and understanding for all clinicians required to perform clinical supervision within their daily practice. A comprehensive thematic literature review was carried out, which included a variety of health disciplines and geographical environments. Literature addressing 'good' clinical supervision consists primarily of descriptive qualitative research comprising mostly small studies that repeated descriptions of student and supervisor opinions of 'good' supervision. Synthesis and thematic analysis of the literature resulted in four 'competency' domains perceived to inform delivery of learning-focused or 'good' clinical supervision. Domains understood to promote student learning are co-dependent and include 'to partner', 'to nurture', 'to engage' and 'to facilitate meaning'. Clinical supervision is a complex phenomenon and establishing a comprehensive understanding across health disciplines can influence the future health workforce. The learning-focused clinical supervision domains presented here provide an alternative perspective of clinical supervision of health students. This paper is the first step in establishing a more comprehensive understanding of learning-focused clinical supervision, which may lead to development of competencies for clinical supervision. © 2016 John Wiley & Sons Ltd.

Bilateral robots for upper-limb stroke rehabilitation: State of the art and future prospects.

PubMed

Sheng, Bo; Zhang, Yanxin; Meng, Wei; Deng, Chao; Xie, Shengquan

2016-07-01

Robot-assisted bilateral upper-limb training grows abundantly for stroke rehabilitation in recent years and an increasing number of devices and robots have been developed. This paper aims to provide a systematic overview and evaluation of existing bilateral upper-limb rehabilitation devices and robots based on their mechanisms and clinical-outcomes. Most of the articles studied here were searched from nine online databases and the China National Knowledge Infrastructure (CNKI) from year 1993 to 2015. Devices and robots were categorized as end-effectors, exoskeletons and industrial robots. Totally ten end-effectors, one exoskeleton and one industrial robot were evaluated in terms of their mechanical characteristics, degrees of freedom (DOF), supported control modes, clinical applicability and outcomes. Preliminary clinical results of these studies showed that all participants could gain certain improvements in terms of range of motion, strength or physical function after training. Only four studies supported that bilateral training was better than unilateral training. However, most of clinical results cannot definitely verify the effectiveness of mechanisms and clinical protocols used in robotic therapies. To explore the actual value of these robots and devices, further research on ingenious mechanisms, dose-matched clinical protocols and universal evaluation criteria should be conducted in the future. Copyright © 2016 IPEM. Published by Elsevier Ltd. All rights reserved.

Evolution of an information literacy curriculum for third-year medical students.

PubMed

O'Dwyer, Linda; Kerns, Stephanie C

2011-01-01

Information literacy curriculum for third-year medical students at Northwestern University has evolved over several years under the guidance of librarians at the Galter Health Sciences Library. Starting as a series of rotation-specific information resource overviews, initial evaluation and feedback led to the curriculum being developed to include more focused and interactive clinical information sessions with a quiz-based assessment. Future enhancements will include web-based self-directed learning using online tutorials, additional search exercises that mimic the on-the-go clinical environment, and better assessment of the curriculum's impact on students' information literacy and clinical search skills.

The virology, epidemiology, and clinical impact of West Nile virus: a decade of advancements in research since its introduction into the Western Hemisphere.

PubMed

Murray, K O; Walker, C; Gould, E

2011-06-01

West Nile virus (WNV) is now endemic in the USA. After the widespread surge of virus activity across the USA, research has flourished, and our knowledge base has significantly expanded over the past 10 years since WNV was first recognized in New York City. This article provides a review of the virology of WNV, history, epidemiology, clinical features, pathology of infection, the innate and adaptive immune response, host risk factors for developing severe disease, clinical sequelae following severe disease, chronic infection, and the future of prevention.

Medicinal cannabis in oncology.

PubMed

Engels, Frederike K; de Jong, Floris A; Mathijssen, Ron H J; Erkens, Joëlle A; Herings, Ron M; Verweij, Jaap

2007-12-01

In The Netherlands, since September 2003, a legal medicinal cannabis product, constituting the whole range of cannabinoids, is available for clinical research, drug development strategies, and on prescription for patients. To date, this policy, initiated by the Dutch Government, has not yet led to the desired outcome; the amount of initiated clinical research is less than expected and only a minority of patients resorts to the legal product. This review aims to discuss the background for the introduction of legal medicinal cannabis in The Netherlands, the past years of Dutch clinical experience in oncology practice, possible reasons underlying the current outcome, and future perspectives.

Electrochemical Sensors for Clinic Analysis

PubMed Central

Wang, You; Xu, Hui; Zhang, Jianming; Li, Guang

2008-01-01

Demanded by modern medical diagnosis, advances in microfabrication technology have led to the development of fast, sensitive and selective electrochemical sensors for clinic analysis. This review addresses the principles behind electrochemical sensor design and fabrication, and introduces recent progress in the application of electrochemical sensors to analysis of clinical chemicals such as blood gases, electrolytes, metabolites, DNA and antibodies, including basic and applied research. Miniaturized commercial electrochemical biosensors will form the basis of inexpensive and easy to use devices for acquiring chemical information to bring sophisticated analytical capabilities to the non-specialist and general public alike in the future. PMID:27879810

A systematic model to compare nurses' optimal and actual competencies in the clinical setting.

PubMed

Meretoja, Riitta; Koponen, Leena

2012-02-01

This paper is a report of a study to develop a model to compare nurses' optimal and actual competencies in the clinical setting.   Although future challenge is to focus the developmental and educational targets in health care, limited information is available on methods for how to predict optimal competencies. A multidisciplinary group of 24 experts on perioperative care were recruited to this study. They anticipated the effects of future challenges on perioperative care and specified the level of optimal competencies by using the Nurse Competence Scale before and after group discussions. The expert group consensus discussions were held to achieve the highest possible agreement on the overall level of optimal competencies. Registered Nurses (n = 87) and their nurse managers from five different units conducted assessments of the actual level of nurse competence with the Nurse Competence Scale instrument. Data were collected in 2006-2007. Group consensus discussions solidified experts' anticipations about the optimal competence level. This optimal competence level was significantly higher than the nurses' self-reported actual or nurse managers' assessed level of actual competence. The study revealed some competence items that were seen as key challenges for future education of professional nursing practice. It is important that the multidisciplinary experts in a particular care context develop a share understanding of the future competency requirements of patient care. Combining optimal competence profiles to systematic competence assessments contribute to targeted continual learning and educational interventions. © 2011 Blackwell Publishing Ltd.

The Influence of Big (Clinical) Data and Genomics on Precision Medicine and Drug Development.

PubMed

Denny, Joshua C; Van Driest, Sara L; Wei, Wei-Qi; Roden, Dan M

2018-03-01

Drug development continues to be costly and slow, with medications failing due to lack of efficacy or presence of toxicity. The promise of pharmacogenomic discovery includes tailoring therapeutics based on an individual's genetic makeup, rational drug development, and repurposing medications. Rapid growth of large research cohorts, linked to electronic health record (EHR) data, fuels discovery of new genetic variants predicting drug action, supports Mendelian randomization experiments to show drug efficacy, and suggests new indications for existing medications. New biomedical informatics and machine-learning approaches advance the ability to interpret clinical information, enabling identification of complex phenotypes and subpopulations of patients. We review the recent history of use of "big data" from EHR-based cohorts and biobanks supporting these activities. Future studies using EHR data, other information sources, and new methods will promote a foundation for discovery to more rapidly advance precision medicine. © 2017 American Society for Clinical Pharmacology and Therapeutics.

Implications of ICD-10 for Sarcopenia Clinical Practice and Clinical Trials: Report by the International Conference on Frailty and Sarcopenia Research Task Force.

PubMed

Vellas, B; Fielding, R A; Bens, C; Bernabei, R; Cawthon, P M; Cederholm, T; Cruz-Jentoft, A J; Del Signore, S; Donahue, S; Morley, J; Pahor, M; Reginster, J-Y; Rodriguez Mañas, L; Rolland, Y; Roubenoff, R; Sinclair, A; Cesari, M

2018-01-01

Establishment of an ICD-10-CM code for sarcopenia in 2016 was an important step towards reaching international consensus on the need for a nosological framework of age-related skeletal muscle decline. The International Conference on Frailty and Sarcopenia Research Task Force met in April 2017 to discuss the meaning, significance, and barriers to the implementation of the new code as well as strategies to accelerate development of new therapies. Analyses by the Sarcopenia Definitions and Outcomes Consortium are underway to develop quantitative definitions of sarcopenia. A consensus conference is planned to evaluate this analysis. The Task Force also discussed lessons learned from sarcopenia trials that could be applied to future trials, as well as lessons from the osteoporosis field, a clinical condition with many constructs similar to sarcopenia and for which ad hoc treatments have been developed and approved by regulatory agencies.

The Value of Clinical Needs Assessments for Point-of-Care Diagnostics

PubMed Central

Weigl, Bernhard H.; Gaydos, Charlotte A.; Kost, Gerald; Beyette, Fred R.; Sabourin, Stephanie; Rompalo, Anne; de los Santos, Tala; McMullan, Jason T.; Haller, John

2013-01-01

Most entrepreneurial ventures fail long before the core technology can be brought to the marketplace because of disconnects in performance and usability measures such as accuracy, cost, complexity, assay stability, and time requirements between technology developers’ specifications and needs of the end-users. By going through a clinical needs assessment (CNA) process, developers will gain vital information and a clear focus that will help minimize the risks associated with the development of new technologies available for use within the health care system. This article summarizes best practices of the principal investigators of the National Institute of Biomedical Imaging and Bioengineering point-of-care (POC) centers within the National Institute of Biomedical Imaging and Bioengineering POC Technologies Research Network. Clinical needs assessments are particularly important for product development areas that do not sufficiently benefit from traditional market research, such as grant-funded research and development, new product lines using cutting-edge technologies developed in start-up companies, and products developed through product development partnerships for low-resource settings. The objectives of this article were to (1) highlight the importance of CNAs for development of POC devices, (2) discuss methods applied by POC Technologies Research Network for assessing clinical needs, and (3) provide a road map for future CNAs. PMID:23935405

On mixed reality environments for minimally invasive therapy guidance: Systems architecture, successes and challenges in their implementation from laboratory to clinic

PubMed Central

Linte, Cristian A.; Davenport, Katherine P.; Cleary, Kevin; Peters, Craig; Vosburgh, Kirby G.; Navab, Nassir; Edwards, Philip “Eddie”; Jannin, Pierre; Peters, Terry M.; Holmes, David R.; Robb, Richard A.

2013-01-01

Mixed reality environments for medical applications have been explored and developed over the past three decades in an effort to enhance the clinician’s view of anatomy and facilitate the performance of minimally invasive procedures. These environments must faithfully represent the real surgical field and require seamless integration of pre- and intra-operative imaging, surgical instrument tracking, and display technology into a common framework centered around and registered to the patient. However, in spite of their reported benefits, few mixed reality environments have been successfully translated into clinical use. Several challenges that contribute to the difficulty in integrating such environments into clinical practice are presented here and discussed in terms of both technical and clinical limitations. This article should raise awareness among both developers and end-users toward facilitating a greater application of such environments in the surgical practice of the future. PMID:23632059

[A historical view of the specialty of clinical microbiology].

PubMed

Pérez, Evelio Perea; Álvarez, Rogelio Martín

2010-10-01

Clinical microbiology today is a well established specialty in Spain whose development has necessarily been linked to improvements in the diagnosis, treatment and prevention of infectious diseases. Over time, clinical, teaching, and research structures have been organized around these diseases. In addition, a scientific society for specialists in infectious diseases (Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica) has been set up, which in turn, publishes the journal ENFERMEDADES INFECCIOSAS Y MICROBIOLOGÍA CLÍNICA, and organizes congresses, meetings, working groups and a quality control program, etc. Clinical microbiologists will continue to be needed to meet future challenges (identification of new pathogenic microorganisms, methodological changes, diagnostic quality and speed, nosocomial infections, the development of antimicrobial resistance, etc.), which constitute a well-defined area of knowledge specific to our specialty. Copyright © 2010 Elsevier España S.L. All rights reserved.

Creativity in clinical communication: from communication skills to skilled communication.

PubMed

Salmon, Peter; Young, Bridget

2011-03-01

Medical Education 2011: 45: 217-226 Objectives  The view that training in communication skills produces skilled communication is sometimes criticised by those who argue that communication is individual and intuitive. We therefore examine the validity of the concept of communication as a skill and identify alternative principles to underpin future development of this field. Methods  We critically examine research evidence about the nature of clinical communication, and draw from theory and evidence concerning education and evaluation, particularly in creative disciplines. Results  Skilled communication cannot be fully described using the concept of communication skills. Attempts to do so risk constraining and distorting pedagogical development in communication. Current education practice often masks the difficulties with the concept by introducing subjectivity into the definition and assessment of skills. As all clinical situations differ to some extent, clinical communication is inherently creative. Because it is rarely possible to attribute specific effects to specific elements of communication, communication needs to be taught and evaluated holistically. Conclusions  For communication teaching to be pedagogically and clinically valid in supporting the inherent creativity of clinical communication, it will need to draw from education theory and practice that have been developed in explicitly creative disciplines. © Blackwell Publishing Ltd 2011.

Clinical neuropsychology in South Korea.

PubMed

Kim, Myung-Sun; Chey, Jeanyung

2016-11-01

Clinical neuropsychology in South Korea, albeit its relatively short history, has advanced dramatically. We review a brief history and current status of clinical neuropsychology in South Korea. The history, the educational pathway, the training pathway, the certification process, and careers in clinical neuropsychology in South Korea are reviewed. We have reviewed the neuropsychological services, including assessment and treatment, research on neurological and psychiatric populations, and neuropsychology education and the requirements related to education, training, and board examinations of those providing neuropsychological services in South Korea. We also describe how the Korean Society for Neuropsychology Research, the first and only meeting for neuropsychologists in the country established in 1999, has played a major role in how clinical neuropsychology is practiced and developed as a professional field in South Korea. Clinical neuropsychology in South Korea has achieved major progress over just a quarter of a century, and its future is promising in light of the increasing demand for neuropsychological services and advances in neuroscience in the country. Challenges that the community of clinical neuropsychologists are currently facing in South Korea, including formalizing neuropsychological curriculum and training programs and developing advanced credentialing procedures, are discussed.

Emergency recompression: clinical audit of service delivery at a national level.

PubMed

Ross, John As; Sayer, Martin Dj

2009-03-01

Clinical audit is an essential element to the maintenance or improvement of delivery of any medical service. During the development phase of a National Recompression Registration Service for Scotland, clinical audit was initiated to provide a standardised tool to monitor the quality of outcome with respect to the severity of presentation. A functional audit process was an essential consideration for planned future measurement of treatment efficacy at local (single hyperbaric unit) and national (multiple hyperbaric units) scales. The audit process was designed to be undemanding, robust and informative, irrespective of the experience of treatment centre and of the clinician in charge of treatment. The clinical records from 104 cases of divers with decompression illness were used to derive and evaluate measures of severity and clinical outcome that could be used for audit and quality assurance. The various measures of disease severity were examined against clinical outcome and days spent in care after admission to a hyperbaric unit. An initial version of the clinical audit format that was developed from this process is presented.

Branched-chain and aromatic amino acid profiles and diabetes risk in Chinese populations.

PubMed

Chen, Tianlu; Ni, Yan; Ma, Xiaojing; Bao, Yuqian; Liu, Jiajian; Huang, Fengjie; Hu, Cheng; Xie, Guoxiang; Zhao, Aihua; Jia, Weiping; Jia, Wei

2016-02-05

Recent studies revealed strong evidence that branched-chain and aromatic amino acids (BCAAs and AAAs) are closely associated with the risk of developing type 2 diabetes in several Western countries. The aim of this study was to evaluate the potential role of BCAAs and AAAs in predicting the diabetes development in Chinese populations. The serum levels of valine, leucine, isoleucine, tyrosine, and phenylalanine were measured in a longitudinal and a cross sectional studies with a total of 429 Chinese participants at different stages of diabetes development, using an ultra-performance liquid chromatography triple quadruple mass spectrometry platform. The alterations of the five AAs in Chinese populations are well in accordance with previous reports. Early elevation of the five AAs and their combined score was closely associated with future development of diabetes, suggesting an important role of these metabolites as early markers of diabetes. On the other hand, the five AAs were not as good as existing clinical markers in differentiating diabetic patients from their healthy counterparts. Our findings verified the close correlation of BCAAs and AAAs with insulin resistance and future development of diabetes in Chinese populations and highlighted the predictive value of these markers for future development of diabetes.

Branched-chain and aromatic amino acid profiles and diabetes risk in Chinese populations

PubMed Central

Chen, Tianlu; Ni, Yan; Ma, Xiaojing; Bao, Yuqian; Liu, Jiajian; Huang, Fengjie; Hu, Cheng; Xie, Guoxiang; Zhao, Aihua; Jia, Weiping; Jia, Wei

2016-01-01

Recent studies revealed strong evidence that branched-chain and aromatic amino acids (BCAAs and AAAs) are closely associated with the risk of developing type 2 diabetes in several Western countries. The aim of this study was to evaluate the potential role of BCAAs and AAAs in predicting the diabetes development in Chinese populations. The serum levels of valine, leucine, isoleucine, tyrosine, and phenylalanine were measured in a longitudinal and a cross sectional studies with a total of 429 Chinese participants at different stages of diabetes development, using an ultra-performance liquid chromatography triple quadruple mass spectrometry platform. The alterations of the five AAs in Chinese populations are well in accordance with previous reports. Early elevation of the five AAs and their combined score was closely associated with future development of diabetes, suggesting an important role of these metabolites as early markers of diabetes. On the other hand, the five AAs were not as good as existing clinical markers in differentiating diabetic patients from their healthy counterparts. Our findings verified the close correlation of BCAAs and AAAs with insulin resistance and future development of diabetes in Chinese populations and highlighted the predictive value of these markers for future development of diabetes. PMID:26846565

Proposal for the development of biologics in pediatric rheumatology.

PubMed

Mori, Masaaki; Nakagawa, Masao; Tsuchida, Nao; Kawada, Kou; Sato, Junko; Sakiyama, Michiyo; Hirano, Shinya; Sato, Katsuaki; Nakamura, Hidefumi

2018-02-01

In order to assess the development, approval and early introduction into clinical practice of biologics in the pediatric field, we herein describe the current status of the development to approval of biologics as anti-rheumatic agents for children in Japan, discuss the present problems and provide a proposal for the future. It has become apparent that the duration of the review period required for the preparation of clinical trials and Pharmaceuticals and Medical Devices Agency approval is clearly reduced compared with the past. Thus, it was speculated that a rate-limiting step in the process from development to approval was the duration of clinical trials from start to end. Hence, we focused on the following key words with regard to promotion of the development of biologics and their early practical use: "registry", "centralization", and "global cooperation", all of which are related to the reduction of duration of a clinical trial. In conclusion, to reduce the duration of a clinical trial, it is essential to complete a world-scale registry system by developing the registry system established by the Pediatric Rheumatology Association of Japan. The next step is then to carefully plan to participate in the international network using the world-scale registry system, and develop global cooperative trials in which we can ensure a sufficient number of entries from Japan. © 2017 Japan Pediatric Society.

Topical Review: Adherence Interventions for Youth on Gluten-Free Diets.

PubMed

Holbein, Christina E; Carmody, Julia K; Hommel, Kevin A

2018-05-01

To summarize gluten-free diet (GFD) nonadherence risk factors, nonadherence rates, and current intervention research within an integrative framework and to develop a research agenda for the development and implementation of evidence-based GFD adherence interventions. Topical review of literature published since 2008 investigating GFD adherence in pediatric samples. Reviews of pediatric studies indicate GFD nonadherence rates ranging from 19 to 56%. There are few evidence-based, published pediatric GFD adherence interventions. Novel assessments of GFD adherence are promising but require further study. Nonmodifiable and modifiable factors within individual, family, community, and health systems domains must be considered when developing future interventions. Clinical implications are discussed. Avenues for future research include development and refinement of adherence assessment tools and development of evidence-based GFD adherence interventions. Novel technologies (e.g., GFD mobile applications) require empirical study but present exciting opportunities for adherence intervention.

Forensic psychiatry in India current status and future development.

PubMed

Shah, L P

1999-07-01

Forensic psychiatry is a developing superspeciality in India and other SAARC countries. After a brief historical review, the paper describes the current status of forensic psychiatry in India and compares it with the development in this field in Europe and America. It takes the stock of current scenario in three different areas viz., i) legal and clinical ii) teaching and training and Hi) research. It deliberates on need for teaching this subject at the undergraduate and the postgraduate medical and legal courses and necessity of full time consultants devoted to the practice of forensic psychiatry. It focuses on the recent developments in the field of forensic psychiatry like enactment of Narcotic and Psychotropic Substance Act (1985), Mental Health Act (1987), Juvenile Justice Act (1989), Act for the Disabled (1994) and the Consumer Protection Act (1986). The paper also recommends some strategies for teaching, training, research and future developments in this field.

FORENSIC PSYCHIATRY IN INDIA CURRENT STATUS AND FUTURE DEVELOPMENT

PubMed Central

Shah, L.P.

1999-01-01

Forensic psychiatry is a developing superspeciality in India and other SAARC countries. After a brief historical review, the paper describes the current status of forensic psychiatry in India and compares it with the development in this field in Europe and America. It takes the stock of current scenario in three different areas viz., i) legal and clinical ii) teaching and training and Hi) research. It deliberates on need for teaching this subject at the undergraduate and the postgraduate medical and legal courses and necessity of full time consultants devoted to the practice of forensic psychiatry. It focuses on the recent developments in the field of forensic psychiatry like enactment of Narcotic and Psychotropic Substance Act (1985), Mental Health Act (1987), Juvenile Justice Act (1989), Act for the Disabled (1994) and the Consumer Protection Act (1986). The paper also recommends some strategies for teaching, training, research and future developments in this field. PMID:21455388

Nitroimidazoles for the treatment of TB: past, present and future

PubMed Central

Mukherjee, Tathagata; Boshoff, Helena

2011-01-01

Tuberculosis remains a leading cause of death resulting from an infectious agent, and the spread of multi- and extensively drug-resistant strains of Mycobacterium tuberculosis poses a threat to management of global health. New drugs that effectively shorten the duration of treatment and are active against drug-resistant strains of this pathogen are urgently required to develop effective chemotherapies to combat this disease. Two nitroimidazoles, PA-824 and OPC-67683, are currently in Phase II clinical trials for the treatment of TB and the outcome of these may determine the future directions of drug development for anti-tubercular nitroimidazoles. In this review we summarize the development of these nitroimidazoles and alternative analogs in these series that may offer attractive alternatives to PA-824 and OPC-67683 for further development in the drug-discovery pipeline. Lastly, the potential pitfalls in the development of nitroimidazoles as drugs for TB are discussed. PMID:21879846

HSV-2 Vaccine: Current Status and Insight into Factors for Developing an Efficient Vaccine

PubMed Central

Zhu, Xiao-Peng; Muhammad, Zaka S.; Wang, Jian-Guang; Lin, Wu; Guo, Shi-Kun; Zhang, Wei

2014-01-01

Herpes simplex virus type 2 (HSV-2), a globally sexually transmitted virus, and also one of the main causes of genital ulcer diseases, increases susceptibility to HIV-1. Effective vaccines to prevent HSV-2 infection are not yet available, but are currently being developed. To facilitate this process, the latest progress in development of these vaccines is reviewed in this paper. A summary of the most promising HSV-2 vaccines tested in animals in the last five years is presented, including the main factors, and new ideas for developing an effective vaccine from animal experiments and human clinical trials. Experimental results indicate that future HSV-2 vaccines may depend on a strategy that targets mucosal immunity. Furthermore, estradiol, which increases the effectiveness of vaccines, may be considered as an adjuvant. Therefore, this review is expected to provide possible strategies for development of future HSV-2 vaccines. PMID:24469503

Food allergy: opportunities and challenges in the clinical practice of allergy and immunology.

PubMed

James, John M

2004-10-01

Food allergy offers numerous opportunities and challenges for the allergy and clinical immunology specialist. Physicians with board certification in allergy and clinical immunology should be the main source of reliable clinical information to educate patients with food-related disorders. There has been a wealth of reliable information published related to food allergy that can be utilized by health care providers in clinical practice. This includes information about the cross-reactivity of food allergens, the evaluation of potential new therapies, and the practical application of new diagnostic methods and management strategies. This article addresses some of the new developments in food allergy, with an emphasis on cross-reactvity of food allergens, recombinant food allergens, and potential future therapies for food allergy.

[Non-commercial clinical trials--who will be the legal sponsor? Sponsorship of investigator-initiated clinical trials according to the German Drug Law].

PubMed

Benninger-Döring, G; Boos, J

2006-07-01

Non-commercial clinical trials may be of great benefit to the patients concerned. The 12th amendment to the German Drug Law (AMG) changed legal liability of the initiators of investigator-initiated clinical trials with extensive consequences for traditional project leaders. The central point under discussion is the sponsor's responsibility according to the AMG. Presently leading management divisions of university hospitals and universities are developing proceedings to assume sponsor responsibility by institutions (institutional sponsorship), which should enable investigator-initiated clinical trials to be conducted according to legal requirements in the future. Detailed problems and special questions can only be resolved in a single-minded fashion, and if necessary political processes should be catalyzed.

Development and application of neuropsychology in Hong Kong: implications of its value and future advancement.

PubMed

Chan, Agnes S; Sze, Sophia L; Cheung, Mei-Chun; Han, Yvonne M Y

2016-11-01

To review the development, application, and value of neuropsychology, and the standard education and training pathway for neuropsychologists or clinical neuropsychologists in Hong Kong. The information provided here was gathered via a literature review of the status of neuropsychology and the validity of commonly adopted neuropsychological tests in Hong Kong. Additional details were acquired via the internet about local tertiary education curricula and the related requirements, the availability of professional associations for licensure or board certification, and relevant statistics/surveys conducted by the government. Some information about the clinical practice of neuropsychology was collected through personal communication with local clinical psychologists. The development of neuropsychology in Hong Kong over the past 20 years is rapid and productive, given the increasing application of advanced neuroimaging techniques, neuropsychological tests, and opportunities for exchanging up-to-date neuropsychological knowledge and professional training through international conferences, workshops, and seminars. Given that neuropsychology services are often provided by clinical psychologists who are master's degree graduates in clinical psychology, the relatively limited training in neuropsychological knowledge and skills and the lack of division for membership or mandatory registration as a neuropsychologist/clinical neuropsychologist may have an impact on the quality of clinical neuropsychological services and the development of this specialty. These findings signify a need for further improvement or refinement of educational and training pathways for neuropsychologist or clinical neuropsychologist along with the recognition of its value in clinical practice through registration of different disciplines of psychology in Hong Kong.

[Evaluation of the first training on clinical research methodology in Chile].

PubMed

Espinoza, Manuel; Cabieses, Báltica; Pedreros, César; Zitko, Pedro

2011-03-01

This paper describes the evaluation of the first training on clinical research methodology in Chile (EMIC-Chile) 12 months after its completion. An online survey was conducted for students and the Delphi method was used for the teaching team. Among the students, the majority reported that the program had contributed to their professional development and that they had shared some of the knowledge acquired with colleagues in their workplace. Forty-one percent submitted a project to obtain research funding through a competitive grants process once they had completed the course. Among the teachers, the areas of greatest interest were the communication strategy, teaching methods, the characteristics of the teaching team, and potential strategies for making the EMIC-Chile permanent in the future. This experience could contribute to future research training initiatives for health professionals. Recognized challenges are the involvement of nonmedical professions in clinical research, the complexities associated with the distance learning methodology, and the continued presence of initiatives of this importance at the national and regional level.

History and future technical innovation in positron emission tomography

PubMed Central

Jones, Terry; Townsend, David

2017-01-01

Abstract. Instrumentation for positron emission tomography (PET) imaging has experienced tremendous improvements in performance over the past 60 years since it was first conceived as a medical imaging modality. Spatial resolution has improved by a factor of 10 and sensitivity by a factor of 40 from the early designs in the 1970s to the high-performance scanners of today. Multimodality configurations have emerged that combine PET with computed tomography (CT) and, more recently, with MR. Whole-body scans for clinical purposes can now be acquired in under 10 min on a state-of-the-art PET/CT. This paper will review the history of these technical developments over 40 years and summarize the important clinical research and healthcare applications that have been made possible by these technical advances. Some perspectives for the future of this technology will also be presented that promise to bring about new applications of this imaging modality in clinical research and healthcare. PMID:28401173

Leadless cardiac pacemakers: present and the future.

PubMed

Chew, Derek S; Kuriachan, Vikas

2018-01-01

Pacing technology for many decades has been composed of a generator attached to leads that are usually transvenous. Recently, leadless pacemakers have been studied in clinical settings and now available for use in many countries. This includes the single-component Nanostim Leadless Cardiac Pacemaker and Micra Transcatheter Pacing System, as well as the multicomponent Wireless Stimulation Endocardial system. Clinical studies in single-component leadless pacing technology has shown that they can be successfully implanted with minimal complications. The follow-up studies also seem to confirm the findings from the initial clinical trials. These systems offer some advantages over a traditional pacing system comprised of a subcutaneous generator and transvenous leads. In many ways, these leadless systems are disruptive technologies that are changing the traditional pacemaker concept and preferred for some patients. Ongoing research is needed to better assess their long-term function, safety, and end-of-life strategies. In the future, multichamber leadless pacing is expected to be developed and perhaps obviating the need for transvenous leads and their associated complications.

Injury to the Preterm Brain and Cerebral Palsy: Clinical Aspects, Molecular Mechanisms, Unanswered Questions, and Future Research Directions

PubMed Central

Babcock, Michael A.; Kostova, Felina V.; Ferriero, Donna M.; Johnston, Michael V.; Brunstrom, Jan E.; Hagberg, Henrik; Maria, Bernard L.

2013-01-01

Cerebral palsy will affect nearly 10% of the 60,000 very-low-birth-weight infants born in the United States in the next year, and an even greater percentage will display some form of permanent neurological impairment resulting from injury to the preterm brain. The 2008 Neurobiology of Disease in Children Symposium, held in conjunction with the 37th annual meeting of the Child Neurology Society, aimed to define current knowledge and to develop specific aims for future clinical, translational, and fundamental science. A complex interplay of both destructive and developmental forces is responsible for injury to the preterm brain. Advances in imaging and histology have implicated a variety of cell types, though pre-oligodendrocyte injury remains the focus. Research into different mechanisms of injury is facilitating new neuroprotective and rehabilitative interventions. A cooperative effort is necessary to translate basic research findings into clinically effective therapies and better care for these children. PMID:19745084

Biomechanics in dermatology: Recent advances and future directions.

PubMed

Lewinson, Ryan T; Haber, Richard M

2017-02-01

Biomechanics is increasingly being recognized as an important research area in dermatology. To highlight only a few examples, biomechanics has contributed to the development of novel topical therapies for aesthetic and medical purposes, enhanced our understanding of the pathogenesis of plantar melanoma, and provided insight into the epidemiology of psoriatic disease. This article summarizes the findings from recent studies to demonstrate the important role that biomechanics may have in dermatologic disease and therapy and places these biomechanical findings in a clinical context for the practicing physician. In addition, areas for future biomechanics research and development in dermatology are discussed. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Future of human mitochondrial DNA editing technologies.

PubMed

Verechshagina, N; Nikitchina, N; Yamada, Y; Harashima, Н; Tanaka, M; Orishchenko, K; Mazunin, I

2018-05-15

ATP and other metabolites, which are necessary for the development, maintenance, and functioning of bodily cells are all synthesized in the mitochondria. Multiple copies of the genome, present within the mitochondria, together with its maternal inheritance, determine the clinical manifestation and spreading of mutations in mitochondrial DNA (mtDNA). The main obstacle in the way of thorough understanding of mitochondrial biology and the development of gene therapy methods for mitochondrial diseases is the absence of systems that allow to directly change mtDNA sequence. Here, we discuss existing methods of manipulating the level of mtDNA heteroplasmy, as well as the latest systems, that could be used in the future as tools for human mitochondrial genome editing.

The development of a diversity mentoring program for faculty and trainees: A program at the Brown Clinical Psychology Training Consortium

PubMed Central

de Dios, Marcel A.; Kuo, Caroline; Hernandez, Lynn; Clark, Uraina S.; Wenze, Susan J.; Boisseau, Christina L.; Hunter, Heather L.; Reddy, Madhavi K.; Tolou-Shams, Marina; Zlotnick, Caron

2013-01-01

There is a critical need for increasing the diversity representation among clinicians and researchers in academic medicine, including departments of psychiatry and psychology. Mentorship of under-represented groups has been identified as an important way to remediate diversity-related barriers in the field. This paper outlines the early development and pilot implementation of a diversity mentorship program at Brown University. In an effort to inform and guide future diversity programs, we discuss the challenges faced in creating the program, the successes experienced during the first year, and the future directions undertaken as a means for improving the program. PMID:25346563

Oncogenic drivers, targeted therapies, and acquired resistance in non-small-cell lung cancer.

PubMed

Gower, Arjan; Wang, Yisong; Giaccone, Giuseppe

2014-07-01

In the past decade, a shift toward targeted therapies in non-small-cell lung cancer following molecular profiling has dramatically changed the way advanced adenocarcinoma is treated. However, tumor cells inevitably acquire resistance to such therapies, circumventing any sustained clinical benefit. As the genomic classification of lung cancer continues to evolve and as the mechanisms of acquired resistance to targeted therapies become elucidated and more improved target-specific drugs come into sight, the future will see more promising results from the clinic through the development of new therapeutic strategies to overcome, or prevent the development of, resistance for lung cancer patients.

[Translational medicine].

PubMed

Antal, János; Timár, Attila

2011-11-20

Translational medicine is the emerging scientific discipline of the last decade which will set the benchmark for the pharmaceutical industry research and development, integrates inputs from the basic sciences of computer modeling and laboratory research through the pre-clinical and clinical phases of human research to the assimilation of new therapies and treatments into everyday practice of patient care and prevention. With this brief insight authors tried in their humble way to summarize the underlying basis, the present and the potential future of this emerging view, to draw attention to some of the challenges and tasks it faces and to highlight some of the promising approaches, trends and model developments and applications.

Current Methods for Skeletal Muscle Tissue Repair and Regeneration

PubMed Central

Liu, Juan; Saul, Dominik; Böker, Kai Oliver; Ernst, Jennifer; Lehman, Wolfgang

2018-01-01

Skeletal muscle has the capacity of regeneration after injury. However, for large volumes of muscle loss, this regeneration needs interventional support. Consequently, muscle injury provides an ongoing reconstructive and regenerative challenge in clinical work. To promote muscle repair and regeneration, different strategies have been developed within the last century and especially during the last few decades, including surgical techniques, physical therapy, biomaterials, and muscular tissue engineering as well as cell therapy. Still, there is a great need to develop new methods and materials, which promote skeletal muscle repair and functional regeneration. In this review, we give a comprehensive overview over the epidemiology of muscle tissue loss, highlight current strategies in clinical treatment, and discuss novel methods for muscle regeneration and challenges for their future clinical translation. PMID:29850487

Survey on multisensory feedback virtual reality dental training systems.

PubMed

Wang, D; Li, T; Zhang, Y; Hou, J

2016-11-01

Compared with traditional dental training methods, virtual reality training systems integrated with multisensory feedback possess potentials advantages. However, there exist many technical challenges in developing a satisfactory simulator. In this manuscript, we systematically survey several current dental training systems to identify the gaps between the capabilities of these systems and the clinical training requirements. After briefly summarising the components, functions and unique features of each system, we discuss the technical challenges behind these systems including the software, hardware and user evaluation methods. Finally, the clinical requirements of an ideal dental training system are proposed. Future research/development areas are identified based on an analysis of the gaps between current systems and clinical training requirements. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Malaria vaccine clinical trials: what’s on the horizon

PubMed Central

Moreno, Alberto; Joyner, Chester

2015-01-01

Significant progress towards a malaria vaccine, specifically for Plasmodium falciparum, has been made in the past few years with the completion of numerous clinical trials. Each trial has utilized a unique combination of antigens, delivery platforms, and adjuvants, and the data that has been obtained provides critical information that has poises the research community for the development of next generation malaria vaccines. Despite the progress towards a P. falciparum vaccine, P. vivax vaccine research requires more momentum and additional investigations to identify novel vaccine candidates. In this review, recently completed and ongoing malaria vaccine clinical trials as well as vaccine candidates that are in the development pipeline are reviewed. Perspectives for future research using post-genomic mining, nonhuman primate models, and systems biology are also discussed. PMID:26172291

Tumor Microenvironment and Immune Effects of Antineoplastic Therapy in Lymphoproliferative Syndromes

PubMed Central

Álvaro, Tomás; de la Cruz-Merino, Luis; Henao-Carrasco, Fernando; Villar Rodríguez, José Luis; Vicente Baz, David; Codes Manuel de Villena, Manuel; Provencio, Mariano

2010-01-01

Lymphomas represent a wide group of heterogenic diseases with different biological and clinical behavior. The underlying microenvironment-specific composition seems to play an essential role in this scenario, harboring the ability to develop successful immune responses or, on the contrary, leading to immune evasion and even promotion of tumor growth. Depending on surrounding lymphoid infiltrates, lymphomas may have different prognosis. Moreover, recent evidences have emerged that confer a significant impact of main lymphoma's treatment over microenvironment, with clinical consequences. In this review, we summarize these concepts from a pathological and clinical perspective. Also, the state of the art of lymphoma's anti-idiotype vaccine development is revised, highlighting the situations where this strategy has proven to be successful and eventual clues to obtain better results in the future. PMID:20814546

Progress and Prospects for Genetic Modification of Nonhuman Primate Models in Biomedical Research

PubMed Central

Chan, Anthony W. S.

2013-01-01

The growing interest of modeling human diseases using genetically modified (transgenic) nonhuman primates (NHPs) is a direct result of NHPs (rhesus macaque, etc.) close relation to humans. NHPs share similar developmental paths with humans in their anatomy, physiology, genetics, and neural functions; and in their cognition, emotion, and social behavior. The NHP model within biomedical research has played an important role in the development of vaccines, assisted reproductive technologies, and new therapies for many diseases. Biomedical research has not been the primary role of NHPs. They have mainly been used for safety evaluation and pharmacokinetics studies, rather than determining therapeutic efficacy. The development of the first transgenic rhesus macaque (2001) revolutionized the role of NHP models in biomedicine. Development of the transgenic NHP model of Huntington's disease (2008), with distinctive clinical features, further suggested the uniqueness of the model system; and the potential role of the NHP model for human genetic disorders. Modeling human genetic diseases using NHPs will continue to thrive because of the latest advances in molecular, genetic, and embryo technologies. NHPs rising role in biomedical research, specifically pre-clinical studies, is foreseeable. The path toward the development of transgenic NHPs and the prospect of transgenic NHPs in their new role in future biomedicine needs to be reviewed. This article will focus on the advancement of transgenic NHPs in the past decade, including transgenic technologies and disease modeling. It will outline new technologies that may have significant impact in future NHP modeling and will conclude with a discussion of the future prospects of the transgenic NHP model. PMID:24174443

Percussion use and training: a survey of music therapy clinicians.

PubMed

Scheffel, Stephanie; Matney, Bill

2014-01-01

Percussion instruments are commonly used in music therapy practice; however, the body of published literature regarding music therapy-related percussion training and practice is limited. The purpose of our survey study was to describe: (a) clinician perspectives of their academic percussion training; (b) use of percussion testing during academic training; (c) clinician perspectives on relevance, adequacy, and importance of academic percussion training; (d) clinician perspectives of their nonacademic percussion training; and (e) current use of percussion in clinical practice. Through comparisons of these parameters, we sought to provide information that may inform future percussion use and training. Participants were selected using an email list from the Certification Board for Music Therapists. Board-certified music therapists (MT-BC) were provided with a researcher-created survey about academic percussion training, nonacademic percussion training, and use of percussion in clinical practice. Survey response rate was 14.4% (611/4234). We used demographic data to address potential nonresponse error and ensure population representation for region of residence and region of academic training. Results revealed concerns about perceived adequacy of percussion training received during music therapy education (14.6% reported receiving no academic percussion training; 40.6% reported training was not adequate), and absence of percussion-specific proficiency exams. Of the training received, 62.8% indicated that training was relevant; however, a majority (76.5%) recommended current music therapy students receive more percussion training on instruments and skills most relevant to clinical practice. Comparisons between academic training, perceived needs in academic training, and clinical usage may inform future training and clinical competency. We provide suggestions for developing future training, as well as for furthering clinical implementation and research. © the American Music Therapy Association 2014. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Teaching Reflective Practice in Practice Settings: Students' Perceptions of Their Clinical Educators

ERIC Educational Resources Information Center

Trede, Franziska; Smith, Megan

2012-01-01

Reflective practice in practice settings can enhance practice knowledge, self-assessment and lifelong learning, develop future practice capability and professional identity, and critically appraise practice traditions rather than reproduce them. The inherent power imbalance between student and educator runs the risk for the reflective practice…

Road stabilization and drainage improvements in North Potosi, Bolivia : improving access to markets, clinics, schools, and facilitating future development

DOT National Transportation Integrated Search

2011-02-01

In a remote and extremely impoverished region of southwestern Bolivia, the only road connecting five communities to the outside world has been historically washed out multiple times per year. With the support of TRANSNOW, the University of Washington...

The Preparation of Educational Leaders: What's Needed and What's Next?

ERIC Educational Resources Information Center

Hills, Jean

This essay formulates some recommendations for educational administrator preparation programs and predicts the course of their future development. While the case of medical practice as a paradigm for the practice of educational administration is found only generally useful, the clinical analogy yields the suggestion that educational leader…

An Antibiotic Resource Program for Students of the Health Professions.

ERIC Educational Resources Information Center

Tritz, Gerald J.

1986-01-01

Provides a description of a computer program developed to supplement instruction in testing of antibiotics on clinical isolates of microorganisms. The program is a simulation and database for interpretation of experimental data designed to enhance laboratory learning and prepare future physicians to use computerized diagnostic instrumentation and…

Effects of Phonetic Context on Relative Fundamental Frequency

ERIC Educational Resources Information Center

Lien, Yu-An S.; Gattuccio, Caitlin I.; Stepp, Cara E.

2014-01-01

Purpose: The effect of phonetic context on relative fundamental frequency (RFF) was examined, in order to develop stimuli sets with minimal within-speaker variability that can be implemented in future clinical protocols. Method: Sixteen speakers with healthy voices produced RFF stimuli. Uniform utterances consisted of 3 repetitions of the same…

Recent findings and future directions for interpolar mitotic kinesin inhibitors in cancer therapy

PubMed Central

Myers, Stephanie M.; Collins, Ian

2016-01-01

The kinesin class of microtubule-associated motor proteins present attractive anti-cancer targets owing to their roles in key functions in dividing cells. Two interpolar mitotic kinesins Eg5 and HSET have opposing motor functions in mitotic spindle assembly with respect to microtubule movement, but both offer opportunities to develop cancer selective therapeutic agents. Here, we summarize the progress to date in developing inhibitors of Eg5 and HSET, with an emphasis on structural biology insights into the binding modes of allosteric inhibitors, compound selectivity and mechanisms of action of different chemical scaffolds. We discuss translation of preclinical studies to clinical experience with Eg5 inhibitors, recent findings on potential resistance mechanisms, and explore the implications for future anticancer drug development against these targets. PMID:26976726

Recent findings and future directions for interpolar mitotic kinesin inhibitors in cancer therapy.

PubMed

Myers, Stephanie M; Collins, Ian

2016-01-01

The kinesin class of microtubule-associated motor proteins present attractive anticancer targets owing to their roles in key functions in dividing cells. Two interpolar mitotic kinesins Eg5 and HSET have opposing motor functions in mitotic spindle assembly with respect to microtubule movement, but both offer opportunities to develop cancer selective therapeutic agents. Here, we summarize the progress to date in developing inhibitors of Eg5 and HSET, with an emphasis on structural biology insights into the binding modes of allosteric inhibitors, compound selectivity and mechanisms of action of different chemical scaffolds. We discuss translation of preclinical studies to clinical experience with Eg5 inhibitors, recent findings on potential resistance mechanisms and explore the implications for future anticancer drug development against these targets.

The use of machine learning for the identification of peripheral artery disease and future mortality risk.

PubMed

Ross, Elsie Gyang; Shah, Nigam H; Dalman, Ronald L; Nead, Kevin T; Cooke, John P; Leeper, Nicholas J

2016-11-01

A key aspect of the precision medicine effort is the development of informatics tools that can analyze and interpret "big data" sets in an automated and adaptive fashion while providing accurate and actionable clinical information. The aims of this study were to develop machine learning algorithms for the identification of disease and the prognostication of mortality risk and to determine whether such models perform better than classical statistical analyses. Focusing on peripheral artery disease (PAD), patient data were derived from a prospective, observational study of 1755 patients who presented for elective coronary angiography. We employed multiple supervised machine learning algorithms and used diverse clinical, demographic, imaging, and genomic information in a hypothesis-free manner to build models that could identify patients with PAD and predict future mortality. Comparison was made to standard stepwise linear regression models. Our machine-learned models outperformed stepwise logistic regression models both for the identification of patients with PAD (area under the curve, 0.87 vs 0.76, respectively; P = .03) and for the prediction of future mortality (area under the curve, 0.76 vs 0.65, respectively; P = .10). Both machine-learned models were markedly better calibrated than the stepwise logistic regression models, thus providing more accurate disease and mortality risk estimates. Machine learning approaches can produce more accurate disease classification and prediction models. These tools may prove clinically useful for the automated identification of patients with highly morbid diseases for which aggressive risk factor management can improve outcomes. Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

SU-E-T-23: A Developing Australian Network for Datamining and Modelling Routine Radiotherapy Clinical Data and Radiomics Information for Rapid Learning and Clinical Decision Support

DOE Office of Scientific and Technical Information (OSTI.GOV)

Thwaites, D; Holloway, L; Bailey, M

2015-06-15

Purpose: Large amounts of routine radiotherapy (RT) data are available, which can potentially add clinical evidence to support better decisions. A developing collaborative Australian network, with a leading European partner, aims to validate, implement and extend European predictive models (PMs) for Australian practice and assess their impact on future patient decisions. Wider objectives include: developing multi-institutional rapid learning, using distributed learning approaches; and assessing and incorporating radiomics information into PMs. Methods: Two initial standalone pilots were conducted; one on NSCLC, the other on larynx, patient datasets in two different centres. Open-source rapid learning systems were installed, for data extraction andmore » mining to collect relevant clinical parameters from the centres’ databases. The European DSSs were learned (“training cohort”) and validated against local data sets (“clinical cohort”). Further NSCLC studies are underway in three more centres to pilot a wider distributed learning network. Initial radiomics work is underway. Results: For the NSCLC pilot, 159/419 patient datasets were identified meeting the PM criteria, and hence eligible for inclusion in the curative clinical cohort (for the larynx pilot, 109/125). Some missing data were imputed using Bayesian methods. For both, the European PMs successfully predicted prognosis groups, but with some differences in practice reflected. For example, the PM-predicted good prognosis NSCLC group was differentiated from a combined medium/poor prognosis group (2YOS 69% vs. 27%, p<0.001). Stage was less discriminatory in identifying prognostic groups. In the good prognosis group two-year overall survival was 65% in curatively and 18% in palliatively treated patients. Conclusion: The technical infrastructure and basic European PMs support prognosis prediction for these Australian patient groups, showing promise for supporting future personalized treatment decisions, improved treatment quality and potential practice changes. The early indications from the distributed learning and radiomics pilots strengthen this. Improved routine patient data quality should strengthen such rapid learning systems.« less

Excerpts from the 1st international NTNU symposium on current and future clinical biomarkers of cancer: innovation and implementation, June 16th and 17th 2016, Trondheim, Norway.

PubMed

Robles, Ana I; Olsen, Karina Standahl; Tsui, Dana W T; Georgoulias, Vassilis; Creaney, Jenette; Dobra, Katalin; Vyberg, Mogens; Minato, Nagahiro; Anders, Robert A; Børresen-Dale, Anne-Lise; Zhou, Jianwei; Sætrom, Pål; Nielsen, Boye Schnack; Kirschner, Michaela B; Krokan, Hans E; Papadimitrakopoulou, Vassiliki; Tsamardinos, Ioannis; Røe, Oluf D

2016-10-19

The goal of biomarker research is to identify clinically valid markers. Despite decades of research there has been disappointingly few molecules or techniques that are in use today. The "1st International NTNU Symposium on Current and Future Clinical Biomarkers of Cancer: Innovation and Implementation", was held June 16th and 17th 2016, at the Knowledge Center of the St. Olavs Hospital in Trondheim, Norway, under the auspices of the Norwegian University of Science and Technology (NTNU) and the HUNT biobank and research center. The Symposium attracted approximately 100 attendees and invited speakers from 12 countries and 4 continents. In this Symposium original research and overviews on diagnostic, predictive and prognostic cancer biomarkers in serum, plasma, urine, pleural fluid and tumor, circulating tumor cells and bioinformatics as well as how to implement biomarkers in clinical trials were presented. Senior researchers and young investigators presented, reviewed and vividly discussed important new developments in the field of clinical biomarkers of cancer, with the goal of accelerating biomarker research and implementation. The excerpts of this symposium aim to give a cutting-edge overview and insight on some highly important aspects of clinical cancer biomarkers to-date to connect molecular innovation with clinical implementation to eventually improve patient care.

Advances in the application of MRI to amyotrophic lateral sclerosis

PubMed Central

Turner, Martin R; Modo, Michel

2011-01-01

Importance of the field With the emergence of therapeutic candidates for the incurable and rapidly progressive neurodegenerative condition of amyotrophic lateral sclerosis (ALS), it will be essential to develop easily obtainable biomarkers for diagnosis, as well as monitoring, in a disease where clinical examination remains the predominant diagnostic tool. Magnetic resonance imaging (MRI) has greatly developed over the past thirty years since its initial introduction to neuroscience. With multi-modal applications, MRI is now offering exciting opportunities to develop practical biomarkers in ALS. Areas covered in this review The historical application of MRI to the field of ALS, its state-of-the-art and future aspirations will be reviewed. Specifically, the significance and limitations of structural MRI to detect gross morphological tissue changes in relation to clinical presentation will be discussed. The more recent application of diffusion tensor imaging (DTI), magnetic resonance spectroscopy (MRS), functional and resting-state MRI (fMRI & R-fMRI) will be contrasted in relation to these more conventional MRI assessments. Finally, future aspirations will be sketched out in providing a more disease mechanism-based molecular MRI. What the reader will gain This review will equip the reader with an overview of the application of MRI to ALS and illustrate its potential to develop biomarkers. This discussion is exemplified by key studies, demonstrating the strengths and limitations of each modality. The reader will gain an expert opinion on both the current and future developments of MR imaging in ALS. Take home message MR imaging generates potential diagnostic, prognostic and therapeutic monitoring biomarkers of ALS. The emerging fusion of structural, functional and potentially molecular imaging will improve our understanding of wider cerebral connectivity and holds the promise of biomarkers sensitive to the earliest changes. PMID:21516259

Advances and Concepts in Cervical Cancer Trials: A Road Map for the Future.

PubMed

Sagae, Satoru; Monk, Bradley J; Pujade-Lauraine, Eric; Gaffney, David K; Narayan, Kailash; Ryu, Sang Young; McCormack, Mary; Plante, Marie; Casado, Antonio; Reuss, Alexander; Chávez-Blanco, Adriana; Kitchener, Henry; Nam, Byung-Ho; Jhingran, Anuja; Temkin, Sarah; Mileshkin, Linda; Berns, Els; Scholl, Suzy; Doll, Corinne; Abu-Rustum, Nadeem R; Lecuru, Fabrice; Small, William

2016-01-01

Cervical cancer is responsible for more than a quarter of a million deaths globally each year, mostly in developing countries, making therapeutic advances in all health care settings a top priority. The Gynecologic Cancer InterGroup (GCIG) is a worldwide collaboration of leading national research groups that develops and promotes multinational trials in gynecologic cancer. In recognition of the pressing need for action, the GCIG convened an international meeting with expert representation from the GCIG groups and selected large sites in low- and middle-income countries. The focus was to develop a consensus on several concepts for future clinical trials, which would be developed and promoted by the GCIG and launched with major international participation. The first half of the meeting was devoted to a resume of the current state of the knowledge and identifying the gaps in need of new evidence, validating control arms for present and future clinical trials and identifying national and international barriers for studies of cervix cancers. The second half of the meeting was concerned with achieving consensus on a path forward. There were 5 principal outcomes as follows: first, a proposal to expand fertility-preserving options with neoadjuvant chemotherapy; second, validation of the assessment of sentinel lymph nodes using minimally invasive surgery with an emphasis on identification and management of low-volume metastasis, such as isolated tumor cells and micrometastasis; third, evaluation of hypofractionation for palliative and curative radiation under the umbrella of the GCIG Cervix Cancer Research Network; fourth, adding to the advances in antiangiogenesis therapy in the setting of metastatic disease; and fifth, developing a maintenance study among women at high risk of relapse. The latter 2 systemic interventions could study PI3K (phosphatidylinositol-3-kinase) inhibitors, immunotherapy, anti-human papillomavirus approaches, or novel antiangiogenic agents/combinations.

Eight-step method to build the clinical content of an evidence-based care pathway: the case for COPD exacerbation

PubMed Central

2012-01-01

Background Optimization of the clinical care process by integration of evidence-based knowledge is one of the active components in care pathways. When studying the impact of a care pathway by using a cluster-randomized design, standardization of the care pathway intervention is crucial. This methodology paper describes the development of the clinical content of an evidence-based care pathway for in-hospital management of chronic obstructive pulmonary disease (COPD) exacerbation in the context of a cluster-randomized controlled trial (cRCT) on care pathway effectiveness. Methods The clinical content of a care pathway for COPD exacerbation was developed based on recognized process design and guideline development methods. Subsequently, based on the COPD case study, a generalized eight-step method was designed to support the development of the clinical content of an evidence-based care pathway. Results A set of 38 evidence-based key interventions and a set of 24 process and 15 outcome indicators were developed in eight different steps. Nine Belgian multidisciplinary teams piloted both the set of key interventions and indicators. The key intervention set was judged by the teams as being valid and clinically applicable. In addition, the pilot study showed that the indicators were feasible for the involved clinicians and patients. Conclusions The set of 38 key interventions and the set of process and outcome indicators were found to be appropriate for the development and standardization of the clinical content of the COPD care pathway in the context of a cRCT on pathway effectiveness. The developed eight-step method may facilitate multidisciplinary teams caring for other patient populations in designing the clinical content of their future care pathways. PMID:23190552

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.

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

PubMed

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

2011-12-01

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

Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the Design and Operation of Multi-center Clinical Trials: a Qualitative Research Study

PubMed Central

Diener, Lawrence W.; Nahm, Meredith; Weinfurt, Kevin P.

2013-01-01

New technologies may be required to integrate the National Institutes of Health’s Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies. PMID:20703765

Dimensions of the transition service coordinator role.

PubMed

Betz, Cecily L; Redcay, Gay

2005-01-01

This article describes the development and implementation of an innovative advanced practice role, as a transition service coordinator for nurses who work with adolescents with special healthcare needs. Transition services for adolescents with special healthcare needs is an area of growing clinical need requiring that all healthcare professionals, including advanced practice nurses develop new clinical knowledge and skills to practice effectively. This emerging specialty area will require advanced practice nurses to provide direct services blending both pediatric and adult healthcare needs and to function in advanced practice roles such as case managers who can ensure the coordination of services between these two very different systems of care while promoting the youth's acquisition of goals for adulthood. This nursing role was first created to provide and coordinate transition services to youth seen in a piloted clinic titled Creating Healthy Futures. This article describes the various components of this nursing role that incorporated the advanced practice dimensions of clinical expert, consultant, change agent, leader, researcher, and educator that can be replicated in other clinical settings.

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.

Access to augmentative and alternative communication: new technologies and clinical decision-making.

PubMed

Fager, Susan; Bardach, Lisa; Russell, Susanne; Higginbotham, Jeff

2012-01-01

Children with severe physical impairments require a variety of access options to augmentative and alternative communication (AAC) and computer technology. Access technologies have continued to develop, allowing children with severe motor control impairments greater independence and access to communication. This article will highlight new advances in access technology, including eye and head tracking, scanning, and access to mainstream technology, as well as discuss future advances. Considerations for clinical decision-making and implementation of these technologies will be presented along with case illustrations.

Stimulating effect of thyroid hormones in peripheral nerve regeneration: research history and future direction toward clinical therapy

PubMed Central

Barakat-Walter, I.; Kraftsik, R.

2018-01-01

Injury to peripheral nerves is often observed in the clinic and severe injuries may cause loss of motor and sensory functions. Despite extensive investigation, testing various surgical repair techniques and neurotrophic molecules, at present, a satisfactory method to ensuring successful recovery does not exist. For successful molecular therapy in nerve regeneration, it is essential to improve the intrinsic ability of neurons to survive and to increase the speed of axonal outgrowth. Also to induce Schwann cell phenotypical changes to prepare the local environment favorable for axonal regeneration and myelination. Therefore, any molecule that regulates gene expression of both neurons and Schwann cells could play a crucial role in peripheral nerve regeneration. Clinical and experimental studies have reported that thyroid hormones are essential for the normal development and function of the nervous system, so they could be candidates for nervous system regeneration. This review provides an overview of studies devoted to testing the effect of thyroid hormones on peripheral nerve regeneration. Also it emphasizes the importance of combining biodegradable tubes with local administration of triiodothyronine for future clinical therapy of human severe injured nerves. We highlight that the local and single administration of triiodothyronine within biodegradable nerve guide improves significantly the regeneration of severed peripheral nerves, and accelerates functional recovering. This technique provides a serious step towards future clinical application of triiodothyronine in human severe injured nerves. The possible regulatory mechanism by which triiodothyronine stimulates peripheral nerve regeneration is a rapid action on both axotomized neurons and Schwann cells. PMID:29722302

[Directions for future development of preventive medicine in Korea].

PubMed

Kim, Joon Youn

2006-05-01

It is the actual state of the medical society in our country that many graduates of medical schools want to be clinicians, and accordingly Korea's medical situation is relatively too focused on curative medicine. However, this situation is changing due to several factors including a growing number of doctors, inappropriate regulations for medical fees, changes in social status of doctors themselves, and excessive competition between doctors. Furthermore, we expect more advances in medical field of Korea since Korean government started to attach great importance to sciences and produced policies to support sciences, and as a result, more and more interest and effort in the fields of basic research including preventive medicine is being attached especially by young doctors as compared against the past. However, decline of clinical medicine fields doesn't always mean bright future for the field of preventive medicine. True future is possible and meaningful only when we prepare for it by ourselves. In other words, as the promising future is closed to one who spares no effort, we shouldn't fear to oppose unknown challenges and simultaneously need to support colleagues who bear such a positive mind. It is the most important thing for our preventive medicine doctors to evaluate the past and the present of preventive medicine and to foster a prospective mind to prepare for the future of preventive medicine. I set forth my several views according to directions for the development of preventive medicine which we already discussed and publicized in the academic circle of preventive medicine. Those directions are recommen dation of clinical preventive medicine, promotion of preventive medicine specialty, fostering the next generations, improving the quality of genetic epidemiologic study, participation in control of environmental pollution and food safety, contribution to chronic disease control, and preparation to role in medical services for unified Korea.

Newer influenza antivirals, biotherapeutics and combinations

PubMed Central

Hayden, Frederick G.

2012-01-01

Please cite this paper as: Hayden FG. (2012) Newer Influenza Antivirals, Biotherapeutics and Combinations. Influenza and Other Respiratory Viruses 7(Suppl. 1), 63–75. This summary provides an overview of investigational antiviral agents for influenza and of future directions for development of influenza therapeutics. While progress in developing clinically useful antiviral agents for influenza has been generally slow, especially with respect to seriously ill and high‐risk patients, important clinical studies of intravenous neuraminidase inhibitors, antibodies and drug combinations are currently in progress. The current decade offers the promise of developing small molecular weight inhibitors with novel mechanisms of action, including host‐directed therapies, new biotherapeutics and drug combinations, that should provide more effective antiviral therapies and help mitigate the problem of antiviral resistance. Immunomodulatory interventions also offer promise but need to be based on better understanding of influenza pathogenesis, particularly in seriously ill patients. The development of combination interventions, immunomodulators and host‐directed therapies presents unique clinical trial design and regulatory hurdles that remain to be addressed. PMID:23279899

Reliability Stress-Strength Models for Dependent Observations with Applications in Clinical Trials

NASA Technical Reports Server (NTRS)

Kushary, Debashis; Kulkarni, Pandurang M.

1995-01-01

We consider the applications of stress-strength models in studies involving clinical trials. When studying the effects and side effects of certain procedures (treatments), it is often the case that observations are correlated due to subject effect, repeated measurements and observing many characteristics simultaneously. We develop maximum likelihood estimator (MLE) and uniform minimum variance unbiased estimator (UMVUE) of the reliability which in clinical trial studies could be considered as the chances of increased side effects due to a particular procedure compared to another. The results developed apply to both univariate and multivariate situations. Also, for the univariate situations we develop simple to use lower confidence bounds for the reliability. Further, we consider the cases when both stress and strength constitute time dependent processes. We define the future reliability and obtain methods of constructing lower confidence bounds for this reliability. Finally, we conduct simulation studies to evaluate all the procedures developed and also to compare the MLE and the UMVUE.

Drug-loaded erythrocytes: on the road toward marketing approval

PubMed Central

Bourgeaux, Vanessa; Lanao, José M; Bax, Bridget E; Godfrin, Yann

2016-01-01

Erythrocyte drug encapsulation is one of the most promising therapeutic alternative approaches for the administration of toxic or rapidly cleared drugs. Drug-loaded erythrocytes can operate through one of the three main mechanisms of action: extension of circulation half-life (bioreactor), slow drug release, or specific organ targeting. Although the clinical development of erythrocyte carriers is confronted with regulatory and development process challenges, industrial development is expanding. The manufacture of this type of product can be either centralized or bedside based, and different procedures are employed for the encapsulation of therapeutic agents. The major challenges for successful industrialization include production scalability, process validation, and quality control of the released therapeutic agents. Advantages and drawbacks of the different manufacturing processes as well as success key points of clinical development are discussed. Several entrapment technologies based on osmotic methods have been industrialized. Companies have already achieved many of the critical clinical stages, thus providing the opportunity in the future to cover a wide range of diseases for which effective therapies are not currently available. PMID:26929599

Drug-loaded erythrocytes: on the road toward marketing approval.

PubMed

Bourgeaux, Vanessa; Lanao, José M; Bax, Bridget E; Godfrin, Yann

2016-01-01

Erythrocyte drug encapsulation is one of the most promising therapeutic alternative approaches for the administration of toxic or rapidly cleared drugs. Drug-loaded erythrocytes can operate through one of the three main mechanisms of action: extension of circulation half-life (bioreactor), slow drug release, or specific organ targeting. Although the clinical development of erythrocyte carriers is confronted with regulatory and development process challenges, industrial development is expanding. The manufacture of this type of product can be either centralized or bedside based, and different procedures are employed for the encapsulation of therapeutic agents. The major challenges for successful industrialization include production scalability, process validation, and quality control of the released therapeutic agents. Advantages and drawbacks of the different manufacturing processes as well as success key points of clinical development are discussed. Several entrapment technologies based on osmotic methods have been industrialized. Companies have already achieved many of the critical clinical stages, thus providing the opportunity in the future to cover a wide range of diseases for which effective therapies are not currently available.

[Development of a portfolio for competency-based assessment in a clinical clerkship curriculum].

PubMed

Roh, HyeRin; Lee, Jong-Tae; Yoon, Yoo Sang; Rhee, Byoung Doo

2015-12-01

The purpose of this report was to describe our experience in planning and developing a portfolio for a clinical clerkship curriculum. We have developed a portfolio for assessing student competency since 2007. During an annual workshop on clinical clerkship curricula, clerkship directors from five Paik hospitals of Inje University met to improve the assessment of the portfolio. We generated templates for students to record their activities and reflection and receive feedback. We uploaded these templates to our school's website for students to download freely. Annually, we have held a faculty development seminar and a workshop for portfolio assessment and feedback. Also, we established an orientation program on how to construct a learning portfolio for students. Future actions include creating a ubiquitous portfolio system, extending the portfolio to the entire curriculum, setting up an advisor system, and managing the quality of the portfolio. This study could be helpful for medical schools that plan to improve their portfolio assessment with an outcome-based approach.

Future directions in early cystic fibrosis lung disease research: an NHLBI workshop report.

PubMed

Ramsey, Bonnie W; Banks-Schlegel, Susan; Accurso, Frank J; Boucher, Richard C; Cutting, Garry R; Engelhardt, John F; Guggino, William B; Karp, Christopher L; Knowles, Michael R; Kolls, Jay K; LiPuma, John J; Lynch, Susan; McCray, Paul B; Rubenstein, Ronald C; Singh, Pradeep K; Sorscher, Eric; Welsh, Michael

2012-04-15

Since the 1989 discovery that mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene cause cystic fibrosis (CF), there has been substantial progress toward understanding the molecular basis for CF lung disease, leading to the discovery and development of new therapeutic approaches. However, the earliest impact of the loss of CFTR function on airway physiology and structure and its relationship to initial infection and inflammation are poorly understood. Universal newborn screening for CF in the United States represents an unprecedented opportunity for investigating CF clinical manifestations very early in life. Recently developed animal models with pulmonary phenotypic manifestations also provide a window into the early consequences of this genetic disorder. For these reasons, the National Heart, Lung, and Blood Institute (NHLBI) convened a working group of extramural experts, entitled "Future Research Directions in Early CF Lung Disease" on September 21-22, 2010, to identify future research directions of great promise in CF. The priority areas identified included (1) exploring pathogenic mechanisms of early CF lung disease; (2) leveraging newborn screening to elucidate the natural history of early lung disease; (3) developing a spectrum of biomarkers of early lung disease that reflects CF pathophysiology, clinical outcome, and response to treatment; (4) exploring the role of genetics/genomics (e.g., modifier genes, gene-environmental interactions, and epigenetics) in early CF pathogenesis; (5) defining early microbiological events in CF lung disease; and (6) elucidating the initial airway inflammatory, remodeling, and repair mechanisms in CF lung disease.

Development of the Computerized Model of Performance-Based Measurement System to Measure Nurses' Clinical Competence.

PubMed

Liou, Shwu-Ru; Liu, Hsiu-Chen; Tsai, Shu-Ling; Cheng, Ching-Yu; Yu, Wei-Chieh; Chu, Tsui-Ping

2016-04-01

Critical thinking skills and clinical competence are for providing quality patient care. The purpose of this study is to develop the Computerized Model of Performance-Based Measurement system based on the Clinical Reasoning Model. The system can evaluate and identify learning needs for clinical competency and be used as a learning tool to increase clinical competency by using computers. The system includes 10 high-risk, high-volume clinical case scenarios coupled with questions testing clinical reasoning, interpersonal, and technical skills. Questions were sequenced to reflect patients' changing condition and arranged by following the process of collecting and managing information, diagnosing and differentiating urgency of problems, and solving problems. The content validity and known-groups validity was established. The Kuder-Richardson Formula 20 was 0.90 and test-retest reliability was supported (r = 0.78). Nursing educators can use the system to understand students' needs for achieving clinical competence, and therefore, educational plans can be made to better prepare students and facilitate their smooth transition to a future clinical environment. Clinical nurses can use the system to evaluate their performance-based abilities and weakness in clinical reasoning. Appropriate training programs can be designed and implemented to practically promote nurses' clinical competence and quality of patient care.

Multi-level assessment protocol (MAP) for adoption in multi-site clinical trials

PubMed Central

Guydish, J.; Manser, S.T.; Jessup, M.; Tajima, B.; Sears, C.; Montini, T.

2010-01-01

The National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) is intended to test promising drug abuse treatment models in multi-site clinical trials, and to support adoption of new interventions into clinical practice. Using qualitative research methods we asked: How might the technology of multi-site clinical trials be modified to better support adoption of tested interventions? A total of 42 participants, representing 8 organizational levels ranging from clinic staff to clinical trial leaders, were interviewed about their role in the clinical trial, its interactions with clinics, and intervention adoption. Among eight clinics participating in the clinical trial, we found adoption of the tested intervention in one clinic only. In analysis of interview data we identified four conceptual themes which are likely to affect adoption and may be informative in future multi-site clinical trials. We offer the conclusion that planning for adoption in the early stages of protocol development will better serve the aim of integrating new interventions into practice. PMID:20890376

What works in genomics education: outcomes of an evidenced-based instructional model for community-based physicians.

PubMed

Reed, E Kate; Johansen Taber, Katherine A; Ingram Nissen, Therese; Schott, Suzanna; Dowling, Lynn O; O'Leary, James C; Scott, Joan A

2016-07-01

Education of practicing health professionals is likely to be one factor that will speed appropriate integration of genomics into routine clinical practice. Yet many health professionals, including physicians, find it difficult to keep up with the rapid pace of clinical genomic advances and are often uncomfortable using genomic information in practice. Having identified the genomics educational needs of physicians in a Silicon Valley-area community hospital, we developed, implemented, and evaluated an educational course entitled Medicine's Future: Genomics for Practicing Doctors. The course structure and approach were based on best practices in adult learning, including interactivity, case-based learning, skill-focused objectives, and sequential monthly modules. Approximately 20-30 physicians attended each module. They demonstrated significant gains in genomics knowledge and confidence in practice skills that were sustained throughout and following the course. Six months following the course, the majority of participants reported that they had changed their practice to incorporate skills learned during the course. We believe the adult-learning principles underlying the development and delivery of Medicine's Future were responsible for participants' outcomes. These principles form a model for the development and delivery of other genomics educational programs for health professionals.Genet Med 18 7, 737-745.

Therapeutic Antibodies for Myeloid Neoplasms—Current Developments and Future Directions

PubMed Central

Schürch, Christian M.

2018-01-01

Therapeutic monoclonal antibodies (mAbs) such as antibody–drug conjugates, ligand–receptor antagonists, immune checkpoint inhibitors and bispecific T cell engagers have shown impressive efficacy in the treatment of multiple human cancers. Numerous therapeutic mAbs that have been developed for myeloid neoplasms, including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), are currently investigated in clinical trials. Because AML and MDS originate from malignantly transformed hematopoietic stem/progenitor cells—the so-called leukemic stem cells (LSCs) that are highly resistant to most standard drugs—these malignancies frequently relapse and have a high disease-specific mortality. Therefore, combining standard chemotherapy with antileukemic mAbs that specifically target malignant blasts and particularly LSCs or utilizing mAbs that reinforce antileukemic host immunity holds great promise for improving patient outcomes. This review provides an overview of therapeutic mAbs for AML and MDS. Antibody targets, the molecular mechanisms of action, the efficacy in preclinical leukemia models, and the results of clinical trials are discussed. New developments and future studies of therapeutic mAbs in myeloid neoplasms will advance our understanding of the immunobiology of these diseases and enhance current therapeutic strategies. PMID:29868474

Regenerative endodontics as a tissue engineering approach: past, current and future.

PubMed

Malhotra, Neeraj; Mala, Kundabala

2012-12-01

With the reported startling statistics of high incidence of tooth decay and tooth loss, the current interest is focused on the development of alternate dental tissue replacement therapies. This has led to the application of dental tissue engineering as a clinically relevant method for the regeneration of dental tissues and generation of bioengineered whole tooth. Although, tissue engineering approach requires the three main key elements of stem cells, scaffold and morphogens, a conductive environment (fourth element) is equally important for successful engineering of any tissue and/or organ. The applications of this science has evolved continuously in dentistry, beginning from the application of Ca(OH)(2) in vital pulp therapy to the development of a fully functional bioengineered tooth (mice). Thus, with advances in basic research, recent reports and studies have shown successful application of tissue engineering in the field of dentistry. However, certain practical obstacles are yet to be overcome before dental tissue regeneration can be applied as evidence-based approach in clinics. The article highlights on the past achievements, current developments and future prospects of tissue engineering and regenerative therapy in the field of endodontics and bioengineered teeth (bioteeth). © 2012 The Authors. Australian Endodontic Journal © 2012 Australian Society of Endodontology.

Modeling paradigms for medical diagnostic decision support: a survey and future directions.

PubMed

Wagholikar, Kavishwar B; Sundararajan, Vijayraghavan; Deshpande, Ashok W

2012-10-01

Use of computer based decision tools to aid clinical decision making, has been a primary goal of research in biomedical informatics. Research in the last five decades has led to the development of Medical Decision Support (MDS) applications using a variety of modeling techniques, for a diverse range of medical decision problems. This paper surveys literature on modeling techniques for diagnostic decision support, with a focus on decision accuracy. Trends and shortcomings of research in this area are discussed and future directions are provided. The authors suggest that-(i) Improvement in the accuracy of MDS application may be possible by modeling of vague and temporal data, research on inference algorithms, integration of patient information from diverse sources and improvement in gene profiling algorithms; (ii) MDS research would be facilitated by public release of de-identified medical datasets, and development of opensource data-mining tool kits; (iii) Comparative evaluations of different modeling techniques are required to understand characteristics of the techniques, which can guide developers in choice of technique for a particular medical decision problem; and (iv) Evaluations of MDS applications in clinical setting are necessary to foster physicians' utilization of these decision aids.

Attitudes towards smoking and tobacco control among pre-clinical medical students in Malaysia.

PubMed

Tee, G H; Hairi, N N; Hairi, F

2012-08-01

Physicians should play a leading role in combatting smoking; information on attitudes of future physicians towards tobacco control measures in a middle-income developing country is limited. Of 310 future physicians surveyed in a medical school in Malaysia, 50% disagreed that it was a doctor's duty to advise smokers to stop smoking; 76.8% agreed that physicians should not smoke before advising others not to smoke; and 75% agreed to the ideas of restricting the sale of cigarettes to minors, making all public places smoke-free and banning advertising of tobacco-related merchandise. Future physicians had positive attitudes towards tobacco regulations but had not grasped their responsibilities in tobacco control measures.

Individualized prediction of lung-function decline in chronic obstructive pulmonary disease

PubMed Central

Zafari, Zafar; Sin, Don D.; Postma, Dirkje S.; Löfdahl, Claes-Göran; Vonk, Judith; Bryan, Stirling; Lam, Stephen; Tammemagi, C. Martin; Khakban, Rahman; Man, S.F. Paul; Tashkin, Donald; Wise, Robert A.; Connett, John E.; McManus, Bruce; Ng, Raymond; Hollander, Zsuszanna; Sadatsafavi, Mohsen

2016-01-01

Background: The rate of lung-function decline in chronic obstructive pulmonary disease (COPD) varies substantially among individuals. We sought to develop and validate an individualized prediction model for forced expiratory volume at 1 second (FEV1) in current smokers with mild-to-moderate COPD. Methods: Using data from a large long-term clinical trial (the Lung Health Study), we derived mixed-effects regression models to predict future FEV1 values over 11 years according to clinical traits. We modelled heterogeneity by allowing regression coefficients to vary across individuals. Two independent cohorts with COPD were used for validating the equations. Results: We used data from 5594 patients (mean age 48.4 yr, 63% men, mean baseline FEV1 2.75 L) to create the individualized prediction equations. There was significant between-individual variability in the rate of FEV1 decline, with the interval for the annual rate of decline that contained 95% of individuals being −124 to −15 mL/yr for smokers and −83 to 15 mL/yr for sustained quitters. Clinical variables in the final model explained 88% of variation around follow-up FEV1. The C statistic for predicting severity grades was 0.90. Prediction equations performed robustly in the 2 external data sets. Interpretation: A substantial part of individual variation in FEV1 decline can be explained by easily measured clinical variables. The model developed in this work can be used for prediction of future lung health in patients with mild-to-moderate COPD. Trial registration: Lung Health Study — ClinicalTrials.gov, no. NCT00000568; Pan-Canadian Early Detection of Lung Cancer Study — ClinicalTrials.gov, no. NCT00751660 PMID:27486205

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 professional efficiency and recognition. © 2017 John Wiley & Sons Ltd.

Beyond Bevacizumab: An Outlook to New Anti-Angiogenics for the Treatment of Ovarian Cancer.

PubMed

Mahner, Sven; Woelber, Linn; Mueller, Volkmar; Witzel, Isabell; Prieske, Katharina; Grimm, Donata; Keller-V Amsberg, Gunhild; Trillsch, Fabian

2015-01-01

In addition to the monoclonal vascular endothelial growth factor (VEGF) antibody bevacizumab, several alternative anti-angiogenic treatment strategies for ovarian cancer patients have been evaluated in clinical trials. Apart from targeting extracellular receptors by the antibody aflibercept or the peptibody trebananib, the multikinase inhibitors pazopanib, nintedanib, cediranib, sunitinib, and sorafenib were developed to interfere with VEGF receptors and multiple additional intracellular pathways. Nintedanib and pazopanib significantly improved progression-free survival in two positive phase III trials for first-line therapy. A reliable effect on overall survival could, however, not be observed for any anti-angiogenic first-line therapies so far. In terms of recurrent disease, two positive phase III trials revealed that trebananib and cediranib are effective anti-angiogenic agents for this indication. Patient selection and biomarker guided prediction of response seems to be a central aspect for future studies. Combining anti-angiogenics with other targeted therapies to possibly spare chemotherapy in certain constellations represents another very interesting future perspective for clinical trials. This short review gives an overview of current clinical trials for anti-angiogenic treatment strategies beyond bevacizumab. In this context, possible future perspectives combining anti-angiogenics with other targeted therapies and the need for specific biomarkers predicting response are elucidated.

Building the capacity for evidence-based clinical nursing leadership: the role of executive co-coaching and group clinical supervision for quality patient services.

PubMed

Alleyne, Jo; Jumaa, Mansour Olawale

2007-03-01

The general aims of this article were to facilitate primary care nurses (District Nurse Team Leaders) to link management and leadership theories with clinical practice and to improve the quality of the service provided to their patients. The specific aim was to identify, create and evaluate effective processes for collaborative working so that the nurses' capacity for clinical decision-making could be improved. This article, part of a doctoral study on Clinical Leadership in Nursing, has wider application in the workplace of the future where professional standards based on collaboration will be more critical in a world of work that will be increasingly complex and uncertain. This article heralds the type of research and development activities that the nursing and midwifery professions should give premier attention to, particularly given the recent developments within the National Health Service in the United Kingdom. The implications of: Agenda for Change, the Knowledge and Skills Framework, 'Our Health, Our Care, Our Say' and the recent proposals from the article 'Modernising Nursing Career', to name but a few, are the key influences impacting on and demanding new ways of clinical supervision for nurses and midwives to improve the quality of patient management and services. The overall approach was based on an action research using a collaborative enquiry within a case study. This was facilitated by a process of executive co-coaching for focused group clinical supervision sessions involving six district nurses as co-researchers and two professional doctoral candidates as the main researchers. The enquiry conducted over a period of two and a half years used evidence-based management and leadership interventions to assist the participants to develop 'actionable knowledge'. Group clinical supervision was not practised in this study as a form of 'therapy' but as a focus for the development of actionable knowledge, knowledge needed for effective clinical management and leadership in the workplace. 1. Management and leadership interventions and approaches have significantly influenced the participants' capacity to improve the quality of services provided to their patients. 2. Using various techniques, tools, methods and frameworks presented at the sessions increased participants' confidence to perform. 3. A structured approach like the Clinical Nursing Leadership Learning and Action Process (CLINLAP) model makes implementing change more practical and manageable within a turbulent care environment. The process of Stakeholder Mapping and Management made getting agreement to do things differently much easier. Generally it is clear that many nurses and midwives, according to the participants, have to carry out management and leadership activities in their day-to-day practice. The traditional boundary between the private, the public and the voluntary sector management is increasingly becoming blurred. It is conclusive that the district nurses on this innovative programme demonstrated how they were making sense of patterns from the past, planning for the future and facilitating the clinical nursing leadership processes today to improve quality patient services tomorrow. Their improved capacity to manage change and lead people was demonstrated, for example, through their questioning attitudes about the dominance of general practitioners. They did this, for example, by initiating and leading case conferences with the multi-disciplinary teams. It became evident from this study that to use group clinical supervision with an executive co-coaching approach for the implementation and to sustain quality service demand that 'good nursing' is accepted as being synonymous with 'good management'. This is the future of 'new nursing'.

The Development of Self-Regulated Learning during the Pre-Clinical Stage of Medical School: A Comparison between a Lecture-Based and a Problem-Based Curriculum

ERIC Educational Resources Information Center

Lucieer, Susanna M.; van der Geest, Jos N.; Elói-Santos, Silvana M.; de Faria, Rosa M. Dellbone; Jonker, Laura; Visscher, Chris; Rikers, Remy M. J. P.; Themmen, Axel P. N.

2016-01-01

Society expects physicians to always improve their competencies and to be up to date with developments in their field. Therefore, an important aim of medical schools is to educate future medical doctors to become self-regulated, lifelong learners. However, it is unclear if medical students become better self-regulated learners during the…

Current and future trends in the prevention, treatment and control of rabies.

PubMed

Rupprecht, Charles E; Willoughby, Rodney; Slate, Dennis

2006-12-01

Rabies remains a global zoonosis of major public health, agricultural and economic significance. Dogs are the major animal reservoirs in developing regions, wildlife maintain cycles of infection even in developed countries and new viral etiological agents continue to emerge. Nearly all human rabies cases are related directly to animal bite and thus, primary disease prevention requires minimization of suspected exposures. Once exposure occurs, modern prophylaxis entails immediate wound care, local infiltration of rabies immune globulin and parenteral administration of modern cell culture vaccines in multiple doses. Pre-exposure vaccination should occur in selected population groups at risk of occupational exposure. Historically, survival from fatal rabies by at least five human patients, vaccinated prior to the onset of clinical signs, signaled initial optimism as to the theoretical utility of medical intervention. Recently, the heroic recovery of an unvaccinated teenager from clinical rabies offers hope of future specific therapy. Canine rabies elimination is the key towards ultimate reduction of the disease burden, as first illustrated in developed countries. Implementation of oral vaccination in free-ranging carnivore hosts demonstrates the feasibility of disease abatement in particular wildlife populations, such as demonstrated in Europe and North America, with an enhanced need for application to developing countries in the Americas, Africa and Eurasia.

Development of a clinical definition for acute respiratory distress syndrome using the Delphi technique.

PubMed

Ferguson, Niall D; Davis, Aileen M; Slutsky, Arthur S; Stewart, Thomas E

2005-06-01

The objective of this study is to describe the implementation of formal consensus techniques in the development of a clinical definition for acute respiratory distress syndrome. A Delphi consensus process was conducted using e-mail. Sixteen panelists who were both researchers and opinion leaders were systematically recruited. The Delphi technique was performed over 4 rounds on the background of an explicit definition framework. Item generation was performed in round 1, item reduction in rounds 2 and 3, and definition evaluation in round 4. Explicit consensus thresholds were used throughout. Of the 16 panelists, 11 actually participated in developing a definition that met a priori consensus rules on the third iteration. New incorporations in the Delphi definition include the use of a standardized oxygenation assessment and the documentation of either a predisposing factor or decreased thoracic compliance. The panelists rated the Delphi definition as acceptable to highly acceptable (median score, 6; range, 5-7 on a 7-point Likert scale). We conclude that it is feasible to consider using formal consensus in the development of future definitions of acute respiratory distress syndrome. Testing of sensibility, reliability, and validity are needed for this preliminary definition; these test results should be incorporated into future iterations of this definition.

Optical coherence tomography in gastroenterology: a review and future outlook

NASA Astrophysics Data System (ADS)

Tsai, Tsung-Han; Leggett, Cadman L.; Trindade, Arvind J.; Sethi, Amrita; Swager, Anne-Fré; Joshi, Virendra; Bergman, Jacques J.; Mashimo, Hiroshi; Nishioka, Norman S.; Namati, Eman

2017-12-01

Optical coherence tomography (OCT) is an imaging technique optically analogous to ultrasound that can generate depth-resolved images with micrometer-scale resolution. Advances in fiber optics and miniaturized actuation technologies allow OCT imaging of the human body and further expand OCT utilization in applications including but not limited to cardiology and gastroenterology. This review article provides an overview of current OCT development and its clinical utility in the gastrointestinal tract, including disease detection/differentiation and endoscopic therapy guidance, as well as a discussion of its future applications.

14th International Congress on Antiphospholipid Antibodies Task Force Report on Catastrophic Antiphospholipid Syndrome.

PubMed

Cervera, Ricard; Rodríguez-Pintó, Ignasi; Colafrancesco, Serena; Conti, Fabrizio; Valesini, Guido; Rosário, Cristina; Agmon-Levin, Nancy; Shoenfeld, Yehuda; Ferrão, Claudia; Faria, Raquel; Vasconcelos, Carlos; Signorelli, Flavio; Espinosa, Gerard

2014-07-01

The 'Task Force on Catastrophic Antiphospholipid Syndrome (CAPS)' was developed on the occasion of the 14th International Congress on Antiphospholipid Antibodies. The objectives of this Task Force were to assess the current knowledge on pathogenesis, clinical and laboratory features, diagnosis and classification, precipitating factors and treatment of this condition in order to address recommendations for future research. This article summarizes the studies analyzed by the Task Force, its recommendations and the future research agenda. Copyright © 2014 Elsevier B.V. All rights reserved.

Ultrasound Elastography and MR Elastography for Assessing Liver Fibrosis: Part 2, Diagnostic Performance, Confounders, and Future Directions

PubMed Central

Tang, An; Cloutier, Guy; Szeverenyi, Nikolaus M.; Sirlin, Claude B.

2016-01-01

OBJECTIVE The purpose of the article is to review the diagnostic performance of ultrasound and MR elastography techniques for detection and staging of liver fibrosis, the main current clinical applications of elastography in the abdomen. CONCLUSION Technical and instrument-related factors and biologic and patient-related factors may constitute potential confounders of stiffness measurements for assessment of liver fibrosis. Future developments may expand the scope of elastography for monitoring liver fibrosis and predict complications of chronic liver disease. PMID:25905762

Clinical ethics protocols in the clinical ethics committees of Madrid.

PubMed

Herreros, Benjamin; Ramnath, Venktesh R; Bishop, Laura; Pintor, Emilio; Martín, María Dolores; Sánchez-González, Miguel A

2014-03-01

Currently, The nature and scope of Clinical Ethics Protocols (CEPs) in Madrid (Spain) are not well understood. The main objective is to describe the features of 'guideline/recommendation' type CEPs that have been or are being developed by existing Clinical Ethics Committees (CECs) in Madrid. Secondary objectives include characterisation of those CECs that have been the most prolific in reference to CEP creation and implementation and identification of any trends in future CEP development. We collected CEPs produced and in process by CECs accredited in the public hospitals in Madrid, Spain, from 1996 to 2008. CECs developed 30 CEPs, with 10 more in process. The most common topic is refusal of treatment (seven CEPs developed; two in process). If CEPs addressing terminal illness, Do-Not-Resuscitate orders and advance directives are placed into a separate 'ethical problems at the end of life' category, this CEP subject emerges as the most common (eight developed; four in process). There is a relationship between the age of the CEC and the development of CEPs (the oldest CECs have developed more CEPs). CECs now seem to be more likely to engage in CEP development. The CECs in Madrid, Spain, have developed a significant number of CEPs (30 in total and 10 in process) and there is a trend towards continued development. The most frequent topics are ethical problems at the end of life and refusal of treatment by the patient.

Reference intervals: current status, recent developments and future considerations.

PubMed

Ozarda, Yesim

2016-01-01

Reliable and accurate reference intervals (RIs) for laboratory analyses are an integral part of the process of correct interpretation of clinical laboratory test results. RIs given in laboratory reports have an important role in aiding the clinician in interpreting test results in reference to values for healthy populations. Since the 1980s, the International Federation of Clinical Chemistry (IFCC) has been proactive in establishing recommendations to clarify the true significance of the term 'RIs, to select the appropriate reference population and statistically analyse the data. The C28-A3 guideline published by the Clinical and Laboratory Standards Institute (CLSI) and IFCC is still the most widely-used source of reference in this area. In recent years, protocols additional to the Guideline have been published by the IFCC, Committee on Reference Intervals and Decision Limits (C-RIDL), including all details of multicenter studies on RIs to meet the requirements in this area. Multicentric RIs studies are the most important development in the area of RIs. Recently, the C-RIDL has performed many multicentric studies to obtain common RIs. Confusion of RIs and clinical decision limits (CDLs) remains an issue and pediatric and geriatric age groups are a significant problem. For future studies of RIs, the genetic effect would seem to be the most challenging area. 
The aim of the review is to present the current theory and practice of RIs, with special emphasis given to multicenter RIs studies, RIs studies for pediatric and geriatric age groups, clinical decision limits and partitioning by genetic effects on RIs.

Reference intervals: current status, recent developments and future considerations

PubMed Central

Ozarda, Yesim

2016-01-01

Reliable and accurate reference intervals (RIs) for laboratory analyses are an integral part of the process of correct interpretation of clinical laboratory test results. RIs given in laboratory reports have an important role in aiding the clinician in interpreting test results in reference to values for healthy populations. Since the 1980s, the International Federation of Clinical Chemistry (IFCC) has been proactive in establishing recommendations to clarify the true significance of the term ‘RIs, to select the appropriate reference population and statistically analyse the data. The C28-A3 guideline published by the Clinical and Laboratory Standards Institute (CLSI) and IFCC is still the most widely-used source of reference in this area. In recent years, protocols additional to the Guideline have been published by the IFCC, Committee on Reference Intervals and Decision Limits (C-RIDL), including all details of multicenter studies on RIs to meet the requirements in this area. Multicentric RIs studies are the most important development in the area of RIs. Recently, the C-RIDL has performed many multicentric studies to obtain common RIs. Confusion of RIs and clinical decision limits (CDLs) remains an issue and pediatric and geriatric age groups are a significant problem. For future studies of RIs, the genetic effect would seem to be the most challenging area.
The aim of the review is to present the current theory and practice of RIs, with special emphasis given to multicenter RIs studies, RIs studies for pediatric and geriatric age groups, clinical decision limits and partitioning by genetic effects on RIs. PMID:26981015

The Ohio Gestational Diabetes Postpartum Care Learning Collaborative: Development of a Quality Improvement Initiative to Improve Systems of Care for Women.

PubMed

Shellhaas, Cynthia; Conrey, Elizabeth; Crane, Dushka; Lorenz, Allison; Wapner, Andrew; Oza-Frank, Reena; Bouchard, Jo

2016-11-01

Objectives To improve clinical practice and increase postpartum visit Type 2 diabetes mellitus (T2DM) screening rates in women with a history of gestational diabetes mellitus (GDM). Methods We recruited clinical sites with at least half of pregnant patients enrolled in Medicaid to participate in an 18-month quality improvement (QI) project. To support clinical practice changes, we developed provider and patient toolkits with educational and clinical practice resources. Clinical subject-matter experts facilitated a learning network to train sites and promote discussion and learning among sites. Sites submitted data from patient chart reviews monthly for key measures that we used to provide rapid-cycle feedback. Providers were surveyed at completion regarding toolkit usefulness and satisfaction. Results Of fifteen practices recruited, twelve remained actively engaged. We disseminated more than 70 provider and 2345 patient toolkits. Documented delivery of patient education improved for timely GDM prenatal screening, reduction of future T2DM risk, smoking cessation, and family planning. Sites reported toolkits were useful and easy to use. Of women for whom postpartum data were available, 67 % had a documented postpartum visit and 33 % had a postpartum T2DM screen. Lack of information sharing between prenatal and postpartum care providers was are barriers to provision and documentation of care. Conclusions for Practice QI and toolkit resources may improve the quality of prenatal education. However, postpartum care did not reach optimal levels. Future work should focus on strategies to support coordination of care between obstetrical and primary care providers.

Bone Tissue Engineering Under Xenogeneic-Free Conditions in a Large Animal Model as a Basis for Early Clinical Applicability.

PubMed

Weigand, Annika; Beier, Justus P; Schmid, Rafael; Knorr, Tobias; Kilian, David; Götzl, Rebekka; Gerber, Thomas; Horch, Raymund E; Boos, Anja M

2017-03-01

For decades, researchers have been developing a range of promising strategies in bone tissue engineering with the aim of producing a significant clinical benefit over existing therapies. However, a major problem concerns the traditional use of xenogeneic substances for the expansion of cells, which complicates direct clinical transfer. The study's aim was to establish a totally autologous sheep model as a basis for further preclinical studies and future clinical application. Ovine mesenchymal stromal cells (MSC) were cultivated in different concentrations (0%, 2%, 5%, 10%, and 25%) of either autologous serum (AS) or fetal calf serum (FCS). With an increase of serum concentration, enhanced metabolic activity and proliferation could be observed. There were minor differences between MSC cultivated in AS or FCS, comparing gene and protein expression of osteogenic and stem cell markers, morphology, and osteogenic differentiation. MSC implanted subcutaneously in the sheep model, together with a nanostructured bone substitute, either in stable block or moldable putty form, induced similar vascularization and remodeling of the bone substitute irrespective of cultivation of MSC in AS or FCS and osteogenic differentiation. The bone substitute in block form together with MSC proved particularly advantageous in the induction of ectopic bone formation compared to the cell-free control and putty form. It could be demonstrated that AS is suitable for replacement of FCS for cultivation of ovine MSC for bone tissue engineering purposes. Substantial progress has been made in the development of a strictly xenogeneic-free preclinical animal model to bring future clinical application of bone tissue engineering strategies within reach.

The role of incretin-based therapies in prediabetes: a review.

PubMed

Ahmadieh, Hala; Azar, Sami T

2014-12-01

Prediabetes, a high-risk state for future development of diabetes, is prevalent globally. Abnormalities in the incretin axis are important in the progression of B-cell failure in type 2 diabetes. Incretin based therapy was found to improve B cell mass and glycaemic control in addition to having multiple beneficial effects on the systolic and diastolic blood pressure, weight loss in addition to their other beneficial effects on the liver and cardiovascular system. In prediabetes, several well-designed preventive trials have shown that lifestyle and pharmacologic interventions such as metformin, thiazolidinediones (TZD), acarbose and, nateglinide and orlistat, are effective in reducing diabetes development. In recent small studies, incretin based therapy (DPP IV inhibitors and GLP-1 agonists) have also been extended to patients with prediabetes since it was shown to better preserve B-cell function and mass in animal studies and in clinical trials and it was also shown to help maintain good long term metabolic control. Because of the limited studies and clinical experience, their side effects and costs currently guidelines do not recommend incretin-based therapies as an option for treatment in patients with prediabetes. With future clinical trials and studies they may be recommended for patients with impaired fasting glucose or impaired glucose tolerance. Copyright © 2014 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

The trauma film paradigm as an experimental psychopathology model of psychological trauma: intrusive memories and beyond.

PubMed

James, Ella L; Lau-Zhu, Alex; Clark, Ian A; Visser, Renée M; Hagenaars, Muriel A; Holmes, Emily A

2016-07-01

A better understanding of psychological trauma is fundamental to clinical psychology. Following traumatic event(s), a clinically significant number of people develop symptoms, including those of Acute Stress Disorder and/or Post Traumatic Stress Disorder. The trauma film paradigm offers an experimental psychopathology model to study both exposure and reactions to psychological trauma, including the hallmark symptom of intrusive memories. We reviewed 74 articles that have used this paradigm since the earliest review (Holmes & Bourne, 2008) until July 2014. Highlighting the different stages of trauma processing, i.e. pre-, peri- and post-trauma, the studies are divided according to manipulations before, during and after film viewing, for experimental as well as correlational designs. While the majority of studies focussed on the frequency of intrusive memories, other reactions to trauma were also modelled. We discuss the strengths and weaknesses of the trauma film paradigm as an experimental psychopathology model of trauma, consider ethical issues, and suggest future directions. By understanding the basic mechanisms underlying trauma symptom development, we can begin to translate findings from the laboratory to the clinic, test innovative science-driven interventions, and in the future reduce the debilitating effects of psychopathology following stressful and/or traumatic events. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Leveraging a Sturge-Weber Gene Discovery: An Agenda for Future Research.

PubMed

Comi, Anne M; Sahin, Mustafa; Hammill, Adrienne; Kaplan, Emma H; Juhász, Csaba; North, Paula; Ball, Karen L; Levin, Alex V; Cohen, Bernard; Morris, Jill; Lo, Warren; Roach, E Steve

2016-05-01

Sturge-Weber syndrome (SWS) is a vascular neurocutaneous disorder that results from a somatic mosaic mutation in GNAQ, which is also responsible for isolated port-wine birthmarks. Infants with SWS are born with a cutaneous capillary malformation (port-wine birthmark) of the forehead or upper eyelid which can signal an increased risk of brain and/or eye involvement prior to the onset of specific symptoms. This symptom-free interval represents a time when a targeted intervention could help to minimize the neurological and ophthalmologic manifestations of the disorder. This paper summarizes a 2015 SWS workshop in Bethesda, Maryland that was sponsored by the National Institutes of Health. Meeting attendees included a diverse group of clinical and translational researchers with a goal of establishing research priorities for the next few years. The initial portion of the meeting included a thorough review of the recent genetic discovery and what is known of the pathogenesis of SWS. Breakout sessions related to neurology, dermatology, and ophthalmology aimed to establish SWS research priorities in each field. Key priorities for future development include the need for clinical consensus guidelines, further work to develop a clinical trial network, improvement of tissue banking for research purposes, and the need for multiple animal and cell culture models of SWS. Copyright © 2016. Published by Elsevier Inc.

Current developments in the treatment of early-stage classical Hodgkin lymphoma.

PubMed

Borchmann, Sven; von Tresckow, Bastian; Engert, Andreas

2016-09-01

After presenting the current treatment recommendations for early-stage Hodgkin lymphoma, we give an overview on recently published clinical trials in this setting. Furthermore, the potential influence of current trials on the treatment of early-stage Hodgkin lymphoma and integration of newly emerging drugs into treatment protocols will be discussed. Trials attempting treatment de-escalation and omission of radiotherapy on the basis of early interim PET-scans have been disappointing so far, but results of some large trials employing this strategy are still awaited. In contrast, a more defensive strategy of starting treatment with less aggressive doxorubicine, bleomycin, vinblastine, dacarbazine (ABVD) chemotherapy and intensifying treatment in early interim PET-positive patients has shown encouraging results. New drugs such as brentuximab vedotin and immune checkpoint inhibitors have shown promising results in relapsed and refractory Hodgkin lymphoma. Clinical trials of brentuximab vedotin in early-stage Hodgkin lymphoma have been initiated. Additionally, biomarker-based treatment de-escalation might be a possible route for future improvements. The challenge for future clinical research in early-stage Hodgkin lymphoma is to continue to cure the majority of patients with first-line treatment while reducing long-term toxicity. New strategies to achieve that goal are currently being developed and will further refine treatment of early-stage Hodgkin lymphoma.

Patient reported outcomes and patient empowerment in clinical genetics services.

PubMed

McAllister, M; Dearing, A

2015-08-01

Evaluation of clinical genetics services (CGS), including genetic counseling and genetic testing, has been problematic. Patient mortality and morbidity are unlikely to be directly improved by interventions offered in CGS. Patient-reported outcomes (PROs) are not routinely measured in CGS evaluation, but this may change as patient-reported outcome measures (PROMs) become a key part of how healthcare services are managed and funded across the world. However, there is no clear consensus about which PROMs are most useful for CGS evaluation. This review summarizes the published research on how PROs from CGS have been measured and how patients may benefit from using those services, with a focus on patient empowerment. Many patient benefits (PROs) identified repeatedly in the research literature can be re-interpreted within a patient empowerment framework. Other important PROs identified include family functioning, social functioning, altruism, sense of purpose, enabling development of future research and treatment/participating in research. Well-validated measures are available to capture (dimensions of) patient empowerment. Although generic measures of family functioning are available, suitable measures capturing social functioning, development of future treatments, and altruism were not identified in this review. Patient empowerment provides one useful approach to measuring PROs from CGS. © 2014 The Authors. Clinical Genetics published by John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Driving clinical study efficiency by using a productivity breakdown model: comparative evaluation of a global clinical study and a similar Japanese study.

PubMed

Takahashi, K; Sengoku, S; Kimura, H

2011-02-01

A fundamental management imperative of pharmaceutical companies is to contain surging costs of developing and launching drugs globally. Clinical studies are a research and development (R&D) cost driver. The objective of this study was to develop a productivity breakdown model, or a key performance indicator (KPI) tree, for an entire clinical study and to use it to compare a global clinical study with a similar Japanese study. We, thereby, hope to identify means of improving study productivity. We developed the new clinical study productivity breakdown model, covering operational aspects and cost factors. Elements for improving clinical study productivity were assessed from a management viewpoint by comparing empirical tracking data from a global clinical study with a Japanese study with similar protocols. The following unique and material differences, beyond simple international difference in cost of living, that could affect the efficiency of future clinical trials were identified: (i) more frequent site visits in the Japanese study, (ii) head counts at the Japanese study sites more than double those of the global study and (iii) a shorter enrollment time window of about a third that of the global study at the Japanese study sites. We identified major differences in the performance of the two studies. These findings demonstrate the potential of the KPI tree for improving clinical study productivity. Trade-offs, such as those between reduction in head count at study sites and expansion of the enrollment time window, must be considered carefully. © 2010 Blackwell Publishing Ltd.

Predictability of the future development of aggressive behavior of cranial dural arteriovenous fistulas based on decision tree analysis.

PubMed

Satomi, Junichiro; Ghaibeh, A Ammar; Moriguchi, Hiroki; Nagahiro, Shinji

2015-07-01

The severity of clinical signs and symptoms of cranial dural arteriovenous fistulas (DAVFs) are well correlated with their pattern of venous drainage. Although the presence of cortical venous drainage can be considered a potential predictor of aggressive DAVF behaviors, such as intracranial hemorrhage or progressive neurological deficits due to venous congestion, accurate statistical analyses are currently not available. Using a decision tree data mining method, the authors aimed at clarifying the predictability of the future development of aggressive behaviors of DAVF and at identifying the main causative factors. Of 266 DAVF patients, 89 were eligible for analysis. Under observational management, 51 patients presented with intracranial hemorrhage/infarction during the follow-up period. The authors created a decision tree able to assess the risk for the development of aggressive DAVF behavior. Evaluated by 10-fold cross-validation, the decision tree's accuracy, sensitivity, and specificity were 85.28%, 88.33%, and 80.83%, respectively. The tree shows that the main factor in symptomatic patients was the presence of cortical venous drainage. In its absence, the lesion location determined the risk of a DAVF developing aggressive behavior. Decision tree analysis accurately predicts the future development of aggressive DAVF behavior.

Building electronic data infrastructure for comparative effectiveness research: accomplishments, lessons learned and future steps.

PubMed

Randhawa, Gurvaneet S

2014-11-01

There are large gaps in our knowledge on the potential impact of diagnostics and therapeutics on outcomes of patients treated in the real world. Comparative effectiveness research aims to fill these gaps to maximize effectiveness of these interventions. Health information technology has the potential to dramatically improve the practice of medicine and of research. This is an overview of about US$100 million of American Recovery and Reinvestment Act investment in 12 projects managed by the Agency for Healthcare Research and Quality to build an electronic clinical data infrastructure that connects research with healthcare delivery. The achievements and lessons learned from these projects provided a foundation for the National Patient-Centered Clinical Research Network (PCORnet)and will help to guide future infrastructure development needed to build an efficient, scalable and sustainable learning health system.

Restorative retinal laser therapy: Present state and future directions.

PubMed

Chhablani, Jay; Roh, Young Jung; Jobling, Andrew I; Fletcher, Erica L; Lek, Jia Jia; Bansal, Pooja; Guymer, Robyn; Luttrull, Jeffrey K

Because of complications and side effects, conventional laser therapy has taken a back seat to drugs in the treatment of macular diseases. Despite this, research on new laser modalities remains active. In particular, various approaches are being pursued to preserve and improve retinal structure and function. These include micropulsing, various exposure titration algorithms, and real-time temperature feedback control of short-pulse continuous wave lasers, and ultra-short-pulse nanosecond lasers. Some of these approaches are at the preclinical stage of development, whereas others are available for clinical use. Cell biology is providing important insights into the mechanisms of action of retinal laser treatment. We outline the technological bases of current laser platforms, their basic science, therapeutic concepts, clinical experience, and future directions for retinal laser treatment. Copyright © 2017 Elsevier Inc. All rights reserved.

Nailfold capillaroscopy for prediction of novel future severe organ involvement in systemic sclerosis.

PubMed

Smith, Vanessa; Riccieri, Valeria; Pizzorni, Carmen; Decuman, Saskia; Deschepper, Ellen; Bonroy, Carolien; Sulli, Alberto; Piette, Yves; De Keyser, Filip; Cutolo, Maurizio

2013-12-01

Assessment of associations of nailfold videocapillaroscopy (NVC) scleroderma (systemic sclerosis; SSc) ("early," "active," and "late") with novel future severe clinical involvement in 2 independent cohorts. Sixty-six consecutive Belgian and 82 Italian patients with SSc underwent NVC at baseline. Images were blindly assessed and classified into normal, early, active, or late NVC pattern. Clinical evaluation was performed for 9 organ systems (general, peripheral vascular, skin, joint, muscle, gastrointestinal tract, lung, heart, and kidney) according to the Medsger disease severity scale (DSS) at baseline and in the future (18-24 months of followup). Severe clinical involvement was defined as category 2 to 4 per organ of the DSS. Logistic regression analysis (continuous NVC predictor variable) was performed. The OR to develop novel future severe organ involvement was stronger according to more severe NVC patterns and similar in both cohorts. In simple logistic regression analysis the OR in the Belgian/Italian cohort was 2.16 (95% CI 1.19-4.47, p = 0.010)/2.33 (95% CI 1.36-4.22, p = 0.002) for the early NVC SSc pattern, 4.68/5.42 for the active pattern, and 10.14/12.63 for the late pattern versus the normal pattern. In multiple logistic regression analysis, adjusting for disease duration, subset, and vasoactive medication, the OR was 2.99 (95% CI 1.31-8.82, p = 0.007)/1.88 (95% CI 1.00-3.71, p = 0.050) for the early NVC SSc pattern, 8.93/3.54 for the active pattern, and 26.69/6.66 for the late pattern versus the normal pattern. Capillaroscopy may be predictive of novel future severe organ involvement in SSc, as attested by 2 independent cohorts.

Depression and prospection.

PubMed

Roepke, Ann Marie; Seligman, Martin E P

2016-03-01

Prospection, the mental representation of possible futures, is usually adaptive. When it goes awry, however, it disrupts emotion and motivation. A negative view of the future is typically seen as one symptom of depression, but we suggest that such negative prospection is the core causal element of depression. Here, we describe the empirical evidence supporting this framework, and we explore the implications for clinical interventions. We integrate several literatures: Using the database PsycInfo, we retrieved empirical studies with the keywords prospection, prediction, expectation, pessimism, mental simulation, future-thinking, future-directed thinking, foresight, and/or mental time travel, in conjunction with depression, depressed, or depressive. Three kinds of faulty prospection, taken together, could drive depression: Poor generation of possible futures, poor evaluation of possible futures, and negative beliefs about the future. Depressed mood and poor functioning, in turn, may maintain faulty prospection and feed a vicious cycle. Future-oriented treatment strategies drawn from cognitive-behavioural therapy help to fix poor prospection, and they deserve to be developed further. Prospection-based techniques may lead to transdiagnostic treatment strategies for depression and other disorders. © 2015 The British Psychological Society.

Increasing workload and changing referral patterns in paediatric cardiology outreach clinics: implications for consultant staffing

PubMed Central

Wagstaff, M; Rigby, M; Redington, A

1998-01-01

Objective—To assess the workload of, and referral patterns to, paediatric cardiology outreach clinics to provide data for future planning.
Design—Descriptive study of outpatient attendance during 1991 and 1996.
Setting—Five district general hospitals with unchanged local demographics and referral patterns during the study period.
Methods—Postal, telephone, and on site survey of clinic records and case notes.
Results—The number of outpatients increased by 61%, with a consequent increase in the number of clinics held and patients seen in each clinic. The number of patients aged between 10 and 15 years doubled.
Conclusion—These data confirm the impression that demands for paediatric cardiology services are increasing. The increased need for attendance at outreach clinics has inevitable consequences for the clinical, teaching, and research activities of specialists in tertiary centres. An increase in the number of paediatric cardiologists, or development of local expertise (general paediatricians with an interest in cardiology), will be required. Furthermore, the increasingly large cohort of older teenagers and young adults with congenital heart disease underscores the need for the development of specialist facilities.

 Keywords: paediatric clinics;  workload;  congenital heart disease PMID:9602652

The MAPP research network: design, patient characterization and operations.

PubMed

Landis, J Richard; Williams, David A; Lucia, M Scott; Clauw, Daniel J; Naliboff, Bruce D; Robinson, Nancy A; van Bokhoven, Adrie; Sutcliffe, Siobhan; Schaeffer, Anthony J; Rodriguez, Larissa V; Mayer, Emeran A; Lai, H Henry; Krieger, John N; Kreder, Karl J; Afari, Niloofar; Andriole, Gerald L; Bradley, Catherine S; Griffith, James W; Klumpp, David J; Hong, Barry A; Lutgendorf, Susan K; Buchwald, Dedra; Yang, Claire C; Mackey, Sean; Pontari, Michel A; Hanno, Philip; Kusek, John W; Mullins, Chris; Clemens, J Quentin

2014-08-01

The "Multidisciplinary Approach to the Study of Chronic Pelvic Pain" (MAPP) Research Network was established by the NIDDK to better understand the pathophysiology of urologic chronic pelvic pain syndromes (UCPPS), to inform future clinical trials and improve clinical care. The evolution, organization, and scientific scope of the MAPP Research Network, and the unique approach of the network's central study and common data elements are described. The primary scientific protocol for the Trans-MAPP Epidemiology/Phenotyping (EP) Study comprises a multi-site, longitudinal observational study, including bi-weekly internet-based symptom assessments, following a comprehensive in-clinic deep-phenotyping array of urological symptoms, non-urological symptoms and psychosocial factors to evaluate men and women with UCPPS. Healthy controls, matched on sex and age, as well as "positive" controls meeting the non-urologic associated syndromes (NUAS) criteria for one or more of the target conditions of Fibromyalgia (FM), Chronic Fatigue Syndrome (CFS) or Irritable Bowel Syndrome (IBS), were also evaluated. Additional, complementary studies addressing diverse hypotheses are integrated into the Trans-MAPP EP Study to provide a systemic characterization of study participants, including biomarker discovery studies of infectious agents, quantitative sensory testing, and structural and resting state neuroimaging and functional neurobiology studies. A highly novel effort to develop and assess clinically relevant animal models of UCPPS was also undertaken to allow improved translation between clinical and mechanistic studies. Recruitment into the central study occurred at six Discovery Sites in the United States, resulting in a total of 1,039 enrolled participants, exceeding the original targets. The biospecimen collection rate at baseline visits reached nearly 100%, and 279 participants underwent common neuroimaging through a standardized protocol. An extended follow-up study for 161 of the UCPPS participants is ongoing. The MAPP Research Network represents a novel, comprehensive approach to the study of UCPPS, as well as other concomitant NUAS. Findings are expected to provide significant advances in understanding UCPPS pathophysiology that will ultimately inform future clinical trials and lead to improvements in patient care. Furthermore, the structure and methodologies developed by the MAPP Network provide the foundation upon which future studies of other urologic or non-urologic disorders can be based. ClinicalTrials.gov identifier: NCT01098279 "Chronic Pelvic Pain Study of Individuals with Diagnoses or Symptoms of Interstitial Cystitis and/or Chronic Prostatitis (MAPP-EP)". http://clinicaltrials.gov/show/NCT01098279.

Optimising translational oncology in clinical practice: strategies to accelerate progress in drug development.

PubMed

Stahel, R; Bogaerts, J; Ciardiello, F; de Ruysscher, D; Dubsky, P; Ducreux, M; Finn, S; Laurent-Puig, P; Peters, S; Piccart, M; Smit, E; Sotiriou, C; Tejpar, S; Van Cutsem, E; Tabernero, J

2015-02-01

Despite intense efforts, the socioeconomic burden of cancer remains unacceptably high and treatment advances for many common cancers have been limited, suggesting a need for a new approach to drug development. One issue central to this lack of progress is the heterogeneity and genetic complexity of many tumours. This results in considerable variability in therapeutic response and requires knowledge of the molecular profile of the tumour to guide appropriate treatment selection for individual patients. While recent advances in the molecular characterisation of different cancer types have the potential to transform cancer treatment through precision medicine, such an approach presents a major economic challenge for drug development, since novel targeted agents may only be suitable for a small cohort of patients. Identifying the patients who would benefit from individual therapies and recruiting sufficient numbers of patients with particular cancer subtypes into clinical trials is challenging, and will require collaborative efforts from research groups and industry in order to accelerate progress. A number of molecular screening platforms have already been initiated across Europe, and it is hoped that these networks, along with future collaborations, will benefit not only patients but also society through cost reductions as a result of more efficient use of resources. This review discusses how current developments in translational oncology may be applied in clinical practice in the future, assesses current programmes for the molecular characterisation of cancer and describes possible collaborative approaches designed to maximise the benefits of translational science for patients with cancer. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

Current concepts in targeting chronic obstructive pulmonary disease pharmacotherapy: making progress towards personalised management.

PubMed

Woodruff, Prescott G; Agusti, Alvar; Roche, Nicolas; Singh, Dave; Martinez, Fernando J

2015-05-02

Chronic obstructive pulmonary disease (COPD) is a common, complex, and heterogeneous disorder that is responsible for substantial and growing morbidity, mortality, and health-care expense worldwide. Of imperative importance to decipher the complexity of COPD is to identify groups of patients with similar clinical characteristics, prognosis, or therapeutic needs, the so-called clinical phenotypes. This strategy is logical for research but might be of little clinical value because clinical phenotypes can overlap in the same patient and the same clinical phenotype could result from different biological mechanisms. With the goal to match assessment with treatment choices, the latest iteration of guidelines from the Global Initiative for Chronic Obstructive Lung Disease reorganised treatment objectives into two categories: to improve symptoms (ie, dyspnoea and health status) and to decrease future risk (as predicted by forced expiratory volume in 1 s level and exacerbations history). This change thus moves treatment closer to individualised medicine with available bronchodilators and anti-inflammatory drugs. Yet, future treatment options are likely to include targeting endotypes that represent subtypes of patients defined by a distinct pathophysiological mechanism. Specific biomarkers of these endotypes would be particularly useful in clinical practice, especially in patients in which clinical phenotype alone is insufficient to identify the underlying endotype. A few series of potential COPD endotypes and biomarkers have been suggested. Empirical knowledge will be gained from proof-of-concept trials in COPD with emerging drugs that target specific inflammatory pathways. In every instance, specific endotype and biomarker efforts will probably be needed for the success of these trials, because the pathways are likely to be operative in only a subset of patients. Network analysis of human diseases offers the possibility to improve understanding of disease pathobiological complexity and to help with the development of new treatment alternatives and, importantly, a reclassification of complex diseases. All these developments should pave the way towards personalised treatment of patients with COPD in the clinic. Copyright © 2015 Elsevier Ltd. All rights reserved.

Gap analysis: a method to assess core competency development in the curriculum.

PubMed

Fater, Kerry H

2013-01-01

To determine the extent to which safety and quality improvement core competency development occurs in an undergraduate nursing program. Rapid change and increased complexity of health care environments demands that health care professionals are adequately prepared to provide high quality, safe care. A gap analysis compared the present state of competency development to a desirable (ideal) state. The core competencies, Nurse of the Future Nursing Core Competencies, reflect the ideal state and represent minimal expectations for entry into practice from pre-licensure programs. Findings from the gap analysis suggest significant strengths in numerous competency domains, deficiencies in two competency domains, and areas of redundancy in the curriculum. Gap analysis provides valuable data to direct curriculum revision. Opportunities for competency development were identified, and strategies were created jointly with the practice partner, thereby enhancing relevant knowledge, attitudes, and skills nurses need for clinical practice currently and in the future.

Is Episodic Future Thinking Important for Instrumental Activities of Daily Living? A Study in Neurological Patients and Healthy Older Adults.

PubMed

Brunette, Amanda M; Calamia, Matthew; Black, Jenah; Tranel, Daniel

2018-06-11

Episodic future thinking is the ability to mentally project oneself into the future. This construct has been explored extensively in cognitive neuroscience and may be relevant for adaptive functioning. However, it has not been determined whether the measurement of episodic future thinking might be valuable in a clinical neuropsychological setting. The current study investigated (1) the relationship between episodic future thinking and instrumental activities of daily living (IADLs); and (2) whether episodic future thinking is related to IADLs over and above standard measures of cognition. Sixty-one older adults with heterogeneous neurological conditions and 41 healthy older adults completed a future thinking task (the adapted Autobiographical Interview), a performance-based measure of instrumental activities of daily living (the Independent Living Scales), and standard clinical measures of memory and executive functioning. Episodic future thinking significantly predicted IADLs after accounting for age, education, gender, and depression (increase in R2 = .050, p = .010). Episodic future thinking significantly predicted IADLs over and above executive functioning (increase in R2 = .025, p = .030), but was not predictive of IADLs over and above memory (p = .157). This study suggests that episodic future thinking is significantly associated with IADLs, beyond what can be accounted for by executive functioning. However, episodic future thinking did not predict IADLs over and above memory. Overall, there is limited evidence for the clinical utility of episodic future thinking. The findings suggest that an episodic future thinking task does not provide enough valuable information about IADLs to justify its inclusion in a clinical neuropsychological setting.

Supporting ward staff in acute care areas: the past, the present and the future?

PubMed

Coad, Sharon; Haines, Susan; Lawrence, Barbara

2002-01-01

Clinical education for acute ward staff caring for critically ill patients has continued to be a strong focus for practice development. Adopting a work-based learning approach to empower ward staff has led to the development of a five-day competency-based high dependency skills course. Developing leadership potential and enhancing networking opportunities for nurses from within critical care and ward areas is essential for the realisation of the aims of Comprehensive Critical Care.

Progress in the clinical development and utilization of vision prostheses: an update

PubMed Central

Brandli, Alice; Luu, Chi D; Guymer, Robyn H; Ayton, Lauren N

2016-01-01

Vision prostheses, or “bionic eyes”, are implantable medical bionic devices with the potential to restore rudimentary sight to people with profound vision loss or blindness. In the past two decades, this field has rapidly progressed, and there are now two commercially available retinal prostheses in the US and Europe, and a number of next-generation devices in development. This review provides an update on the development of these devices and a discussion on the future directions for the field. PMID:28539798

Applied breath analysis: an overview of the challenges and opportunities in developing and testing sensor technology for human health monitoring in aerospace and clinical applications

PubMed Central

Hunter, Gary W; Dweik, Raed A

2010-01-01

The aerospace industry requires the development of a range of chemical sensor technologies for such applications as leak detection, emission monitoring, fuel leak detection, environmental monitoring, and fire detection. A family of chemical sensors are being developed based on micromachining and microfabrication technology to fabricate microsensors with minimal size, weight, and power consumption, and the use of nanomaterials and structures to develop sensors with improved stability combined with higher sensitivity. However, individual sensors are limited in the amount of information that they can provide in environments that contain multiple chemical species. Thus, sensor arrays are being developed to address detection needs in such multi-species environments. These technologies and technical approaches have direct relevance to breath monitoring for clinical applications. This paper gives an overview of developing cutting-edge sensor technology and possible barriers to new technology implementation. This includes lessons learned from previous microsensor development, recent work in development of a breath monitoring system, and future directions in the implementation of cutting edge sensor technology. Clinical applications and the potential impact to the biomedical field of miniaturized smart gas sensor technology are discussed. PMID:20622933

Examining temporal alterations in Social Anxiety Disorder and Posttraumatic Stress Disorder: The relation between autobiographical memory, future goals, and current self-views.

PubMed

Krans, Julie; Peeters, Manon; Näring, Gérard; Brown, Adam D; de Bree, June; van Minnen, Agnes

2017-12-01

The self is a multi-faceted and temporally dynamic construct reflecting representations and beliefs about identity in the past, present, and future. Clinical studies have shown that individuals with Posttraumatic Stress Disorder (PTSD) and Social Anxiety Disorder (SAD) exhibit alterations in self-related processing but these studies have focused primarily on memory. Few studies in PTSD and SAD have examined self-related processing for the present and future, and no studies have directly compared these processes across these two disorders. Individuals diagnosed with PTSD (n=21), SAD (n=21), and healthy controls (n=21) completed cognitive tasks related to the past, present, and future. Disorder congruent temporal alterations were found across both disorders. Further, regression analyses revealed that trauma-related memories were significantly predicted by future goals related to the trauma, whereas social anxiety-related recall was predicted by current socially anxious self-views. Thus, although self-related processing may be common in PTSD and SAD, those aspects of the self most strongly associated with disorder-congruent recall differ by disorder. Self-alterations may be modifiable and developing a better understanding of past, present, and future self-processing might aid in the development of interventions that target these process. Copyright © 2017 Elsevier Ltd. All rights reserved.

Clinical research and the development of medical therapeutics.

PubMed

Antman, Elliott M

2014-01-01

Clinical research plays a central role in the development of medical therapeutics, but the current system is estimated to take 10-15 years from initial discovery to regulatory approval, at a cost of approximately US$1 billion. Contrast the paths by which 2 anticoagulant options for atrial fibrillation were discovered and ultimately established as treatment options in clinical medicine. Warfarin was discovered by serendipity and compared with placebo in relatively small trials; this was associated with a low cost of development. The new oral anticoagulants were synthesized to provide highly specific, targeted inhibition of critical steps in the coagulation system. They were compared with warfarin for prevention of stroke and systemic embolic events in large, phase 3 trials; this resulted in very expensive development programs. Neither of these paths is desirable for future development of therapeutics. We need to focus on innovative approaches at the preclinical level (systems approach, greater use of inducible pluripotent stem cells, use of novel bioengineering platforms) and clinical trial level (adaptive design, greater use of new and emerging technology). Focusing on disruptive innovations for development of medical therapeutics has the potential to bring us closer to the goal of precision medicine where safer, more effective treatments are discovered in a more efficient system.