NCI Awards 18 Grants to Continue the Early Detection Research Network (EDRN) Biomarkers Effort | Division of Cancer Prevention

Cancer.gov

The NCI has awarded 18 grants to continue the Early Detection Research Network (EDRN), a national infrastructure that supports the integrated development, validation, and clinical application of biomarkers for the early detection of cancer. The awards fund 7 Biomarker Developmental Laboratories, 8 Clinical Validation Centers, 2 Biomarker Reference Laboratories, and a Data

Pacific Association for Clinical Training (PACT): lessons learned and next steps in developing a sustainable continuing health professionals education system in the United States-Affiliated Pacific Island (USAPI) jurisdictions.

PubMed

Buenconsejo-Lum, Lee E; Maskarinec, Gregory G; Palafox, Neal A

2007-03-01

In response to the 1998 Institute of Medicine report, "Pacific Partnerships for Health ", acknowledging the need for the continuing education of health workers in the United States-Affiliated Pacific Island (USAPI) jurisdictions, the U.S. Health Resources and Services Administration (HRSA) awarded a grant (1999-2003) to the University of Washington for a continuing education project in the Pacific. When shortfalls in HRSA funding threatened continuation of the program, Pacific advocates aggressively made a case for refunding of this important project. In 2003, HRSA announced competitive funding for a new program for continuing education. The Department of Family Medicine and Community Health (DFMCH) at the University of Hawai'i (UH), John A. Burns School of Medicine (JABSOM) was awarded the HRSA Cooperative Agreement to run from September 2003 through August 2007, creating PACT the Pacific Association for Clinical Training. PACT assembled a professional, community-based advisory board, most of whom were indigenous Pacific Islanders, and conducted a continuing clinical education needs assessment in every jurisdiction, subsequently developing and delivering programs utilizing distance education relevant to the needs of each USAPI jurisdiction. Priority health areas included diabetes, oral health and geriatrics, as mandated by HRSA. This report describes the processes, accomplishments, challenges and lessons learned from the project. PACT needs assessment reports for each jurisdiction and an executive summary are published as Original Articles in this issue of Pacific Health Dialog. As funding for PACT comes to an end, it is clear that much work remains to be done in the region. "Continuing clinical education" is only one part of a continuum of human resources for health (HRH) workforce development. Continued USAPI regional, U.S. national and international collaboration and resources are needed to achieve the ultimate goal of improved health and health care delivery in the USAPI.

Current management of wound healing.

PubMed

Gottrup, F; Karlsmark, T

2009-06-01

While the understanding of wound pathophysiology has progressed considerably over the past decades the improvements in clinical treatment has occurred to a minor degree. During the last years, however, new trends and initiatives have been launched, and we will continue to attain new information in the next decade. It is the hope that increasing parts of the new knowledge from basic wound healing research will be implemented in daily clinical practice. The development of new treatment products will also continue, and especially new technologies with combined types of dressing materials or dressing containing active substances will be accentuated. Further developments in the management structure and education will also continue and consensus of treatment guidelines, recommendations and organization models will hopefully be achieved.

Being a Clinical Educator

ERIC Educational Resources Information Center

Higgs, Joy; Mcallister, Lindy

2007-01-01

What is it like to be a clinical educator? How do clinical educators experience and describe their continuing journey of becoming a clinical educator? Within the model developed in this research, dimensions of being a clinical educator were identified. These dimensions include (a) having a sense of self (and the impact of bringing self into the…

Factors Important to the Prioritization and Development of Successful Topical Microbicides for HIV-1

PubMed Central

Buckheit, Karen W.; Buckheit, Robert W.

2012-01-01

Significant advancements in topical microbicide development have occurred since the prevention strategy was first described as a means to inhibit the sexual transmission of HIV-1. The lack of clinical efficacy of the first generation microbicide products has focused development attention on specific antiretroviral agents, and these agents have proven partially successful in human clinical trials. With greater understanding of vaginal and rectal virus infection, replication, and dissemination, better microbicide products and delivery strategies should result in products with enhanced potency. However, a variety of development gaps exist which relate to product dosing, formulation and delivery, and pharmacokinetics and pharmacodynamics which must be better understood in order to prioritize microbicide products for clinical development. In vitro, ex vivo, and in vivo models must be optimized with regard to these development gaps in order to put the right product at the right place, at the right time, and at the right concentration for effective inhibition of virus transmission. As the microbicide field continues to evolve, we must harness the knowledge gained from unsuccessful and successful clinical trials and development programs to continuously enhance our preclinical development algorithms. PMID:22848826

Clinical risk and depression (continuing education credit).

PubMed

Sharkey, S

1997-01-22

This article provides information and guidance to nurses on clinical risks in mental health, particularly that of depression. It relates to UKCC professional development category: Reducing risk and Care enhancement.

An evaluation of the role of the clinical education facilitator.

PubMed

McCormack, Brendan; Slater, Paul

2006-02-01

The objective of the study was to identify whether clinical education facilitators made a difference to the learning experiences of nurses in a large teaching hospital. Strategies for enabling continuous professional development are well established in health care organizations as key components of approaches to lifelong learning. The benefits of continuous professional development include the maintenance of high standards of care, the improvement and development of services, ensuring the competency of all nursing staff and guaranteeing the accountability of nurses for their actions. The role of clinical education facilitator is relatively new and little evaluation of this role has been undertaken. This study highlights important issues to be considered in developing a 'learning culture' in a hospital organization, through the adoption of such roles as clinical education facilitators. Whilst the roles have had an important function in the active coordination of learning activities in the hospital, there is little evidence of the role directly impacting on the learning culture of clinical settings. Learning mechanisms have been identified. The results of this evaluation can be subjected to further testing through ongoing evaluation of the outcomes arising from the learning mechanisms in place. Given the emphasis on work-based learning and continuing professional development in health care, then this ongoing evaluation can yield important information about future directions for nurse education. The study highlights the importance of supported learning in the workplace. However, more importantly, it identifies the need for a culture of professional practice to be developed in order to sustain learning in practice. Classroom-based learning alone, cannot create a culture of development in nursing and there is thus a need for models of work-based learning to be integrated into practice environments.

Developing and Using Interdisciplinary Case Studies in Teaching Geriatrics to Practicing Health Care Professionals.

ERIC Educational Resources Information Center

Owens, Norma J.; Padula, Cynthia A.; Hume, Anne L.

2002-01-01

Interdisciplinary clinical case studies in geriatrics were developed using active and problem-based learning approaches that simulate clinical environments. Feedback from their use in continuing education indicated that facilitators need interdisciplinary group skills, well-written discussion questions enhanced learning, and the presence of all…

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.

A Text-Computer Assisted Instruction Program as a Viable Alternative for Continuing Education in Laboratory Medicine.

ERIC Educational Resources Information Center

Bruce, A. Wayne

1986-01-01

Describes reasons for developing combined text and computer assisted instruction (CAI) teaching programs for delivery of continuing education to laboratory professionals, and mechanisms used for developing a CAI program on method evaluation in the clinical laboratory. Results of an evaluation of the software's cost effectiveness and instructional…

SU-F-T-100: Development and Implementation of a Treatment Planning Tracking System Into the Radiation Oncology Clinic

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

Kabat, C; Cline, K; Li, Y

Purpose: With increasing numbers of cancer patients being diagnosed and the complexity of radiotherapy treatments rising it’s paramount that patient plan development continues to stay fluid within the clinic. In order to maintain a high standard of care and clinical efficiency the establishment of a tracking system for patient plan development allows healthcare providers to view real time plan progression and drive clinical workflow. In addition, it provides statistical datasets which can further identify inefficiencies within the clinic. Methods: An application was developed utilizing Microsoft’s ODBC SQL database engine to track patient plan status throughout the treatment planning process whilemore » also managing key factors pertaining to the patient’s treatment. Pertinent information is accessible to staff in many locations, including tracking monitors within dosimetry, the clinic network for both computers and handheld devices, and through email notifications. Plans are initiated with a CT and continually tracked through planning stages until final approval by staff. Patient’s status is dynamically updated by the physicians, dosimetrists, and medical physicists based on the stage of the patient’s plan. Results: Our application has been running over a six month period with all patients being processed through the system. Modifications have been made to allow for new features to be implemented along with additional tracking parameters. Based on in-house feedback, the application has been supportive in streamlining patient plans through the treatment planning process and data has been accumulating to further improve procedures within the clinic. Conclusion: Over time the clinic will continue to track data with this application. As data accumulates the clinic will be able to highlight inefficiencies within the workflow and adapt accordingly. We will add in new features to help support the treatment planning process in the future.« less

Strategies in disability management. Corporate disability management programs implemented at the work site.

PubMed

Kalina, C M

1999-10-30

Managers are challenged to demonstrate all programs as economically essential to the business, generating an appreciable return on investment. Further challenge exists to blend and integrate clinical and business objectives in program development. Disability management programs must be viewed as economically essential to the financial success of the business to assure management support for clinical interventions and return-to-work strategies essential for a successful program. This paper discusses a disability management program integrating clinical and business goals and objectives in return-to-work strategies to effect positive clinical, social-cultural, and business results. Clinical, educational, social, and economic challenges in the development, implementation, and continued management of a disability program at a large corporation with multiple global work sites are defined. Continued discussion addresses the effective clinical interventions and educational strategies utilized successfully within the workplace environment in response to each defined challenge. A multiple disciplinary team approach, clinical and business outcome measures, and quality assurance indicators are discussed as major program components. This article discusses a successful program approach focusing on business process and methodology. These parameters are used to link resources to strategy, developing a product for implementing and managing a program demonstrating economic value added through effective clinical medical case management.

'Governance of' and 'Governance by': implementing a clinical governance framework in an area mental health service.

PubMed

O'Connor, Nick; Paton, Michael

2008-04-01

A framework developed to promote the understanding and application of clinical governance principles in an area mental health service is described. The framework is operationalized through systems, processes, roles and responsibilities. The development of an explicit and operationalizable framework for clinical governance arose from the authors' experiences in leading and managing mental health services. There is a particular emphasis on improvement of quality of care and patient safety. The framework is informed by recent developments in thinking about clinical governance, including key documents from Australia and the United Kingdom. The operational nature of the framework allows for key components of clinical governance to be described explicitly, communicated effectively, and continually tested and improved. Further consideration and assessment of the value of differing approaches to this task are required. For example, a general, illustrative approach to raise clinician awareness can be contrasted with prescriptive and specified approaches which progressively encompass the many functions and processes of a mental health service. Mental health clinicians and managers can be guided by a framework that will ensure safe, high quality and continually improving processes of care.

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.

Automated information systems provide health information management support to veterans' healthcare.

PubMed

Lloyd, S S

1992-06-01

The Veterans Health Administration has implemented a comprehsnsive DHCP which supports the VA healthcare system at both local and national levels. Numerous clinical and management modules have been developed; an overview was given of selected applications impacting health information managers. Continuing development includes an automated clinical record and expanded electronic data exchange.

The development of the rotigotine transdermal patch: a historical perspective.

PubMed

Waters, Cheryl

2013-08-01

The rotigotine transdermal system is a dopamine receptor agonist delivered over a 24-hour period. It is approved for the treatment of idiopathic Parkinson's disease (PD). This article reviews the development of the rotigotine transdermal system, including rotigotine's receptor profile, steady-state pharmacokinetics, and metabolism. Preclinical studies of rotigotine in animal models of PD and proof-of-concept studies in patients with PD are reviewed. These preclinical and clinical studies established this system as an effective method for providing continuous rotigotine delivery across the skin providing the basis for continued clinical development of rotigotine for the treatment of early and advanced PD. Copyright © 2013 Elsevier Inc. All rights reserved.

Prosthetists' perceptions and use of outcome measures in clinical practice: Long-term effects of focused continuing education.

PubMed

Hafner, Brian J; Spaulding, Susan E; Salem, Rana; Morgan, Sara J; Gaunaurd, Ignacio; Gailey, Robert

2017-06-01

Continuing education is intended to facilitate clinicians' skills and knowledge in areas of practice, such as administration and interpretation of outcome measures. To evaluate the long-term effect of continuing education on prosthetists' confidence in administering outcome measures and their perceptions of outcomes measurement in clinical practice. Pretest-posttest survey methods. A total of 66 prosthetists were surveyed before, immediately after, and 2 years after outcomes measurement education and training. Prosthetists were grouped as routine or non-routine outcome measures users, based on experience reported prior to training. On average, prosthetists were just as confident administering measures 1-2 years after continuing education as they were immediately after continuing education. In all, 20% of prosthetists, initially classified as non-routine users, were subsequently classified as routine users at follow-up. Routine and non-routine users' opinions differed on whether outcome measures contributed to efficient patient evaluations (79.3% and 32.4%, respectively). Both routine and non-routine users reported challenges integrating outcome measures into normal clinical routines (20.7% and 45.9%, respectively). Continuing education had a long-term impact on prosthetists' confidence in administering outcome measures and may influence their clinical practices. However, remaining barriers to using standardized measures need to be addressed to keep practitioners current with evolving practice expectations. Clinical relevance Continuing education (CE) had a significant long-term impact on prosthetists' confidence in administering outcome measures and influenced their clinical practices. In all, approximately 20% of prosthetists, who previously were non-routine outcome measure users, became routine users after CE. There remains a need to develop strategies to integrate outcome measurement into routine clinical practice.

Yearning for the Vastness of the Sea: Reflections and Commentary on Professional Training in Hypnosis.

PubMed

Baker, Elgan L

2017-01-01

Educational programs are a major focus of most professional hypnosis societies. Many of these programs rely on traditional curricula and teaching strategies with variable success. The articles in this special issue examine and critique these training models and suggest innovative approaches to professional education with an emphasis on more uniform course content and goals and more dynamic and effective educational processes. A convergence of themes is noted and examined including the need to continue to expand the acceptance and utilization of clinical hypnosis, the importance of attending to broader clinical competence beyond hypnosis skills, the need for faculty development and evaluation, and the imperative that course content reflects academic rigor and contemporary science as well as providing for demonstration and supervised clinical practice. These themes are explicated for the development of new training paradigms and for continued programs in the field of clinical hypnosis.

Training the Trainer: Developing Educators for Continuing Professional Education.

ERIC Educational Resources Information Center

Canellos, Harriete; Medio, Franklin J.; Mozlin, Rochelle; Perry, Claudia A.

2000-01-01

Describes a program at the State University of New York College of Optometry targeted at training younger clinical faculty who wish to become involved in continuing professional education. Covers the program's purpose and the institution's experiences with implementation. (DB)

Evaluating staff and student experiences of multidisciplinary continuous professional development via distance-learning.

PubMed

Hurst, J

2005-01-01

Continuous professional development (CPD) in caring for people with kidney disease is limited in some regions of the UK and within Europe generally. This is compounded for all by limited resources for course fees and the lack of study leave granted away from the clinical area for full-time courses. This is set against recommendations from National and European governments, and renal clinical guidelines concerning expectations of CPD and clinical competency levels of renal nurses (1-4). In the past renal practitioners have been trained in all areas of the renal speciality by Schools of Nursing linked to renal units based in large teaching hospitals. However, more recent changes in the structure of Health Care provision have led in some instances to a rationalising of post registration education delivery.

Integrating Social Determinants of Health into Primary Care Clinical and Informational Workflow during Care Transitions

PubMed Central

Hewner, Sharon; Casucci, Sabrina; Sullivan, Suzanne; Mistretta, Francine; Xue, Yuqing; Johnson, Barbara; Pratt, Rebekah; Lin, Li; Fox, Chester

2017-01-01

Context: Care continuity during transitions between the hospital and home requires reliable communication between providers and settings and an understanding of social determinants that influence recovery. Case Description: The coordinating transitions intervention uses real time alerts, delivered directly to the primary care practice for complex chronically ill patients discharged from an acute care setting, to facilitate nurse care coordinator led telephone outreach. The intervention incorporates claims-based risk stratification to prioritize patients for follow-up and an assessment of social determinants of health using the Patient-centered Assessment Method (PCAM). Results from transitional care are stored and transmitted to qualified healthcare providers across the continuum. Findings: Reliance on tools that incorporated interoperability standards facilitated exchange of health information between the hospital and primary care. The PCAM was incorporated into both the clinical and informational workflow through the collaboration of clinical, industry, and academic partners. Health outcomes improved at the study practice over their baseline and in comparison with control practices and the regional Medicaid population. Major Themes: Current research supports the potential impact of systems approaches to care coordination in improving utilization value after discharge. The project demonstrated that flexibility in developing the informational and clinical workflow was critical in developing a solution that improved continuity during transitions. There is additional work needed in developing managerial continuity across settings such as shared comprehensive care plans. Conclusions: New clinical and informational workflows which incorporate social determinant of health data into standard practice transformed clinical practice and improved outcomes for patients.

Passing the baton: a grounded practical theory of handoff communication between multidisciplinary providers in two Department of Veterans Affairs outpatient settings.

PubMed

Koenig, Christopher J; Maguen, Shira; Daley, Aaron; Cohen, Greg; Seal, Karen H

2013-01-01

Handoffs are communication processes that enact the transfer of responsibility between providers across clinical settings. Prior research on handoff communication has focused on inpatient settings between provider teams and has emphasized patient safety. This study examines handoff communication within multidisciplinary provider teams in two outpatient settings. To conduct an exploratory study that describes handoff communication among multidisciplinary providers, to develop a theory-driven descriptive framework for outpatient handoffs, and to evaluate the strengths and weaknesses of different handoff types. Qualitative, in-depth, semi-structured interviews with 31 primary care, mental health, and social work providers in two Department of Veterans Affairs (VA) Medical Center outpatient clinics. Audio-recorded interviews were transcribed and analyzed using Grounded Practical Theory to develop a theoretical model of and a descriptive framework for handoff communication among multidisciplinary providers. Multidisciplinary providers reported that handoff decisions across settings were made spontaneously and without clear guidelines. Two situated values, clinic efficiency and patient-centeredness, shaped multidisciplinary providers' handoff decisions. Providers reported three handoff techniques along a continuum: the electronic handoff, which was the most clinically efficient; the provider-to-provider handoff, which balanced clinic efficiency and patient-centeredness; and the collaborative handoff, which was the most patient-centered. Providers described handoff choice as a practical response to manage constituent features of clinic efficiency (time, space, medium of communication) and patient-centeredness (information continuity, management continuity, relational continuity, and social interaction). We present a theoretical and descriptive framework to help providers evaluate differential handoff use, reflect on situated values guiding clinic communication, and guide future research. Handoff communication reflected multidisciplinary providers' efforts to balance clinic efficiency with patient-centeredness within the constraints of day-to-day clinical practice. Evaluating the strengths and weaknesses among alternative handoff options may enhance multidisciplinary provider handoff decision-making and may contribute to increased coordination and continuity of care across outpatient settings.

Using electronic clinical practice audits as needs assessment to produce effective continuing medical education programming.

PubMed

Klein, Doug; Staples, John; Pittman, Carmen; Stepanko, Cheryl

2012-01-01

The traditional needs assessment used in developing continuing medical education programs typically relies on surveying physicians and tends to only capture perceived learning needs. Instead, using tools available in electronic medical record systems to perform a clinical audit on a physician's practice highlights physician-specific practice patterns. The purpose of this study was to test the feasibility of implementing an electronic clinical audit needs assessment process for family physicians in Canada. A clinical audit of 10 preventative care interventions and 10 chronic disease interventions was performed on family physician practices in Alberta, Canada. The physicians used the results from the audit to produce personalized learning needs, which were then translated into educational programming. A total of 26 family practices and 4489 patient records were audited. Documented completion rates for interventions ranged from 13% for ensuring a patient's tetanus vaccine is current to 97% of pregnant patients receiving the recommended prenatal vitamins. Electronic medical record-based needs assessments may provide a better basis for developing continuing medical education than a more traditional survey-based needs assessment. This electronic needs assessment uses the physician's own patient outcome information to assist in determining learning objectives that reflect both perceived and unperceived needs.

The Development of a Peer Assisted Learning Model for the Clinical Education of Physiotherapy Students

ERIC Educational Resources Information Center

Sevenhuysen, Samantha L.; Nickson, Wendy; Farlie, Melanie K.; Raitman, Lyn; Keating, Jennifer L.; Molloy, Elizabeth; Skinner, Elizabeth; Maloney, Stephen; Haines, Terry P.

2013-01-01

Demand for clinical placements in physiotherapy education continues to outstrip supply. Peer assisted learning, in various formats, has been trialled to increase training capacity and facilitate student learning during clinical education. There are no documented examples of measurable or repeatable peer assisted learning models to aid clinicians…

Reflecting on the essence of our problem-based learning discussions: the importance of faculty development and our continuous quest for applications of problem-based learning.

PubMed

Chan, Engle Angela

2009-05-01

While problem-based learning (PBL) is a teaching strategy to promote critical thinking, creativity and self-directedness in learning is very important. It is the meaning of the learning, with a contextual understanding, that marks the significance of this approach in our healthcare education. At the 2008 Kaohsiung Medical University International Conference and Workshop on PBL, the scholarly discourse on sharing empirical findings and practical experience with various aspects of PBL brought forth the importance of the teachers' continued learning about the meaning, the dynamics of the process, and the pragmatic details of PBL. This quest for a continuous learning and understanding about PBL parallels our search to extend the classroom PBL into students' clinical experience. The development of clinical teachers in the understanding of PBL was explored as part of their experiential learning in clinical teaching after their PBL workshops. While the clinical teachers who participated in the project appreciated the merits of clinical PBL, the complex balance between patient service and student teaching--in an unpredictable clinical setting--has led to the use of a simulated clinical environment with simulated patients. We also piloted PBL for interprofessional education of undergraduate students of nursing and social work. The ways we can adopt PBL in various settings with different intents will help prepare our healthcare graduates in meeting the challenges of our ever more complex healthcare systems, and the demands of holistic patient care.

Electronic Nursing Documentation: Patient Care Continuity Using the Clinical Care Classification System (CCC).

PubMed

Whittenburg, Luann; Meetim, Aunchisa

2016-01-01

An innovative nursing documentation project conducted at Bumrungrad International Hospital in Bangkok, Thailand demonstrated patient care continuity between nursing patient assessments and nursing Plans of Care using the Clinical Care Classification System (CCC). The project developed a new generation of interactive nursing Plans of Care using the six steps of the American Nurses Association (ANA) Nursing process and the MEDCIN^® clinical knowledgebase to present CCC coded concepts as a natural by-product of a nurse's documentation process. The MEDCIN^® clinical knowledgebase is a standardized point-of-care terminology intended for use in electronic health record systems. The CCC is an ANA recognized nursing terminology.

Clinical guidance of community physiotherapists regarding people with MS: professional development and continuity of care.

PubMed

Normann, Britt; Sørgaard, Knut W; Salvesen, Rolf; Moe, Siri

2014-03-01

Clinical guidance to community physiotherapists (cPTs) is an integral part of physiotherapy service offered in hospital outpatient (OP) clinics for people with multiple sclerosis (PwMS). There is currently a lack of knowledge on the significance of such guidance. The aims of this study were 1) to identify the features that cPTs perceive to be significant in clinical guidance and 2) how this guidance may affect the cPTs' subsequent treatment of PwMS. A phenomenological-hermeneutical framework was selected, and qualitative research interviews were performed and complemented with non-participating observations of a strategic sample of nine cPTs who received clinical guidance for their patients. The interviews were recorded and transcribed, and content analysis was conducted by using systematic text condensation, using theories of practice knowledge as analytic perspectives. The results indicate that cPTs identify participation in authentic movement analysis of a familiar patient as significant for professional development. Vital features are evaluation of the interplay between body parts, exploration of improvement of movement embedded in the OP clinic physiotherapist's explanations, followed by discussion. These elements provide access to dynamic elements in practice knowledge that are available only through first-hand experience and promote clinical reasoning through enhanced reflection during action as well as following action. Such guidance suggests direction for subsequent treatment and may enhance the continuity of care, particularly if the cPTs are experienced. Mutual information flow implementing the cPTs' perspective is requested, as are the use of plain language and supervision of the cPTs handling skills. Professional guidance for cPTs in OP clinics for PwMS should be considered when programmes aiming to develop competency in neurological physiotherapy are designed and when continuity of care for PwMS is discussed. More research regarding potential long-term impact of professional guidance in these clinics is requested. Copyright © 2013 John Wiley & Sons, Ltd.

Conducting clinical trials in Singapore.

PubMed

Woo, K T

1999-04-01

All clinical trials in Singapore will now have to conform to the Medicines (Clinical Trials) Amended Regulations 1998 and the Singapore Good Clinical Practice (GCP) Guidelines 1998. The Medical Clinical Research Committee (MCRC) has been established to oversee the conduct of clinical drug trials in Singapore and together with the legislations in place, these will ensure that clinical trials conducted in Singapore are properly controlled and the well-being of trial subjects are safe guarded. All clinical drug trials require a Clinical Trial Certificate from the MCRC before the trial can proceed. The hospital ethics committee (EC) vets the application for a trial certificate before it is sent to MCRC. The drug company sponsoring the trial has to indemnify the trial investigators and the hospital for negligence arising from the trial. The MCRC, apart from ensuring the safety of trial subjects, has to provide continuing review of the clinical trial and monitors adverse events in the course of the trial. The EC will conduct continuing review of clinical trials. When a non-drug clinical trial is carried out, the EC will ensure that the proposed protocol addresses ethical concerns and meets regulatory requirements for such trials. There is great potential for pharmaceutical Research & Development (R&D) in Singapore. We must develop our skills and infrastructure in clinical trials to enable Singapore to be a regional hub for R&D of drugs in Asia.

Dynamic value assessments in oncology supported by the PACE Continuous Innovation Indicators.

PubMed

Paddock, Silvia; Goodman, Clifford; Shortenhaus, Scott; Grainger, David; Zummo, Jacqueline; Thomas, Samuel

2017-10-01

Several recently developed frameworks aim to assess the value of cancer treatments, but the most appropriate metrics remain uncertain. We use data from the Patient Access to Cancer care Excellence Continuous Innovation Indicators to examine the relationship between hazard ratios (HRs) from clinical trials and dynamic therapeutic value accumulating over time. Our analysis shows that HRs from initial clinical trials poorly predict the eventual therapeutic value of cancer treatments. Relying strongly on HRs from registration trials to predict the long-term success of treatments leaves a lot of the variance unexplained. The Continuous Innovation Indicators offer a complementing, dynamic method to track the therapeutic value of cancer treatments and continuously update value assessments as additional evidence accumulates.

Novel diffuse optics system for continuous tissue viability monitoring: extended recovery in vivo testing in a porcine flap model

NASA Astrophysics Data System (ADS)

Lee, Seung Yup; Pakela, Julia M.; Hedrick, Taylor L.; Vishwanath, Karthik; Helton, Michael C.; Chung, Yooree; Kolodziejski, Noah J.; Stapels, Christopher J.; McAdams, Daniel R.; Fernandez, Daniel E.; Christian, James F.; O'Reilly, Jameson; Farkas, Dana; Ward, Brent B.; Feinberg, Stephen E.; Mycek, Mary-Ann

2017-02-01

In reconstructive surgery, tissue perfusion/vessel patency is critical to the success of microvascular free tissue flaps. Early detection of flap failure secondary to compromise of vascular perfusion would significantly increase the chances of flap salvage. We have developed a compact, clinically-compatible monitoring system to enable automated, minimally-invasive, continuous, and quantitative assessment of flap viability/perfusion. We tested the system's continuous monitoring capability during extended non-recovery surgery using an in vivo porcine free flap model. Initial results indicated that the system could assess flap viability/perfusion in a quantitative and continuous manner. With proven performance, the compact form constructed with cost-effective components would make this system suitable for clinical translation.

Developing a business-practice model for pharmacy services in ambulatory settings.

PubMed

Harris, Ila M; Baker, Ed; Berry, Tricia M; Halloran, Mary Ann; Lindauer, Kathleen; Ragucci, Kelly R; McGivney, Melissa Somma; Taylor, A Thomas; Haines, Stuart T

2008-02-01

A business-practice model is a guide, or toolkit, to assist managers and clinical pharmacy practitioners in the exploration, proposal, development and implementation of new clinical pharmacy services and/or the enhancement of existing services. This document was developed by the American College of Clinical Pharmacy Task Force on Ambulatory Practice to assist clinical pharmacy practitioners and administrators in the development of business-practice models for new and existing clinical pharmacy services in ambulatory settings. This document provides detailed instructions, examples, and resources on conducting a market assessment and a needs assessment, types of clinical services, operations, legal and regulatory issues, marketing and promotion, service development and exit plan, evaluation of service outcomes, and financial considerations in the development of a clinical pharmacy service in the ambulatory environment. Available literature is summarized, and an appendix provides valuable citations and resources. As ambulatory care practices continue to evolve, there will be increased knowledge of how to initiate and expand the services. This document is intended to serve as an essential resource to assist in the growth and development of clinical pharmacy services in the ambulatory environment.

Clinical leadership: using observations of care to focus risk management and quality improvement activities in the clinical setting.

PubMed

Ferguson, Lorraine; Calvert, Judy; Davie, Marilyn; Fallon, Mark; Fred, Nada; Gersbach, Vicki; Sinclair, Lynn

2007-04-01

In an era when patient safety and quality of care are a daily concern for health care professionals, it is important for nurse managers and other clinical leaders to have a repertoire of skills and interventions that can be used to motivate and engage clinical teams in risk assessment and continuous quality improvement at the level of patient care delivery. This paper describes how a cohort of clinical leaders who were undertaking a leadership development program used a relatively simple, patient-focused intervention called the 'observation of care' to help focus the clinical team's attention on areas for improvement within the clinical setting. The main quality and safety themes arising out of the observations that were undertaken by the Clinical Leaders (CLs) were related to the environment, occupational health and safety, communication and team function, clinical practice and patient care. The observations of care also provided the CLs with many opportunities to acknowledge and celebrate exemplary practice as it was observed as a means of enhancing the development of a quality and safety culture within the clinical setting. The 'observation of care' intervention can be used by Clinical Leader's to engage and motivate clinical teams to focus on continuously improving the safety and quality of their own work environment and the care delivered to patients within that environment.

Early developments and clinical applications of total parenteral nutrition.

PubMed

Dudrick, Stanley J

2003-01-01

This article recounts the conditions and status of surgical nutrition support in the 1960s and the antecedent basic and clinical investigational work leading to the development of a practical and efficacious method of adequate nourishment entirely by vein in Beagle puppies; describes the subsequent clinical application of the knowledge, techniques, and technology to the first successful long-term total parenteral nutrition (TPN) support of critically ill pediatric and adult patients; and admonishes nutritionists of all backgrounds that some need for parenteral nutrition will likely always exist and that it is incumbent upon everyone to continue endeavors to advance the germinal methodology to perfection. The relevant indications, limitations, hindrances, motivational factors, and studies regarding the development of TPN are reviewed, and the fundamental investigational work culminating in the first successful growth and development of Beagle puppies and a human infant fed entirely by vein are described firsthand. The details of the orderly and logical scientific development of the principles and components of the techniques in animals, infants, and adults are related. Knowledge, techniques, and technologic constituents of the first successful long-term TPN system were developed in the basic biochemical and animal laboratories initially in 6 puppies and subsequently adapted clinically for the efficacious long-term i.v. support of 6 critically ill surgical adult patients and a newborn infant before its widespread clinical application. Long-term TPN was inaugurated successfully as a safe and effective i.v. feeding technique nearly 4 decades ago. However, basic and clinical investigations must continue to be encouraged, supported, and carried out in the quest to perfect the current rudimentary technology, methodology, and outcomes.

Emerging and recurrent issues in drug development.

PubMed

Anello, C

This paper reviews several emerging and recurrent issues relating to the drug development process. These emerging issues include changes to the FDA regulatory environment, internationalization of drug development, advances in computer technology and visualization tools, and efforts to incorporate meta-analysis methodology. Recurrent issues include: renewed interest in statistical methods for handling subgroups in the design and analysis of clinical trials; renewed interest in alternatives to the 'intention-to-treat' analysis in the presence of non-compliance in randomized clinical trials; renewed interest in methodology to address the multiplicities resulting from a variety of sources inherent in the drug development process, and renewed interest in methods to assure data integrity. These emerging and recurrent issues provide a continuing challenge to the international community of statisticians involved in drug development. Moreover, the involvement of statisticians with different perspectives continues to enrich the field and contributes to improvement in the public health.

Effects of an Art-Based Curriculum on Clinical Trials Attitudes and Breast Cancer Prevention Knowledge

ERIC Educational Resources Information Center

Herman, Patricia M.; Larkey, Linda K.

2006-01-01

Although Latinos now comprise the largest minority in the U.S. population, they continue to be seriously underrepresented in clinical trials. A nonrandomized controlled study of an innovative community-developed clinical trial and breast cancer education program targeting Latinas tested whether use of an art-based curriculum could increase…

Seeking a progressive relationship for learning: A theoretical scheme about the continuity of the student-educator relationship in clinical nursing education.

PubMed

Yaghoubinia, Fariba; Heydari, Abbas; Latifnejad Roudsari, Robab

2014-01-01

The student-educator relationship is an educational tool in nursing education and has long-lasting influence on the professional development of nursing students. Currently, this relationship in clinical settings is different from that in the past due to a paradigm shift in nursing education and its emphasis on the centrality of the relationship. The purpose of this grounded theory study was to explore the continuity of the student-educator relationship in the Iranian context of clinical nursing education. Ten bachelor nursing students and 10 clinical educators at Mashhad University of Medical Sciences, Iran, were selected through purposive and theoretical sampling. The data were collected through semi-structured interviews and participant observation. Interviews were transcribed verbatim, and data analysis was done through open, axial, and selective coding, using MAXQDA ver. 2007 qualitative data analysis software. The core category emerging from the data analysis was "seeking a progressive relationship for learning". Other major categories linked to and embraced within this core category were: "creating emotional connection", "trying to continue the relationship chain", and "adapting the behaviors". The findings indicated that in the Iranian sociocultural context, students and educators gain some action/interaction strategies for continuity of their relationship. It is obvious that the role of the nursing clinical educators and their relationship skills are critical in the relationship continuity of clinical settings. © 2013 The Authors. Japan Journal of Nursing Science © 2013 Japan Academy of Nursing Science.

Development and psychometric characteristics of a new domain of the stanford faculty development program instrument.

PubMed

Owolabi, Mayowa O

2014-01-01

Teacher's attitude domain, a pivotal aspect of clinical teaching, is missing in the Stanford Faculty Development Program Questionnaire (SFDPQ), the most widely used student-based assessment method of clinical teaching skills. This study was conducted to develop and validate the teacher's attitude domain and evaluate the validity and internal consistency reliability of the augmented SFDPQ. Items generated for the new domain included teacher's enthusiasm, sobriety, humility, thoroughness, empathy, and accessibility. The study involved 20 resident doctors assessed once by 64 medical students using the augmented SFDPQ. Construct validity was explored using correlation among the different domains and a global rating scale. Factor analysis was performed. The response rate was 94%. The new domain had a Cronbach's alpha of 0.89, with 1-factor solution explaining 57.1% of its variance. It showed the strongest correlation to the global rating scale (rho = 0.71). The augmented SFDPQ, which had a Cronbach's alpha of 0.93, correlated better (rho = 0.72, p < 0.00001) to the global rating scale than the original SFDPQ (rho = 0.67, p < 0.00001). The new teacher's attitude domain exhibited good internal consistency and construct and factorial validity. It enhanced the content and construct validity of the SFDPQ. The validated construct of the augmented SFDPQ is recommended for design and evaluation of basic and continuing clinical teaching programs. © 2014 The Alliance for Continuing Education in the Health Professions, the Society for Academic Continuing Medical Education, and the Council on Continuing Medical Education, Association for Hospital Medical Education.

Enhancing clinical decision making: development of a contiguous definition and conceptual framework.

PubMed

Tiffen, Jennifer; Corbridge, Susan J; Slimmer, Lynda

2014-01-01

Clinical decision making is a term frequently used to describe the fundamental role of the nurse practitioner; however, other terms have been used interchangeably. The purpose of this article is to begin the process of developing a definition and framework of clinical decision making. The developed definition was "Clinical decision making is a contextual, continuous, and evolving process, where data are gathered, interpreted, and evaluated in order to select an evidence-based choice of action." A contiguous framework for clinical decision making specific for nurse practitioners is also proposed. Having a clear and unique understanding of clinical decision making will allow for consistent use of the term, which is relevant given the changing educational requirements for nurse practitioners and broadening scope of practice. Copyright © 2014 Elsevier Inc. All rights reserved.

Educating residents in behavioral health care and collaboration: integrated clinical training of pediatric residents and psychology fellows.

PubMed

Pisani, Anthony R; leRoux, Pieter; Siegel, David M

2011-02-01

Pediatric residency practices face the challenge of providing both behavioral health (BH) training for pediatricians and psychosocial care for children. The University of Rochester School of Medicine and Dentistry and Rochester General Hospital developed a joint training program and continuity clinic infrastructure in which pediatric residents and postdoctoral psychology fellows train and practice together. The integrated program provides children access to BH care in a primary care setting and gives trainees the opportunity to integrate collaborative BH care into their regular practice routines. During 1998-2008, 48 pediatric residents and 8 psychology fellows trained in this integrated clinical environment. The program's accomplishments include longevity, faculty and fiscal stability, sustained support from pediatric leadership and community payers, the development in residents and faculty of greater comfort in addressing BH problems and collaborating with BH specialists, and replication of the model in two other primary care settings. In addition to quantitative program outcomes data, the authors present a case example that illustrates how the integrated program works and achieves its goals. They propose that educating residents and psychology trainees side by side in collaborative BH care is clinically and educationally valuable and potentially applicable to other settings. A companion report published in this issue provides results from a study comparing the perceptions of pediatric residents whose primary care continuity clinic took place in this integrated setting with those of residents from the same pediatric residency who had their continuity clinic training in a nonintegrated setting.

Social Learning in a Longitudinal Integrated Clinical Placement

ERIC Educational Resources Information Center

Roberts, Chris; Daly, Michele; Held, Fabian; Lyle, David

2017-01-01

Recent research has demonstrated that longitudinal integrated placements (LICs) are an alternative mode of clinical education to traditional placements. Extended student engagement in community settings provide the advantages of educational continuity as well as increased service provision in underserved areas. Developing and maintaining LICs…

Design of a cluster-randomized minority recruitment trial: RECRUIT.

PubMed

Tilley, Barbara C; Mainous, Arch G; Smith, Daniel W; McKee, M Diane; Amorrortu, Rossybelle P; Alvidrez, Jennifer; Diaz, Vanessa; Ford, Marvella E; Fernandez, Maria E; Hauser, Robert A; Singer, Carlos; Landa, Veronica; Trevino, Aron; DeSantis, Stacia M; Zhang, Yefei; Daniels, Elvan; Tabor, Derrick; Vernon, Sally W

2017-06-01

Racial/ethnic minority groups remain underrepresented in clinical trials. Many strategies to increase minority recruitment focus on minority communities and emphasize common diseases such as hypertension. Scant literature focuses on minority recruitment to trials of less common conditions, often conducted in specialty clinics and dependent on physician referrals. We identified trust/mistrust of specialist physician investigators and institutions conducting medical research and consequent participant reluctance to participate in clinical trials as key-shared barriers across racial/ethnic groups. We developed a trust-based continuous quality improvement intervention to build trust between specialist physician investigators and community minority-serving physicians and ultimately potential trial participants. To avoid the inherent biases of non-randomized studies, we evaluated the intervention in the national Randomized Recruitment Intervention Trial (RECRUIT). This report presents the design of RECRUIT. Specialty clinic follow-up continues through April 2017. We hypothesized that specialist physician investigators and coordinators trained in the trust-based continuous quality improvement intervention would enroll a greater proportion of minority participants in their specialty clinics than specialist physician investigators in control specialty clinics. Specialty clinic was the unit of randomization. Using continuous quality improvement, the specialist physician investigators and coordinators tailored recruitment approaches to their specialty clinic characteristics and populations. Primary analyses were adjusted for clustering by specialty clinic within parent trial and matching covariates. RECRUIT was implemented in four multi-site clinical trials (parent trials) supported by three National Institutes of Health institutes and included 50 associated specialty clinics from these parent trials. Using current data, we have 88% power or greater to detect a 0.15 or greater difference from the currently observed control proportion adjusting for clustering. We detected no differences in baseline matching criteria between intervention and control specialty clinics (all p values > 0.17). RECRUIT was the first multi-site randomized control trial to examine the effectiveness of a trust-based continuous quality improvement intervention to increase minority recruitment into clinical trials. RECRUIT's innovations included its focus on building trust between specialist investigators and minority-serving physicians, the use of continuous quality improvement to tailor the intervention to each specialty clinic's specific racial/ethnic populations and barriers to minority recruitment, and the use of specialty clinics from more than one parent multi-site trial to increase generalizability. The effectiveness of the RECRUIT intervention will be determined after the completion of trial data collection and planned analyses.

Clinical Practice Guideline Selection, Development, Implementation, and Evaluation

DTIC Science & Technology

2000-02-01

interventions for a particular diagnosis” (Henning, 1997) developed by members of the hospital staff. They can be Clinical Practice Guidelines6 conceptualized...health care environment , it is more important than ever for health care organizations to select the most cost-effective procedures, and to continuously...of the studies regarding the targeted illness/injury will enable this team to identify those interventions strongly supported by significant

Using a Quasi-Experimental Research Design to Assess Knowledge in Continuing Medical Education Programs

ERIC Educational Resources Information Center

Markert, Ronald J.; O'Neill, Sally C.; Bhatia, Subhash C.

2003-01-01

Introduction: The objectives of continuing medical education (CME) programs include knowledge acquisition, skill development, clinical reasoning and decision making, and health care outcomes. We conducted a yearlong medical education research study in which knowledge acquisition in our CME programs was assessed. Method: A randomized…

Self-Assessment and Continuing Professional Development: The Canadian Perspective

ERIC Educational Resources Information Center

Silver, Ivan; Campbell, Craig; Marlow, Bernard; Sargeant, Joan

2008-01-01

Introduction: Several recent studies highlight that physicians are not very accurate at assessing their competence in clinical domains when compared to objective measures of knowledge and performance. Instead of continuing to try to train physicians to be more accurate self-assessors, the research suggests that physicians will benefit from…

Continuous Positive Airway Pressure (CPAP)

MedlinePlus

... Programs Professional Development Home AcademyU Home Study Course Maintenance of Certification Conferences & Events Practice Management Home Resources Quality Clinical Data Registry Research Reimbursement ...

A resource management tool for public health continuity of operations during disasters.

PubMed

Turner, Anne M; Reeder, Blaine; Wallace, James C

2013-04-01

We developed and validated a user-centered information system to support the local planning of public health continuity of operations for the Community Health Services Division, Public Health - Seattle & King County, Washington. The Continuity of Operations Data Analysis (CODA) system was designed as a prototype developed using requirements identified through participatory design. CODA uses open-source software that links personnel contact and licensing information with needed skills and clinic locations for 821 employees at 14 public health clinics in Seattle and King County. Using a web-based interface, CODA can visualize locations of personnel in relationship to clinics to assist clinic managers in allocating public health personnel and resources under dynamic conditions. Based on user input, the CODA prototype was designed as a low-cost, user-friendly system to inventory and manage public health resources. In emergency conditions, the system can run on a stand-alone battery-powered laptop computer. A formative evaluation by managers of multiple public health centers confirmed the prototype design's usefulness. Emergency management administrators also provided positive feedback about the system during a separate demonstration. Validation of the CODA information design prototype by public health managers and emergency management administrators demonstrates the potential usefulness of building a resource management system using open-source technologies and participatory design principles.

A Resource Management Tool for Public Health Continuity of Operations During Disasters

PubMed Central

Turner, Anne M.; Reeder, Blaine; Wallace, James C.

2014-01-01

Objective We developed and validated a user-centered information system to support the local planning of public health continuity of operations for the Community Health Services Division, Public Health - Seattle & King County, Washington. Methods The Continuity of Operations Data Analysis (CODA) system was designed as a prototype developed using requirements identified through participatory design. CODA uses open-source software that links personnel contact and licensing information with needed skills and clinic locations for 821 employees at 14 public health clinics in Seattle and King County. Using a web-based interface, CODA can visualize locations of personnel in relationship to clinics to assist clinic managers in allocating public health personnel and resources under dynamic conditions. Results Based on user input, the CODA prototype was designed as a low-cost, user-friendly system to inventory and manage public health resources. In emergency conditions, the system can run on a stand-alone battery-powered laptop computer. A formative evaluation by managers of multiple public health centers confirmed the prototype design’s usefulness. Emergency management administrators also provided positive feedback about the system during a separate demonstration. Conclusions Validation of the CODA information design prototype by public health managers and emergency management administrators demonstrates the potential usefulness of building a resource management system using open-source technologies and participatory design principles. PMID:24618165

Wearable sensor-based objective assessment of motor symptoms in Parkinson's disease.

PubMed

Ossig, Christiana; Antonini, Angelo; Buhmann, Carsten; Classen, Joseph; Csoti, Ilona; Falkenburger, Björn; Schwarz, Michael; Winkler, Jürgen; Storch, Alexander

2016-01-01

Effective management and development of new treatment strategies of motor symptoms in Parkinson's disease (PD) largely depend on clinical rating instruments like the Unified PD rating scale (UPDRS) and the modified abnormal involuntary movement scale (mAIMS). Regarding inter-rater variability and continuous monitoring, clinical rating scales have various limitations. Patient-administered questionnaires such as the PD home diary to assess motor stages and fluctuations in late-stage PD are frequently used in clinical routine and as clinical trial endpoints, but diary/questionnaire are tiring, and recall bias impacts on data quality, particularly in patients with cognitive dysfunction or depression. Consequently, there is a strong need for continuous and objective monitoring of motor symptoms in PD for improving therapeutic regimen and for usage in clinical trials. Recent advances in battery technology, movement sensors such as gyroscopes, accelerometers and information technology boosted the field of objective measurement of movement in everyday life and medicine using wearable sensors allowing continuous (long-term) monitoring. This systematic review summarizes the current wearable sensor-based devices to objectively assess the various motor symptoms of PD.

10 x '20 Progress--development of new drugs active against gram-negative bacilli: an update from the Infectious Diseases Society of America.

PubMed

Boucher, Helen W; Talbot, George H; Benjamin, Daniel K; Bradley, John; Guidos, Robert J; Jones, Ronald N; Murray, Barbara E; Bonomo, Robert A; Gilbert, David

2013-06-01

Infections caused by antibiotic-resistant bacteria, especially the "ESKAPE" pathogens, continue to increase in frequency and cause significant morbidity and mortality. New antimicrobial agents are greatly needed to treat infections caused by gram-negative bacilli (GNB) resistant to currently available agents. The Infectious Diseases Society of America (IDSA) continues to propose legislative, regulatory, and funding solutions to this continuing crisis. The current report updates the status of development and approval of systemic antibiotics in the United States as of early 2013. Only 2 new antibiotics have been approved since IDSA's 2009 pipeline status report, and the number of new antibiotics annually approved for marketing in the United States continues to decline. We identified 7 drugs in clinical development for treatment of infections caused by resistant GNB. None of these agents was included in our 2009 list of antibacterial compounds in phase 2 or later development, but unfortunately none addresses the entire spectrum of clinically relevant GNB resistance. Our survey demonstrates some progress in development of new antibacterial drugs that target infections caused by resistant GNB, but progress remains alarmingly elusive. IDSA stresses our conviction that the antibiotic pipeline problem can be solved by the collaboration of global leaders to develop creative incentives that will stimulate new antibacterial research and development. Our aim is the creation of a sustainable global antibacterial drug research and development enterprise with the power in the short term to develop 10 new, safe, and efficacious systemically administered antibiotics by 2020 as called for in IDSA's "10 × '20 Initiative."

Robotic path-finding in inverse treatment planning for stereotactic radiosurgery with continuous dose delivery

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

Vandewouw, Marlee M., E-mail: marleev@mie.utoronto

Purpose: Continuous dose delivery in radiation therapy treatments has been shown to decrease total treatment time while improving the dose conformity and distribution homogeneity over the conventional step-and-shoot approach. The authors develop an inverse treatment planning method for Gamma Knife® Perfexion™ that continuously delivers dose along a path in the target. Methods: The authors’ method is comprised of two steps: find a path within the target, then solve a mixed integer optimization model to find the optimal collimator configurations and durations along the selected path. Robotic path-finding techniques, specifically, simultaneous localization and mapping (SLAM) using an extended Kalman filter, aremore » used to obtain a path that travels sufficiently close to selected isocentre locations. SLAM is novelly extended to explore a 3D, discrete environment, which is the target discretized into voxels. Further novel extensions are incorporated into the steering mechanism to account for target geometry. Results: The SLAM method was tested on seven clinical cases and compared to clinical, Hamiltonian path continuous delivery, and inverse step-and-shoot treatment plans. The SLAM approach improved dose metrics compared to the clinical plans and Hamiltonian path continuous delivery plans. Beam-on times improved over clinical plans, and had mixed performance compared to Hamiltonian path continuous plans. The SLAM method is also shown to be robust to path selection inaccuracies, isocentre selection, and dose distribution. Conclusions: The SLAM method for continuous delivery provides decreased total treatment time and increased treatment quality compared to both clinical and inverse step-and-shoot plans, and outperforms existing path methods in treatment quality. It also accounts for uncertainty in treatment planning by accommodating inaccuracies.« less

Organizational impact of nurse supply and workload on nurses continuing professional development opportunities: an integrative review.

PubMed

Coventry, Tracey H; Maslin-Prothero, Sian E; Smith, Gilly

2015-12-01

To identify the best evidence on the impact of healthcare organizations' supply of nurses and nursing workload on the continuing professional development opportunities of Registered Nurses in the acute care hospital. To maintain registration and professional competence nurses are expected to participate in continuing professional development. One challenge of recruitment and retention is the Registered Nurse's ability to participate in continuing professional development opportunities. The integrative review method was used to present Registered Nurses perspectives on this area of professional concern. The review was conducted for the period of 2001-February 2015. Keywords were: nurs*, continuing professional development, continuing education, professional development, supply, shortage, staffing, workload, nurse: patient ratio, barrier and deterrent. The integrative review used a structured approach for literature search and data evaluation, analysis and presentation. Eleven international studies met the inclusion criteria. Nurses are reluctant or prevented from leaving clinical settings to attend continuing professional development due to lack of relief cover, obtaining paid or unpaid study leave, use of personal time to undertake mandatory training and organizational culture and leadership issues constraining the implementation of learning to benefit patients. Culture, leadership and workload issues impact nurses' ability to attend continuing professional development. The consequences affect competence to practice, the provision of safe, quality patient care, maintenance of professional registration, job satisfaction, recruitment and retention. Organizational leadership plays an important role in supporting attendance at continuing professional development as an investment for the future. © 2015 John Wiley & Sons Ltd.

Use of generalised additive models to categorise continuous variables in clinical prediction

PubMed Central

2013-01-01

Background In medical practice many, essentially continuous, clinical parameters tend to be categorised by physicians for ease of decision-making. Indeed, categorisation is a common practice both in medical research and in the development of clinical prediction rules, particularly where the ensuing models are to be applied in daily clinical practice to support clinicians in the decision-making process. Since the number of categories into which a continuous predictor must be categorised depends partly on the relationship between the predictor and the outcome, the need for more than two categories must be borne in mind. Methods We propose a categorisation methodology for clinical-prediction models, using Generalised Additive Models (GAMs) with P-spline smoothers to determine the relationship between the continuous predictor and the outcome. The proposed method consists of creating at least one average-risk category along with high- and low-risk categories based on the GAM smooth function. We applied this methodology to a prospective cohort of patients with exacerbated chronic obstructive pulmonary disease. The predictors selected were respiratory rate and partial pressure of carbon dioxide in the blood (PCO2), and the response variable was poor evolution. An additive logistic regression model was used to show the relationship between the covariates and the dichotomous response variable. The proposed categorisation was compared to the continuous predictor as the best option, using the AIC and AUC evaluation parameters. The sample was divided into a derivation (60%) and validation (40%) samples. The first was used to obtain the cut points while the second was used to validate the proposed methodology. Results The three-category proposal for the respiratory rate was ≤ 20;(20,24];> 24, for which the following values were obtained: AIC=314.5 and AUC=0.638. The respective values for the continuous predictor were AIC=317.1 and AUC=0.634, with no statistically significant differences being found between the two AUCs (p =0.079). The four-category proposal for PCO2 was ≤ 43;(43,52];(52,65];> 65, for which the following values were obtained: AIC=258.1 and AUC=0.81. No statistically significant differences were found between the AUC of the four-category option and that of the continuous predictor, which yielded an AIC of 250.3 and an AUC of 0.825 (p =0.115). Conclusions Our proposed method provides clinicians with the number and location of cut points for categorising variables, and performs as successfully as the original continuous predictor when it comes to developing clinical prediction rules. PMID:23802742

Enabling professional development in mental health nursing: the role of clinical leadership.

PubMed

Ennis, G; Happell, B; Reid-Searl, K

2015-10-01

Clinical leadership is acknowledged as important to the nursing profession. While studies continue to identify its significance in contributing to positive outcomes for consumers, the role that clinical leadership has in enabling and supporting professional development in mental health nursing is poorly understood. This study utilized a grounded theory methodology to explore the characteristics clinicians consider important for clinical leadership and its significance for mental health nursing in day-to-day clinical practice. Individual face-to-face, semi-structured interviews were conducted with nurses working in mental health settings. Participants described the important role that clinical leaders play in enabling professional development of others through role modelling and clinical teaching. They describe how nurses, whom they perceive as clinical leaders, use role modelling and clinical teaching to influence the professional development of nursing staff and undergraduate nursing students. Attributes such as professionalism and honesty were seen, by participants, as enablers for clinical leaders in effectively and positively supporting the professional development of junior staff and undergraduate nurses in mental health nursing. This paper examines clinical leadership from the perspective of mental health nurses delivering care, and highlights the important role of clinical leaders in supporting professional development in mental health nursing. © 2015 John Wiley & Sons Ltd.

[Clinical-pharmacological aspects to accelerate the development process from the preclinical to the clinical phase/1st communication: The contribution of clinical pharmacology].

PubMed

Kuhlmann, Jochen

2004-01-01

To improve the transition from research to development a critical evaluation of the individual project by research and disease area teams is required to include input from pharmacology, toxicology, pharmacokinetics, galenics, clinical pharmacology, clinical as well as regulatory experts and marketing. Decisions on the individual development strategy should be made prior to the start of development and all projects should be reviewed at predefined stages throughout the product development life cycle. This ensures consistency of decision-making not only during the development of individual products but throughout the entire development pipeline. Studies in the exploratory stage of drug development should be designed for decision making in contrast to later clinical trials in the confirmatory stage that require power for proof-of-safety and proof-of-efficacy. The more thorough and profound studies have been carried out during this exploratory stage of drug development, the earlier a decision can be made on the continuation or discontinuation of further development, thus saving development time and money and assessing and considerably reducing the risk for the patients and increasing the success rate of the project in the later confirmatory effectiveness trial with an adequate number of subjects receiving the new therapy under typical conditions of use. Strategies which may be helpful to improve the quality of decisions in drug discovery and drug development are: discovery experiments should be done to critically evaluate the compound, the "killer" experiments should be done as early as possible, continuous effort on preclinical disease models is necessary to improve predictability of efficacy in patients ("humanized" research): genomic technology should be used to identify novel, disease-related targets and to characterise preclinical test systems, improvement of knowledge and experience concerning the relevance of new technologies for the clinical picture; genotyping of clinical trial patients to select patient groups which are likely to respond to treatment (pharmacogenomics), modelling and simulation of preclinical and clinical trials, integration of pharmacokinetic and pharmacodynamic principles into drug development, assessment of the interaction potential (CYP-450, trasporter proteins and others), increasing use of biomarker/surrogate marker for rapid clinical feedback, involvement of the target population as soon as possible, applying statistical data analysis techniques for proving effectiveness, co-operation with high quality centers. To reach this goal clinical pharmacology must be fully integrated in the whole process from the candidate selection to its positioning within the market.

Skeletal and Clinical Effects of Exoskeletal Assisted - Gait

DTIC Science & Technology

2016-10-01

assisted gait and derive estimates of loads applied to the bones. The research team continues to recruit study volunteers . 15. SUBJECT TERMS biomechanical...subjects. As we submit this annual report, we continue to actively schedule study volunteers for screening in order to reach the target sample size for... volunteers and apply the biomechanical models developed so far to the datasets that will be collected from study volunteers . We anticipate continuing to

Clinical governance and external audit.

PubMed

Glazebrook, S G; Buchanan, J G

2001-01-01

This paper describes a model of clinical governance that was developed at South Auckland Health during the period 1995 to 2000. Clinical quality and safety are core objectives. A multidisciplinary Clinical Board is responsible for the development and publicising of sound clinical policies together with monitoring the effects of their implementation on quality and safety. The Clinical Board has several committees, including an organization-wide Continuous Quality Improvement Committee to enhance the explicit nature of the quality system in terms of structure, staff awareness and involvement, and to develop the internal audit system. The second stream stems from the Chief Medical Officer and clinical directors in a clinical management sense. The Audit Committee of the Board of Directors covers both clinical and financial audit. The reporting lines back to that committee are described and the role of the external auditor of clinical standards is explained. The aim has been to create a supportive culture where quality initiatives and innovation can flourish, and where the emphasis is not on censure but improvement.

Gentamicin in the Clinical Setting

ERIC Educational Resources Information Center

Pillers, De-Ann M.; Schleiss, Mark R.

2005-01-01

Gentamicin is an aminoglycoside antibiotic that has been a mainstay in pediatric care for decades. Although new antibiotics are constantly under development, gentamicin continues to play an important role in clinical medicine. Although this may be surprising in the context of evidence of an association with hearing loss, both on a toxicity and a…

77 FR 21985 - Agency Information Collection Activities; Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-12

... activities, and better allocate resources. Data from clinical interviews completed in 2008 were combined with the main interview short scale data to develop a predictive model that was applied to the full main sample to estimate SMI. Follow-up clinical interviews continued to be conducted with NSDUH respondents...

[Continuing education in ethics: from clinical ethics to institutional ethics].

PubMed

Brazeau-Lamontagne, Lucie

2012-01-01

The mandate of the Ethics Committee of the Conseil de médecins, dentistes et pharmaciens (CMDP) at the Centre hospitalier universitaire de Sherbrooke (CHUS), Sherbrooke, Quebec is three-fold: to guide the clinical decision; to address the institutional ethical function; to create the program for continuing education in ethics (Formation éthique continue or FEC). Might FEC be the means of bridging from individual ethics to institutional ethics at a hospital? To take the FEC perspectives considered appropriate for doctors and consider them for validation or disproving in the context of those of other professionals. Situate the proposed FEC mandate in a reference framework to evaluate (or triangulate) the clinical decision and the institutional ethic. CONVICTION: Sustainable professional development for doctors (DPD) includes ethics; it cannot be ignored. Without constant attention to upgrading one's abilities in professional ethics, these suffer the same fate as other professional aptitudes and competences (for example, techniques and scientific knowledge): decay.

CURRENT CONCEPTS OF PLYOMETRIC EXERCISE.

PubMed

Davies, George; Riemann, Bryan L; Manske, Robert

2015-11-01

As knowledge regarding rehabilitation science continues to increase, exercise programs following musculoskeletal athletic injury continue to evolve. Rehabilitation programs have drastically changed, especially in the terminal phases of rehabilitation, which include performance enhancement, development of power, and a safe return to activity. Plyometric exercise has become an integral component of late phase rehabilitation as the patient nears return to activity. Among the numerous types of available exercises, plyometrics assist in the development of power, a foundation from which the athlete can refine the skills of their sport. Therefore, the purpose of this clinical commentary is to provide an overview of plyometrics including: definition, phases, the physiological, mechanical and neurophysiological basis of plyometrics, and to describe clinical guidelines and contraindications for implementing plyometric programs.

Breast Cancer Screening in a Low Income Managed Care Population

DTIC Science & Technology

1998-10-01

is the only screening test to be demonstrated by prospective clinical trial to decrease cancer mortality (11-13). Its efficiency and relative safety...increase in the utilization of mammography in conjunction with clinical breast exam, the technology continues to be underutilized, especially among certain...Using familiar sites for special program activities e.g. churches, clinic sites; Developing culturally-sensitive information at the appropriate literacy

Pediatric siMS score: A new, simple and accurate continuous metabolic syndrome score for everyday use in pediatrics.

PubMed

Vukovic, Rade; Milenkovic, Tatjana; Stojan, George; Vukovic, Ana; Mitrovic, Katarina; Todorovic, Sladjana; Soldatovic, Ivan

2017-01-01

The dichotomous nature of the current definition of metabolic syndrome (MS) in youth results in loss of information. On the other hand, the calculation of continuous MS scores using standardized residuals in linear regression (Z scores) or factor scores of principal component analysis (PCA) is highly impractical for clinical use. Recently, a novel, easily calculated continuous MS score called siMS score was developed based on the IDF MS criteria for the adult population. To develop a Pediatric siMS score (PsiMS), a modified continuous MS score for use in the obese youth, based on the original siMS score, while keeping the score as simple as possible and retaining high correlation with more complex scores. The database consisted of clinical data on 153 obese (BMI ≥95th percentile) children and adolescents. Continuous MS scores were calculated using Z scores and PCA, as well as the original siMS score. Four variants of PsiMS score were developed in accordance with IDF criteria for MS in youth and correlation of these scores with PCA and Z score derived MS continuous scores was assessed. PsiMS score calculated using formula: (2xWaist/Height) + (Glucose(mmol/l)/5.6) + (triglycerides(mmol/l)/1.7) + (Systolic BP/130)-(HDL(mmol/l)/1.02) showed the highest correlation with most of the complex continuous scores (0.792-0.901). The original siMS score also showed high correlation with continuous MS scores. PsiMS score represents a practical and accurate score for the evaluation of MS in the obese youth. The original siMS score should be used when evaluating large cohorts consisting of both adults and children.

Creating innovative clinical nurse leader practicum experiences through academic and practice partnerships.

PubMed

Jukkala, Angela; Greenwood, Rebecca; Motes, Terry; Block, Velinda

2013-01-01

The new Clinical Nurse Leader (CNL) nursing role was developed to meet the complex health care needs of patients, families, and health care systems. This article describes the process used by nurse leaders at the University of Alabama at Birmingham School of Nursing and Hospital to develop Model C CNL practicum courses, recruit and prepare clinical preceptors, prepare clinical microsystems for CNL students, and develop additional practice partnerships throughout the region. MANAGEMENT AND OUTCOME: Critical to the success of the CNL role is a dynamic partnership between academic and practice leaders.The partnership allows faculty to develop curricula that are relevant and responsive to the rapidly changing health care system. Clinical leaders become more aware of trends and issues in nursing education. Continued growth and success of the CNL role is largely dependent on the ability of faculty and practice partners to collaborate on innovative educational programs and models of care delivery.

[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".

Rational Combinations of Targeted Agents in AML

PubMed Central

Bose, Prithviraj; Grant, Steven

2015-01-01

Despite modest improvements in survival over the last several decades, the treatment of AML continues to present a formidable challenge. Most patients are elderly, and these individuals, as well as those with secondary, therapy-related, or relapsed/refractory AML, are particularly difficult to treat, owing to both aggressive disease biology and the high toxicity of current chemotherapeutic regimens. It has become increasingly apparent in recent years that coordinated interruption of cooperative survival signaling pathways in malignant cells is necessary for optimal therapeutic results. The modest efficacy of monotherapy with both cytotoxic and targeted agents in AML testifies to this. As the complex biology of AML continues to be elucidated, many “synthetic lethal” strategies involving rational combinations of targeted agents have been developed. Unfortunately, relatively few of these have been tested clinically, although there is growing interest in this area. In this article, the preclinical and, where available, clinical data on some of the most promising rational combinations of targeted agents in AML are summarized. While new molecules should continue to be combined with conventional genotoxic drugs of proven efficacy, there is perhaps a need to rethink traditional philosophies of clinical trial development and regulatory approval with a focus on mechanism-based, synergistic strategies. PMID:26113989

[Clinical-pharmacological aspects to accelerate the development process from the preclinical to the clinical phase/2nd communication: promising strategies].

PubMed

Kuhlmann, Jochen

2004-01-01

To improve the transition from research to development a critical evaluation of the individual project by research and disease area teams is required to include input from pharmacology, toxicology, pharmacokinetics, galenics, clinical pharmacology, clinical as well as regulatory experts and marketing. Decisions on the individual development strategy should be made prior to the start of development and all projects should be reviewed at predefined stages throughout the product development life cycle. This ensures consistency of decision-making not only during the development of individual products but throughout the entire development pipeline. Studies in the exploratory stage of drug development should be designed for decision making in contrast to later clinical trials in the confirmatory stage that require power for proof-of-safety and proof-of-efficacy. The more thorough and profound studies have been carried out during this exploratory stage of drug development, the earlier a decision can be made on the continuation or discontinuation of further development, thus saving development time and money and assessing and considerably reducing the risk for the patients and increasing the success rate of the project in the later confirmatory effectiveness trial with an adequate number of subjects receiving the new therapy under typical conditions of use. Strategies which may be helpful to improve the quality of decisions in drug discovery and drug development are: discovery experiments should be done to critically evaluate the compound, the "killer" experiments should be done as early as possible, continuous effort on preclinical disease models is necessary to improve predictability of efficacy in patients ("humanized" research): genomic technology should be used to identify novel, disease-related targets and to characterise preclinical test systems, improvement of knowledge and experience concerning the relevance of new technologies for the clinical picture, genotyping of clinical trial patients to select patient groups which are likely to respond to treatment (pharmacogenomics), modelling and simulation of preclinical and clinical trials, integration of pharmacokinetic and pharmacodynamic principles into drug development, assessment of the interaction potential (CYP-450, trasporter proteins and others), increasing use of biomarker/surrogate marker for rapid clinical feedback, involvement of the target population as soon as possible, applying statistical data analysis techniques for proving effectiveness, co-operation with high quality centers. To reach this goal clinical pharmacology must be fully integrated in the whole process from the candidate selection to its positioning within the market.

Teaching trainers to incorporate evidence-based medicine (EBM) teaching in clinical practice: the EU-EBM project.

PubMed

Thangaratinam, Shakila; Barnfield, Gemma; Weinbrenner, Susanne; Meyerrose, Berit; Arvanitis, Theodoros N; Horvath, Andrea R; Zanrei, Gianni; Kunz, Regina; Suter, Katja; Walczak, Jacek; Kaleta, Anna; Oude Rengerink, Katrien; Gee, Harry; Mol, Ben W J; Khan, Khalid S

2009-09-10

Evidence based medicine (EBM) is considered an integral part of medical training, but integration of teaching various EBM steps in everyday clinical practice is uncommon. Currently EBM is predominantly taught through theoretical courses, workshops and e-learning. However, clinical teachers lack confidence in teaching EBM in workplace and are often unsure of the existing opportunities for teaching EBM in the clinical setting. There is a need for continuing professional development (CPD) courses that train clinical trainers to teach EBM through on-the-job training by demonstration of applied EBM real time in clinical practice. We developed such a course to encourage clinically relevant teaching of EBM in post-graduate education in various clinical environments. We devised an e-learning course targeting trainers with EBM knowledge to impart educational methods needed to teach application of EBM teaching in commonly used clinical settings. The curriculum development group comprised experienced EBM teachers, clinical epidemiologists, clinicians and educationalists from institutions in seven European countries. The e-learning sessions were designed to allow participants (teachers) to undertake the course in the workplace during short breaks within clinical activities. An independent European steering committee provided input into the process. The curriculum defined specific learning objectives for teaching EBM by exploiting educational opportunities in six different clinical settings. The e-modules incorporated video clips that demonstrate practical and effective methods of EBM teaching in everyday clinical practice. The course encouraged focussed teaching activities embedded within a trainer's personal learning plan and documentation in a CPD portfolio for reflection. This curriculum will help senior clinicians to identify and make the best use of available opportunities in everyday practice in clinical situations to teach various steps of EBM and demonstrate their applicability to clinical practice. Once fully implemented, the ultimate outcome of this pilot project will be a European qualification in teaching EBM, which will be used by doctors, hospitals, professional bodies responsible for postgraduate qualifications and continuing medical education.

Teaching trainers to incorporate evidence-based medicine (EBM) teaching in clinical practice: the EU-EBM project

PubMed Central

Thangaratinam, Shakila; Barnfield, Gemma; Weinbrenner, Susanne; Meyerrose, Berit; Arvanitis, Theodoros N; Horvath, Andrea R; Zanrei, Gianni; Kunz, Regina; Suter, Katja; Walczak, Jacek; Kaleta, Anna; Rengerink, Katrien Oude; Gee, Harry; Mol, Ben WJ; Khan, Khalid S

2009-01-01

Background Evidence based medicine (EBM) is considered an integral part of medical training, but integration of teaching various EBM steps in everyday clinical practice is uncommon. Currently EBM is predominantly taught through theoretical courses, workshops and e-learning. However, clinical teachers lack confidence in teaching EBM in workplace and are often unsure of the existing opportunities for teaching EBM in the clinical setting. There is a need for continuing professional development (CPD) courses that train clinical trainers to teach EBM through on-the-job training by demonstration of applied EBM real time in clinical practice. We developed such a course to encourage clinically relevant teaching of EBM in post-graduate education in various clinical environments. Methods We devised an e-learning course targeting trainers with EBM knowledge to impart educational methods needed to teach application of EBM teaching in commonly used clinical settings. The curriculum development group comprised experienced EBM teachers, clinical epidemiologists, clinicians and educationalists from institutions in seven European countries. The e-learning sessions were designed to allow participants (teachers) to undertake the course in the workplace during short breaks within clinical activities. An independent European steering committee provided input into the process. Results The curriculum defined specific learning objectives for teaching EBM by exploiting educational opportunities in six different clinical settings. The e-modules incorporated video clips that demonstrate practical and effective methods of EBM teaching in everyday clinical practice. The course encouraged focussed teaching activities embedded within a trainer's personal learning plan and documentation in a CPD portfolio for reflection. Conclusion This curriculum will help senior clinicians to identify and make the best use of available opportunities in everyday practice in clinical situations to teach various steps of EBM and demonstrate their applicability to clinical practice. Once fully implemented, the ultimate outcome of this pilot project will be a European qualification in teaching EBM, which will be used by doctors, hospitals, professional bodies responsible for postgraduate qualifications and continuing medical education. PMID:19744327

Biomechanical Behavior of Bioprosthetic Heart Valve Heterograft Tissues: Characterization, Simulation, and Performance

PubMed Central

Soares, Joao S.; Feaver, Kristen R.; Zhang, Will; Kamensky, David; Aggarwal, Ankush; Sacks, Michael S.

2017-01-01

The use of replacement heart valves continues to grow due to the increased prevalence of valvular heart disease resulting from an ageing population. Since bioprosthetic heart valves (BHVs) continue to be the preferred replacement valve, there continues to be a strong need to develop better and more reliable BHVs through and improved the general understanding of BHV failure mechanisms. The major technological hurdle for the lifespan of the BHV implant continues to be the durability of the constituent leaflet biomaterials, which if improved can lead to substantial clinical impact. In order to develop improved solutions for BHV biomaterials, it is critical to have a better understanding of the inherent biomechanical behaviors of the leaflet biomaterials, including chemical treatment technologies, the impact of repetitive mechanical loading, and the inherent failure modes. This review seeks to provide a comprehensive overview of these issues, with a focus on developing insight on the mechanisms of BHV function and failure. Additionally, this review provides a detailed summary of the computational biomechanical simulations that have been used to inform and develop a higher level of understanding of BHV tissues and their failure modes. Collectively, this information should serve as a tool not only to infer reliable and dependable prosthesis function, but also to instigate and facilitate the design of future bioprosthetic valves and clinically impact cardiology. PMID:27507280

[Factors influencing nurses' clinical decision making--focusing on critical thinking disposition].

PubMed

Park, Seungmi; Kwon, In Gak

2007-10-01

The purpose of this study was to investigate the factors influencing nurses' clinical decision making focusing on critical thinking disposition. The subjects of this study consisted of 505 nurses working at one of the general hospitals located in Seoul. Data was collected by a self-administered questionnaire between December 2006 and January 2007. Data was analyzed by one way ANOVA, Pearson correlation coefficients, and stepwise multiple regression using SPSS Win 14.0. The mean scores of critical thinking disposition and clinical decision making were 99.10 and 134.32 respectively. Clinical decision making scores were significantly higher in groups under continuing education, with a master or higher degree, with clinical experience more than 5 years, or with experts. Critical thinking disposition and its subscales have a significant correlation with clinical decision making. Intellectual eagerness/curiosity, prudence, clinical experience, intellectual honesty, self-confidence, and healthy skepticism were important factors influencing clinical decision making(adjusted R(2)=33%). Results of this study suggest that various strategies such as retaining experienced nurses, encouraging them to continue with education and enhancing critical thinking disposition are warranted for development of clinical decision making.

India's growing clinical research sector: opportunity for global companies.

PubMed

Varawalla, Nermeen

2007-06-01

Backed by a compelling foundation of essential requirements necessary for effective clinical trial conduct, and aided by initiatives that address concerns of data quality, regulatory timelines and IP protection, the clinical development sector in India has experienced annual revenue growth rates of 25% in the past two to three years, and is poised to participate substantially in global drug development. As both clinical trial sponsors and CROs increase their research capabilities in India, the clinical development sector is facing challenges with staff resourcing and facilities. Existing initiatives in the clinical sector must continue, and further investment must be made by stakeholders to overcome the current limitations in sector growth. Furthermore, global organizations seeking to derive long-term sustainable revenue growth and competitive advantage in the global marketplace from their business units in India must establish an appropriate organizational culture and an effective intra-organizational and industry interface for their operations.

10 × '20 Progress—Development of New Drugs Active Against Gram-Negative Bacilli: An Update From the Infectious Diseases Society of America

PubMed Central

Boucher, Helen W.; Talbot, George H.; Benjamin, Daniel K.; Bradley, John; Guidos, Robert J.; Jones, Ronald N.; Murray, Barbara E.; Bonomo, Robert A.; Gilbert, David

2013-01-01

Infections caused by antibiotic-resistant bacteria, especially the “ESKAPE” pathogens, continue to increase in frequency and cause significant morbidity and mortality. New antimicrobial agents are greatly needed to treat infections caused by gram-negative bacilli (GNB) resistant to currently available agents. The Infectious Diseases Society of America (IDSA) continues to propose legislative, regulatory, and funding solutions to this continuing crisis. The current report updates the status of development and approval of systemic antibiotics in the United States as of early 2013. Only 2 new antibiotics have been approved since IDSA's 2009 pipeline status report, and the number of new antibiotics annually approved for marketing in the United States continues to decline. We identified 7 drugs in clinical development for treatment of infections caused by resistant GNB. None of these agents was included in our 2009 list of antibacterial compounds in phase 2 or later development, but unfortunately none addresses the entire spectrum of clinically relevant GNB resistance. Our survey demonstrates some progress in development of new antibacterial drugs that target infections caused by resistant GNB, but progress remains alarmingly elusive. IDSA stresses our conviction that the antibiotic pipeline problem can be solved by the collaboration of global leaders to develop creative incentives that will stimulate new antibacterial research and development. Our aim is the creation of a sustainable global antibacterial drug research and development enterprise with the power in the short term to develop 10 new, safe, and efficacious systemically administered antibiotics by 2020 as called for in IDSA's “10 × '20 Initiative.” PMID:23599308

Intentional Modelling: A Process for Clinical Leadership Development in Mental Health Nursing.

PubMed

Ennis, Gary; Happell, Brenda; Reid-Searl, Kerry

2016-05-01

Clinical leadership is becoming more relevant for nurses, as the positive impact that it can have on the quality of care and outcomes for consumers is better understood and more clearly articulated in the literature. As clinical leadership continues to become more relevant, the need to gain an understanding of how clinical leaders in nursing develop will become increasingly important. While the attributes associated with effective clinical leadership are recognized in current literature there remains a paucity of research on how clinical leaders develop these attributes. This study utilized a grounded theory methodology to generate new insights into the experiences of peer identified clinical leaders in mental health nursing and the process of developing clinical leadership skills. Participants in this study were nurses working in a mental health setting who were identified as clinical leaders by their peers as opposed to identifying them by their role or organizational position. A process of intentional modeling emerged as the substantive theory identified in this study. Intentional modeling was described by participants in this study as a process that enabled them to purposefully identify models that assisted them in developing the characteristics of effective clinical leaders as well as allowing them to model these characteristics to others. Reflection on practice is an important contributor to intentional modelling. Intentional modelling could be developed as a framework for promoting knowledge and skill development in the area of clinical leadership.

Glucose Biosensors: An Overview of Use in Clinical Practice

PubMed Central

Yoo, Eun-Hyung; Lee, Soo-Youn

2010-01-01

Blood glucose monitoring has been established as a valuable tool in the management of diabetes. Since maintaining normal blood glucose levels is recommended, a series of suitable glucose biosensors have been developed. During the last 50 years, glucose biosensor technology including point-of-care devices, continuous glucose monitoring systems and noninvasive glucose monitoring systems has been significantly improved. However, there continues to be several challenges related to the achievement of accurate and reliable glucose monitoring. Further technical improvements in glucose biosensors, standardization of the analytical goals for their performance, and continuously assessing and training lay users are required. This article reviews the brief history, basic principles, analytical performance, and the present status of glucose biosensors in the clinical practice. PMID:22399892

Competency Management and Learning Organization in a New Clinical Fieldwork Course

ERIC Educational Resources Information Center

Putthinoi, Supawadee; Lersilp, Suchitporn; Chakpitak, Nopasit

2015-01-01

As Thailand transitions into an ageing society, greater demands will be placed on healthcare systems. The concept of competency management and learning organization can be beneficial in continually expanding organizational capacity in order to create response. This study aimed to develop a new clinical fieldwork course in the community by…

Adapting Objective Structured Clinical Examinations to Assess Social Work Students' Performance and Reflections

ERIC Educational Resources Information Center

Bogo, Marion; Regehr, Cheryl; Logie, Carmen; Katz, Ellen; Mylopoulos, Maria; Regehr, Glenn

2011-01-01

The development of standardized, valid, and reliable methods for assessment of students' practice competence continues to be a challenge for social work educators. In this study, the Objective Structured Clinical Examination (OSCE), originally used in medicine to assess performance through simulated interviews, was adapted for social work to…

77 FR 34959 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-12

..., direct program activities, and better allocate resources. Data from clinical interviews completed in 2008 were combined with the main interview short scale data to develop a predictive model that was applied to the full main sample to estimate SMI. Follow-up clinical interviews continued to be conducted with...

Using speed dating sessions to foster collaboration in continuing interdisciplinary education.

PubMed

Laprise, Réjean; Thivierge, Robert L

2012-01-01

There are numerous examples of care gaps that could be reduced through enhanced knowledge exchange and practice collaboration between medical specialist physicians. In this paper, we report preliminary results on using speed-dating sessions (SDSs) to stimulate the development of continuing interdisciplinary education (CIDE) activities. In 2007, a 35-minute SDS was carried out during a 2-hour faculty development workshop to provide continuing medical education (CME) directors of Quebec's 35 medical specialist associations with a formal opportunity to quickly share clinical issues and goals. A post-workshop survey was used to assess participants' satisfaction and whether they had met new colleagues, learned about interdisciplinary issues, and discovered opportunities for collaboration. CME accreditation files were audited to assess the occurrence of CIDE activities in the year prior and the 2 years that followed the workshop. CME directors were called to assess whether the development of these activities was directly attributable to their participation in the SDS. CME directors of 26 specialist physician associations attended the faculty development workshop. The vast majority of survey respondents (n = 18/20) were satisfied with the SDS and believed that this method was a stimulating and efficient way to meet new colleagues, quickly share clinical issues and goals, learn about unexpected but important interdisciplinary issues, and identify opportunities for CIDE collaboration. Sixty percent (12/20) reported having identified at least 1 opportunity for collaboration that was worth pursuing in the near future, and 19% of attending CME directors (5/26) developed a CIDE activity within 2 years, as compared with none in the previous year and for the 9 nonparticipating associations. Results suggest that SDSs enhanced networking, knowledge exchange, and collaboration in continuing education among CME providers who participated in a faculty development activity on CIDE. Copyright © 2012 The Alliance for Continuing Education in the Health Professions, the Society for Academic Continuing Medical Education, and the Council on CME, Association for Hospital Medical Education.

An integrated educational model for continuing nurse education.

PubMed

Duff, Beverley; Gardner, Glenn; Osborne, Sonya

2014-01-01

This paper reports on the development and evaluation of an integrated clinical learning model to inform ongoing education for surgical nurses. The research aim was to evaluate the effectiveness of implementing a Respiratory Skills Update (ReSKU) education program, in the context of organisational utility, on improving surgical nurses' practice in the area of respiratory assessment. Continuous development and integration of technological innovations and research in the healthcare environment mandate the need for continuing education for nurses. Despite an increased worldwide emphasis on this, there is scant empirical evidence of program effectiveness. A quasi experimental pre test, post test non-equivalent control group design evaluated the impact of the ReSKU program on surgical nurses' clinical practice. The 2008 study was conducted in a 400 bed regional referral public hospital and was consistent with contemporary educational approaches using multi-modal, interactive teaching strategies. The study demonstrated statistically significant differences between groups regarding reported use of respiratory skills, three months after ReSKU program attendance. Between group data analysis indicated that the intervention group's reported beliefs and attitudes pertaining to subscale descriptors showed statistically significant differences in three of the six subscales. The construct of critical thinking in the clinical context, combined with clinical reasoning and purposeful reflection, was a powerful educational strategy to enhance competency and capability in clinicians. Crown Copyright © 2012. Published by Elsevier Ltd. All rights reserved.

Barriers and strategies for the clinical translation of advanced orthopaedic tissue engineering protocols.

PubMed

Madry, H; Alini, M; Stoddart, M J; Evans, C; Miclau, T; Steiner, S

2014-05-06

Research in orthopaedic tissue engineering has intensified over the last decade and new protocols continue to emerge. The clinical translation of these new applications, however, remains associated with a number of obstacles. This report highlights the major issues that impede the clinical translation of advanced tissue engineering concepts, discusses strategies to overcome these barriers, and examines the need to increase incentives for translational strategies. The statements are based on presentations and discussions held at the AO Foundation-sponsored symposium "Where Science meets Clinics 2013" held at the Congress Center in Davos, Switzerland, in September, 2013. The event organisers convened a diverse group of over one hundred stakeholders involved in clinical translation of orthopaedic tissue engineering, including scientists, clinicians, healthcare industry professionals and regulatory agency representatives. A major point that emerged from the discussions was that there continues to be a critical need for early trans-disciplinary communication and collaboration in the development and execution of research approaches. Equally importantly was the need to address the shortage of sustained funding programs for multidisciplinary teams conducting translational research. Such detailed discussions between experts contribute towards the development of a roadmap to more successfully advance the clinical translation of novel tissue engineering concepts and ultimately improve patient care in orthopaedic and trauma surgery.

Anatomy and history of an external quality assessment program for interpretative comments in clinical biochemistry.

PubMed

Vasikaran, Samuel D

2015-05-01

The provision of clinical interpretation of results, either verbally or in the printed report, may be considered an integral part of clinical biochemistry diagnostic service. Proficiency testing or external quality assessment (EQA) of such activity may be useful in education, training, continuing professional development and ensuring the quality of such service. Details of the Patient Report Comments Program (RPCProgram) developed by the Royal College of Pathologists of Australasia (RCPA) Chemical Pathology Quality Assurance Programs Pty Ltd (QAP) is described in this review. The program is aimed at pathologists, clinical scientists and trainees. Registered participants are provided a report with case details and a set of clinical biochemistry results at monthly intervals and submit an interpretative comment for the report. Comments received are broken up into components that are translated into common key phrases. An expert panel evaluates the key phrases, classifies them according to appropriateness and drafts a suggested comment, a case summary and a rationale, which are included in a summary report returned to participants. There is considerable diversity in the quality of interpretative comments received from participants of the PRCProgram. The primary purpose of EQA of interpretative commenting is educational self-assessment, and they are recognized as a continuing professional development activity. Whilst there is some evidence for the utility of interpretative comments in improving patient outcomes, evidence for the utility of EQA in improving quality of comments is awaited. Copyright © 2014 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Australasian emergency physicians: a learning and educational needs analysis. Part one: background and methodology. Profile of FACEM.

PubMed

Dent, Andrew W; Asadpour, Ali; Weiland, Tracey J; Paltridge, Debbie

2008-02-01

Fellows of the Australasian College for Emergency Medicine (FACEM) have opportunities to participate in a range of continuing professional development activities. To inform FACEM and assist those involved in planning continuing professional development interventions for FACEM, we undertook a learning needs analysis of emergency physicians. Exploratory study using survey methodology. Following questionnaire development by iterative feedback with emergency physicians and researchers, a mailed survey was distributed to all FACEM. The survey comprised eight items on work and demographic characteristics of FACEM, and 194 items on attitudes to existing learning opportunities, barriers to learning, and perceived learning needs and preferences. Fifty-eight percent (503/854) of all FACEM surveyed responded to the questionnaire, almost half of whom attained their FACEM after year 2000. The sample comprised mostly males (72.8%) with mean age of the sample 41.6 years, similar to ACEM database. Most respondents reported working in ACEM accredited hospitals (89%), major referral hospitals (54%), and practiced on both children and adults (78%). FACEM reported working on average 26.7 clinical hours per week with those at private hospitals working a greater proportion of clinical hours than other hospital types. As the first of six related reports, this paper documents the methodology used, including questionnaire development, and provides the demographics of responding FACEM, including the clinical and non-clinical hours worked and type of hospital of principal employment.

Emergence of a scientific and commercial research and development infrastructure for human gene therapy.

PubMed

Crofts, Christine; Krimsky, Sheldon

2005-02-01

A research and clinical subfield known as "human gene therapy" has grown rapidly since 1990, when the first human trials were approved in the United States. Using quantitative data, this paper describes and analyzes the research and commercial infrastructure, including academic centers, publications, intellectual property, and biotechnology firms, that has developed around the goal of discovering clinical applications for the modification and transport of DNA to somatic cells. Despite setbacks and few documented successes, the subfield of human gene therapy continues to serve as an influential clinical paradigm for the treatment of inherited and noninherited diseases.

Diverse Applications of Nanomedicine

PubMed Central

2017-01-01

The design and use of materials in the nanoscale size range for addressing medical and health-related issues continues to receive increasing interest. Research in nanomedicine spans a multitude of areas, including drug delivery, vaccine development, antibacterial, diagnosis and imaging tools, wearable devices, implants, high-throughput screening platforms, etc. using biological, nonbiological, biomimetic, or hybrid materials. Many of these developments are starting to be translated into viable clinical products. Here, we provide an overview of recent developments in nanomedicine and highlight the current challenges and upcoming opportunities for the field and translation to the clinic. PMID:28290206

System for the Management of Trauma and Emergency Surgery in Space

NASA Technical Reports Server (NTRS)

Houtchens, B.

1984-01-01

The need to develop a systems approach to the management of trauma and other major clinical medical events in space along with appropriate development and evaluation of surgical techniques and required hardware was investigated. A prototype zero gravity surgical module was constructed and tested aboard a KC-135 aircraft during parabolic arc zero G flight. To insure parity of quality care to that available on Earth, it was recommended that a clinical medical and bioengineering advisory committee define and help develop the necessary components of the clinical medical care system for the space station and lunar base. Key components of the system are aerospace surgical training, medical equipment development, including support hardware and software, rapid access to a network of specialty expertise, and continued research and development.

From staff nurse to nurse consultant.

PubMed

Fowler, John

John Fowler Independent education consultant, continues his series for clinical nurses hoping to share their experiences with a wider audience, with advice on developing a potential article for a professional journal.

Integrated continuous bioprocessing: Economic, operational, and environmental feasibility for clinical and commercial antibody manufacture.

PubMed

Pollock, James; Coffman, Jon; Ho, Sa V; Farid, Suzanne S

2017-07-01

This paper presents a systems approach to evaluating the potential of integrated continuous bioprocessing for monoclonal antibody (mAb) manufacture across a product's lifecycle from preclinical to commercial manufacture. The economic, operational, and environmental feasibility of alternative continuous manufacturing strategies were evaluated holistically using a prototype UCL decisional tool that integrated process economics, discrete-event simulation, environmental impact analysis, operational risk analysis, and multiattribute decision-making. The case study focused on comparing whole bioprocesses that used either batch, continuous or a hybrid combination of batch and continuous technologies for cell culture, capture chromatography, and polishing chromatography steps. The cost of goods per gram (COG/g), E-factor, and operational risk scores of each strategy were established across a matrix of scenarios with differing combinations of clinical development phase and company portfolio size. The tool outputs predict that the optimal strategy for early phase production and small/medium-sized companies is the integrated continuous strategy (alternating tangential flow filtration (ATF) perfusion, continuous capture, continuous polishing). However, the top ranking strategy changes for commercial production and companies with large portfolios to the hybrid strategy with fed-batch culture, continuous capture and batch polishing from a COG/g perspective. The multiattribute decision-making analysis highlighted that if the operational feasibility was considered more important than the economic benefits, the hybrid strategy would be preferred for all company scales. Further considerations outside the scope of this work include the process development costs required to adopt continuous processing. © 2017 The Authors Biotechnology Progress published by Wiley Periodicals, Inc. on behalf of American Institute of Chemical Engineers Biotechnol. Prog., 33:854-866, 2017. © 2017 The Authors Biotechnology Progress published by Wiley Periodicals, Inc. on behalf of American Institute of Chemical Engineers.

Integrated continuous bioprocessing: Economic, operational, and environmental feasibility for clinical and commercial antibody manufacture

PubMed Central

Pollock, James; Coffman, Jon; Ho, Sa V.

2017-01-01

This paper presents a systems approach to evaluating the potential of integrated continuous bioprocessing for monoclonal antibody (mAb) manufacture across a product's lifecycle from preclinical to commercial manufacture. The economic, operational, and environmental feasibility of alternative continuous manufacturing strategies were evaluated holistically using a prototype UCL decisional tool that integrated process economics, discrete‐event simulation, environmental impact analysis, operational risk analysis, and multiattribute decision‐making. The case study focused on comparing whole bioprocesses that used either batch, continuous or a hybrid combination of batch and continuous technologies for cell culture, capture chromatography, and polishing chromatography steps. The cost of goods per gram (COG/g), E‐factor, and operational risk scores of each strategy were established across a matrix of scenarios with differing combinations of clinical development phase and company portfolio size. The tool outputs predict that the optimal strategy for early phase production and small/medium‐sized companies is the integrated continuous strategy (alternating tangential flow filtration (ATF) perfusion, continuous capture, continuous polishing). However, the top ranking strategy changes for commercial production and companies with large portfolios to the hybrid strategy with fed‐batch culture, continuous capture and batch polishing from a COG/g perspective. The multiattribute decision‐making analysis highlighted that if the operational feasibility was considered more important than the economic benefits, the hybrid strategy would be preferred for all company scales. Further considerations outside the scope of this work include the process development costs required to adopt continuous processing. © 2017 The Authors Biotechnology Progress published by Wiley Periodicals, Inc. on behalf of American Institute of Chemical Engineers Biotechnol. Prog., 33:854–866, 2017 PMID:28480535

21 CFR 862.2150 - Continuous flow sequential multiple chemistry analyzer for clinical use.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Continuous flow sequential multiple chemistry..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862.2150 Continuous flow sequential multiple chemistry...

21 CFR 862.2150 - Continuous flow sequential multiple chemistry analyzer for clinical use.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Continuous flow sequential multiple chemistry..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862.2150 Continuous flow sequential multiple chemistry...

21 CFR 862.2150 - Continuous flow sequential multiple chemistry analyzer for clinical use.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Continuous flow sequential multiple chemistry..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862.2150 Continuous flow sequential multiple chemistry...

21 CFR 862.2150 - Continuous flow sequential multiple chemistry analyzer for clinical use.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Continuous flow sequential multiple chemistry..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862.2150 Continuous flow sequential multiple chemistry...

21 CFR 862.2150 - Continuous flow sequential multiple chemistry analyzer for clinical use.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Continuous flow sequential multiple chemistry..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory Instruments § 862.2150 Continuous flow sequential multiple chemistry...

[How to write, how to implement and how to evaluate a practice guideline in order to improve quality of care?].

PubMed

Moret, L; Lefort, C; Terrien, N

2012-11-01

Initiatives of clinical practices improvement have been gradually developing in France for 20 years. Nevertheless, effective implementation of change is still difficult for numerous reasons. The use of clinical practices guidelines is one of the different ways of improvement. It is however necessary to adapt these national guidelines to the specificities of the hospital and the team, to ensure implementation and appropriation by the professionals. These recommendations are thus translated into applicable and concrete standard operating procedures. These documents have to be built by and for the concerned professionals. They are also communication and training tools, precise, directive, uniform in terms of presentation and attractive visually. Once drafted, they have to be distributed widely to the professionals to facilitate implementation. The simple distribution of the recommendations is insufficient to modify the clinical practices and require association of several methods of promotion for an optimal appropriation. How then to make sure of their effective use? Practices evaluation is one of the steps of continuous professional development, including continuous training and analysis of clinical practices by using methods promoted by the "Haute Autorité de santé". One of them is the clinical audit; use of method assessing non-pertinent treatment is interesting too. Analysis of the non-conformities and gaps between theory and practice allows identifying various possible causes (professional, institutional, organizational or personal) in order to implement corrective action plans, in a logic of continuous improvement. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

Continuous Practice-Based Research on the Use of Standardized Patients: Experience from Shanghai Medical College of Fudan University

ERIC Educational Resources Information Center

Zeng, Yong; Wu, Yan; Lai, Yanni; Lu, Yingqing; Zou, Hejian; Feng, Xueshan

2014-01-01

In the past ten years, the objective structured clinical examination (OSCE) project team of the Shanghai Medical College of Fudan University has continuously conducted further study on the development and maintenance of standardized patients and their application in teaching. The team carried out a series of randomized controlled studies on the…

A novel mentorship programme for residents integrating academic development, clinical teaching and graduate medical education assessment.

PubMed

Bhatia, Kriti; Takayesu, James Kimo; Nadel, Eric S

2016-02-01

Mentorship fosters career development and growth. During residency training, mentorship should support clinical development along with intellectual and academic interests. Reported resident mentoring programmes do not typically include clinical components. We designed a programme that combines academic development with clinical feedback and assessment in a four-year emergency medicine residency programme. Incoming interns were assigned an advisor. At the conclusion of the intern year, residents actively participated in selecting a mentor for the duration of residency. The programme consisted of quarterly meetings, direct clinical observation and specific competency assessment, assistance with lecture preparation, real-time feedback on presentations, simulation coaching sessions, and discussions related to career development. Faculty participation was recognized as a valuable component of the annual review process. Residents were surveyed about the overall programme and individual components. Over 88 % of the respondents said that the programme was valuable and should be continued. Senior residents most valued the quarterly meetings and presentation help and feedback. Junior residents strongly valued the clinical observation and simulation sessions. A comprehensive mentorship programme integrating clinical, professional and academic development provides residents individualized feedback and coaching and is valued by trainees. Individualized assessment of clinical competencies can be conducted through such a programme.

A dedicated undergraduate gynaecology teaching clinic: The Keele experience.

PubMed

Katali, Hamza Mahamadu; Parry-Smith, William Rhys; Eliot, Rees L; O'Mahony, Fidelma

2016-01-01

Much discussion in the literature centres on how best to teach medical students the intricacies of gynaecological assessment and the subsequent formulation of a management plan. At Keele University skills are initially developed in a simulated setting and then transferred to the workplace where students continue to develop their skills. A dedicated undergraduate gynaecology teaching clinic has been developed and comprises of 2-3 students and a tutor. All 38 students rotating through the department between January and June 2013 were invited to complete an anonymous questionnaire to evaluate this clinic and 36 (95%) of them responded. Respondents felt significantly more comfortable taking a gynaecology history, ensuring privacy during examination and formulating a management plan post-clinic (all p < 0.001), with female students feeling significantly more comfortable than their male counterparts (p = 0.04). The use of this clinic shows great promise to help students learn an unfamiliar and challenging skill.

Long-term Continuous EEG Monitoring in Small Rodent Models of Human Disease Using the Epoch Wireless Transmitter System

PubMed Central

Zayachkivsky, Andrew; Lehmkuhle, Mark J.; Dudek, F. Edward

2015-01-01

Many progressive neurologic diseases in humans, such as epilepsy, require pre-clinical animal models that slowly develop the disease in order to test interventions at various stages of the disease process. These animal models are particularly difficult to implement in immature rodents, a classic model organism for laboratory study of these disorders. Recording continuous EEG in young animal models of seizures and other neurological disorders presents a technical challenge due to the small physical size of young rodents and their dependence on the dam prior to weaning. Therefore, there is not only a clear need for improving pre-clinical research that will better identify those therapies suitable for translation to the clinic but also a need for new devices capable of recording continuous EEG in immature rodents. Here, we describe the technology behind and demonstrate the use of a novel miniature telemetry system, specifically engineered for use in immature rats or mice, which is also effective for use in adult animals. PMID:26274779

Lidocaine/monoethylglycinexylidide test, galactose elimination test, and sorbitol elimination test for metabolic assessment of liver cell bioreactors.

PubMed

Gerlach, Jörg C; Brayfield, Candace; Puhl, Gero; Borneman, Reiner; Müller, Christian; Schmelzer, Eva; Zeilinger, Katrin

2010-06-01

Various metabolic tests were compared for the performance characterization of a liver cell bioreactor as a routine function assessment of cultures in a standby for patient application in clinical studies. Everyday quality assessment (QA) is essential to ensure a continuous level of cellular functional capacity in the development of hepatic progenitor cell expansion systems providing cells for regenerative medicine research; it is also of interest to meet safety requirements in bioartificial extracorporeal liver support systems under clinical evaluation. Quality criteria for the description of bioreactor cultures were developed using primary porcine liver cells as a model. Porcine liver cells isolated by collagenase perfusion with an average of 3 x 10(9) primary cells were used in 39 bioreactors for culture periods up to 33 days. Measurements of monoethylglycinexylidide synthesis and elimination of lidocaine, galactose elimination, and sorbitol elimination proved to be useful for routine QA of primary liver cell cultures. We demonstrate two methods for dispensing test substances, bolus administration and continuous, steady-state administration. Bolus test data were grouped in Standard, Therapy, Infection/Contamination, and Cell-free control groups. Statistical analyses show significant differences among all groups for every test substance. Post hoc comparisons indicated significant differences between Standard and Cell-free groups for all elimination parameters. For continuous tests, results were categorized according to number of culture days and time-dependent changes were analyzed. Continuous administration enables a better view of culture health and the time dependency of cellular function, whereas bolus administration is more flexible. Both procedures can be used to define cell function. Assessment of cellular function and bioreactor quality can contribute significantly to the quality of experimental or clinical studies in the field of hepatic bioreactor development.

A Methodology for Anatomic Ultrasound Image Diagnostic Quality Assessment.

PubMed

Hemmsen, Martin Christian; Lange, Theis; Brandt, Andreas Hjelm; Nielsen, Michael Bachmann; Jensen, Jorgen Arendt

2017-01-01

This paper discusses the methods for the assessment of ultrasound image quality based on our experiences with evaluating new methods for anatomic imaging. It presents a methodology to ensure a fair assessment between competing imaging methods using clinically relevant evaluations. The methodology is valuable in the continuing process of method optimization and guided development of new imaging methods. It includes a three phased study plan covering from initial prototype development to clinical assessment. Recommendations to the clinical assessment protocol, software, and statistical analysis are presented. Earlier uses of the methodology has shown that it ensures validity of the assessment, as it separates the influences between developer, investigator, and assessor once a research protocol has been established. This separation reduces confounding influences on the result from the developer to properly reveal the clinical value. This paper exemplifies the methodology using recent studies of synthetic aperture sequential beamforming tissue harmonic imaging.

Defining quality criteria for online continuing medical education modules using modified nominal group technique.

PubMed

Shortt, S E D; Guillemette, Jean-Marc; Duncan, Anne Marie; Kirby, Frances

2010-01-01

The rapid increase in the use of the Internet for continuing education by physicians suggests the need to define quality criteria for accredited online modules. Continuing medical education (CME) directors from Canadian medical schools and academic researchers participated in a consensus process, Modified Nominal Group Technique, to develop agreement on the most important quality criteria to guide module development. Rankings were compared to responses to a survey of a subset of Canadian Medical Association (CMA) members. A list of 17 items was developed, of which 10 were deemed by experts to be important and 7 were considered secondary. A quality module would: be needs-based; presented in a clinical format; utilize evidence-based information; permit interaction with content and experts; facilitate and attempt to document practice change; be accessible for later review; and include a robust course evaluation. There was less agreement among CMA members on criteria ranking, with consensus on ranking reached on only 12 of 17 items. In contrast to experts, members agreed that the need to assess performance change as a result of an educational experience was not important. This project identified 10 quality criteria for accredited online CME modules that representatives of Canadian organizations involved in continuing education believe should be taken into account when developing learning products. The lack of practitioner support for documentation of change in clinical behavior may suggest that they favor traditional attendance- or completion-based CME; this finding requires further research.

Consensus guidelines for the diagnosis and management of patients with classic hairy cell leukemia.

PubMed

Grever, Michael R; Abdel-Wahab, Omar; Andritsos, Leslie A; Banerji, Versha; Barrientos, Jacqueline; Blachly, James S; Call, Timothy G; Catovsky, Daniel; Dearden, Claire; Demeter, Judit; Else, Monica; Forconi, Francesco; Gozzetti, Alessandro; Ho, Anthony D; Johnston, James B; Jones, Jeffrey; Juliusson, Gunnar; Kraut, Eric; Kreitman, Robert J; Larratt, Loree; Lauria, Francesco; Lozanski, Gerard; Montserrat, Emili; Parikh, Sameer A; Park, Jae H; Polliack, Aaron; Quest, Graeme R; Rai, Kanti R; Ravandi, Farhad; Robak, Tadeusz; Saven, Alan; Seymour, John F; Tadmor, Tamar; Tallman, Martin S; Tam, Constantine; Tiacci, Enrico; Troussard, Xavier; Zent, Clive S; Zenz, Thorsten; Zinzani, Pier Luigi; Falini, Brunangelo

2017-02-02

Hairy cell leukemia is an uncommon hematologic malignancy characterized by pancytopenia and marked susceptibility to infection. Tremendous progress in the management of patients with this disease has resulted in high response rates and improved survival, yet relapse and an appropriate approach to re-treatment present continuing areas for research. The disease and its effective treatment are associated with immunosuppression. Because more patients are being treated with alternative programs, comparison of results will require general agreement on definitions of response, relapse, and methods of determining minimal residual disease. The development of internationally accepted, reproducible criteria is of paramount importance in evaluating and comparing clinical trials to provide optimal care. Despite the success achieved in managing these patients, continued participation in available clinical trials in the first-line and particularly in the relapse setting is highly recommended. The Hairy Cell Leukemia Foundation convened an international conference to provide common definitions and structure to guide current management. There is substantial opportunity for continued research in this disease. In addition to the importance of optimizing the prevention and management of the serious risk of infection, organized evaluations of minimal residual disease and treatment at relapse offer ample opportunities for clinical research. Finally, a scholarly evaluation of quality of life in the increasing number of survivors of this now manageable chronic illness merits further study. The development of consensus guidelines for this disease offers a framework for continued enhancement of the outcome for patients.

Consensus guidelines for the diagnosis and management of patients with classic hairy cell leukemia

PubMed Central

Abdel-Wahab, Omar; Andritsos, Leslie A.; Banerji, Versha; Barrientos, Jacqueline; Blachly, James S.; Call, Timothy G.; Catovsky, Daniel; Dearden, Claire; Demeter, Judit; Else, Monica; Forconi, Francesco; Gozzetti, Alessandro; Ho, Anthony D.; Johnston, James B.; Jones, Jeffrey; Juliusson, Gunnar; Kraut, Eric; Kreitman, Robert J.; Larratt, Loree; Lauria, Francesco; Lozanski, Gerard; Montserrat, Emili; Parikh, Sameer A.; Park, Jae H.; Polliack, Aaron; Quest, Graeme R.; Rai, Kanti R.; Ravandi, Farhad; Robak, Tadeusz; Saven, Alan; Seymour, John F.; Tadmor, Tamar; Tallman, Martin S.; Tam, Constantine; Tiacci, Enrico; Troussard, Xavier; Zent, Clive S.; Zenz, Thorsten; Zinzani, Pier Luigi; Falini, Brunangelo

2017-01-01

Hairy cell leukemia is an uncommon hematologic malignancy characterized by pancytopenia and marked susceptibility to infection. Tremendous progress in the management of patients with this disease has resulted in high response rates and improved survival, yet relapse and an appropriate approach to re-treatment present continuing areas for research. The disease and its effective treatment are associated with immunosuppression. Because more patients are being treated with alternative programs, comparison of results will require general agreement on definitions of response, relapse, and methods of determining minimal residual disease. The development of internationally accepted, reproducible criteria is of paramount importance in evaluating and comparing clinical trials to provide optimal care. Despite the success achieved in managing these patients, continued participation in available clinical trials in the first-line and particularly in the relapse setting is highly recommended. The Hairy Cell Leukemia Foundation convened an international conference to provide common definitions and structure to guide current management. There is substantial opportunity for continued research in this disease. In addition to the importance of optimizing the prevention and management of the serious risk of infection, organized evaluations of minimal residual disease and treatment at relapse offer ample opportunities for clinical research. Finally, a scholarly evaluation of quality of life in the increasing number of survivors of this now manageable chronic illness merits further study. The development of consensus guidelines for this disease offers a framework for continued enhancement of the outcome for patients. PMID:27903528

Dedicated Education Unit: an innovative clinical partner education model.

PubMed

Moscato, Susan Randles; Miller, Judith; Logsdon, Karen; Weinberg, Stephen; Chorpenning, Lori

2007-01-01

This article describes the implementation and evaluation of the Dedicated Education Unit (DEU) as an innovative model of clinical nursing education. A partnership of nurse executives, staff nurses and faculty transformed patient care units into environments of support for nursing students and staff nurses while continuing the critical work of providing quality care to acutely ill adults. Various methods were used to obtain formative data during the implementation of this model in which staff nurses assumed the role of nursing instructors. Results showed high student and nurse satisfaction and a marked increase in clinical capacity that allowed for increased enrollment. This article reports on a 3-year project to operationalize the DEU concept with 6 nursing units in 3 hospitals. The development of staff nurses as clinical instructors, best practices to teach and evaluate critical thinking in students, and the mix of student learners continue as focus areas.

Efficacy of a pressure-sensing mattress cover system for reducing interface pressure: study protocol for a randomized controlled trial.

PubMed

Wong, Holly; Kaufman, Jaime; Baylis, Barry; Conly, John M; Hogan, David B; Stelfox, Henry T; Southern, Danielle A; Ghali, William A; Ho, Chester H

2015-09-29

Interface pressure is a key risk factor in the development of pressure ulcers. Visual feedback of continuous interface pressure between the body and support surface could inform clinicians on repositioning strategies and play a key role in an overall strategy for the prevention and management of pressure ulcers. A parallel two-group randomized controlled clinical trial will be conducted to study the effect of continuous pressure imaging on reducing interface pressure and on the incidence of pressure ulcers in vulnerable hospital patients. A total of 678 eligible consenting inpatients at risk of pressure ulcer development in a tertiary acute care institution will be randomly allocated to either having the ForeSite PT™ system with the liquid-crystal display monitor turned on to provide visual feedback to the clinicians while also collecting continuous interface pressure data (intervention group) or to having the ForeSite PT™ system with monitor turned off (that is, not providing visual feedback) but still collecting continuous interface pressure data (control group), in a ratio of 1:1. Continuous interface pressure data will be collected in both groups for 3 days (72 h). Data collection will continue until discharge for a subset of approximately 60 patients. The primary outcome will be the differences in the two groups' interface pressure analysis. Interface pressure readings will be collected through hourly samplings of continuous interface pressure recordings. Secondary outcomes will be the differences between the two groups in pressure-related skin and soft tissue changes in areas at risk of pressure ulcer (obtained at baseline within 24 h of admission) and on the third day of the trial or at discharge and perceptions of the intervention by patients and clinicians (obtained on the third day or at discharge). This will be the first randomized controlled trial to investigate the effect of visual feedback with continuous interface pressure of vulnerable hospital patients across different care settings, and the association between interface pressure and development of pressure-related skin and soft tissue changes. The results could provide important information to guide clinical practice in the prevention and management of pressure ulcers. ClinicalTrials.gov NCT02325388 (date of registration: 24 December 2014).

A competency-based approach to nurses' continuing education for clinical reasoning and leadership through reflective practice in a care situation.

PubMed

Goudreau, Johanne; Pepin, Jacinthe; Larue, Caroline; Dubois, Sylvie; Descôteaux, Renée; Lavoie, Patrick; Dumont, Katia

2015-11-01

Newly graduated nurses need to demonstrate high levels of competencies when they enter the workplace. A competency-based approach to their education is recommended to ensure patients' needs are met. A continuing education intervention consistent with the competency-based approach to education was designed and implemented in eight care units in two teaching hospitals. It consists of a series of 30-min reflective practice groups on clinical events that newly graduated nurses encountered in their practice. It was evaluated using a descriptive longitudinal evaluative research design, combining individual and group interviews with stakeholders, the analysis of facilitators' journal entries, and a research assistant's field notes. The results suggest that issues associated with the implementation of the continuing education intervention revolved around leadership for managers, flexibility for nursing staff, and role shifting for the facilitators. Newly graduated nurses who participated in the study noted that the reflective practice sessions contributed to the development of both clinical reasoning and leadership. Nursing managers stated the advantages of the intervention on nurses' professional development and for the quality and safety of care. Following the end of the study, participants from two units managed to pursue the activity during their work time. Copyright © 2015 Elsevier Ltd. All rights reserved.

Excellence in clinical teaching: knowledge transformation and development required.

PubMed

Irby, David M

2014-08-01

Clinical teachers in medicine face the daunting task of mastering the many domains of knowledge needed for practice and teaching. The breadth and complexity of this knowledge continue to increase, as does the difficulty of transforming the knowledge into concepts that are understandable to learners. Properly targeted faculty development has the potential to expedite the knowledge transformation process for clinical teachers. Based on my own research in clinical teaching and faculty development, as well as the work of others, I describe the unique forms of clinical teacher knowledge, the transformation of that knowledge for teaching purposes and implications for faculty development. The following forms of knowledge for clinical teaching in medicine need to be mastered and transformed: (i) knowledge of medicine and patients; (ii) knowledge of context; (iii) knowledge of pedagogy and learners, and (iv) knowledge integrated into teaching scripts. This knowledge is employed and conveyed through the parallel processes of clinical reasoning and clinical instructional reasoning. Faculty development can facilitate this knowledge transformation process by: (i) examining, deconstructing and practising new teaching scripts; (ii) focusing on foundational concepts; (iii) demonstrating knowledge-in-use, and (iv) creating a supportive organisational climate for clinical teaching. To become an excellent clinical teacher in medicine requires the transformation of multiple forms of knowledge for teaching purposes. These domains of knowledge allow clinical teachers to provide tailored instruction to learners at varying levels in the context of fast-paced and demanding clinical practice. Faculty development can facilitate this knowledge transformation process. © 2014 John Wiley & Sons Ltd.

Point-of-care diagnostics: extending the laboratory network to reach the last mile.

PubMed

Drain, Paul K; Rousseau, Christine

2017-03-01

More point-of-care (POC) diagnostic tests are becoming available for HIV diagnosis and treatment in resource-limited settings. These novel technologies have the potential to foster decentralized HIV care and treatment for the benefit of clinical laboratories, HIV clinics, and HIV-infected patients. There continue to be many business, technological, and operational challenges that limit product development and regulatory approval, which limits products available for the required operational and cost-effectiveness studies and delays policy adoption and implementation. Although the rapid HIV diagnostic test has been widely successful, the pathways for POC CD4 cell count and HIV viral load assay analyzers have been more challenging. We describe significant hurdles for product development, approval, and implementation, which include the business case, technical development, clinical impact, and integrating laboratory and clinical networks. The objective of this review is to highlight the obstacles for developing and implementing appropriate strategies for POC HIV testing assays to improve the clinical services for HIV-infected patients in resource-limited settings.

Clinic Design and Continuity in Internal Medicine Resident Clinics: Findings of the Educational Innovations Project Ambulatory Collaborative.

PubMed

Francis, Maureen D; Wieland, Mark L; Drake, Sean; Gwisdalla, Keri Lyn; Julian, Katherine A; Nabors, Christopher; Pereira, Anne; Rosenblum, Michael; Smith, Amy; Sweet, David; Thomas, Kris; Varney, Andrew; Warm, Eric; Wininger, David; Francis, Mark L

2015-03-01

Many internal medicine (IM) programs have reorganized their resident continuity clinics to improve trainees' ambulatory experience. Downstream effects on continuity of care and other clinical and educational metrics are unclear. This multi-institutional, cross-sectional study included 713 IM residents from 12 programs. Continuity was measured using the usual provider of care method (UPC) and the continuity for physician method (PHY). Three clinic models (traditional, block, and combination) were compared using analysis of covariance. Multivariable linear regression analysis was used to analyze the effect of practice metrics and clinic model on continuity. UPC, reflecting continuity from the patient perspective, was significantly different, and was highest in the block model, midrange in combination model, and lowest in the traditional model programs. PHY, reflecting continuity from the perspective of the resident provider, was significantly lower in the block model than in combination and traditional programs. Panel size, ambulatory workload, utilization, number of clinics attended in the study period, and clinic model together accounted for 62% of the variation found in UPC and 26% of the variation found in PHY. Clinic model appeared to have a significant effect on continuity measured from both the patient and resident perspectives. Continuity requires balance between provider availability and demand for services. Optimizing this balance to maximize resident education, and the health of the population served, will require consideration of relevant local factors and priorities in addition to the clinic model.

Clinic Design and Continuity in Internal Medicine Resident Clinics: Findings of the Educational Innovations Project Ambulatory Collaborative

PubMed Central

Francis, Maureen D.; Wieland, Mark L.; Drake, Sean; Gwisdalla, Keri Lyn; Julian, Katherine A.; Nabors, Christopher; Pereira, Anne; Rosenblum, Michael; Smith, Amy; Sweet, David; Thomas, Kris; Varney, Andrew; Warm, Eric; Wininger, David; Francis, Mark L.

2015-01-01

Background Many internal medicine (IM) programs have reorganized their resident continuity clinics to improve trainees' ambulatory experience. Downstream effects on continuity of care and other clinical and educational metrics are unclear. Methods This multi-institutional, cross-sectional study included 713 IM residents from 12 programs. Continuity was measured using the usual provider of care method (UPC) and the continuity for physician method (PHY). Three clinic models (traditional, block, and combination) were compared using analysis of covariance. Multivariable linear regression analysis was used to analyze the effect of practice metrics and clinic model on continuity. Results UPC, reflecting continuity from the patient perspective, was significantly different, and was highest in the block model, midrange in combination model, and lowest in the traditional model programs. PHY, reflecting continuity from the perspective of the resident provider, was significantly lower in the block model than in combination and traditional programs. Panel size, ambulatory workload, utilization, number of clinics attended in the study period, and clinic model together accounted for 62% of the variation found in UPC and 26% of the variation found in PHY. Conclusions Clinic model appeared to have a significant effect on continuity measured from both the patient and resident perspectives. Continuity requires balance between provider availability and demand for services. Optimizing this balance to maximize resident education, and the health of the population served, will require consideration of relevant local factors and priorities in addition to the clinic model. PMID:26217420

The National Health Service Knowledge and Skills Framework and its implications for continuing professional development in nursing.

PubMed

Gould, Dinah; Berridge, Emma-Jane; Kelly, Daniel

2007-01-01

The National Health Service Knowledge and Skills Framework has been introduced as part of the Agenda for Change Reforms in the United Kingdom to link pay and career progression to competency. The purpose of this paper is to consider the implications for nurses, their managers and the impact on university departments delivering continuing professional development for nurses. The new system has the potential to increase the human resources management aspect of the clinical nurse managers' role and could have legal implications, for example if practitioners perceive that their needs for continuing professional development have been overlooked to the detriment of their pay and career aspirations. The new system also has implications for providers of continuing professional development in the universities and is likely to demand closer liaison between education providers and trust staff who commission education and training. The Knowledge and Skills Framework is of interest to nurses and nurse educators internationally because the system, if effective, could be introduced elsewhere.

Antibiotics in the clinical pipeline in 2013.

PubMed

Butler, Mark S; Blaskovich, Mark A; Cooper, Matthew A

2013-10-01

The continued emergence of multi-drug-resistant bacteria is a major public health concern. The identification and development of new antibiotics, especially those with new modes of action, is imperative to help treat these infections. This review lists the 22 new antibiotics launched since 2000 and details the two first-in-class antibiotics, fidaxomicin (1) and bedaquiline (2), launched in 2011 and 2012, respectively. The development status, mode of action, spectra of activity, historical discovery and origin of the drug pharmacophore (natural product, natural product derived, synthetic or protein/mammalian peptide) of the 49 compounds and 6 β-lactamase/β-lactam combinations in active clinical development are discussed, as well as compounds that have been discontinued from clinical development since 2011. New antibacterial pharmacophore templates are also reviewed and analyzed.

An emerging playbook for antibody-drug conjugates: lessons from the laboratory and clinic suggest a strategy for improving efficacy and safety.

PubMed

Drake, Penelope M; Rabuka, David

2015-10-01

Antibody-drug conjugates (ADCs) have become de rigueur for pharmaceutical oncology drug development pipelines. There are more than 40 ADCs undergoing clinical trials and many more in preclinical development. The field has rushed to follow the initial successes of Kadcyla™ and Adcetris™, and moved forward with new targets without much pause for optimization. In some respects, the ADC space has become divided into the clinical realm-where the proven technologies continue to represent the bulk of clinical candidates with a few exceptions-and the research realm-where innovations in conjugation chemistry and linker technologies have suggested that there is much room for improvement in the conventional methods. Now, two and four years after the approvals of Kadcyla™ and Adcetris™, respectively, consensus may at last be building that these two drugs rely on rather unique target antigens that enable their success. It is becoming increasingly clear that future target antigens will require additional innovative approaches. Next-generation ADCs have begun to move out of the lab and into the clinic, where there is a pressing need for continued innovation to overcome the twin challenges of safety and efficacy. Copyright © 2015 Elsevier Ltd. All rights reserved.

Development of a Diagnostic Clinical Score for Hemodynamically Significant Patent Ductus Arteriosus

PubMed Central

Kindler, Annemarie; Seipolt, Barbara; Heilmann, Antje; Range, Ursula; Rüdiger, Mario; Hofmann, Sigrun Ruth

2017-01-01

There is no consensus about the hemodynamic significance and, therefore, the need to treat a persistent ductus arteriosus in preterm newborns. Since the diagnosis of a hemodynamically significant persistent ductus arteriosus (hsPDA) is made by a summary of non-uniform echo-criteria in combination with the clinical deterioration of the preterm neonate, standardized clinical and ultrasound scoring systems are needed. The objective of this study was the development of a clinical score for the detection and follow-up of hsPDA. In this observational cohort study of 154 preterm neonates (mean gestational age 28.1 weeks), clinical signs for the development of hsPDA were recorded in a standardized score and compared to echocardiography. Analyzing the significance of single score parameters compared to the diagnosis by echocardiography, we developed a short clinical score (calculated sensitivity 84% and specificity 80%). In conclusion, this clinical diagnostic PDA score is non-invasive and quickly to implement. The continuous assessment of defined clinical parameters allows for a more precise diagnosis of hemodynamic significance of PDA and, therefore, should help to detect preterm neonates needing PDA-treatment. The score, therefore, allows a more targeted use of echocardiography in these very fragile preterm neonates. PMID:29312911

Factors affecting knowledge transfer from continuing professional education to clinical practice: Development and psychometric properties of a new instrument.

PubMed

Vasli, Parvaneh; Dehghan-Nayeri, Nahid; Khosravi, Laleh

2018-01-01

Despite the emphasis placed on the implementation of continuing professional education programs in Iran, researchers or practitioners have not developed an instrument for assessing the factors that affect the knowledge transfer from such programs to clinical practice. The aim of this study was to design and validate such instrument for the Iranian context. The research used a three-stage mix method. In the first stage, in-depth interviews with nurses and content analysis were conducted, after which themes were extracted from the data. In the second stage, the findings of the content analysis and literature review were examined, and preliminary instrument options were developed. In the third stage, qualitative content validity, face validity, content validity ratio, content validity index, and construct validity using exploratory factor analysis was conducted. The reliability of the instrument was measured before and after the determination of construct validity. Primary tool instrument initially comprised 53 items, and its content validity index was 0.86. In the multi-stage factor analysis, eight questions were excluded, thereby reducing 11 factors to five and finally, to four. The final instrument with 43 items consists of the following dimensions: structure and organizational climate, personal characteristics, nature and status of professionals, and nature of educational programs. Managers can use the Iranian instrument to identify factors affecting knowledge transfer of continuing professional education to clinical practice. Copyright © 2017. Published by Elsevier Ltd.

75 FR 66766 - NIAID Blue Ribbon Panel Meeting on Adjuvant Discovery and Development

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-29

..., identifies gaps in knowledge and capabilities, and defines NIAID's goals for the continued discovery... DEPARTMENT OF HEALTH AND HUMAN SERVICES NIAID Blue Ribbon Panel Meeting on Adjuvant Discovery and... agenda for the discovery, development and clinical evaluation of adjuvants for use with preventive...

Clinical Trials in a Dish: A Perspective on the Coming Revolution in Drug Development.

PubMed

Fermini, Bernard; Coyne, Shawn T; Coyne, Kevin P

2018-05-01

The pharmaceutical industry is facing unprecedented challenges as the cost of developing new drugs has reached unsustainable levels, fueled in large parts by a high attrition rate in clinical development. Strategies to bridge studies between preclinical testing and clinical trials are needed to reduce the knowledge gap and allow earlier decisions to be made on the continuation or discontinuation of further development of drugs. The discovery and development of human induced pluripotent stem cells (hiPSCs) have opened up new avenues that support the concept of screening for cell-based safety and toxicity at the level of a population. This approach, termed "Clinical Trials in a Dish" (CTiD), allows testing medical therapies for safety or efficacy on cells collected from a representative sample of human patients, before moving into actual clinical trials. It can be applied to the development of drugs for specific populations, and it allows predicting not only the magnitude of effects but also the incidence of patients in a population who will benefit or be harmed by these drugs. This, in turn, can lead to the selection of safer drugs to move into clinical development, resulting in a reduction in attrition. The current article offers a perspective of this new model for "humanized" preclinical drug development.

Enabling breakthroughs in Parkinson’s disease with wearable technologies and big data analytics

PubMed Central

Cohen, Shahar; Martig, Adria K.

2016-01-01

Parkinson’s disease (PD) is a progressive, degenerative disorder of the central nervous system that is diagnosed and measured clinically by the Unified Parkinson’s Disease Rating Scale (UPDRS). Tools for continuous and objective monitoring of PD motor symptoms are needed to complement clinical assessments of symptom severity to further inform PD therapeutic development across several arenas, from developing more robust clinical trial outcome measures to establishing biomarkers of disease progression. The Michael J. Fox Foundation for Parkinson’s Disease Research and Intel Corporation have joined forces to develop a mobile application and an Internet of Things (IoT) platform to support large-scale studies of objective, continuously sampled sensory data from people with PD. This platform provides both population and per-patient analyses, measuring gait, activity level, nighttime activity, tremor, as well as other structured assessments and tasks. All data collected will be available to researchers on an open-source platform. Development of the IoT platform raised a number of engineering considerations, including wearable sensor choice, data management and curation, and algorithm validation. This project has successfully demonstrated proof of concept that IoT platforms, wearable technologies and the data they generate offer exciting possibilities for more robust, reliable, and low-cost research methodologies and patient care strategies. PMID:28293596

Enabling breakthroughs in Parkinson's disease with wearable technologies and big data analytics.

PubMed

Cohen, Shahar; Bataille, Lauren R; Martig, Adria K

2016-01-01

Parkinson's disease (PD) is a progressive, degenerative disorder of the central nervous system that is diagnosed and measured clinically by the Unified Parkinson's Disease Rating Scale (UPDRS). Tools for continuous and objective monitoring of PD motor symptoms are needed to complement clinical assessments of symptom severity to further inform PD therapeutic development across several arenas, from developing more robust clinical trial outcome measures to establishing biomarkers of disease progression. The Michael J. Fox Foundation for Parkinson's Disease Research and Intel Corporation have joined forces to develop a mobile application and an Internet of Things (IoT) platform to support large-scale studies of objective, continuously sampled sensory data from people with PD. This platform provides both population and per-patient analyses, measuring gait, activity level, nighttime activity, tremor, as well as other structured assessments and tasks. All data collected will be available to researchers on an open-source platform. Development of the IoT platform raised a number of engineering considerations, including wearable sensor choice, data management and curation, and algorithm validation. This project has successfully demonstrated proof of concept that IoT platforms, wearable technologies and the data they generate offer exciting possibilities for more robust, reliable, and low-cost research methodologies and patient care strategies.

The Impact of Continuous Medicaid Enrollment on Diagnosis, Treatment, and Survival in Six Surgical Cancers

PubMed Central

Dawes, Aaron J; Louie, Rachel; Nguyen, David K; Maggard-Gibbons, Melinda; Parikh, Punam; Ettner, Susan L; Ko, Clifford Y; Zingmond, David S

2014-01-01

Objective To examine the effect of Medicaid enrollment on the diagnosis, treatment, and survival of six surgically relevant cancers among poor and underserved Californians. Data Sources California Cancer Registry (CCR), California's Patient Discharge Database (PDD), and state Medicaid enrollment files between 2002 and 2008. Study Design We linked clinical and administrative records to differentiate patients continuously enrolled in Medicaid from those receiving coverage at the time of their cancer diagnosis. We developed multivariate logistic regression models to predict death within 1 year for each cancer after controlling for sociodemographic and clinical variables. Data Collection/Extraction Methods All incident cases of six cancers (colon, esophageal, lung, pancreas, stomach, and ovarian) were identified from CCR. CCR records were linked to hospitalizations (PDD) and monthly Medicaid enrollment. Principal Findings Continuous enrollment in Medicaid for at least 6 months prior to diagnosis improves survival in three surgically relevant cancers. Discontinuous Medicaid patients have higher stage tumors, undergo fewer definitive operations, and are more likely to die even after risk adjustment. Conclusions Expansion of continuous insurance coverage under the Affordable Care Act is likely to improve both access and clinical outcomes for cancer patients in California. PMID:25256223

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.

Bridging the gap between primary care and the cancer system

PubMed Central

Sisler, Jeffrey; McCormack-Speak, Pat

2009-01-01

ABSTRACT PROBLEM BEING ADDRESSED Patient care is poorly coordinated between family physicians and the cancer system and the working relationships are not strong. OBJECTIVE OF PROGRAM To improve integration of patient care and communication between FPs and cancer specialists; enhance FPs’ knowledge of cancer and the cancer system; and promote the role of primary care within the cancer care system. PROGRAM DESCRIPTION The Uniting Primary Care and Oncology (UPCON) Network of CancerCare Manitoba has created partnerships with 12 primary care clinics in Winnipeg, Man, by providing the following: access to the provincial electronic medical record for cancer; small group continuing professional development for a “lead physician” from each clinic to make him or her the local cancer resource; educational outreach to all clinic staff; and changes within CancerCare Manitoba to highlight the role of FPs. CONCLUSION Lead physicians are appreciated by their clinic colleagues, and these FPs are the main users of the cancer electronic medical record. A strong cancer continuing professional development program has been implemented and a voice for primary care has been created within the agency. The UPCON Network is now expanding throughout Manitoba. PMID:19282538

ACR Appropriateness Criteria®  Resectable Rectal Cancer

PubMed Central

2012-01-01

The management of resectable rectal cancer continues to be guided by clinical trials and advances in technique. Although surgical advances including total mesorectal excision continue to decrease rates of local recurrence, the management of locally advanced disease (T3-T4 or N+) benefits from a multimodality approach including neoadjuvant concomitant chemotherapy and radiation. Circumferential resection margin, which can be determined preoperatively via MRI, is prognostic. Toxicity associated with radiation therapy is decreased by placing the patient in the prone position on a belly board, however for patients who cannot tolerate prone positioning, IMRT decreases the volume of normal tissue irradiated. The use of IMRT requires knowledge of the patterns of spreads and anatomy. Clinical trials demonstrate high variability in target delineation without specific guidance demonstrating the need for peer review and the use of a consensus atlas. Concomitant with radiation, fluorouracil based chemotherapy remains the standard, and although toxicity is decreased with continuous infusion fluorouracil, oral capecitabine is non-inferior to the continuous infusion regimen. Additional chemotherapeutic agents, including oxaliplatin, continue to be investigated, however currently should only be utilized on clinical trials as increased toxicity and no definitive benefit has been demonstrated in clinical trials. The ACR Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed every two years by a multidisciplinary expert panel. The guideline development and review include an extensive analysis of current medical literature from peer reviewed journals and the application of a well-established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures by the panel. In those instances where evidence is lacking or not definitive, expert opinion may be used to recommend imaging or treatment. PMID:23006527

Predictors of attrition for a sexual assault forensic examiner (SAFE) blended learning training program.

PubMed

Patterson, Debra; Resko, Stella

2015-01-01

Participant attrition is a major concern for online continuing education health care courses. The current study sought to understand what factors predicted health care professionals completing the online component of a sexual assault forensic examiner (SAFE) blended learning training program (12-week online course and 2-day in-person clinical skills workshop). The study used a Web-based survey to examine participant characteristics, motivation, and external barriers that may influence training completion. Hierarchical logistic regression was utilized to examine the predictors of training completion, while the Cox proportional hazards (Cox PH) regression model helped determine the factors associated with the timing of participant attrition. Results show that 79.3% of the enrolled professionals completed the online component. The study also found that clinicians who work in rural communities and those who were interested in a 2-day clinical skills workshop were more likely to complete the online course. In terms of when attrition occurred, we found that participants who were motivated by the 2-day clinical workshop, those who worked in a rural community, and participants interested in the training program because of its online nature were more likely to complete more of the online course. Blending an online course with a brief in-person clinical component may serve as a motivator for completing an online course because it provides the opportunity to develop clinical skills while receiving immediate feedback. Participant attrition appears to be less of a concern for rural clinicians because this modality can reduce their barriers to accessing continuing education. © 2015 The Alliance for Continuing Education in the Health Professions, the Society for Academic Continuing Medical Education, and the Council on Continuing Medical Education, Association for Hospital Medical Education.

Fibrin Sealant: The Only Approved Hemostat, Sealant, and Adhesive—a Laboratory and Clinical Perspective

PubMed Central

Spotnitz, William D.

2014-01-01

Background. Fibrin sealant became the first modern era material approved as a hemostat in the United States in 1998. It is the only agent presently approved as a hemostat, sealant, and adhesive by the Food and Drug Administration (FDA). The product is now supplied as patches in addition to the original liquid formulations. Both laboratory and clinical uses of fibrin sealant continue to grow. The new literature on this material also continues to proliferate rapidly (approximately 200 papers/year). Methods. An overview of current fibrin sealant products and their approved uses and a comprehensive PubMed based review of the recent literature (February 2012, through March 2013) on the laboratory and clinical use of fibrin sealant are provided. Product information is organized into sections based on a classification system for commercially available materials. Publications are presented in sections based on both laboratory research and clinical topics are listed in order of decreasing frequency. Results. Fibrin sealant remains useful hemostat, sealant, and adhesive. New formulations and applications continue to be developed. Conclusions. This agent remains clinically important with the recent introduction of new commercially available products. Fibrin sealant has multiple new uses that should result in further improvements in patient care. PMID:24729902

Organizational Change, Leadership, and the Transformation of Continuing Professional Development: Lessons Learned From the American College of Cardiology.

PubMed

Beliveau, Mary Ellen; Warnes, Carole A; Harrington, Robert A; Nishimura, Rick A; O'Gara, Patrick T; Sibley, Janice B; Oetgen, William J

2015-01-01

There is a need for a transformational change in clinical education. In postgraduate medical education we have traditionally had a faculty-centric model. That is, faculty knew what needed to be taught and who were the best teachers to teach it. They built the agenda, and worked with staff to follow Accreditation Council for Continuing Medical Education (ACCME) accreditation criteria and manage logistics. Changes in the health care marketplace now demand a learner-centric model-one that embraces needs assessments, identification of practice gaps relative to competency, development of learning objectives, contemporary adult learning theory, novel delivery systems, and measurable outcomes. This article provides a case study of one medical specialty society's efforts to respond to this demand. © 2015 The Alliance for Continuing Education in the Health Professions, the Society for Academic Continuing Medical Education, and the Council on Continuing Medical Education, Association for Hospital Medical Education.

The value of mentorship in medical education.

PubMed

Dalgaty, Faith; Guthrie, Greg; Walker, Heather; Stirling, Kevin

2017-04-01

The transition from senior medical student to working safely and effectively as a new junior doctor is one of the biggest challenges that a new graduate will face. In 2014 the General Medical Council published The state of medical education and practice in the UK, reporting that some new doctors continue to struggle with increased responsibilities. We classify these instances as a 'performance gap', describing occasions in clinical practice where an individual exceeds their performance capacity. The Medical Mentorship Programme addressed identified performance gaps through a structured curriculum of simulation-based education and facilitated clinical practice. Programme content was based on the experiences of the authors and their peers in graduating from their undergraduate training programme and becoming junior doctors. A questionnaire was disseminated to junior doctors in their first clinical rotation. The questionnaire asked doctors to describe instances where they experienced a performance gap. These data informed the development of the Medical Mentorship Programme. The effect of this programme was then evaluated via focus group discussion. The Medical Mentorship Programme has been shown to be an effective conduit for supporting the transfer of learning needed to address performance gaps in students. The programme increased the confidence of students in preparation for clinical practice and allowed junior doctors to reflect on their professional development. The programme combined complementary teaching techniques - mentorship, simulation and direct clinical experience - to aid the professional development of both students and mentors. Some new doctors continue to struggle with increased responsibilities. © 2016 John Wiley & Sons Ltd.

Childrens Hospital Integrated Patient Electronic Record System Continuation (CHIPERS)

DTIC Science & Technology

2015-12-01

of our interactive BPAs and order set technology. The Cumberland Group has been the primary consulting group assisting the entire inpatient and...to allow for continued BPA development and iteration during the upgrade period, while also effecting a seamless transition of BPA and order set...clinical decision support system. Our BPA logic includes: Severe Sepsis Alert Logic Summary: Age + Temperature + White Blood Cell and (lethargy or

Peer coaching: the next step in staff development.

PubMed

Waddell, Donna L; Dunn, Nancy

2005-01-01

A common problem in continuing nursing education and staff development is the transfer of learning to clinical practice. Peer coaching offers a solution to this problem. Initiated by educators, peer coaching has been researched in educational settings and found to be effective in facilitating the transfer of newly acquired knowledge and skill into classroom teaching strategies. This article describes the background, components, process, characteristics, and benefits of peer coaching. A specific example of using peer coaching to teach clinical breast examination skills is used to illustrate the application of peer coaching to the staff development of healthcare professionals. Peer coaching is the next step in nursing staff development.

Development and validation of the JAX Cancer Treatment Profile™ for detection of clinically actionable mutations in solid tumors

PubMed Central

Ananda, Guruprasad; Mockus, Susan; Lundquist, Micaela; Spotlow, Vanessa; Simons, Al; Mitchell, Talia; Stafford, Grace; Philip, Vivek; Stearns, Timothy; Srivastava, Anuj; Barter, Mary; Rowe, Lucy; Malcolm, Joan; Bult, Carol; Karuturi, Radha Krishna Murthy; Rasmussen, Karen; Hinerfeld, Douglas

2015-01-01

Background The continued development of targeted therapeutics for cancer treatment has required the concomitant development of more expansive methods for the molecular profiling of the patient’s tumor. We describe the validation of the JAX Cancer Treatment Profile™ (JAX-CTP™), a next generation sequencing (NGS)-based molecular diagnostic assay that detects actionable mutations in solid tumors to inform the selection of targeted therapeutics for cancer treatment. Methods NGS libraries are generated from DNA extracted from formalin fixed paraffin embedded tumors. Using hybrid capture, the genes of interest are enriched and sequenced on the Illumina HiSeq 2500 or MiSeq sequencers followed by variant detection and functional and clinical annotation for the generation of a clinical report. Results The JAX-CTP™ detects actionable variants, in the form of single nucleotide variations and small insertions and deletions (≤50bp) in 190 genes in specimens with a neoplastic cell content of ≥10%. The JAX-CTP™ is also validated for the detection of clinically actionable gene amplifications. Conclusions There is a lack of consensus in the molecular diagnostics field on the best method for the validation of NGS-based assays in oncology, thus the importance of communicating methods, as contained in this report. The growing number of targeted therapeutics and the complexity of the tumor genome necessitates continued development and refinement of advanced assays for tumor profiling to enable precision cancer treatment. PMID:25562415

Ambulatory-based education in internal medicine: current organization and implications for transformation. Results of a national survey of resident continuity clinic directors.

PubMed

Nadkarni, Mohan; Reddy, Siddharta; Bates, Carol K; Fosburgh, Blair; Babbott, Stewart; Holmboe, Eric

2011-01-01

Many have called for ambulatory training redesign in internal medicine (IM) residencies to increase primary care career outcomes. Many believe dysfunctional, clinic environments are a key barrier to meaningful ambulatory education, but little is actually known about the educational milieu of continuity clinics nationwide. We wished to describe the infrastructure and educational milieu at resident continuity clinics and assess clinic readiness to meet new IM-RRC requirements. National survey of ACGME accredited IM training programs. Directors of academic and community-based continuity clinics. Two hundred and twenty-one out of 365 (62%) of clinic directors representing 49% of training programs responded. Wide variation amongst continuity clinics in size, structure and educational organization exist. Clinics below the 25th percentile of total clinic sessions would not meet RRC-IM requirements for total number of clinic sessions. Only two thirds of clinics provided a longitudinal mentor. Forty-three percent of directors reported their trainees felt stressed in the clinic environment and 25% of clinic directors felt overwhelmed. The survey used self reported data and was not anonymous. A slight predominance of larger clinics and university based clinics responded. Data may not reflect changes to programs made since 2008. This national survey demonstrates that the continuity clinic experience varies widely across IM programs, with many sites not yet meeting new ACGME requirements. The combination of disadvantaged and ill patients with inadequately resourced clinics, stressed residents, and clinic directors suggests that many sites need substantial reorganization and institutional commitment.New paradigms, encouraged by ACGME requirement changes such as increased separation of inpatient and outpatient duties are needed to improve the continuity clinic experience.

Nursing faculty preparedness for clinical teaching.

PubMed

Suplee, Patricia Dunphy; Gardner, Marcia; Jerome-D'Emilia, Bonnie

2014-03-01

Nursing faculty who teach in clinical settings face complex situations requiring evidence-based educational and evaluative strategies, yet many have had limited preparation for these tasks. A convenience sample of 74 nursing faculty participated in a survey about clinical teaching in prelicensure nursing programs. Most faculty developed teaching skills through conferences (57%), orientation at their educational institution (53%), or exposure in graduate school (38%). Thirty-one percent reported having no preparation for clinical teaching. Faculty felt least prepared to manage students with learning, physical, or emotional disabilities and incivility. Twenty-six percent had no preparation for evaluating students in the clinical setting, and only 17% had worked with a faculty mentor. Few evidence-based teaching strategies were used by the faculty. These findings indicate gaps exist in the preparation of clinical faculty. Graduate education, comprehensive orientation programs, and continuing professional development may help to ensure faculty are effective in managing and evaluating student learning. Copyright 2014, SLACK Incorporated.

Organization-based self-development prescriptive model for the promotion of professional development of Iranian clinical nurses.

PubMed

Rahimaghaee, Flora; Nayeri, Nahid Dehghan; Mohammadi, Eesa; Salavati, Shahram

2015-01-01

Professional development is reiterated in the new definition of modern organizations as a serious undertaking of organizations. This article aims to present and describe a prescriptive model to increase the quality of professional development of Iranian nurses within an organization-based framework. This article is an outcome of the results of a study based on grounded theory describing how Iranian nurses develop. The present study adopted purposive sampling and the initial participants were experienced clinical nurses. Then, the study continued by theoretical sampling. The present study involved 21 participants. Data were mainly collected through interviews. Analysis began with open coding and continued with axial coding and selective coding. Trustworthiness was ensured by applying Lincoln and Guba criteria such as credibility, dependability, and conformability. Based on the data gathered in the study and a thorough review of related literature, a prescriptive model has been designed by use of the methodology of Walker and Avant (2005). In this model, the first main component is a three-part structure: Reformation to establish a value-assigning structure, a position for human resource management, and a job redesigning. The second component is certain of opportunities for organization-oriented development. These strategies are as follows: Raising the sensitivity of the organization toward development, goal setting and planning the development of human resources, and improving management practices. Through this model, clinical nurses' professional development can transform the profession from an individual, randomized activity into more planned and systematized services. This model can lead to a better quality of care.

Organization-based self-development prescriptive model for the promotion of professional development of Iranian clinical nurses

PubMed Central

Rahimaghaee, Flora; Nayeri, Nahid Dehghan; Mohammadi, Eesa; Salavati, Shahram

2015-01-01

Background: Professional development is reiterated in the new definition of modern organizations as a serious undertaking of organizations. This article aims to present and describe a prescriptive model to increase the quality of professional development of Iranian nurses within an organization-based framework. Materials and Methods: This article is an outcome of the results of a study based on grounded theory describing how Iranian nurses develop. The present study adopted purposive sampling and the initial participants were experienced clinical nurses. Then, the study continued by theoretical sampling. The present study involved 21 participants. Data were mainly collected through interviews. Analysis began with open coding and continued with axial coding and selective coding. Trustworthiness was ensured by applying Lincoln and Guba criteria such as credibility, dependability, and conformability. Based on the data gathered in the study and a thorough review of related literature, a prescriptive model has been designed by use of the methodology of Walker and Avant (2005). Results: In this model, the first main component is a three-part structure: Reformation to establish a value-assigning structure, a position for human resource management, and a job redesigning. The second component is certain of opportunities for organization-oriented development. These strategies are as follows: Raising the sensitivity of the organization toward development, goal setting and planning the development of human resources, and improving management practices. Conclusions: Through this model, clinical nurses’ professional development can transform the profession from an individual, randomized activity into more planned and systematized services. This model can lead to a better quality of care. PMID:26457100

A Data Base Management System for Clinical and Epidemiologic Studies In Systemic Lupus Erythematosus: Design and Maintenance

PubMed Central

Kosmides, Victoria S.; Hochberg, Marc C.

1984-01-01

This report describes the development, design specifications, features and implementation of a data base management system (DBMS) for clinical and epidemiologic studies in SLE. The DBMS is multidimensional with arrays formulated across patients, studies and variables. The major impact of this DBMS has been to increase the efficiency of managing and analyzing vast amounts of clinical and laboratory data and, as a result, to allow for continued growth in research productivity in areas related to SLE.

Basic immunology of antibody targeted radiotherapy

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

Wong, Jeffrey Y.C.

2006-10-01

Antibody targeted radiotherapy brings an important new treatment modality to Radiation oncology clinic. Radiation dose to tumor and normal tissues are determined by a complex interplay of antibody, antigen, tumor, radionuclide, and host-related factors. A basic understanding of these immunologic and physiologic factors is important to optimally utilize this therapy in the clinic. Preclinical and clinical studies need to be continued to broaden our understanding and to develop new strategies to further improve the efficacy of this promising form of targeted therapy.

How to confidently teach EBM on foot: development and evaluation of a web-based e-learning course.

PubMed

Weberschock, Tobias; Sorinola, Olanrewaju; Thangaratinam, Shakila; Oude Rengerink, Katrien; Arvanitis, Theodoros N; Khan, Khalid S

2013-10-01

Scarcity of well-trained clinical tutors is a key constraint in integrating teaching of evidence-based medicine (EBM) into clinical activities. We developed a web-based educational course for clinical trainers to confidently teach EBM principles in everyday practice. Its e-learning modules defined the learning objectives and incorporated video clips of practical and effective EBM teaching methods for exploiting educational opportunities in six different clinical settings. We evaluated the course with clinical tutors in different specialties across six European countries using a questionnaire to capture learning achievement against preset objectives. Among 56 tutors, 47 participants (84%) improved their scores from baseline. The mean pre-course score was 69.2 (SD=10.4), which increased to 77.3 (SD=11.7) postcourse (p<0.0001). The effect size was moderate with a Cohen's d of 0.73. An e-learning approach incorporating videos of applied EBM teaching and learning based on real clinical scenarios in the workplace can be useful in facilitating EBM teaching on foot. It can be integrated in the continuing professional development programmes for clinical trainers.

Leveraging the power of pooled data for cancer outcomes research.

PubMed

Hugh-Yeun, Kiara; Cheung, Winson Y

2016-08-02

Clinical trials continue to be the gold standard for determining the efficacy of novel cancer treatments, but they may also expose participants to the potential risks of unpredictable or severe toxicities. The development of validated tools that better inform patients of the benefits and risks associated with clinical trial participation can facilitate the informed consent process. The design and validation of such instruments are strengthened when we leverage the power of pooled data analysis for cancer outcomes research. In a recent study published in the Journal of Clinical Oncology entitled "Determinants of early mortality among 37,568 patients with colon cancer who participated in 25 clinical trials from the adjuvant colon cancer endpoints database," using a large pooled analysis of over 30,000 study participants who were enrolled in clinical trials of adjuvant therapy for early-stage colon cancer, we developed and validated a nomogram depicting the predictors of early cancer mortality. This database of pooled individual-level data allowed for a comprehensive analysis of poor prognostic factors associated with early death; furthermore, it enabled the creation of a nomogram that was able to reliably capture and quantify the benefit-to-risk profile for patients who are considering clinical trial participation. This tool can facilitate treatment decision-making discussions. As China and other Asian countries continue to conduct oncology clinical trials, efforts to collate patient-level information from these studies into a large data repository should be strongly considered since pooled data can increase future capacity for cancer outcomes research, which, in turn, can enhance patient-physician discussions and optimize clinical care.

Investigational Antimicrobial Agents of 2013

PubMed Central

Pucci, Michael J.

2013-01-01

SUMMARY New antimicrobial agents are always needed to counteract the resistant pathogens that continue to be selected by current therapeutic regimens. This review provides a survey of known antimicrobial agents that were currently in clinical development in the fall of 2012 and spring of 2013. Data were collected from published literature primarily from 2010 to 2012, meeting abstracts (2011 to 2012), government websites, and company websites when appropriate. Compared to what was reported in previous surveys, a surprising number of new agents are currently in company pipelines, particularly in phase 3 clinical development. Familiar antibacterial classes of the quinolones, tetracyclines, oxazolidinones, glycopeptides, and cephalosporins are represented by entities with enhanced antimicrobial or pharmacological properties. More importantly, compounds of novel chemical structures targeting bacterial pathways not previously exploited are under development. Some of the most promising compounds include novel β-lactamase inhibitor combinations that target many multidrug-resistant Gram-negative bacteria, a critical medical need. Although new antimicrobial agents will continue to be needed to address increasing antibiotic resistance, there are novel agents in development to tackle at least some of the more worrisome pathogens in the current nosocomial setting. PMID:24092856

The fourth branchial complex anomaly: a rare clinical entity.

PubMed

Patel, Alpen B; Hinni, Michael L

2011-01-01

Fourth branchial pouch anomalies are rare congenital disorders of the neck and are a consequence of abnormal development of the branchial apparatus during embryogenesis. Failure to appropriately recognize these anomalies may result in misdiagnosis, insufficient treatment, and continued recurrence. Here, we present an unique presentation of two cases, describe their diagnosis, clinical course, and management, and review the literature regarding these interesting anomalies.

The Fourth Branchial Complex Anomaly: A Rare Clinical Entity

PubMed Central

Patel, Alpen B.; Hinni, Michael L.

2011-01-01

Fourth branchial pouch anomalies are rare congenital disorders of the neck and are a consequence of abnormal development of the branchial apparatus during embryogenesis. Failure to appropriately recognize these anomalies may result in misdiagnosis, insufficient treatment, and continued recurrence. Here, we present an unique presentation of two cases, describe their diagnosis, clinical course, and management, and review the literature regarding these interesting anomalies. PMID:22937376

Blood substitutes.

PubMed Central

Kostrzewska, E.

1976-01-01

With the development of modern methods of surgery, anaesthesia, and pre- and postoperative care the requirement for blood substitutes is continuously increasing. We present a review of the different blood substitutes which are already in clinical use or in an advanced stage of experimental investigation for possible practical administration. Our own clinical experience with dextrans and experimental studies on stroma-free haemoglobin and hydroxyethyl starch solutions are described. PMID:57736

Use of regenerative tissue for urinary diversion.

PubMed

Sopko, Nikolai A; Kates, Max; Bivalacqua, Trinity J

2015-11-01

There is a large interest in developing tissue engineered urinary diversions (TEUDs) in order to reduce the significant morbidity that results from utilization of the alimentary tract in the urinary system. Preclinical trials have been favorable but durable clinical results have not been realized. The present article will review the pertinent concepts for the clinical development of a successful TEUD. Studies continue to identify novel scaffold materials and cell populations that are combined to generate TEUDs. Scaffold composition range from synthetic material to decelluarized bladder tissue. Cell types vary from fully differentiated adult populations such as smooth muscle cells isolated from the bladder to stem cell populations including mesenchymal stem cells and induced pluripotent stem cells. Each scaffold and cell type has its advantages and disadvantages with no clear superior component having been identified. Recent clinical trials have been disappointing, supporting the need for additional investigation. Successful application of TEUDs requires a complex interplay of scaffold, cells, and host environment. Studies continue to investigate candidate scaffold materials, cell populations, and combinations thereof to determine which will best recapitulate the complex structure of the human genitourinary tract.

Movement measurements at home for multiple sclerosis: walking speed measured by a novel ambient measurement system.

PubMed

Smith, Victoria Mj; Varsanik, Jonathan S; Walker, Rachel A; Russo, Andrew W; Patel, Kevin R; Gabel, Wendy; Phillips, Glenn A; Kimmel, Zebadiah M; Klawiter, Eric C

2018-01-01

Gait disturbance is a major contributor to clinical disability in multiple sclerosis (MS). A sensor was developed to assess walking speed at home for people with MS using infrared technology in real-time without the use of wearables. To develop continuous in-home outcome measures to assess gait in adults with MS. Movement measurements were collected continuously for 8 months from six people with MS. Average walking speed and peak walking speed were calculated from movement data, then analyzed for variability over time, by room (location), and over the course of the day. In-home continuous gait outcomes and variability were correlated with standard in-clinic gait outcomes. Measured in-home average walking speed of participants ranged from 0.33 m/s to 0.96 m/s and peak walking speed ranged from 0.89 m/s to 1.51 m/s. Mean total within-participant coefficient of variation for daily average walking speed and peak walking speed were 10.75% and 10.93%, respectively. Average walking speed demonstrated a moderately strong correlation with baseline Timed 25-Foot Walk (r s  = 0.714, P  = 0.111). New non-wearable technology provides reliable and continuous in-home assessment of walking speed.

Clinical veterinary education: insights from faculty and strategies for professional development in clinical teaching.

PubMed

Lane, India F; Strand, Elizabeth

2008-01-01

Missing in the recent calls for accountability and assurance of veterinary students' clinical competence are similar calls for competence in clinical teaching. Most clinician educators have no formal training in teaching theory or method. At the University of Tennessee College of Veterinary Medicine (UTCVM), we have initiated multiple strategies to enhance the quality of teaching in our curriculum and in clinical settings. An interview study of veterinary faculty was completed to investigate the strengths and weaknesses of clinical education; findings were used in part to prepare a professional development program in clinical teaching. Centered on principles of effective feedback, the program prepares participants to organize clinical rotation structure and orientation, maximize teaching moments, improve teaching and participation during formal rounds, and provide clearer summative feedback to students at the end of a rotation. The program benefits from being situated within a larger college-wide focus on teaching improvement. We expect the program's audience and scope to continue to expand.

A wearable computing platform for developing cloud-based machine learning models for health monitoring applications.

PubMed

Patel, Shyamal; McGinnis, Ryan S; Silva, Ikaro; DiCristofaro, Steve; Mahadevan, Nikhil; Jortberg, Elise; Franco, Jaime; Martin, Albert; Lust, Joseph; Raj, Milan; McGrane, Bryan; DePetrillo, Paolo; Aranyosi, A J; Ceruolo, Melissa; Pindado, Jesus; Ghaffari, Roozbeh

2016-08-01

Wearable sensors have the potential to enable clinical-grade ambulatory health monitoring outside the clinic. Technological advances have enabled development of devices that can measure vital signs with great precision and significant progress has been made towards extracting clinically meaningful information from these devices in research studies. However, translating measurement accuracies achieved in the controlled settings such as the lab and clinic to unconstrained environments such as the home remains a challenge. In this paper, we present a novel wearable computing platform for unobtrusive collection of labeled datasets and a new paradigm for continuous development, deployment and evaluation of machine learning models to ensure robust model performance as we transition from the lab to home. Using this system, we train activity classification models across two studies and track changes in model performance as we go from constrained to unconstrained settings.

Pervasive Computing Technologies to Continuously Assess Alzheimer's Disease Progression and Intervention Efficacy.

PubMed

Lyons, Bayard E; Austin, Daniel; Seelye, Adriana; Petersen, Johanna; Yeargers, Jonathan; Riley, Thomas; Sharma, Nicole; Mattek, Nora; Wild, Katherine; Dodge, Hiroko; Kaye, Jeffrey A

2015-01-01

Traditionally, assessment of functional and cognitive status of individuals with dementia occurs in brief clinic visits during which time clinicians extract a snapshot of recent changes in individuals' health. Conventionally, this is done using various clinical assessment tools applied at the point of care and relies on patients' and caregivers' ability to accurately recall daily activity and trends in personal health. These practices suffer from the infrequency and generally short durations of visits. Since 2004, researchers at the Oregon Center for Aging and Technology (ORCATECH) at the Oregon Health and Science University have been working on developing technologies to transform this model. ORCATECH researchers have developed a system of continuous in-home monitoring using pervasive computing technologies that make it possible to more accurately track activities and behaviors and measure relevant intra-individual changes. We have installed a system of strategically placed sensors in over 480 homes and have been collecting data for up to 8 years. Using this continuous in-home monitoring system, ORCATECH researchers have collected data on multiple behaviors such as gait and mobility, sleep and activity patterns, medication adherence, and computer use. Patterns of intra-individual variation detected in each of these areas are used to predict outcomes such as low mood, loneliness, and cognitive function. These methods have the potential to improve the quality of patient health data and in turn patient care especially related to cognitive decline. Furthermore, the continuous real-world nature of the data may improve the efficiency and ecological validity of clinical intervention studies.

Pervasive Computing Technologies to Continuously Assess Alzheimer’s Disease Progression and Intervention Efficacy

PubMed Central

Lyons, Bayard E.; Austin, Daniel; Seelye, Adriana; Petersen, Johanna; Yeargers, Jonathan; Riley, Thomas; Sharma, Nicole; Mattek, Nora; Wild, Katherine; Dodge, Hiroko; Kaye, Jeffrey A.

2015-01-01

Traditionally, assessment of functional and cognitive status of individuals with dementia occurs in brief clinic visits during which time clinicians extract a snapshot of recent changes in individuals’ health. Conventionally, this is done using various clinical assessment tools applied at the point of care and relies on patients’ and caregivers’ ability to accurately recall daily activity and trends in personal health. These practices suffer from the infrequency and generally short durations of visits. Since 2004, researchers at the Oregon Center for Aging and Technology (ORCATECH) at the Oregon Health and Science University have been working on developing technologies to transform this model. ORCATECH researchers have developed a system of continuous in-home monitoring using pervasive computing technologies that make it possible to more accurately track activities and behaviors and measure relevant intra-individual changes. We have installed a system of strategically placed sensors in over 480 homes and have been collecting data for up to 8 years. Using this continuous in-home monitoring system, ORCATECH researchers have collected data on multiple behaviors such as gait and mobility, sleep and activity patterns, medication adherence, and computer use. Patterns of intra-individual variation detected in each of these areas are used to predict outcomes such as low mood, loneliness, and cognitive function. These methods have the potential to improve the quality of patient health data and in turn patient care especially related to cognitive decline. Furthermore, the continuous real-world nature of the data may improve the efficiency and ecological validity of clinical intervention studies. PMID:26113819

From staff nurse to nurse consultant. Writing for publication part 7: structure and presentation.

PubMed

Fowler, John

John Fowler, independent education consultant, continues his series for clinical nurses hoping to share their experiences with a wider audience, with advice on developing a potential article for a professional journal.

Challenges faced in long term ventricular assist device support.

PubMed

Ikegami, Hirohisa; Kurlansky, Paul; Takeda, Koji; Naka, Yoshifumi

2016-08-01

The development of ventricular assist device (VAD) has been one of the revolutionary advancements in end-stage heart failure management. Although the device has developed and improved significantly over the last few decades, we still face multiple challenges. This review will discuss quality of life, survival, and clinically encountered complications in patients with VAD support. The literature was extensively reviewed for studies describing the above topic area. We describe the impact of major challenges faced in VAD support and discuss their future and expectations. Expert commentary: The technological advancement of VADs has contributed to major improvement of overall survival, enhancement of quality of life and decrease of incidence of complications. It is expected that technologies will continue to evolve. At the same time, the indications for and timing of device implantation, and selection of device type are continuously important in clinical practice setting.

A regional teaching fellow community of practice.

PubMed

Little, David; Butcher, Katrina; Atkinson, Simon; Still, Duncan; Vasant, Julia

2014-12-01

Increasing numbers of clinical teaching fellows are responsible for a significant proportion of undergraduate teaching nationally. Developing a regional community of practice can help overcome the isolation of these posts, with potential benefits for all involved. A community of practice relies on the mutual engagement of people in a similar situation working towards a common goal. Working together and sharing resources enables teaching fellows to make the most of their post, which ultimately benefits those that they are teaching. We developed a regional clinical teaching fellow community of practice in Bristol in 2010/11. Our community has continued to develop since completing our posts as clinical teaching fellows, and has provided a platform for new communities to develop amongst the groups of subsequent teaching fellows coming through. We encourage all regions who have clinical teaching fellows to develop a regional community of practice We encourage all regions who have clinical teaching fellows to develop a regional community of practice. We also encourage trainees to join TASME (Trainees in the Association for the Study of Medical Education), a new national community of practice for trainees involved in medical education. © 2014 John Wiley & Sons Ltd.

Family medicine patients who use retail clinics have lower continuity of care.

PubMed

Rohrer, James E; Angstman, Kurt B; Garrison, Gregory M; Maxson, Julie A; Furst, Joseph W

2013-04-01

The purpose of this study was to compare continuity of care for family medicine patients using retail medicine clinics to continuity for patients not using retail clinics. Retail medicine clinics have become popular in some markets. However, their impact on continuity of care has not been studied. Electronic medical records of adult primary care patients seen in a large group practice in Minnesota in 2011 were analyzed for this study. Two randomly chosen groups of patients were selected (N = 400): those using 1 of 3 retail walk-in clinics staffed by nurse practitioners in addition to standard office care and a comparison group that only used standard office care. Continuity was measured as the percentage of visits that involved the primary care provider. We also compared patients who made zero visits to their primary care providers with those who made some visits to their primary care providers. Continuity of care was lower for patients who used retail clinics than for patients who did not use retail clinics (0.17 vs 0.44, mean difference 0.27). The percentage of patients who made zero visits to their primary care providers was 54.5 for users of retail clinics versus 31.0 for those who did not use retail clinics. Continuity of care should be monitored as retail medicine continues to expand.

Graphical Presentation of Patient-Treatment Interaction Elucidated by Continuous Biomarkers. Current Practice and Scope for Improvement.

PubMed

Shen, Yu-Ming; Le, Lien D; Wilson, Rory; Mansmann, Ulrich

2017-01-09

Biomarkers providing evidence for patient-treatment interaction are key in the development and practice of personalized medicine. Knowledge that a patient with a specific feature - as demonstrated through a biomarker - would have an advantage under a given treatment vs. a competing treatment can aid immensely in medical decision-making. Statistical strategies to establish evidence of continuous biomarkers are complex and their formal results are thus not easy to communicate. Good graphical representations would help to translate such findings for use in the clinical community. Although general guidelines on how to present figures in clinical reports are available, there remains little guidance for figures elucidating the role of continuous biomarkers in patient-treatment interaction (CBPTI). To combat the current lack of comprehensive reviews or adequate guides on graphical presentation within this topic, our study proposes presentation principles for CBPTI plots. In order to understand current practice, we review the development of CBPTI methodology and how CBPTI plots are currently used in clinical research. The quality of a CBPTI plot is determined by how well the presentation provides key information for clinical decision-making. Several criteria for a good CBPTI plot are proposed, including general principles of visual display, use of units presenting absolute outcome measures, appropriate quantification of statistical uncertainty, correct display of benchmarks, and informative content for answering clinical questions especially on the quantitative advantage for an individual patient with regard to a specific treatment. We examined the development of CBPTI methodology from the years 2000 - 2014, and reviewed how CBPTI plots were currently used in clinical research in six major clinical journals from 2013 - 2014 using the principle of theoretical saturation. Each CBPTI plot found was assessed for appropriateness of its presentation and clinical utility. In our review, a total of seven methodological papers and five clinical reports used CBPTI plots which we categorized into four types: those that distinguish the outcome effect for each treatment group; those that show the outcome differences between treatment groups (by either partitioning all individuals into subpopulations or modelling the functional form of the interaction); those that evaluate the proportion of population impact of the biomarker; and those that show the classification accuracy of the biomarker. The current practice of utilizing CBPTI plots in clinical reports suffers from methodological shortcomings: the lack of presentation of statistical uncertainty, the outcome measure scaled by relative unit instead of absolute unit, incorrect use of benchmarks, and being non-informative in answering clinical questions. There is considerable scope for improvement in the graphical representation of CBPTI in clinical reports. The current challenge is to develop instruments for high-quality graphical plots which not only convey quantitative concepts to readers with limited statistical knowledge, but also facilitate medical decision-making.

Evaluation of a continuing professional development training program for physicians and physician assistants in hospitals in Laos based on the Kirkpatrick model

PubMed Central

2016-01-01

Purpose: Medical professionals from Korea and Laos have been working together to develop a continuing professional development training program covering the major clinical fields of primary care. This study aimed to evaluate the effectiveness of the program from 2013 to 2014 using the Kirkpatrick model. Methods: A questionnaire was used to evaluate the reaction of the trainees, and the trainers assessed the level of trainees’ performance at the beginning and the end of each clinical section. The transfer (behavioral change) of the trainees was evaluated through the review of medical records written by the trainees before and after the training program. Results: The trainees were satisfied with the training program, for which the average score was 4.48 out of 5.0. The average score of the trainees’ performance at the beginning was 2.39 out of 5.0, and rose to 3.88 at the end of each section. The average score of the medical records written before the training was 2.92 out of 5.0, and it rose to 3.34 after the training. The number of patient visits to the district hospitals increased. Conclusion: The continuing professional development training program, which was planned and implemented with the full engagement and responsibility of Lao health professionals, proved to be effective. PMID:27246494

Student-generated e-learning for clinical education.

PubMed

Isaacs, Alex N; Nisly, Sarah; Walton, Alison

2017-04-01

Within clinical education, e-learning facilitates a standardised learning experience to augment the clinical experience while enabling learner and teacher flexibility. With the shift of students from consumers to creators, student-generated content is expanding within higher education; however, there is sparse literature evaluating the impact of student-developed e-learning within clinical education. The aim of this study was to implement and evaluate a student-developed e-learning clinical module series within ambulatory care clinical pharmacy experiences. Three clinical e-learning modules were developed by students for use prior to clinical experiences. E-learning modules were created by fourth-year professional pharmacy students and reviewed by pharmacy faculty members. A pre-/post-assessment was performed to evaluate knowledge comprehension before and after participating in the e-learning modules. Additionally, a survey on student perceptions of this educational tool was performed at the end of the clinical experience. There is sparse literature evaluating the impact of student-developed e-learning within clinical education RESULTS: Of the 31 students eligible for study inclusion, 94 per cent participated in both the pre- and post-assessments. The combined post-assessment score was significantly improved after participating in the student-developed e-learning modules (p = 0.008). The student perception survey demonstrated positive perceptions of e-learning within clinical education. Student-generated e-learning was able to enhance knowledge and was positively perceived by learners. As e-learning continues to expand within health sciences education, students can be incorporated into the development and execution of this educational tool. © 2016 John Wiley & Sons Ltd.

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

Long-acting injectable hormonal dosage forms for contraception.

PubMed

Wu, Linfeng; Janagam, Dileep R; Mandrell, Timothy D; Johnson, James R; Lowe, Tao L

2015-07-01

Although great efforts have been made to develop long-acting injectable hormonal contraceptives for more than four decades, few long-acting injectable contraceptives have reached the pharmaceutical market or even entered clinical trials. On the other hand, in clinical practice there is an urgent need for injectable long-acting reversible contraceptives which can provide contraceptive protection for more than 3 months after one single injection. Availability of such products will offer great flexibility to women and resolve certain continuation issues currently occurring in clinics. Herein, we reviewed the strategies exploited in the past to develop injectable hormonal contraceptive dosages including drug microcrystal suspensions, drug-loaded microsphere suspensions and in situ forming depot systems for long-term contraception and discussed the potential solutions for remaining issues met in the previous development.

Basket Studies: Redefining Clinical Trials in the Era of Genome-Driven Oncology.

PubMed

Tao, Jessica J; Schram, Alison M; Hyman, David M

2018-01-29

Understanding a tumor's detailed molecular profile has become increasingly necessary to deliver the standard of care for patients with advanced cancer. Innovations in both tumor genomic sequencing technology and the development of drugs that target molecular alterations have fueled recent gains in genome-driven oncology care. "Basket studies," or histology-agnostic clinical trials in genomically selected patients, represent one important research tool to continue making progress in this field. We review key aspects of genome-driven oncology care, including the purpose and utility of basket studies, biostatistical considerations in trial design, genomic knowledgebase development, and patient matching and enrollment models, which are critical for translating our genomic knowledge into clinically meaningful outcomes.

Development and implementation of sepsis alert systems

PubMed Central

Harrison, Andrew M.; Gajic, Ognjen; Pickering, Brian W.; Herasevich, Vitaly

2016-01-01

Synopsis/Summary Development and implementation of sepsis alert systems is challenging, particularly outside the monitored intensive care unit (ICU) setting. Important barriers to wider use of sepsis alerts include evolving clinical definitions of sepsis, information overload & alert fatigue, due to suboptimal alert performance. Outside the ICU, additional barriers include differences in health care delivery models, charting behaviors, and availability of electronic data. Currently available evidence does not support routine use of sepsis alert systems in clinical practice. However, continuous improvement in both the afferent (data availability and accuracy of detection algorithms) and efferent (evidence-based decision support and smoother integration into clinical workflow) limbs of sepsis alert systems will help translate theoretical advantages into measurable patient benefit. PMID:27229639

An innovative portfolio of research training programs for medical students.

PubMed

Zier, Karen; Wyatt, Christina; Muller, David

2012-12-01

Medical student education continues to evolve, with an increasing emphasis on evidence-based decision making in clinical settings. Many schools are introducing scholarly programs to their curriculum in order to foster the development of critical thinking and analytic skills, encourage self-directed learning, and develop more individualized learning experiences. In addition, participation in rigorous scholarly projects teaches students that clinical care and research should inform each other, with the goal of providing more benefit to patients and society. Physician-scientists, and physicians who have a better appreciation of science, have the potential to be leaders in the field who will deliver outstanding clinical care, contribute new knowledge, and educate their patients.

Clinical Chemistry Laboratory Automation in the 21st Century - Amat Victoria curam (Victory loves careful preparation)

PubMed Central

Armbruster, David A; Overcash, David R; Reyes, Jaime

2014-01-01

The era of automation arrived with the introduction of the AutoAnalyzer using continuous flow analysis and the Robot Chemist that automated the traditional manual analytical steps. Successive generations of stand-alone analysers increased analytical speed, offered the ability to test high volumes of patient specimens, and provided large assay menus. A dichotomy developed, with a group of analysers devoted to performing routine clinical chemistry tests and another group dedicated to performing immunoassays using a variety of methodologies. Development of integrated systems greatly improved the analytical phase of clinical laboratory testing and further automation was developed for pre-analytical procedures, such as sample identification, sorting, and centrifugation, and post-analytical procedures, such as specimen storage and archiving. All phases of testing were ultimately combined in total laboratory automation (TLA) through which all modules involved are physically linked by some kind of track system, moving samples through the process from beginning-to-end. A newer and very powerful, analytical methodology is liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS). LC-MS/MS has been automated but a future automation challenge will be to incorporate LC-MS/MS into TLA configurations. Another important facet of automation is informatics, including middleware, which interfaces the analyser software to a laboratory information systems (LIS) and/or hospital information systems (HIS). This software includes control of the overall operation of a TLA configuration and combines analytical results with patient demographic information to provide additional clinically useful information. This review describes automation relevant to clinical chemistry, but it must be recognised that automation applies to other specialties in the laboratory, e.g. haematology, urinalysis, microbiology. It is a given that automation will continue to evolve in the clinical laboratory, limited only by the imagination and ingenuity of laboratory scientists. PMID:25336760

Clinical Chemistry Laboratory Automation in the 21st Century - Amat Victoria curam (Victory loves careful preparation).

PubMed

Armbruster, David A; Overcash, David R; Reyes, Jaime

2014-08-01

The era of automation arrived with the introduction of the AutoAnalyzer using continuous flow analysis and the Robot Chemist that automated the traditional manual analytical steps. Successive generations of stand-alone analysers increased analytical speed, offered the ability to test high volumes of patient specimens, and provided large assay menus. A dichotomy developed, with a group of analysers devoted to performing routine clinical chemistry tests and another group dedicated to performing immunoassays using a variety of methodologies. Development of integrated systems greatly improved the analytical phase of clinical laboratory testing and further automation was developed for pre-analytical procedures, such as sample identification, sorting, and centrifugation, and post-analytical procedures, such as specimen storage and archiving. All phases of testing were ultimately combined in total laboratory automation (TLA) through which all modules involved are physically linked by some kind of track system, moving samples through the process from beginning-to-end. A newer and very powerful, analytical methodology is liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS). LC-MS/MS has been automated but a future automation challenge will be to incorporate LC-MS/MS into TLA configurations. Another important facet of automation is informatics, including middleware, which interfaces the analyser software to a laboratory information systems (LIS) and/or hospital information systems (HIS). This software includes control of the overall operation of a TLA configuration and combines analytical results with patient demographic information to provide additional clinically useful information. This review describes automation relevant to clinical chemistry, but it must be recognised that automation applies to other specialties in the laboratory, e.g. haematology, urinalysis, microbiology. It is a given that automation will continue to evolve in the clinical laboratory, limited only by the imagination and ingenuity of laboratory scientists.

Program evaluation of a model to integrate internationally educated health professionals into clinical practice

PubMed Central

2013-01-01

Background The demand for health professionals continues to increase, partially due to the aging population and the high proportion of practitioners nearing retirement. The University of British Columbia (UBC) has developed a program to address this demand, by providing support for internationally trained Physiotherapists in their preparation for taking the National Physiotherapy competency examinations. The aim was to create a program comprised of the educational tools and infrastructure to support internationally educated physiotherapists (IEPs) in their preparation for entry to practice in Canada and, to improve their pass rate on the national competency examination. Methods The program was developed using a logic model and evaluated using program evaluation methodology. Program tools and resources included educational modules and curricular packages which were developed and refined based on feedback from clinical experts, IEPs and clinical physical therapy mentors. An examination bank was created and used to include test-enhanced education. Clinical mentors were recruited and trained to provide clinical and cultural support for participants. Results The IEP program has recruited 124 IEPs, with 69 now integrated into the Canadian physiotherapy workforce, and more IEPs continuing to apply to the program. International graduates who participated in the program had an improved pass rate on the national Physiotherapy Competency Examination (PCE); participation in the program resulted in them having a 28% (95% CI, 2% to 59%) greater possibility of passing the written section than their counterparts who did not take the program. In 2010, 81% of all IEP candidates who completed the UBC program passed the written component, and 82% passed the clinical component. Conclusion The program has proven to be successful and sustainable. This program model could be replicated to support the successful integration of other international health professionals into the workforce. PMID:24119470

Design, Development, and Initial Evaluation of a Terminology for Clinical Decision Support and Electronic Clinical Quality Measurement.

PubMed

Lin, Yanhua; Staes, Catherine J; Shields, David E; Kandula, Vijay; Welch, Brandon M; Kawamoto, Kensaku

2015-01-01

When coupled with a common information model, a common terminology for clinical decision support (CDS) and electronic clinical quality measurement (eCQM) could greatly facilitate the distributed development and sharing of CDS and eCQM knowledge resources. To enable such scalable knowledge authoring and sharing, we systematically developed an extensible and standards-based terminology for CDS and eCQM in the context of the HL7 Virtual Medical Record (vMR) information model. The development of this terminology entailed three steps: (1) systematic, physician-curated concept identification from sources such as the Health Information Technology Standards Panel (HITSP) and the SNOMED-CT CORE problem list; (2) concept de-duplication leveraging the Unified Medical Language System (UMLS) MetaMap and Metathesaurus; and (3) systematic concept naming using standard terminologies and heuristic algorithms. This process generated 3,046 concepts spanning 68 domains. Evaluation against representative CDS and eCQM resources revealed approximately 50-70% concept coverage, indicating the need for continued expansion of the terminology.

Design, Development, and Initial Evaluation of a Terminology for Clinical Decision Support and Electronic Clinical Quality Measurement

PubMed Central

Lin, Yanhua; Staes, Catherine J; Shields, David E; Kandula, Vijay; Welch, Brandon M; Kawamoto, Kensaku

2015-01-01

When coupled with a common information model, a common terminology for clinical decision support (CDS) and electronic clinical quality measurement (eCQM) could greatly facilitate the distributed development and sharing of CDS and eCQM knowledge resources. To enable such scalable knowledge authoring and sharing, we systematically developed an extensible and standards-based terminology for CDS and eCQM in the context of the HL7 Virtual Medical Record (vMR) information model. The development of this terminology entailed three steps: (1) systematic, physician-curated concept identification from sources such as the Health Information Technology Standards Panel (HITSP) and the SNOMED-CT CORE problem list; (2) concept de-duplication leveraging the Unified Medical Language System (UMLS) MetaMap and Metathesaurus; and (3) systematic concept naming using standard terminologies and heuristic algorithms. This process generated 3,046 concepts spanning 68 domains. Evaluation against representative CDS and eCQM resources revealed approximately 50–70% concept coverage, indicating the need for continued expansion of the terminology. PMID:26958220

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.

Toward Clarity in Clinical Vitamin D Status Assessment: 25(OH)D Assay Standardization.

PubMed

Binkley, Neil; Carter, Graham D

2017-12-01

Widespread variation in 25-hydroxyvitamin D (25(OH)D) assays continues to compromise efforts to develop clinical and public health guidelines regarding vitamin D status. The Vitamin D Standardization Program helps alleviate this problem. Reference measurement procedures and standard reference materials have been developed to allow current, prospective, and retrospective standardization of 25(OH)D results. Despite advances in 25(OH)D measurement, substantial variability in clinical laboratory 25(OH)D measurement persists. Existing guidelines have not used standardized data and, as a result, it seems unlikely that consensus regarding definitions of vitamin D deficiency, inadequacy, sufficiency, and excess will soon be reached. Until evidence-based consensus is reached, a reasonable clinical approach is advocated. Copyright © 2017 Elsevier Inc. All rights reserved.

Cardiorespiratory dynamics measured from continuous ECG monitoring improves detection of deterioration in acute care patients: A retrospective cohort study

PubMed Central

Clark, Matthew T.; Calland, James Forrest; Enfield, Kyle B.; Voss, John D.; Lake, Douglas E.; Moorman, J. Randall

2017-01-01

Background Charted vital signs and laboratory results represent intermittent samples of a patient’s dynamic physiologic state and have been used to calculate early warning scores to identify patients at risk of clinical deterioration. We hypothesized that the addition of cardiorespiratory dynamics measured from continuous electrocardiography (ECG) monitoring to intermittently sampled data improves the predictive validity of models trained to detect clinical deterioration prior to intensive care unit (ICU) transfer or unanticipated death. Methods and findings We analyzed 63 patient-years of ECG data from 8,105 acute care patient admissions at a tertiary care academic medical center. We developed models to predict deterioration resulting in ICU transfer or unanticipated death within the next 24 hours using either vital signs, laboratory results, or cardiorespiratory dynamics from continuous ECG monitoring and also evaluated models using all available data sources. We calculated the predictive validity (C-statistic), the net reclassification improvement, and the probability of achieving the difference in likelihood ratio χ2 for the additional degrees of freedom. The primary outcome occurred 755 times in 586 admissions (7%). We analyzed 395 clinical deteriorations with continuous ECG data in the 24 hours prior to an event. Using only continuous ECG measures resulted in a C-statistic of 0.65, similar to models using only laboratory results and vital signs (0.63 and 0.69 respectively). Addition of continuous ECG measures to models using conventional measurements improved the C-statistic by 0.01 and 0.07; a model integrating all data sources had a C-statistic of 0.73 with categorical net reclassification improvement of 0.09 for a change of 1 decile in risk. The difference in likelihood ratio χ2 between integrated models with and without cardiorespiratory dynamics was 2158 (p value: <0.001). Conclusions Cardiorespiratory dynamics from continuous ECG monitoring detect clinical deterioration in acute care patients and improve performance of conventional models that use only laboratory results and vital signs. PMID:28771487

Cardiorespiratory dynamics measured from continuous ECG monitoring improves detection of deterioration in acute care patients: A retrospective cohort study.

PubMed

Moss, Travis J; Clark, Matthew T; Calland, James Forrest; Enfield, Kyle B; Voss, John D; Lake, Douglas E; Moorman, J Randall

2017-01-01

Charted vital signs and laboratory results represent intermittent samples of a patient's dynamic physiologic state and have been used to calculate early warning scores to identify patients at risk of clinical deterioration. We hypothesized that the addition of cardiorespiratory dynamics measured from continuous electrocardiography (ECG) monitoring to intermittently sampled data improves the predictive validity of models trained to detect clinical deterioration prior to intensive care unit (ICU) transfer or unanticipated death. We analyzed 63 patient-years of ECG data from 8,105 acute care patient admissions at a tertiary care academic medical center. We developed models to predict deterioration resulting in ICU transfer or unanticipated death within the next 24 hours using either vital signs, laboratory results, or cardiorespiratory dynamics from continuous ECG monitoring and also evaluated models using all available data sources. We calculated the predictive validity (C-statistic), the net reclassification improvement, and the probability of achieving the difference in likelihood ratio χ2 for the additional degrees of freedom. The primary outcome occurred 755 times in 586 admissions (7%). We analyzed 395 clinical deteriorations with continuous ECG data in the 24 hours prior to an event. Using only continuous ECG measures resulted in a C-statistic of 0.65, similar to models using only laboratory results and vital signs (0.63 and 0.69 respectively). Addition of continuous ECG measures to models using conventional measurements improved the C-statistic by 0.01 and 0.07; a model integrating all data sources had a C-statistic of 0.73 with categorical net reclassification improvement of 0.09 for a change of 1 decile in risk. The difference in likelihood ratio χ2 between integrated models with and without cardiorespiratory dynamics was 2158 (p value: <0.001). Cardiorespiratory dynamics from continuous ECG monitoring detect clinical deterioration in acute care patients and improve performance of conventional models that use only laboratory results and vital signs.

Status of vaccine research and development of vaccines for malaria.

PubMed

Birkett, Ashley J

2016-06-03

Despite recent progress in reducing deaths attributable to malaria, it continues to claim approximately 500,000 lives per year and is associated with approximately 200 million infections. New tools, including safe and effective vaccines, are needed to ensure that the gains of the last 15 years are leveraged toward achieving the ultimate goal of malaria parasite eradication. In 2015, the European Medicines Agency announced the adoption of a positive opinion for the malaria vaccine candidate most advanced in development, RTS,S/AS01, which provides modest protection against clinical malaria; in early 2016, WHO recommended large-scale pilot implementations of RTS,S in settings of moderate-to-high malaria transmission. In alignment with these advancements, the community goals and preferred product characteristics for next-generation vaccines have been updated to inform the development of vaccines that are highly efficacious in preventing clinical malaria, and those needed to accelerate parasite elimination. Next-generation vaccines, targeting all stages of the parasite lifecycle, are in early-stage development with the most advanced in Phase 2 trials. Importantly, progress is being made in the definition of feasible regulatory pathways to accelerate timelines, including for vaccines designed to interrupt transmission of parasites from humans to mosquitoes. The continued absence of financially lucrative, high-income markets to drive investment in malaria vaccine development points to continued heavy reliance on public and philanthropic funding. Copyright © 2016 World Health Organization. Published by Elsevier Ltd.. All rights reserved.

The NCI Alliance for Nanotechnology in Cancer: achievement and path forward.

PubMed

Ptak, Krzysztof; Farrell, Dorothy; Panaro, Nicholas J; Grodzinski, Piotr; Barker, Anna D

2010-01-01

Nanotechnology is a 'disruptive technology', which can lead to a generation of new diagnostic and therapeutic products, resulting in dramatically improved cancer outcomes. The National Cancer Institute (NCI) of National Institutes of Health explores innovative approaches to multidisciplinary research allowing for a convergence of molecular biology, oncology, physics, chemistry, and engineering and leading to the development of clinically worthy technological approaches. These initiatives include programmatic efforts to enable nanotechnology as a driver of advances in clinical oncology and cancer research, known collectively as the NCI Alliance for Nanotechnology in Cancer (ANC). Over the last 5 years, ANC has demonstrated that multidisciplinary approach catalyzes scientific developments and advances clinical translation in cancer nanotechnology. The research conducted by ANC members has improved diagnostic assays and imaging agents, leading to the development of point-of-care diagnostics, identification and validation of numerous biomarkers for novel diagnostic assays, and the development of multifunctional agents for imaging and therapy. Numerous nanotechnology-based technologies developed by ANC researchers are entering clinical trials. NCI has re-issued ANC program for next 5 years signaling that it continues to have high expectations for cancer nanotechnology's impact on clinical practice. The goals of the next phase will be to broaden access to cancer nanotechnology research through greater clinical translation and outreach to the patient and clinical communities and to support development of entirely new models of cancer care.

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.

Reassessing Phase II Heart Failure Clinical Trials: Consensus Recommendations

PubMed Central

Butler, Javed; Hamo, Carine E.; Udelson, James E.; O’Connor, Christopher; Sabbah, Hani N.; Metra, Marco; Shah, Sanjiv J.; Kitzman, Dalane W.; Teerlink, John; Bernstein, Harold S.; Brooks, Gabriel; Depre, Christophe; DeSouza, Mary M.; Dinh, Wilfried; Donovan, Mark; Frische-Danielson, Regina; Frost, Robert J.; Garza, Dahlia; Gohring, Udo-Michael; Hellawell, Jennifer; Hsia, Judith; Ishihara, Shiro; Kay-Mugford, Patricia; Koglin, Joerg; Kozinn, Marc; Larson, Christopher J.; Mayo, Martha; Gan, Li-Ming; Mugnier, Pierrre; Mushonga, Sekayi; Roessig, Lothar; Russo, Cesare; Salsali, Afshin; Satler, Carol; Shi, Victor; Ticho, Barry; van der Laan, Michael; Yancy, Clyde; Stockbridge, Norman; Gheorghiade, Mihai

2017-01-01

The increasing burden and the continued suboptimal outcomes for patients with heart failure underlines the importance of continued research to develop novel therapeutics for this disorder. This can only be accomplished with successful translation of basic science discoveries into direct human application through effective clinical trial design and execution that results in a substantially improved clinical course and outcomes. In this respect, phase II clinical trials play a pivotal role in determining which of the multitude of potential basic science discoveries should move to the large and expansive registration trials in humans. A critical examination of the phase II trials in heart failure reveals multiple shortcomings in their concept, design, execution, and interpretation. To further a dialogue regarding the challenges and potential for improvement and the role of phase II trials in patients with heart failure, the Food and Drug Administration facilitated a meeting on October 17th 2016 represented by clinicians, researchers, industry members, and regulators. This document summarizes the discussion from this meeting and provides key recommendations for future directions. PMID:28356300

From staff nurse to nurse consultant. Part 9: writing for publication using client case studies.

PubMed

Fowler, John

John Fowler, independent education consultant, continues his series for clinical nurses hoping to share their experiences with a wider audience, with advice on developing a potential article for a professional journal.

From staff nurse to nurse consultant: Writing for publication part 10: publishing a project report.

PubMed

Fowler, John

John Fowler, independent education consultant, continues his series for clinical nurses hoping to share their experiences with a wider audience, with advice on developing a potential article for a professional journal.

Training mid- to late-career health professionals for clinical work in low-income regions abroad.

PubMed

Harris, W Andrew; Spencer, Peter; Winthrop, Kevin; Kravitz, Jay

2014-01-01

Oregon Health & Science University (OHSU) Global Health Center has developed a unique training program-Professionals' Training in Global Health (PTGH)--for mid- and late-career health professionals wanting to perform clinical services overseas in low-income countries. A multidisciplinary, multifaceted, structured curriculum underpins the clinical retraining, with classes aimed to be practical for clinical settings in resource-poor regions of the world. Preceptorships in family medicine and emergency medicine offer specialists the opportunity to observe primary care physicians one-on-one. In addition, PTGH trainees volunteer at free medical clinics where they work under the guidance and supervision of a family physician. For those individuals who live at some distance from Portland, Oregon, the course offers live videoconferencing, as well as archived streaming for later review. As of November 2013, 79 health professionals have completed the course, with 45 graduates having subsequently volunteered on one or more overseas medical missions, for a total of 109 medical service visits to 36 countries. Pre- and post-course testing shows improvements in clinical skills and knowledge base. Professionals' Training in Global Health has a 6-year record of interprofessional training and service both overseas and at home. The course has trained physicians, nurses, nurse practitioners, physician assistants, midwives, paramedics and other health professionals. © 2014 The Alliance for Continuing Education in the Health Professions, the Society for Academic Continuing Medical Education, and the Council on Continuing Medical Education, Association for Hospital Medical Education.

The current status and trend of clinical pharmacology in developing countries

PubMed Central

2013-01-01

Background Several international forums for promoting clinical pharmacology in developing countries have been held since 1980, and several clinical pharmacology programmes targeting developing countries were instituted such that the status of clinical pharmacology in developing countries is not where it was 50 years ago. Therefore, a survey and an appraisal of the literature on the current status of clinical pharmacology in developing countries were undertaken with a hope that it would enable development of appropriate strategies for further promotion of clinical pharmacology in these countries. Methods First, nine determinants (or enabling factors) for running a successful clinical pharmacology programme were identified, i.e., disease burden, drug situation, economic growth, clinical pharmacology activities, recognition, human capital, government support, international collaboration, and support for traditional/alternative medicines. These factors were then evaluated with regard to their current status in the developing countries that responded to an electronic questionnaire, and their historical perspective, using the literature appraisal. From these, a projected trend was constructed with recommendations on the way forward. Results Clinical pharmacology services, research and teaching in developing countries have improved over the past 50 years with over 90% of countries having the appropriate policies for regulation and rational use of medicines in place. Unfortunately, policy implementation remains a challenge, owing to a worsening disease burden and drug situation, versus fewer clinical pharmacologists and other competing priorities for the national budgets. This has led to a preference for training ‘a physician clinical pharmacologist’ in programmes emphasizing local relevancy and for a shorter time, and the training of other professionals in therapeutics for endemic diseases (task shifting), as the most promising strategies of ensuring rational use of medicines. Conclusion Clinical pharmacology in developing countries is advancing in a different way to that in the developed world and continuing support for these efforts will go a long way in promoting improved health for all. PMID:24074056

Spinal cord injury: promising interventions and realistic goals.

PubMed

McDonald, John W; Becker, Daniel

2003-10-01

Long regarded as impossible, spinal cord repair is approaching the realm of reality as efforts to bridge the gap between bench and bedside point to novel approaches to treatment. It is important to recognize that the research playing field is rapidly changing and that new mechanisms of resource development are required to effectively make the transition from basic science discoveries to effective clinical treatments. This article reviews recent laboratory studies and phase 1 clinical trials in neural and nonneural cell transplantation, stressing that the transition from basic science to clinical applications requires a parallel rather than serial approach, with continuous, two-way feedback to most efficiently translate basic science findings, through evaluation and optimization, to clinical treatments. An example of mobilizing endogenous stem cells for repair is reviewed, with emphasis on the rapid application of basic science to clinical therapy. Successful and efficient transition from basic science to clinical applications requires (1) a parallel rather than a serial approach; (2) development of centers that integrate three spheres of science, translational, transitional, and clinical trials; and (3) development of novel resources to fund the most critically limited step of transitional to clinical trials.

Space Biosensor Systems: Implications for Technology Transfer

NASA Technical Reports Server (NTRS)

Hines, J. W.; Somps, C. J.; Madou, M.; Imprescia, Clifford C. (Technical Monitor)

1997-01-01

To meet the need for continuous, automated monitoring of animal subjects, including; humans, during space flight, NASA is developing advanced physiologic sensor and biotelemetry system technologies. The ability to continuously track basic physiological parameters, such as heart rate, blood pH, and body temperature, in untethered subjects in space is a challenging task. At NASA's Ames Research Center, where a key focus is gravitational biology research, engineers have teamed with life scientists to develop wireless sensor systems for automated physiologic monitoring of animal models as small as the rat. This technology is also being adapted, in collaboration with medical professionals, to meet human clinical monitoring needs both in space and on the ground. Thus, these advanced monitoring technologies have important dual-use functions; they meet space flight data collection requirements and constraints, while concurrently addressing a number of monitoring and data acquisition challenges on the ground in areas of clinical monitoring and biomedical research. Additional applications for these and related technologies are being sought and additional partnerships established that enhance development efforts, reduce costs and facilitate technology infusion between the public and private sectors. This paper describes technology transfer and co-development projects that have evolved out of NASA's miniaturized, implantable chemical sensor development efforts.

Creating an educationally minded schedule: one approach to minimize the impact of duty hour standards on intern continuity clinic experience.

PubMed

DeBlasio, Dominick; Kerrey, M Kathleen; Sucharew, Heidi; Klein, Melissa

2014-11-01

To determine if implementing an educationally minded schedule utilizing consecutive night shifts can moderate the impact of the 2011 duty hour standards on education and patient continuity of care in longitudinal primary care experience (continuity clinic). A 14-month pre-post study was performed in continuity clinic with one supervising physician group and two intern groups. Surveys to assess attitudes and education were distributed to the supervising physicians and interns before and after the changes in duty hour standards. Intern groups' schedules were reviewed for the number of regular and alternative day clinic (i.e. primary care experience on a different weekday) sessions and patient continuity of care. Fifteen supervising physicians and 51 interns participated (25 in 2011, 26 in 2012). Intern groups' comfort when discussing patient issues, educational needs and teamwork perception did not differ. Supervising physicians' understanding of learning needs and provision of feedback did not differ between groups. Supervising physicians indicated a greater ability to provide feedback and understand learning needs during regular continuity clinic sessions compared with alternative day clinics (all p < 0.05). No significant difference was detected between intern groups in the number of regularly scheduled continuity clinics, alternative day clinics or patient continuity of care. The 2011 duty hour standards required significant alterations to intern schedules, but educationally minded scheduling limited impact on education and patient continuity in care.

Clinical evaluation of pixellated NaI:Tl and continuous LaBr 3:Ce, compact scintillation cameras for breast tumors imaging

NASA Astrophysics Data System (ADS)

Pani, R.; Pellegrini, R.; Betti, M.; De Vincentis, G.; Cinti, M. N.; Bennati, P.; Vittorini, F.; Casali, V.; Mattioli, M.; Orsolini Cencelli, V.; Navarria, F.; Bollini, D.; Moschini, G.; Iurlaro, G.; Montani, L.; de Notaristefani, F.

2007-02-01

The principal limiting factor in the clinical acceptance of scintimammography is certainly its low sensitivity for cancers sized <1 cm, mainly due to the lack of equipment specifically designed for breast imaging. The National Institute of Nuclear Physics (INFN) has been developing a new scintillation camera based on Lanthanum tri-Bromide Cerium-doped crystal (LaBr 3:Ce), that demonstrating superior imaging performances with respect to the dedicated scintillation γ-camera that was previously developed. The proposed detector consists of continuous LaBr 3:Ce scintillator crystal coupled to a Hamamatsu H8500 Flat Panel PMT. One centimeter thick crystal has been chosen to increase crystal detection efficiency. In this paper, we propose a comparison and evaluation between lanthanum γ-camera and a Multi PSPMT camera, NaI(Tl) discrete pixel based, previously developed under "IMI" Italian project for technological transfer of INFN. A phantom study has been developed to test both the cameras before introducing them in clinical trials. High resolution scans produced by LaBr 3:Ce camera showed higher tumor contrast with a detailed imaging of uptake area than pixellated NaI(Tl) dedicated camera. Furthermore, with the lanthanum camera, the Signal-to-Noise Ratio ( SNR) value was increased for a lesion as small as 5 mm, with a consequent strong improvement in detectability.

Approaching near real-time biosensing: microfluidic microsphere based biosensor for real-time analyte detection.

PubMed

Cohen, Noa; Sabhachandani, Pooja; Golberg, Alexander; Konry, Tania

2015-04-15

In this study we describe a simple lab-on-a-chip (LOC) biosensor approach utilizing well mixed microfluidic device and a microsphere-based assay capable of performing near real-time diagnostics of clinically relevant analytes such cytokines and antibodies. We were able to overcome the adsorption kinetics reaction rate-limiting mechanism, which is diffusion-controlled in standard immunoassays, by introducing the microsphere-based assay into well-mixed yet simple microfluidic device with turbulent flow profiles in the reaction regions. The integrated microsphere-based LOC device performs dynamic detection of the analyte in minimal amount of biological specimen by continuously sampling micro-liter volumes of sample per minute to detect dynamic changes in target analyte concentration. Furthermore we developed a mathematical model for the well-mixed reaction to describe the near real time detection mechanism observed in the developed LOC method. To demonstrate the specificity and sensitivity of the developed real time monitoring LOC approach, we applied the device for clinically relevant analytes: Tumor Necrosis Factor (TNF)-α cytokine and its clinically used inhibitor, anti-TNF-α antibody. Based on the reported results herein, the developed LOC device provides continuous sensitive and specific near real-time monitoring method for analytes such as cytokines and antibodies, reduces reagent volumes by nearly three orders of magnitude as well as eliminates the washing steps required by standard immunoassays. Copyright © 2014 Elsevier B.V. All rights reserved.

Prospective randomized trial to assess effects of continuing hormone therapy on cerebral function in postmenopausal women at risk for dementia.

PubMed

Rasgon, Natalie L; Geist, Cheri L; Kenna, Heather A; Wroolie, Tonita E; Williams, Katherine E; Silverman, Daniel H S

2014-01-01

The objective of this study was to examine the effects of estrogen-based hormone therapy (HT) on regional cerebral metabolism in postmenopausal women (mean age = 58, SD = 5) at risk for development of dementia. The prospective clinical trial design included pre- and post-intervention neuroimaging of women randomized to continue (HT+) or discontinue (HT-) therapy following an average of 10 years of use. The primary outcome measure was change in brain metabolism during the subsequent two years, as assessed with fluorodeoxyglucose-18 positron emission tomography (FDG-PET). Longitudinal FDG-PET data were available for 45 study completers. Results showed that women randomized to continue HT experienced relative preservation of frontal and parietal cortical metabolism, compared with women randomized to discontinue HT. Women who discontinued 17-β estradiol (17βE)-based HT, as well as women who continued conjugated equine estrogen (CEE)-based HT, exhibited significant decline in metabolism of the precuneus/posterior cingulate cortical (PCC) area. Significant decline in PCC metabolism was additionally seen in women taking concurrent progestins (with either 17βE or CEE). Together, these findings suggest that among postmenopausal subjects at risk for developing dementia, regional cerebral cortical metabolism is relatively preserved for at least two years in women randomized to continue HT, compared with women randomized to discontinue HT. In addition, continuing unopposed 17βE therapy is associated specifically with preservation of metabolism in PCC, known to undergo the most significant decline in the earliest stages of Alzheimer's disease. ClinicalTrials.gov NCT00097058.

Service quality framework for clinical laboratories.

PubMed

Ramessur, Vinaysing; Hurreeram, Dinesh Kumar; Maistry, Kaylasson

2015-01-01

The purpose of this paper is to illustrate a service quality framework that enhances service delivery in clinical laboratories by gauging medical practitioner satisfaction and by providing avenues for continuous improvement. The case study method has been used for conducting the exploratory study, with focus on the Mauritian public clinical laboratory. A structured questionnaire based on the SERVQUAL service quality model was used for data collection, analysis and for the development of the service quality framework. The study confirms the pertinence of the following service quality dimensions within the context of clinical laboratories: tangibility, reliability, responsiveness, turnaround time, technology, test reports, communication and laboratory staff attitude and behaviour. The service quality framework developed, termed LabSERV, is vital for clinical laboratories in the search for improving service delivery to medical practitioners. This is a pioneering work carried out in the clinical laboratory sector in Mauritius. Medical practitioner expectations and perceptions have been simultaneously considered to generate a novel service quality framework for clinical laboratories.

Developments in the field of allergy in 2010 through the eyes of Clinical and Experimental Allergy.

PubMed

Katelaris, C H; Linneberg, A; Magnan, A; Thomas, W R; Wardlaw, A J; Wark, P

2011-12-01

In 2010 over 200 articles were published in Clinical and Experimental Allergy including editorials, reviews, opinion articles, letters, book reviews and of course at the heart of the journal, papers containing original data which have moved the field of allergy forward on a number of fronts. For the third year running the editors felt it would be of value to summarize the key messages contained in these papers as a snapshot of where the cutting edge of research into allergic disease is leading. We have broadly followed the sections of the journal, although this year the mechanistic articles are grouped together and the studies involving experimental models of disease are discussed throughout the paper. In the field of asthma and rhinitis phenotypes and biomarkers continue to a major pre-occupation of our authors. There is continued interest in mechanisms of inflammation and disordered lung function with the mouse model of asthma continuing to offer new insights. There is also a steady flow of papers investigating new therapies, including those derived from plants and herbs, although many are mechanistic with too few high quality clinical trials. The mechanisms involved in allergic disease are well covered with many strong papers using clinical material to ask relevant questions. Pro-pre and snybiotics continue to be of major interest to our authors and this remains a controversial and complicated field. The discipline of epidemiology has retained its interest in risk factors for the development of allergic disease with a view to refining and debating the reasons for the allergy epidemic. There is continued interest in the relationship between helminthic disease and allergy with a new twist in 2010 involving studies using infection with helminths as a potential treatment. The genetics of allergic disease continues to be very productive, although the field has moved on from only investigating single nucleotide polymorphisms of candidate genes to Genome Wide Association Studies and an increasing and welcome emphasis on gene-environment interactions. In the field of clinical allergy there is steady flow of papers describing patterns of drug allergy with renewed interest in reactions to contrast media, but food allergy is the major area of interest in this section of the journal. Lastly in the field of allergens there is a growing interest in the role of component resolved diagnosis in improving the diagnosis and management of allergic disease. Another excellent year, full of fascinating and high quality work, which the journal has been proud to bring to the allergy community. © 2011 Blackwell Publishing Ltd.

Creating a Longitudinal Integrated Clerkship with Mutual Benefits for an Academic Medical Center and a Community Health System

PubMed Central

Poncelet, Ann Noelle; Mazotti, Lindsay A; Blumberg, Bruce; Wamsley, Maria A; Grennan, Tim; Shore, William B

2014-01-01

The longitudinal integrated clerkship is a model of clinical education driven by tenets of social cognitive theory, situated learning, and workplace learning theories, and built on a foundation of continuity between students, patients, clinicians, and a system of care. Principles and goals of this type of clerkship are aligned with primary care principles, including patient-centered care and systems-based practice. Academic medical centers can partner with community health systems around a longitudinal integrated clerkship to provide mutual benefits for both organizations, creating a sustainable model of clinical training that addresses medical education and community health needs. A successful one-year longitudinal integrated clerkship was created in partnership between an academic medical center and an integrated community health system. Compared with traditional clerkship students, students in this clerkship had better scores on Clinical Performance Examinations, internal medicine examinations, and high perceptions of direct observation of clinical skills. Advantages for the academic medical center include mitigating the resources required to run a longitudinal integrated clerkship while providing primary care training and addressing core competencies such as systems-based practice, practice-based learning, and interprofessional care. Advantages for the community health system include faculty development, academic appointments, professional satisfaction, and recruitment. Success factors include continued support and investment from both organizations’ leadership, high-quality faculty development, incentives for community-based physician educators, and emphasis on the mutually beneficial relationship for both organizations. Development of a longitudinal integrated clerkship in a community health system can serve as a model for developing and expanding these clerkship options for academic medical centers. PMID:24867551

Creating a longitudinal integrated clerkship with mutual benefits for an academic medical center and a community health system.

PubMed

Poncelet, Ann Noelle; Mazotti, Lindsay A; Blumberg, Bruce; Wamsley, Maria A; Grennan, Tim; Shore, William B

2014-01-01

The longitudinal integrated clerkship is a model of clinical education driven by tenets of social cognitive theory, situated learning, and workplace learning theories, and built on a foundation of continuity between students, patients, clinicians, and a system of care. Principles and goals of this type of clerkship are aligned with primary care principles, including patient-centered care and systems-based practice. Academic medical centers can partner with community health systems around a longitudinal integrated clerkship to provide mutual benefits for both organizations, creating a sustainable model of clinical training that addresses medical education and community health needs. A successful one-year longitudinal integrated clerkship was created in partnership between an academic medical center and an integrated community health system. Compared with traditional clerkship students, students in this clerkship had better scores on Clinical Performance Examinations, internal medicine examinations, and high perceptions of direct observation of clinical skills.Advantages for the academic medical center include mitigating the resources required to run a longitudinal integrated clerkship while providing primary care training and addressing core competencies such as systems-based practice, practice-based learning, and interprofessional care. Advantages for the community health system include faculty development, academic appointments, professional satisfaction, and recruitment.Success factors include continued support and investment from both organizations' leadership, high-quality faculty development, incentives for community-based physician educators, and emphasis on the mutually beneficial relationship for both organizations. Development of a longitudinal integrated clerkship in a community health system can serve as a model for developing and expanding these clerkship options for academic medical centers.

Exemplary Care and Learning Sites: A Model for Achieving Continual Improvement in Care and Learning in the Clinical Setting

PubMed Central

Ogrinc, Greg; Hoffman, Kimberly G.; Stevenson, Katherine M.; Shalaby, Marc; Beard, Albertine S.; Thörne, Karin E.; Coleman, Mary T.; Baum, Karyn D.

2016-01-01

Problem Current models of health care quality improvement do not explicitly describe the role of health professions education. The authors propose the Exemplary Care and Learning Site (ECLS) model as an approach to achieving continual improvement in care and learning in the clinical setting. Approach From 2008–2012, an iterative, interactive process was used to develop the ECLS model and its core elements—patients and families informing process changes; trainees engaging both in care and the improvement of care; leaders knowing, valuing, and practicing improvement; data transforming into useful information; and health professionals competently engaging both in care improvement and teaching about care improvement. In 2012–2013, a three-part feasibility test of the model, including a site self-assessment, an independent review of each site’s ratings, and implementation case stories, was conducted at six clinical teaching sites (in the United States and Sweden). Outcomes Site leaders reported the ECLS model provided a systematic approach toward improving patient (and population) outcomes, system performance, and professional development. Most sites found it challenging to incorporate the patients and families element. The trainee element was strong at four sites. The leadership and data elements were self-assessed as the most fully developed. The health professionals element exhibited the greatest variability across sites. Next Steps The next test of the model should be prospective, linked to clinical and educa tional outcomes, to evaluate whether it helps care delivery teams, educators, and patients and families take action to achieve better patient (and population) outcomes, system performance, and professional development. PMID:26760058

Nuclear Molecular and Theranostic Imaging for Differentiated Thyroid Cancer

PubMed Central

Sheikh, Arif; Polack, Berna; Rodriguez, Yvette; Kuker, Russ

2017-01-01

Traditional nuclear medicine is rapidly being transformed by the evolving concepts in molecular imaging and theranostics. The utility of new approaches in differentiated thyroid cancer (DTC) diagnostics and therapy has not been fully appreciated. The clinical information, relevant to disease management and patient care, obtained by scintigraphy is still being underestimated. There has been a trend towards moving away from the use of radioactive iodine (RAI) imaging in the management of the disease. This paradigm shift is supported by the 2015 American Thyroid Association Guidelines (1). A more systematic and comprehensive understanding of disease pathophysiology and imaging methodologies is needed for optimal utilization of different imaging modalities in the management of DTC. There have been significant developments in radiotracer and imaging technology, clinically proven to contribute to the understanding of tumor biology and the clinical assessment of patients with DTC. The research and development in the field continues to evolve, with expected emergence of many novel diagnostic and therapeutic techniques. The role for nuclear imaging applications will continue to evolve and be reconfigured in the changing paradigm. This article aims to review the clinical uses and controversies surrounding the use of scintigraphy, and the information it can provide in assisting in the management and treatment of DTC. PMID:28117289

New Zealand’s Drug Development Industry

PubMed Central

Lockhart, Michelle Marie; Babar, Zaheer-Ud-Din; Carswell, Christopher; Garg, Sanjay

2013-01-01

The pharmaceutical industry’s profitability depends on identifying and successfully developing new drug candidates while trying to contain the increasing costs of drug development. It is actively searching for new sources of innovative compounds and for mechanisms to reduce the enormous costs of developing new drug candidates. There is an opportunity for academia to further develop as a source of drug discovery. The rising levels of industry outsourcing also provide prospects for organisations that can reduce the costs of drug development. We explored the potential returns to New Zealand (NZ) from its drug discovery expertise by assuming a drug development candidate is out-licensed without clinical data and has anticipated peak global sales of $350 million. We also estimated the revenue from NZ’s clinical research industry based on a standard per participant payment to study sites and the number of industry-sponsored clinical trials approved each year. Our analyses found that NZ’s clinical research industry has generated increasing foreign revenue and appropriate policy support could ensure that this continues to grow. In addition the probability-based revenue from the out-licensing of a drug development candidate could be important for NZ if provided with appropriate policy and financial support. PMID:24065037

From papyrus to the electronic tablet: a brief history of the clinical medical record with lessons for the digital age.

PubMed

Gillum, Richard F

2013-10-01

A major transition is underway in documentation of patient-related data in clinical settings with rapidly accelerating adoption of the electronic health record and electronic medical record. This article examines the history of the development of medical records in the West in order to suggest lessons applicable to the current transition. The first documented major transition in the evolution of the clinical medical record occurred in antiquity, with the development of written case history reports for didactic purposes. Benefiting from Classical and Hellenistic models earlier than physicians in the West, medieval Islamic physicians continued the development of case histories for didactic use. A forerunner of modern medical records first appeared in Paris and Berlin by the early 19th century. Development of the clinical record in America was pioneered in the 19th century in major teaching hospitals. However, a clinical medical record useful for direct patient care in hospital and ambulatory settings was not developed until the 20th century. Several lessons are drawn from the 4000-year history of the medical record that may help physicians improve patient care in the digital age. Copyright © 2013 Elsevier Inc. All rights reserved.

Designs and adaptive analysis plans for pivotal clinical trials of therapeutics and companion diagnostics.

PubMed

Simon, Richard

2008-06-01

Developments in genomics and biotechnology provide unprecedented opportunities for the development of effective therapeutics and companion diagnostics for matching the right drug to the right patient. Effective co-development involves many new challenges with increased opportunity for success as well as delay and failure. Clinical trial designs and adaptive analysis plans for the prospective design of pivotal trials of new therapeutics and companion diagnostics are reviewed. Effective co-development requires careful prospective planning of the design and analysis strategy for pivotal clinical trials. Randomized clinical trials continue to be important for evaluating the effectiveness of new treatments, but the target populations for analysis should be prospectively specified based on the companion diagnostic. Post hoc analyses of traditionally designed randomized clinical trials are often deeply problematic. Clear separation is generally required of the data used for developing the diagnostic test, including their threshold of positivity, from the data used for evaluating treatment effectiveness in subsets determined by the test. Adaptive analysis can be used to provide flexibility to the analysis but the use of such methods requires careful planning and prospective definition in order to assure that the pivotal trial adequately limits the chance of erroneous conclusions.

The continued value of disk diffusion for assessing antimicrobial susceptibility in clinical laboratories: report from the Clinical and Laboratory Standards Institute Methods Development and Standardization Working Group.

PubMed

Humphries, Romney M; Kircher, Susan; Ferrell, Andrea; Krause, Kevin M; Malherbe, Rianna; Hsiung, Andre; Burnham, C A

2018-05-09

Expedited pathways to antimicrobial agent approval by the United States Food and Drug Administration (FDA) have led to increased delays between drug approval and the availability of FDA-cleared antimicrobial susceptibility testing (AST) devices. Antimicrobial disks for use with disk diffusion testing are among the first AST devices available to clinical laboratories. However, many laboratories are reluctant to implement a disk diffusion method for a variety of reasons, including dwindling proficiency with this method, interruptions to laboratory workflow, uncertainty surrounding the quality and reliability of a disk diffusion test, and perceived need to report an MIC to clinicians. This mini-review provides a report from the Clinical and Laboratory Standards Institute Working Group on Methods Development and Standardization on the current standards and clinical utility of disk diffusion testing. Copyright © 2018 American Society for Microbiology.

Integrating research into clinical internship training bridging the science/practice gap in pediatric psychology.

PubMed

McQuaid, Elizabeth L; Spirito, Anthony

2012-03-01

Existing literature highlights a critical gap between science and practice in clinical psychology. The internship year is a "capstone experience"; training in methods of scientific evaluation should be integrated with the development of advanced clinical competencies. We provide a rationale for continued exposure to research during the clinical internship year, including, (a) critical examination and integration of the literature regarding evidence-based treatment and assessment, (b) participation in faculty-based and independent research, and (c) orientation to the science and strategy of grantsmanship. Participation in research provides exposure to new empirical models and can foster the development of applied research questions. Orientation to grantsmanship can yield an initial sense of the "business of science." Internship provides an important opportunity to examine the challenges to integrating the clinical evidence base into professional practice; for that reason, providing research exposure on internship is an important strategy in training the next generation of pediatric psychologists.

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.

[Effects of Breastfeeding Empowerment Program on Breastfeeding Self-efficacy, Adaptation and Continuation in Primiparous Women].

PubMed

Song, Seon Mi; Park, Mi Kyung

2016-06-01

The purpose of this study was to develop a breastfeeding empowerment program and to investigate the effects of the breastfeeding empowerment program on self-efficacy, adaptation and continuation of breastfeeding for primiparous women. The 5 session breastfeeding empowerment program was developed and a non-equivalent control group non-synchronized quasi-experiment design was used. Fifty-five participants were assigned to either the experimental group (n=27) or the control group (n=28). Effects were tested using repeated measures ANOVA and χ²-test. Scores for self-efficacy, adaptation and continuation of breastfeeding of in the experimental group after program were significantly higher than 1 week, 4 weeks, 8 weeks scores in control group. The effects of the breastfeeding empowerment program for elevating self-efficacy, adaptation and continuation of breastfeeding in primiparous women were validated. Therefore, this program can be recommended for vigorous use in clinical practice.

Combining continuing education with expert consultation via telemedicine in Cambodia.

PubMed

Engle, Xavier; Aird, James; Tho, Ly; Bintcliffe, Fiona; Monsell, Fergal; Gollogly, Jim; Noor, Saqib

2014-04-01

Telemedicine has the potential to increase access to both clinical consultation and continuing medical education in Cambodia. We present a Cambodian surgical centre's experience with a collaboration in which complicated orthopaedic cases were presented to a panel of consultants using free online videoconferencing software, providing a combined opportunity for both continuing education and the enhancement of patient care. Effects of the case conference on patient care were examined via a retrospective review and clinician perspectives were elicited via a qualitative survey. The case conference altered patient care in 69% of cases. All Cambodian staff reported learning from the conference and 78% reported changes in their care for patients not presented at the conference. Real-time videoconferencing between consultants in the developed world and physicians in a developing country may be an effective, low-cost and easily replicable means of combining direct benefits to patient care with continuing medical education.

European League against rheumatism - selected presentation and poster a highlights June 11th to 13th 2013.

PubMed

Braddock, Martin

2014-02-01

The heterogeneous pathology of many autoimmune diseases warrants the continual discovery and development of new drugs. Drawing on selected oral presentations and selected poster displays, this article highlights some new developments in the pharmacological validation of molecular targets implicated in inflammatory autoimmune disease and may be of direct importance to scientists working in this field. This report describes the current state of the pharmacology of selected drugs and targets which may have utility in modulating immune function and autoimmune inflammatory disease. Many new molecules are progressing through clinical development for the treatment of rheumatological diseases. The value of the basic nonclinical and clinical research presented is to further pharmacological knowledge of the molecule, better understand the benefit-risk associated with clinical development and to assist in supporting the potential position of a new drug in the current treatment paradigm.

Key issues in the management of patients with systemic lupus erythematosus: latest developments and clinical implications

PubMed Central

Jordan, Natasha; D’Cruz, David

2015-01-01

Systemic lupus erythematous (SLE) is a chronic multisystem disease with significant associated morbidity and mortality. A deeper understanding of the pathogenesis of SLE has led to the development of biologic agents, primarily targeting B cells and others inhibiting costimulatory molecules, type I interferons and cytokines such as interleukin-6. Several of these agents have been studied in clinical trials; some have shown promise while others have yielded disappointing results. Economic and regulatory issues continue to hamper the availability of such therapies for SLE patients. With increasing recognition that recurrent flares of disease activity lead to long-term damage accrual, one of the most important recent developments in patient management has been the concept of treat-to-target in SLE while minimizing patient exposure to excessive corticosteroid and other immunosuppressive therapy. This article reviews these key issues in SLE management, outlining recent developments and clinical implications for patients. PMID:26622325

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

PubMed

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

2008-03-01

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

Mobile learning: a workforce development strategy for nurse supervisors.

PubMed

Mather, Carey; Cummings, Elizabeth

2014-01-01

Digital technology provides opportunities for using mobile learning strategies in healthcare environments. To realise the vision of the National Workforce Development Strategy there needs to be innovation of health professionals to further develop knowledge and skills of clinical supervisors to access and gain an understanding of the value of mobile learning at the workplace. The use of digital technology by clinical supervisors was explored in 2012 as part of a teaching development grant to evaluate the use of Web 2.0 technology to develop a community of practice about clinical supervision. Prior to developing the virtual network of clinical supervisors, feedback about the use of Web 2.0 technology by clinicians was sought via an online survey. Over 90% of respondents used social media, 85% understood what a blog and wiki were and approximately half of the respondents used smart phones. More than one-third indicated they would participate in a virtual community of practice and would like to receive information about clinical facilitation at least once per week. Findings indicate both inhibitors and opportunities for workforce development within healthcare environments that need to be addressed. Support of graduate-ready nurses can be achieved through an integrated outlook that enables health professionals within organisations to undertake mobile learning in situ. A flexible and collaborative approach to continuing professional development within organisations could enhance practice development and could positively impact on workforce development.

Use of near-infrared spectroscopy (NIRS) in cerebral tissue oxygenation monitoring in neonates.

PubMed

Gumulak, Rene; Lucanova, Lucia Casnocha; Zibolen, Mirko

2017-06-01

Near-infrared spectroscopy (NIRS) is a technology capable of non-invasive, continuous measuring of regional tissue oxygen saturation (StO 2 ). StO 2 represents a state of hemodynamic stability, which is influenced by many factors. Extensive research has been done in the field of measuring StO 2 of various organs. The current clinical availability of several NIRS-based devices reflects an important development in prevention, detection and correction of discrepancy in oxygen delivery to the brain and vital organs. Managing cerebral ischemia remains a significant issue in the neonatal intensive care units (NICU). Cerebral tissue oxygenation (cStO 2 ) and cerebral fractional tissue extraction (cFTOE) are reported in a large number of clinical studies. This review provides a summary of the concept of function, current variability of NIRS-based devices used in neonatology, clinical applications in continuous cStO 2 monitoring, limitations, disadvantages, and the potential of current technology.

Ambiguity Within Nursing Practice: An Evolutionary Concept Analysis.

PubMed

McMahon, Michelle A; Dluhy, Nancy M

2017-02-01

To analyze the concept of ambiguity in a nursing context. Ambiguity is inherent within nursing practice. As health care becomes increasingly complex, nurses must continue to successfully deal with greater amounts of clinical ambiguity. Although ambiguity is discussed in nursing, minimal concept refinement exists to capture the contextual intricacies from a nursing lens. Nurse perception of an ambiguous clinical event, in combination with nurse tolerance level for ambiguity, can impact nurse response. Yet, little is known about what constitutes ambiguity within nursing practice (AWNP). Rodgers evolutionary method was used to explore AWNP, with emphasis on nurse thinking during ambiguous clinical situations. Literature searches across multiple databases yielded 38 articles for analysis. Attributes of AWNP include (a) variations in cues/available information, (b) multiple interpretations, (c) novel/nonroutine presentations, and (d) unpredictable. Antecedents include (a) a context-specific, clinical situation with ambiguous features needing evaluation and (b) an individual to sense a knowledge gap or perceive ambiguity. Consequences include ranges of (a) emotional, (b) behavioral, and (c) cognitive clinician responses. Preliminary findings support AWNP as a distinct concept in which ambiguity perceived by the nurse likely affects judgment, decision making, and clinical interventions. AWNP is a clinically relevant concept requiring continued development.

Stem cell therapy clinical research: A regulatory conundrum for academia.

PubMed

Nagpal, Anjali; Juttner, Chris; Hamilton-Bruce, Monica Anne; Rolan, Paul; Koblar, Simon A

2017-12-01

The encouraging pace of discovery and development in the field of regenerative medicine holds tremendous potential for bringing therapies to the clinic that may offer meaningful benefit to patients, particularly in diseases with no or suboptimal therapeutic options. Academic researchers will continue to play a critical role in developing concepts and therapies, thus determining whether regenerative medicine will be able to live up to this potential that clearly excites clinicians, researchers and patients alike. This review summarises recent developments in regulatory frameworks across different countries that aim to ensure adequate oversight of the development of regenerative medicine products, which are unique in structural and functional complexity when compared to traditional chemical drugs and fully characterised biological drugs. It discusses the implications of these developments for researchers aiming to make the challenging transition from laboratory to clinical development of these therapies and considers possible pragmatic solutions that could accelerate this process that is essential to maintain research credibility and ensure patient safety. Copyright © 2016 Elsevier B.V. All rights reserved.

Survey of methods used to determine if a patient has a deep vein thrombosis: An exploratory research report.

PubMed

Heick, John D; Farris, James W

2017-09-01

The use of evidence-based practice (EBP) is encouraged in the physical therapy profession, but integrating evidence into practice can be difficult for clinicians because of lack of time and other constraints. To survey physical therapy clinical instructors and determine the methods they use for screening for deep vein thrombosis (DVT), a type of venous thromboembolism (VTE) in the lower extremities. Exploratory survey. Twelve survey questions written specifically for this study were sent to a convenience sample of clinical instructors associated with seven universities across 43 states. Eight hundred fifty clinical instructors (22.4% response rate) completed the survey. Of those who responded, 80.5% were taught to use Homans sign to screen for a possible DVT in their entry-level education and 67.9% continued to use Homans sign in clinical practice. Regardless of post-graduate education, respondents were more likely to choose Homans sign than a clinical decision rule (CDR) to screen for a suspected DVT. Additionally, nearly two-thirds of respondents failed to correctly identify one or more of the major risk factors for developing a DVT/VTE. The response rate was 22.4% and therefore may not fully represent the population of physical therapy clinical instructors in the United States. Results from this exploratory survey indicated that approximately two-thirds of physical therapy clinical instructors used outdated DVT/VTE screening methods that they were taught in their entry-level education and nearly two-thirds did not identify the major risk factors associated with DVT/VTE. These results suggest that change is necessary in physical therapy education, clinical practice, and continuing professional development to ensure a more evidenced-based identification of DVT and VTE.

HTA decision support system for sustainable business continuity management in hospitals. The case of surgical activity at the University Hospital in Florence.

PubMed

Miniati, Roberto; Dori, Fabrizio; Cecconi, Giulio; Gusinu, Roberto; Niccolini, Fabrizio; Gentili, Guido Biffi

2013-01-01

A fundamental element of the social and safety function of a health structure is the need to guarantee continuity of clinical activity through the continuity of technology. This paper aims to design a Decision Support System (DSS) for medical technology evaluations based on the use of Key Performance Indicators (KPI) in order to provide a multi-disciplinary valuation of a technology in a health structure. The methodology used in planning the DSS followed the following key steps: the definition of relevant KPIs, the development of a database to calculate the KPIs, the calculation of the defined KPIs and the resulting study report. Finally, the clinical and economic validation of the system was conducted though a case study of Business Continuity applied in the operating department of the Florence University Hospital AOU Careggi in Italy. A web-based support system was designed for HTA in health structures. The case study enabled Business Continuity Management (BCM) to be implemented in a hospital department in relation to aspects of a single technology and the specific clinical process. Finally, an economic analysis of the procedure was carried out. The system is useful for decision makers in that it precisely defines which equipment to include in the BCM procedure, using a scale analysis of the specific clinical process in which the equipment is used. In addition, the economic analysis shows how the cost of the procedure is completely covered by the indirect costs which would result from the expenses incurred from a broken device, hence showing the complete auto-sustainability of the methodology.

The Continuity of Care Experience in Australian midwifery education-What have we achieved?

PubMed

Tierney, Olivia; Sweet, Linda; Houston, Don; Ebert, Lyn

2017-06-01

The Continuity of Care Experience is a mandated workplace based component of midwifery education in Australia. Since its inclusion in midwifery clinical education, the pedagogical approaches used across Australia have varied. The purpose of this integrative review is to determine the outcomes of the Continuity of Care Experience as an educational model. A search for relevant research literature was undertaken in 2015 using a range of databases and by examining relevant bibliographies. Articles published in English, which provided information about the outcomes of Continuity of Care Experiences for midwifery education were included. A total of 20 studies were selected. The included studies were primarily exploratory and descriptive. Studies reported the value that both students and women place on the relationship they developed. This relationship resulted in opportunities that enhanced student learning by providing a context in which clinical practice learning was optimized. Challenges identified included managing time and workload pressures for students in relation to the CCE, inconsistencies in academic use of the experience, and variations in how the healthcare system influences the continuity experience. No research was found that reports on the educational model in terms of defining learning objectives and assessment of outcomes. This represents an important omission in mandating this clinical practice model in midwifery curricula without sufficient guidance to unify and maximize learning for students. Research is required to explore the educational intent and assessment methods of the Continuity of Care Experience as an educational model. Copyright © 2016 Australian College of Midwives. Published by Elsevier Ltd. All rights reserved.

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.

Design, development, and evaluation of a novel microneedle array-based continuous glucose monitor.

PubMed

Jina, Arvind; Tierney, Michael J; Tamada, Janet A; McGill, Scott; Desai, Shashi; Chua, Beelee; Chang, Anna; Christiansen, Mark

2014-05-01

The development of accurate, minimally invasive continuous glucose monitoring (CGM) devices has been the subject of much work by several groups, as it is believed that a less invasive and more user-friendly device will result in greater adoption of CGM by persons with insulin-dependent diabetes. This article presents the results of preliminary clinical studies in subjects with diabetes of a novel prototype microneedle-based continuous glucose monitor. In this device, an array of tiny hollow microneedles is applied into the epidermis from where glucose in interstitial fluid (ISF) is transported via passive diffusion to an amperometric glucose sensor external to the body. Comparison of 1396 paired device glucose measurements and fingerstick blood glucose readings for up to 72-hour wear in 10 diabetic subjects shows the device to be accurate and well tolerated by the subjects. Overall mean absolute relative difference (MARD) is 15% with 98.4% of paired points in the A+B region of the Clarke error grid. The prototype device has demonstrated clinically accurate glucose readings over 72 hours, the first time a microneedle-based device has achieved such performance. © 2014 Diabetes Technology Society.

Lifelong Learning for Clinical Practice: How to Leverage Technology for Telebehavioral Health Care and Digital Continuing Medical Education.

PubMed

Hilty, Donald M; Turvey, Carolyn; Hwang, Tiffany

2018-03-12

Psychiatric practice continues to evolve and play an important role in patients' lives, the field of medicine, and health care delivery. Clinicians must learn a variety of clinical care systems and lifelong learning (LLL) is crucial to apply knowledge, develop skills, and adjust attitudes. Technology is rapidly becoming a key player-in delivery, lifelong learning, and education/training. The evidence base for telepsychiatry/telemental health via videoconferencing has been growing for three decades, but a greater array of technologies have emerged in the last decade (e.g., social media/networking, text, apps). Clinicians are combining telepsychiatry and these technologies frequently and they need to reflect on, learn more about, and develop skills for these technologies. The digital age has solidified the role of technology in continuing medical education and day-to-day practice. Other fields of medicine are also adapting to the digital age, as are graduate and undergraduate medical education and many allied mental health organizations. In the future, there will be more online training, simulation, and/or interactive electronic examinations, perhaps on a monthly cycle rather than a quasi-annual or 10-year cycle of recertification.

NMDA receptor modulators: an updated patent review (2013-2014).

PubMed

Strong, Katie L; Jing, Yao; Prosser, Anthony R; Traynelis, Stephen F; Liotta, Dennis C

2014-12-01

The NMDA receptor mediates a slow component of excitatory synaptic transmission, and NMDA receptor dysfunction has been implicated in numerous neurological disorders. Thus, interest in developing modulators that are capable of regulating the channel continues to be strong. Recent research has led to the discovery of a number of compounds that hold therapeutic and clinical value. Deeper insight into the NMDA intersubunit interactions and structural motifs gleaned from the recently solved crystal structures of the NMDA receptor should facilitate a deeper understanding of how these compounds modulate the receptor. This article discusses the known pharmacology of NMDA receptors. A discussion of the patent literature since 2012 is also included, with an emphasis on those that claimed new chemical entities as regulators of the NMDA receptor. The number of patents involving novel NMDA receptor modulators suggests a renewed interest in the NMDA receptor as a therapeutic target. Subunit-selective modulators continue to show promise, and the development of new subunit-selective NMDA receptor modulators appears poised for continued growth. Although a modest number of channel blocker patents were published, successful clinical outcomes involving ketamine have led to a resurgent interest in low-affinity channel blockers as therapeutics.

Psychology, technology, and diabetes management.

PubMed

Gonder-Frederick, Linda A; Shepard, Jaclyn A; Grabman, Jesse H; Ritterband, Lee M

2016-10-01

Use of technology in diabetes management is rapidly advancing and has the potential to help individuals with diabetes achieve optimal glycemic control. Over the past 40 years, several devices have been developed and refined, including the blood glucose meter, insulin pump, and continuous glucose monitor. When used in tandem, the insulin pump and continuous glucose monitor have prompted the Artificial Pancreas initiative, aimed at developing control system for fully automating glucose monitoring and insulin delivery. In addition to devices, modern technology, such as the Internet and mobile phone applications, have been used to promote patient education, support, and intervention to address the behavioral and emotional challenges of diabetes management. These state-of-the-art technologies not only have the potential to improve clinical outcomes, but there are possible psychological benefits, such as improved quality of life, as well. However, practical and psychosocial limitations related to advanced technology exist and, in the context of several technology-related theoretical frameworks, can influence patient adoption and continued use. It is essential for future diabetes technology research to address these barriers given that the clinical benefits appear to largely depend on patient engagement and consistence of technology use. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Dimensions of integration, continuity and longitudinality in clinical clerkships.

PubMed

Ellaway, Rachel H; Graves, Lisa; Cummings, Beth-Ann

2016-09-01

Over the past few decades, longitudinal integrated clerkships (LICs) have been proposed to address many perceived short-coming of traditional block clerkships. This growing interest in LICs has raised broader questions regarding the role of integration, continuity and longitudinality in medical education. A study with complementary theoretical and empirical dimensions was conducted to derive a more precise way of defining these three underlying concepts within the design of medical education curricula. The theoretical dimension involved a thematic review of the literature on integration, continuity and longitudinality in medical education. The empirical dimension surveyed all 17 Canadian medical schools on how they have operationalised integration, continuity and longitudinality in their undergraduate programmes. The two dimensions were iteratively synthesised to explore the meaning and expression of integration, continuity and longitudinality in medical education curriculum design. Integration, continuity and longitudinality were expressed in many ways and forms, including: integration of clinical disciplines, combined horizontal integration and vertical integration, and programme-level integration. Types of continuity included: continuity of patients, continuity of teaching, continuity of location and peer continuity. Longitudinality focused on connected or repeating episodes of training or on connecting activities, such as encounter logging across educational episodes. Twelve of the 17 schools were running an LIC of some kind, although only one school had a mandatory LIC experience. An ordinal scale of uses of integration, continuity and longitudinality during clerkships was developed, and new definitions of these concepts in the clerkship context were generated. Different clerkship designs embodied different forms and levels of integration, continuity and longitudinality. A dichotomous view of LICs and rotation-based clerkships was found not to represent current practices in Canada, which instead tended to fall along a continuum of integration, continuity and longitudinality. © 2016 John Wiley & Sons Ltd and The Association for the Study of Medical Education.

Cross-continuum Care Continuity: Achieving Seamless Care and Managing Comorbidities.

PubMed

Boston-Fleischhauer, Carol; Rose, Robert; Hartwig, Laurie

As healthcare systems continue to design care models responsive to payment changes and the assumption of clinical and financial risk, the need exists for a comprehensive approach to address cross-continuum care transitions. This article will highlight key learnings from the Nurse Executive Center's research on achieving care continuity. The business case for developing a cross-continuum care transition strategy will be discussed, as well as systemic enablers for the achievement of seamless care. A case study example of 1 system's solution for supporting the multiple comorbid patient population as part of its cross-continuum care transition strategy will be examined.

Internal Medicine Residents' Perceptions of Team-Based Care and its Educational Value in the Continuity Clinic: A Qualitative Study.

PubMed

Soones, Tacara N; O'Brien, Bridget C; Julian, Katherine A

2015-09-01

In order to teach residents how to work in interprofessional teams, educators in graduate medical education are implementing team-based care models in resident continuity clinics. However, little is known about the impact of interprofessional teams on residents' education in the ambulatory setting. To identify factors affecting residents' experience of team-based care within continuity clinics and the impact of these teams on residents' education. This was a qualitative study of focus groups with internal medicine residents. Seventy-seven internal medicine residents at the University of California San Francisco at three continuity clinic sites participated in the study. Qualitative interviews were audiotaped and transcribed. The authors used a general inductive approach with sensitizing concepts in four frames (structural, human resources, political and symbolic) to develop codes and identify themes. Residents believed that team-based care improves continuity and quality of care. Factors in four frames affected their ability to achieve these goals. Structural factors included communication through the electronic medical record, consistent schedules and regular team meetings. Human resources factors included the presence of stable teams and clear roles. Political and symbolic factors negatively impacted team-based care, and included low staffing ratios and a culture of ultimate resident responsibility, respectively. Regardless of the presence of these factors or resident perceptions of their teams, residents did not see the practice of interprofessional team-based care as intrinsically educational. Residents' experiences practicing team-based care are influenced by many principles described in the interprofessional teamwork literature, including understanding team members' roles, good communication and sufficient staffing. However, these attributes are not correlated with residents' perceptions of the educational value of team-based care. Including residents in interprofessional teams in their clinic may not be sufficient to teach residents how team-based care can enhance their overall learning and future practice.

When children have children: the teen pregnancy predicament.

PubMed

Carter, D M; Felice, M E; Rosoff, J; Zabin, L S; Beilenson, P L; Dannenberg, A L

1994-01-01

Despite developments in contraceptive technology and changes in societal norms, adolescent pregnancy remains a key issue for politicians, social scientists, health care providers, and educators. The adolescent's access to contraception and abortion services continues to spark legal debate. The implications of research call for the development of innovative programs to address larger issues, such as poverty and limited access to health care, in the management and prevention of adolescent pregnancies. Clinical interventions, such as school-linked clinics to provide contraception and prenatal care programs to reduce perinatal morbidity, have varied in their approaches and their subsequent success.

Development and Implementation of Sepsis Alert Systems.

PubMed

Harrison, Andrew M; Gajic, Ognjen; Pickering, Brian W; Herasevich, Vitaly

2016-06-01

Development and implementation of sepsis alert systems is challenging, particularly outside the monitored intensive care unit (ICU) setting. Barriers to wider use of sepsis alerts include evolving clinical definitions of sepsis, information overload, and alert fatigue, due to suboptimal alert performance. Outside the ICU, barriers include differences in health care delivery models, charting behaviors, and availability of electronic data. Current evidence does not support routine use of sepsis alert systems in clinical practice. Continuous improvement in the afferent and efferent aspects will help translate theoretic advantages into measurable patient benefit. Copyright © 2016 Elsevier Inc. All rights reserved.

Antibody–Drug Conjugates for Cancer Therapy

PubMed Central

Parslow, Adam C.; Parakh, Sagun; Lee, Fook-Thean; Gan, Hui K.; Scott, Andrew M.

2016-01-01

Antibody–drug conjugates (ADCs) take advantage of the specificity of a monoclonal antibody to deliver a linked cytotoxic agent directly into a tumour cell. The development of these compounds provides exciting opportunities for improvements in patient care. Here, we review the key issues impacting on the clinical success of ADCs in cancer therapy. Like many other developing therapeutic classes, there remain challenges in the design and optimisation of these compounds. As the clinical applications for ADCs continue to expand, key strategies to improve patient outcomes include better patient selection for treatment and the identification of mechanisms of therapy resistance. PMID:28536381

Data-intensive drug development in the information age: applications of Systems Biology/Pharmacology/Toxicology.

PubMed

Kiyosawa, Naoki; Manabe, Sunao

2016-01-01

Pharmaceutical companies continuously face challenges to deliver new drugs with true medical value. R&D productivity of drug development projects depends on 1) the value of the drug concept and 2) data and in-depth knowledge that are used rationally to evaluate the drug concept's validity. A model-based data-intensive drug development approach is a key competitive factor used by innovative pharmaceutical companies to reduce information bias and rationally demonstrate the value of drug concepts. Owing to the accumulation of publicly available biomedical information, our understanding of the pathophysiological mechanisms of diseases has developed considerably; it is the basis for identifying the right drug target and creating a drug concept with true medical value. Our understanding of the pathophysiological mechanisms of disease animal models can also be improved; it can thus support rational extrapolation of animal experiment results to clinical settings. The Systems Biology approach, which leverages publicly available transcriptome data, is useful for these purposes. Furthermore, applying Systems Pharmacology enables dynamic simulation of drug responses, from which key research questions to be addressed in the subsequent studies can be adequately informed. Application of Systems Biology/Pharmacology to toxicology research, namely Systems Toxicology, should considerably improve the predictability of drug-induced toxicities in clinical situations that are difficult to predict from conventional preclinical toxicology studies. Systems Biology/Pharmacology/Toxicology models can be continuously improved using iterative learn-confirm processes throughout preclinical and clinical drug discovery and development processes. Successful implementation of data-intensive drug development approaches requires cultivation of an adequate R&D culture to appreciate this approach.

Continuous infusion of amphotericin B deoxycholate: an innovative, low-cost strategy in antifungal treatment.

PubMed

Falci, Diego R; dos Santos, Rodrigo P; Wirth, Fernanda; Goldani, Luciano Z

2011-03-01

The combination of amphotericin B and sodium deoxycholate is the formulation most used in clinical practice. The development of new agents such as amphotericin with lipid formulations, caspofungin, voriconazole and other azolic derivatives, promoted alternatives to amphotericin B deoxycholate. However, because of the high cost of these new drugs, their use is difficult in a scenario of limited resources. A few strategies have been devised to make the use of amphotericin B deoxycholate less toxic. In this review, we seek to describe the accumulated knowledge about this molecule, with focus on its use in continuous infusion, which appears to be an alternative to reduce toxicity, while maintaining its clinical efficacy. © 2009 Blackwell Verlag GmbH.

Management of Charcot–Marie–Tooth disease: improving long-term care with a multidisciplinary approach

PubMed Central

McCorquodale, Donald; Pucillo, Evan M; Johnson, Nicholas E

2016-01-01

Charcot–Marie–Tooth (CMT) disease is the most common inherited neuropathy and one of the most common inherited diseases in humans. The diagnosis of CMT is traditionally made by the neurologic specialist, yet the optimal management of CMT patients includes genetic counselors, physical and occupational therapists, physiatrists, orthotists, mental health providers, and community resources. Rapidly developing genetic discoveries and novel gene discovery techniques continue to add a growing number of genetic subtypes of CMT. The first large clinical natural history and therapeutic trials have added to our knowledge of each CMT subtype and revealed how CMT impacts patient quality of life. In this review, we discuss several important trends in CMT research factors that will require a collaborative multidisciplinary approach. These include the development of large multicenter patient registries, standardized clinical instruments to assess disease progression and disability, and increasing recognition and use of patient-reported outcome measures. These developments will continue to guide strategies in long-term multidisciplinary efforts to maintain quality of life and preserve functionality in CMT patients. PMID:26855581

Using the Affective Domain to Enhance Teaching of the ACGME Competencies in Anesthesiology Training.

PubMed

Yanofsky, Samuel D; Nyquist, Julie G

2010-01-01

Teaching and assessing the advanced competencies will continue to be a challenge. Incorporating new and nontraditional skills into an already complex and challenging clinical curriculum and practice is not easy. This makes development of methods for curricular design, teaching and assessment of anesthesiology resident and fellow performance essential. The Domains of learning, particularly the Affective Domain can serve as an organizing structure for developing objectives and selecting teaching and assessment techniques. Using the Affective Domain to select targeted teaching techniques might help foster development of key beliefs and values that underlie the advanced competencies (and sub-competencies). Targeted teaching, outside of the patient care arena, when combined with traditional clinical teaching practices, may help to ensure continued performance of desired behaviors. These include acting in a consultative role for other health professionals (ICS), providing culturally responsive care (Professionalism), using evidence to enhance the care of patients (PBLI), and advocating for quality of care and working to enhance patient safety (SBP). As educators, our aim is not only to impact knowledge, attitudes and skills, but to impact the daily behavior of our graduates.

Using the Affective Domain to Enhance Teaching of the ACGME Competencies in Anesthesiology Training

PubMed Central

2010-01-01

Teaching and assessing the advanced competencies will continue to be a challenge. Incorporating new and nontraditional skills into an already complex and challenging clinical curriculum and practice is not easy. This makes development of methods for curricular design, teaching and assessment of anesthesiology resident and fellow performance essential. The Domains of learning, particularly the Affective Domain can serve as an organizing structure for developing objectives and selecting teaching and assessment techniques. Using the Affective Domain to select targeted teaching techniques might help foster development of key beliefs and values that underlie the advanced competencies (and sub-competencies). Targeted teaching, outside of the patient care arena, when combined with traditional clinical teaching practices, may help to ensure continued performance of desired behaviors. These include acting in a consultative role for other health professionals (ICS), providing culturally responsive care (Professionalism), using evidence to enhance the care of patients (PBLI), and advocating for quality of care and working to enhance patient safety (SBP). As educators, our aim is not only to impact knowledge, attitudes and skills, but to impact the daily behavior of our graduates. PMID:27175387

Applications of Doppler ultrasound in clinical vascular disease

NASA Technical Reports Server (NTRS)

Barnes, R. W.; Hokanson, D. E.; Sumner, D. S.; Strandness, D. E., Jr.

1975-01-01

Doppler ultrasound has become the most useful and versatile noninvasive technique for objective evaluation of clinical vascular disease. Commercially available continuous-wave instruments provide qualitative and quantitative assessment of venous and arterial disease. Pulsed Doppler ultrasound was developed to provide longitudinal and transverse cross-sectional images of the arterial lumen with a resolution approaching that of conventional X-ray techniques. Application of Doppler ultrasound in venous, peripheral arterial, and cerebrovascular diseases is reviewed.

Naval Medical Research and Development News. Volume 8, Issue 4, April 2016

DTIC Science & Technology

2016-04-01

for both research efforts and clinical decision-making within the trauma and critical care fields. NAMRU-SA Focuses on Monitoring Immune System to...Restorative Medicine Directorate at Naval Medical Research Unit San Antonio (NAMRU-SA) is dedicated to assessing dental related factors that influence...assigned. The number of CAD/CAM restorations placed is expected to continue rising as more milling devices are placed in Navy dental clinics and

Naval Medical Research And Development News. Volume 8, Issue 4, April 2016

DTIC Science & Technology

2016-04-01

for both research efforts and clinical decision-making within the trauma and critical care fields. NAMRU-SA Focuses on Monitoring Immune System to...Restorative Medicine Directorate at Naval Medical Research Unit San Antonio (NAMRU-SA) is dedicated to assessing dental related factors that influence...assigned. The number of CAD/CAM restorations placed is expected to continue rising as more milling devices are placed in Navy dental clinics and

Experience inheritance from famous specialists based on real-world clinical research paradigm of traditional Chinese medicine.

PubMed

Song, Guanli; Wang, Yinghui; Zhang, Runshun; Liu, Baoyan; Zhou, Xuezhong; Zhou, Xiaji; Zhang, Hong; Guo, Yufeng; Xue, Yanxing; Xu, Lili

2014-09-01

The current modes of experience inheritance from famous specialists in traditional Chinese medicine (TCM) include master and disciple, literature review, clinical-epidemiology-based clinical research observation, and analysis and data mining via computer and database technologies. Each mode has its advantages and disadvantages. However, a scientific and instructive experience inheritance mode has not been developed. The advent of the big data era as well as the formation and practice accumulation of the TCM clinical research paradigm in the real world have provided new perspectives, techniques, and methods for inheriting experience from famous TCM specialists. Through continuous exploration and practice, the research group proposes the innovation research mode based on the real-world TCM clinical research paradigm, which involves the inheritance and innovation of the existing modes. This mode is formulated in line with its own development regularity of TCM and is expected to become the main mode of experience inheritance in the clinical field.

Journal Writing in Health Education.

ERIC Educational Resources Information Center

Gillis, Angela J.

2001-01-01

Notes the growing use of journals in nursing education and health professions continuing education. Describes a three-step method involving critical analysis of clinical practice, peer group discussion, and self-evaluation. Presents practical guidelines for journal writing and ways to use journals to develop competence. (SK)

Cardiac radiology: centenary review.

PubMed

de Roos, Albert; Higgins, Charles B

2014-11-01

During the past century, cardiac imaging technologies have revolutionized the diagnosis and treatment of acquired and congenital heart disease. Many important contributions to the field of cardiac imaging were initially reported in Radiology. The field developed from the early stages of cardiac imaging, including the use of coronary x-ray angiography and roentgen kymography, to nowadays the widely used echocardiographic, nuclear medicine, cardiac computed tomographic (CT), and magnetic resonance (MR) applications. It is surprising how many of these techniques were not recognized for their potential during their early inception. Some techniques were described in the literature but required many years to enter the clinical arena and presently continue to expand in terms of clinical application. The application of various CT and MR contrast agents for the diagnosis of myocardial ischemia is a case in point, as the utility of contrast agents continues to expand the noninvasive characterization of myocardium. The history of cardiac imaging has included a continuous process of advances in our understanding of the anatomy and physiology of the cardiovascular system, along with advances in imaging technology that continue to the present day.

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.

The practice of clinical neuropsychology in Australia.

PubMed

Ponsford, Jennie

2016-11-01

This paper describes the development and practice of clinical neuropsychology in Australia. Clinical Neuropsychology has shown rapid growth in Australia over the past three decades. Comprehensive and specialized training programs are producing high quality graduates who are employed in a broad range of settings or private practice. Australia now has a substantial number of clinical neuropsychologists with specialist training. Whilst the majority of Australian clinical neuropsychologists still undertake assessment predominantly, there are growing opportunities for clinical neuropsychologists in rehabilitation and in a broad range of research contexts. Cultural issues relating to the assessment of Indigenous Australians and immigrants from many countries present significant challenges. Some major contributions have been made in the realms of test development and validation across various age groups. Australian clinical neuropsychologists are also contributing significantly to research in the fields of traumatic brain injury, aging and dementias, epilepsy, memory assessment, rehabilitation, substance abuse, and other psychiatric disorders. Expansion of roles of clinical neuropsychologists, in domains such as rehabilitation and research is seen as essential to underpin continuing growth of employment opportunities for the profession.

Enhancing reflective practice through online learning: impact on clinical practice

PubMed Central

Sim, J; Radloff, A

2008-01-01

Purpose Traditionally, radiographers and radiation therapists function in a workplace environment that is protocol-driven with limited functional autonomy. The workplace promotes a culture of conformity and discourages practitioners from reflective and critical thinking, essential attributes for continuing learning and advancing workplace practices. As part of the first author’s doctoral study, a continuing professional development (CPD) educational framework was used to design and implement an online module for radiation therapists’ CPD activities. The study aimed to determine if it is possible to enhance healthcare practitioners’ reflective practice via online learning and to establish the impact of reflective learning on clinical practice. Materials and methods The objectives of the online module were to increase radiation therapists’ knowledge in planning for radiation therapy for the breast by assisting them engage in reflective practice. The cyclical process of action research was used to pilot the module twice with two groups of volunteer radiation therapists (twenty-six participants) from Australia, New Zealand and Canada. Results The online module was evaluated using Kirkpatrick’s four-level evaluation model. Evidence indicated that participants were empowered as a result of participation in the module. They began reflecting in the workplace while assuming a more proactive role and increased clinical responsibilities, engaged colleagues in collaborative reflections and adopted evidence-based approaches in advancing clinical practices. Conclusion The study shows that it is possible to assist practitioners engage in reflective practice using an online CPD educational framework. Participants were able to apply the reflective learning they had developed in their workplace. As a result of their learning, they felt empowered to continue to effect changes in their workplace beyond the cessation of the online module. PMID:21614319

Partners with Clinical Practice: Evaluating the Student and Staff Experiences of On-Line Continuing Professional Development for Qualified Nephrology Practitioners

ERIC Educational Resources Information Center

Hurst, Judith; Quinsee, Susannah

2005-01-01

The inclusion of online learning technologies into the higher education (HE) curriculum is frequently associated with the design and development of new models of learning. One could argue that e-learning even demands a reconfiguration of traditional methods of learning and teaching. However, this transformation in pedagogic methodology does not…

The power of partnership to shape the future of nursing: the evolution of the clinical nurse leader.

PubMed

Tornabeni, Jolene; Miller, Judith Fitzgerald

2008-07-01

This article describes the evolution of the clinical nurse leader role and demonstrates the vital nature of partnerships between academia and practice in the design and implementation of this new role. The health care system as it exists in the United States may put patients at risk in terms of safety and quality of care. Nursing leadership from across the US recognized a need for nursing practice and academia to work in partnership to develop workable and effective solutions. The vision was of a nurse generalist who would be prepared to address the complexities that make the current systems dysfunctional. Review, share experiences and discuss the benefits of engaging stakeholders with broad and diverse viewpoints. Engaging a group of stakeholders with diverse backgrounds, varied world views and experiences for the purpose of developing common mutually beneficial goals, creates synergy and greater commitment to the goals, which results in success. The power of partnership in the development and implementation of the CNL is evident. Old ways of trying to 'go it alone' are no longer viable in a complex health care environment. With continued collaboration, practice and academia can continue to confront challenges and develop effective solutions.

An evaluation of internal medicine residency continuity clinic redesign to a 50/50 outpatient-inpatient model.

PubMed

Wieland, Mark L; Halvorsen, Andrew J; Chaudhry, Rajeev; Reed, Darcy A; McDonald, Furman S; Thomas, Kris G

2013-08-01

There have been recent calls for improved internal medicine outpatient training, yet assessment of clinical and educational variables within existing models is lacking. To assess the impact of clinic redesign from a traditional weekly clinic model to a 50/50 outpatient-inpatient model on clinical and educational outcomes. Pre-intervention and post-intervention study intervals, comparing the 2009-2010 and 2010-2011 academic years. Ninety-six residents in a Primary Care Internal Medicine site of a large academic internal medicine residency program who provide care for > 13,000 patients. Continuity clinic redesign from a traditional weekly clinic model to a 50/50 model characterized by 50 % outpatient and 50 % inpatient experiences scheduled in alternating 1 month blocks, with twice weekly continuity clinic during outpatient months and no clinic during inpatient months. 1) Clinical outcomes (panel size, patient visits, adherence with chronic disease and preventive service guidelines, continuity of care, patient satisfaction, and perceived safety/teamwork in clinic); 2) Educational outcomes (attendance at teaching conference, resident and faculty satisfaction, faculty assessment of resident clinic performance, and residents' perceived preparedness for outpatient management). Redesign was associated with increased mean panel size (120 vs. 137.6; p ≤ 0.001), decreased continuity of care (63 % vs. 48 % from provider perspective; 61 % vs. 51 % from patient perspective; p ≤  0.001 for both; team continuity was preserved), decreased missed appointments (12.5 % vs. 10.9 %; p ≤  0.01), improved perceived safety and teamwork (3.6 vs. 4.1 on 5-point scale; p ≤  0.001), improved mean teaching conference attendance (57.1 vs. 64.4; p ≤  0.001), improved resident clinic performance (3.6 vs. 3.9 on 5-point scale; p ≤  0.001), and little change in other outcomes. Although this model requires further study in other settings, these results suggest that a 50/50 model may allow residents to manage more patients while enhancing the climate of teamwork and safety in the continuity clinic, compared to traditional models. Future work should explore ways to preserve continuity of care within this model.

A Quality Model to Select Patients in Cupping Therapy Clinics: A New Tool for Ensuring Safety in Clinical Practice.

PubMed

Aboushanab, Tamer; AlSanad, Saud

2018-06-08

Cupping therapy is a popular treatment in various countries and regions, including Saudi Arabia. Cupping therapy is regulated in Saudi Arabia by the National Center for Complementary and Alternative Medicine (NCCAM), Ministry of Health. The authors recommend that this quality model for selecting patients in cupping clinics - first version (QMSPCC-1) - be used routinely as part of clinical practice and quality management in cupping clinics. The aim of the quality model is to ensure the safety of patients and to introduce and facilitate quality and auditing processes in cupping therapy clinics. Clinical evaluation of this tool is recommended. Continued development, re-evaluation and reassessment of this tool are important. Copyright © 2018. Published by Elsevier B.V.

Kilogram-scale prexasertib monolactate monohydrate synthesis under continuous-flow CGMP conditions.

PubMed

Cole, Kevin P; Groh, Jennifer McClary; Johnson, Martin D; Burcham, Christopher L; Campbell, Bradley M; Diseroad, William D; Heller, Michael R; Howell, John R; Kallman, Neil J; Koenig, Thomas M; May, Scott A; Miller, Richard D; Mitchell, David; Myers, David P; Myers, Steven S; Phillips, Joseph L; Polster, Christopher S; White, Timothy D; Cashman, Jim; Hurley, Declan; Moylan, Robert; Sheehan, Paul; Spencer, Richard D; Desmond, Kenneth; Desmond, Paul; Gowran, Olivia

2017-06-16

Advances in drug potency and tailored therapeutics are promoting pharmaceutical manufacturing to transition from a traditional batch paradigm to more flexible continuous processing. Here we report the development of a multistep continuous-flow CGMP (current good manufacturing practices) process that produced 24 kilograms of prexasertib monolactate monohydrate suitable for use in human clinical trials. Eight continuous unit operations were conducted to produce the target at roughly 3 kilograms per day using small continuous reactors, extractors, evaporators, crystallizers, and filters in laboratory fume hoods. Success was enabled by advances in chemistry, engineering, analytical science, process modeling, and equipment design. Substantial technical and business drivers were identified, which merited the continuous process. The continuous process afforded improved performance and safety relative to batch processes and also improved containment of a highly potent compound. Copyright © 2017, American Association for the Advancement of Science.

Product-Related Impurities in Clinical-Grade Recombinant AAV Vectors: Characterization and Risk Assessment

PubMed Central

Wright, J. Fraser

2014-01-01

Adeno-associated virus (AAV)-based vectors expressing therapeutic genes continue to demonstrate great promise for the treatment of a wide variety of diseases and together with other gene transfer vectors represent an emerging new therapeutic paradigm comparable in potential impact on human health to that achieved by recombinant proteins and vaccines. A challenge for the current pipeline of AAV-based investigational products as they advance through clinical development is the identification, characterization and lot-to-lot control of the process- and product-related impurities present in even highly purified preparations. Especially challenging are AAV vector product-related impurities that closely resemble the vector itself and are, in some cases, without clear precedent in established biotherapeutic products. The determination of acceptable levels of these impurities in vectors prepared for human clinical product development, with the goal of new product licensure, requires careful risk and feasibility assessment. This review focuses primarily on the AAV product-related impurities that have been described in vectors prepared for clinical development. PMID:28548061

Increased Screen Time: Implications for Early Childhood Development and Behavior.

PubMed

Radesky, Jenny S; Christakis, Dimitri A

2016-10-01

The authors review trends in adoption of new digital technologies (eg, mobile and interactive media) by families with young children (ages 0-8 years), continued use of television and video games, and the evidence for learning from digital versus hands-on play. The authors also discuss continued concerns about health and developmental/behavioral risks of excessive media use for child cognitive, language, literacy, and social-emotional development. This evidence is then applied to clinical care in terms of the screening questions providers can use, tools available to providers and parents, and changes in anticipatory guidance. Copyright © 2016 Elsevier Inc. All rights reserved.

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.

Robotics in urological surgery: evolution, current status and future perspectives.

PubMed

Sivaraman, A; Sanchez-Salas, R; Prapotnich, D; Barret, E; Mombet, A; Cathala, N; Rozet, F; Galiano, M; Cathelineau, X

2015-09-01

Robotic surgery is rapidly evolving and has become an essential part of surgical practice in several parts of the world. Robotic technology will expand globally and most of the surgeons around the world will have access to surgical robots in the future. It is essential that we are updated about the outcomes of robot assisted surgeries which will allow everyone to develop an unbiased opinion on the clinical utility of this innovation. In this review we aim to present the evolution, objective evaluation of clinical outcomes and future perspectives of robot assisted urologic surgeries. A systematic literature review of clinical outcomes of robotic urological surgeries was made in the PUBMED. Randomized control trials, cohort studies and review articles were included. Moreover, a detailed search in the web based search engine was made to acquire information on evolution and evolving technologies in robotics. The present evidence suggests that the clinical outcomes of the robot assisted urologic surgeries are comparable to the conventional open surgical and laparoscopic results and are associated with fewer complications. However, long term results are not available for all the common robotic urologic surgeries. There are plenty of novel developments in robotics to be available for clinical use in the future. Robotic urologic surgery will continue to evolve in the future. We should continue to critically analyze whether the advances in technology and the higher cost eventually translates to improved overall surgical performance and outcomes. Copyright © 2014 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

Evaluation of service quality in family planning clinics in Lusaka, Zambia.

PubMed

Hancock, Nancy L; Vwalika, Bellington; Sitali, Elizabeth Siyama; Mbwili-Muleya, Clara; Chi, Benjamin H; Stuart, Gretchen S

2015-10-01

To determine the quality of contraceptive services in family planning clinics in Lusaka, Zambia, using a standardized approach. We utilized the Quick Investigation of Quality, a cross-sectional survey tool consisting of a facility assessment, client-provider observation and client exit interview, in public-sector family planning clinics. Data were collected on availability of seven contraceptive methods, information given to clients, interpersonal relations between providers and clients, providers' technical competence and mechanisms for continuity and follow-up. Data were collected from five client-provider observations and client exit interviews in each of six public-sector family planning clinics. All clinics had at least two contraceptive methods continuously available for the preceding 6 months. Most providers asked clients about concerns with their contraceptive method (80%) and told clients when to return to the clinic (87%). Most clients reported that the provider advised what to do if a problem develops (93%), described possible side effects (89%), explained how to use the method effectively (85%) and told them when to come for follow-up (83%). Clients were satisfied with services received (93%). This application of the Quick Investigation of Quality showed that the participating family planning clinics in Lusaka, Zambia, were prepared to offer high-quality services with the available commodities and that clients were satisfied with the received services. Despite the subjective client satisfaction, quality improvement efforts are needed to increase contraceptive availability. Although clients perceived the quality of care received to be high, family planning service quality could be improved to continuously offer the full spectrum of contraceptive options. The Quick Investigation of Quality was easily implemented in Lusaka, Zambia, and this simple approach could be utilized in a variety of settings as a modality for quality improvement. Copyright © 2015 Elsevier Inc. All rights reserved.

Development and initial evaluation of an instrument to assess physiotherapists' clinical reasoning focused on clients' behavior change.

PubMed

Elvén, Maria; Hochwälder, Jacek; Dean, Elizabeth; Söderlund, Anne

2018-05-01

A systematically developed and evaluated instrument is needed to support investigations of physiotherapists' clinical reasoning integrated with the process of clients' behavior change. This study's aim was to develop an instrument to assess physiotherapy students' and physiotherapists' clinical reasoning focused on clients' activity-related behavior and behavior change, and initiate its evaluation, including feasibility and content validity. The study was conducted in three phases: 1) determination of instrument structure and item generation, based on a model, guidelines for assessing clinical reasoning, and existing measures; 2) cognitive interviews with five physiotherapy students to evaluate item understanding and feasibility; and 3) a Delphi process with 18 experts to evaluate content relevance. Phase 1 resulted in an instrument with four domains: Physiotherapist; Input from client; Functional behavioral analysis; and Strategies for behavior change. The instrument consists of case scenarios followed by items in which key features are identified, prioritized, or interpreted. Phase 2 resulted in revisions of problems and approval of feasibility. Phase 3 demonstrated high level of consensus regarding the instrument's content relevance. This feasible and content-validated instrument shows potential for use in investigations of physiotherapy students' and physiotherapists' clinical reasoning, however continued development and testing are needed.

Ongoing Response in BRAF V600E-Mutant Melanoma After Cessation of Intermittent Vemurafenib Therapy: A Case Report.

PubMed

Dooley, Andrew J; Gupta, Avinash; Middleton, Mark R

2016-08-01

The selective BRAF inhibitors vemurafenib and dabrafenib yield high response rates and improved overall survival in patients with BRAF V600E-mutant metastatic melanoma. Treatment traditionally continues until disease progression or the development of unacceptable toxicity. Acquired drug resistance and toxicity are key challenges with the use of these drugs. Resistance to vemurafenib usually develops within 6-8 months. Management of drug toxicity typically involves stopping vemurafenib until resolution, before restarting at a lower dose, or permanently ceasing vemurafenib therapy. We have recently considered whether intermittent dosing could be used as an alternative to dose reduction/termination in the management of vemurafenib toxicity. One patient treated with intermittent vemurafenib was an 89-year-old woman with metastatic melanoma, who initially showed a good response to continuous dosing. Recurrent toxicity meant that the continuous vemurafenib dosage was repeatedly ceased before restarting at a lower dose. Ten months after vemurafenib was first begun, an intermittent dosing regimen was introduced in an attempt to control toxicity. This continued for 2 months, before cessation due to continued unacceptable toxicity. A further 24 months later, the patient remains fit and well in complete clinical remission, with no recurrence of her previous melanoma and no new primary malignancies. To the best of our knowledge, a continued response after the cessation of selective BRAF inhibitors has never before been described in melanoma. Induction of an immune response and/or epigenetic changes could explain continued disease response after cessation of vemurafenib therapy. Care should be taken when extrapolating the findings from the continued response after vemurafenib cessation to other tumour types. We recommend the collection and analysis of data to investigate the clinical responses seen after cessation of vemurafenib due to intolerable toxicities, which could help further explain vemurafenib's mechanism of action.

The changing training needs of clinical nurse managers: exploring issues for continuing professional development.

PubMed

Gould, D; Kelly, D; Goldstone, L; Maidwell, A

2001-04-01

To identify areas where clinical nurse managers perceived that they would benefit from further training and to make recommendations for planning future programmes to meet their needs. The effectiveness of the clinical nurse manager has traditionally been associated with maintaining standards of care. Continuing professional development (CPD) is essential to ensure this important group feel adequately prepared to perform their role and has been recognized as an important factor in maintaining job satisfaction and reducing wasteful staff turnover. A review of the literature indicated that since the 1980s the CPD needs of clinical nurse managers have tended to be overlooked despite increasing complexity of the tasks expected of them. Thus it appeared that a fresh study to address these needs would be justified and should take into account sources of work-related stress and variables relating to job satisfaction. The study involved clinical nurse managers employed in all four acute hospital National Health Service (NHS) trusts where training needs were served by a major inner city educational consortium. Data collection proceeded in two stages. Initially interviews were undertaken with a random sample of 15 clinical nurse managers to provide in-depth, qualitative data. This information was used to develop a survey questionnaire distributed to the remaining 182 clinical nurse managers in each of the trusts. Data from the interviews indicated that clinical nurse managers appeared to feel clinically competent but generally experienced lack of confidence when dealing with a range of issues, in particular; human resources, managing budgets, deputizing for senior colleagues across the trust ('acting up') and using information technology in everyday practice. Response rate to the survey was good (65%). The results corroborated the interview findings, indicating a need for updating in the same wide range of topics. There were few differences in training needs across all four trusts. Clinical nurse managers who perceived that they had been well-prepared for their role demonstrated higher levels of job satisfaction. Perceived preparation for clinical leadership was the same irrespective of the employing trust, length of time in post and other sociodemographic variables. The study findings confirm that CPD remains a major issue for clinical nurse managers in the United Kingdom (UK) and that providing opportunities for such development may be an important factor in enhancing job satisfaction. The study findings should help those providing CPD to plan more effectively for this group and have implications for staff recruitment and retention.

An overview of clinical governance policies, practices and initiatives.

PubMed

Braithwaite, Jeffrey; Travaglia, Joanne F

2008-02-01

To map the emergence of, and define, clinical governance; to discuss current best practices, and to explore the implications of these for boards of directors and executives wishing to promote a clinical governance approach in their health services. Review and analysis of the published and grey literature on clinical governance from 1966 to 2006. Medline and CINAHL databases, key journals and websites were systematically searched. Central issues were identified in the literature as key to effective clinical governance. These include: ensuring that links are made between health services' clinical and corporate governance; the use of clinical governance to promote quality and safety through a focus on quality assurance and continuous improvement; the creation of clinical governance structures to improve safety and quality and manage risk and performance; the development of strategies to ensure the effective exchange of data, knowledge and expertise; and the sponsoring of a patient-centred approach to service delivery. A comprehensive approach to clinical governance necessarily includes the active participation of boards and executives in sponsoring and promoting clinical governance as a quality and safety strategy. Although this is still a relatively recent development, the signs are promising.

A Simple Composite Metric for the Assessment of Glycemic Status from Continuous Glucose Monitoring Data: Implications for Clinical Practice and the Artificial Pancreas.

PubMed

Hirsch, Irl B; Balo, Andrew K; Sayer, Kevin; Garcia, Arturo; Buckingham, Bruce A; Peyser, Thomas A

2017-06-01

The potential clinical benefits of continuous glucose monitoring (CGM) have been recognized for many years, but CGM is used by a small fraction of patients with diabetes. One obstacle to greater use of the technology is the lack of simplified tools for assessing glycemic control from CGM data without complicated visual displays of data. We developed a simple new metric, the personal glycemic state (PGS), to assess glycemic control solely from continuous glucose monitoring data. PGS is a composite index that assesses four domains of glycemic control: mean glucose, glycemic variability, time in range and frequency and severity of hypoglycemia. The metric was applied to data from six clinical studies for the G4 Platinum continuous glucose monitoring system (Dexcom, San Diego, CA). The PGS was also applied to data from a study of artificial pancreas comparing results from open loop and closed loop in adolescents and in adults. The new metric for glycemic control, PGS, was able to characterize the quality of glycemic control in a wide range of study subjects with various mean glucose, minimal, moderate, and excessive glycemic variability and subjects on open loop versus closed loop control. A new composite metric for the assessment of glycemic control based on CGM data has been defined for use in assessing glycemic control in clinical practice and research settings. The new metric may help rapidly identify problems in glycemic control and may assist with optimizing diabetes therapy during time-constrained physician office visits.

Fusion of nonclinical and clinical data to predict human drug safety.

PubMed

Johnson, Dale E

2013-03-01

Adverse drug reactions continue to be a major cause of morbidity in both patients receiving therapeutics and in drug R&D programs. Predicting and possibly eliminating these adverse events remains a high priority in industry, government agencies and healthcare systems. With small molecule candidates, the fusion of nonclinical and clinical data is essential in establishing an overall system that creates a true translational science approach. Several new advances are taking place that attempt to create a 'patient context' mechanism early in drug research and development and ultimately into the marketplace. This 'life-cycle' approach has as its core the development of human-oriented, nonclinical end points and the incorporation of clinical knowledge at the drug design stage. The next 5 years should witness an explosion of what the author views as druggable and safe chemical space, pharmacosafety molecular targets and the most important aspect, an understanding of unique susceptibilities in patients developing adverse drug reactions. Our current knowledge of clinical safety relies completely on pharmacovigilance data from approved and marketed drugs, with a few exceptions of drugs failing in clinical trials. Massive data repositories now and soon to be available via cloud computing should stimulate a major effort in expanding our view of clinical drug safety and its incorporation into early drug research and development.

A homecare application based on the ASTM E2369-05 Standard Specification for Continuity of Care Record.

PubMed

Botsivaly, M; Spyropoulos, B; Koutsourakis, K; Mertika, K

2006-01-01

The purpose of this study is the presentation of a system appropriate to be used upon the transition of a patient from hospital to homecare. The developed system is structured according to the ASTM E2369-05 Standard Specification for Continuity of Care Record and its function is based upon the creation of a structured subset of data, containing the patient's most relevant clinical information, enabling simultaneously the planning and the optimal documentation of the provided homecare.

Light Visor

NASA Technical Reports Server (NTRS)

1993-01-01

Seasonal Affective Disorder is a form of depression brought on by reduced light. For some people, this can lead to clinical depression. NASA has conducted research in light therapy and employs it to help astronauts adjust internal rhythms during orbital flight. Dr. George Brainard, a medical researcher and NASA consultant, has developed a portable light therapy device, which is commercially available. The Light Visor allows continuous light therapy and can be powered by either batteries or electricity. Dr. Brainard continues to research various aspects of light therapy.

Tendon Tissue Engineering: Progress, Challenges, and Translation to the Clinic

PubMed Central

Shearn, Jason T.; Kinneberg, Kirsten R.C.; Dyment, Nathaniel A.; Galloway, Marc T.; Kenter, Keith; Wylie, Christopher; Butler, David L.

2013-01-01

The tissue engineering field has made great strides in understanding how different aspects of tissue engineered constructs (TECs) and the culture process affect final tendon repair. However, there remain significant challenges in developing strategies that will lead to a clinically effective and commercially successful product. In an effort to increase repair quality, a better understanding of normal development, and how it differs from adult tendon healing, may provide strategies to improve tissue engineering. As tendon tissue engineering continues to improve, the field needs to employ more clinically relevant models of tendon injury such as degenerative tendons. We need to translate successes to larger animal models to begin exploring the clinical implications of our treatments. By advancing the models used to validate our TECs, we can help convince our toughest customer, the surgeon, that our products will be clinically efficacious. As we address these challenges in musculoskeletal tissue engineering, the field still needs to address the commercialization of products developed in the laboratory. TEC commercialization faces numerous challenges because each injury and patient is unique. This review aims to provide tissue engineers with a summary of important issues related to engineering tendon repairs and potential strategies for producing clinically successful products. PMID:21625053

Professional challenges and opportunities in clinical microbiology and infectious diseases in Europe.

PubMed

Read, Robert C; Cornaglia, Giuseppe; Kahlmeter, Gunnar

2011-05-01

The two closely linked specialties of clinical microbiology and infectious diseases face important challenges. We report the consensus of clinical microbiologists and infectious disease physicians assembled by the European Society for Clinical Microbiology and Infectious Diseases. Both specialties have different training requirements in different European countries and are not universally recognised as professions. The specialties are rapidly evolving as they adapt to the changing demands within hospital practice, including the need to deal with emerging infections, rapidly increasing internationalisation, and immigration. Clinical microbiology needs to develop and master technological advances such as laboratory automation and an avalanche of new methods for rapid diagnostics. Simultaneously, the pressure for concentration, amalgamation, and out-sourcing of laboratory services is ever-increasing. Infectious disease physicians have to meet the professional challenge of subspecialisation and the continual need to find new niches for their skills. Despite these challenges, each of these specialties continues to thrive in Europe and will enjoy important opportunities over the next few years. The recently formed European Centre for Disease Prevention and Control in Stockholm, Sweden, will increase demands in areas of surveillance of infectious diseases and antimicrobial resistance on both specialties. Copyright © 2011 Elsevier Ltd. All rights reserved.

Companion diagnostics and molecular imaging-enhanced approaches for oncology clinical trials.

PubMed

Van Heertum, Ronald L; Scarimbolo, Robert; Ford, Robert; Berdougo, Eli; O'Neal, Michael

2015-01-01

In the era of personalized medicine, diagnostic approaches are helping pharmaceutical and biotechnology sponsors streamline the clinical trial process. Molecular assays and diagnostic imaging are routinely being used to stratify patients for treatment, monitor disease, and provide reliable early clinical phase assessments. The importance of diagnostic approaches in drug development is highlighted by the rapidly expanding global cancer diagnostics market and the emergent attention of regulatory agencies worldwide, who are beginning to offer more structured platforms and guidance for this area. In this paper, we highlight the key benefits of using companion diagnostics and diagnostic imaging with a focus on oncology clinical trials. Nuclear imaging using widely available radiopharmaceuticals in conjunction with molecular imaging of oncology targets has opened the door to more accurate disease assessment and the modernization of standard criteria for the evaluation, staging, and treatment responses of cancer patients. Furthermore, the introduction and validation of quantitative molecular imaging continues to drive and optimize the field of oncology diagnostics. Given their pivotal role in disease assessment and treatment, the validation and commercialization of diagnostic tools will continue to advance oncology clinical trials, support new oncology drugs, and promote better patient outcomes.

Preventing group B streptococcal infections in newborns.

PubMed

Porta, Kelly; Rizzolo, Denise

2015-03-01

Despite advances in intrapartum antibiotic prophylaxis (IAP), group B streptococcal infection continues to be a predominant cause of early-onset disease in neonates. About 2% of neonates exposed to group B Streptococcus develop clinical manifestations including sepsis, pneumonia, and meningitis. Screening in late pregnancy reduces the incidence of early-onset sepsis by more than 80%. Clinicians must be able to identify the risk factors and clinical manifestations of group B streptococcal infection and to understand management and prevention guidelines.

An immodest proposal: pay equity for nursing faculty who do clinical teaching.

PubMed

Boughn, S

1992-05-01

Pay equity, the concept of equal pay for equal or comparable work, will continue to be of paramount importance to women as the 20th century draws to a close. While it might have been anticipated that women in academic settings would enjoy pay equity, clinical teaching in nursing education provides a model for gender discrimination as related to women's work. Elements of proposal development and a case study for contesting pay inequity are presented.

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

Bookman, M.A.; Bast, R.C. Jr.

Small volume residual peritoneal disease in patients undergoing therapy for ovarian carcinoma remains an attractive, but elusive, target for immunobiological therapy. Hypothetical advantages and disadvantages of regional peritoneal therapy are being better defined through increased clinical experience and more sophisticated animal models. Developments in cytokine biology, adoptive cellular therapy, monoclonal antibody conjugation, and molecular biology continue to provide an exciting, and nearly overwhelming, array of reagents for clinical evaluation. Ongoing and anticipated investigational trials should provide intriguing data in years to follow.198 references.

Advances in arterial spin labelling MRI methods for measuring perfusion and collateral flow.

PubMed

van Osch, Matthias Jp; Teeuwisse, Wouter M; Chen, Zhensen; Suzuki, Yuriko; Helle, Michael; Schmid, Sophie

2017-01-01

With the publication in 2015 of the consensus statement by the perfusion study group of the International Society for Magnetic Resonance in Medicine (ISMRM) and the EU-COST action 'ASL in dementia' on the implementation of arterial spin labelling MRI (ASL) in a clinical setting, the development of ASL can be considered to have become mature and ready for clinical prime-time. In this review article new developments and remaining issues will be discussed, especially focusing on quantification of ASL as well as on new technological developments of ASL for perfusion imaging and flow territory mapping. Uncertainty of the achieved labelling efficiency in pseudo-continuous ASL (pCASL) as well as the presence of arterial transit time artefacts, can be considered the main remaining challenges for the use of quantitative cerebral blood flow (CBF) values. New developments in ASL centre around time-efficient acquisition of dynamic ASL-images by means of time-encoded pCASL and diversification of information content, for example by combined 4D-angiography with perfusion imaging. Current vessel-encoded and super-selective pCASL-methodology have developed into easily applied flow-territory mapping methods providing relevant clinical information with highly similar information content as digital subtraction angiography (DSA), the current clinical standard. Both approaches seem therefore to be ready for clinical use.

Recommended Implementation of Arterial Spin Labeled Perfusion MRI for Clinical Applications: A consensus of the ISMRM Perfusion Study Group and the European Consortium for ASL in Dementia

PubMed Central

Alsop, David C.; Detre, John A.; Golay, Xavier; Günther, Matthias; Hendrikse, Jeroen; Hernandez-Garcia, Luis; Lu, Hanzhang; MacIntosh, Bradley J.; Parkes, Laura M.; Smits, Marion; van Osch, Matthias J. P.; Wang, Danny JJ; Wong, Eric C.; Zaharchuk, Greg

2014-01-01

This article provides a summary statement of recommended implementations of arterial spin labeling (ASL) for clinical applications. It is a consensus of the ISMRM Perfusion Study Group and the European ‘ASL in Dementia’ consortium, both of whom met to reach this consensus in October 2012 in Amsterdam. Although ASL continues to undergo rapid technical development, we believe that current ASL methods are robust and ready to provide useful clinical information, and that a consensus statement on recommended implementations will help the clinical community to adopt a standardized approach. In this article we describe the major considerations and tradeoffs in implementing an ASL protocol, and provide specific recommendations for a standard approach. Our conclusions are that, as an optimal default implementation we recommend: pseudo-continuous labeling, background suppression, a segmented 3D readout without vascular crushing gradients, and calculation and presentation of both label/control difference images and cerebral blood flow in absolute units using a simplified model. PMID:24715426

mHealth: Mobile Technologies to Virtually Bring the Patient Into an Oncology Practice.

PubMed

Pennell, Nathan A; Dicker, Adam P; Tran, Christine; Jim, Heather S L; Schwartz, David L; Stepanski, Edward J

2017-01-01

Accompanied by the change in the traditional medical landscape, advances in wireless technology have led to the development of telehealth or mobile health (mHealth), which offers an unparalleled opportunity for health care providers to continually deliver high-quality care. This revolutionary shift makes the patient the consumer of health care and empowers patients to be the driving force of management of their own health through mobile devices and wearable technology. This article presents an overview of technology as it pertains to clinical practice considerations. Telemedicine is changing the way clinical care is delivered without regard for proximity to the patient, whereas nonclinical telehealth applications affect distance education for consumers or clinicians, meetings, research, continuing medical education, and health care management. Technology has the potential to reduce administrative burdens and improve both efficiency and quality of care delivery in the clinic. Finally, the potential for telehealth approaches as cost-effective ways to improve adherence to treatment is explored. As telehealth advances, health care providers must understand the fundamental framework for applying telehealth strategies to incorporate into successful clinical practice.

Nanocarriers for delivery of platinum anticancer drugs☆

PubMed Central

Oberoi, Hardeep S.; Nukolova, Natalia V.; Kabanov, Alexander V.; Bronich, Tatiana K.

2014-01-01

Platinum based anticancer drugs have revolutionized cancer chemotherapy, and continue to be in widespread clinical use especially for management of tumors of the ovary, testes, and the head and neck. However, several dose limiting toxicities associated with platinum drug use, partial anti-tumor response in most patients, development of drug resistance, tumor relapse, and many other challenges have severely limited the patient quality of life. These limitations have motivated an extensive research effort towards development of new strategies for improving platinum therapy. Nanocarrier-based delivery of platinum compounds is one such area of intense research effort beginning to provide encouraging preclinical and clinical results and may allow the development of the next generation of platinum chemotherapy. This review highlights current understanding on the pharmacology and limitations of platinum compounds in clinical use, and provides a comprehensive analysis of various platinum–polymer complexes, micelles, dendrimers, liposomes and other nanoparticles currently under investigation for delivery of platinum drugs. PMID:24113520

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.

Two-Year Institution Part-Time Nurse Faculty Experiences During Role Transition and Identity Development: A Phenomenological Study.

PubMed

Owens, Rhoda A

This study explored two-year institution part-time nurse faculty's perceptions of their experiences during their role transitions from nurses in clinical practice to part-time clinical instructors. Part-time nurse faculty enter academia as expert clinicians, but most have little or no training in the pedagogy of effective student learning. A phenomenological study was used to explore the faculty role transition experiences. Findings support the proposition that six participants transitioned from their expert clinician to instructor identities; however, two continue in the process. Critical to this process are relationships with individuals in their environments, past and present experiences, the incentive to learn to be better instructors, and the importance of support and training. A model emerged, Process of Role Transition and Professional Identity Formation for Part-Time Clinical Instructors at Two-Year Institutions, that is potentially useful for administrators in developing individualized orientation and professional development programs.

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

PubMed

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

2015-11-01

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

Interpretation of lung cancer study outcomes.

PubMed

Cortinovis, Diego; Abbate, Marida; Bidoli, Paolo; Pelizzoni, Davide; Canova, Stefania

2015-11-01

Lung cancer is the leading cause of cancer death in developed countries. However, in the last few years we observed an important acceleration in drug development due to oncogenic driver tumors discovery. Sharing and putting together preclinical data from benchmark and data from clinical research is the scientific paradigm that allows real breakthrough in clinical practice in this field, but only a few targeted agents are worthy and practice changing. The clinical research and proper use of statistical methodology are the pillars to continue to achieve important goals like improvement of overall survival. A good medical oncologist should be able to critically read a scientific paper and move from the observed outcomes into clinical perspective. Despite clinical improvements, sometimes the union of promising targeted agents and optimistic expectations misrepresent the reality and the value of clinical research. In this article, we try to analyze the meaning of statistical assumptions from clinical trials, especially in lung cancer, through a critical review of the concept of value-based medicine. We also attempt to give the reader some practical tools to weigh scientific value of literature reports.

Continuous non-contact vital sign monitoring in neonatal intensive care unit

PubMed Central

Guazzi, Alessandro; Jorge, João; Davis, Sara; Watkinson, Peter; Green, Gabrielle; Shenvi, Asha; McCormick, Kenny; Tarassenko, Lionel

2014-01-01

Current technologies to allow continuous monitoring of vital signs in pre-term infants in the hospital require adhesive electrodes or sensors to be in direct contact with the patient. These can cause stress, pain, and also damage the fragile skin of the infants. It has been established previously that the colour and volume changes in superficial blood vessels during the cardiac cycle can be measured using a digital video camera and ambient light, making it possible to obtain estimates of heart rate or breathing rate. Most of the papers in the literature on non-contact vital sign monitoring report results on adult healthy human volunteers in controlled environments for short periods of time. The authors' current clinical study involves the continuous monitoring of pre-term infants, for at least four consecutive days each, in the high-dependency care area of the Neonatal Intensive Care Unit (NICU) at the John Radcliffe Hospital in Oxford. The authors have further developed their video-based, non-contact monitoring methods to obtain continuous estimates of heart rate, respiratory rate and oxygen saturation for infants nursed in incubators. In this Letter, it is shown that continuous estimates of these three parameters can be computed with an accuracy which is clinically useful. During stable sections with minimal infant motion, the mean absolute error between the camera-derived estimates of heart rate and the reference value derived from the ECG is similar to the mean absolute error between the ECG-derived value and the heart rate value from a pulse oximeter. Continuous non-contact vital sign monitoring in the NICU using ambient light is feasible, and the authors have shown that clinically important events such as a bradycardia accompanied by a major desaturation can be identified with their algorithms for processing the video signal. PMID:26609384

Continuous non-contact vital sign monitoring in neonatal intensive care unit.

PubMed

Villarroel, Mauricio; Guazzi, Alessandro; Jorge, João; Davis, Sara; Watkinson, Peter; Green, Gabrielle; Shenvi, Asha; McCormick, Kenny; Tarassenko, Lionel

2014-09-01

Current technologies to allow continuous monitoring of vital signs in pre-term infants in the hospital require adhesive electrodes or sensors to be in direct contact with the patient. These can cause stress, pain, and also damage the fragile skin of the infants. It has been established previously that the colour and volume changes in superficial blood vessels during the cardiac cycle can be measured using a digital video camera and ambient light, making it possible to obtain estimates of heart rate or breathing rate. Most of the papers in the literature on non-contact vital sign monitoring report results on adult healthy human volunteers in controlled environments for short periods of time. The authors' current clinical study involves the continuous monitoring of pre-term infants, for at least four consecutive days each, in the high-dependency care area of the Neonatal Intensive Care Unit (NICU) at the John Radcliffe Hospital in Oxford. The authors have further developed their video-based, non-contact monitoring methods to obtain continuous estimates of heart rate, respiratory rate and oxygen saturation for infants nursed in incubators. In this Letter, it is shown that continuous estimates of these three parameters can be computed with an accuracy which is clinically useful. During stable sections with minimal infant motion, the mean absolute error between the camera-derived estimates of heart rate and the reference value derived from the ECG is similar to the mean absolute error between the ECG-derived value and the heart rate value from a pulse oximeter. Continuous non-contact vital sign monitoring in the NICU using ambient light is feasible, and the authors have shown that clinically important events such as a bradycardia accompanied by a major desaturation can be identified with their algorithms for processing the video signal.

[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.

Promoting Bedside Nurse-Led Research Through a Dedicated Neuroscience Nursing Research Fellowship.

PubMed

Stutzman, Sonja; Olson, DaiWai; Supnet, Charlene; Harper, Caryn; Brown-Cleere, Shelley; McCulley, Becky; Goldberg, Mark

2016-12-01

We hypothesized that nurses would benefit from the fellowship model traditionally used to engage physicians in clinical research. The Neuroscience Nursing Research Center (NNRC) fellowship program was created as a model for engaging nurses at all levels of clinical practice to become active in clinical research. The NNRC was established in 2013 as a novel approach to promote bedside nurses as primary investigators in clinical research. The NNRC developed 4 pathways to nursing research success: research fellowship, student-nurse internship, didactic training, and research consultation. Fellows have enrolled more than 900 participants in 14 studies. Nurses have presented more than 20 abstracts at 12 conferences and submitted 11 manuscripts for publication. The NNRC has provided research training to more than 150 nurses. The NNRC program is successful in engaging nurses in research. It shows promise to continue to develop nursing research that is applicable to clinicians and thus improve patient care.

[Discussion of the Application of Micro-lecture in the Clinical Training 
of Thoracic Surgery].

PubMed

Li, Xiaofei; Lei, Jie

2018-04-20

Today, with the rapid development of network information technology, the micro-lecture plays a role in the teaching activities is becoming more and more important. The short and efficient teaching content of micro-lecture can be downloaded rapidly, expediently, and repeatedly, which improve the learning efficiency and independent learning capability. The clinical training of thoracic surgery elementarily remains at the scrabble stage. We require continuous reform and introduce new modes of teaching, which compatible with the development of society and the study habits of novice, to enhance the effectiveness of clinical training. In this paper, the concept, characteristic and advantage of micro-lecture was discussed, and the feasibility of application of micro-lecture in thoracic surgery teaching was also discussed. Our aim was to promote the application of micro-lecture in the clinical training of thoracic surgery reasonable and extensive.
.

Innovations in clinical trials informatics.

PubMed

Summers, Ron; Vyas, Hiten; Dudhal, Nilesh; Doherty, Neil F; Coombs, Crispin R; Hepworth, Mark

2008-01-01

This paper will investigate innovations in information management for use in clinical trials. The application typifies a complex, adaptive, distributed and information-rich environment for which continuous innovation is necessary. Organisational innovation is highlighted as well as the technical innovations in workflow processes and their representation as an integrated set of web services. Benefits realization uncovers further innovations in the business strand of the work undertaken. Following the description of the development of this information management system, the semantic web is postulated as a possible solution to tame the complexity related to information management issues found within clinical trials support systems.

Development of a simple 12-item theory-based instrument to assess the impact of continuing professional development on clinical behavioral intentions.

PubMed

Légaré, France; Borduas, Francine; Freitas, Adriana; Jacques, André; Godin, Gaston; Luconi, Francesca; Grimshaw, Jeremy

2014-01-01

Decision-makers in organizations providing continuing professional development (CPD) have identified the need for routine assessment of its impact on practice. We sought to develop a theory-based instrument for evaluating the impact of CPD activities on health professionals' clinical behavioral intentions. Our multipronged study had four phases. 1) We systematically reviewed the literature for instruments that used socio-cognitive theories to assess healthcare professionals' clinically-oriented behavioral intentions and/or behaviors; we extracted items relating to the theoretical constructs of an integrated model of healthcare professionals' behaviors and removed duplicates. 2) A committee of researchers and CPD decision-makers selected a pool of items relevant to CPD. 3) An international group of experts (n = 70) reached consensus on the most relevant items using electronic Delphi surveys. 4) We created a preliminary instrument with the items found most relevant and assessed its factorial validity, internal consistency and reliability (weighted kappa) over a two-week period among 138 physicians attending a CPD activity. Out of 72 potentially relevant instruments, 47 were analyzed. Of the 1218 items extracted from these, 16% were discarded as improperly phrased and 70% discarded as duplicates. Mapping the remaining items onto the constructs of the integrated model of healthcare professionals' behaviors yielded a minimum of 18 and a maximum of 275 items per construct. The partnership committee retained 61 items covering all seven constructs. Two iterations of the Delphi process produced consensus on a provisional 40-item questionnaire. Exploratory factorial analysis following test-retest resulted in a 12-item questionnaire. Cronbach's coefficients for the constructs varied from 0.77 to 0.85. A 12-item theory-based instrument for assessing the impact of CPD activities on health professionals' clinical behavioral intentions showed adequate validity and reliability. Further studies could assess its responsiveness to behavior change following CPD activities and its capacity to predict health professionals' clinical performance.

Development of a Simple 12-Item Theory-Based Instrument to Assess the Impact of Continuing Professional Development on Clinical Behavioral Intentions

PubMed Central

Légaré, France; Borduas, Francine; Freitas, Adriana; Jacques, André; Godin, Gaston; Luconi, Francesca; Grimshaw, Jeremy

2014-01-01

Background Decision-makers in organizations providing continuing professional development (CPD) have identified the need for routine assessment of its impact on practice. We sought to develop a theory-based instrument for evaluating the impact of CPD activities on health professionals' clinical behavioral intentions. Methods and Findings Our multipronged study had four phases. 1) We systematically reviewed the literature for instruments that used socio-cognitive theories to assess healthcare professionals' clinically-oriented behavioral intentions and/or behaviors; we extracted items relating to the theoretical constructs of an integrated model of healthcare professionals' behaviors and removed duplicates. 2) A committee of researchers and CPD decision-makers selected a pool of items relevant to CPD. 3) An international group of experts (n = 70) reached consensus on the most relevant items using electronic Delphi surveys. 4) We created a preliminary instrument with the items found most relevant and assessed its factorial validity, internal consistency and reliability (weighted kappa) over a two-week period among 138 physicians attending a CPD activity. Out of 72 potentially relevant instruments, 47 were analyzed. Of the 1218 items extracted from these, 16% were discarded as improperly phrased and 70% discarded as duplicates. Mapping the remaining items onto the constructs of the integrated model of healthcare professionals' behaviors yielded a minimum of 18 and a maximum of 275 items per construct. The partnership committee retained 61 items covering all seven constructs. Two iterations of the Delphi process produced consensus on a provisional 40-item questionnaire. Exploratory factorial analysis following test-retest resulted in a 12-item questionnaire. Cronbach's coefficients for the constructs varied from 0.77 to 0.85. Conclusion A 12-item theory-based instrument for assessing the impact of CPD activities on health professionals' clinical behavioral intentions showed adequate validity and reliability. Further studies could assess its responsiveness to behavior change following CPD activities and its capacity to predict health professionals' clinical performance. PMID:24643173

Geographic atrophy in patients with advanced dry age-related macular degeneration: current challenges and future prospects.

PubMed

Danis, Ronald P; Lavine, Jeremy A; Domalpally, Amitha

2015-01-01

Geographic atrophy (GA) of the retinal pigment epithelium (RPE) is a devastating complication of age-related macular degeneration (AMD). GA may be classified as drusen-related (drusen-associated GA) or neovascularization-related (neovascular-associated GA). Drusen-related GA remains a large public health concern due to the burden of blindness it produces, but pathophysiology of the condition is obscure and there are no proven treatment options. Genotyping, cell biology, and clinical imaging point to upregulation of parainflammatory pathways, oxidative stress, and choroidal sclerosis as contributors, among other factors. Onset and monitoring of progression is accomplished through clinical imaging instrumentation such as optical coherence tomography, photography, and autofluorescence, which are the tools most helpful in determining end points for clinical trials at present. A number of treatment approaches with diverse targets are in development at this time, some of which are in human clinical trials. Neovascular-associated GA is a consequence of RPE loss after development of neovascular AMD. The neovascular process leads to a plethora of cellular stresses such as ischemia, inflammation, and dramatic changes in cell environment that further taxes RPE cells already dysfunctional from drusen-associated changes. GA may therefore develop secondary to the neovascular process de novo or preexisting drusen-associated GA may continue to worsen with the development of neovascular AMD. Neovascular-associated GA is a prominent cause of continued vision loss in patients with otherwise successfully treated neovascular AMD. Clearly, treatment with vascular endothelial growth factor (VEGF) inhibitors early in the course of the neovascular disease is of great clinical benefit. However, there is a rationale and some suggestive evidence that anti-VEGF agents themselves could be toxic to RPE and enhance neovascular-associated GA. The increasing prevalence of legal blindness from this condition due to the aging of the general population lends urgency to the search for a therapy to ameliorate GA.

Geographic atrophy in patients with advanced dry age-related macular degeneration: current challenges and future prospects

PubMed Central

Danis, Ronald P; Lavine, Jeremy A; Domalpally, Amitha

2015-01-01

Geographic atrophy (GA) of the retinal pigment epithelium (RPE) is a devastating complication of age-related macular degeneration (AMD). GA may be classified as drusen-related (drusen-associated GA) or neovascularization-related (neovascular-associated GA). Drusen-related GA remains a large public health concern due to the burden of blindness it produces, but pathophysiology of the condition is obscure and there are no proven treatment options. Genotyping, cell biology, and clinical imaging point to upregulation of parainflammatory pathways, oxidative stress, and choroidal sclerosis as contributors, among other factors. Onset and monitoring of progression is accomplished through clinical imaging instrumentation such as optical coherence tomography, photography, and autofluorescence, which are the tools most helpful in determining end points for clinical trials at present. A number of treatment approaches with diverse targets are in development at this time, some of which are in human clinical trials. Neovascular-associated GA is a consequence of RPE loss after development of neovascular AMD. The neovascular process leads to a plethora of cellular stresses such as ischemia, inflammation, and dramatic changes in cell environment that further taxes RPE cells already dysfunctional from drusen-associated changes. GA may therefore develop secondary to the neovascular process de novo or preexisting drusen-associated GA may continue to worsen with the development of neovascular AMD. Neovascular-associated GA is a prominent cause of continued vision loss in patients with otherwise successfully treated neovascular AMD. Clearly, treatment with vascular endothelial growth factor (VEGF) inhibitors early in the course of the neovascular disease is of great clinical benefit. However, there is a rationale and some suggestive evidence that anti-VEGF agents themselves could be toxic to RPE and enhance neovascular-associated GA. The increasing prevalence of legal blindness from this condition due to the aging of the general population lends urgency to the search for a therapy to ameliorate GA. PMID:26640366

Predictive Modeling of Cardiac Ischemia

NASA Technical Reports Server (NTRS)

Anderson, Gary T.

1996-01-01

The goal of the Contextual Alarms Management System (CALMS) project is to develop sophisticated models to predict the onset of clinical cardiac ischemia before it occurs. The system will continuously monitor cardiac patients and set off an alarm when they appear about to suffer an ischemic episode. The models take as inputs information from patient history and combine it with continuously updated information extracted from blood pressure, oxygen saturation and ECG lines. Expert system, statistical, neural network and rough set methodologies are then used to forecast the onset of clinical ischemia before it transpires, thus allowing early intervention aimed at preventing morbid complications from occurring. The models will differ from previous attempts by including combinations of continuous and discrete inputs. A commercial medical instrumentation and software company has invested funds in the project with a goal of commercialization of the technology. The end product will be a system that analyzes physiologic parameters and produces an alarm when myocardial ischemia is present. If proven feasible, a CALMS-based system will be added to existing heart monitoring hardware.

Patient-Centered Appointment Scheduling Using Agent-Based Simulation

PubMed Central

Turkcan, Ayten; Toscos, Tammy; Doebbeling, Brad N.

2014-01-01

Enhanced access and continuity are key components of patient-centered care. Existing studies show that several interventions such as providing same day appointments, walk-in services, after-hours care, and group appointments, have been used to redesign the healthcare systems for improved access to primary care. However, an intervention focusing on a single component of care delivery (i.e. improving access to acute care) might have a negative impact other components of the system (i.e. reduced continuity of care for chronic patients). Therefore, primary care clinics should consider implementing multiple interventions tailored for their patient population needs. We collected rapid ethnography and observations to better understand clinic workflow and key constraints. We then developed an agent-based simulation model that includes all access modalities (appointments, walk-ins, and after-hours access), incorporate resources and key constraints and determine the best appointment scheduling method that improves access and continuity of care. This paper demonstrates the value of simulation models to test a variety of alternative strategies to improve access to care through scheduling. PMID:25954423

JPRS Report, Science & Technology, USSR: Science & Technology Policy.

DTIC Science & Technology

1990-08-22

RESOURCE-CONSERVING AND ECOLOGI- CALLY CLEAN PROCESSES FOR METALLURGY AND CHEMISTRY : 25 MILLION RUBLES. Continuous and combined processes in metallurgy...class hydrocarbons from natural gas were developed. They are of great production importance. At the Institute of General and Inorganic Chemistry a...clinics of the country the study of the narcotic analgesic fenaridin, which was developed at the Institute of Fine Organic Chemistry , was completed. The

Proposing a New Conceptual Model and an Exemplar Measure Using Health Information: Technology to Examine the Impact of Relational Nurse Continuity on Hospital-Acquired Pressure Ulcers

PubMed Central

STIFTER, Janet; YAO, Yingwei; LOPEZ, Karen Dunn; KHOKHAR, Ashfaq; WILKIE, Diana J.; KEENAN, Gail M.

2015-01-01

The influence of the staffing variable nurse continuity on patient outcomes has been rarely studied and with inconclusive results. Multiple definitions and an absence of systematic methods for measuring the influence of continuity have resulted in its exclusion from nurse-staffing studies and conceptual models. We present a new conceptual model and an innovative use of health information technology to measure nurse continuity and to demonstrate the potential for bringing the results of big data science back to the bedside. Understanding the power of big data to address critical clinical issues may foster a new direction for nursing administration theory development. PMID:26244480

Development of a clinical practice guideline for testing nasogastric tube placement.

PubMed

Peter, Sue; Gill, Fenella

2009-01-01

A Perth metropolitan hospital group standardized changes to nasogastric tube placement, including removal of the "whoosh test" and litmus paper, and introduction of pH testing. Two audits were conducted: bedside data collection at a pediatric hospital and a point-prevalence audit across seven hospitals. Aspirate was obtained for 97% of all tests and pH was < or = 5.5 for 84%, validating the practice changes. However, patients on continuous feeds and/or receiving acid-inhibiting medications had multiple pH testing fails. Nasogastric tube placement continues to present a challenge for those high-risk patients on continuous feeds and/or receiving acid-inhibiting medications.

Anatomists Provide the Foundation for Learning Pathophysiology

ERIC Educational Resources Information Center

McBride, Jennifer M.; Bierer, S. B.

2012-01-01

The need for interdisciplinary graduate training programs which prepare students to conceptualize the application of their research in clinical settings continues to grow. Though several programs have been cultivated to address this need, demand still outweighs supply. The following describes a curriculum developed with the intent of incorporating…

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

PubMed

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

2016-06-01

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

Practice databases and their uses in clinical research.

PubMed

Tierney, W M; McDonald, C J

1991-04-01

A few large clinical information databases have been established within larger medical information systems. Although they are smaller than claims databases, these clinical databases offer several advantages: accurate and timely data, rich clinical detail, and continuous parameters (for example, vital signs and laboratory results). However, the nature of the data vary considerably, which affects the kinds of secondary analyses that can be performed. These databases have been used to investigate clinical epidemiology, risk assessment, post-marketing surveillance of drugs, practice variation, resource use, quality assurance, and decision analysis. In addition, practice databases can be used to identify subjects for prospective studies. Further methodologic developments are necessary to deal with the prevalent problems of missing data and various forms of bias if such databases are to grow and contribute valuable clinical information.

Continuity, but at what cost? The impact of telemonitoring COPD on continuities of care: a qualitative study.

PubMed

Fairbrother, Peter; Pinnock, Hilary; Hanley, Janet; McCloughan, Lucy; Sheikh, Aziz; Pagliari, Claudia; McKinstry, Brian

2012-09-01

Continuity of care is widely regarded as an important marker of quality in the management of patients with long-term conditions. New services that integrate telemonitoring into care pathways have potential to change aspects of continuity in both positive and negative ways. A telemonitoring service for patients with chronic obstructive pulmonary disease (COPD) was introduced in Lothian, Scotland, in 2009. A qualitative study, nested within the TELESCOT COPD randomised control trial, was undertaken to explore the views of patients and professionals on telemonitoring. The perceived impact of telemonitoring on continuity of care was investigated as part of the research. Semi-structured interviews were undertaken with 38 patients (47% male, mean age 67.5 years). A maximum variation sample in relation to age, sex, socio-economic background, disease severity, and compliance with telemonitoring was recruited. Thirty-two stakeholders (healthcare professionals and managers) were interviewed. Transcribed coded data were analysed thematically using the framework approach. Interpretation was supported by multidisciplinary discussion. Patients and healthcare professionals considered that relationship-based continuity of care was important in the delivery of telemonitoring services. Managers placed emphasis on improved continuity of clinical management as a means of reducing healthcare costs. However, professionals described many operational challenges arising from the 'bolting-on' of telemonitoring provision to existing usual care provision which, they considered, resulted in the proliferation of additional managerial discontinuities. Managers and healthcare professionals face major challenges in meeting demands for both relationship continuity and continuity of clinical management in the development of telemonitoring services.

Protective role of parnaparin in reducing systemic inflammation and atherosclerotic plaque formation in ApoE-/- mice.

PubMed

Artico, Marco; Riganò, Rachele; Buttari, Brigitta; Profumo, Elisabetta; Ionta, Brunella; Bosco, Sandro; Rasile, Manuela; Bianchi, Enrica; Bruno, Moira; Fumagalli, Lorenzo

2011-04-01

Atherosclerosis is a degenerative disease whose role in the onset and development of cardiovascular pathologies and complications is of importance. Due to its silent but progressive development, and considering the endothelial, immunological and inflammatory processes that are involved in its clinical course, this still relatively unknown pathological condition has been and continues to be a matter of investigation worldwide. Our experience with previous studies on atherosclerosis led us to investigate the possible influence of a low molecular weight heparin (LMWH) - Parnaparin® on the development and clinical course of atherosclerosis in double knock-out laboratory animals (ApoE-/- mice). Our experiments demonstrated a possible role of Parnaparin (PNP) in the control of atherogenic disease. In fact, in treated mice vs. untreated ones, PNP reduced the number and the size of atherosclerotic lesions in the aortic wall, as well as the development of liver steatosis, which was massive in untreated animals and moderate in treated ones. These preliminary observations require further clinical studies, but demonstrate a possible role of Parnaparin in the control of the development and clinical evolution of atherosclerosis and liver steatosis in laboratory animals.

Liquid biopsy for brain tumors

PubMed Central

Shankar, Ganesh M.; Balaj, Leonora; Stott, Shannon L.; Nahed, Brian; Carter, Bob S.

2018-01-01

Introduction Minimally invasive methods will augment the clinical approach for establishing the diagnosis or monitoring treatment response of central nervous system tumors. Liquid biopsy by blood or cerebrospinal fluid sampling holds promise in this regard. Areas covered In this literature review, the authors highlight recent studies describing the analysis of circulating tumor cells, cell free nucleic acids, and extracellular vesicles as strategies to accomplish liquid biopsy in glioblastoma and metastatic tumors. The authors then discuss the continued efforts to improve signal detection, standardize the liquid biopsy handling and preparation, develop platforms for clinical application, and establish a role for liquid biopsies in personalized medicine. Expert commentary As the technologies used to analyze these biomarkers continue to evolve, we propose that there is a future potential to precisely diagnose and monitor treatment response with liquid biopsies. PMID:28875730

Liquid biopsy for brain tumors.

PubMed

Shankar, Ganesh M; Balaj, Leonora; Stott, Shannon L; Nahed, Brian; Carter, Bob S

2017-10-01

Minimally invasive methods will augment the clinical approach for establishing the diagnosis or monitoring treatment response of central nervous system tumors. Liquid biopsy by blood or cerebrospinal fluid sampling holds promise in this regard. Areas covered: In this literature review, the authors highlight recent studies describing the analysis of circulating tumor cells, cell free nucleic acids, and extracellular vesicles as strategies to accomplish liquid biopsy in glioblastoma and metastatic tumors. The authors then discuss the continued efforts to improve signal detection, standardize the liquid biopsy handling and preparation, develop platforms for clinical application, and establish a role for liquid biopsies in personalized medicine. Expert commentary: As the technologies used to analyze these biomarkers continue to evolve, we propose that there is a future potential to precisely diagnose and monitor treatment response with liquid biopsies.

Concepts of Mental Disorders in Trainee Clinical Psychologists.

PubMed

Read, R; Moberly, N J; Salter, D; Broome, M R

2017-03-01

The models of mental disorders held by all mental health professionals are implicit in their attitudes and inform all aspects of theory and practice. The present study aims to explore the attitudes of trainee clinical psychologists towards mental disorders by building on a study conducted by Harland et al. () with psychiatrists. In so doing, the present study contributes to an evidence base that can inform the development of clinical training programs and multidisciplinary working. The Maudsley Attitude Questionnaire was administered in an online survey of trainee clinical psychologists (n = 289). Analyses of variance revealed main effects of model, and of diagnostic category, and a significant interaction effect between model and diagnostic category. Principal component analysis revealed a biological-psychosocial continuum and cognitive/behavioural and psychodynamic/spiritual dimensions. Comparisons with Harland et al.'s () psychiatrists revealed large differences, particularly in biological and social constructionist model endorsement. Results suggest that the attitudes of psychologists and psychiatrists continue to sit at opposite ends of a biological-psychosocial continuum. However, an area of consensus regarding psychotherapeutic models was indicated. Training courses can be reassured that strong opinions tended to reflect the evidence base. Future research with similarly large representative samples from different disciplines would allow findings of the current study to be better contextualized. Copyright © 2016 John Wiley & Sons, Ltd. The models of mental disorders held by clinical psychologists are implicit in their attitudes and inform all aspects of theory and practice. We found that trainee clinical psychologists continue to favour psychosocial over biological understandings of mental disorders, giving the cognitive, behavioural and psychodynamic models equal value overall, and stronger attitudes were supported by the evidence base. We found that trainee clinical psychologists organized their attitudes around a biological-psychosocial continuum and cognitive/behavioural and psychodynamic/spiritual dimensions. These findings may be useful for those involved in developing clinical training programs and multidisciplinary working because they provide an insight into the attitudes of emerging clinical psychologists. Copyright © 2016 John Wiley & Sons, Ltd.

The origins of SPECT and SPECT/CT.

PubMed

Hutton, Brian F

2014-05-01

Single photon emission computed tomography (SPECT) has a long history of development since its initial demonstration by Kuhl and Edwards in 1963. Although clinical utility has been dominated by the rotating gamma camera, there have been many technological innovations with the recent popularity of organ-specific dedicated SPECT systems. The combination of SPECT and CT evolved from early transmission techniques used for attenuation correction with the initial commercial systems predating the release of PET/CT. The development and acceptance of SPECT/CT has been relatively slow with continuing debate as to what cost/performance ratio is justified. Increasingly, fully diagnostic CT is combined with SPECT so as to facilitate optimal clinical utility.

'Mobile' health needs and opportunities in developing countries.

PubMed

Kahn, James G; Yang, Joshua S; Kahn, James S

2010-02-01

Developing countries face steady growth in the prevalence of chronic diseases, along with a continued burden from communicable diseases. "Mobile" health, or m-health-the use of mobile technologies such as cellular phones to support public health and clinical care-offers promise in responding to both types of disease burdens. Mobile technologies are widely available and can play an important role in health care at the regional, community, and individual levels. We examine various m-health applications and define the risks and benefits of each. We find positive examples but little solid evaluation of clinical or economic performance, which highlights the need for such evaluation.

Advances in the development of new tuberculosis drugs and treatment regimens.

PubMed

Zumla, Alimuddin; Nahid, Payam; Cole, Stewart T

2013-05-01

Despite the introduction 40 years ago of the inexpensive and effective four-drug (isoniazid, rifampicin, pyrazinamide and ethambutol) treatment regimen, tuberculosis (TB) continues to cause considerable morbidity and mortality worldwide. For the first time since the 1960s, new and novel drugs and regimens for all forms of TB are emerging. Such regimens are likely to utilize both repurposed drugs and new chemical entities, and several of these regimens are now progressing through clinical trials. This article covers current concepts and recent advances in TB drug discovery and development, including an update of ongoing TB treatment trials, newer clinical trial designs, TB biomarkers and adjunct host-directed therapies.

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.

Expertise in Clinical Psychology. The Effects of University Training and Practical Experience on Expertise in Clinical Psychology

PubMed Central

Vollmer, Sabine; Spada, Hans; Caspar, Franz; Burri, Salome

2013-01-01

How do university training and subsequent practical experience affect expertise in clinical psychology? To answer this question we developed methods to assess psychological knowledge and the competence to diagnose, construct case conceptualizations, and plan psychotherapeutic treatment: a knowledge test and short case studies in a first study, and a complex, dynamically evolving case study in the second study. In our cross-sectional studies, psychology students, trainees in a certified postgraduate psychotherapist curriculum, and behavior therapists with more than 10 years of experience were tested (100 in total: 20 each of novice, intermediate, and advanced university students, postgraduate trainees, and therapists). Clinical knowledge and competence increased up to the level of trainees but unexpectedly decreased at the level of experienced therapists. We discuss the results against the background of expertise research and the training of clinical psychologists (in Germany). Important factors for the continuing professional development of psychotherapists are proposed. PMID:23543213

Therapeutic interventions in sepsis: current and anticipated pharmacological agents

PubMed Central

Shukla, Prashant; Rao, G Madhava; Pandey, Gitu; Sharma, Shweta; Mittapelly, Naresh; Shegokar, Ranjita; Mishra, Prabhat Ranjan

2014-01-01

Sepsis is a clinical syndrome characterized by a multisystem response to a pathogenic assault due to underlying infection that involves a combination of interconnected biochemical, cellular and organ–organ interactive networks. After the withdrawal of recombinant human-activated protein C (rAPC), researchers and physicians have continued to search for new therapeutic approaches and targets against sepsis, effective in both hypo- and hyperinflammatory states. Currently, statins are being evaluated as a viable option in clinical trials. Many agents that have shown favourable results in experimental sepsis are not clinically effective or have not been clinically evaluated. Apart from developing new therapeutic molecules, there is great scope for for developing a variety of drug delivery strategies, such as nanoparticulate carriers and phospholipid-based systems. These nanoparticulate carriers neutralize intracorporeal LPS as well as deliver therapeutic agents to targeted tissues and subcellular locations. Here, we review and critically discuss the present status and new experimental and clinical approaches for therapeutic intervention in sepsis. PMID:24977655

Integration of fall prevention into state policy in Connecticut.

PubMed

Murphy, Terrence E; Baker, Dorothy I; Leo-Summers, Linda S; Bianco, Luann; Gottschalk, Margaret; Acampora, Denise; King, Mary B

2013-06-01

To describe the ongoing efforts of the Connecticut Collaboration for Fall Prevention (CCFP) to move evidence regarding fall prevention into clinical practice and state policy. A university-based team developed methods of networking with existing statewide organizations to influence clinical practice and state policy. We describe steps taken that led to funding and legislation of fall prevention efforts in the state of Connecticut. We summarize CCFP's direct outreach by tabulating the educational sessions delivered and the numbers and types of clinical care providers that were trained. Community organizations that had sustained clinical practices incorporating evidence-based fall prevention were subsequently funded through mini-grants to develop innovative interventional activities. These mini-grants targeted specific subpopulations of older persons at high risk for falls. Building collaborative relationships with existing stakeholders and care providers throughout the state, CCFP continues to facilitate the integration of evidence-based fall prevention into clinical practice and state-funded policy using strategies that may be useful to others.

Integrating Research Into Clinical Internship Training Bridging the Science/Practice Gap in Pediatric Psychology

PubMed Central

Spirito, Anthony

2012-01-01

Existing literature highlights a critical gap between science and practice in clinical psychology. The internship year is a “capstone experience”; training in methods of scientific evaluation should be integrated with the development of advanced clinical competencies. We provide a rationale for continued exposure to research during the clinical internship year, including, (a) critical examination and integration of the literature regarding evidence-based treatment and assessment, (b) participation in faculty-based and independent research, and (c) orientation to the science and strategy of grantsmanship. Participation in research provides exposure to new empirical models and can foster the development of applied research questions. Orientation to grantsmanship can yield an initial sense of the “business of science.” Internship provides an important opportunity to examine the challenges to integrating the clinical evidence base into professional practice; for that reason, providing research exposure on internship is an important strategy in training the next generation of pediatric psychologists. PMID:22286345

A clinical nurse specialist-led intervention to enhance medication adherence using the plan-do-check-act cycle for continuous self-improvement.

PubMed

Russell, Cynthia L

2010-01-01

A clinical nurse specialist-led intervention to improve medication adherence in chronically ill adults using renal transplant recipients as an exemplar population is proposed. Meta-analyses and systematic reviews of chronically ill and transplant patients indicate that patient-specific characteristics not only are poor and inconsistent predictors for medication nonadherence but also are not amenable to intervention. Adherence has not meaningfully improved, despite meta-analyses and systematic narrative reviews of randomized controlled trials (RCTs) dealing with medication nonadherence in acutely and chronically ill persons and RCTs dealing with transplant patients. Interventions with a superior potential to enhance medication adherence must be developed. Use of a clinical nurse specialist-led continuous self-improvement intervention with adult renal transplant recipients is proposed. Continuous self-improvement focuses on improving personal systems thinking and behavior using the plan-do-check-act process. Electronic medication monitoring reports, one of several objective measures of medication adherence, are used by the clinician to provide patient feedback during the check process on medication-taking patterns. Continuous self-improvement as an intervention holds promise in supporting patient self-management and diminishing the blame that clinicians place on patients for medication nonadherence. Using an objective measure of medication adherence such as an electronic monitoring report fosters collaborative patient-clinician discussions of daily medication-taking patterns. Through collaboration, ideas for improving medication taking can be explored. Changes can be followed and evaluated for effectiveness through the continuous self-improvement process. Future studies should include RCTs comparing educational and/or behavioral interventions to improve medication adherence.

A Human Serum-Based Enzyme-Free Continuous Glucose Monitoring Technique Using a Needle-Type Bio-Layer Interference Sensor.

PubMed

Seo, Dongmin; Paek, Sung-Ho; Oh, Sangwoo; Seo, Sungkyu; Paek, Se-Hwan

2016-09-24

The incidence of diabetes is continually increasing, and by 2030, it is expected to have increased by 69% and 20% in underdeveloped and developed countries, respectively. Therefore, glucose sensors are likely to remain in high demand in medical device markets. For the current study, we developed a needle-type bio-layer interference (BLI) sensor that can continuously monitor glucose levels. Using dialysis procedures, we were able to obtain hypoglycemic samples from commercial human serum. These dialysis-derived samples, alongside samples of normal human serum were used to evaluate the utility of the sensor for the detection of the clinical interest range of glucose concentrations (70-200 mg/dL), revealing high system performance for a wide glycemic state range (45-500 mg/dL). Reversibility and reproducibility were also tested over a range of time spans. Combined with existing BLI system technology, this sensor holds great promise for use as a wearable online continuous glucose monitoring system for patients in a hospital setting.

Clinical Nurse Specialists Guide Staff Nurses to Promote Practice Accountability Through Peer Review.

PubMed

Semper, Julie; Halvorson, Betty; Hersh, Mary; Torres, Clare; Lillington, Linda

2016-01-01

The aim of the study was to describe the clinical nurse specialist role in developing and implementing a staff nurse education program to promote practice accountability using peer review principles. Peer review is essential for professional nursing practice demanding a significant culture change. Clinical nurse specialists in a Magnet-designated community hospital were charged with developing a staff nurse peer review education program. Peer review is a recognized mechanism of professional self-regulation to ensure delivery of quality care. The American Nurses Association strongly urges incorporating peer review in professional nursing practice models. Clinical nurse specialists play a critical role in educating staff nurses about practice accountability. Clinical nurse specialists developed an education program guided by the American Nurses Association's principles of peer review. A baseline needs assessment identified potential barriers and learning needs. Content incorporated tools and strategies to build communication skills, collaboration, practice change, and peer accountability. The education program resulted in increased staff nurse knowledge about peer review and application of peer review principles in practice. Clinical nurse specialists played a critical role in helping staff nurses understand peer review and its application to practice. The clinical nurse specialist role will continue to be important in sustaining the application of peer review principles in practice.

Establishing nurse-led active surveillance for men with localised prostate cancer: development and formative evaluation of a model of care in the ProtecT trial.

PubMed

Wade, Julia; Holding, Peter N; Bonnington, Susan; Rooshenas, Leila; Lane, J Athene; Salter, C Elizabeth; Tilling, Kate; Speakman, Mark J; Brewster, Simon F; Evans, Simon; Neal, David E; Hamdy, Freddie C; Donovan, Jenny L

2015-09-18

To develop a nurse-led, urologist-supported model of care for men managed by active surveillance or active monitoring (AS/AM) for localised prostate cancer and provide a formative evaluation of its acceptability to patients, clinicians and nurses. Nurse-led care, comprising an explicit nurse-led protocol with support from urologists, was developed as part of the AM arm of the Prostate testing for cancer and Treatment (ProtecT) trial. Interviews and questionnaire surveys of clinicians, nurses and patients assessed acceptability. Nurse-led clinics were established in 9 centres in the ProtecT trial and compared with 3 non-ProtecT urology centres elsewhere in UK. Within ProtecT, 22 men receiving AM nurse-led care were interviewed about experiences of care; 11 urologists and 23 research nurses delivering ProtecT trial care completed a questionnaire about its acceptability; 20 men managed in urology clinics elsewhere in the UK were interviewed about models of AS/AM care; 12 urologists and three specialist nurses working in these clinics were also interviewed about management of AS/AM. Nurse-led care was commended by ProtecT trial participants, who valued the flexibility, accessibility and continuity of the service and felt confident about the quality of care. ProtecT consultant urologists and nurses also rated it highly, identifying continuity of care and resource savings as key attributes. Clinicians and patients outside the ProtecT trial believed that nurse-led care could relieve pressure on urology clinics without compromising patient care. The ProtecT AM nurse-led model of care was acceptable to men with localised prostate cancer and clinical specialists in urology. The protocol is available for implementation; we aim to evaluate its impact on routine clinical practice. NCT02044172; ISRCTN20141297. 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.

Establishing nurse-led active surveillance for men with localised prostate cancer: development and formative evaluation of a model of care in the ProtecT trial

PubMed Central

Wade, Julia; Holding, Peter N; Bonnington, Susan; Rooshenas, Leila; Lane, J Athene; Salter, C Elizabeth; Tilling, Kate; Speakman, Mark J; Brewster, Simon F; Evans, Simon; Neal, David E; Hamdy, Freddie C; Donovan, Jenny L

2015-01-01

Objectives To develop a nurse-led, urologist-supported model of care for men managed by active surveillance or active monitoring (AS/AM) for localised prostate cancer and provide a formative evaluation of its acceptability to patients, clinicians and nurses. Nurse-led care, comprising an explicit nurse-led protocol with support from urologists, was developed as part of the AM arm of the Prostate testing for cancer and Treatment (ProtecT) trial. Design Interviews and questionnaire surveys of clinicians, nurses and patients assessed acceptability. Setting Nurse-led clinics were established in 9 centres in the ProtecT trial and compared with 3 non-ProtecT urology centres elsewhere in UK. Participants Within ProtecT, 22 men receiving AM nurse-led care were interviewed about experiences of care; 11 urologists and 23 research nurses delivering ProtecT trial care completed a questionnaire about its acceptability; 20 men managed in urology clinics elsewhere in the UK were interviewed about models of AS/AM care; 12 urologists and three specialist nurses working in these clinics were also interviewed about management of AS/AM. Results Nurse-led care was commended by ProtecT trial participants, who valued the flexibility, accessibility and continuity of the service and felt confident about the quality of care. ProtecT consultant urologists and nurses also rated it highly, identifying continuity of care and resource savings as key attributes. Clinicians and patients outside the ProtecT trial believed that nurse-led care could relieve pressure on urology clinics without compromising patient care. Conclusions The ProtecT AM nurse-led model of care was acceptable to men with localised prostate cancer and clinical specialists in urology. The protocol is available for implementation; we aim to evaluate its impact on routine clinical practice. Trial registration numbers NCT02044172; ISRCTN20141297. PMID:26384727

Supervision and autonomy of ophthalmology residents in the outpatient Clinic in the United States: a survey of ACGME-accredited programs.

PubMed

Singman, Eric L; Srikumaran, Divya; Green, Laura; Tian, Jing; McDonnell, Peter

2017-06-26

The development and demonstration of incremental trainee autonomy is required by the ACGME. However, there is scant published research concerning autonomy of ophthalmology residents in the outpatient clinic setting. This study explored the landscape of resident ophthalmology outpatient clinics in the United States. A link to an online survey using the QualtricsTM platform was emailed to the program directors of all 115 ACGME-accredited ophthalmology programs in the United States. Survey questions explored whether resident training programs hosted a continuity clinic where residents would see their own patients, and if so, the degree of faculty supervision provided therein. Metrics such as size of the resident program, number of faculty and clinic setting were also recorded. Correlations between the degree of faculty supervision and other metrics were explored. The response rate was 94%; 69% of respondents indicated that their trainees hosted continuity clinics. Of those programs, 30% required a faculty member to see each patient treated by a resident, while 42% expected the faculty member to at least discuss (if not see) each patient. All programs expected some degree of faculty interaction based upon circumstances such as the level of training of the resident or complexity of the clinical situation. 67% of programs that tracked the contribution of the clinic to resident surgical caseloads reported that these clinics provided more than half of the resident surgical volumes. More ¾ of resident clinics were located in urban settings. The degree of faculty supervision did not correlate to any of the other metrics evaluated. The majority of ophthalmology resident training programs in the United States host a continuity clinic located in an urban environment where residents follow their own patients. Furthermore, most of these clinics require supervising faculty to review both the patients seen and the medical documentation created by the resident encounters. The different degrees of faculty supervision outlined by this survey might provide a useful guide presuming they can be correlated with validated metrics of educational quality. Finally, this study could provide an adjunctive resource to current international efforts to standardize ophthalmic residency education.

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.

Continuity of care in dermatology residency programs in the United States.

PubMed

Loh, Tiffany; Vazirnia, Aria; Afshar, Maryam; Dorschner, Robert; Paravar, Taraneh

2017-05-15

As established by the AccreditationCouncil for Graduate Medical Education (ACGME),dermatology residents in the United States must participate in continuity clinic. This requirement may be achieved through multiple means, allowing for program variation. To better assess continuity clinic's role in resident learning, more data on this component of graduate medical education is needed. An anonymous online survey was distributed via the American Board of Dermatology list serv to all U.S. dermatology residents. Continuity clinic organization, setting, frequency, and patient and preceptor characteristics were assessed; resident satisfaction and learning were compared. Of 231 responses, 7.8% reported continuity clinic daily, 77.1% weekly, 9.1% every other week, 3.0%monthly, 0.4% once every several months, and 2.2%only during certain blocks. Of the clinics reported,80.1% were "resident-run with attending" and 11.3%were attending-run. The rest were "resident-run with no attending" (0.9%), both resident and attending run(3.0%), or "other" (4.8%). Trainees in resident-run clinics (with attendings) reported greater continuity of care than those in attending-run clinics (p<0.001).Residents reported better teaching with attending presence during patient encounters than when attendings were present only if concerns were raised(p<0.01).

Clinical teaching and support for learners in the practice environment.

PubMed

McBrien, Barry

The purpose of planned clinical experience for students of nursing is primarily to provide students with the opportunity to develop their clinical skills, integrate theory and practice, and assist with their socialization into nursing. Nursing, in the main, is a practice-based profession. To this extent, it is essential that nurse education continues to have a strong practical element despite its full integration into higher education institutions (Department of Health, 1999). However, providing adequate support and supervision for learners is challenging. Undoubtedly, exacerbated by increasing numbers of learners, staff shortages and mentors training deficits. This article aims to critically analyse several strategies, which can be used to promote clinical learning.

Remune trial will stop; new trials planned.

PubMed

James, J S

1999-05-21

A clinical trial using remune, the anti-HIV vaccine developed by the late Dr. Jonas Salk, has been ended. The study is a clinical-endpoint trial which looks for statistically significant differences in AIDS sickness or death between patients who add remune to their treatment regimens versus those who use a placebo. Agouron Pharmaceuticals and the Immune Response Corporation who were conducting the trial announced their decision to stop it after an analysis by the Data Safety Monitoring Board. No differences in clinical endpoints were found and it was projected that continuing the trial would likely not find any. The companies are now planning two new Phase III trials using viral load testing rather than clinical endpoints as study criteria.

Economics of recombinant antibody production processes at various scales: Industry-standard compared to continuous precipitation.

PubMed

Hammerschmidt, Nikolaus; Tscheliessnig, Anne; Sommer, Ralf; Helk, Bernhard; Jungbauer, Alois

2014-06-01

Standard industry processes for recombinant antibody production employ protein A affinity chromatography in combination with other chromatography steps and ultra-/diafiltration. This study compares a generic antibody production process with a recently developed purification process based on a series of selective precipitation steps. The new process makes two of the usual three chromatographic steps obsolete and can be performed in a continuous fashion. Cost of Goods (CoGs) analyses were done for: (i) a generic chromatography-based antibody standard purification; (ii) the continuous precipitation-based purification process coupled to a continuous perfusion production system; and (iii) a hybrid process, coupling the continuous purification process to an upstream batch process. The results of this economic analysis show that the precipitation-based process offers cost reductions at all stages of the life cycle of a therapeutic antibody, (i.e. clinical phase I, II and III, as well as full commercial production). The savings in clinical phase production are largely attributed to the fact that expensive chromatographic resins are omitted. These economic analyses will help to determine the strategies that are best suited for small-scale production in parallel fashion, which is of importance for antibody production in non-privileged countries and for personalized medicine. Copyright © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Childhood bullying and the association with psychosis in non-clinical and clinical samples: a review and meta-analysis.

PubMed

van Dam, D S; van der Ven, E; Velthorst, E; Selten, J P; Morgan, C; de Haan, L

2012-12-01

Approximately 11% of schoolchildren are bullied on a regular basis. It has been argued that continuous exposure to stress is related to the development of psychotic symptoms. The current study sought to investigate whether being bullied in childhood is related to the development of psychotic symptoms. A search of PubMed, PsycINFO and EMBASE was conducted. The reference lists of included papers were searched to identify other eligible papers. A meta-analysis was performed on a subgroup of studies. We found four clinical and 10 general population studies that met inclusion criteria. The results of the clinical studies were mixed. However, the results of the non-clinical studies provided more consistent evidence that school bullying is related to the development of non-clinical psychotic symptoms. Stronger associations were found with increased frequency and severity and longer duration of being bullied. We performed a meta-analysis on seven population-based studies, yielding unadjusted and adjusted odds ratios (ORs) of 2.7 [95% confidence interval (CI) 2.1-3.6] and 2.3 (95% CI 1.5-3.4) respectively. Although there is some evidence of an association between bullying and psychosis in clinical samples, the research is too sparse to draw any firm conclusions. However, population-based non-clinical studies support the role of bullying in the development of psychotic symptoms later in life. These findings are consistent with findings of an increased risk of psychotic symptoms among those exposed to other types of abuse.

Evaluation of a continual compliance monitoring program for dapsone in an outpatient Hansen's disease clinic.

PubMed

Fischer, J H; West, D P; Worobec, S M

1986-12-01

Guidelines for the assessment of patient compliance to dapsone were developed and evaluated. The urinary dapsone-to-creatinine (D/C) ratio following standardization by dose, ideal body weight, and time since last dose was used for assessment of compliance. Compliance standards were established in 12 patients of known compliance and confirmed prospectively in nine inpatients on 14 occasions. Compliance increased significantly among outpatients (N = 30) attending the University of Illinois Hansen's Disease Clinic from 47% at base line to 73% at 6 months and 80% at 18 months after establishing the monitoring program. In a subgroup of 18 patients, a similar increase in compliance was observed from 50% to 80%. A good therapeutic response was seen in the subgroup patients who were compliant. A poor therapeutic response was seen in the consistently noncompliant patients. These results demonstrate that use of a continual compliance monitoring program can improve patient drug compliance in an outpatient Hansen's disease clinic.

Developmental improvements in dynamic control of fingertip forces last throughout childhood and into adolescence

PubMed Central

Dayanidhi, Sudarshan; Hedberg, Åsa; Forssberg, Hans

2013-01-01

While it is clear that the development of dexterous manipulation in children exhibits dramatic improvements over an extended period, it is difficult to separate musculoskeletal from neural contributors to these important functional gains. This is in part due to the inability of current methods to disambiguate improvements in hand strength from gains in finger dexterity (i.e., the dynamic control of fingertip force vectors at low magnitudes). We adapted our novel instrumentation to evaluate finger dexterity in 130 typically developing children between the ages of 4 and 16 yr. We find that finger dexterity continues to develop well into late adolescence and musculoskeletal growth and strength are poorly correlated with the improvements in dexterity. Importantly, because these behavioral results seem to mirror the known timelines of neuroanatomical development up to adolescence, we speculate that they reflect the functional benefits of such continual neural maturation. This novel perspective now enables the systematic study of the functional roles of specific neuroanatomical structures and their connectivity, maturity, and plasticity. Moreover, the temporal dynamics of the fingertip force vectors shows improvements in stability that provide a novel way to look at the maturation of finger control. From a clinical perspective, our results provide a practical means to chart functional development of dexterous manipulation in typically developing children and could be adapted for clinical use and for use in children with developmental disorders. PMID:23864371

Risk factors for corneal infiltrative events during continuous wear of silicone hydrogel contact lenses.

PubMed

Szczotka-Flynn, Loretta; Lass, Jonathan H; Sethi, Ajay; Debanne, Sara; Benetz, Beth Ann; Albright, Matthew; Gillespie, Beth; Kuo, Jana; Jacobs, Michael R; Rimm, Alfred

2010-11-01

This study determined which microbiologic, clinical, demographic, and behavioral factors are associated with corneal infiltrative events (CIEs) during continuous wear of silicone hydrogel (SH) contact lenses. Subjects (n = 205) were fitted with lotrafilcon A lenses for continuous wear and observed for 1 year. The main exposures of interest were corneal staining and bacterial lens contamination. Kaplan-Meier (KM) plots were used to estimate the cumulative unadjusted probability of remaining CIE free, and Cox proportional hazards regression was used to model the hazard of having a CIE, as a function of key predictor variables. The KM-unadjusted cumulative probability of remaining CIE free was 73.3%. Approximately 53% of subjects had repeated episodes of corneal staining (mild or greater), and 11.3% had repeated episodes of moderate or greater corneal staining. Corneal staining was not associated with the development of a CIE. The frequency of substantial bacterial bioburden on worn lenses at the time of a CIE was 64.7%, compared with only 12.2% during uncomplicated wear. The presence of substantial lens bacterial bioburden was associated with the development of a CIE (adjusted hazards ratio [HR], 8.66; 95% confidence interval [CI], 2.88-26.01). Smoking was also associated with a CIE (adjusted HR, 4.13; 95% CI, 1.27-13.45). Corneal staining is common during continuous wear of SH lenses, but it is not associated with the development of a CIE. Smoking and substantial lens bacterial bioburden pose prominent risks of a CIE. In this study, more than 70% of the total risk of CIE in those with substantial lens bioburden is attributable to this exposure. (ClinicalTrials.gov number, NCT00727402).

Risk Factors for Corneal Infiltrative Events during Continuous Wear of Silicone Hydrogel Contact Lenses

PubMed Central

Lass, Jonathan H.; Sethi, Ajay; Debanne, Sara; Benetz, Beth Ann; Albright, Matthew; Gillespie, Beth; Kuo, Jana; Jacobs, Michael R.; Rimm, Alfred

2010-01-01

Purpose. This study determined which microbiologic, clinical, demographic, and behavioral factors are associated with corneal infiltrative events (CIEs) during continuous wear of silicone hydrogel (SH) contact lenses. Methods. Subjects (n = 205) were fitted with lotrafilcon A lenses for continuous wear and observed for 1 year. The main exposures of interest were corneal staining and bacterial lens contamination. Kaplan-Meier (KM) plots were used to estimate the cumulative unadjusted probability of remaining CIE free, and Cox proportional hazards regression was used to model the hazard of having a CIE, as a function of key predictor variables. Results. The KM-unadjusted cumulative probability of remaining CIE free was 73.3%. Approximately 53% of subjects had repeated episodes of corneal staining (mild or greater), and 11.3% had repeated episodes of moderate or greater corneal staining. Corneal staining was not associated with the development of a CIE. The frequency of substantial bacterial bioburden on worn lenses at the time of a CIE was 64.7%, compared with only 12.2% during uncomplicated wear. The presence of substantial lens bacterial bioburden was associated with the development of a CIE (adjusted hazards ratio [HR], 8.66; 95% confidence interval [CI], 2.88–26.01). Smoking was also associated with a CIE (adjusted HR, 4.13; 95% CI, 1.27–13.45). Conclusions. Corneal staining is common during continuous wear of SH lenses, but it is not associated with the development of a CIE. Smoking and substantial lens bacterial bioburden pose prominent risks of a CIE. In this study, more than 70% of the total risk of CIE in those with substantial lens bioburden is attributable to this exposure. (ClinicalTrials.gov number, NCT00727402). PMID:20538985

Pharmacology in the Era of Targeted Therapies: The Case of PI3K Inhibitors.

PubMed

Toska, Eneda; Baselga, José

2016-05-01

The PI3K pathway is often aberrantly activated in estrogen receptor positive (ER(+)) breast cancer and therapies combining PI3K inhibitors and antiestrogens are under clinical development. Given that many PI3K inhibitors have substantial toxicities with continuous dosing and that alternate dosing schedules are equally active, further clinical exploration is warranted. Clin Cancer Res; 22(9); 2099-101. ©2016 AACRSee related article by Yang et al., p. 2250. ©2016 American Association for Cancer Research.

Care in post-traumatic syndrome due to gender violence: a case report.

PubMed

Sánchez-Herrero, Héctor; Duarte-Clíments, Gonzalo; González-Pérez, Teodoro; Sánchez-Gómez, María Begoña; Gomariz-Bolarín, David

This article describes a clinical case of a patient attended at a continuous care point for a generalized anxiety disorder, principally due to abuse suffered from her ex partner. The patient was followed up at family nursing clinic, and the appropriate nursing interventions were developed to cover a series of needs prioritized by nurses using the AREA method and taking into account the prioritization of the user herself. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

Using an imaginary scrapbook for neurolinguistic programming in the aftermath of a clinical depression: a case history.

PubMed

Hossack, A; Standidge, K

1993-04-01

We employed neurolinguistic programming (NLP) principles to develop a positive self-identity in an elderly male patient in England recovering from clinical depression. This novel technique encouraged recall of intrinsically rewarding past experiences. Each experience was conceptualized in an image and compiled chronologically in an imaginary book, providing continuity to what were chaotic and fragmented recollections during the immediate postdepressive stage. The patient's anxiety and depression were alleviated and his own functional goals largely realized.

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.

Applying Brain-Based Learning Principles to Athletic Training Education

ERIC Educational Resources Information Center

Craig, Debbie I.

2007-01-01

Objective: To present different concepts and techniques related to the application of brain-based learning principles to Athletic Training clinical education. Background: The body of knowledge concerning how our brains physically learn continues to grow. Brain-based learning principles, developed by numerous authors, offer advice on how to…

Training Is in SCC's Genes

ERIC Educational Resources Information Center

Weinstein, Margery

2011-01-01

For SCC Soft Computer, a clinical information management systems provider, learning and development long has played an essential role in maintaining a high-growth global company. In 2010, the organization proved through ramped-up offerings, improved training success rates, and continual programming evolution that training is still a top priority.…

Influences on Self-Evaluation during a Clinical Skills Programme for Nurses

ERIC Educational Resources Information Center

Yeo, J.; Steven, A.; Pearson, P.; Price, C.

2010-01-01

Education has moved from teacher to student-centred practices. Increasing emphasis is placed on "life-long" learning in the context of a rapidly changing knowledge base. Self-evaluation is seen as one strategy to facilitate student-centred continuous professional development. The literature, however, suggests that learners' ability to…

Check Sample Abstracts.

PubMed

Alter, David; Grenache, David G; Bosler, David S; Karcher, Raymond E; Nichols, James; Rajadhyaksha, Aparna; Camelo-Piragua, Sandra; Rauch, Carol; Huddleston, Brent J; Frank, Elizabeth L; Sluss, Patrick M; Lewandrowski, Kent; Eichhorn, John H; Hall, Janet E; Rahman, Saud S; McPherson, Richard A; Kiechle, Frederick L; Hammett-Stabler, Catherine; Pierce, Kristin A; Kloehn, Erica A; Thomas, Patricia A; Walts, Ann E; Madan, Rashna; Schlesinger, Kathie; Nawgiri, Ranjana; Bhutani, Manoop; Kanber, Yonca; Abati, Andrea; Atkins, Kristen A; Farrar, Robert; Gopez, Evelyn Valencerina; Jhala, Darshana; Griffin, Sonya; Jhala, Khushboo; Jhala, Nirag; Bentz, Joel S; Emerson, Lyska; Chadwick, Barbara E; Barroeta, Julieta E; Baloch, Zubair W; Collins, Brian T; Middleton, Owen L; Davis, Gregory G; Haden-Pinneri, Kathryn; Chu, Albert Y; Keylock, Joren B; Ramoso, Robert; Thoene, Cynthia A; Stewart, Donna; Pierce, Arand; Barry, Michelle; Aljinovic, Nika; Gardner, David L; Barry, Michelle; Shields, Lisa B E; Arnold, Jack; Stewart, Donna; Martin, Erica L; Rakow, Rex J; Paddock, Christopher; Zaki, Sherif R; Prahlow, Joseph A; Stewart, Donna; Shields, Lisa B E; Rolf, Cristin M; Falzon, Andrew L; Hudacki, Rachel; Mazzella, Fermina M; Bethel, Melissa; Zarrin-Khameh, Neda; Gresik, M Vicky; Gill, Ryan; Karlon, William; Etzell, Joan; Deftos, Michael; Karlon, William J; Etzell, Joan E; Wang, Endi; Lu, Chuanyi M; Manion, Elizabeth; Rosenthal, Nancy; Wang, Endi; Lu, Chuanyi M; Tang, Patrick; Petric, Martin; Schade, Andrew E; Hall, Geraldine S; Oethinger, Margret; Hall, Geraldine; Picton, Avis R; Hoang, Linda; Imperial, Miguel Ranoa; Kibsey, Pamela; Waites, Ken; Duffy, Lynn; Hall, Geraldine S; Salangsang, Jo-Anne M; Bravo, Lulette Tricia C; Oethinger, Margaret D; Veras, Emanuela; Silva, Elvia; Vicens, Jimena; Silva, Elvio; Keylock, Joren; Hempel, James; Rushing, Elizabeth; Posligua, Lorena E; Deavers, Michael T; Nash, Jason W; Basturk, Olca; Perle, Mary Ann; Greco, Alba; Lee, Peng; Maru, Dipen; Weydert, Jamie Allen; Stevens, Todd M; Brownlee, Noel A; Kemper, April E; Williams, H James; Oliverio, Brock J; Al-Agha, Osama M; Eskue, Kyle L; Newlands, Shawn D; Eltorky, Mahmoud A; Puri, Puja K; Royer, Michael C; Rush, Walter L; Tavora, Fabio; Galvin, Jeffrey R; Franks, Teri J; Carter, James Elliot; Kahn, Andrea Graciela; Lozada Muñoz, Luis R; Houghton, Dan; Land, Kevin J; Nester, Theresa; Gildea, Jacob; Lefkowitz, Jerry; Lacount, Rachel A; Thompson, Hannis W; Refaai, Majed A; Quillen, Karen; Lopez, Ana Ortega; Goldfinger, Dennis; Muram, Talia; Thompson, Hannis

2009-02-01

The following abstracts are compiled from Check Sample exercises published in 2008. These peer-reviewed case studies assist laboratory professionals with continuing medical education and are developed in the areas of clinical chemistry, cytopathology, forensic pathology, hematology, microbiology, surgical pathology, and transfusion medicine. Abstracts for all exercises published in the program will appear annually in AJCP.

Incorporating temporal and clinical reasoning in a new measure of continuity of care.

PubMed Central

Spooner, S. A.

1994-01-01

Previously described quantitative methods for measuring continuity of care have assumed that perfect continuity exists when a patient sees only one provider, regardless of the temporal pattern and clinical context of the visits. This paper describes an implementation of a new operational model of continuity--the Temporal Continuity Index--that takes into account time intervals between well visits in a pediatric residency continuity clinic. Ideal continuity in this model is achieved when intervals between visits are appropriate based on the age of the patient and clinical context of the encounters. The fundamental concept in this model is the expectation interval, which contains the length of the maximum ideal follow-up interval for a visit and the maximum follow-up interval. This paper describes an initial implementation of the TCI model and compares TCI calculations to previous quantitative methods and proposes its use as part of the assessment of resident education in outpatient settings. PMID:7950019

Improved continuity of care in a resident clinic.

PubMed

Butler, Melissa; Kim, Hyungkoo; Sansone, Randy

2017-02-01

For residents in the out-patient clinic, continuity in patient care is an integral and vital aspect of internal medicine training, but is frequently compromised by resident in-patient schedules, the structure of the out-patient clinic and the need to comply with the increasing regulation of duty hours. In this study, we examined whether the creation and implementation of a new team approach, the Firms Model, would improve the continuity of patient care in the internal medicine resident out-patient clinic. Before the implementation of the Firms Model, an examination of a consecutive clinic sample indicated that patients were seen by their assigned resident providers 41.9 per cent of the time (n = 1319 clinic visits). After implementation of the Firms Model, an examination of a consecutive clinic sample indicated that patients were seen by their assigned Firm resident providers 88.9 per cent of the time (n = 1341 clinic visits). Implementation of the Firms Model resulted in a statistically significant increase in the percentage of patients seen by assigned resident providers in an internal medicine out-patient clinic, culminating in a substantial improvement in continuity of care within our resident out-patient clinic. We discuss the implications of these findings. Continuity in patient care is an integral and vital aspect of internal medicine training, but is frequently compromised. © 2016 John Wiley & Sons Ltd.

Continuous leg dyskinesia assessment in Parkinson's disease -clinical validity and ecological effect.

PubMed

Ramsperger, Robert; Meckler, Stefan; Heger, Tanja; van Uem, Janet; Hucker, Svenja; Braatz, Ulrike; Graessner, Holm; Berg, Daniela; Manoli, Yiannos; Serrano, J Artur; Ferreira, Joaquim J; Hobert, Markus A; Maetzler, Walter

2016-05-01

Dyskinesias in Parkinson's disease (PD) patients are a common side effect of long-term dopaminergic therapy and are associated with motor dysfunctions, including gait and balance deficits. Although promising compounds have been developed to treat these symptoms, clinical trials have failed. This failure may, at least partly, be explained by the lack of objective and continuous assessment strategies. This study tested the clinical validity and ecological effect of an algorithm that detects and quantifies dyskinesias of the legs using a single ankle-worn sensor. Twenty-three PD patients (seven with leg dyskinesias) and 13 control subjects were investigated in the lab. Participants performed purposeful daily activity-like tasks while being video-taped. Clinical evaluation was performed using the leg dyskinesia item of the Unified Dyskinesia Rating Scale. The ecological effect of the developed algorithm was investigated in a multi-center, 12-week, home-based sub-study that included three patients with and seven without dyskinesias. In the lab-based sub-study, the sensor-based algorithm exhibited a specificity of 98%, a sensitivity of 85%, and an accuracy of 0.96 for the detection of dyskinesias and a correlation level of 0.61 (p < 0.001) with the clinical severity score. In the home-based sub-study, all patients could be correctly classified regarding the presence or absence of leg dyskinesias, supporting the ecological relevance of the algorithm. This study provides evidence of clinical validity and ecological effect of an algorithm derived from a single sensor on the ankle for detecting leg dyskinesias in PD patients. These results should motivate the investigation of leg dyskinesias in larger studies using wearable sensors. Copyright © 2016 Elsevier Ltd. All rights reserved.

[Continuing training plan in a clinical management unit].

PubMed

Gamboa Antiñolo, Fernando Miguel; Bayol Serradilla, Elia; Gómez Camacho, Eduardo

2011-01-01

Continuing Care Unit (UCA) focused the attention of frail patients, polypathological patients and palliative care. UCA attend patients at home, consulting, day unit, telephone consulting and in two hospitals of the health area. From 2002 UCA began as a management unit, training has been a priority for development. Key elements include: providing education to the workplace, including key aspects of the most prevalent health care problems in daily work, directing training to all staff including organizational aspects of patient safety and the environment, improved working environment, development of new skills and knowledge supported by the evidence-based care for the development of different skills. The unit can be the ideal setting to undertake the reforms necessary conceptual training of professionals to improve the quality of care. 2010 SESPAS. Published by Elsevier Espana. All rights reserved.

Framework for enhancing clinical practice guidelines through continuous patient engagement.

PubMed

Armstrong, Melissa J; Rueda, Juan-David; Gronseth, Gary S; Mullins, C Daniel

2017-02-01

Patient engagement in clinical practice guideline (CPG) development is recommended by multiple institutions and instruments measuring guideline quality. Approaches to engaging patients, however, vary between oversight organizations, quality tools and guideline developers. We propose a ten-step framework outlining steps and options for patient engagement in guideline development with the goal of highlighting steps for patient engagement and methods by which this can be achieved. This framework provides a model for continuous patient engagement in CPGs by outlining ten steps of guideline development occurring at the levels of the developer/committee and the individual guideline project. At the developer level, patients can assist in topic nomination (step 1), topic prioritization (step 2) and guideline development group selection (step 3). Within specific guideline projects, patients' opinions may be incorporated when framing the question (step 4), creating an analytic framework and research plan (step 5), conducting the systematic review and conclusion formation (step 6), development of recommendations (step 7) and dissemination and implementation (step 8). At the end of process, patients can again be engaged at the developer level by helping determine when guidelines need updating (step 9) and evaluating the developer's approach to patient engagement (step 10). Patient engagement at each CPG development step has different purposes, mechanisms, advantages and disadvantages, and implications for resource utilization. This framework can serve as a resource for guideline developers desiring to increase patient engagement and reference for researchers investigating engagement methodology at different steps of the CPG lifecycle. © 2016 The Authors. Health Expectations Published by John Wiley & Sons Ltd.

An in silico method to identify computer-based protocols worthy of clinical study: An insulin infusion protocol use case

PubMed Central

Wong, Anthony F; Pielmeier, Ulrike; Haug, Peter J; Andreassen, Steen

2016-01-01

Objective Develop an efficient non-clinical method for identifying promising computer-based protocols for clinical study. An in silico comparison can provide information that informs the decision to proceed to a clinical trial. The authors compared two existing computer-based insulin infusion protocols: eProtocol-insulin from Utah, USA, and Glucosafe from Denmark. Materials and Methods The authors used eProtocol-insulin to manage intensive care unit (ICU) hyperglycemia with intravenous (IV) insulin from 2004 to 2010. Recommendations accepted by the bedside clinicians directly link the subsequent blood glucose values to eProtocol-insulin recommendations and provide a unique clinical database. The authors retrospectively compared in silico 18 984 eProtocol-insulin continuous IV insulin infusion rate recommendations from 408 ICU patients with those of Glucosafe, the candidate computer-based protocol. The subsequent blood glucose measurement value (low, on target, high) was used to identify if the insulin recommendation was too high, on target, or too low. Results Glucosafe consistently provided more favorable continuous IV insulin infusion rate recommendations than eProtocol-insulin for on target (64% of comparisons), low (80% of comparisons), or high (70% of comparisons) blood glucose. Aggregated eProtocol-insulin and Glucosafe continuous IV insulin infusion rates were clinically similar though statistically significantly different (Wilcoxon signed rank test P = .01). In contrast, when stratified by low, on target, or high subsequent blood glucose measurement, insulin infusion rates from eProtocol-insulin and Glucosafe were statistically significantly different (Wilcoxon signed rank test, P < .001), and clinically different. Discussion This in silico comparison appears to be an efficient nonclinical method for identifying promising computer-based protocols. Conclusion Preclinical in silico comparison analytical framework allows rapid and inexpensive identification of computer-based protocol care strategies that justify expensive and burdensome clinical trials. PMID:26228765

Guidelines on treatment of perinatal depression with antidepressants: An international review

PubMed Central

Kamperman, Astrid M; Boyce, Philip; Bergink, Veerle

2018-01-01

Objective: Several countries have developed Clinical Practice Guidelines regarding treatment of perinatal depressive symptoms and perinatal use of antidepressant. We aimed to compare guidelines to guide clinicians in best clinical practice. Methods: An extensive search in guideline databases, MEDLINE and PsycINFO was performed. When no guidelines were (publicly) available online, we contacted psychiatric-, obstetric-, perinatal- and mood disorder societies of all first world countries and the five largest second world countries. Only Clinical Practice Guidelines adhering to quality criteria of the Appraisal of Guidelines for Research and Evaluation instrument and including a systematic review of evidence were included. Data extraction focussed on recommendations regarding continuation or withdrawal of antidepressants and preferred treatment in newly depressed patients. Results: Our initial search resulted in 1094 articles. After first screening, 40 full-text articles were screened. Of these, 24 were excluded for not being an official Clinical Practice Guidelines. In total, 16 Clinical Practice Guidelines were included originating from 12 countries. Eight guidelines were perinatal specific and eight were general guidelines. Conclusion: During pregnancy, four guidelines advise to continue antidepressants, while there is a lack of evidence supporting this recommendation. Five guidelines do not specifically advise or discourage continuation. For new episodes, guidelines agree on psychotherapy (especially cognitive behavioural therapy) as initial treatment for mild to moderate depression and antidepressants for severe depression, with a preference for sertraline. Paroxetine is not preferred treatment for new episodes but switching antidepressants for ongoing treatment is discouraged (three guidelines). If mothers use antidepressants, observation of the neonate is generally recommended and breastfeeding encouraged. PMID:29506399

Guidelines on treatment of perinatal depression with antidepressants: An international review.

PubMed

Molenaar, Nina M; Kamperman, Astrid M; Boyce, Philip; Bergink, Veerle

2018-04-01

Several countries have developed Clinical Practice Guidelines regarding treatment of perinatal depressive symptoms and perinatal use of antidepressant. We aimed to compare guidelines to guide clinicians in best clinical practice. An extensive search in guideline databases, MEDLINE and PsycINFO was performed. When no guidelines were (publicly) available online, we contacted psychiatric-, obstetric-, perinatal- and mood disorder societies of all first world countries and the five largest second world countries. Only Clinical Practice Guidelines adhering to quality criteria of the Appraisal of Guidelines for Research and Evaluation instrument and including a systematic review of evidence were included. Data extraction focussed on recommendations regarding continuation or withdrawal of antidepressants and preferred treatment in newly depressed patients. Our initial search resulted in 1094 articles. After first screening, 40 full-text articles were screened. Of these, 24 were excluded for not being an official Clinical Practice Guidelines. In total, 16 Clinical Practice Guidelines were included originating from 12 countries. Eight guidelines were perinatal specific and eight were general guidelines. During pregnancy, four guidelines advise to continue antidepressants, while there is a lack of evidence supporting this recommendation. Five guidelines do not specifically advise or discourage continuation. For new episodes, guidelines agree on psychotherapy (especially cognitive behavioural therapy) as initial treatment for mild to moderate depression and antidepressants for severe depression, with a preference for sertraline. Paroxetine is not preferred treatment for new episodes but switching antidepressants for ongoing treatment is discouraged (three guidelines). If mothers use antidepressants, observation of the neonate is generally recommended and breastfeeding encouraged.

Tissue engineering of ligaments for reconstructive surgery.

PubMed

Hogan, MaCalus V; Kawakami, Yohei; Murawski, Christopher D; Fu, Freddie H

2015-05-01

The use of musculoskeletal bioengineering and regenerative medicine applications in orthopaedic surgery has continued to evolve. The aim of this systematic review was to address tissue-engineering strategies for knee ligament reconstruction. A systematic review of PubMed/Medline using the terms "knee AND ligament" AND "tissue engineering" OR "regenerative medicine" was performed. Two authors performed the search, independently assessed the studies for inclusion, and extracted the data for inclusion in the review. Both preclinical and clinical studies were reviewed, and the articles deemed most relevant were included in this article to provide relevant basic science and recent clinical translational knowledge concerning "tissue-engineering" strategies currently used in knee ligament reconstruction. A total of 224 articles were reviewed in our initial PubMed search. Non-English-language studies were excluded. Clinical and preclinical studies were identified, and those with a focus on knee ligament tissue-engineering strategies including stem cell-based therapies, growth factor administration, hybrid biomaterial, and scaffold development, as well as mechanical stimulation modalities, were reviewed. The body of knowledge surrounding tissue-engineering strategies for ligament reconstruction continues to expand. Presently, various tissue-engineering techniques have some potential advantages, including faster recovery, better ligamentization, and possibly, a reduction of recurrence. Preclinical research of these novel therapies continues to provide promising results. There remains a need for well-designed, high-powered comparative clinical studies to serve as a foundation for successful translation into the clinical setting going forward. Level IV, systematic review of Level IV studies. Copyright © 2015 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Advancing working and learning through critical action research: creativity and constraints.

PubMed

Bellman, Loretta; Bywood, Catherine; Dale, Susan

2003-12-01

Continuous professional development is an essential component within many health care 'Learning Organisations'. The paper describes the first phase of an initiative to develop a professional practice development framework for nurses in an NHS general hospital. The project was undertaken within a critical action research methodology. A tripartite arrangement between the hospital, a university and professional nursing organisation enabled clinical, educational and research support for the nurses (co-researchers) engaged in the project. Initial challenges were from some managers, educationalists and the ethics committee who did not appear to understand the action research process. A multi-method approach to data collection was undertaken to capture the change process from different stakeholders' perceptions. Triangulation of the data was undertaken. Despite organisational constraints, transformational leadership and peer support enabled the co-researchers to identify and initiate three patient-focused initiatives. The change process for the co-researchers included: enlightening personal journey, exploring the research-practice gap, enhancing personal and professional knowledge, evolving cultural change and collaborative working, empowering and disempowering messages. A hospital merger and corporate staff changes directly impacted on the project. A more flexible time-scale and longer term funding are required to enable continuity for trust-wide projects undertaken in dynamic clinical settings.

Behavior analytic approaches to problem behavior in intellectual disabilities.

PubMed

Hagopian, Louis P; Gregory, Meagan K

2016-03-01

The purpose of the current review is to summarize recent behavior analytic research on problem behavior in individuals with intellectual disabilities. We have focused our review on studies published from 2013 to 2015, but also included earlier studies that were relevant. Behavior analytic research on problem behavior continues to focus on the use and refinement of functional behavioral assessment procedures and function-based interventions. During the review period, a number of studies reported on procedures aimed at making functional analysis procedures more time efficient. Behavioral interventions continue to evolve, and there were several larger scale clinical studies reporting on multiple individuals. There was increased attention on the part of behavioral researchers to develop statistical methods for analysis of within subject data and continued efforts to aggregate findings across studies through evaluative reviews and meta-analyses. Findings support continued utility of functional analysis for guiding individualized interventions and for classifying problem behavior. Modifications designed to make functional analysis more efficient relative to the standard method of functional analysis were reported; however, these require further validation. Larger scale studies on behavioral assessment and treatment procedures provided additional empirical support for effectiveness of these approaches and their sustainability outside controlled clinical settings.

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

PubMed

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

2015-08-13

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

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

PubMed Central

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

2015-01-01

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

Strategies for bringing drug delivery tools into discovery.

PubMed

Kwong, Elizabeth; Higgins, John; Templeton, Allen C

2011-06-30

The past decade has yielded a significant body of literature discussing approaches for development and discovery collaboration in the pharmaceutical industry. As a result, collaborations between discovery groups and development scientists have increased considerably. The productivity of pharma companies to deliver new drugs to the market, however, has not increased and development costs continue to rise. Inability to predict clinical and toxicological response underlies the high attrition rate of leads at every step of drug development. A partial solution to this high attrition rate could be provided by better preclinical pharmacokinetics measurements that inform PD response based on key pathways that drive disease progression and therapeutic response. A critical link between these key pharmacology, pharmacokinetics and toxicology studies is the formulation. The challenges in pre-clinical formulation development include limited availability of compounds, rapid turn-around requirements and the frequent un-optimized physical properties of the lead compounds. Despite these challenges, this paper illustrates some successes resulting from close collaboration between formulation scientists and discovery teams. This close collaboration has resulted in development of formulations that meet biopharmaceutical needs from early stage preclinical in vivo model development through toxicity testing and development risk assessment of pre-clinical drug candidates. Published by Elsevier B.V.

Regulatory considerations on new adjuvants and delivery systems.

PubMed

Sesardic, D

2006-04-12

New and improved vaccines and delivery systems are increasingly being developed for prevention, treatment and diagnosis of human diseases. Prior to their use in humans, all new biological products must undergo pre-clinical evaluation. These pre-clinical studies are important not only to establish the biological properties of the material and to evaluate its possible risk to the public, but also to plan protocols for subsequent clinical trials from which safety and efficacy can be evaluated. For vaccines, evaluation in pre-clinical studies is particularly important as information gained may also contribute to identifying the optimum composition and formulation process and provide an opportunity to develop suitable indicator tests for quality control. Data from pre-clinical and laboratory evaluation studies, which continue during clinical studies, is used to support an application for marketing authorisation. Addition of a new adjuvant and exploration of new delivery systems for vaccines presents challenges to both manufacturers and regulatory authorities. Because no adjuvant is licensed as a medicinal product in its own right, but only as a component of a particular vaccine, pre-clinical and appropriate toxicology studies need to be designed on a case-by-case basis to evaluate the safety profile of the adjuvant and adjuvant/vaccine combination. Current regulatory requirements for the pharmaceutical and pre-clinical safety assessment of vaccines are insufficient and initiatives are in place to develop more specific guidelines for evaluation of adjuvants in vaccines.

[Continuity of nutritional care at discharge in the era of ICT].

PubMed

Martínez Olmos, Miguel Ángel

2015-05-07

Telemedicine represents the union of information technology and telecommunication services in health. This allows the improvement of health care, especially in underserved areas, bringing professionals working in continuing education and improving patient care at home. The application of telemedicine in various hospital complexes, clinics and health centers, has helped to provide a better service, within the parameters of efficiency, effectiveness, cost-benefit, with increasing satisfaction of medical staff and patients. The development and application of various types of telemedicine, the technological development of audio, text, video and data, and constant improvement of infrastructure in telecommunications, have favored the expansion and development of telemedicine in various medical specialties. The use of electronic health records by different health professionals can have a positive impact on the care provided to patients. This should also be supported by the development of better health policies, legal security and greater awareness in health professionals and patients regarding the potential benefits. Regarding the clinical activity in Nutrition, new technologies also provide an opportunity to improve in various educational, preventive, diagnostic and treatment aspects, including shared track between Nutrition Units and Primary Care Teams, for patients who need home nutritional care at, with shared protocols, providing teleconsultation in required cases and avoiding unnecessary travel to hospital.

Hybrid Continuous-Flow Total Artificial Heart.

PubMed

Fox, Carson; Chopski, Steven; Murad, Nohra; Allaire, Paul; Mentzer, Robert; Rossano, Joseph; Arabia, Francisco; Throckmorton, Amy

2018-05-01

Clinical studies using total artificial hearts (TAHs) have demonstrated that pediatric and adult patients derive quality-of-life benefits from this form of therapy. Two clinically-approved TAHs and other pumps under development, however, have design challenges and limitations, including thromboembolic events, neurologic impairment, infection risk due to large size and percutaneous drivelines, and lack of ambulation, to name a few. To address these limitations, we are developing a hybrid-design, continuous-flow, implantable or extracorporeal, magnetically-levitated TAH for pediatric and adult patients with heart failure. This TAH has only two moving parts: an axial impeller for the pulmonary circulation and a centrifugal impeller for the systemic circulation. This device will utilize the latest generation of magnetic bearing technology. Initial geometries were established using pump design equations, and computational modeling provided insight into pump performance. The designs were the basis for prototype manufacturing and hydraulic testing. The study results demonstrate that the TAH is capable of delivering target blood flow rates of 1-6.5 L/min with pressure rises of 1-92 mm Hg for the pulmonary circulation and 24-150 mm Hg for the systemic circulation at 1500-10 000 rpm. This initial design of the TAH was successful and serves as the foundation to continue its development as a novel, more compact, nonthrombogenic, and effective therapeutic alternative for infants, children, adolescents, and adults with heart failure. © 2018 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

What is the veterinary professional identity? Preliminary findings from web-based continuing professional development in veterinary professionalism.

PubMed

Armitage-Chan, E; Maddison, J; May, S A

2016-03-26

Professionalism and professional skills are increasingly being incorporated into veterinary curricula; however, lack of clarity in defining veterinary professionalism presents a potential challenge for directing course outcomes that are of benefit to the veterinary professional. An online continuing education course in veterinary professionalism was designed to address a deficit in postgraduate support in this area; as part of this course, delegates of varying practice backgrounds participated in online discussions reflecting on the implications of professional skills for their clinical practice. The discussions surrounding the role of the veterinary professional and reflecting on strengths and weaknesses in professional skills were analysed using narrative methodology, which provided an understanding of the defining skills and attributes of the veterinary professional, from the perspectives of those involved (i.e. how vets understood their own career identity). The veterinary surgeon was understood to be an interprofessional team member, who makes clinical decisions in the face of competing stakeholder needs and works in a complex environment comprising multiple and diverse challenges (stress, high emotions, financial issues, work-life balance). It was identified that strategies for accepting fallibility, and those necessary for establishing reasonable expectations of professional behaviour and clinical ability, are poorly developed. British Veterinary Association.

Current status of Zika vaccine development: Zika vaccines advance into clinical evaluation.

PubMed

Barrett, Alan D T

2018-01-01

Zika virus (ZIKV), a mosquito-borne flavivirus, was first identified in the 1940s in Uganda in Africa and emerged in the Americas in Brazil in May 2015. In the 30 months since ZIKV emerged as a major public health problem, spectacular progress has been made with vaccine development cumulating with the publication of three reports of phase 1 clinical trials in the 4th quarter of 2017. Clinical trials involving candidate DNA and purified inactivated virus vaccines showed all were safe and well-tolerated in the small number of volunteers and all induced neutralizing antibodies, although these varied by vaccine candidate and dosing regimen. These results suggest that a Zika vaccine can be developed and that phase 2 clinical trials are warranted. However, it is difficult to compare the results from the different phase 1 studies or with neutralizing antibodies induced by licensed flavivirus vaccines (Japanese encephalitis, tick-borne encephalitis, and yellow fever) as neutralizing antibody assays vary and, unfortunately, there are no standards for Zika virus neutralizing antibodies. In addition to clinical studies, substantial progress continues to be made in nonclinical development, particularly in terms of the ability of candidate vaccines to protect reproductive tissues, and the potential use of monoclonal antibodies for passive prophylaxis.

An assessment of the faculty development needs of junior clinical faculty in emergency medicine.

PubMed

Farley, Heather; Casaletto, Jennifer; Ankel, Felix; Young, Kelly D; Hockberger, Robert

2008-07-01

Academic physicians must be able to access the resources necessary to support their ongoing professional development and meet requirements for continued academic advancement. The authors sought to determine the self-perceived career development needs of junior clinical faculty in emergency medicine (EM) and the availability of educational resources to meet those needs. An educational "needs assessment" survey was distributed to 954 American College of Emergency Physicians (ACEP) members listed in the ACEP database as being faculty at EM residency programs in the United States and having graduated from an EM residency within the past 7 years. Respondents were asked to rank the importance of 22 areas of faculty development to their own professional growth and then to indicate whether educational resources in each area were available to them. Respondents were also asked to note the educational formats they prefer. A search for currently available resources in each topic area was undertaken and compared to the survey results. A total of 240 responses were received. Self-perceived career development needs were identified in the following areas: bedside teaching, lecture development, business skills, managerial skills, educational research, mentorship and career counseling, interpersonal skills, leadership skills, scholarly writing skills, physician wellness, and knowledge of the faculty development process. While a review of currently available educational resources revealed lectures, conferences, and online materials pertinent to most of these topics, a relative lack of resources in the areas of mentorship and physician wellness was identified. Junior clinical faculty in EM perceive a lack of educational resources in a number of areas of faculty development. The academic community of EM should strive to improve awareness of and access to currently existing resources and to develop additional resources to address the area of physician wellness. The lack of mentorship in academic EM continues to be a problem in search of a solution.

Developing online continuing education content for enhancing caring among Taiwan nurses.

PubMed

Hsu, Tzu-Chuan; Turton, Michael A; Cheng, Su-Fen; Lee-Hsieh, Jane

2013-04-01

To promote the quality of nursing care, a hospital in Taiwan committed to implementing its SHARE framework for clinical practice. This study was conducted to develop caring content for the SHARE framework in the form of online continuing education videos. Five focus group interviews were conducted with 19 exemplary nurses. A constant comparative method was used to extract caring themes that were integrated into the five components of SHARE: S: Sense patient's needs; H: Help patient out; A: Acknowledge patient's feelings; R: Respect patient's dignity and privacy; E: Explain what is happening. Concrete caring behaviors consistent with SHARE were identified. Real-world scenarios were used to produce five videos demonstrating the components of SHARE for use in online caring education. This project offers a new strategy for strengthening caring behavior in nurse-patient interactions and may help to establish a model for caring in nursing continuing education in Taiwan. Copyright 2013, SLACK Incorporated.

[The history and phenomenology of the concept of psychosis. A perspective of the Heidelberg school (1913-2008)].

PubMed

Bürgy, M

2009-05-01

The accomplishments of Heidelberg psychopathology and their continued development are illustrated using the example of the concept of psychosis. Jaspers founded the Heidelberg school by methodologically collating the psychiatric knowledge of his time in a structured fashion and in doing so laid the foundation for modern nosology. While, however, ICD and DSM classifications tend to be modelled on symptoms of expression and behaviour, the phenomenological models which Jaspers introduced into the field of psychiatry rather focused on symptoms of subjective experience. The phenomenological developments of psychopathology which originated in this context are, in the case of the schizophrenic psychoses, presented in a kaleidoscope-like manner. It becomes evident that a legacy-oriented, phenomenological search for specific symptoms is of continued relevance. This historical wealth of knowledge and the clinical exploration of phenomena continue to represent sources of impetus and momentum for the field of psychopathology.

Impact of the Alzheimer's Disease Neuroimaging Initiative, 2004 to 2014.

PubMed

Weiner, Michael W; Veitch, Dallas P; Aisen, Paul S; Beckett, Laurel A; Cairns, Nigel J; Cedarbaum, Jesse; Donohue, Michael C; Green, Robert C; Harvey, Danielle; Jack, Clifford R; Jagust, William; Morris, John C; Petersen, Ronald C; Saykin, Andrew J; Shaw, Leslie; Thompson, Paul M; Toga, Arthur W; Trojanowski, John Q

2015-07-01

The Alzheimer's Disease Neuroimaging Initiative (ADNI) was established in 2004 to facilitate the development of effective treatments for Alzheimer's disease (AD) by validating biomarkers for AD clinical trials. We searched for ADNI publications using established methods. ADNI has (1) developed standardized biomarkers for use in clinical trial subject selection and as surrogate outcome measures; (2) standardized protocols for use across multiple centers; (3) initiated worldwide ADNI; (4) inspired initiatives investigating traumatic brain injury and post-traumatic stress disorder in military populations, and depression, respectively, as an AD risk factor; (5) acted as a data-sharing model; (6) generated data used in over 600 publications, leading to the identification of novel AD risk alleles, and an understanding of the relationship between biomarkers and AD progression; and (7) inspired other public-private partnerships developing biomarkers for Parkinson's disease and multiple sclerosis. ADNI has made myriad impacts in its first decade. A competitive renewal of the project in 2015 would see the use of newly developed tau imaging ligands, and the continued development of recruitment strategies and outcome measures for clinical trials. Copyright © 2015 The Alzheimer's Association. All rights reserved.

Impact of the Alzheimer’s Disease Neuroimaging Initiative, 2004 to 2014

PubMed Central

Weiner, Michael W.; Veitch, Dallas P.; Aisen, Paul S.; Beckett, Laurel A.; Cairns, Nigel J.; Cedarbaum, Jesse; Donohue, Michael C.; Green, Robert C.; Harvey, Danielle; Jack, Clifford R.; Jagust, William; Morris, John C.; Petersen, Ronald C.; Saykin, Andrew J.; Shaw, Leslie; Thompson, Paul M.; Toga, Arthur W.; Trojanowski, John Q.

2015-01-01

Introduction The Alzheimer’s Disease Neuroimaging Initiative (ADNI) was established in 2004 to facilitate the development of effective treatments for Alzheimer’s disease (AD) by validating biomarkers for AD clinical trials. Methods We searched for ADNI publications using established methods. Results ADNI has (1) developed standardized biomarkers for use in clinical trial subject selection and as surrogate outcome measures; (2) standardized protocols for use across multiple centers; (3) initiated worldwide ADNI; (4) inspired initiatives investigating traumatic brain injury and post-traumatic stress disorder in military populations, and depression, respectively, as an AD risk factor; (5) acted as a data-sharing model; (6) generated data used in over 600 publications, leading to the identification of novel AD risk alleles, and an understanding of the relationship between biomarkers and AD progression; and (7) inspired other public-private partnerships developing biomarkers for Parkinson’s disease and multiple sclerosis. Discussion ADNI has made myriad impacts in its first decade. A competitive renewal of the project in 2015 would see the use of newly developed tau imaging ligands, and the continued development of recruitment strategies and outcome measures for clinical trials. PMID:26194320

Opioid analgesics and P-glycoprotein efflux transporters: a potential systems-level contribution to analgesic tolerance.

PubMed

Mercer, Susan L; Coop, Andrew

2011-01-01

Chronic clinical pain remains poorly treated. Despite attempts to develop novel analgesic agents, opioids remain the standard analgesics of choice in the clinical management of chronic and severe pain. However, mu opioid analgesics have undesired side effects including, but not limited to, respiratory depression, physical dependence and tolerance. A growing body of evidence suggests that P-glycoprotein (P-gp), an efflux transporter, may contribute a systems-level approach to the development of opioid tolerance. Herein, we describe current in vitro and in vivo methodology available to analyze interactions between opioids and P-gp and critically analyze P-gp data associated with six commonly used mu opioids to include morphine, methadone, loperamide, meperidine, oxycodone, and fentanyl. Recent studies focused on the development of opioids lacking P-gp substrate activity are explored, concentrating on structure-activity relationships to develop an optimal opioid analgesic lacking this systems-level contribution to tolerance development. Continued work in this area will potentially allow for delineation of the mechanism responsible for opioid-related P-gp up-regulation and provide further support for evidence based medicine supporting clinical opioid rotation.

Mechanisms of Adaptation and Progression in Idiosyncratic Drug Induced Liver Injury, Clinical Implications

PubMed Central

Dara, Lily; Liu, Zhang-Xu; Kaplowitz, Neil

2015-01-01

In the past decade our understanding of idiosyncratic drug induced liver injury (IDILI) and the contribution of genetic susceptibility and the adaptive immune system to the pathogenesis of this disease process has grown tremendously. One of the characteristics of IDILI is that it occurs rarely and only in a subset of individuals with a presumed susceptibility to the drug. Despite a clear association between single nucleotide polymorphisms in human leukocyte antigen (HLA) genes and certain drugs that cause IDILI, not all individuals with susceptible HLA genotypes develop clinically significant liver injury when exposed to drugs. The adaptation hypothesis has been put forth as an explanation for why only a small percentage of susceptible individuals develop overt IDILI and severe injury, while the majority with susceptible genotypes develop only mild abnormalities that resolve spontaneously upon continuation of the drug. This spontaneous resolution is referred to as clinical adaptation. Failure to adapt or defective adaptation leads to clinically significant liver injury. In this review we explore the immuno-tolerant microenvironment of the liver and the mechanisms of clinical adaptation in IDILI with a focus on the role of immune-tolerance and cellular adaptive responses. PMID:26484420

Developments in the field of allergy in 2009 through the eyes of Clinical and Experimental Allergy.

PubMed

Chu, H W; Lloyd, C M; Karmaus, W; Maestrelli, P; Mason, P; Salcedo, G; Thaikoottathil, J; Wardlaw, A J

2010-11-01

In 2009 the journal published in the region of 200 papers including reviews, editorials, opinion pieces and original papers that ran the full gamut of allergic disease. It is instructive to take stock of this output to determine patterns of interest and where the cutting edge lies. We have surveyed the field of allergic disease as seen through the pages of Clinical and Experimental Allergy (CEA) highlighting trends, emphasizing notable observations and placing discoveries in the context of other key papers published during the year. The review is divided into similar sections as the journal. In the field of Asthma and Rhinitis CEA has contributed significantly to the debate about asthma phenotypes and expressed opinions about the cause of intrinsic asthma. It has also added its halfpennyworth to the hunt for meaningful biomarkers. In Mechanisms the considerable interest in T cell subsets including Th17 and T regulatory cells continues apace and the discipline of Epidemiology continues to invoke a steady stream of papers on risk factors for asthma with investigators still trying to explain the post-second world war epidemic of allergic disease. Experimental Models continue to make important contributions to our understanding of pathogenesis of allergic disease and in the Clinical Allergy section various angles on immunotherapy are explored. New allergens continue to be described in the allergens section to make those allergen chips even more complicated. A rich and vibrant year helpfully summarized by some of our associate editors. © 2010 Blackwell Publishing Ltd.

Developments in the field of allergy in 2009 through the eyes of Clinical and Experimental Allergy

PubMed Central

Chu, H. W.; Lloyd, C. M.; Karmaus, W.; Maestrelli, P.; Mason, P.; Salcedo, G.; Thaikoottathil, J.; Wardlaw, A. J.

2012-01-01

Summary In 2009 the journal published in the region of 200 papers including reviews, editorials, opinion pieces and original papers that ran the full gamut of allergic disease. It is instructive to take stock of this output to determine patterns of interest and where the cutting edge lies. We have surveyed the field of allergic disease as seen through the pages of Clinical and Experimental Allergy (CEA) highlighting trends, emphasizing notable observations and placing discoveries in the context of other key papers published during the year. The review is divided into similar sections as the journal. In the field of Asthma and Rhinitis CEA has contributed significantly to the debate about asthma phenotypes and expressed opinions about the cause of intrinsic asthma. It has also added its halfpennyworth to the hunt for meaningful biomarkers. In Mechanisms the considerable interest in T cell subsets including Th17 and T regulatory cells continues apace and the discipline of Epidemiology continues to invoke a steady stream of papers on risk factors for asthma with investigators still trying to explain the post-second world war epidemic of allergic disease. Experimental Models continue to make important contributions to our understanding of pathogenesis of allergic disease and in the Clinical Allergy section various angles on immunotherapy are explored. New allergens continue to be described in the allergens section to make those allergen chips even more complicated. A rich and vibrant year helpfully summarized by some of our associate editors. PMID:21039970

Clinical solid waste management practices and its impact on human health and environment - A review

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

Hossain, Md. Sohrab; Santhanam, Amutha; Nik Norulaini, N.A.

2011-04-15

Research highlights: > Appropriate waste management technology for safe handling and disposal of clinical solid waste. > Infectious risk assessment on unsafe handling of clinical solid waste. > Recycling-reuse program of clinical solid waste materials. > Effective sterilization technology to reduce exposure of infectious risk. - Abstract: The management of clinical solid waste (CSW) continues to be a major challenge, particularly, in most healthcare facilities of the developing world. Poor conduct and inappropriate disposal methods exercised during handling and disposal of CSW is increasing significant health hazards and environmental pollution due to the infectious nature of the waste. This articlemore » summarises a literature review into existing CSW management practices in the healthcare centers. The information gathered in this paper has been derived from the desk study of open literature survey. Numerous researches have been conducted on the management of CSW. Although, significant steps have been taken on matters related to safe handling and disposal of the clinical waste, but improper management practice is evident from the point of initial collection to the final disposal. In most cases, the main reasons of the mismanagement of CSW are the lack of appropriate legislation, lack of specialized clinical staffs, lack of awareness and effective control. Furthermore, most of the healthcare centers of the developing world have faced financial difficulties and therefore looking for cost effective disposal methods of clinical waste. This paper emphasizes to continue the recycle-reuse program of CSW materials after sterilization by using supercritical fluid carbon dioxide (SF-CO2) sterilization technology at the point of initial collection. Emphasis is on the priority to inactivate the infectious micro-organisms in CSW. In that case, waste would not pose any threat to healthcare workers. The recycling-reuse program would be carried out successfully with the non-specialized clinical staffs. Therefore, the adoption of SF-CO2 sterilization technology in management of clinical solid waste can reduce exposure to infectious waste, decrease labor, lower costs, and yield better compliance with regulatory. Thus healthcare facilities can both save money and provide a safe environment for patients, healthcare staffs and clinical staffs.« less

[Survey of professional practices within the framework of the Continuous professional development: an experience led on a national scale on the theme of macroenzymes].

PubMed

Leon, Anthony; Aimone-Gastin, Isabelle

2014-01-01

The recent HPST law (reform of the hospital and relative to the patients, to the health and to the territories) states that the formation of the healthcare professionals is now "independent" and "compulsory". This law introduces the term of "Continuous professional development". The "Continuous professional development" groups together the former systems of both Evaluation of the professional practices and in-services training. Indeed, our practice gave us an opportunity to evaluate the practices of the professional of the specialists in laboratory medicine. We had to deal with very unsual cases of interference with a medicine (tenofovir) during the dosage of creatines kinases induced by the presence of a macroenzyme. To achieve this goal, a situation scenario was constructed and sent to a sample of practitioners. The first part deals with a clinical case with an analytic interference provoked by a macroenzyme. The second part refers to the usual techniques employed to reveal the presence of macroenzymes. The results were returned as a document suggesting a way to behave "in front of a suspicion of macroenzymes". This study is an illustration of what can be realized to answer the obligations of continuous professional development.

Ten steps to developing a national agenda to address financial conflicts of interest in industry sponsored clinical research.

PubMed

Tereskerz, Patricia M; Moreno, Jonathan

2005-01-01

Financial liaisons between clinical researchers, research institutions, and industrial sponsors have gained momentum in recent years. In the process, it has been argued by many that trust in the research infrastructure is being eroded by the financial conflicts of interest that emerge from these arrangements. Yet, the financial resources of industry are needed to continue technology transfer from the bench to the bedside. Policy makers and government regulators are currently struggling to determine how to best manage financial conflicts of interest that emerge from these liaisons. Various organizations and government entities have proposed different strategies. This paper explores the limitations of existing measures and recommends that a unified national agenda is needed. We propose 10 steps to develop an agenda to address financial conflicts of interest in industry-sponsored clinical research.

Chemical and microbiologic aspects of penems, a distinct class of beta-lactams: focus on faropenem.

PubMed

Hamilton-Miller, Jeremy M T

2003-11-01

Many beta-lactam antimicrobials were developed between the 1960s and 1980s, with continuing development driven by the emergence of microbial resistance. Penems form a discrete class of beta-lactams that comprises structural hybrids of penicillins (penams) and cephalosporins (cephems). The chemistry and microbiology of the representative penems MEN 10700, ritipenem, CGP 31608, sulopenem, BRL 42715, and faropenem are reviewed. Particular emphasis is placed on faropenem, which is in late clinical development.

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.

Thinking and practice of accelerating transformation of traditional Chinese medicine from experience medicine to evidence-based medicine.

PubMed

Liu, Baoyan; Zhang, Yanhong; Hu, Jingqing; He, Liyun; Zhou, Xuezhong

2011-06-01

The gradual development of Chinese medicine is based on constant accumulation and summary of experience in clinical practice, but without the benefit of undergoing the experimental medicine stage. Although Chinese medicine has formed a systematic and unique theory system through thousands of years, with the development of evidence-based medicine, the bondage of the research methods of experience medicine to Chinese medicine is appearing. The rapid transition and transformation from experience medicine to evidence-based medicine have become important content in the development of Chinese medicine. According to the features of Chinese medicine, we propose the research idea of "taking two ways simultaneously," which is the study both in the ideal condition and in the real world. Analyzing and constructing the theoretical basis and methodology of clinical research in the real world, and building the stage for research technique is key to the effective clinical research of Chinese medicine. Only by gradually maturing and completing the clinical research methods of the real world could we realize "taking two ways simultaneously" and complementing each other, continuously produce scientific and reliable evidence of Chinese medicine, as well as transform and develop Chinese medicine from experience medicine to evidence-based medicine.

Clinical biochemistry education in Spain.

PubMed

Queraltó, J M

1994-12-31

Clinical biochemistry in Spain was first established in 1978 as an independent specialty. It is one of several clinical laboratory sciences specialties, together with haematology, microbiology, immunology and general laboratory (Clinical analysis, análisis clinicos). Graduates in Medicine, Pharmacy, Chemistry and Biological Sciences can enter post-graduate training in Clinical Chemistry after a nation-wide examination. Training in an accredited Clinical Chemistry department is 4 years. A national committee for medical and pharmacist specialties advises the government on the number of trainees, program and educational units accreditation criteria. Technical staff includes nurses and specifically trained technologists. Accreditation of laboratories is developed at different regional levels. The Spanish Society for Clinical Biochemistry and Molecular Pathology (SECQ), the national representative in the IFCC, has 1600 members, currently publishes a scientific journal (Química Clinica) and a newsletter. It organizes a continuous education program, a quality control program and an annual Congress.

Micrometastases in neuroblastoma: are they clinically important?

PubMed Central

Burchill, S A

2004-01-01

Despite advances in the treatment of neuroblastoma (NBL), recurrence and metastases continue to pose major problems in clinical management. The relation between micrometastases and the development of secondary disease is not fully understood. However, accurate methods to detect low numbers of tumour cells may allow the evaluation of their role in the disease process, and by implication the possible benefits of eliminating them. Although there is substantial evidence for the increased sensitivity of current molecular methods for the detection of NBL cells compared with more conventional cytology, the clinical relevance and usefulness of detecting this disease remain controversial. The primary goal of current translational research must be to evaluate the clinical relevance of micrometastatic disease detected by these methods in multicentre prospective clinical outcome studies. Only then can the clinical usefulness of these methods be defined so that they may be introduced into relevant clinical practice. PMID:14693828

A Homecare Application based on the ASTM E2369-05 Standard Specification for Continuity of Care Record

PubMed Central

Botsivaly, M.; Spyropoulos, B.; Koutsourakis, K.; Mertika, K.

2006-01-01

The purpose of this study is the presentation of a system appropriate to be used upon the transition of a patient from hospital to homecare. The developed system is structured according to the ASTM E2369-05 Standard Specification for Continuity of Care Record and its function is based upon the creation of a structured subset of data, containing the patient’s most relevant clinical information, enabling simultaneously the planning and the optimal documentation of the provided homecare. PMID:17238479

The Timer-Logger-Communicator for Continuous, Mobile Measurement of Wheelchair Pressure Reliefs

PubMed Central

Grip, Jeffrey C.; Merbitz, Charles T.

1985-01-01

A recently developed device which provides continuous, direct monitoring of the pressure-relief performance of persons confined to wheelchairs is reported. A custom portable computer records the data, which is transferred for analysis to an Apple IIe. The mobile computer can also signal the patient to relieve pressure based on preset criteria and the patient's performance. Teaching lift-offs to prevent ischial pressure sores is the object. Data collected with the device are used clinically and for research. Examples of such data are presented. The benefits of the device are reviewed.

Cabo Verde telemedicine program: initial results of nationwide implementation.

PubMed

Latifi, Rifat; Dasho, Erion; Merrell, Ronald C; Lopes, Miguel; Azevedo, Vanda; Bekteshi, Flamur; Osmani, Kalterina L; Qesteri, Orland; Kucani, Julian; Lecaj, Ismet

2014-11-01

Telemedicine and e-health have been suggested as one solution for closing the health disparity gap between the developed world and the developing world. Yet evidence is lacking from current successful programs in the developing world and, in particular, from sub-Saharan Africa. The primary objective of our study was to present the preliminary results of our efforts in building the Integrated Telemedicine and e-Health Program for Cabo Verde (ITeHP-CV), with an emphasis on initial utilization and results. This is a prospective study of data collected while we worked to establish a fully functional, integrated national telemedicine network and virtual education network in Cabo Verde. We used the International Virtual e-Hospital Foundation strategic approach known as "initiate-build-operate-transfer" over a 26-month period (November 2011-December 2013). We describe herein the five main pillars of this process that have been implemented: (1) capacity building; (2) network development and deployment of equipment; (3) implementation of clinical telemedicine; (4) implementation of activities related to continuing medical education, delivered from within the country and from abroad; and (5) establishment and use of the electronic virtual library. Based on comprehensive technical and medical assessment of the country's needs, 10 fully functional telemedicine centers in all nine inhabited islands of the Republic of Cabo Verde have been established. RESULTS are presented under the five main pillars of capacity building, network deployment, implementation of clinical telemedicine, implementation of continuing medical education activities, and establishment of the electronic virtual library. The ITeHP-CV has been successfully launched, and the initial results are encouraging. The continuity of the program and sustainability are primary goals once the program is transferred fully to the Ministry of Health of Cabo Verde. A long-term follow-up study is required in order to ensure sustainability and continuity goals are met.

Imaging of inflammatory processes with labeled cells

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

Froelich, J.W.; Swanson, D.

1984-04-01

Radionuclide techniques for localizing inflammatory processes had relied heavily upon /sup 67/Ga-citrate until McAfee and Thakur described the technique for the radiolabeling of leukocytes with /sup 111/In-oxine. Since their initial description in 1976 there has been continued development of the radiopharmaceutical, as well as clinical efficacy. At present /sup 111/In-labeled leukocytes continue to be handled as an investigational new drug but this has not greatly limited its clinical availability. Indium-/sup 111/ leukocytes are the agent of choice for evaluation of patients with fever of unknown origin, osteomyelitis, and prosthetic graft infections; and preliminary data shows great promise in the areamore » of detecting reoccurrence of inflammatory bowel disease. This article attempts to review currently accepted uses of 111In leukocytes as well as potential areas of application.« less

Evolving Clinical Cancer Radiotherapy: Concerns Regarding Normal Tissue Protection and Quality Assurance

PubMed Central

Choi, Won Hoon

2016-01-01

Radiotherapy, which is one of three major cancer treatment methods in modern medicine, has continued to develop for a long period, more than a century. The development of radiotherapy means allowing the administration of higher doses to tumors to improve tumor control rates while minimizing the radiation doses absorbed by surrounding normal tissues through which radiation passes for administration to tumors, thereby reducing or removing the incidence of side effects. Such development of radiotherapy was accomplished by the development of clinical radiation oncology, the development of computers and machine engineering, the introduction of cutting-edge imaging technology, a deepened understanding of biological studies on the effects of radiation on human bodies, and the development of quality assurance (QA) programs in medical physics. The development of radiotherapy over the last two decades has been quite dazzling. Due to continuous improvements in cancer treatment, the average five-year survival rate of cancer patients has been close to 70%. The increases in cancer patients’ complete cure rates and survival periods are making patients’ quality of life during or after treatment a vitally important issue. Radiotherapy is implemented in approximately 1/3 to 2/3s of all cancer patients; and has improved the quality of life of cancer patients in the present age. Over the last century, as a noninvasive treatment, radiotherapy has unceasingly enhanced complete tumor cure rates and the side effects of radiotherapy have been gradually decreasing, resulting in a tremendous improvement in the quality of life of cancer patients. PMID:26908993

Clinical translation of handheld optical coherence tomography: practical considerations and recent advancements

NASA Astrophysics Data System (ADS)

Monroy, Guillermo L.; Won, Jungeun; Spillman, Darold R.; Dsouza, Roshan; Boppart, Stephen A.

2017-12-01

Since the inception of optical coherence tomography (OCT), advancements in imaging system design and handheld probes have allowed for numerous advancements in disease diagnostics and characterization of the structural and optical properties of tissue. OCT system developers continue to reduce form factor and cost, while improving imaging performance (speed, resolution, etc.) and flexibility for applicability in a broad range of fields, and nearly every clinical specialty. An extensive array of components to construct customized systems has also become available, with a range of commercial entities that produce high-quality products, from single components to full systems, for clinical and research use. Many advancements in the development of these miniaturized and portable systems can be linked back to a specific challenge in academic research, or a clinical need in medicine or surgery. Handheld OCT systems are discussed and explored for various applications. Handheld systems are discussed in terms of their relative level of portability and form factor, with mention of the supporting technologies and surrounding ecosystem that bolstered their development. Additional insight from our efforts to implement systems in several clinical environments is provided. The trend toward well-designed, efficient, and compact handheld systems paves the way for more widespread adoption of OCT into point-of-care or point-of-procedure applications in both clinical and commercial settings.

A user-centred approach to requirements elicitation in medical device development: a case study from an industry perspective.

PubMed

Martin, Jennifer L; Clark, Daniel J; Morgan, Stephen P; Crowe, John A; Murphy, Elizabeth

2012-01-01

The healthcare industry is dependent upon the provision of well designed medical devices. To achieve this it is recommended that user-centred design should begin early, and continue throughout device development. This is a challenge, particularly for smaller companies who may lack the necessary expertise and knowledge. The aim of this study was to conduct a rigorous yet focused investigation into the user requirements for a new medical imaging device. Open-ended semi-structured interviews were conducted with potential clinical users of the device to investigate the clinical need for the device and the potential benefits for patients and clinical users. The study identified a number of new and significant clinical needs that suggested that the concept of the device should be fundamentally changed. The clinical and organisational priorities of the clinical users were identified, as well as a number of factors that would act as barriers to the safe and effective adoption of the device. The developers reported that this focused approach to early requirements elicitation would result in an improved product, reduce the time to market, and save the time and cost of producing and evaluating an inappropriate prototype. Copyright © 2011 Elsevier Ltd and The Ergonomics Society. All rights reserved.

Clinical chemistry as scientific discipline: historical perspectives.

PubMed

Büttner, J

1994-12-31

The fundamental ideas which underlie clinical chemistry as an independent scientific field were formed over the course of centuries. Exactly 200 years ago the first modern concepts for this discipline were formulated in close connection with the restructuring of medical education during the French Revolution on the one hand, and the emergence of a new idea of a 'clinic' on the other hand. However, not until 1840 was clinical chemistry institutionalized as academic subject and simultaneously integrated into medical teaching. After about 1860, clinical chemistry was practiced by the clinicians themselves in close relationship with clinical activities, yet again with emphasis on teaching. In this period, clinics and hospitals established 'clinical laboratories'. With the start of the 20th century, after biochemistry had developed into an independent scientific field, clinical chemistry continued to evolve in close relationship with that latter discipline. This was particularly true in the United States, where an 'American School of Clinical Biochemistry' emerged which was to greatly influence the field.

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.

Integrating Continuing Professional Development With Health System Reform: Building Pillars of Support.

PubMed

Davis, David A; Rayburn, William F

2016-01-01

Clinical failures sparked a widespread desire for health system reform at the beginning of the 21st century, but related efforts have resulted in changes that are either slow or nonexistent. In response, academic medicine has moved in two directions: (1) system-wide reform using electronic health records, practice networks, and widespread data applications (a macro pathway); and (2) professional development of individual clinicians through continuous performance improvement (a micro pathway). Both pathways exist to improve patient care and population health, yet each suffers from limitations in widespread implementation. The authors call for a better union between these two parallel pathways through four pillars of support: (1) an acknowledgment that both pathways are essential to each other and to the final outcome they intend to achieve, (2) a strong faculty commitment to educate about quality improvement and patient safety at all education levels, (3) a reengineering of tools for professional development to serve as effective change agents, and (4) the development of standards to sustain this alignment of pathways. With these pillars of support integrating continuing professional development with health system reform, the authors envision a better functioning system, with improved metrics and value to enhance patient care and population health.

Enhancing Research Capacity for Global Health: Evaluation of a Distance-Based Program for International Study Coordinators

PubMed Central

Wilson, Lynda Law; Rice, Marti; Jones, Carolynn T.; Joiner, Cynthia; LaBorde, Jennifer; McCall, Kimberly; Jester, Penelope M; Carter, Sheree C.; Boone, Chrissy; Onwuzuligbo, Uzoma; Koneru, Alaya

2013-01-01

Introduction Due to the increasing number of clinical trials conducted globally, there is a need for quality continuing education for health professionals in clinical research manager (CRM) roles. This paper describes the development, implementation, and evaluation of a distance-based continuing education program for CRMs working outside the United States. Methods A total of 692 applications were received from CRMs in 50 countries. Of these, 166 were admitted to the program in two cohorts. The program, taught online and in English, included four required and one optional course. Course materials were also provided as hard copies and on CDs. A pretest/posttest design was used to evaluate the outcome of the program in terms of changes in knowledge, participants’ capacity-building activities at their research sites; and participant and supervisor perceptions of program impact. Results Participants demonstrated significant improvements in knowledge about clinical research, rated course content and teaching strategies positively, and identified the opportunity for interactions with international peers as a major program strength. Challenges for participants were limited time to complete assignments and erratic internet access. Participants offered capacity building programs to 5061 individuals at their research sites. Supervisors indicated that they would recommend the program and perceived the program improved CRM effectiveness and site research capacity. Findings Results suggest that this type of continuing education program addresses a growing need for education of CRMs working in countries that have previously had limited involvement with global clinical trials. PMID:23512562

Defining the Path Forward: Guidance for Laboratory Medicine Guidelines

PubMed Central

Jones, Patricia M.; Chin, Alex C.; Christenson, Robert H.

2015-01-01

The National Academy of Clinical Biochemistry (NACB) has developed consensus-based guidelines for the laboratory evaluation and monitoring of patients with specified disorders for two decades. In 1997, the NACB recognized the need to standardize the process of guideline development and promulgated its first Standard Operating Procedure (SOP) for this purpose. In 2010, the American Association of Clinical Chemistry (AACC) and NACB created the Evidence-Based Laboratory Medicine Committee (EBLMC). Among other roles, this group was given responsibility to provide oversight of clinical practice guideline development in accordance with SOP guidance and using currently accepted good practices. In 2011, the U.S. Institute of Medicine (IOM) published two reports of relevance: ‘Clinical Practice Guidelines We Can Trust’ and ‘Finding What Works in Health Care – Standards for Systematic Reviews.’ These reports were created as part of a response to a legislative mandate from the U.S. Congress requesting that steps be taken to implement recommendations from lOM’s report on ‘Knowing What Works in Health Care’ (2008). The latest revision of the laboratory medicine practice guidelines (LMPG) SOP was in part driven by these reports. NACB continues to develop LMPGs at a rate of roughly one per year through standard processes detailed in its 2014 revision of the SOP. This article describes the NACB and EBLMC experience in developing LMPGs with a focus on the evolution and use of the latest SOP. AACC and NACB have established a solid track record in collaboratively working with many clinical societies and professional organizations on clinical practice guideline development. Presently, three LMPG’s are in various stages of development and all with the collaboration of other clinical/professional groups. The practices and tools being used for current LMPGs in progress are also highlighted in the context of the challenges that presently exist for effective clinical practice guideline development in the U.S. PMID:27683491

Clinical Research Informatics for Big Data and Precision Medicine.

PubMed

Weng, C; Kahn, M G

2016-11-10

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

Clinical Research Informatics for Big Data and Precision Medicine

PubMed Central

Kahn, M. G.

2016-01-01

Summary Objectives To reflect on the notable events and significant developments in Clinical Research Informatics (CRI) in the year of 2015 and discuss near-term trends impacting CRI. Methods We selected key publications that highlight not only important recent advances in CRI but also notable events likely to have significant impact on CRI activities over the next few years or longer, and consulted the discussions in relevant scientific communities and an online living textbook for modern clinical trials. We also related the new concepts with old problems to improve the continuity of CRI research. Results The highlights in CRI in 2015 include the growing adoption of electronic health records (EHR), the rapid development of regional, national, and global clinical data research networks for using EHR data to integrate scalable clinical research with clinical care and generate robust medical evidence. Data quality, integration, and fusion, data access by researchers, study transparency, results reproducibility, and infrastructure sustainability are persistent challenges. Conclusion The advances in Big Data Analytics and Internet technologies together with the engagement of citizens in sciences are shaping the global clinical research enterprise, which is getting more open and increasingly stakeholder-centered, where stakeholders include patients, clinicians, researchers, and sponsors. PMID:27830253

Clinical leadership and pre-registration nursing programmes: A model for clinical leadership and a prospective curriculum implementation and evaluation research strategy.

PubMed

Brown, Angela; Dewing, Jan; Crookes, Patrick

2016-07-01

To present for wider debate a conceptual model for clinical leadership development in pre-registration nursing programmes and a proposed implementation plan. Globally, leadership in nursing has become a significant issue. Whilst there is continued support for leadership preparation in pre-registration nursing programmes, there have been very few published accounts of curriculum content and/or pedagogical approaches that foster clinical leadership development in pre-registration nursing. A doctoral research study has resulted in the creation of an overarching model for clinical leadership. A multi-method research study using theoretical and empirical literature 1974-2015, a focus group, expert opinion and a national on-line survey. A conceptual model of clinical leadership development in pre-registration nursing programme is presented, including the infinity loop of clinical leadership, an integral curriculum thread and a conceptual model: a curriculum-pedagogy nexus for clinical leadership. In order to test out usability and evaluate effectiveness, a multi method programme of research in one school of nursing in Australia is outlined. Implementation of the proposed conceptual model for clinical leadership development in pre-registration nursing programmes and a programme of (post-doctoral) research will contribute to what is known about curriculum content and pedagogy for nurse academics. Importantly, for nursing students and the profession as a whole, there is a clearer expectation of what clinical leadership might look like in the novice registered nurse. For nurse academics a model is offered for consideration in curriculum design and implementation with an evaluation strategy that could be replicated. Copyright © 2016 Elsevier Ltd. All rights reserved.

Medical Teachers Conceptualize a Distinctive Form of Clinical Knowledge

ERIC Educational Resources Information Center

Barrett, J.; Yates, L.; McColl, G.

2015-01-01

For over four decades, there have been efforts to specify the types of knowledge that medical students need, how that knowledge is acquired and how its constituent parts are related. It is one of the areas of continuing concern underlying medical education reform. Despite their importance to medical students' learning and development, the…

The Social Interactive Coding System (SICS): An On-Line, Clinically Relevant Descriptive Tool.

ERIC Educational Resources Information Center

Rice, Mabel L.; And Others

1990-01-01

The Social Interactive Coding System (SICS) assesses the continuous verbal interactions of preschool children as a function of play areas, addressees, script codes, and play levels. This paper describes the 26 subjects and the setting involved in SICS development, coding definitions and procedures, training procedures, reliability, sample…

Overview of practice management in child and adolescent psychiatry.

PubMed

Schreter, Robert K

2010-01-01

The manager of a psychiatric practice must create and direct a clinical delivery system, design and oversee the administrative services necessary to support the system, and guide the business operations that contribute to its success. Regardless of the size of the practice, the psychiatrist administrator must handle seven core administrative responsibilities and oversee individual functions and capabilities within each domain. These responsibilities include practice development, clinical services management, medical office operations, clinical management, information management, business management, and risk management. This article provides a roadmap for creating and sustaining successful clinical and administrative endeavors. It can also be used by existing practices as an audit instrument to provide a snapshot of current capabilities so that strengths as well as opportunities for continued growth can be identified.

Recent Progress in the Development of Diagnostic Tests for Malaria.

PubMed

Krampa, Francis D; Aniweh, Yaw; Awandare, Gordon A; Kanyong, Prosper

2017-09-19

The impact of malaria on global health has continually prompted the need to develop effective diagnostic strategies. In malaria endemic regions, routine diagnosis is hampered by technical and infrastructural challenges to laboratories. These laboratories lack standard facilities, expertise or diagnostic supplies; thus, therapy is administered based on clinical or self-diagnosis. There is the need for accurate diagnosis of malaria due to the continuous increase in the cost of medication, and the emergence and spread of drug resistant strains. However, the widely utilized Giemsa-stained microscopy and immunochromatographic tests for malaria are liable to several drawbacks, including inadequate sensitivity and false-positive outcomes. Alternative methods that offer improvements in performance are either expensive, have longer turnaround time or require a level of expertise that makes them unsuitable for point-of-care (POC) applications. These gaps necessitate exploration of more efficient detection techniques with the potential of POC applications, especially in resource-limited settings. This minireview discusses some of the recent trends and new approaches that are seeking to improve the clinical diagnosis of malaria.

The Importance of Global Health Experiences in the Development of New Cardiologists

PubMed Central

Abdalla, Marwah; Kovach, Neal; Liu, Connie; Damp, Julie B.; Jahangir, Eiman; Hilliard, Anthony; Gopinathannair, Rakesh; Abu-Fadel, Mazen S.; El Chami, Mikhael F.; Gafoor, Sameer; Vedanthan, Rajesh; Sanchez-Shields, Monica; George, Jon C.; Priester, Tiffany; Alasnag, Mirvat; Barker, Colin; Freeman, Andrew M.

2016-01-01

As the global burden of cardiovascular disease continues to increase worldwide, nurturing the development of early-career cardiologists interested in global health is essential in order to create a cadre of providers with the skill set to prevent and treat cardiovascular diseases in international settings. As such, interest in global health has increased among cardiology trainees and early-career cardiologists over the past decade. International clinical and research experiences abroad present an additional opportunity for growth and development beyond traditional cardiovascular training. We describe the American College of Cardiology International Cardiovascular Exchange Database, a new resource for cardiologists interested in pursuing short-term clinical exchange opportunities abroad, and report some of the benefits and challenges of global health cardiovascular training in both resource-limited and resource-abundant settings. PMID:26763797

A continuous quality improvement approach to improving clinical practice in the areas of sedation, analgesia, and neuromuscular blockade.

PubMed

Arbour, Richard

2003-01-01

Practice concerns associated with the medical prescription and nurses' administration and monitoring of sedatives, analgesics, and neuromuscular blocking agents were identified by the clinical nurse specialist within a surgical intensive care unit of a large, tertiary-care referral center. These concerns were identified using a variety of needs assessment strategies. Results of the needs assessment were used to develop a program of care, including a teaching initiative, specific to these practice areas. The teaching initiative incorporated principles of andragogy, the theory of adult learning. Educational techniques included inservice education, bedside instruction using "teaching moments," competency-based education modules, and integration of instruction into critical care orientation. Content and approach were based on the background and level of experience of participants. Educational program outcomes included increased consistency in monitoring neuromuscular blockade by clinical assessment and peripheral nerve stimulation. A second outcome was more accurate patient assessment leading to the provision of drug therapy specific to the patients' clinical states, including anxiety or pain. The continuous quality improvement approach offers a model for improving patient care using individualized needs assessment, focused educational interventions, and program evaluation strategies.

Continuing Education for Professionals: A Practice-Oriented Approach.

ERIC Educational Resources Information Center

Toombs, William; Lindsay, Carl A.

The Continuing Professional Education Project at The Pennsylvania State University is described. Five professions were involved: architecture, accounting, clinical psychology, clinical dietetics, and nursing. The objectives were: (1) to bring the university and the professions into collaboration, (2) to focus continuing education activities as…

The clinical academic workforce in Australia and New Zealand: report on the second binational summit to implement a sustainable training pathway.

PubMed

Windsor, John; Garrod, Tamsin; Talley, Nicholas J; Tebbutt, Carmel; Churchill, James; Farmer, Elizabeth; Baur, Louise; Smith, Julian A

2017-04-01

There has been a decline in the proportion of clinical academics compared with full-time clinicians, since 2004. A Working Party was established to help develop and implement a model for the training of clinical academics. After a highly successful first summit in 2014 that summarised the challenges faced by clinical academics in Australia and New Zealand, a second summit was convened late in 2015 to report on progress and to identify key areas for further action. The second summit provided survey results that identified the varied training pathways currently offered to clinical academics and the institutions willing to be involved in developing improved pathways. A literature review also described the contributions that clinical academics make to the health sector and the challenges faced by this workforce sector. Current training pathways created for clinical academics by Australasian institutions were presented as examples of what can be done. The perspectives of government and research organisations presented at the summit helped define how key stakeholders can contribute. Following the summit, there was a strong commitment to continue to work towards developing a sustainable and defined training pathway for clinical academics. The need for a coordinated and integrated approach was highlighted. Some key objectives were agreed upon for the next phase, including identifying and engaging key advocates within government and leading institutions; publishing and profiling the contributions of successful clinical academics to healthcare outcomes; defining the stages of a clinical academic training pathway; and establishing a mentoring programme for training clinical academics. © 2017 Royal Australasian College of Physicians.

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.

Strengthening the career development of clinical translational scientist trainees: a consensus statement of the Clinical Translational Science Award (CTSA) Research Education and Career Development Committees.

PubMed

Meyers, Frederick J; Begg, Melissa D; Fleming, Michael; Merchant, Carol

2012-04-01

The challenges for scholars committed to successful careers in clinical and translational science are increasingly well recognized. The Education and Career Development (EdCD) of the national Clinical and Translational Science Award consortium gathered thought leaders to propose sustainable solutions and an agenda for future studies that would strengthen the infrastructure across the spectrum of pre- and postdoctoral, MD and PhD, scholars. Six consensus statements were prepared that include: (1) the requirement for career development of a qualitatively different investigator; (2) the implications of interdisciplinary science for career advancement including institutional promotion and tenure actions that were developed for discipline-specific accomplishments; (3) the need for long-term commitment of institutions to scholars; (4) discipline-specific curricula are still required but curricula designed to promote team work and interdisciplinary training will promote innovation; (5) PhD trainees have many pathways to career satisfaction and success; and (6) a centralized infrastructure to enhance and reward mentoring is required. Several themes cut across all of the recommendations including team science, innovation, and sustained institutional commitment. Implied themes include an effective and diverse job force and the requirement for a well-crafted public policy that supports continued investments in science education. © 2012 Wiley Periodicals, Inc.

Developing a "clinical presentation" curriculum at the University of Calgary.

PubMed

Mandin, H; Harasym, P; Eagle, C; Watanabe, M

1995-03-01

Currently, medical curricula are structured according to disciplines, body systems, or clinical problems. Beginning in 1988, the faculty of the University of Calgary Faculty of Medicine (U of C) carefully evaluated the advantages and disadvantages of each of these models in seeking to revise their school's curriculum. However, all three models fell short of a curricular structure based on current knowledge and principles of adult learning, clinical problem solving, community demands, and curriculum management. By 1991, the U of C had formulated a strategic plan for a revised curriculum structure based on the way patients present to physicians, and implementation of this plan has begun. In creating the new curriculum, 120 clinical presentations (e.g., "loss of consciousness/syncope") were defined and each was assigned to an individual or small group of faculty for development based on faculty expertise and interest. Terminal objectives (i.e., "what to do") were defined for each presentation to describe the appropriate clinical behaviors of a graduating physician. Experts developed schemes that outlined how they differentiated one cause (i.e., disease category) from another. The underlying enabling objectives (i.e., knowledge, skills, and attitudes) for reaching the terminal objectives for each clinical presentation were assigned as departmental responsibilities. A new administrative structure evolved in which there is a partnership between a centralized multidisciplinary curriculum committee and the departments. This new competency-based, clinical presentation curriculum is expected to significantly enhance students' development of clinical problem-solving skills and affirms the premise that prudent, continuous updating is essential for improving the quality of medical education.

Aspiring to Unintended Consequences of Natural Language Processing: A Review of Recent Developments in Clinical and Consumer-Generated Text Processing.

PubMed

Demner-Fushman, D; Elhadad, N

2016-11-10

This paper reviews work over the past two years in Natural Language Processing (NLP) applied to clinical and consumer-generated texts. We included any application or methodological publication that leverages text to facilitate healthcare and address the health-related needs of consumers and populations. Many important developments in clinical text processing, both foundational and task-oriented, were addressed in community- wide evaluations and discussed in corresponding special issues that are referenced in this review. These focused issues and in-depth reviews of several other active research areas, such as pharmacovigilance and summarization, allowed us to discuss in greater depth disease modeling and predictive analytics using clinical texts, and text analysis in social media for healthcare quality assessment, trends towards online interventions based on rapid analysis of health-related posts, and consumer health question answering, among other issues. Our analysis shows that although clinical NLP continues to advance towards practical applications and more NLP methods are used in large-scale live health information applications, more needs to be done to make NLP use in clinical applications a routine widespread reality. Progress in clinical NLP is mirrored by developments in social media text analysis: the research is moving from capturing trends to addressing individual health-related posts, thus showing potential to become a tool for precision medicine and a valuable addition to the standard healthcare quality evaluation tools.

Improving health services to displaced persons in Aceh, Indonesia: a balanced scorecard.

PubMed

Chan, Grace J; Parco, Kristin B; Sihombing, Melva E; Tredwell, Susan P; O'Rourke, Edward J

2010-09-01

After the Indian Ocean tsunami in December 2004, the International Organization for Migration constructed temporary health clinics to provide medical services to survivors living in temporary accommodation centres throughout Aceh, Indonesia. Limited resources, inadequate supervision, staff turnover and lack of a health information system made it challenging to provide quality primary health services. A balanced scorecard was developed and implemented in collaboration with local health clinic staff and district health officials. Performance targets were identified. Staff collected data from clinics and accommodation centres to develop 30 simple performance measures. These measures were monitored periodically and discussed at meetings with stakeholders to guide the development of health interventions. Two years after the tsunami, 34 000 displaced persons continued to receive services from temporary health clinics in two districts of Aceh province. From March to December 2007, the scorecard was implemented in seven temporary health clinics. Interventions stimulated and tracked by the scorecard showed measurable improvements in preventive medicine, child health, capacity building of clinic staff and availability of essential drugs. By enhancing communication, the scorecard also led to qualitative benefits. The balanced scorecard is a practical tool to focus attention and resources to facilitate improvement in disaster rehabilitation settings where health information infrastructure is poor. Introducing a mechanism for rapid improvement fostered communication between nongovernmental organizations, district health officials, clinic health workers and displaced persons.

Competency-based medical education and continuing professional development: A conceptualization for change.

PubMed

Lockyer, Jocelyn; Bursey, Ford; Richardson, Denyse; Frank, Jason R; Snell, Linda; Campbell, Craig

2017-06-01

Competency-based medical education (CBME) is as important in continuing professional development (CPD) as at any other stage of a physician's career. Principles of CBME have the potential to revolutionize CPD. Transitioning to CBME-based CPD will require a cultural change to gain commitment from physicians, their employers and institutions, CPD providers, professional organizations, and medical regulators. It will require learning to be aligned with professional and workplace standards. Practitioners will need to develop the expertise to systematically examine their own clinical performance data, identify performance improvement opportunities and possibilities, and develop a plan to address areas of concern. Health care facilities and systems will need to produce data on a regular basis and to develop and train CPD educators who can work with physician groups. Stakeholders, such as medical regulatory authorities who are responsible for licensing physicians and other standard-setting bodies that credential and develop maintenance-of-certification systems, will need to change their paradigm of competency enhancement through CPD.

A multi-institutional quality improvement initiative to transform education for chronic illness care in resident continuity practices.

PubMed

Stevens, David P; Bowen, Judith L; Johnson, Julie K; Woods, Donna M; Provost, Lloyd P; Holman, Halsted R; Sixta, Constance S; Wagner, Ed H

2010-09-01

There is a gap between the need for patient-centered, evidence-based primary care for the large burden of chronic illness in the US, and the training of resident physicians to provide that care. To improve training for residents who provide chronic illness care in teaching practice settings. US teaching hospitals were invited to participate in one of two 18-month Breakthrough Series Collaboratives-either a national Collaborative, or a subsequent California Collaborative-to implement the Chronic Care Model (CCM) and related curriculum changes in resident practices. Most practices focused on patients with diabetes mellitus. Educational redesign strategies with related performance measures were developed for curricular innovations anchored in the CCM. In addition, three clinical measures-HbA1c <7%, LDL <100 mg/dL, and blood pressure

A Multi-Institutional Quality Improvement Initiative to Transform Education for Chronic Illness Care in Resident Continuity Practices

PubMed Central

Bowen, Judith L.; Johnson, Julie K.; Woods, Donna M.; Provost, Lloyd P.; Holman, Halsted R.; Sixta, Constance S.; Wagner, Ed H.

2010-01-01

BACKGROUND There is a gap between the need for patient-centered, evidence-based primary care for the large burden of chronic illness in the US, and the training of resident physicians to provide that care. OBJECTIVE To improve training for residents who provide chronic illness care in teaching practice settings. DESIGN US teaching hospitals were invited to participate in one of two 18-month Breakthrough Series Collaboratives—either a national Collaborative, or a subsequent California Collaborative—to implement the Chronic Care Model (CCM) and related curriculum changes in resident practices. Most practices focused on patients with diabetes mellitus. Educational redesign strategies with related performance measures were developed for curricular innovations anchored in the CCM. In addition, three clinical measures—HbA1c <7%, LDL <100 mg/dL, and blood pressure ≤130/80—and three process measures—retinal and foot examinations, and patient self-management goals—were tracked. PARTICIPANTS Fifty-seven teams from 37 self-selected teaching hospitals committed to implement the CCM in resident continuity practices; 41 teams focusing on diabetes improvement participated over the entire duration of one of the Collaboratives. INTERVENTIONS Teaching-practice teams—faculty, residents and staff—participated in Collaboratives by attending monthly calls and regular 2-day face-to-face meetings with the other teams. The national Collaborative faculty led calls and meetings. Each team used rapid cycle quality improvement (PDSA cycles) to implement the CCM and curricular changes. Teams reported education and clinical performance measures monthly. RESULTS Practices underwent extensive redesign to establish CCM elements. Education measures tracked substantial development of CCM-related learning. The clinical and process measures improved, however inconsistently, during the Collaboratives. CONCLUSIONS These initiatives suggest that systematic practice redesign for implementing the CCM along with linked educational approaches are achievable in resident continuity practices. Improvement of clinical outcomes in such practices is daunting but achievable. PMID:20737232

Educating generalists: factors of resident continuity clinic associated with perceived impact on choosing a generalist career.

PubMed

Laponis, Ryan; O'Sullivan, Patricia S; Hollander, Harry; Cornett, Patricia; Julian, Katherine

2011-12-01

Fewer residents are choosing general internal medicine (GIM) careers, and their choice 5 be influenced by the continuity clinic experience during residency. We sought to explore the relationship between resident satisfaction with the continuity clinic experience and expressed interest in pursuing a GIM career. We surveyed internal medicine residents by using the Veterans Health Administration Office of Academic Affiliations Learners' Perceptions Survey-a 76-item instrument with established reliability and validity that measures satisfaction with faculty interactions, and learning, working, clinical, and physical environments, and personal experience. We identified 15 reliable subscales within the survey and asked participants whether their experience would prompt them to consider future employment opportunities in GIM. We examined the association between satisfaction measures and future GIM interest with 1-way analyses of variance followed by Student-Newman-Keuls post hoc tests. Of 217 residents, 90 (41%) completed the survey. Residents felt continuity clinic influenced career choice, with 22% more likely to choose a GIM career and 43% less likely. Those more likely to choose a GIM career had higher satisfaction with the learning (P  =  .001) and clinical (P  =  .002) environments and personal experience (P < .001). They also had higher satisfaction with learning processes (P  =  .002), patient diversity (P < .001), coordination of care (P  =  .009), workflow (P  =  .001), professional/personal satisfaction (P < .001), and work/life balance (P < .001). The continuity clinic experience 5 influence residents' GIM career choice. Residents who indicate they are more likely to pursue GIM based on that clinical experience have higher levels of satisfaction. Further prospective data are needed to assess if changes in continuity clinic toward these particular factors can enhance career choice.

Building capacity in the rural physiotherapy workforce: a paediatric training partnership.

PubMed

Williams, E N; McMeeken, J M

2014-01-01

Building capacity in the rural physiotherapy workforce: a paediatric training partnership' provided 6 months postgraduate paediatric clinical and academic training for two physiotherapists in rural Australia. It is described as a model for improving services and workforce retention. The need for 'an appropriate, skilled and well-supported health workforce' is the third goal in Australia's National Strategic Framework for Rural and Remote Health 2011. The World Health Organization recently published its first global policy for improving the retention of rural and remote health workers. Education is its first recommendation and aims to 'design continuing education and professional development programmes that meet the needs of rural health workers and that are accessible from where they live and work, so as to support their retention …'. Additionally, '… to be successful, continuing education needs to be linked to career paths, as well as with other education interventions'. The problem is a lack of paediatric physiotherapy expertise in rural areas due to an absence of postgraduate clinical training opportunities in the rural workforce. The result is fragmented local services for families who are forced to travel to metropolitan services, costly in terms of both time and money. The aims were to improve local paediatric physiotherapy clinical services, provide physiotherapists additional access to professional development and subsequently provide a career path to retain these health professionals. Evaluation of the project used purpose-built questionnaires as there are no specific indicators to monitor the performance of systems and services that are available to children and families in Australia. The paediatric physiotherapy training program was enabled through initial funding for a 12-month pilot project. Further government funding built on that success for this reported 6-month project. Funding to employ the postgraduate physiotherapists was essential to the success of the clinical training program, and lack of future funding is a barrier to its sustainability. The program included the consolidation of the initial management and education committees and the expert reference group. Weekly tutorials, case studies and presentations formed an important part of clinical rotation between hospital outpatients, specialist school and the disability sector. This increased the provision of skilled paediatric physiotherapy services close to home in a timely fashion not previously available. Concurrently, the training increased the clinicians' paediatric knowledge and confidence, promoting workforce retention by providing a career pathway. The senior clinicians who provided clinical supervision reported that it enabled succession planning through introduction of appropriately skilled younger peers to their clinical practice. Project recommendations are that funding and stakeholder partnerships are necessary to enable health professionals to undertake postgraduate clinical training in paediatrics in rural areas. The partnership should include education providers (university), rural health service providers (hospital) and community or disability services (government and non-government) with financial recognition of expertise in the rural workforce for clinical supervision. The training experience was reported as a very positive experience from trainees, families, clinical supervisors, managers, academics and paediatricians. Lack of continued funding to educate skilled postgraduate paediatric physiotherapy clinicians means that rural children with physical disabilities will continue to be disadvantaged.

Continuity of care: an Italian clinical experience.

PubMed

Tarquini, Roberto; Coletta, Davide; Mazzoccoli, Gianluigi; Gensini, Gian Franco

2013-10-01

Recently, there is a growing interest in the concept of "continuity of care," since patients, being older and more complex, are increasingly seen by an array of providers in a wide variety of organizations and places. Different models of continuity of care have been proposed, yet no single model of care coordination has been proven to be universally applicable across patient (and disease) populations. In the present paper, we introduce a novel model of continuity of care, the Ospedale Santa Verdiana, in Castelfiorentino (Tuscany, Italy), and its first period (1 year) of implementation, since January 2010. There are two main cornerstones: (a) the clinical and urgent need to bridge the gap between primary care and hospital care; and (b) the development and implementation of a model of continuity and coordination of care, which target the so-called complex patient. It is not specific for a single disease but it works "across diseases." There are three driving forces: (a) "primary care" since one of the two Hospital Coordinators is a primary care physician; (b) "hospital care" since patients in the decompensated phase often require hospitalization; and (c) the "University of Florence", which is the "glue". The duties of the Hospital Coordinator, who is an assistant professor at University of Florence, are to guarantee an efficacious and dynamic communication between primary care physicians and hospitalists, and by creating a school for practitioners of the continuity and coordination of care, to make this model exportable.

Decision support systems for clinical radiological practice — towards the next generation

PubMed Central

Stivaros, S M; Gledson, A; Nenadic, G; Zeng, X-J; Keane, J; Jackson, A

2010-01-01

The huge amount of information that needs to be assimilated in order to keep pace with the continued advances in modern medical practice can form an insurmountable obstacle to the individual clinician. Within radiology, the recent development of quantitative imaging techniques, such as perfusion imaging, and the development of imaging-based biomarkers in modern therapeutic assessment has highlighted the need for computer systems to provide the radiological community with support for academic as well as clinical/translational applications. This article provides an overview of the underlying design and functionality of radiological decision support systems with examples tracing the development and evolution of such systems over the past 40 years. More importantly, we discuss the specific design, performance and usage characteristics that previous systems have highlighted as being necessary for clinical uptake and routine use. Additionally, we have identified particular failings in our current methodologies for data dissemination within the medical domain that must be overcome if the next generation of decision support systems is to be implemented successfully. PMID:20965900

A Systematic Review of CPAP Adherence Across Age Groups: Clinical and Empiric Insights for Developing CPAP Adherence Interventions

PubMed Central

Sawyer, A.M.; Gooneratne, N.; Marcus, C.L.; Ofer, D.; Richards, K.C.; Weaver, T.E.

2011-01-01

Continuous positive airway pressure (CPAP) is a highly efficacious treatment for obstructive sleep apnea (OSA) but adherence to the treatment limits its overall effectiveness across all age groups of patients. Factors that influence adherence to CPAP include disease and patient characteristics, treatment titration procedures, technological device factors and side effects, and psychological and social factors. These influential factors have guided the development of interventions to promote CPAP adherence. Various intervention strategies have been described and include educational, technological, psychosocial, pharmacological, and multi-dimensional approaches. Though evidence to date has led to innovative strategies that address adherence in CPAP-treated children, adults, and older adults, significant opportunities exist to develop and test interventions that are clinically applicable, specific to subgroups of patients likely to demonstrate poor adherence, and address the multifactorial nature of CPAP adherence. The translation of CPAP adherence promotion interventions to clinical practice is imperative to improve health and functional outcomes in all persons with CPAP-treated OSA. PMID:21652236

Single-Walled Carbon Nanotube-Based Near-Infrared Optical Glucose Sensors toward In Vivo Continuous Glucose Monitoring

PubMed Central

Yum, Kyungsuk; McNicholas, Thomas P.; Mu, Bin; Strano, Michael S.

2013-01-01

This article reviews research efforts on developing single-walled carbon nanotube (SWNT)-based near-infrared (NIR) optical glucose sensors toward long-term in vivo continuous glucose monitoring (CGM). We first discuss the unique optical properties of SWNTs and compare SWNTs with traditional organic and nanoparticle fluorophores regarding in vivo glucose-sensing applications. We then present our development of SWNT-based glucose sensors that use glucose-binding proteins and boronic acids as a high-affinity molecular receptor for glucose and transduce binding events on the receptors to modulate SWNT fluorescence. Finally, we discuss opportunities and challenges in translating the emerging technology of SWNT-based NIR optical glucose sensors into in vivo CGM for practical clinical use. PMID:23439162

Safety assessment of immunomodulatory biologics: the promise and challenges of regulatory T-cell modulation.

PubMed

Ponce, Rafael A

2011-01-01

Regulatory T-cell (T(reg)) modulation is developing as an important therapeutic opportunity for the treatment of a number of important diseases, including cancer, autoimmunity, infection, and organ transplant rejection. However, as demonstrated with IL-2 and TGN-1412, our understanding of the complex immunological interactions that occur with T(reg) modulation in both non-clinical models and in patients remains limited and appears highly contextual. This lack of understanding will challenge our ability to identify the patient population who might derive the highest benefit from T(reg) modulation and creates special challenges as we transition these therapeutics from non-clinical models into humans. Thus, in vivo testing in the most representative animal model systems, with careful progress in the clinic, will remain critical in developing therapeutics targeting T(reg) and understanding their clinical utility. Moreover, toxicology models can inform some of the potential liabilities associated with T(reg) modulation, but not all, suggesting a continued need to explore and validate predictive models.

Complement inhibition in pre-clinical models of periodontitis and prospects for clinical application.

PubMed

Hajishengallis, George; Hajishengallis, Evlambia; Kajikawa, Tetsuhiro; Wang, Baomei; Yancopoulou, Despina; Ricklin, Daniel; Lambris, John D

2016-06-01

Periodontitis is a dysbiotic inflammatory disease leading to the destruction of the tooth-supporting tissues. Current therapies are not always effective and this prevalent oral disease continues to be a significant health and economic burden. Early clinical studies have associated periodontitis with elevated complement activity. Consistently, subsequent genetic and pharmacological studies in rodents have implicated the central complement component C3 and downstream signaling pathways in periodontal host-microbe interactions that promote dysbiosis and inflammatory bone loss. This review discusses these mechanistic advances and moreover focuses on the compstatin family of C3 inhibitors as a novel approach to treat periodontitis. In this regard, local application of the current lead analog Cp40 was recently shown to block both inducible and naturally occurring periodontitis in non-human primates. These promising results from non-human primate studies and the parallel development of Cp40 for clinical use highlight the feasibility for developing an adjunctive, C3-targeted therapy for human periodontitis. Copyright © 2016 Elsevier Ltd. All rights reserved.

SFINX-a drug-drug interaction database designed for clinical decision support systems.

PubMed

Böttiger, Ylva; Laine, Kari; Andersson, Marine L; Korhonen, Tuomas; Molin, Björn; Ovesjö, Marie-Louise; Tirkkonen, Tuire; Rane, Anders; Gustafsson, Lars L; Eiermann, Birgit

2009-06-01

The aim was to develop a drug-drug interaction database (SFINX) to be integrated into decision support systems or to be used in website solutions for clinical evaluation of interactions. Key elements such as substance properties and names, drug formulations, text structures and references were defined before development of the database. Standard operating procedures for literature searches, text writing rules and a classification system for clinical relevance and documentation level were determined. ATC codes, CAS numbers and country-specific codes for substances were identified and quality assured to ensure safe integration of SFINX into other data systems. Much effort was put into giving short and practical advice regarding clinically relevant drug-drug interactions. SFINX includes over 8,000 interaction pairs and is integrated into Swedish and Finnish computerised decision support systems. Over 31,000 physicians and pharmacists are receiving interaction alerts through SFINX. User feedback is collected for continuous improvement of the content. SFINX is a potentially valuable tool delivering instant information on drug interactions during prescribing and dispensing.

Clinical Applications of Personalized Medicine: A New Paradigm and Challenge.

PubMed

Di Sanzo, Mariantonia; Cipolloni, Luigi; Borro, Marina; La Russa, Raffaele; Santurro, Alessandro; Scopetti, Matteo; Simmaco, Maurizio; Frati, Paola

2017-01-01

The personalized medicine is an emergent and rapidly developing method of clinical practice that uses new technologies to provide decisions in regard to the prediction, prevention, diagnosis and treatment of disease. A continuous evolution of technology and the developments in molecular diagnostics and genomic analysis increased the possibility of an even more understanding and interpretation of the human genome and exome, allowing a "personalized" approach to clinical care, so that the concepts of "Systems Medicine" and "System Biology" are actually increasing. The purpose of this study is to evaluate the personalized medicine about its indications and benefits, actual clinical applications and future perspectives as well as its issues and health care implications. A careful review of the scientific literature on this field that highlighted the applicability and usefulness of this new medical approach as well as the fact that personalized medicine strategy is even more increasing in numerous fields of applications. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Independent extended and supplementary nurse prescribing practice in the UK: a national questionnaire survey.

PubMed

Courtenay, Molly; Carey, Nicola; Burke, Joanna

2007-09-01

Nurses are able to prescribe independently from a list of nearly 250 prescription only medicines for a range of over 100 medical conditions or, from the whole British National Formulary as a supplementary prescriber. There is some evidence available on the prescribing practices of district nurses and health visitors and early independent extended prescribers. Little or no attention has focussed on supplementary nurse prescribing. To provide an overview of the prescribing practices of independent extended/supplementary nurse prescribers and the factors that facilitate or inhibit prescribing. National questionnaire survey. United Kingdom. A convenience sample of 868 qualified independent extended/supplementary nurse prescribers self-completed a written questionnaire. A total of 756 (87%) used independent extended prescribing; 304 (35%) used supplementary prescribing to treat a range of chronic conditions (including asthma, diabetes and hypertension); 710 (82%) nurses worked in primary care. Nurses in general practice reported the largest number of reasons preventing prescribing. Reasons included the inability to computer generate prescriptions and to implement the Clinical Management Plan. Nurses in primary care reported more continuing professional development needs. These needs included update on prescribing policy and the treatment management of conditions. A total of 277 (32%) nurses were unable to access continuing professional development. Independent extended/supplementary nurse prescribers work predominantly in primary care and do prescribe medicines. These nurses are highly qualified and have many years clinical experience. Supplementary prescribing is used by a minority of nurses. Implementing the Clinical Management Plan is a barrier preventing the use of this mode of prescribing. The continuing professional development needs of independent extended/supplementary nurse prescribers are frequently unmet. It will become increasingly important that these needs are met once nurses are able to prescribe the full range of medicines included in the British National Formulary, limited only by their area of competence.

The development of a clinical outcomes survey research application: Assessment Center.

PubMed

Gershon, Richard; Rothrock, Nan E; Hanrahan, Rachel T; Jansky, Liz J; Harniss, Mark; Riley, William

2010-06-01

The National Institutes of Health sponsored Patient-Reported Outcome Measurement Information System (PROMIS) aimed to create item banks and computerized adaptive tests (CATs) across multiple domains for individuals with a range of chronic diseases. Web-based software was created to enable a researcher to create study-specific Websites that could administer PROMIS CATs and other instruments to research participants or clinical samples. This paper outlines the process used to develop a user-friendly, free, Web-based resource (Assessment Center) for storage, retrieval, organization, sharing, and administration of patient-reported outcomes (PRO) instruments. Joint Application Design (JAD) sessions were conducted with representatives from numerous institutions in order to supply a general wish list of features. Use Cases were then written to ensure that end user expectations matched programmer specifications. Program development included daily programmer "scrum" sessions, weekly Usability Acceptability Testing (UAT) and continuous Quality Assurance (QA) activities pre- and post-release. Assessment Center includes features that promote instrument development including item histories, data management, and storage of statistical analysis results. This case study of software development highlights the collection and incorporation of user input throughout the development process. Potential future applications of Assessment Center in clinical research are discussed.

Opioid Analgesics and P-glycoprotein Efflux Transporters: A Potential Systems-Level Contribution to Analgesic Tolerance

PubMed Central

Mercer, Susan L.; Coop, Andrew

2012-01-01

Chronic clinical pain remains poorly treated. Despite attempts to develop novel analgesic agents, opioids remain the standard analgesics of choice in the clinical management of chronic and severe pain. However, mu opioid analgesics have undesired side effects including, but not limited to, respiratory depression, physical dependence and tolerance. A growing body of evidence suggests that P-glycoprotein (P-gp), an efflux transporter, may contribute a systems-level approach to the development of opioid tolerance. Herein, we describe current in vitro and in vivo methodology available to analyze interactions between opioids and P-gp and critically analyze P-gp data associated with six commonly used mu opioids to include morphine, methadone, loperamide, meperidine, oxycodone, and fentanyl. Recent studies focused on the development of opioids lacking P-gp substrate activity are explored, concentrating on structure-activity relationship development to develop an optimal opioid analgesic lacking this systems-level contribution to tolerance development. Continued work in this area will potentially allow for delineation of the mechanism responsible for opioid-related P-gp up-regulation and provide further support for evidence based medicine supporting clinical opioid rotation. PMID:21050174

Professionals' views of fetal-monitoring support the development of devices to provide objective longer-term assessment of fetal wellbeing.

PubMed

Brown, Rebecca; Johnstone, Edward D; Heazell, Alexander E P

2016-01-01

Continuous longer-term fetal monitoring has been proposed to address limitations of current technologies in the detection of fetal compromise. We aimed to assess professionals' views regarding current fetal-monitoring techniques and proposed longer-term continuous fetal monitoring. A questionnaire was designed and validated to assess obstetricians' and midwives' use of current fetal-monitoring techniques and their views towards continuous monitoring. 125 of 173 received responses (72% obstetricians, 28% midwives) were analysed. Professionals had the strongest views about supporting evidence for the most commonly employed fetal-monitoring techniques (maternal awareness of fetal movements, ultrasound assessment of fetal growth and umbilical artery Doppler). 45.1% of professionals agreed that a continuous monitoring device would be beneficial (versus 28.7% who disagreed); this perceived benefit was not influenced by professionals' views regarding current techniques or professional background. Professionals have limited experience of continuous fetal monitoring, but most respondents believed that it would increase maternal anxiety (64.3%) and would have concerns with its use in clinical practice (81.7%). Continuous fetal monitoring would be acceptable to the majority of professionals. However, development of these technologies must be accompanied by extended examination of professionals' and women's views to determine barriers to its introduction.

The Columbia-Bronx VA amalgamative clerkship: an effective, 12-week, integrated, longitudinal clinical experience.

PubMed

Diuguid-Gerber, Jillian; Porter, Samuel; Quiah, Samuel C; Nickerson, Katherine; Jones, Deborah; Audi, Zeena; Richards, Boyd F

2017-01-01

Many medical schools have adopted the longitudinal integrated clerkship (LIC) model in response to calls for increased continuity in clinical learning environments. However, because of implementation challenges, such programs are not feasible at some institutions or are limited to a small number of students. In January 2014, Columbia University College of Physicians and Surgeons (P&S) recognized the need to explore different LIC formats and began offering four, 12-week amalgamative clerkships (AC). Students within this curricular track experienced primary care, internal medicine 'away', orthopedic surgery, urology, and an elective in an integrated format. P&S developed the AC in partnership with the James J. Peters VA Medical Center in Bronx, NY (BVA). All patient care and educational conferences took place at the BVA during the 12-week experience. The learning objectives of the AC were aligned to the learning objectives of a 52-week20 LIC also offered at Columbia. An evaluation process was developed to determine studentlearning experiences and preliminary outcomes, including how well the LIC-related objectivescould be achieved in a shorter period of time. In 2015, P&S collected AC evaluation data through three student feedback sessions. Students reported that the AC provided opportunity for patient continuity, patient-centered care approaches, meaningful roles for students, career development opportunities, and health systems awareness. Early outcomes indicate that the BVA AC provides a degree of longitudinality that can influence student perceptions of patient care, career development, and health systems, consistent with the larger LIC. The team continues to gather additional data on students' experiences and investigate additional sites that have potential to serve as future AC learning environments.

The Columbia-Bronx VA amalgamative clerkship: an effective, 12-week, integrated, longitudinal clinical experience

PubMed Central

Diuguid-Gerber, Jillian; Porter, Samuel; Quiah, Samuel C.; Nickerson, Katherine; Jones, Deborah; Audi, Zeena; Richards, Boyd F.

2017-01-01

ABSTRACT Background: Many medical schools have adopted the longitudinal integrated clerkship (LIC) model in response to calls for increased continuity in clinical learning environments. However, because of implementation challenges, such programs are not feasible at some institutions or are limited to a small number of students. Objective: In January 2014, Columbia University College of Physicians and Surgeons (P&S) recognized the need to explore different LIC formats and began offering four, 12-week amalgamative clerkships (AC). Students within this curricular track experienced primary care, internal medicine ‘away’, orthopedic surgery, urology, and an elective in an integrated format. Design: P&S developed the AC in partnership with the James J. Peters VA Medical Center in Bronx, NY (BVA). All patient care and educational conferences took place at the BVA during the 12-week experience. The learning objectives of the AC were aligned to the learning objectives of a 52-week LIC also offered at Columbia. An evaluation process was developed to determine student learning experiences and preliminary outcomes, including how well the LIC-related objectives could be achieved in a shorter period of time. Results: In 2015, P&S collected AC evaluation data through three student feedback sessions. Students reported that the AC provided opportunity for patient continuity, patient-centered care approaches, meaningful roles for students, career development opportunities, and health systems awareness. Conclusions: Early outcomes indicate that the BVA AC provides a degree of longitudinality that can influence student perceptions of patient care, career development, and health systems, consistent with the larger LIC. The team continues to gather additional data on students’ experiences and investigate additional sites that have potential to serve as future AC learning environments. PMID:28317473

Rapid Globalization of Medical Device Clinical Development Programs in Japan　- The Case of Drug-Eluting Stents.

PubMed

Murakami, Madoka; Suzuki, Yuka; Tominaga, Toshiyoshi

2018-02-23

Delays in the introduction to the Japanese market of drug-eluting stents (DES) developed overseas (i.e., "device lag") decreased sharply between 2004 and 2012. The reduction accompanied a shift in clinical development from a succession pattern (initial product development and approval overseas followed by eventual entrance into the Japanese market) to parallel development (employing multiregional clinical trials (MRCTs)). Although resource-intensive in the short-term, MRCTs are proving to be an effective tool in simultaneous global product development. Creative study designs and the absence of significant ethnic differences in Japanese subjects regarding DES safety and efficacy and the pharmacokinetic behavior of their coating drugs propel this process. More general factors such as medical need and industry incentivization also encourage this shift. Physicians' preference for DES over other percutaneous coronary interventions, the expanding global DES market, and streamlined development and approval prospects each motivate industry to continue investing in DES product development. The efforts of various stakeholders were also integral to overcoming practical obstacles, and contributions by 'Harmonization by Doing' and a premarket collaboration initiative between the USA and Japan were particularly effective. Today, USA/Japan regulatory cooperation is routine, and Japan is now integrated into global medical device development. MRCTs including Japanese subjects, sites, and investigators are now commonplace.

Study on traditional Chinese medicine theory of lung being connected with large intestine.

PubMed

Liu, Ping; Wang, Ping; Tian, Daizhi; Liu, Junfeng; Chen, Gang; Liu, Songlin

2012-09-01

The theory of lung being connected with large intestine, which is a major topic in Traditional Chinese Medicine (TCM), has guided clinical practice for thousands of years in China. In this study, we analyzed the history, main contents, clinical application, and material basis of the theory, to attempt to improve the potential clinical significance of "lung being connected with large intestine" in China. The lung being connected with large intestine was first described in "Huang Di Nei Jing", and formed one of the basic theories of TCM. For thousands of years, the majority of TCM practitioners explored this theory continuously, leading to its development and use as an important theory in the guidance of TCM clinics In the last decade, researchers in the field of integrated TCM and Western medicine have studied clinical applications and biomedical mechanisms with experimental methods to explore the implications of the theory. With the further development of science and technology, research concerning the theory of lung being connected with large intestine will be greatly stimulated and contribute to the modernization of TCM.

[Clinical case of management of a patient with Guillain-Barre syndrome].

PubMed

Popov, A V; Babak, C I; Murashko, N K

2012-01-01

Syndrome of Giyena-Barre can arise up in any age, in different regions, for men more frequent, than for women. There are descriptions of clinical supervisions of syndrome in domestic literature, combining with the defeat of the nervous system as a result of different pathogens which are procatarxiss in the start of mechanisms of immune attack on the albumens of mielina. However this disease continues to remain one of most heavy, requiring neyroreanimacionnykh measures, that causes the necessity of development of new methods of treatment in same queue.

A portable 12-wavelength parallel near-infrared spectral tomography (NIRST) system for efficient characterization of breast cancer during neoadjuvant chemotherapy

NASA Astrophysics Data System (ADS)

Zhao, Yan; Burger, William R.; Zhou, Mingwei; Pogue, Brian W.; Paulsen, Keith D.; Jiang, Shudong

2017-02-01

A portable, 12-wavelength hybrid frequency domain (FD) and continuous wave (CW) near-infrared spectral tomography (NIRST) system was developed for efficient characterization of breast cancer in a clinical oncology setting. Two sets of three FD and three CW measurements were acquired simultaneously. The imaging time was reduced from 90 to 55 seconds with a new gain adjustment scheme of the optical detector. The study of integrating this system into the workflow of clinical oncology practice is ongoing.

The role of the nurse executive in health care philanthropy.

PubMed

Martinez, Donell

2014-01-01

As the health care landscape continues to change with reform, obtaining funding for clinical initiatives is becoming increasingly difficult. At Catholic Health Initiatives, a number of nurse executives have recognized the need for creative philanthropy to advance specific projects. They have embraced opportunities for partnerships with their hospital foundation chief development officers to leverage philanthropy toward clinical innovations and to improve quality of care. Following are their discussions which reveal just how important nurse and employee involvement is to attracting and using philanthropy dollars in the next era of health care.

Assessment of posaconazole salvage therapy in chronic pulmonary aspergillosis by using predefined response criteria.

PubMed

Rodriguez-Goncer, Isabel; Harris, Chris; Kosmidis, Chris; Muldoon, Eavan G; Newton, Pippa J; Denning, David W

2018-06-12

Chronic pulmonary aspergillosis (CPA) is a progressive infection that destroys lung tissue in non-immunocompromised patients. First line therapies for CPA (itraconazole and/or voriconazole) are often curtailed due to toxicity or the development of drug resistance. Posaconazole is a potential alternative for these patients. Use of posaconazole was funded by the NHS Highly Specialised National Commissioners on an individual basis for patients who failed or did not tolerate first line therapy; those who met predefined criteria for improvement at 4 and 6 months (weight gain and/or improvement in St George's Respiratory Questionnaire) continued posaconazole long-term. We recorded response, failure, discontinuation rates, and adverse events. Seventy-eight patients received posaconazole as salvage therapy. Thirty-four (44%) achieved targets for continuation of therapy. Fourteen (18%) failed therapy; 5 (36%) patients did not achieve clinical targets at 4 or 6 months of assessment and 9 (64%) developed clinical and/or radiological failure. Twenty-eight (36%) discontinued their trial early; 8 (29%) died and 20 (71%) had significant side effects. One patient was non-compliant and another was lost to follow up. Establishing criteria for therapeutic success offered a clear, safe and sustainable method of identifying patients who benefit from additional therapy, and minimised continuation of ineffective therapy in those who did not. Copyright © 2018. Published by Elsevier B.V.

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

PubMed

Sung, Lillian; Crowther, Mark; Byrd, John; Gitlin, Scott D; Basso, Joe; Burns, Linda

2015-12-01

The American Society of Hematology developed the Clinical Research Training Institute (CRTI) to address the lack of training in patient-oriented research among hematologists. As the program continues, we need to consider metrics for measuring the benefits of such a training program. This article addresses the benefits of clinical research training programs. The fundamental and key components are education and mentorship. However, there are several other benefits including promotion of collaboration, job and advancement opportunities, and promotion of work-life balance. The benefits of clinical research training programs need to be measured so that funders and society can judge if they are worth the investment in time and resources. Identification of elements that are important to program benefit is essential to measuring the benefit of the program as well as program planning. Future work should focus on the constructs which contribute to benefits of clinical research training programs such as CRTI.

Continuous quality improvement interventions to improve long-term outcomes of antiretroviral therapy in women who initiated therapy during pregnancy or breastfeeding in the Democratic Republic of Congo: design of an open-label, parallel, group randomized trial.

PubMed

Yotebieng, Marcel; Behets, Frieda; Kawende, Bienvenu; Ravelomanana, Noro Lantoniaina Rosa; Tabala, Martine; Okitolonda, Emile W

2017-04-26

Despite the rapid adoption of the World Health Organization's 2013 guidelines, children continue to be infected with HIV perinatally because of sub-optimal adherence to the continuum of HIV care in maternal and child health (MCH) clinics. To achieve the UNAIDS goal of eliminating mother-to-child HIV transmission, multiple, adaptive interventions need to be implemented to improve adherence to the HIV continuum. The aim of this open label, parallel, group randomized trial is to evaluate the effectiveness of Continuous Quality Improvement (CQI) interventions implemented at facility and health district levels to improve retention in care and virological suppression through 24 months postpartum among pregnant and breastfeeding women receiving ART in MCH clinics in Kinshasa, Democratic Republic of Congo. Prior to randomization, the current monitoring and evaluation system will be strengthened to enable collection of high quality individual patient-level data necessary for timely indicators production and program outcomes monitoring to inform CQI interventions. Following randomization, in health districts randomized to CQI, quality improvement (QI) teams will be established at the district level and at MCH clinics level. For 18 months, QI teams will be brought together quarterly to identify key bottlenecks in the care delivery system using data from the monitoring system, develop an action plan to address those bottlenecks, and implement the action plan at the level of their district or clinics. If proven to be effective, CQI as designed here, could be scaled up rapidly in resource-scarce settings to accelerate progress towards the goal of an AIDS free generation. The protocol was retrospectively registered on February 7, 2017. ClinicalTrials.gov Identifier: NCT03048669 .

A Human Serum-Based Enzyme-Free Continuous Glucose Monitoring Technique Using a Needle-Type Bio-Layer Interference Sensor

PubMed Central

Seo, Dongmin; Paek, Sung-Ho; Oh, Sangwoo; Seo, Sungkyu; Paek, Se-Hwan

2016-01-01

The incidence of diabetes is continually increasing, and by 2030, it is expected to have increased by 69% and 20% in underdeveloped and developed countries, respectively. Therefore, glucose sensors are likely to remain in high demand in medical device markets. For the current study, we developed a needle-type bio-layer interference (BLI) sensor that can continuously monitor glucose levels. Using dialysis procedures, we were able to obtain hypoglycemic samples from commercial human serum. These dialysis-derived samples, alongside samples of normal human serum were used to evaluate the utility of the sensor for the detection of the clinical interest range of glucose concentrations (70–200 mg/dL), revealing high system performance for a wide glycemic state range (45–500 mg/dL). Reversibility and reproducibility were also tested over a range of time spans. Combined with existing BLI system technology, this sensor holds great promise for use as a wearable online continuous glucose monitoring system for patients in a hospital setting. PMID:27669267

Continuing education at the cutting edge: promoting transformative knowledge translation.

PubMed

McWilliam, Carol L

2007-01-01

As the evidence-based practice movement gains momentum, continuing education practitioners increasingly confront the challenge of developing and conducting opportunities for achieving research uptake. Recent thinking invites new approaches to continuing education for health professionals, with due consideration of what knowledge merits uptake by practitioners, who should play what role in the knowledge transfer process, and what educational approach should be used. This article presents an innovative theory-based strategy that encompasses this new perspective. Through a facilitated experience of perspective transformation, clinicians are engaged in an on-the-job process of developing a deeply felt interest in research findings relevant to everyday practice, as well as ownership of that knowledge and its application. The strategy becomes a sustainable, integrated part of clinical practice, fitting naturally within its dynamic, unique environment, context, and climate and overcoming the barrier of time. Clinician experience of a top-down push toward prescribed practice change is avoided. With an expanded role encompassing facilitation of active learning partnerships for practice change, the continuing educator fosters a learning organization culture across the institution. The resultant role changes and leadership and accountability issues are elaborated.

Exploring ward nurses' perceptions of continuing education in clinical settings.

PubMed

Govranos, Melissa; Newton, Jennifer M

2014-04-01

Health care systems demand that nurses are flexible skilful workers who maintain currency and competency in order to deliver safe effective patient centered care. Nurses must continually build best practice into their care and acquire lifelong learning. Often this learning is acquired within the work environment and is facilitated by the clinical nurse educator. Understanding clinical nurses' values and needs of continuing education is necessary to ensure appropriate education service delivery and thus enhance patient care. To explore clinical ward-based nurses' values and perceptions towards continuing education and what factors impact on continuing education in the ward. A case study approach was utilized. A major teaching hospital in Melbourne, Australia. A range of clinical nursing staff (n=23). Four focus groups and six semi-structured individual interviews were undertaken. Focus group interviews explored participants' values and perceptions on continuing education through a values clarification tool. Thematic analysis of interviews was undertaken to identify themes and cluster data. Three central themes: 'culture and attitudes', 'what is learning?' and 'being there-being seen', emerged reflecting staffs' values and perceptions of education and learning in the workplace. Multiple factors influence ward nurses' ability and motivation to incorporate lifelong learning into their practice. Despite variance in nurses' values and perceptions of CE in clinical environments, CE was perceived as important. Nurses yearned for changes to facilitate lifelong learning and cultivate a learning culture. Clinical nurse educators need to be cognizant of adult learners' characteristics such as values, beliefs, needs and potential barriers, to effectively facilitate support in a challenging and complex learning environment. Organizational support is essential so ward managers in conjunction with educational departments can promote and sustain continuing education, lifelong learning and a culture conducive to learning. © 2013.

Clinical translation and regulatory aspects of CAR/TCR-based adoptive cell therapies-the German Cancer Consortium approach.

PubMed

Krackhardt, Angela M; Anliker, Brigitte; Hildebrandt, Martin; Bachmann, Michael; Eichmüller, Stefan B; Nettelbeck, Dirk M; Renner, Matthias; Uharek, Lutz; Willimsky, Gerald; Schmitt, Michael; Wels, Winfried S; Schüssler-Lenz, Martina

2018-04-01

Adoptive transfer of T cells genetically modified by TCRs or CARs represents a highly attractive novel therapeutic strategy to treat malignant diseases. Various approaches for the development of such gene therapy medicinal products (GTMPs) have been initiated by scientists in recent years. To date, however, the number of clinical trials commenced in Germany and Europe is still low. Several hurdles may contribute to the delay in clinical translation of these therapeutic innovations including the significant complexity of manufacture and non-clinical testing of these novel medicinal products, the limited knowledge about the intricate regulatory requirements of the academic developers as well as limitations of funds for clinical testing. A suitable good manufacturing practice (GMP) environment is a key prerequisite and platform for the development, validation, and manufacture of such cell-based therapies, but may also represent a bottleneck for clinical translation. The German Cancer Consortium (DKTK) and the Paul-Ehrlich-Institut (PEI) have initiated joint efforts of researchers and regulators to facilitate and advance early phase, academia-driven clinical trials. Starting with a workshop held in 2016, stakeholders from academia and regulatory authorities in Germany have entered into continuing discussions on a diversity of scientific, manufacturing, and regulatory aspects, as well as the benefits and risks of clinical application of CAR/TCR-based cell therapies. This review summarizes the current state of discussions of this cooperative approach providing a basis for further policy-making and suitable modification of processes.

Designing healthcare information technology to catalyse change in clinical care.

PubMed

Lester, William T; Zai, Adrian H; Grant, Richard W; Chueh, Henry C

2008-01-01

The gap between best practice and actual patient care continues to be a pervasive problem in our healthcare system. Efforts to improve on this knowledge-performance gap have included computerised disease management programs designed to improve guideline adherence. However, current computerised reminder and decision support interventions directed at changing physician behaviour have had only a limited and variable effect on clinical outcomes. Further, immediate pay-for-performance financial pressures on institutions have created an environment where disease management systems are often created under duress, appended to existing clinical systems and poorly integrated into the existing workflow, potentially limiting their real-world effectiveness. The authors present a review of disease management as well as a conceptual framework to guide the development of more effective health information technology (HIT) tools for translating clinical information into clinical action.

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

[Syndrome of emotional burnout among women-physicians elderly].

PubMed

Myakotnykh, V S; Borovkova, T A

2017-01-01

The article presents the results of a comparative study of clinical symptoms of syndrome of emotional burnout among 84 working in the specialty physician of older women and 48 officially ceasing operations in this specialty. The findings suggest that burnout can take place among representatives of older age and more it is continued, provided professional activities. The cessation of the work activities leads to stress, often with the subsequent development post-traumatic stress disorder and stress-induced diseases. However in this case the clinical symptoms of the syndrome of emotional burnout, does not disappear, but only happens their clinical transformation attach various psychosomatic disorders. Thus, the elderly, suffering the syndrome of emotional burnout, are at high risk group with regard to the formation and development of diseases, associated with stress and require close monitoring in the framework of the compulsory program of medical examination.

Teaching clinical pharmacology and therapeutics with an emphasis on the therapeutic reasoning of undergraduate medical students

PubMed Central

Richir, Milan C.; Tichelaar, Jelle; Geijteman, Eric C. T.

2008-01-01

Background The rational prescribing of drugs is an essential skill of medical doctors. Clinical pharmacologists play an important role in the development of these skills by teaching clinical pharmacology and therapeutics (CP&T) to undergraduate medical students. Although the approaches to teaching CP&T have undergone many changes over the last decennia, it is essential that the actual teaching of CP&T continues to be a major part of the undergraduate medical curriculum. Objectives The learning objectives of CP&T teaching in terms of developing the therapeutic competencies of undergraduate medical students are described, with an emphasis on therapeutic decision-making. On the basis of current theories of cognitive psychology and medical education, context-learning is presented as an effective approach by which to achieve therapeutic competencies. An example of a CP&T curriculum is presented. PMID:18228012

Provision of genetics services on Guam.

PubMed

McWalter, Kirsty; Hasegawa, Lianne; Au, Sylvia Mann

2013-12-01

Guam's geographic isolation and lack of community resources have resulted in unique healthcare needs. In 2006, the Western States Genetic Services Collaborative (WSGSC) conducted a genetics needs assessment and found that professional development is limited, families lack access to genetic services, and improved coverage of genetic testing is needed. With funding from the WSGSC, a Guam genetics outreach clinic was established and staffed by genetic counselors and a medical geneticist from Hawaii. Four clinics have been held to date. Although several challenges have been encountered, including minimal coverage of genetic testing by Guam insurance companies, limited referrals for families with private insurance, and inappropriate referral indications, the outreach clinic has been successful at increasing access to genetic services and improving professional development. With more collaborative work by staff from Guam, Hawaii, and the WSGSC, provision and reimbursement of genetic services and testing will continue to improve.

Pediatric Hypothyroidism: Diagnosis and Treatment.

PubMed

Wassner, Ari J

2017-08-01

Thyroid hormone has important physiologic functions in nearly every organ system. The critical role of thyroid hormone in growth and in physical and neurologic development lends particular importance to the prompt diagnosis and appropriate treatment of hypothyroidism in infants and children. Congenital hypothyroidism is common and has potentially devastating neurologic consequences. While the approach to diagnosis and treatment of severe congenital hypothyroidism is well established, data continue to emerge about the genetic causes, clinical significance, and prognosis of the milder forms of congenital hypothyroidism that are increasingly being diagnosed by newborn screening. Similarly, the diagnosis and treatment of severe acquired hypothyroidism is straightforward and clearly of clinical benefit, but uncertainty remains about the optimal management of mild subclinical hypothyroidism. This review summarizes current knowledge of the causes, clinical manifestations, diagnosis, treatment, and prognosis of hypothyroidism in infants and children, with a focus on recent developments and areas of uncertainty in this field.

Sm-p80-Based Schistosomiasis Vaccine: Preparation for Human Clinical Trials.

PubMed

Siddiqui, Afzal A; Siddiqui, Sabrina Z

2017-03-01

Mass antiparasitic drug administration programs and other control strategies have made important contributions in reducing the global prevalence of helminths. Schistosomiasis, however, continues to spread to new geographic areas. The advent of a viable vaccine and its deployment, coupled with existing control efforts, is expected to make significant headway towards sustained schistosomiasis control. In 2016, Science ranked the schistosomiasis vaccine as one of the top 10 vaccines that needs to be urgently developed. A vaccine that is effective against geographically distinct forms of intestinal/hepatic and urinary disease is essential to make a meaningful impact in global reduction of the disease burden. In this opinion article, we focus on salient features of schistosomiasis vaccines in different phases of the clinical development pipeline and highlight the Sm-p80-based vaccine which is now being prepared for human clinical trials. Copyright © 2016 Elsevier Ltd. All rights reserved.

Use of atypical antipsychotics for treatment-resistant major depressive disorder.

PubMed

Papakostas, George I; Shelton, Richard C

2008-12-01

Despite the progressive increase in the number of pharmacologic agents with potential antidepressant activity, many patients suffering from major depressive disorder (MDD) continue to be symptomatic. Clearly, an urgent need exists to develop safer, better tolerated, and more effective treatments for MDD. Use of atypical antipsychotic agents as adjunctive treatment for treatment-resistant MDD (TRD) represents one such effort toward novel pharmacotherapy development. Atypical antipsychotic agents have been hypothesized to be beneficial in treating mood disorders, including TRD, as a result of their complex mechanisms of action. After an initial series of positive case reports, series, and small clinical trials, subsequent larger-scale projects have yielded conflicting results. However, more recently, larger-scale clinical trials have supported the effectiveness of at least some of these medications. This review summarizes the existing data regarding the effectiveness of these medications in treating TRD, including biochemical rationale and clinical data.

Inflection Points in Magnetic Resonance Imaging Technology-35 Years of Collaborative Research and Development.

PubMed

Wood, Michael L; Griswold, Mark A; Henkelman, Mark; Hennig, Jürgen

2015-09-01

The technology for clinical magnetic resonance imaging (MRI) has advanced with remarkable speed and in such a manner reflecting the influence of 3 forces-collaboration between disciplines, collaboration between academia and industry, and the enabling of software applications by hardware. The forces are evident in the key developments from the past and emerging trends for the future highlighted in this review article. These developments are associated with MRI system attributes, such as wider, shorter, and stronger magnets; specialty magnets and hybrid devices; k space; and the notion that magnetic field gradients perform a Fourier transform on the spatial distribution of magnetization, phased-array coils and parallel imaging, the user interface, the wide range of contrast possible, and applications that exploit motion-induced phase shifts. An attempt is made to show connections between these developments and how the 3 forces mentioned previously will continue to shape the technology used so productively in clinical MRI.

Down syndrome and Alzheimer's disease: Common pathways, common goals

PubMed Central

Hartley, Dean; Blumenthal, Thomas; Carrillo, Maria; DiPaolo, Gilbert; Esralew, Lucille; Gardiner, Katheleen; Granholm, Ann-Charlotte; Iqbal, Khalid; Krams, Michael; Lemere, Cynthia; Lott, Ira; Mobley, William; Ness, Seth; Nixon, Ralph; Potter, Huntington; Reeves, Roger; Sabbagh, Marwan; Silverman, Wayne; Tycko, Benjamin; Whitten, Michelle; Wisniewski, Thomas

2016-01-01

In the United States, estimates indicate there are between 250,000 and 400,000 individuals with Down syndrome (DS), and nearly all will develop Alzheimer's disease (AD) pathology starting in their 30s. With the current lifespan being 55 to 60 years, approximately 70% will develop dementia, and if their life expectancy continues to increase, the number of individuals developing AD will concomitantly increase. Pathogenic and mechanistic links between DS and Alzheimer's prompted the Alzheimer's Association to partner with the Linda Crnic Institute for Down Syndrome and the Global Down Syndrome Foundation at a workshop of AD and DS experts to discuss similarities and differences, challenges, and future directions for this field. The workshop articulated a set of research priorities: (1) target identification and drug development, (2) clinical and pathological staging, (3) cognitive assessment and clinical trials, and (4) partnerships and collaborations with the ultimate goal to deliver effective disease-modifying treatments. PMID:25510383

Rehabilitation robots for the treatment of sensorimotor deficits: a neurophysiological perspective.

PubMed

Gassert, Roger; Dietz, Volker

2018-06-05

The past decades have seen rapid and vast developments of robots for the rehabilitation of sensorimotor deficits after damage to the central nervous system (CNS). Many of these innovations were technology-driven, limiting their clinical application and impact. Yet, rehabilitation robots should be designed on the basis of neurophysiological insights underlying normal and impaired sensorimotor functions, which requires interdisciplinary collaboration and background knowledge.Recovery of sensorimotor function after CNS damage is based on the exploitation of neuroplasticity, with a focus on the rehabilitation of movements needed for self-independence. This requires a physiological limb muscle activation that can be achieved through functional arm/hand and leg movement exercises and the activation of appropriate peripheral receptors. Such considerations have already led to the development of innovative rehabilitation robots with advanced interaction control schemes and the use of integrated sensors to continuously monitor and adapt the support to the actual state of patients, but many challenges remain. For a positive impact on outcome of function, rehabilitation approaches should be based on neurophysiological and clinical insights, keeping in mind that recovery of function is limited. Consequently, the design of rehabilitation robots requires a combination of specialized engineering and neurophysiological knowledge. When appropriately applied, robot-assisted therapy can provide a number of advantages over conventional approaches, including a standardized training environment, adaptable support and the ability to increase therapy intensity and dose, while reducing the physical burden on therapists. Rehabilitation robots are thus an ideal means to complement conventional therapy in the clinic, and bear great potential for continued therapy and assistance at home using simpler devices.This review summarizes the evolution of the field of rehabilitation robotics, as well as the current state of clinical evidence. It highlights fundamental neurophysiological factors influencing the recovery of sensorimotor function after a stroke or spinal cord injury, and discusses their implications for the development of effective rehabilitation robots. It thus provides insights on essential neurophysiological mechanisms to be considered for a successful development and clinical inclusion of robots in rehabilitation.

Clinical Core Competency Training for NASA Flight Surgeons

NASA Technical Reports Server (NTRS)

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

2007-01-01

Introduction: The cohort of NASA flight surgeons (FS) is a very accomplished group with varied clinical backgrounds; however, the NASA Flight Surgeon Office has identified that the extremely demanding schedule of this cohort prevents many of these physicians from practicing clinical medicine on a regular basis. In an effort to improve clinical competency, the NASA FS Office has dedicated one day a week for the FS to receive clinical training. Each week, an FS is assigned to one of five clinical settings, one being medical patient simulation. The Medical Operations Support Team (MOST) was tasked to develop curricula using medical patient simulation that would meet the clinical and operational needs of the NASA FS Office. Methods: The MOST met with the Lead FS and Training Lead FS to identify those core competencies most important to the FS cohort. The MOST presented core competency standards from the American Colleges of Emergency Medicine and Internal Medicine as a basis for developing the training. Results: The MOST identified those clinical areas that could be best demonstrated and taught using medical patient simulation, in particular, using high fidelity human patient simulators. Curricula are currently being developed and additional classes will be implemented to instruct the FS cohort. The curricula will incorporate several environments for instruction, including lab-based and simulated microgravity-based environments. Discussion: The response from the NASA FS cohort to the initial introductory class has been positive. As a result of this effort, the MOST has identified three types of training to meet the clinical needs of the FS Office; clinical core competency training, individual clinical refresher training, and just-in-time training (specific for post-ISS Expedition landings). The MOST is continuing to work with the FS Office to augment the clinical training for the FS cohort, including the integration of Web-based learning.

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.

Development of a Cost-Effective Modular Pixelated NaI(Tl) Detector for Clinical SPECT Applications

PubMed Central

Rozler, Mike; Liang, Haoning; Chang, Wei

2013-01-01

A new pixelated detector for high-resolution clinical SPECT applications was designed and tested. The modular detector is based on a scintillator block comprised of 2.75×2.75×10 mm3 NaI(Tl) pixels and decoded by an array of 51 mm diameter single-anode PMTs. Several configurations, utilizing two types of PMTs, were evaluated using a collimated beam source to measure positioning accuracy directly. Good pixel separation was observed, with correct pixel identification ranging from 60 to 72% averaged over the entire area of the modules, depending on the PMT type and configuration. This translates to a significant improvement in positioning accuracy compared to continuous slab detectors of the same thickness, along with effective reduction of “dead” space at the edges. The observed 10% average energy resolution compares well to continuous slab detectors. The combined performance demonstrates the suitability of pixelated detectors decoded with a relatively small number of medium-sized PMTs as a cost-effective approach for high resolution clinical SPECT applications, in particular those involving curved detector geometries. PMID:24146436

Development and implementation of a psychotherapy tracking database in primary care.

PubMed

Craner, Julia R; Sawchuk, Craig N; Mack, John D; LeRoy, Michelle A

2017-06-01

Although there is a rapid increase in the integration of behavioral health services in primary care, few studies have evaluated the effectiveness of these services in real-world clinical settings, in part due to the difficulty of translating traditional mental health research designs to this setting. Accordingly, innovative approaches are needed to fit the unique challenges of conducting research in primary care. The development and implementation of one such approach is described in this article. A continuously populating database for psychotherapy services was implemented across 5 primary care clinics in a large health system to assess several levels of patient care, including service utilization, symptomatic outcomes, and session-by-session use of psychotherapy principles by providers. Each phase of implementation revealed challenges, including clinician time, dissemination to clinics with different resources, and fidelity of data collection strategy across providers, as well as benefits, including the generation of useful data to inform clinical care, program development, and empirical research. The feasible and sustainable implementation of data collection for routine clinical practice in primary care has the potential to fuel the evidence base around integrated care. The current project describes the development of an innovative approach that, with further empirical study and refinement, could enable health care professionals and systems to understand their population and clinical process in a way that addresses essential gaps in the integrated care literature. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

False dichotomies: EBM, clinical freedom, and the art of medicine.

PubMed

Parker, M

2005-06-01

According to numerous commentators, clinical freedom, the art of medicine, and, by implication, a degree of patient welfare, are threatened by evidence based medicine (EBM). As EBM has developed over the last fifteen years, claims about better evidence for medical treatments, and improvements in healthcare delivery, have been matched by critiques of EBM's reductionism and uniformity, its problematic application to individual patients, and its alleged denial of the continuing need for clinical interpretation, insight, and judgment. Most of these attacks on EBM and defences of clinical freedom fail. They are based on erroneous understandings of the relationships between inductive knowledge, clinical uncertainty, and action. Evidence based medicine is a necessary condition for clinical freedom, not a threat to it, and EBM is not something to be balanced with either clinical experience or patient preferences. The art and science of medicine are more conceptually and practically connected than the defenders of clinical freedom, whatever they conceive that to be, are willing to admit.

Audit of rheumatology services for adolescents and young adults in the UK. British Paediatric Rheumatology Group.

PubMed

McDonagh, J E; Foster, H E; Hall, M A; Chamberlain, M A

2000-06-01

Juvenile idiopathic arthritis (JIA) is associated with significant morbidity in adulthood with at least one third of children continuing to have active inflammatory disease into their adult years and up to 60% of all patients continuing to have some limitation of their activities of daily living. A survey of service provision for these young people in the transition from paediatric to adult rheumatology care was therefore undertaken. A postal questionnaire was sent to all 92 members of the British Paediatric Rheumatology Group, representing 61 units providing a paediatric rheumatology service in the UK and Eire. Fifty-five replies were received representing a 60% completion rate of doctors and 84% of units on the mailing list. The majority of respondents were adult rheumatologists (n = 36, 65%) with 42% of respondents based in teaching hospitals. A median of 24 patients (new and follow-up, range 1-225) were seen in a median of two paediatric rheumatology clinics (range 0-15) per month. Eighteen per cent of units had a dedicated adolescent clinic (n = 9) with a median of one clinic per month and a median number of new patients per month of two (range 0-24) and 10 review patients (4-32). All the adolescent clinics involved an adult rheumatologist with five having a paediatrician in clinic and four having access to a paediatrician. The majority of clinics involved a specialist registrar (n = 6), a nurse specialist (n = 6), an occupational therapist (n = 6) and a physiotherapist (n = 5). The majority of clinics had flexible entry and exit criteria. In seven clinics there was a standardized process of transfer, first discussed at a median age of 13 yr (range 12-16) but no unit provided literature or organized pre-visits for this process. A demand for patient information resources (e.g. disease and drug information, careers) specifically aimed at adolescents with rheumatic diseases was identified. Generic health issues were only addressed by two clinics. Obstacles to current service provision and ideas for future developments were identified. This survey identifies a heterogeneity of provision of healthcare for adolescents with rheumatic disease and highlights the potential for further research and development.

Multimodal imaging of cutaneous wound tissue

NASA Astrophysics Data System (ADS)

Zhang, Shiwu; Gnyawali, Surya; Huang, Jiwei; Ren, Wenqi; Gordillo, Gayle; Sen, Chandan K.; Xu, Ronald

2015-01-01

Quantitative assessment of wound tissue ischemia, perfusion, and inflammation provides critical information for appropriate detection, staging, and treatment of chronic wounds. However, few methods are available for simultaneous assessment of these tissue parameters in a noninvasive and quantitative fashion. We integrated hyperspectral, laser speckle, and thermographic imaging modalities in a single-experimental setup for multimodal assessment of tissue oxygenation, perfusion, and inflammation characteristics. Algorithms were developed for appropriate coregistration between wound images acquired by different imaging modalities at different times. The multimodal wound imaging system was validated in an occlusion experiment, where oxygenation and perfusion maps of a healthy subject's upper extremity were continuously monitored during a postocclusive reactive hyperemia procedure and compared with standard measurements. The system was also tested in a clinical trial where a wound of three millimeters in diameter was introduced on a healthy subject's lower extremity and the healing process was continuously monitored. Our in vivo experiments demonstrated the clinical feasibility of multimodal cutaneous wound imaging.

Shortened lengths of stay: ensuring continuity of care for mothers and babies.

PubMed

Welsh, C; Ludwig-Beymer, P

1998-01-01

Hospital discharge on the day after an uncomplicated vaginal delivery may be appropriate if clinical criteria are used for the selection of patients and post-discharge follow-up plans are in place. To ensure safety for these patients, Advocate Health Care developed a mother/baby philosophy statement, guidelines for maternal and infant discharge in less than 48 hours, and an algorithm to assure that appropriate follow-up care takes place after discharge. To evaluate the Mother/Baby Home Transition Program, home health follow up, readmission rates, and sentinel events were tracked. Most home health visits occurred within 48 hours. Infant readmission rates ranged from 1.1-2.6%, whereas maternal readmission rates ranged from 0-0.52%. Three sentinel events in 1996 and three in 1997 required readmissions to an ICU. Data continue to be monitored and shared monthly with clinical leaders.

LOSS OF BLOOD AT OPERATION—A Method for Continuous Measurement

PubMed Central

Borden, Fred W.

1957-01-01

A method for continuous measurement of surgical blood loss has been devised and has been used clinically in some 400 cases. The method combines volumetric measure of the suction loss and gravimetric measure of the sponge loss. The volumetric device automatically deducts the volume of rinse water used and thus measures the amount of blood collected in a metering cylinder. The suction loss scale shows continuously the amount of blood in the metering cylinder. The gravimetric device requires counting sponges into the weighing pan, and turning a dial scale to deduct the initial weight of the sponges. The volume of blood in the sponges is then read directly on the dial scale. Use of the instrument, which is under the supervision of the anesthesiologist, adds about two minutes per hour to the time normally required for counting the sponges; and about three minutes per hour is required for tending the volumetric instrument. In clinical use, knowing constantly the amount of blood loss permits the starting of transfusion before serious deficit develops, and then maintaining the patient's blood volume at a predetermined optimum level. In some 400 cases the continuous measurement of the blood loss served as a reliable guide for carrying out the loss-replacement plan within close limits of accuracy. ImagesFigure 2.p97-a PMID:13446754

Automatic burst detection for the EEG of the preterm infant.

PubMed

Jennekens, Ward; Ruijs, Loes S; Lommen, Charlotte M L; Niemarkt, Hendrik J; Pasman, Jaco W; van Kranen-Mastenbroek, Vivianne H J M; Wijn, Pieter F F; van Pul, Carola; Andriessen, Peter

2011-10-01

To aid with prognosis and stratification of clinical treatment for preterm infants, a method for automated detection of bursts, interburst-intervals (IBIs) and continuous patterns in the electroencephalogram (EEG) is developed. Results are evaluated for preterm infants with normal neurological follow-up at 2 years. The detection algorithm (MATLAB®) for burst, IBI and continuous pattern is based on selection by amplitude, time span, number of channels and numbers of active electrodes. Annotations of two neurophysiologists were used to determine threshold values. The training set consisted of EEG recordings of four preterm infants with postmenstrual age (PMA, gestational age + postnatal age) of 29-34 weeks. Optimal threshold values were based on overall highest sensitivity. For evaluation, both observers verified detections in an independent dataset of four EEG recordings with comparable PMA. Algorithm performance was assessed by calculation of sensitivity and positive predictive value. The results of algorithm evaluation are as follows: sensitivity values of 90% ± 6%, 80% ± 9% and 97% ± 5% for burst, IBI and continuous patterns, respectively. Corresponding positive predictive values were 88% ± 8%, 96% ± 3% and 85% ± 15%, respectively. In conclusion, the algorithm showed high sensitivity and positive predictive values for bursts, IBIs and continuous patterns in preterm EEG. Computer-assisted analysis of EEG may allow objective and reproducible analysis for clinical treatment.

Situational Analysis of Physical Therapist Clinical Instructors' Facilitation of Students' Emerging Embodiment of Movement in Practice.

PubMed

Covington, Kyle; Barcinas, Susan J

2017-06-01

Physical therapists improve the functional ability of patients after injury and disease. A unique component of their practice is the ability to use the movement of their own bodies to effect change in their patients. This ability has been recognized as a distinctive attribute of expert physical therapists. The purpose of this qualitative situational analysis study was to examine how physical therapist clinical instructors perceive and facilitate their students' emerging integration of movement in practice. Data collection and analysis were guided by a theoretical framework for understanding "professional ways of being." Data were analyzed using coding and mapping strategies consistent with situational analysis techniques. The study included 5 physical therapist clinical instructors and their respective 5 physical therapist students. Data were collected during beginning, midterm, and final weeks of the students' clinical internships using participant interviews, observation, and document analysis. Coded data were summarized using situational analysis mapping strategies, resulting in 11 maps. These maps were further analyzed and reduced to 5 thematic behaviors enacted by a clinical instructor as he or she helps facilitate students' use of movement in practice. These behaviors are adapt, prepare, enhance, connect , and develop . The limited number of participants and the relative homogeneity of the student sample may have limited the diversity of data collected. The 5 behaviors are useful when considered as a trajectory of development. To our knowledge, this study marks the first description of how physical therapist clinical instructors develop students' use of movement in practice and how to enact behaviors important in students' continued professional development. The findings are important for clinical instructors and academic programs considering how best to prepare students to use movement and develop their skills early in practice. © 2017 American Physical Therapy Association

Planning Your Journey in Coaching: Building a Network for Success

ERIC Educational Resources Information Center

Van Mullem, Pete; Croft, Chris

2015-01-01

A coach develops his or her craft by reflecting on previous playing experiences (Erickson, Côté, & Fraser-Thomas, 2007) and continuing to seek learning opportunities through a variety of informal and non-formal learning methods (e.g. discussion with other coaches, trial and error, observation, advice of a mentor, clinics, web sites, books and…

Development of a Pilot Telehealth Bariatric Surgery Support Group

ERIC Educational Resources Information Center

Schofield, Carin K.

2013-01-01

The prevalence of obesity in the United States continues to grow. Bariatric surgery is becoming more common and accepted in the treatment of obesity. Clinical candidates for bariatric surgery should have a BMI > 40 kg/m[superscript 2] alone, or a BMI > 35 kg/m[superscript 2] plus one comorbidity. A trend is emerging in the literature showing…

A wearable device for continuous monitoring of heart mechanical function based on impedance cardiography.

PubMed

Panfili, G; Piccini, L; Maggi, L; Parini, S; Andreoni, G

2006-01-01

In this study we explored the possibility to realize a low power device for Cardiac Output continuous monitoring based on impedance cardiography technique. We assessed the possibility to develop a system able to record data allow an intra-subjective analysis based on the daily variations of this measure. The device was able to acquire and to send signals using a wireless Bluetooth transmission. The electronic circuit was designed in order to minimize power consumption, dimension and weight. The reported results were interesting for what concerns the power consumption and then noise level. In this way was obtained a wearable device that will permit to define specific clinical protocols based on continuous monitoring of the Cardiac Output signal.

The ERA-EDTA today and tomorrow: a progress document by the ERA-EDTA Council.

PubMed

Zoccali, Carmine; Arici, Mustafa; Blankestijn, Peter J; Bruchfeld, Annette; Capasso, Giovambattista; Fliser, Danilo; Fouque, Denis; Goumenos, Dimitrios; Ketteler, Markus; Malyszko, Jolanta; Massy, Ziad; Rychlík, Ivan; Spasovski, Goce

2018-05-23

Scientific societies are increasingly seen as central to the advancement of information sharing and collaboration among scientists and clinical investigators for the progress of medical research and the promotion of education, professional competence, integrity and quality studies. To more effectively serve the practicing nephrologists and investigators dedicated to renal science, the Council of the European Renal Association and European Dialysis and Transplantation Association (ERA-EDTA) reorganized and integrated the various activities of the society into two branches, the Clinical Nephrology Governance branch and the Renal Science branch. New affordable initiatives to promote research, education and professional development and to advocate for the recognition of chronic kidney disease as a major public health issue at the European level will be put in place and/or potentiated in the new organizational frame. Educational initiatives will be espoused to Continuous Professional Development and, starting from 2019, 14 Education & Continuous Professional Development courses will be held covering the full range of knowledge areas of modern nephrology. Consolidation and development is the short- and medium-term mantra of the ERA-EDTA. The society has a rich portfolio of successful activities and brilliant, creative scientists among its members. Integrating the various activities of the ERA-EDTA and treasuring the expertise and wisdom of its most accomplished members will facilitate collaborative research, education and its public impact at large.

Basic MR relaxation mechanisms and contrast agent design.

PubMed

De León-Rodríguez, Luis M; Martins, André F; Pinho, Marco C; Rofsky, Neil M; Sherry, A Dean

2015-09-01

The diagnostic capabilities of magnetic resonance imaging (MRI) have undergone continuous and substantial evolution by virtue of hardware and software innovations and the development and implementation of exogenous contrast media. Thirty years since the first MRI contrast agent was approved for clinical use, a reliance on MR contrast media persists, largely to improve image quality with higher contrast resolution and to provide additional functional characterization of normal and abnormal tissues. Further development of MR contrast media is an important component in the quest for continued augmentation of diagnostic capabilities. In this review we detail the many important considerations when pursuing the design and use of MR contrast media. We offer a perspective on the importance of chemical stability, particularly kinetic stability, and how this influences one's thinking about the safety of metal-ligand-based contrast agents. We discuss the mechanisms involved in MR relaxation in the context of probe design strategies. A brief description of currently available contrast agents is accompanied by an in-depth discussion that highlights promising MRI contrast agents in the development of future clinical and research applications. Our intention is to give a diverse audience an improved understanding of the factors involved in developing new types of safe and highly efficient MR contrast agents and, at the same time, provide an appreciation of the insights into physiology and disease that newer types of responsive agents can provide. © 2015 Wiley Periodicals, Inc.

"Basic MR Relaxation Mechanisms & Contrast Agent Design"

PubMed Central

De León-Rodríguez, Luis M.; Martins, André F.; Pinho, Marco; Rofsky, Neil; Sherry, A. Dean

2015-01-01

The diagnostic capabilities of magnetic resonance imaging (MRI) have undergone continuous and substantial evolution by virtue of hardware and software innovations and the development and implementation of exogenous contrast media. Thirty years since the first MRI contrast agent was approved for clinical use, a reliance on MR contrast media persists largely to improve image quality with higher contrast resolution and to provide additional functional characterization of normal and abnormal tissues. Further development of MR contrast media is an important component in the quest for continued augmentation of diagnostic capabilities. In this review we will detail the many important considerations when pursuing the design and use of MR contrast media. We will offer a perspective on the importance of chemical stability, particularly kinetic stability, and how this influences one's thinking about the safety of metal-ligand based contrast agents. We will discuss the mechanisms involved in magnetic resonance relaxation in the context of probe design strategies. A brief description of currently available contrast agents will be accompanied by an in-depth discussion that highlights promising MRI contrast agents in development for future clinical and research applications. Our intention is to give a diverse audience an improved understanding of the factors involved in developing new types of safe and highly efficient MR contrast agents and, at the same time, provide an appreciation of the insights into physiology and disease that newer types of responsive agents can provide. PMID:25975847

Continuing Education Instrumentation Training in Clinical Chemistry.

ERIC Educational Resources Information Center

LeBlanc, Jacqueline; Frankel, Saundra

1980-01-01

Describes the continuing education program for clinical chemistry instrumentation training established at The College of Staten Island, New York. A course consisting of 14 sessions is outlined and discussed. (CS)

Continuous glucose monitoring technology for personal use: an educational program that educates and supports the patient.

PubMed

Evert, Alison; Trence, Dace; Catton, Sarah; Huynh, Peter

2009-01-01

The purpose of this article is to describe the development and implementation of an educational program for the initiation of real-time continuous glucose monitoring (CGM) technology for personal use, not 3-day CGMS diagnostic studies. The education program was designed to meet the needs of patients managing their diabetes with either diabetes medications or insulin pump therapy in an outpatient diabetes education center using a team-based approach. Observational research, complemented by literature review, was used to develop an educational program model and teaching strategies. Diabetes educators, endocrinologists, CGM manufacturer clinical specialists, and patients with diabetes were also interviewed for their clinical observations and experience. The program follows a progressive educational model. First, patients learn in-depth about real-time CGM technology by attending a group presensor class that provides detailed information about CGM. This presensor class facilitates self-selection among patients concerning their readiness to use real-time CGM. If the patient decides to proceed with real-time CGM use, CGM initiation is scheduled, using a clinic-centered protocol for both start-up and follow-up. Successful use of real-time CGM involves more than just patient enthusiasm or interest in a new technology. Channeling patient interest into a structured educational setting that includes the benefits and limitations of real-time CGM helps to manage patient expectations.

A novel approach for analyzing data on recurrent events with duration to estimate the combined cumulative rate of both variables over time.

PubMed

Bhattacharya, Sudipta

2018-06-01

Recurrent adverse events, once occur often continue for some duration of time in clinical trials; and the number of events along with their durations is clinically considered as a measure of severity of a disease under study. While there are methods available for analyzing recurrent events or durations or for analyzing both side by side, no effort has been made so far to combine them and present as a single measure. However, this single-valued combined measure may help clinicians assess the wholesome effect of recurrence of incident comprising events and durations. Non-parametric approach is adapted here to develop an estimator for estimating the combined rate of both, the recurrence of events as well as the event-continuation, that is the duration per event. The proposed estimator produces a single numerical value, the interpretation and meaningfulness of which are discussed through the analysis of a real-life clinical dataset. The algebraic expression of variance is derived, asymptotic normality of the estimator is noted, and demonstration is provided on how the estimator can be used in the setup of testing of statistical hypothesis. Further possible development of the estimator is also noted, to adjust for the dependence of event occurrences on the history of the process generating recurrent events through covariates and for the case of dependent censoring.

Expression of a CD20-specific chimeric antigen receptor enhances cytotoxic activity of NK cells and overcomes NK-resistance of lymphoma and leukemia cells.

PubMed

Müller, Tina; Uherek, Christoph; Maki, Guitta; Chow, Kai Uwe; Schimpf, Annemarie; Klingemann, Hans-Georg; Tonn, Torsten; Wels, Winfried S

2008-03-01

Despite the clinical success of CD20-specific antibody rituximab, malignancies of B-cell origin continue to present a major clinical challenge, in part due to an inability of the antibody to activate antibody-dependent cell-mediated cytotoxicity (ADCC) in some patients, and development of resistance in others. Expression of chimeric antigen receptors in effector cells operative in ADCC might allow to bypass insufficient activation via FcgammaRIII and other resistance mechanisms that limit natural killer (NK)-cell activity. Here we have generated genetically modified NK cells carrying a chimeric antigen receptor that consists of a CD20-specific scFv antibody fragment, via a flexible hinge region connected to the CD3zeta chain as a signaling moiety. As effector cells we employed continuously growing, clinically applicable human NK-92 cells. While activity of the retargeted NK-92 against CD20-negative targets remained unchanged, the gene modified NK cells displayed markedly enhanced cytotoxicity toward NK-sensitive CD20 expressing cells. Importantly, in contrast to parental NK-92, CD20-specific NK cells efficiently lysed CD20 expressing but otherwise NK-resistant established and primary lymphoma and leukemia cells, demonstrating that this strategy can overcome NK-cell resistance and might be suitable for the development of effective cell-based therapeutics for the treatment of B-cell malignancies.

New Unintended Adverse Consequences of Electronic Health Records

PubMed Central

Wright, A.; Ash, J.; Singh, H.

2016-01-01

Summary Although the health information technology industry has made considerable progress in the design, development, implementation, and use of electronic health records (EHRs), the lofty expectations of the early pioneers have not been met. In 2006, the Provider Order Entry Team at Oregon Health & Science University described a set of unintended adverse consequences (UACs), or unpredictable, emergent problems associated with computer-based provider order entry implementation, use, and maintenance. Many of these originally identified UACs have not been completely addressed or alleviated, some have evolved over time, and some new ones have emerged as EHRs became more widely available. The rapid increase in the adoption of EHRs, coupled with the changes in the types and attitudes of clinical users, has led to several new UACs, specifically: complete clinical information unavailable at the point of care; lack of innovations to improve system usability leading to frustrating user experiences; inadvertent disclosure of large amounts of patient-specific information; increased focus on computer-based quality measurement negatively affecting clinical workflows and patient-provider interactions; information overload from marginally useful computer-generated data; and a decline in the development and use of internally-developed EHRs. While each of these new UACs poses significant challenges to EHR developers and users alike, they also offer many opportunities. The challenge for clinical informatics researchers is to continue to refine our current systems while exploring new methods of overcoming these challenges and developing innovations to improve EHR interoperability, usability, security, functionality, clinical quality measurement, and information summarization and display. PMID:27830226

Continuous quality improvement and medical informatics: the convergent synergy.

PubMed

Werth, G R; Connelly, D P

1992-01-01

Continuous quality improvement (CQI) and medical informatics specialists need to converge their efforts to create synergy for improving health care. Health care CQI needs medical informatics' expertise and technology to build the information systems needed to manage health care organizations according to quality improvement principles. Medical informatics needs CQI's philosophy and methods to build health care information systems that can evolve to meet the changing needs of clinicians and other stakeholders. This paper explores the philosophical basis for convergence of CQI and medical informatics efforts, and then examines a clinical computer workstation development project that is applying a combined approach.

Building and Maintaining Organizational Infrastructure to Attain Clinical Excellence.

PubMed

Lebak, Kelly; Lane, Jason; Taus, Richard; Kim, Hansol; Stecker, Michael S; Hall, Michael; Lane-Fall, Meghan B; Weiss, Mark S

2017-12-01

Active maintenance of highly functional teams is critical to ensuring safe, efficient patient care in the non-operating room anesthesia (NORA) suite. In addition to developing collaborative relationships and patient care protocols, individual and team training is needed. For anesthesiologists, this training must begin during residency. The training should be supplemented with continuing education in this field for providers who find themselves working in the NORA space. As NORA continues to grow, robust NORA-specific quality assurance and improvement programs will empower anesthesiologists with the tools they need to best care for these patients. Copyright © 2017 Elsevier Inc. All rights reserved.

Continuing evolution of in-vitro diagnostic instrumentation

NASA Astrophysics Data System (ADS)

Cohn, Gerald E.

2000-04-01

The synthesis of analytical instrumentation and analytical biochemistry technologies in modern in vitro diagnostic instrumentation continues to generate new systems with improved performance and expanded capability. Detection modalities have expanded to include multichip modes of fluorescence, scattering, luminescence and reflectance so as to accommodate increasingly sophisticated immunochemical and nucleic acid based reagent systems. The time line graph of system development now extends from the earliest automated clinical spectrophotometers through molecule recognition assays and biosensors to the new breakthroughs of biochip and DNA diagnostics. This brief review traces some of the major innovations in the evolution of system technologies and previews the conference program.

[Clinical ethics committees in Mexico: their development in the Mexican Institute of Social Security].

PubMed

Valdez-Martínez, Edith; Bedolla, Miguel

2007-01-01

The Mexican Institute of Social Security (IMSS) considers the relevance of ethics in a similar context than other countries have developed. According to these considerations, IMSS implemented formally of system of local committees on clinical ethics (CLEC), not only to provide support when ethical dilemmas emerge, but to facilitate the development of an ethics culture among health professionals. The implementation of the CLEC network started in 2004, and since then, its number has increased across the country. Currently IMSS has 78 CLECs. Their number continues to grow due to the level of awareness about the importance of ethics for making medical decisions. In November 2006 the first CLEC national meeting was held and the need to redefine strategies to improve performance of CLECS emerged. This article reports the current situation of the CLECs in Mexico.

Lab and Imaging Tests

MedlinePlus

... Grant Grant Finder Therapy Acceleration Program Academic Concierge Biotechnology Accelerator Clinical Trials Division Resources for HCPs Continuing ... Grant Grant Finder Therapy Acceleration Program Academic Concierge Biotechnology Accelerator Clinical Trials Division Resources for HCPs Continuing ...

Getting started in academic cardiothoracic surgery.

PubMed

Verrier, E D

2000-04-01

Preparing to begin a career in academic cardiothoracic surgery requires forethought and desire. Success mandates honesty, discipline, opportunity, and support. This article will attempt to review some fundamental concepts important in starting such an academic career. The thoughts are somewhat personal and not meant to be inclusive. The article will briefly discuss the following issues: choosing the first job, transitions, effective time management, developing clinical confidence, the continued need for mentorship, developing educational value, developing a philosophy of academic growth, intellectual and emotional honesty, myths, mental and physical health, and keys to success.

[Hypoglossal nerve stimulation in patients with CPAP failure : Evolution of an alternative treatment for patients with obstructive sleep apnea].

PubMed

Heiser, C; Hofauer, B

2017-02-01

Obstructive sleep apnea (OSA) is a common disease in western industrialized countries with increasing prevalence. Gold standard of therapy is nocturnal positive pressure ventilation by continuous positive airway pressure (CPAP). Due to complications and side effects of ventilation, therapy adherence is limited. Recently an alternative surgical treatment has become available for these patients, which uses established techniques to stimulate the hypoglossus nerve to open the upper airway during sleep. The aim of this work is to provide an overview of the history and current state of scientific knowledge of this therapy in the treatment of OSA. Currently, two systems are available on the market: respiratory-driven hypoglossal nerve stimulation (Inspire Medical Systems) and continuous hypoglossal nerve stimulation (ImThera Medical). For respiratory-driven hypoglossal nerve stimulation, a solid body of evidence is available and the therapy has been investigated in numerous multicenter clinical studies with regard to safety and efficacy. Only a small number of publications is available for continuous hypoglossal nerve stimulation. At the end of the last century, promising clinical results were shown in the first patients treated with hypoglossal nerve stimulation. Consequent technological and scientific development of respiratory-driven hypoglossal nerve stimulation in recent years led to its implementation in today's clinical routine. This therapy significantly broadens the spectrum of therapies in the treatment of OSA, especially for patients with CPAP intolerance.

A Distance Blended Learning Program to Upgrade the Clinical Competence of District Non-doctor Anesthesia Providers in Nepal.

PubMed

Shah, Shristi; Knoble, Stephen; Ross, Oliver; Pickering, Stephen

2017-12-01

Across Nepal, anesthesia at a district level is provided mostly by non-doctor anesthesia providers (anesthesia assistants-AAs). Nepal's Government recognized the need to sustain competence with continuous professional development and to upgrade 6-month trained working AAs to professional equivalence with the new national standard of 12-month training. As they are essential district health workers and AA clinical training sites are full, an innovative distance blended learning, competency-based, upgrade 1-year course was developed and conducted in 2014-2017 for two batches. The course content was developed over 18 months by a team of Nepali and overseas AA training experts. The 1-year course started with a refresher course, continued with tablet-based 12-month self-learning modules and clinical case logs, regular educational mentor communication, midcourse 2-week contact time in an AA training site, regular text messaging and ended with clinical examination and multiple-choice questions. Tablet content included 168 new case studies, pre- and posttests, video lectures, matching exercises and a resource library. All module work and logged clinical cases were uploaded centrally, where clinical mentors were able to review work. Clinical skills were upgraded, as needed, through direct clinical contact midway through the course. Quantitative and qualitative course assessments were included. Fourteen working AAs in first batch and eight working AAs in second batch from district, zonal and mission hospitals across Nepal were enrolled. All remained working at their hospitals throughout the course, and there were no significant tablet problems inhibiting course completion. Twenty-one AAs completed all modules successfully with time required for module completion averaging 19.2 h (range 11.2-32). One AA left the course after 3 months with a personal problem. Subjectively, AAs felt that the obstetric and pediatric modules were more difficult; lowest marks were objectively seen in the airway module. Clinical mentors averaged 8.2 h mentoring review work per module with direct student communication of 2.9 h per module per month. Participants logged a total of 5473 clinical cases, ranging between 50 and 788 cases each. Complications were recorded; outcomes were good. Challenges were the national IT infrastructure making data synchronization difficult and the lack of clinical exposure at some AA's hospitals. Nineteen AAs attended the final examination, and all passed. Two AAs withdrew before the final examination period due to personal and logistic reasons. This is the first use of distance blended learning to upgrade district health workers in Nepal and perhaps for non-doctor anesthesia providers globally. Key success factors were motivated students, cultural and contextualized clinical content, good educational mentoring relationships with regular communication, central IT and motivational support, and face-to-face midcourse clinical contact time.

Clinical trials update: highlights of the scientific sessions of the American Heart Association year 2000: Val HeFT, COPERNICUS, MERIT, CIBIS-II, BEST, AMIOVIRT, V-MAC, BREATHE, HEAT, MIRACL, FLORIDA, VIVA and the first human cardiac skeletal muscle myoblast transfer for heart failure.

PubMed

Thackray, S D; Witte, K K; Khand, A; Dunn, A; Clark, A L; Cleland, J G

2001-01-01

This article continues a series of reports summarising recent research developments pertinent to the topic of heart failure. This is a summary of presentations made at scientific sessions of the American Heart Association in November 2000. Clinical studies of particular interest to people caring for patients with heart failure include Val-HeFT, AMIOVIRT and V-MAC. New data from beta-blockers trials are reviewed, highlights from some important developments in post-infarction care, including MIRACL and FLORIDA, discussed and results of some early studies of gene therapy reported.

Intracranial Pressure Monitoring—Review and Avenues for Development

PubMed Central

Dolmans, Rianne G. F.

2018-01-01

Intracranial pressure (ICP) monitoring is a staple of neurocritical care. The most commonly used current methods of monitoring in the acute setting include fluid-based systems, implantable transducers and Doppler ultrasonography. It is well established that management of elevated ICP is critical for clinical outcomes. However, numerous studies show that current methods of ICP monitoring cannot reliably define the limit of the brain’s intrinsic compensatory capacity to manage increases in pressure, which would allow for proactive ICP management. Current work in the field hopes to address this gap by harnessing live-streaming ICP pressure-wave data and a multimodal integration with other physiologic measures. Additionally, there is continued development of non-invasive ICP monitoring methods for use in specific clinical scenarios. PMID:29401746

International collaboration for pediatric oncology nursing leadership: Nicaragua and Canada.

PubMed

Orozco, A; Marin, V; Reyes, S; Challinor, J; Carpio, B

2009-01-01

In 2005, with financial support from the Pediatric Oncology Group of Ontario, a pilot nursing leadership project linked pediatric oncology nurses from Canada with nurses at the La Mascota Hospital in Managua, Nicaragua. Following consultation with the pediatric oncology team in Nicaragua, a program was developed to strengthen clinical nursing leadership in a clinical setting through continuing education. The nurses believed that care of the patient and family improved due to the increased leadership skills of nurses in the unit and as the profile and credibility of nurses as peers in the health care team became evident. Providing nurses with the autonomy and financing for a project related directly to nursing care represented an important development for leadership in the profession.

Functional Recovery Measures for Spinal Cord Injury: An Evidence-Based Review for Clinical Practice and Research

PubMed Central

Anderson, Kim; Aito, Sergio; Atkins, Michal; Biering-Sørensen, Fin; Charlifue, Susan; Curt, Armin; Ditunno, John; Glass, Clive; Marino, Ralph; Marshall, Ruth; Mulcahey, Mary Jane; Post, Marcel; Savic, Gordana; Scivoletto, Giorgio; Catz, Amiram

2008-01-01

Background/Objective: The end goal of clinical care and clinical research involving spinal cord injury (SCI) is to improve the overall ability of persons living with SCI to function on a daily basis. Neurologic recovery does not always translate into functional recovery. Thus, sensitive outcome measures designed to assess functional status relevant to SCI are important to develop. Method: Evaluation of currently available SCI functional outcome measures by a multinational work group. Results: The 4 measures that fit the prespecified inclusion criteria were the Modified Barthel Index (MBI), the Functional Independence Measure (FIM), the Quadriplegia Index of Function (QIF), and the Spinal Cord Independence Measure (SCIM). The MBI and the QIF were found to have minimal evidence for validity, whereas the FIM and the SCIM were found to be reliable and valid. The MBI has little clinical utility for use in the SCI population. Likewise, the FIM applies mainly when measuring burden of care, which is not necessarily a reflection of functional recovery. The QIF is useful for measuring functional recovery but only in a subpopulation of people with SCI, and substantial validity data are still required. The SCIM is the only functional recovery outcome measure designed specifically for SCI. Conclusions: The multinational work group recommends that the latest version of the SCIM (SCIM III) continue to be refined and validated and subsequently implemented worldwide as the primary functional recovery outcome measure for SCI. The QIF may continue to be developed and validated for use as a supplemental tool for the nonambulatory tetraplegic population. PMID:18581660

Evaluation of a Shared Decision-Making Intervention on the Utilization of Evidence-Based Psychotherapy in a VA Outpatient PTSD Clinic.

PubMed

Hessinger, Jonathan D; London, Melissa J; Baer, Sheila M

2017-03-13

The Veterans Health Administration (VHA) has continued to emphasize the availability, access, and utilization of high quality mental health care particularly in the treatment of posttraumatic stress disorder (PTSD). While dissemination and availability of evidence-based psychotherapies (EBPs) have only increased, treatment engagement and utilization have continued to be oft-noted challenges. Administrators, researchers, and individual clinicians have continued to develop and explore novel systemic and individualized interventions to address these issues. Pilot studies utilizing shared decision-making models to aid in veteran treatment selection have demonstrated the impact this approach may have on selection of and engagement in EBPs for PTSD. Based on these promising studies, a Department of Veterans Affairs (VA) outpatient PTSD clinic began to implement a shared-decision making intervention as part of a clinic redesign. In seeking to evaluate the impact of this intervention, archival clinical data from 1,056 veterans were reviewed by the authors for rates of treatment selection, EBP initiation, session attendance, and EBP completion. Time elapsed from consult until EBP initiation was also computed by the authors. These variables were then compared on the basis of whether the veteran received the shared-decision making intervention. Veterans who received the intervention were more likely to select and thus initiate an EBP for PTSD sooner than veterans who did not receive this intervention. Veterans, whether receiving the intervention or not, did not differ in therapy session attendance and completion. Implications of these findings and directions for future study are further discussed. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Bilateral rectus sheath haematoma complicating dengue virus infection in a patient on warfarin for mechanical aortic valve replacement: a case report.

PubMed

Rosa, Chamith Thushanga; Navinan, Mitrakrishnan Rayno; Samarawickrama, Sincy; Hamza, Himam; Gunarathne, Maheshika; Arulanantham, Arulprashanth; Subba, Neeha; Samarasiri, Udari; Mathias, Thushara; Kulatunga, Aruna

2017-01-07

The management of Dengue virus infection can be challenging. Varied presentations and numerous complications intrinsic to dengue by itself increase the complexity of treatment and potential mortality. When burdened with the presence of additional comorbidities and the need to continue compulsory medications, clear stepwise definitive guidance is lacking and patients tend to have more complex complications and outcomes calling to question the clinical decisions that may have been taken. The use and continuation of warfarin in dengue virus infection is one such example. We report a 65 year old South Asian female who presented with dengue fever. She had a history bronchial asthma, a prior abdominal surgery, and was on warfarin and maintained a therapeutically appropriate internationalized normalized ratio for a mechanical aortic valve replacement. Though preemptive decision to stop warfarin was taken with decreasing platelet counts, her clinical course was complicated with the development of bilateral rectus sheath haematoma's requiring resuscitation with blood transfusions. Though management of dengue viral fever has seen drastic evolution with recent updated guidance, clinical scenarios seen in the course of the illness still pose challenges to the managing physician. The need to continue obligatory anticoagulation which may seem counterintuitive during a complex disease such as dengue virus infection must be considered after understanding the potential risks versus that of its benefits. Though case by case decisions maybe warranted, a clear protocol would be very helpful in making clinical decisions, as the correct preemptive decision may potentially avert catastrophic and unpredictable bleeding events.

Found in Translation: How Preclinical Research Is Guiding the Clinical Development of the BCL2-Selective Inhibitor Venetoclax.

PubMed

Leverson, Joel D; Sampath, Deepak; Souers, Andrew J; Rosenberg, Saul H; Fairbrother, Wayne J; Amiot, Martine; Konopleva, Marina; Letai, Anthony

2017-12-01

Since the discovery of apoptosis as a form of programmed cell death, targeting the apoptosis pathway to induce cancer cell death has been a high-priority goal for cancer therapy. After decades of effort, drug-discovery scientists have succeeded in generating small-molecule inhibitors of antiapoptotic BCL2 family proteins. Innovative medicinal chemistry and structure-based drug design, coupled with a strong fundamental understanding of BCL2 biology, were essential to the development of BH3 mimetics such as the BCL2-selective inhibitor venetoclax. We review a number of preclinical studies that have deepened our understanding of BCL2 biology and facilitated the clinical development of venetoclax. Significance: Basic research into the pathways governing programmed cell death have paved the way for the discovery of apoptosis-inducing agents such as venetoclax, a BCL2-selective inhibitor that was recently approved by the FDA and the European Medicines Agency. Preclinical studies aimed at identifying BCL2-dependent tumor types have translated well into the clinic thus far and will likely continue to inform the clinical development of venetoclax and other BCL2 family inhibitors. Cancer Discov; 7(12); 1376-93. ©2017 AACR. ©2017 American Association for Cancer Research.

Drug development and nonclinical to clinical translational databases: past and current efforts.

PubMed

Monticello, Thomas M

2015-01-01

The International Consortium for Innovation and Quality (IQ) in Pharmaceutical Development is a science-focused organization of pharmaceutical and biotechnology companies. The mission of the Preclinical Safety Leadership Group (DruSafe) of the IQ is to advance science-based standards for nonclinical development of pharmaceutical products and to promote high-quality and effective nonclinical safety testing that can enable human risk assessment. DruSafe is creating an industry-wide database to determine the accuracy with which the interpretation of nonclinical safety assessments in animal models correctly predicts human risk in the early clinical development of biopharmaceuticals. This initiative aligns with the 2011 Food and Drug Administration strategic plan to advance regulatory science and modernize toxicology to enhance product safety. Although similar in concept to the initial industry-wide concordance data set conducted by International Life Sciences Institute's Health and Environmental Sciences Institute (HESI/ILSI), the DruSafe database will proactively track concordance, include exposure data and large and small molecules, and will continue to expand with longer duration nonclinical and clinical study comparisons. The output from this work will help identify actual human and animal adverse event data to define both the reliability and the potential limitations of nonclinical data and testing paradigms in predicting human safety in phase 1 clinical trials. © 2014 by The Author(s).

Development and Integration of Professional Core Values Among Practicing Clinicians.

PubMed

McGinnis, Patricia Quinn; Guenther, Lee Ann; Wainwright, Susan F

2016-09-01

The physical therapy profession has adopted professional core values, which define expected values for its members, and developed a self-assessment tool with sample behaviors for each of the 7 core values. However, evidence related to the integration of these core values into practice is limited. The aims of this study were: (1) to gain insight into physical therapists' development of professional core values and (2) to gain insight into participants' integration of professional core values into clinical practice. A qualitative design permitted in-depth exploration of the development and integration of the American Physical Therapy Association's professional core values into physical therapist practice. Twenty practicing physical therapists were purposefully selected to explore the role of varied professional, postprofessional, and continuing education experiences related to exposure to professional values. The Core Values Self-Assessment and résumé sort served as prompts for reflection via semistructured interviews. Three themes were identified: (1) personal values were the foundation for developing professional values, which were further shaped by academic and clinical experiences, (2) core values were integrated into practice independent of practice setting and varied career paths, and (3) participants described the following professional core values as well integrated into their practice: integrity, compassion/caring, and accountability. Social responsibility was an area consistently identified as not being integrated into their practice. The Core Values Self-Assessment tool is a consensus-based document developed through a Delphi process. Future studies to establish reliability and construct validity of the tool may be warranted. Gaining an in-depth understanding of how practicing clinicians incorporate professional core values into clinical practice may shed light on the relationship between core values mastery and its impact on patient care. Findings may help shape educators' decisions for professional (entry-level), postprofessional, and continuing education. © 2016 American Physical Therapy Association.

Continuous glucose monitoring: 40 years, what we've learned and what's next.

PubMed

Gifford, Raeann

2013-07-22

After 40 years of research and development, today continuous glucose monitoring (CGM) is demonstrating the benefit it provides for millions with diabetes. To provide in vivo accuracy, new permselective membranes and mediated systems have been developed to prevent enzyme saturation and to minimize interference signals. Early in vivo implanted sensor research clearly showed that the foreign body response was a more difficult issue to overcome. Understanding the biological interface and circumventing the inflammatory response continue to drive development of a CGM sensor with accuracy and reliability performance suitable in a closed-loop artificial pancreas. Along with biocompatible polymer development, other complimentary algorithm and data analysis techniques have improved the performance of commercial systems significantly. For example, the mean average relative difference of Dexcom's CGM system improved from 26 to 14% and its use-life was extended from 3 to 7 d. Significant gains in usability, including size, flexibility, insertion, calibration, and data interface, have been incorporated into new generations of commercial CGM systems. Besides Medtronic, Dexcom, and Abbott, other major players are also investing in CGM. Becton Dickinson is conducting clinical trials with an optical galactose glucose binding system. Development of fully implanted sensor systems fulfills the desire for a discreet, reliable CGM system. Research continues to find innovative ways to help make living with diabetes easier and more normal, and new segments are being pursued (intensive care unit, surgery, behavior modification) in which CGM is being utilized. Copyright © 2013 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Oral insulin reloaded: a structured approach.

PubMed

Zijlstra, Eric; Heinemann, Lutz; Plum-Mörschel, Leona

2014-05-01

Optimal coverage of insulin needs is the paramount aim of insulin replacement therapy in patients with diabetes mellitus. To apply insulin without breaking the skin barrier by a needle and/or to allow a more physiological provision of insulin are the main reasons triggering the continuous search for alternative routes of insulin administration. Despite numerous attempts over the past 9 decades to develop an insulin pill, no insulin for oral dosing is commercially available. By way of a structured approach, we aim to provide a systematic update on the most recent developments toward an orally available insulin formulation with a clear focus on data from clinical-experimental and clinical studies. Thirteen companies that claim to be working on oral insulin formulations were identified. However, only 6 of these companies published new clinical trial results within the past 5 years. Interestingly, these clinical data reports make up a mere 4% of the considerably high total number of publications on the development of oral insulin formulations within this time period. While this picture clearly reflects the rising research interest in orally bioavailable insulin formulations, it also highlights the fact that the lion's share of research efforts is still allocated to the preclinical stages. © 2014 Diabetes Technology Society.

Therapeutic Antibodies by Phage Display.

PubMed

Shim, Hyunbo

2016-01-01

Antibody phage display is a major technological platform for the generation of fully human antibodies for therapeutic purposes. The in vitro binder selection by phage display allows researchers to have more extensive control over binding parameters and facilitates the isolation of clinical candidate antibodies with desired binding and/or functional profiles. Since the invention of antibody phage display in late 1980s, significant technological advancements in the design, construction, and selection of the antibody libraries have been made, and several fully human antibodies generated by phage display are currently approved or in various clinical development stages. In this review, the background and details of antibody phage display technology, and representative antibody libraries with natural or synthetic sequence diversity and different construction strategies are described. The generation, optimization, functional and biophysical properties, and preclinical and clinical developments of some of the phage display-derived therapeutic antibodies approved for use in patients or in late-stage clinical trials are also discussed. With evolving novel disease targets and therapeutic strategies, antibody phage display is expected to continue to play a central role in the development of the next generation of therapeutic antibodies. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Using Clinical Questions Asked by Primary Care Providers Through eConsults to Inform Continuing Professional Development.

PubMed

Archibald, Douglas; Liddy, Clare; Lochnan, Heather A; Hendry, Paul J; Keely, Erin J

2018-01-01

Continuing professional development (CPD) offerings should address the educational needs of health care providers. Innovative programs, such as electronic consultations (eConsults), provide unique educational opportunities for practice-based needs assessment. The purpose of this study is to assess whether CPD offerings match the needs of physicians by coding and comparing session content to clinical questions asked through eConsults. This study analyzes questions asked by primary care providers between July 2011 and January 2015 using a service that allows specialists to provide consultation over a secure web-based server. The content of these questions was compared with the CPD courses offered in the area in which these primary care providers are practicing over a similar period (2012-2014). The clinical questions were categorized by the content area. The percentage of questions asked about each content area was calculated for each of the 12 specialties consulted. CPD course offerings were categorized using the same list of content areas. Percentage of minutes dedicated to each content area was calculated for each specialty. The percentage of questions asked and the percentage of CPD course minutes for each content area were compared. There were numerous congruencies and discrepancies between the proportion of questions asked about a given content area and the CPD minutes dedicated to it. Traditional needs assessment may underestimate the need to address topics that are frequently the subject of eConsults. Planners should recognize eConsult questions as a valuable source of practice-associated challenges that can identify professional development needs of physicians.

A Unique Digital Electrocardiographic Repository for the Development of Quantitative Electrocardiography and Cardiac Safety: The Telemetric and Holter ECG Warehouse (THEW)

PubMed Central

Couderc, Jean-Philippe

2010-01-01

The sharing of scientific data reinforces open scientific inquiry; it encourages diversity of analysis and opinion while promoting new research and facilitating the education of next generations of scientists. In this article, we present an initiative for the development of a repository containing continuous electrocardiographic information and their associated clinical information. This information is shared with the worldwide scientific community in order to improve quantitative electrocardiology and cardiac safety. First, we present the objectives of the initiative and its mission. Then, we describe the resources available in this initiative following three components: data, expertise and tools. The Data available in the Telemetric and Holter ECG Warehouse (THEW) includes continuous ECG signals and associated clinical information. The initiative attracted various academic and private partners whom expertise covers a large list of research arenas related to quantitative electrocardiography; their contribution to the THEW promotes cross-fertilization of scientific knowledge, resources, and ideas that will advance the field of quantitative electrocardiography. Finally, the tools of the THEW include software and servers to access and review the data available in the repository. To conclude, the THEW is an initiative developed to benefit the scientific community and to advance the field of quantitative electrocardiography and cardiac safety. It is a new repository designed to complement the existing ones such as Physionet, the AHA-BIH Arrhythmia Database, and the CSE database. The THEW hosts unique datasets from clinical trials and drug safety studies that, so far, were not available to the worldwide scientific community. PMID:20863512

Impact of new information technologies on training and continuing education for rural health professionals.

PubMed

Crandall, L A; Coggan, J M

1994-01-01

Recently developed and emerging information and communications technologies offer the potential to move the clinical training of physicians and other health professionals away from the resource intensive urban academic health center, with its emphasis on tertiary care, and into rural settings that may be better able to place emphasis on the production of badly needed primary care providers. These same technologies also offer myriad opportunities to enhance the continuing education of health professionals in rural settings. This article explores the effect of new technologies for rural tele-education by briefly reviewing the effect of technology on health professionals' education, describing ongoing applications of tele-education, and discussing the likely effect of new technological developments on the future of tele-education. Tele-education has tremendous potential for improving the health care of rural Americans, and policy-makers must direct resources to its priority development in rural communities.

Equitable treatment for HIV/AIDS clinical trial participants: a focus group study of patients, clinician researchers, and administrators in Western Kenya.

PubMed

Shaffer, D N; Yebei, V N; Ballidawa, J B; Sidle, J E; Greene, J Y; Meslin, E M; Kimaiyo, S J N; Tierney, W M

2006-01-01

To describe the concerns and priorities of key stakeholders in a developing country regarding ethical obligations held by researchers and perceptions of equity or "what is fair" for study participants in an HIV/AIDS clinical drug trial. Qualitative study with focus groups. Teaching and referral hospital and rural health centre in Western Kenya. Potential HIV/AIDS clinical trial participants, clinician researchers, and administrators. Eighty nine individuals participated in a total of 11 focus groups over a four month period. The desire for continued drug therapy, most often life long, following an HIV/AIDS clinical trial was the most common priority expressed in all focus groups. Patients with and without HIV/AIDS also thought subsidizing of drug therapies and education were critical forms of compensation for clinical trial participation. Financial incentives were considered important primarily for purchasing drug therapy as well as obtaining food. Patients noted a concern for the potential mismanagement of any money offered. Clinician researchers and administrators felt strongly that researchers have a moral obligation to participants following a trial to provide continued drug therapy, adverse event monitoring, and primary care. Finally, clinician researchers and administrators stressed the need for thorough informed consent to avoid coercion of study participants. Kenyan patients, clinician researchers, and administrators believe that it would be unfair to stop antiretroviral therapy following an HIV/AIDS clinical trial and that researchers have a long term obligation to participants.

Imaging biomarker roadmap for cancer studies

PubMed Central

O’Connor, James P. B.; Aboagye, Eric O.; Adams, Judith E.; Aerts, Hugo J. W. L.; Barrington, Sally F.; Beer, Ambros J.; Boellaard, Ronald; Bohndiek, Sarah E.; Brady, Michael; Brown, Gina; Buckley, David L.; Chenevert, Thomas L.; Clarke, Laurence P.; Collette, Sandra; Cook, Gary J.; deSouza, Nandita M.; Dickson, John C.; Dive, Caroline; Evelhoch, Jeffrey L.; Faivre-Finn, Corinne; Gallagher, Ferdia A.; Gilbert, Fiona J.; Gillies, Robert J.; Goh, Vicky; Griffiths, John R.; Groves, Ashley M.; Halligan, Steve; Harris, Adrian L.; Hawkes, David J.; Hoekstra, Otto S.; Huang, Erich P.; Hutton, Brian F.; Jackson, Edward F.; Jayson, Gordon C.; Jones, Andrew; Koh, Dow-Mu; Lacombe, Denis; Lambin, Philippe; Lassau, Nathalie; Leach, Martin O.; Lee, Ting-Yim; Leen, Edward L.; Lewis, Jason S.; Liu, Yan; Lythgoe, Mark F.; Manoharan, Prakash; Maxwell, Ross J.; Miles, Kenneth A.; Morgan, Bruno; Morris, Steve; Ng, Tony; Padhani, Anwar R.; Parker, Geoff J. M.; Partridge, Mike; Pathak, Arvind P.; Peet, Andrew C.; Punwani, Shonit; Reynolds, Andrew R.; Robinson, Simon P.; Shankar, Lalitha K.; Sharma, Ricky A.; Soloviev, Dmitry; Stroobants, Sigrid; Sullivan, Daniel C.; Taylor, Stuart A.; Tofts, Paul S.; Tozer, Gillian M.; van Herk, Marcel; Walker-Samuel, Simon; Wason, James; Williams, Kaye J.; Workman, Paul; Yankeelov, Thomas E.; Brindle, Kevin M.; McShane, Lisa M.; Jackson, Alan; Waterton, John C.

2017-01-01

Imaging biomarkers (IBs) are integral to the routine management of patients with cancer. IBs used daily in oncology include clinical TNM stage, objective response and left ventricular ejection fraction. Other CT, MRI, PET and ultrasonography biomarkers are used extensively in cancer research and drug development. New IBs need to be established either as useful tools for testing research hypotheses in clinical trials and research studies, or as clinical decision-making tools for use in healthcare, by crossing ‘translational gaps’ through validation and qualification. Important differences exist between IBs and biospecimen-derived biomarkers and, therefore, the development of IBs requires a tailored ‘roadmap’. Recognizing this need, Cancer Research UK (CRUK) and the European Organisation for Research and Treatment of Cancer (EORTC) assembled experts to review, debate and summarize the challenges of IB validation and qualification. This consensus group has produced 14 key recommendations for accelerating the clinical translation of IBs, which highlight the role of parallel (rather than sequential) tracks of technical (assay) validation, biological/clinical validation and assessment of cost-effectiveness; the need for IB standardization and accreditation systems; the need to continually revisit IB precision; an alternative framework for biological/clinical validation of IBs; and the essential requirements for multicentre studies to qualify IBs for clinical use. PMID:27725679

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.

Supporting new graduate professional development: a clinical learning framework.

PubMed

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

2015-02-01

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

Clopidogrel and warfarin pharmacogenetic tests: what is the evidence for use in clinical practice?

PubMed Central

Shahin, Mohamed H.A.; Johnson, Julie A.

2013-01-01

Purpose of review To review the most promising genetic markers associated with the variability in the safety or efficacy of warfarin and clopidogrel and highlight the verification and validation initiatives for translating clopidogrel and warfarin pharmacogenetic tests to clinical practice. Recent findings Rapid advances in pharmacogenetics, continuous decrease in genotyping cost, development of point-of-care devices and the newly established clinical genotyping programs at several institutions hold the promise of individualizing clopidogrel and warfarin based on genotype. Guidelines have been established to assist clinicians in prescribing clopidogrel or warfarin dose based on genotype. However, the clinical utility of clopidogrel and warfarin is still limited. Accordingly, large randomized clinical trials are underway to define the role of clopidogrel and warfarin pharmacogenetics in clinical practice. Summary Pharmacogenetics has offered compelling evidence toward the individualization of clopidogrel and warfarin therapies. The rapid advances in technology make the clinical implementation of clopidogrel and warfarin pharmacogenetics possible. The clinical genotyping programs and the ongoing clinical trials will help in overcoming some of the barriers facing the clinical implementation of clopidogrel and warfarin pharmacogenetics. PMID:23478884

Wearable medical systems for p-Health.

PubMed

Teng, Xiao-Fei; Zhang, Yuan-Ting; Poon, Carmen C Y; Bonato, Paolo

2008-01-01

Driven by the growing aging population, prevalence of chronic diseases, and continuously rising healthcare costs, the healthcare system is undergoing a fundamental transformation, from the conventional hospital-centered system to an individual-centered system. Current and emerging developments in wearable medical systems will have a radical impact on this paradigm shift. Advances in wearable medical systems will enable the accessibility and affordability of healthcare, so that physiological conditions can be monitored not only at sporadic snapshots but also continuously for extended periods of time, making early disease detection and timely response to health threats possible. This paper reviews recent developments in the area of wearable medical systems for p-Health. Enabling technologies for continuous and noninvasive measurements of vital signs and biochemical variables, advances in intelligent biomedical clothing and body area networks, approaches for motion artifact reduction, strategies for wearable energy harvesting, and the establishment of standard protocols for the evaluation of wearable medical devices are presented in this paper with examples of clinical applications of these technologies.

Aspiring to Unintended Consequences of Natural Language Processing: A Review of Recent Developments in Clinical and Consumer-Generated Text Processing

PubMed Central

Elhadad, N.

2016-01-01

Summary Objectives This paper reviews work over the past two years in Natural Language Processing (NLP) applied to clinical and consumer-generated texts. Methods We included any application or methodological publication that leverages text to facilitate healthcare and address the health-related needs of consumers and populations. Results Many important developments in clinical text processing, both foundational and task-oriented, were addressed in community-wide evaluations and discussed in corresponding special issues that are referenced in this review. These focused issues and in-depth reviews of several other active research areas, such as pharmacovigilance and summarization, allowed us to discuss in greater depth disease modeling and predictive analytics using clinical texts, and text analysis in social media for healthcare quality assessment, trends towards online interventions based on rapid analysis of health-related posts, and consumer health question answering, among other issues. Conclusions Our analysis shows that although clinical NLP continues to advance towards practical applications and more NLP methods are used in large-scale live health information applications, more needs to be done to make NLP use in clinical applications a routine widespread reality. Progress in clinical NLP is mirrored by developments in social media text analysis: the research is moving from capturing trends to addressing individual health-related posts, thus showing potential to become a tool for precision medicine and a valuable addition to the standard healthcare quality evaluation tools. PMID:27830255

The visual and functional impacts of astigmatism and its clinical management.

PubMed

Read, Scott A; Vincent, Stephen J; Collins, Michael J

2014-05-01

To provide a comprehensive overview of research examining the impact of astigmatism on clinical and functional measures of vision, the short and longer term adaptations to astigmatism that occur in the visual system, and the currently available clinical options for the management of patients with astigmatism. The presence of astigmatism can lead to substantial reductions in visual performance in a variety of clinical vision measures and functional visual tasks. Recent evidence demonstrates that astigmatic blur results in short-term adaptations in the visual system that appear to reduce the perceived impact of astigmatism on vision. In the longer term, uncorrected astigmatism in childhood can also significantly impact on visual development, resulting in amblyopia. Astigmatism is also associated with the development of spherical refractive errors. Although the clinical correction of small magnitudes of astigmatism is relatively straightforward, the precise, reliable correction of astigmatism (particularly high astigmatism) can be challenging. A wide variety of refractive corrections are now available for the patient with astigmatism, including spectacle, contact lens and surgical options. Astigmatism is one of the most common refractive errors managed in clinical ophthalmic practice. The significant visual and functional impacts of astigmatism emphasise the importance of its reliable clinical management. With continued improvements in ocular measurement techniques and developments in a range of different refractive correction technologies, the future promises the potential for more precise and comprehensive correction options for astigmatic patients. © 2014 The Authors Ophthalmic & Physiological Optics © 2014 The College of Optometrists.

Improving health services to displaced persons in Aceh, Indonesia: a balanced scorecard

PubMed Central

Parco, Kristin B; Sihombing, Melva E; Tredwell, Susan P; O'Rourke, Edward J

2010-01-01

Abstract Problem After the Indian Ocean tsunami in December 2004, the International Organization for Migration constructed temporary health clinics to provide medical services to survivors living in temporary accommodation centres throughout Aceh, Indonesia. Limited resources, inadequate supervision, staff turnover and lack of a health information system made it challenging to provide quality primary health services. Approach A balanced scorecard was developed and implemented in collaboration with local health clinic staff and district health officials. Performance targets were identified. Staff collected data from clinics and accommodation centres to develop 30 simple performance measures. These measures were monitored periodically and discussed at meetings with stakeholders to guide the development of health interventions. Local setting Two years after the tsunami, 34 000 displaced persons continued to receive services from temporary health clinics in two districts of Aceh province. From March to December 2007, the scorecard was implemented in seven temporary health clinics. Relevant changes Interventions stimulated and tracked by the scorecard showed measurable improvements in preventive medicine, child health, capacity building of clinic staff and availability of essential drugs. By enhancing communication, the scorecard also led to qualitative benefits. Lessons learnt The balanced scorecard is a practical tool to focus attention and resources to facilitate improvement in disaster rehabilitation settings where health information infrastructure is poor. Introducing a mechanism for rapid improvement fostered communication between nongovernmental organizations, district health officials, clinic health workers and displaced persons. PMID:20865077

Strengthening the Career Development of Clinical Translational Scientist Trainees: A Consensus Statement of the Clinical Translational Science Award (CTSA) Research Education and Career Development Committees

PubMed Central

Meyers, Frederick J.; Begg, Melissa D.; Fleming, Michael; Merchant, Carol

2012-01-01

Abstract  The challenges for scholars committed to successful careers in clinical and translational science are increasingly well recognized. The Education and Career Development (EdCD) of the national Clinical and Translational Science Award consortium gathered thought leaders to propose sustainable solutions and an agenda for future studies that would strengthen the infrastructure across the spectrum of pre‐ and postdoctoral, MD and PhD, scholars. Six consensus statements were prepared that include: (1) the requirement for career development of a qualitatively different investigator; (2) the implications of interdisciplinary science for career advancement including institutional promotion and tenure actions that were developed for discipline‐specific accomplishments; (3) the need for long‐term commitment of institutions to scholars; (4) discipline‐specific curricula are still required but curricula designed to promote team work and interdisciplinary training will promote innovation; (5) PhD trainees have many pathways to career satisfaction and success; and (6) a centralized infrastructure to enhance and reward mentoring is required. Several themes cut across all of the recommendations including team science, innovation, and sustained institutional commitment. Implied themes include an effective and diverse job force and the requirement for a well‐crafted public policy that supports continued investments in science education. Clin Trans Sci 2012; Volume #: 1–6 PMID:22507118