75 FR 57472 - Clinical Investigator Training Course

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0456... scientific, regulatory, and ethical considerations involved in the conduct of clinical trials. DATES: The... development of medical products. They bear the responsibility for ensuring the safe and ethical treatment of...

Translation of an Evidence-Based Tailored Childhood Injury Prevention Program

PubMed Central

Weaver, Nancy L.; Williams, Janice; Jacobsen, Heather A.; Botello-Harbaum, Maria; Glasheen, Cristie; Noelcke, Elizabeth; Nansel, Tonja R.

2008-01-01

This article describes the process of translating Safe n’ Sound, a computer-based program for parents of young children, for a general clinic environment. Safe n’ Sound is designed to reduce the risk of unintentional childhood injuries, the leading cause of death among children older than 1 year in the United States. The evidence-based program produces tailored information for parents and their healthcare provider about burns, falls, poisoning, drowning, suffocations, choking prevention, and car safety. To offer Safe n’ Sound to a broader audience, we translated the program from the form used for efficacy testing to a stand-alone application. Notable steps in this translation included (1) conducting an organizational assessment to determine the needs of the clinic staff and feasibility of implementation, (2) modifying the program to reduce length, prioritize risk areas, and update content, (3) repackaging the program to minimize cost and space requirements, and (4) developing promotional and instructional materials. Factors contributing to the success of this effort include strong collaborative partnerships, the relative advantage of Safe n’ Sound over traditional materials, the modifiable design of the program, and the support of the clinic staff and providers. Challenges and areas for future work are discussed. PMID:18287925

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

PubMed Central

Krause, Beatrix; Cohen Kadosh, Roi

2013-01-01

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

Human germline gene editing: Recommendations of ESHG and ESHRE.

PubMed

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

2018-04-01

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

Capturing Essential Information to Achieve Safe Interoperability

PubMed Central

Weininger, Sandy; Jaffe, Michael B.; Rausch, Tracy; Goldman, Julian M.

2016-01-01

In this article we describe the role of “clinical scenario” information to assure the safety of interoperable systems, as well as the system’s ability to deliver the requisite clinical functionality to improve clinical care. Described are methods and rationale for capturing the clinical needs, workflow, hazards, and device interactions in the clinical environment. Key user (clinician and clinical engineer) needs and system requirements can be derived from this information, therefore improving the communication from clinicians to medical device and information technology system developers. This methodology is intended to assist the health care community, including researchers, standards developers, regulators, and manufacturers, by providing clinical definition to support requirements in the systems engineering process, particularly those focusing on development of Integrated Clinical Environments described in standard ASTM F2761. Our focus is on identifying and documenting relevant interactions and medical device capabilities within the system using a documentation tool called medical device interface data sheets (MDIDSa) and mitigating hazardous situations related to workflow, product usability, data integration, and the lack of effective medical device-health information technology system integration to achieve safe interoperability. Portions of the analysis of a clinical scenario for a “Patient-controlled analgesia safety interlock” are provided to illustrate the method. Collecting better clinical adverse event information and proposed solutions can help identify opportunities to improve current device capabilities and interoperability and support a Learning Health System to improve health care delivery. Developing and analyzing clinical scenarios are the first steps in creating solutions to address vexing patient safety problems and enable clinical innovation. A web-based research tool for implementing a means of acquiring and managing this information, the Clinical Scenario Repository™, is described. PMID:27387840

Capturing Essential Information to Achieve Safe Interoperability.

PubMed

Weininger, Sandy; Jaffe, Michael B; Rausch, Tracy; Goldman, Julian M

2017-01-01

In this article, we describe the role of "clinical scenario" information to assure the safety of interoperable systems, as well as the system's ability to deliver the requisite clinical functionality to improve clinical care. Described are methods and rationale for capturing the clinical needs, workflow, hazards, and device interactions in the clinical environment. Key user (clinician and clinical engineer) needs and system requirements can be derived from this information, therefore, improving the communication from clinicians to medical device and information technology system developers. This methodology is intended to assist the health care community, including researchers, standards developers, regulators, and manufacturers, by providing clinical definition to support requirements in the systems engineering process, particularly those focusing on development of Integrated Clinical Environments described in standard ASTM F2761. Our focus is on identifying and documenting relevant interactions and medical device capabilities within the system using a documentation tool called medical device interface data sheets and mitigating hazardous situations related to workflow, product usability, data integration, and the lack of effective medical device-health information technology system integration to achieve safe interoperability. Portions of the analysis of a clinical scenario for a "patient-controlled analgesia safety interlock" are provided to illustrate the method. Collecting better clinical adverse event information and proposed solutions can help identify opportunities to improve current device capabilities and interoperability and support a learning health system to improve health care delivery. Developing and analyzing clinical scenarios are the first steps in creating solutions to address vexing patient safety problems and enable clinical innovation. A Web-based research tool for implementing a means of acquiring and managing this information, the Clinical Scenario Repository™ (MD PnP Program), is described.

Exploring the teaching and learning of clinical reasoning, risks, and benefits of cervical spine manipulation.

PubMed

Yamamoto, Katie; Condotta, Luca; Haldane, Chloe; Jaffrani, Sahar; Johnstone, Victoria; Jachyra, Patrick; Gibson, Barbara E; Yeung, Euson

2018-02-01

The aim of this study was to examine how risks and benefits of cervical spine manipulation (CSM) were framed and discussed in the context of mentorship and their impact on the perception of safe practice of CSM in clinical physiotherapy settings. A multi-method qualitative approach was employed, including a document analysis of established educational guidelines, observations of mentoring sessions, and individual face-to-face interviews with five mentees in the process of learning CSM, and four mentors with Orthopedic Manual Physical Therapy (OMPT) certification. Results demonstrated that participants' clinical decision-making processes to perform CSM were primarily oriented to the mitigation of risk. Achieving proficiency in the "science" of clinical reasoning and the "art" of "feel" related to mastering technical skills were viewed as means to mitigating risk and enhancing confidence to use CSM safely in clinical practice. While the "art" of technical skill mastery was of high importance to mentees and considered important to developing competency in performing CSM, it was discussed as distinct from their clinical reasoning processes. Thus, promoting a more balanced and integrated use of the "art" and "science" of safe practice for CSM in OMPT training may result in greater confidence and judicious use of CSM by physiotherapists.

Non-clinical studies in the process of new drug development - Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies.

PubMed

Andrade, E L; Bento, A F; Cavalli, J; Oliveira, S K; Schwanke, R C; Siqueira, J M; Freitas, C S; Marcon, R; Calixto, J B

2016-12-12

The process of drug development involves non-clinical and clinical studies. Non-clinical studies are conducted using different protocols including animal studies, which mostly follow the Good Laboratory Practice (GLP) regulations. During the early pre-clinical development process, also known as Go/No-Go decision, a drug candidate needs to pass through several steps, such as determination of drug availability (studies on pharmacokinetics), absorption, distribution, metabolism and elimination (ADME) and preliminary studies that aim to investigate the candidate safety including genotoxicity, mutagenicity, safety pharmacology and general toxicology. These preliminary studies generally do not need to comply with GLP regulations. These studies aim at investigating the drug safety to obtain the first information about its tolerability in different systems that are relevant for further decisions. There are, however, other studies that should be performed according to GLP standards and are mandatory for the safe exposure to humans, such as repeated dose toxicity, genotoxicity and safety pharmacology. These studies must be conducted before the Investigational New Drug (IND) application. The package of non-clinical studies should cover all information needed for the safe transposition of drugs from animals to humans, generally based on the non-observed adverse effect level (NOAEL) obtained from general toxicity studies. After IND approval, other GLP experiments for the evaluation of chronic toxicity, reproductive and developmental toxicity, carcinogenicity and genotoxicity, are carried out during the clinical phase of development. However, the necessity of performing such studies depends on the new drug clinical application purpose.

Review on research of suppression male fertility and male contraceptive drug development by natural products.

PubMed

Bajaj, Vijay Kumar; Gupta, Radhey S

2013-08-01

Male contraceptive development in the present scenario is most viable aspect of research due to uncontrolled population growth in the world. In this respect investigators are busy to find out a safe male contraceptive drug. Researchers have started their finding for a suitable drug from natural sources because these are safe and easily acceptable for common man, most of natural sources are plants and their products. In this review 137 plants and their effects on reproduction and reproductive physiology are summarized. Some of them have intense effect on male reproductive system and do not produce any side effects. Reproductive toxicological studies are also important aspects of these kinds of researches, so it is important that drugs are safe and widely acceptable. An ideal male contraceptive can influence semen, testes, hormone level, accessory reproductive organs and general physiology of animals and produced some alterations. Many plants in this review are showing antifertility as well as antispermatogenic effects, so these may be used for further study for contraceptives development but it is important to find out the mechanism of reaction and further laboratory and clinical research on some plants are needed for final male contraceptive drug development. In conclusion this review will help for finding suitable plant products for male contraceptive clinical and laboratory studies.

Safe and successful implementation of CPOE for chemotherapy at a children's cancer center.

PubMed

Hoffman, James M; Baker, Donald K; Howard, Scott C; Laver, Joseph H; Shenep, Jerry L

2011-02-01

Computerized prescriber order entry (CPOE) for medications has been implemented in only approximately 1 in 6 United States hospitals, with CPOE for chemotherapy lagging behind that for nonchemotherapy medications. The high risks associated with chemotherapy combined with other aspects of cancer care present unique challenges for the safe and appropriate use of CPOE. This article describes the process for safe and successful implementation of CPOE for chemotherapy at a children's cancer center. A core principle throughout the development and implementation of this system was that it must be as safe (and eventually safer) as existing paper systems and processes. The history of requiring standardized, regimen-specific, preprinted paper order forms served as the foundation for safe implementation of CPOE for chemotherapy. Extensive use of electronic order sets with advanced functionality; formal process redesign and system analysis; automated clinical decision support; and a phased implementation approach were essential strategies for safe implementation of CPOE. With careful planning and adequate resources, CPOE for chemotherapy can be safely implemented.

Plant-based vaccines against diarrheal diseases.

PubMed

Tacket, Carol O

2007-01-01

Every year 1.6 million deaths occur due to diarrhea related to unsafe water and inadequate sanitation-the vast majority in children under 5 years old. Safe and effective vaccines against enteric infections could contribute to control of these diseases. However, purification of protective antigens for inclusion in vaccines using traditional expression systems is expensive and unattractive to vaccine manufacturers who see the vaccine market as economically uninviting. Cost is one of the persistent barriers to deployment of new vaccines to populations that need them most urgently. Transgenic plant-derived vaccines offer a new strategy for development of safe, inexpensive vaccines against diarrheal diseases. In phase 1 clinical studies, these vaccines have been safe and immunogenic without the need for a buffer or vehicle other than the plant cell. This paper describes early clinical studies evaluating oral transgenic plant vaccines against enteric infections such as enterotoxigenic E. coli infection and norovirus.

Plant-Based Vaccines Against Diarrheal Diseases

PubMed Central

Tacket, Carol O.

2007-01-01

Every year 1.6 million deaths occur due to diarrhea related to unsafe water and inadequate sanitation—the vast majority in children under 5 years old. Safe and effective vaccines against enteric infections could contribute to control of these diseases. However, purification of protective antigens for inclusion in vaccines using traditional expression systems is expensive and unattractive to vaccine manufacturers who see the vaccine market as economically uninviting. Cost is one of the persistent barriers to deployment of new vaccines to populations that need them most urgently. Transgenic plant-derived vaccines offer a new strategy for development of safe, inexpensive vaccines against diarrheal diseases. In phase 1 clinical studies, these vaccines have been safe and immunogenic without the need for a buffer or vehicle other than the plant cell. This paper describes early clinical studies evaluating oral transgenic plant vaccines against enteric infections such as enterotoxigenic E. coli infection and norovirus. PMID:18528491

The anatomical (angiosome) and clinical territories of cutaneous perforating arteries: development of the concept and designing safe flaps.

PubMed

Taylor, G Ian; Corlett, Russell J; Dhar, Shymal C; Ashton, Mark W

2011-04-01

Island "perforator flaps" have become state of the art for free-skin flap transfer. Recent articles by Saint-Cyr et al. and Rozen et al. have focused on the anatomical and the clinical territories of individual cutaneous perforating arteries in flap planning, and it is timely to compare this work with our angiosome concept. The angiosome concept, published in 1987, was reviewed and correlated with key experimental and clinical work by the authors, published subsequently at different times in different journals. In addition, new data are introduced to define these anatomical and clinical territories of the cutaneous perforators and to aid in the planning of safe skin flaps for local and free-flap transfer. The anatomical territory of a cutaneous perforator was defined in the pig, dog, guinea pig, and rabbit by a line drawn through its perimeter of anastomotic vessels that link it with adjacent perforators in all directions. The safe clinical territory of that perforator, seen not only in the same range of animals but also in the human using either the Doppler probe or computed tomography angiography to locate the vessels, was found reliably to extend to include the anatomical territory of the next adjacent cutaneous perforator, situated radially in any direction. The data provided by Saint-Cyr et al. and Rozen et al., coupled with the authors' own original work on the vascular territories of the body and their subsequent studies, reinforce the angiosome concept and provide the basis for the design of safe flaps for patient benefit.

Zika virus vaccines.

PubMed

Abbink, Peter; Stephenson, Kathryn E; Barouch, Dan H

2018-06-19

The recent epidemic of Zika virus (ZIKV) in the Americas has revealed the devastating consequences of ZIKV infection, particularly in pregnant women. Congenital Zika syndrome, characterized by malformations and microcephaly in neonates as well as developmental challenges in children, highlights the need for the development of a safe and effective vaccine. Multiple vaccine candidates have been developed and have shown promising results in both animal models and phase I clinical trials. However, important challenges remain for the clinical development of these vaccines. In this Progress article, we discuss recent preclinical studies and lessons learned from first-in-human clinical trials with ZIKV vaccines.

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

PubMed

Krause, Beatrix; Cohen Kadosh, Roi

2013-10-01

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

WHO consultation on Respiratory Syncytial Virus Vaccine Development Report from a World Health Organization Meeting held on 23-24 March 2015.

PubMed

Modjarrad, Kayvon; Giersing, Birgitte; Kaslow, David C; Smith, Peter G; Moorthy, Vasee S

2016-01-04

Respiratory syncytial virus (RSV) is a globally prevalent cause of lower respiratory infection in neonates and infants. Despite its disease burden, a safe and effective RSV vaccine has remained elusive. In recent years, improved understanding of RSV biology and innovations in immunogen design has resulted in the advancement of multiple vaccine candidates into the clinical development pipeline. Given the growing number of vaccines in clinical trials, the rapid pace at which they are being tested, and the likelihood that an RSV vaccine will reach the commercial market in the next 5-10 years, consensus and guidance on clinical development pathways and licensure routes are needed now, before large-scale efficacy trials commence. In pursuit of this aim, the World Health Organization convened the first RSV vaccine consultation in 15 years on the 23rd and 24th of March, 2015 in Geneva, Switzerland. The meeting's primary objective was to provide guidance on clinical endpoints and development pathways for vaccine trials with a focus on considerations of low- and middle-income countries. Meeting participants reached consensus on candidate case definitions for RSV disease, considerations for clinical efficacy endpoints, and the clinical development pathway for active and passive immunization trials in maternal and pediatric populations. The strategic focus of this meeting was on the development of high quality, safe and efficacious RSV preventive interventions for global use and included: (1) maternal/passive immunization to prevent RSV disease in infants less than 6 months; (2) pediatric immunization to prevent RSV disease in infants and young children once protection afforded by maternal immunization wanes. Copyright © 2015 World Health Organization; licensee Elsevier. Published by Elsevier Ltd.. All rights reserved.

University of Chicago — Nanoscale Metal-organic Frameworks

Cancer.gov

This project addresses the unmet needs in developing highly efficient and safe nanoparticle PSs that can have much broader clinical applications for cancer by Near-IR triggered PDT and X-ray induced PDT (X-PDT).

Dendrimers: a class of polymers in the nanotechnology for the delivery of active pharmaceuticals.

PubMed

Samad, Abdus; Alam, Md Intakhab; Saxena, Kinshuk

2009-01-01

Dendrimers represent a class of novel polymers having unique molecular architectures characterized by their well-defined structure, with a high degree of molecular uniformity, low polydispersity and properties that make them attractive materials for the development of nanomedicines. The dendrimer drug delivery can be achieved by coupling a drug through one of two approaches. Hydrophobic drugs can be complexed within the hydrophobic dendrimer interior to make them water-soluble or drugs can be covalently coupled onto the surface of the dendrimer. In addition, dendrimers have been shown to be capable of bypassing efflux transporters. A new generation of dendrimer-based delivery systems will enable the efficient transport of drugs across cellular barriers. This review deals principally with the synthesis, characterization and recent applications of dendrimers. In future it will only ever be possible to designate a dendrimer as safe means of drug delivery related to a specific application. However, so far limited clinical experience using dendrimers makes it impossible to designate any particular system which is safe and non toxic. Although there is widespread concern as to the safety of nanosized particles, preclinical and clinical experience gained during the development of polymeric excipients, biomedical polymers and polymer therapeutics showed that judicious development of dendrimer chemistry for each specific application will ensure development of safe and important materials for biomedical and pharmaceutical use.

Investing in nursing research in practice settings: a blueprint for building capacity.

PubMed

Jeffs, Lianne; Smith, Orla; Beswick, Susan; Maoine, Maria; Ferris, Ella

2013-12-01

Engaging clinical nurses in practice-based research is a cornerstone of professional nursing practice and a critical element in the delivery of high-quality patient care. Practising staff nurses are well suited to identify the phenomena and issues that are clinically relevant and appropriate for research. In response to the need to invest in and build capacity in nursing research, hospitals have developed creative approaches to spark interest in nursing research and to equip clinical nurses with research competencies. This paper outlines a Canadian hospital's efforts to build research capacity as a key strategy to foster efficacious, safe and cost-effective patient care practices. Within a multi-pronged framework, several strategies are described that collectively resulted in enhanced research and knowledge translation productivity aimed at improving the delivery of safe and high-quality patient care.

From Cheerleader to Coach: The Developmental Progression of Bedside Teachers in Giving Feedback to Early Learners.

PubMed

Wenrich, Marjorie D; Jackson, Molly Blackley; Maestas, Ramoncita R; Wolfhagen, Ineke H A P; Scherpbier, Albert J J

2015-11-01

Medical students learn clinical skills at the bedside from teaching clinicians, who often learn to teach by teaching. Little is known about the process of becoming an effective clinical teacher. Understanding how teaching skills and approaches change with experience may help tailor faculty development for new teachers. Focusing on giving feedback to early learners, the authors asked: What is the developmental progression of clinician-teachers as they learn to give clinical skills feedback to medical students? This qualitative study included longitudinal interviews with clinician-teachers over five years in a new clinical skills teaching program for preclinical medical students. Techniques derived from grounded theory were used for initial analyses. The current study focused on one theme identified in initial analyses: giving feedback to students. Transcript passages were organized by interview year, coded, and discussed in year clusters; thematic codes were compared and emergent codes developed. Themes related to giving feedback demonstrated a dyadic structure: characteristic of less experienced teachers versus characteristic of experienced teachers. Seven dominant dyadic themes emerged, including teacher as cheerleader versus coach, concern about student fragility versus understanding resilience, and focus on creating a safe environment versus challenging students within a safe environment. With consistent teaching, clinical teachers demonstrated progress in giving feedback to students in multiple areas, including understanding students' developmental trajectory and needs, developing tools and strategies, and adopting a dynamic, challenging, inclusive team approach. Ongoing teaching opportunities with targeted faculty development may help improve clinician-teachers' feedback skills and approaches.

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

Supporting safe driving with arthritis: developing a driving toolkit for clinical practice and consumer use.

PubMed

Vrkljan, Brenda H; Cranney, Ann; Worswick, Julia; O'Donnell, Siobhan; Li, Linda C; Gélinas, Isabelle; Byszewski, Anna; Man-Son-Hing, Malcolm; Marshall, Shawn

2010-01-01

We conducted a series of focus groups to explore the information needs of clinicians and consumers related to arthritis and driving. An open coding analysis identified common themes across both consumer and clinician-based focus groups that underscored the importance of addressing driving-related concerns and the challenges associated with assessing safety. The results revealed that although driving is critical for maintaining independence and community mobility, drivers with arthritis experience several problems that can affect safe operation of a motor vehicle. Findings from this study are part of a broader research initiative that will inform the development of the Arthritis and Driving toolkit. This toolkit outlines strategies to support safe mobility for people with arthritis and will be an important resource in the coming years given the aging population.

Exploring the oxygen supply and demand framework as a learning tool in undergraduate nursing education.

PubMed

Gillespie, Mary; Shackell, Eileen

2017-11-01

In nursing education, physiological concepts are typically presented within a body 'systems' framework yet learners are often challenged to apply this knowledge in the holistic and functional manner needed for effective clinical decision-making and safe patient care. A nursing faculty addressed this learning challenge by developing an advanced organizer as a conceptual and integrative learning tool to support learners in diverse learning environments and practice settings. A mixed methods research study was conducted that explored the effectiveness of the Oxygen Supply and Demand Framework as a learning tool in undergraduate nursing education. A pretest/post-test assessment and reflective journal were used to gather data. Findings indicated the Oxygen Supply and Demand Framework guided the development of pattern recognition and thinking processes and supported knowledge development, knowledge application and clinical decision-making. The Oxygen Supply and Demand Framework supports undergraduate students learning to provide safe and effective nursing care. Copyright © 2017 Elsevier Ltd. All rights reserved.

Unified Approach to the Biomechanics of Dental Implantology

NASA Technical Reports Server (NTRS)

Grenoble, D. E.; Knoell, A. C.

1973-01-01

The human need for safe and effective dental implants is well-recognized. Although many implant designs have been tested and are in use today, a large number have resulted in clinical failure. These failures appear to be due to biomechanical effects, as well as biocompatibility and surgical factors. A unified approach is proposed using multidisciplinary systems technology, for the study of the biomechanical interactions between dental implants and host tissues. The approach progresses from biomechanical modeling and analysis, supported by experimental investigations, through implant design development, clinical verification, and education of the dental practitioner. The result of the biomechanical modeling, analysis, and experimental phases would be the development of scientific design criteria for implants. Implant designs meeting these criteria would be generated, fabricated, and tested in animals. After design acceptance, these implants would be tested in humans, using efficient and safe surgical and restorative procedures. Finally, educational media and instructional courses would be developed for training dental practitioners in the use of the resulting implants.

A protocol for evaluating progressive levels of simulation fidelity in the development of technical skills, integrated performance and woman centred clinical assessment skills in undergraduate midwifery students

PubMed Central

2013-01-01

Background Simulation as a pedagogical approach has been used in health professional education to address the need to safely develop effective clinical skills prior to undertaking clinical practice. However, evidence for the use of simulation in midwifery is largely anecdotal, and research evaluating the effectiveness of different levels of simulation fidelity are lacking. Woman centred care is a core premise of the midwifery profession and describes the behaviours of an individual midwife who demonstrates safe and effective care of the individual woman. Woman centred care occurs when the midwife modifies the care to ensure the needs of each individual woman are respected and addressed. However, a review of the literature demonstrates an absence of a valid and reliable tool to measure the development of woman centred care behaviours. This study aims to determine which level of fidelity in simulated learning experiences provides the most effective learning outcomes in the development of woman centred clinical assessment behaviors and skills in student midwives. Methods/Design Three-arm, randomised, intervention trial. In this research we plan to: a) trial three levels of simulation fidelity - low, medium and progressive, on student midwives performing the procedure of vaginal examination; b) measure clinical assessment skills using the Global Rating Scale (GRS) and Integrated Procedural Performance Instrument (IPPI); and c) pilot the newly developed Woman Centred Care Scale (WCCS) to measure clinical behaviors related to Woman-Centredness. Discussion This project aims to enhance knowledge in relation to the appropriate levels of fidelity in simulation that yield the best educational outcomes for the development of woman centred clinical assessment in student midwives. The outcomes of this project may contribute to improved woman centred clinical assessment for student midwives, and more broadly influence decision making regarding education resource allocation for maternity simulation. PMID:23706037

Simulated learning environment experience in nursing students for paediatric practice.

PubMed

Mendoza-Maldonado, Yessy; Barría-Pailaquilén, René Mauricio

The training of health professionals requires the acquisition of clinical skills in a safe and efficient manner, which is facilitated by a simulated learning environment (SLE). It is also an efficient alternative when there are limitations for clinical practice in certain areas. This paper shows the work undertaken in a Chilean university in implementing paediatric practice using SLE. Over eight days, the care experience of a hospitalized infant was studied applying the nursing process. The participation of a paediatrician, resident physician, nursing technician, and simulated user was included in addition to the use of a simulation mannequin and equipment. Simulation of care was integral and covered interaction with the child and family and was developed in groups of six students by a teacher. The different phases of the simulation methodology were developed from a pedagogical point of view. The possibility of implementing paediatric clinical practice in an efficient and safe way was confirmed. The experience in SLE was highly valued by the students, allowing them to develop different skills and abilities required for paediatric nursing through simulation. Copyright © 2018 Elsevier España, S.L.U. All rights reserved.

Optimization of protocol design: a path to efficient, lower cost clinical trial execution

PubMed Central

Malikova, Marina A

2016-01-01

Managing clinical trials requires strategic planning and efficient execution. In order to achieve a timely delivery of important clinical trials’ outcomes, it is useful to establish standardized trial management guidelines and develop robust scoring methodology for evaluation of study protocol complexity. This review will explore the challenges clinical teams face in developing protocols to ensure that the right patients are enrolled and the right data are collected to demonstrate that a drug is safe and efficacious, while managing study costs and study complexity based on proposed comprehensive scoring model. Key factors to consider when developing protocols and techniques to minimize complexity will be discussed. A methodology to identify processes at planning phase, approaches to increase fiscal return and mitigate fiscal compliance risk for clinical trials will be addressed. PMID:28031939

Development of replication-competent viral vectors for HIV vaccine delivery

PubMed Central

Parks, Christopher L.; Picker, Louis J.; King, C. Richter

2014-01-01

Purpose of review Briefly describe some of the replication-competent (RC) vectors being investigated for development of candidate HIV vaccines focusing primarily on technologies that have advanced to testing in macaques or have entered clinical trials. Recent findings RC viral vectors have advanced to the stage were decisions can be made regarding future development of HIV vaccines. The viruses being used as RC vector platforms vary considerably, and their unique attributes make it possible to test multiple vaccine design concepts and also mimic various aspects of an HIV infection. RC viral vectors encoding SIV or HIV proteins can be used to safely immunize macaques, and in some cases, there is evidence of significant vaccine efficacy in challenge protection studies. Several live HIV vaccine vectors are in clinical trials to evaluate immunogenicity, safety, the effect of mucosal delivery, and potential effects of pre-existing immunity. Summary A variety of DNA and RNA viruses are being used to develop RC viral vectors for HIV vaccine delivery. Multiple viral vector platforms have proven to be safe and immunogenic with evidence of efficacy in macaques. Some of the more advanced HIV vaccine prototypes based on vesicular stomatitis virus, vaccinia virus, measles virus, and Sendai virus are in clinical trials. PMID:23925000

Evaluation Of Back Shape Using The ISIS Scanner

NASA Astrophysics Data System (ADS)

Turner-Smith, Alan R.; Thomas, David C.

1989-04-01

The Integrated Shape Investigation System (ISIS) is a structured light scanner and shape analysis system, developed as a safe alternative to follow-up radiographs for the clinical assessment of deformities of the human back. The system is described and results presented of several clinic studies. These show a significant correlation between ISIS measures and conventional radiographic measures of spinal curvature, such as the Cobb angle. The development of a predictor for deterioration in adolescent idiopathic scoliosis, based on surface shape weasures, is discussed.

Recombinant modified vaccinia virus Ankara-based malaria vaccines.

PubMed

Sebastian, Sarah; Gilbert, Sarah C

2016-01-01

A safe and effective malaria vaccine is a crucial part of the roadmap to malaria elimination/eradication by the year 2050. Viral-vectored vaccines based on adenoviruses and modified vaccinia virus Ankara (MVA) expressing malaria immunogens are currently being used in heterologous prime-boost regimes in clinical trials for induction of strong antigen-specific T-cell responses and high-titer antibodies. Recombinant MVA is a safe and well-tolerated attenuated vector that has consistently shown significant boosting potential. Advances have been made in large-scale MVA manufacture as high-yield producer cell lines and high-throughput purification processes have recently been developed. This review describes the use of MVA as malaria vaccine vector in both preclinical and clinical studies in the past 5 years.

Quantitative imaging of the human upper airway: instrument design and clinical studies

NASA Astrophysics Data System (ADS)

Leigh, M. S.; Armstrong, J. J.; Paduch, A.; Sampson, D. D.; Walsh, J. H.; Hillman, D. R.; Eastwood, P. R.

2006-08-01

Imaging of the human upper airway is widely used in medicine, in both clinical practice and research. Common imaging modalities include video endoscopy, X-ray CT, and MRI. However, no current modality is both quantitative and safe to use for extended periods of time. Such a capability would be particularly valuable for sleep research, which is inherently reliant on long observation sessions. We have developed an instrument capable of quantitative imaging of the human upper airway, based on endoscopic optical coherence tomography. There are no dose limits for optical techniques, and the minimally invasive imaging probe is safe for use in overnight studies. We report on the design of the instrument and its use in preliminary clinical studies, and we present results from a range of initial experiments. The experiments show that the instrument is capable of imaging during sleep, and that it can record dynamic changes in airway size and shape. This information is useful for research into sleep disorders, and potentially for clinical diagnosis and therapies.

Clinical reasoning of nursing students on clinical placement: Clinical educators' perceptions.

PubMed

Hunter, Sharyn; Arthur, Carol

2016-05-01

Graduate nurses may have knowledge and adequate clinical psychomotor skills however they have been identified as lacking the clinical reasoning skills to deliver safe, effective care suggesting contemporary educational approaches do not always facilitate the development of nursing students' clinical reasoning. While nursing literature explicates the concept of clinical reasoning and develops models that demonstrate clinical reasoning, there is very little published about nursing students and clinical reasoning during clinical placements. Semi-structured interviews were conducted with ten clinical educators to gain an understanding of how they recognised, developed and appraised nursing students' clinical reasoning while on clinical placement. This study found variability in the clinical educators' conceptualisation, recognition, and facilitation of students' clinical reasoning. Although most of the clinical educators conceptualised clinical reasoning as a process those who did not demonstrated the greatest variability in the recognition and facilitation of students' clinical reasoning. The clinical educators in this study also described being unable to adequately appraise a student's clinical reasoning during clinical placement with the use of the current performance assessment tool. Copyright © 2016 Elsevier Ltd. All rights reserved.

Making and Executing Decisions for Safe and Independent Living (MED-SAIL): development and validation of a brief screening tool.

PubMed

Mills, Whitney L; Regev, Tziona; Kunik, Mark E; Wilson, Nancy L; Moye, Jennifer; McCullough, Laurence B; Naik, Aanand D

2014-03-01

Older adults prefer to remain in their own homes for as long as possible. The purpose of this article is to describe the development and preliminary validation of Making and Executing Decisions for Safe and Independent Living (MED-SAIL), a brief screening tool for capacity to live safely and independently in the community. Prospective preliminary validation study. Outpatient geriatrics clinic located in a community-based hospital. Forty-nine community-dwelling older adults referred to the clinic for a comprehensive capacity assessment. We examined internal consistency, criterion-based validity, concurrent validity, and accuracy of classification for MED-SAIL. The items included in MED-SAIL demonstrated internal consistency (5 items; α = 0.85). MED-SAIL was significantly correlated with the Independent Living Scales (r = 0.573, p ≤0.001) and instrumental activities of daily living (r = 0.440, p ≤0.01). The Mann-Whitney U test revealed significant differences between the no capacity and partial/full capacity classifications on MED-SAIL (U(48) = 60.5, Z = -0.38, p <0.0001). The area under the curve was 0.864 (95% confidence interval: 0.84-0.99). This study demonstrated the validity of MED-SAIL as a brief screening tool to identify older adults with impaired capacity for remaining safe and independent in their current living environment. MED-SAIL is useful tool for health and social service providers in the community for the purpose of referral for definitive capacity evaluation. Published by Elsevier Inc.

MRI-guided stereotactic neurosurgical procedures in a diagnostic MRI suite: Background and safe practice recommendations.

PubMed

Larson, Paul S; Willie, Jon T; Vadivelu, Sudhakar; Azmi-Ghadimi, Hooman; Nichols, Amy; Fauerbach, Loretta Litz; Johnson, Helen Boehm; Graham, Denise

2017-07-01

The development of navigation technology facilitating MRI-guided stereotactic neurosurgery has enabled neurosurgeons to perform a variety of procedures ranging from deep brain stimulation to laser ablation entirely within an intraoperative or diagnostic MRI suite while having real-time visualization of brain anatomy. Prior to this technology, some of these procedures required multisite workflow patterns that presented significant risk to the patient during transport. For those facilities with access to this technology, safe practice guidelines exist only for procedures performed within an intraoperative MRI. There are currently no safe practice guidelines or parameters available for facilities looking to integrate this technology into practice in conventional MRI suites. Performing neurosurgical procedures in a diagnostic MRI suite does require precautionary measures. The relative novelty of technology and workflows for direct MRI-guided procedures requires consideration of safe practice recommendations, including those pertaining to infection control and magnet safety issues. This article proposes a framework of safe practice recommendations designed for assessing readiness and optimization of MRI-guided neurosurgical interventions in the diagnostic MRI suite in an effort to mitigate patient risk. The framework is based on existing clinical evidence, recommendations, and guidelines related to infection control and prevention, health care-associated infections, and magnet safety, as well as the clinical and practical experience of neurosurgeons utilizing this technology. © 2017 American Society for Healthcare Risk Management of the American Hospital Association.

Development of Safe and Effective Botanical Dietary Supplements

PubMed Central

2015-01-01

Regulated differently than drugs or foods, the market for botanical dietary supplements continues to grow worldwide. The recently implemented U.S. FDA regulation that all botanical dietary supplements must be produced using good manufacturing practice is an important step toward enhancing the safety of these products, but additional safeguards could be implemented, and unlike drugs, there are currently no efficacy requirements. To ensure a safe and effective product, botanical dietary supplements should be developed in a manner analogous to pharmaceuticals that involves identification of mechanisms of action and active constituents, chemical standardization based on the active compounds, biological standardization based on pharmacological activity, preclinical evaluation of toxicity and potential for drug–botanical interactions, metabolism of active compounds, and finally, clinical studies of safety and efficacy. Completing these steps will enable the translation of botanicals from the field to safe human use as dietary supplements. PMID:26125082

Safe Practices for Copy and Paste in the EHR

PubMed Central

Lehmann, Christoph U.; Michel, Jeremy; Solomon, Ronni; Possanza, Lorraine; Gandhi, Tejal

2017-01-01

Summary Background Copy and paste functionality can support efficiency during clinical documentation, but may promote inaccurate documentation with risks for patient safety. The Partnership for Health IT Patient Safety was formed to gather data, conduct analysis, educate, and disseminate safe practices for safer care using health information technology (IT). Objective To characterize copy and paste events in clinical care, identify safety risks, describe existing evidence, and develop implementable practice recommendations for safe reuse of information via copy and paste. Methods The Partnership 1) reviewed 12 reported safety events, 2) solicited expert input, and 3) performed a systematic literature review (2010 to January 2015) to identify publications addressing frequency, perceptions/attitudes, patient safety risks, existing guidance, and potential interventions and mitigation practices. Results The literature review identified 51 publications that were included. Overall, 66% to 90% of clinicians routinely use copy and paste. One study of diagnostic errors found that copy and paste led to 2.6% of errors in which a missed diagnosis required patients to seek additional unplanned care. Copy and paste can promote note bloat, internal inconsistencies, error propagation, and documentation in the wrong patient chart. Existing guidance identified specific responsibilities for authors, organizations, and electronic health record (EHR) developers. Analysis of 12 reported copy and paste safety events was congruent with problems identified from the literature review. Conclusion Despite regular copy and paste use, evidence regarding direct risk to patient safety remains sparse, with significant study limitations. Drawing on existing evidence, the Partnership developed four safe practice recommendations: 1) Provide a mechanism to make copy and paste material easily identifiable; 2) Ensure the provenance of copy and paste material is readily available; 3) Ensure adequate staff training and education; 4) Ensure copy and paste practices are regularly monitored, measured, and assessed. PMID:28074211

Safe Practices for Copy and Paste in the EHR. Systematic Review, Recommendations, and Novel Model for Health IT Collaboration.

PubMed

Tsou, Amy Y; Lehmann, Christoph U; Michel, Jeremy; Solomon, Ronni; Possanza, Lorraine; Gandhi, Tejal

2017-01-11

Copy and paste functionality can support efficiency during clinical documentation, but may promote inaccurate documentation with risks for patient safety. The Partnership for Health IT Patient Safety was formed to gather data, conduct analysis, educate, and disseminate safe practices for safer care using health information technology (IT). To characterize copy and paste events in clinical care, identify safety risks, describe existing evidence, and develop implementable practice recommendations for safe reuse of information via copy and paste. The Partnership 1) reviewed 12 reported safety events, 2) solicited expert input, and 3) performed a systematic literature review (2010 to January 2015) to identify publications addressing frequency, perceptions/attitudes, patient safety risks, existing guidance, and potential interventions and mitigation practices. The literature review identified 51 publications that were included. Overall, 66% to 90% of clinicians routinely use copy and paste. One study of diagnostic errors found that copy and paste led to 2.6% of errors in which a missed diagnosis required patients to seek additional unplanned care. Copy and paste can promote note bloat, internal inconsistencies, error propagation, and documentation in the wrong patient chart. Existing guidance identified specific responsibilities for authors, organizations, and electronic health record (EHR) developers. Analysis of 12 reported copy and paste safety events was congruent with problems identified from the literature review. Despite regular copy and paste use, evidence regarding direct risk to patient safety remains sparse, with significant study limitations. Drawing on existing evidence, the Partnership developed four safe practice recommendations: 1) Provide a mechanism to make copy and paste material easily identifiable; 2) Ensure the provenance of copy and paste material is readily available; 3) Ensure adequate staff training and education; 4) Ensure copy and paste practices are regularly monitored, measured, and assessed.

TU-C-218-01: Effective Medical Imaging Physics Education.

PubMed

Sprawls, P

2012-06-01

A practical and applied knowledge of physics and the associated technology is required for the clinically effective and safe use of the various medical imaging modalities. This is needed by all involved in the imaging process, including radiologists, especially residents in training, technologists, and physicists who provide consultation on optimum and safe procedures and as educators for the other imaging professionals. This area of education is undergoing considerable change and evolution for three reasons: 1. Increasing capabilities and complexity of medical imaging technology and procedures, 2.Expanding scope and availability of educational resources, especially on the internet, and 3. A significant increase in our knowledge of the mental learning process and the design of learning activities to optimize effectiveness and efficiency, especially for clinically applied physics. This course will address those three issues by providing guidance on establishing appropriate clinically focused learning outcomes, a review of the brain function for enhancing clinically applied physics, and the design and delivery of effective learning activities beginning with the classroom and continuing through learning physics during the clinical practice of radiology. Characteristics of each type of learning activity will be considered with respect to effectiveness and efficiency in achieving appropriate learning outcomes. A variety of available resources will be identified and demonstrated for use in the different phases of learning process. A major focus is on enhancing the role of the medical physicist in clinical radiology both as a resource and educator with contemporary technology being the tool, but not the teacher. 1. Develop physics learning objectives that will support effective and safe medical imaging procedures. 2. Understand specific brain functions that are involved in learning and applying physics. 3. Describe the characteristics and development of mental knowledge structures for applied clinical physics. 4. List the established levels of learning and associate each with specific functions that can be performed. 5. Analyze the different types of learning activities (classroom, individual study, clinical, etc.) with respect to effectiveness and efficiency. 6. Design and Provide a comprehensive physics education program with each activity optimized with respect to outcomes and available resources. © 2012 American Association of Physicists in Medicine.

Hospital bed occupancy: more than queuing for a bed.

PubMed

Keegan, Andrew D

2010-09-06

Timely access to safe hospital care remains a major concern. Target bed-occupancy rates have been proposed as a measure of the ability of a hospital to function safely and effectively. High bed-occupancy rates have been shown to be associated with greater risks of hospital-associated infection and access block and to have a negative impact on staff health. Clinical observational data have suggested that bed occupancies above 85% could adversely affect safe, effective hospital function. Using this figure, at least initially, would be of value in the planning and operational management of public hospital beds in Australia. There is an urgent need to develop meaningful outcome measures of patient care that could replace the process measures currently in use.

Development of an intradermal DNA vaccine delivery strategy to achieve single-dose immunity against respiratory syncytial virus.

PubMed

Smith, Trevor R F; Schultheis, Katherine; Morrow, Matthew P; Kraynyak, Kimberly A; McCoy, Jay R; Yim, Kevin C; Muthumani, Karuppiah; Humeau, Laurent; Weiner, David B; Sardesai, Niranjan Y; Broderick, Kate E

2017-05-15

Respiratory syncytial virus (RSV) is a massive medical burden in infants, children and the elderly worldwide, and an effective, safe RSV vaccine remains an unmet need. Here we assess a novel vaccination strategy based on the intradermal delivery of a SynCon® DNA-based vaccine encoding engineered RSV-F antigen using a surface electroporation device (SEP) to target epidermal cells, in clinically relevant experimental models. We demonstrate the ability of this strategy to elicit robust immune responses. Importantly we demonstrate complete resistance to pulmonary infection at a single low dose of vaccine in the cotton rat RSV/A challenge model. In contrast to the formalin-inactivated RSV (FI-RSV) vaccine, there was no enhanced lung inflammation upon virus challenge after DNA vaccination. In summary the data presented outline the pre-clinical development of a highly efficacious, tolerable and safe non-replicating vaccine delivery strategy. Copyright © 2017. Published by Elsevier Ltd.

Safe Administration of Ipilimumab, Pembrolizumab, and Nivolumab in a Patient with Metastatic Melanoma, Psoriasis, and a Previous Guillain-Barré Syndrome.

PubMed

Cortellini, Alessio; Parisi, Alessandro; Fargnoli, Maria Concetta; Cannita, Katia; Irelli, Azzurra; Porzio, Giampiero; Martinazzo, Claudio; Ficorella, Corrado

2018-01-01

Patients with autoimmune diseases were not evaluated in clinical trials with immune checkpoint inhibitors (ICIs), since a history of immune disorders, such as Guillain-Barré syndrome (GBS) and psoriasis, is one of the major risk factors for the development of immune-related adverse events (irAEs). This risk cannot be defined; therefore, physicians are called to manage these patients in clinical practice. We report the case of a 62-year-old male patient affected by metastatic melanoma, with a history of GBS and psoriasis, and treated with sequential ipilimumab, pembrolizumab, and nivolumab, without significant toxicities. This case report supports that although a history of immune disorders is one of the major risk factors for development of irAEs, in some patients, it could be possible to safely administer sequential treatments with ICIs. A proper decision should be made, considering therapeutic options, disease-related risks, and those related to a recurrence of preexisting autoimmune disorders.

Developing a general ward nursing dashboard.

PubMed

Russell, Margot; Hogg, Maggie; Leach, Stuart; Penman, Mags; Friel, Susan

2014-12-15

The seventh and final article in the series on Leading Better Care explores some of the challenges in clinical practice relating to the use of data and making information meaningful to senior charge nurses and ward sisters. It describes the collaborative approach taken by NHS Lanarkshire, which involved nursing staff, programme leads and the eHealth team in the development of a general ward nursing dashboard as a means of ensuring safe, effective person-centred care. The article also illustrates how this web-based data-reporting programme is used to support clinical practice.

Determining if an older adult can make and execute decisions to live safely at home: a capacity assessment and intervention model

PubMed Central

Skelton, Felicia; Kunik, Mark E.; Regev, Tziona; Naik, Aanand D.

2009-01-01

Determining an older adult’s capacity to live safely and independently in the community presents a serious and complicated challenge to the health care system. Evaluating one’s ability to make and execute decisions regarding safe and independent living incorporates clinical assessments, bioethical considerations, and often legal declarations of capacity. Capacity assessments usually result in life changes for patients and their families, including a caregiver managing some everyday tasks, placement outside of the home, and even legal guardianship. The process of determining capacity and recommending intervention is often inefficient and highly variable in most cases. Physicians are rarely trained to conduct capacity assessments and assessment methods are heterogeneous. An interdisciplinary team of clinicians developed the capacity assessment and intervention (CAI) model at a community outpatient geriatrics clinic to address these critical gaps. This report follows one patient through the entire CAI model, describing processes for a typical case. It then examines two additional case reports that highlight common challenges in capacity assessment. The CAI model uses assessment methods common to geriatrics clinical practice and conducts assessments and interventions in a standardized fashion. Reliance on common, validated measures increases generalizability of the model across geriatrics practice settings and patient populations. PMID:19481271

[ISMP-Spain questionnaire and strategy for improving good medication practices in the Andalusian health system].

PubMed

Padilla-Marín, V; Corral-Baena, S; Domínguez-Guerrero, F; Santos-Rubio, M D; Santana-López, V; Moreno-Campoy, E

2012-01-01

To describe the strategy employed by Andalusian public health service hospitals to foster safe medication use. The self-evaluation questionnaire on drug system safety in hospitals, adapted by the Spanish Institute for Safe Medication Practices was used as a fundamental tool to that end. The strategy is developed in several phases. We analyse the report evaluating drug system safety in Andalusian public hospitals published by the Spanish Ministry of Health and Consumption in 2008 and establish a grading system to assess safe medication practices in Andalusian hospitals and prioritise areas needing improvement. We developed a catalogue of best practices available in the web environment belonging to the Andalusian health care quality agency's patient safety observatory. We publicised the strategy through training seminars and implemented a system allowing hospitals to evaluate the degree of compliance for each of the best practices, and based on that system, we were able to draw up a map of centres of reference. We found areas for improvement among several of the questionnaire's fundamental criteria. These areas for improvement were related to normal medication procedures in daily clinical practice. We therefore wrote 7 best practice guides that provide a cross-section of the assessment components of the questionnaire related to the clinical process needing improvement. The self-evaluation questionnaire adapted by ISMP-Spain is a good tool for designing a systematic, rational intervention to promote safe medication practices and intended for a group of hospitals that share the same values. Copyright © 2011 SEFH. Published by Elsevier Espana. All rights reserved.

Making and Executing Decisions for Safe and Independent Living (MED-SAIL): Development and Validation of a Brief Screening Tool

PubMed Central

Mills, Whitney L.; Regev, Tziona; Kunik, Mark E.; Wilson, Nancy L.; Moye, Jennifer; McCullough, Laurence B.; Naik, Aanand D.

2017-01-01

Objectives Older adults prefer to remain in their own homes for as long as possible. The purpose of this article is to describe the development and preliminary validation of Making and Executing Decisions for Safe and Independent Living (MED-SAIL), a brief screening tool for capacity to live safely and independently in the community. Design Prospective preliminary validation study. Setting Outpatient geriatrics clinic located in a community-based hospital. Participants Forty-nine community-dwelling older adults referred to the clinic for a comprehensive capacity assessment. Measurements We examined internal consistency, criterion-based validity, concurrent validity, and accuracy of classification for MED-SAIL. Results The items included in MED-SAIL demonstrated internal consistency (5 items; α = 0.85). MED-SAIL was significantly correlated with the Independent Living Scales (r = 0.573, p ≤ 0.001) and instrumental activities of daily living (r = 0.440, p ≤ 0.01). The Mann-Whitney U test revealed significant differences between the no capacity and partial/full capacity classifications on MED-SAIL (U(48) = 60.5, Z = −0.38, p <0.0001). The area under the curve was 0.864 (95% confidence interval: 0.84–0.99). Conclusions This study demonstrated the validity of MED-SAIL as a brief screening tool to identify older adults with impaired capacity for remaining safe and independent in their current living environment. MED-SAIL is useful tool for health and social service providers in the community for the purpose of referral for definitive capacity evaluation. PMID:23567420

Biotherapeutics in non-clinical development: Strengthening the interface between safety, pharmacokinetics-pharmacodynamics and manufacturing.

PubMed

Ulrich, Peter; Blaich, Guenter; Baumann, Andreas; Fagg, Rajni; Hey, Adam; Kiessling, Andrea; Kronenberg, Sven; Lindecrona, Rikke Hvid; Mohl, Silke; Richter, Wolfgang F; Tibbitts, Jay; Crameri, Flavio; Weir, Lucinda

2018-04-01

Biological drugs comprise a wide field of different modalities with respect to structure, pharmacokinetics and pharmacological function. Considerable non-clinical experience in the development of proteins (e.g. insulin) and antibodies has been accumulated over the past thirty years. In order to improve the efficacy and the safety of these biotherapeutics, Fc modifications (e.g. Fc silent antibody versions), combinations (antibody-drug conjugates, protein-nanoparticle combinations), and new constructs (darpins, fynomers) have been introduced. In the last decade, advanced therapy medicinal products (ATMPs) in research and development have become a considerable and strongly growing part of the biotherapeutic portfolio. ATMPs consisting of gene and cell therapy modalities or even combinations of them, further expand the level of complexity, which already exists in non-clinical development strategies for biological drugs and has thereby led to a further diversification of expertise in safety and PKPD assessment of biological drugs. It is the fundamental rationale of the BioSafe meetings, held yearly in the EU and in the US, to convene experts on a regular basis and foster knowledge exchange and mutual understanding in this fast growing area. In order to reflect at least partially the variety of the biotherapeutics field, the 2016 EU BioSafe meeting addressed the following topics in six sessions: (i) In vitro Meets in vivo to Leverage Biologics Development (ii) New developments and regulatory considerations in the cell and gene therapy field (iii) CMC Challenges with Biologics development (iv) Minipigs in non-clinical safety assessment (v) Opportunities of PKPD Assessment in Less Common Administration Routes In the breakout sessions the following questions were discussed: (i) Cynomolgus monkey as a reprotoxicology Species: Impact of Immunomodulators on Early Pregnancy Maintenance (ii) Safety Risk of Inflammation and Autoimmunity Induced by Immunomodulators (iii) Experience with non-GMP Material in Pivotal Non-clinical Safety Studies to Support First in Man (FiM) Trials (iv) Safety Assessment of Combination Products for Non-oncology. Copyright © 2018 Elsevier Inc. All rights reserved.

Implementation of an Oxytocin Checklist to Improve Clinical Outcomes.

PubMed

Sundin, Courtney; Mazac, Lauren; Ellis, Kathleen; Garbo, Candon

Oxytocin is one of the most common drugs administered in obstetrics. Since its designation as a high-alert medication by the Institute for Safe Medication Practices in 2007, there has been much attention to oxytocin administration during labor. Oxytocin is generally safe when administered correctly, but adverse perinatal outcomes can occur during uterine tachysystole. The purpose of this project was to evaluate and compare results of maternal and fetal outcomes of induction of labor for women at term prior to and after implementation of a newly developed oxytocin checklist. To evaluate the practice change associated with the implementation of the new oxytocin checklist, 200 cases based on retrospective medical record reviews were compared with 200 cases after implementation. Use of the checklist was associated with several significant clinical outcomes, including decreases in tachysystole, decreases in cesarean births for concern about fetal status based on electronic fetal monitoring data, decreases in length of first stage labor, and decreases in maximum dose of oxytocin. Results are similar to previous research. Early physician buy-in, clinical team education, and ongoing evaluation enhanced facilitation of the oxytocin checklist. Clinical outcomes were favorable.

Bioreducible Fluorinated Peptide Dendrimers Capable of Circumventing Various Physiological Barriers for Highly Efficient and Safe Gene Delivery.

PubMed

Cai, Xiaojun; Jin, Rongrong; Wang, Jiali; Yue, Dong; Jiang, Qian; Wu, Yao; Gu, Zhongwei

2016-03-09

Polymeric vectors have shown great promise in the development of safe and efficient gene delivery systems; however, only a few have been developed in clinical settings due to poor transport across multiple physiological barriers. To address this issue and promote clinical translocation of polymeric vectors, a new type of polymeric vector, bioreducible fluorinated peptide dendrimers (BFPDs), was designed and synthesized by reversible cross-linking of fluorinated low generation peptide dendrimers. Through masterly integration all of the features of reversible cross-linking, fluorination, and polyhedral oligomeric silsesquioxane (POSS) core-based peptide dendrimers, this novel vector exhibited lots of unique features, including (i) inactive surface to resist protein interactions; (ii) virus-mimicking surface topography to augment cellular uptake; (iii) fluorination-mediated efficient cellular uptake, endosome escape, cytoplasm trafficking, and nuclear entry, and (iv) disulfide-cleavage-mediated polyplex disassembly and DNA release that allows efficient DNA transcription. Noteworthy, all of these features are functionally important and can synergistically facilitate DNA transport from solution to the nucleus. As a consequences, BFPDs showed excellent gene transfection efficiency in several cell lines (∼95% in HEK293 cells) and superior biocompatibility compared with polyethylenimine (PEI). Meanwhile BFPDs provided excellent serum resistance in gene delivery. More importantly, BFPDs offer considerable in vivo gene transfection efficiency (in muscular tissues and in HepG2 tumor xenografts), which was approximately 77-fold higher than that of PEI in luciferase activity. These results suggest bioreducible fluorinated peptide dendrimers are a new class of highly efficient and safe gene delivery vectors and should be used in clinical settings.

The uncomfortable reality … We simply do not know if general anesthesia negatively impacts the neurocognitive development of our small children.

PubMed

Mann, Glenn E; Kahana, Madelyn

2015-09-01

Annually in the United States more than one million children under the age of 5 years are exposed to anesthetics for therapeutic and diagnostic procedures. Pre-clinical data in animal models has consistently shown that anesthetic exposure to the developing brain results in long-term cognitive deficits. Current clinical data addressing the safety of these pharmaceutical agents on the developing human brain is limited. Recently, there has been an enormous amount of attention directed at this potential public health issue in both pre-clinical investigations and ongoing human research. A number of these studies should add to our understanding about the impact anesthetic exposure will have on the developing human brain. Until then, there is little data that absolutely reassures clinicians and parents that the pharmaceutical agents used are indeed safe for our children. The uncomfortable reality is that despite the fact that there are more than one million children younger than 5 years old who receive general anesthesia in the United States annually, and thousands more who are deeply sedated for imaging and diagnostic studies or as a necessary adjunct to care in the intensive care unit, there is little data that assures clinicians and parents that the pharmaceutical agents used are indeed safe for the developing brain. That said, there are no convincing human data to suggest that they are not. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

A large-scale field randomized trial demonstrates safety and efficacy of the vaccine LetiFend® against canine leishmaniosis.

PubMed

Fernández Cotrina, Javier; Iniesta, Virginia; Monroy, Isabel; Baz, Victoria; Hugnet, Christophe; Marañon, Francisco; Fabra, Mercedes; Gómez-Nieto, Luis Carlos; Alonso, Carlos

2018-04-05

Canine leishmaniosis is a zoonotic disease caused by Leishmania infantum. Extensive research is currently ongoing to develop safe and effective vaccines to protect from disease development. The European Commission has granted a marketing authorization for LetiFend®, a new vaccine containing recombinant Protein Q. The efficacy of LetiFend® vaccination in a large-scale dog population of both sexes, different breeds and ages in endemic areas is reported in this multicenter, randomized, double-blind, placebo-controlled field trial. Dogs (n = 549) living in France and Spain were randomly selected to receive a single subcutaneous dose of LetiFend® or placebo per year, and were naturally exposed to two L. infantum transmission seasons. Clinical examinations, blood and lymphoid organ sampling to evaluate serological, parasitological and disease status of the dogs were performed at different time points during the study. LetiFend® was very well tolerated and clearly reduced the incidence of clinical signs related to leishmaniosis. The number of confirmed cases of leishmaniosis was statistically significantly lower in the vaccine group. The number of dogs with parasites was close to be significantly reduced in the vaccine group (p = 0.0564). Re-vaccination of seropositive dogs demonstrated to be safe and not to worsen the course of the disease. The likelihood that a dog vaccinated with LetiFend® develops a confirmed case or clinical signs of leishmaniosis in areas with high pressure is, respectively, 5 and 9.8 time less than that for an unvaccinated dog. Thus, the overall efficacy of the LetiFend® vaccine in the prevention of confirmed cases of leishmaniosis in endemic areas with high disease pressure was shown to be 72%. In conclusion, this field trial demonstrates that LetiFend® is a novel, safe and effective vaccine for the active immunization of non-infected dogs from 6 months of age in reducing the risk of developing clinical leishmaniosis after natural infection with Leishmania infantum. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: report of the first FDA-PWG-PhRMA-DruSafe Workshop.

PubMed

Lesko, Lawrence J; Salerno, Ronald A; Spear, Brian B; Anderson, Donald C; Anderson, Timothy; Brazell, Celia; Collins, Jerry; Dorner, Andrew; Essayan, David; Gomez-Mancilla, Baltazar; Hackett, Joseph; Huang, Shiew-Mei; Ide, Susan; Killinger, Joanne; Leighton, John; Mansfield, Elizabeth; Meyer, Robert; Ryan, Stephen G; Schmith, Virginia; Shaw, Peter; Sistare, Frank; Watson, Mark; Worobec, Alexandra

2003-04-01

The use of pharmacogenetics and pharmacogenomics in the drug development process, and in the assessment of such data submitted to regulatory agencies by industry, has generated significant enthusiasm as well as important reservations within the scientific and medical communities. This situation has arisen because of the increasing number of exploratory and confirmatory investigations into variations in RNA expression patterns and DNA sequences being conducted in the preclinical and clinical phases of drug development, and the uncertainty surrounding the acceptance of these data by regulatory agencies. This report summarizes the outcome of a workshop cosponsored by the Food and Drug Administration (FDA), the Pharmacogenetics Working Group (PWG), the Pharmaceutical Research and Manufacturers of America (PhRMA), and the PhRMA Preclinical Safety Committee (DruSafe). The specific aim of the workshop was to identify key issues associated with the application of pharmacogenetics and pharmacogenomics, including the feasibility of a regulatory "safe harbor" for exploratory genome-based data, and to provide a forum for industry-regulatory agency dialogue on these important issues.

Stem Cell Sciences plc.

PubMed

Daniels, Sebnem

2006-09-01

Stem Cell Sciences' core objective is to develop safe and effective stem cell-based therapies for currently incurable diseases. In order to achieve this goal, Stem Cell Sciences recognizes the need for multiple technologies and a globally integrated stem cell initiative. The key challenges for the successful application of stem cells in the clinic is the need for a reproducible supply of pure, fully characterized stem cells that have been grown in suitable conditions for use in the clinic.

Evaluation of the acceptability and usability of a decision support system to encourage safe and effective use of opioid therapy for chronic, noncancer pain by primary care providers.

PubMed

Trafton, Jodie; Martins, Susana; Michel, Martha; Lewis, Eleanor; Wang, Dan; Combs, Ann; Scates, Naquell; Tu, Samson; Goldstein, Mary K

2010-04-01

To develop and evaluate a clinical decision support system (CDSS) named Assessment and Treatment in Healthcare: Evidenced-Based Automation (ATHENA)-Opioid Therapy, which encourages safe and effective use of opioid therapy for chronic, noncancer pain. CDSS development and iterative evaluation using the analysis, design, development, implementation, and evaluation process including simulation-based and in-clinic assessments of usability for providers followed by targeted system revisions. Volunteers provided detailed feedback to guide improvements in the graphical user interface, and content and design changes to increase clinical usefulness, understandability, clinical workflow fit, and ease of completing guideline recommended practices. Revisions based on feedback increased CDSS usability ratings over time. Practice concerns outside the scope of the CDSS were also identified. Usability testing optimized the CDSS to better address barriers such as lack of provider education, confusion in dosing calculations and titration schedules, access to relevant patient information, provider discontinuity, documentation, and access to validated assessment tools. It also highlighted barriers to good clinical practice that are difficult to address with CDSS technology in its current conceptualization. For example, clinicians indicated that constraints on time and competing priorities in primary care, discomfort in patient-provider communications, and lack of evidence to guide opioid prescribing decisions impeded their ability to provide effective, guideline-adherent pain management. Iterative testing was essential for designing a highly usable and acceptable CDSS; however, identified barriers may limit the impact of the ATHENA-Opioid Therapy system and other CDSS on clinical practices and outcomes unless CDSS are paired with parallel initiatives to address these issues.

Obesity and Pediatric Drug Development.

PubMed

Vaughns, Janelle D; Conklin, Laurie S; Long, Ying; Zheng, Panli; Faruque, Fahim; Green, Dionna J; van den Anker, John N; Burckart, Gilbert J

2018-05-01

There is a lack of dosing guidelines for use in obese children. Moreover, the impact of obesity on drug safety and clinical outcomes is poorly defined. The paucity of information needed for the safe and effective use of drugs in obese patients remains a problem, even after drug approval. To assess the current incorporation of obesity as a covariate in pediatric drug development, the pediatric medical and clinical pharmacology reviews under the Food and Drug Administration (FDA) Amendments Act of 2007 and the FDA Safety and Innovation Act (FDASIA) of 2012 were reviewed for obesity studies. FDA labels were also reviewed for statements addressing obesity in pediatric patients. Forty-five drugs studied in pediatric patients under the FDA Amendments Act were found to have statements and key words in the medical and clinical pharmacology reviews and labels related to obesity. Forty-four products were identified similarly with pediatric studies under FDASIA. Of the 89 product labels identified, none provided dosing information related to obesity. The effect of body mass index on drug pharmacokinetics was mentioned in only 4 labels. We conclude that there is little information presently available to provide guidance related to dosing in obese pediatric patients. Moving forward, regulators, clinicians, and the pharmaceutical industry should consider situations in drug development in which the inclusion of obese patients in pediatric trials is necessary to facilitate the safe and effective use of new drug products in the obese pediatric population. © 2018, The American College of Clinical Pharmacology.

Reflections on clinical research in sub-Saharan Africa.

PubMed

Kuepfer, Irene; Burri, Christian

2009-07-15

The urgent need for new, safe and sustainable interventions against diseases that disproportionally affect the poor is finally receiving global attention and the funding landscape for development projects has significantly improved during the past decade. For the development of new drug and vaccine candidates, clinical trials have become the most important tool to assess their safety and efficacy. Recently, there has been a seismic shift in the number of clinical trials conducted in resource-limited settings. We discuss the current framework of clinical research in sub-Saharan Africa, from building product pipelines to the capacities needed for the conduct of trials according the harmonised Good Clinical Practice (GCP) ICH E6 guideline. We place emphasis on clinical research in neglected tropical diseases which still frequently has to be conducted with limited financial, logistical and human resources. Given those short-comings we recommend minimum standards needed at the local, national and sponsor levels to provide GCP-compliant clinical research.

Safe transport from a specialist paediatric intensive care unit to a referral hospital.

PubMed

Solomon, Jennifer; Clarke, Dave

2009-12-01

There are 23 paediatric intensive care units (PICU) in the UK and 19 of these have a retrieval team responsible for the safe and uneventful transfer of critically ill children from referring hospitals. There are two established PICUs in University Hospitals of Leicester (UHL) NHS Trust that work as a team. In 2001, a transfer service was introduced to support the UHL PICU retrieval service and the referring district general hospitals. At the time of writing this article there was no other PICU in the UK providing a dedicated paediatric clinical transport nurse service, whose main responsibility is the safe transfer of infants and children back to their local hospitals. This article will discuss the development of this service and the benefits to PICU and referral hospitals.

A training paradigm to enhance performance and safe use of an innovative neuroendovascular device

PubMed Central

Ricci, Donald R.; Marotta, Thomas R.; Riina, Howard A.; Wan, Martina; De Vries, Joost

2016-01-01

Training has been important to facilitate the safe use of new devices designed to repair vascular structures. This paper outlines the generic elements of a training program for vascular devices and uses as an example the actual training requirements for a novel device developed for the treatment of bifurcation intracranial aneurysms. Critical elements of the program include awareness of the clinical problem, technical features of device, case selection, and use of a simulator. Formal proctoring, evaluation of the training, and recording the clinical outcomes complement these elements. Interventional physicians should embrace the merits of a training module to improve the user experience, and vendors, physicians, and patients alike should be aligned in the goal of device training to improve its success rate and minimize complications of the procedure. PMID:27867466

Rational use of medicines in older adults: Can we do better during clinical development?

PubMed

Saeed, M A; Vlasakakis, G; Della Pasqua, O

2015-05-01

There is an evidence gap to ensuring safe/effective use of medicines in older adults. Generating clinical data in these patients poses ethical and operational challenges, yielding results that may not be generalizable to the overall population. Modeling and simulation (M&S) is proposed as a basis for assessing the impact of age-related changes and their clinical implications. M&S can be used in conjunction with bridging and extrapolation to ensure the selection of appropriate dose(s)/regimen(s) in this population. © 2015 ASCPT.

Choice of Insulin in Type 2 Diabetes: A Southeast Asian Perspective.

PubMed

Kalra, Sanjay; Thai, Hong Quang; Deerochanawong, Chaicharn; Su-Yen, Goh; Mohamed, Mafauzy; Latt, Tint Swe; Aye, Than Than; Latif, Zafar Ahmed; Katulanda, Prasad; Khun, Touch; Satha, Sum; Vongvandy, Vadsana

2017-01-01

Southeast Asia faces a diabetes epidemic, which has created significant challenges for health care. The unique Asian diabetes phenotype, coupled with peculiar lifestyle, diet, and healthcare-seeking behavior, makes it imperative to develop clinical pathways and guidelines which address local needs and requirements. From an insulin-centric viewpoint, the preparations prescribed in such pathways should be effective, safe, well tolerated, nonintrusive, and suitable for the use in multiple clinical situations including initiation and intensification. This brief communication describes the utility of premixed or dual action insulin in such clinical pathways and guidelines.

The Universal Anaesthesia Machine (UAM): assessment of a new anaesthesia workstation built with global health in mind.

PubMed

de Beer, D A H; Nesbitt, F D; Bell, G T; Rapuleng, A

2017-04-01

The Universal Anaesthesia Machine has been developed as a complete anaesthesia workstation for use in low- and middle-income countries, where the provision of safe general anaesthesia is often compromised by unreliable supply of electricity and anaesthetic gases. We performed a functional and clinical assessment of this anaesthetic machine, with particular reference to novel features and functioning in the intended environment. The Universal Anaesthesia Machine was found to be reliable, safe and consistent across a range of tests during targeted functional testing. © 2016 The Association of Anaesthetists of Great Britain and Ireland.

Infectious Mononucleosis: Ensuring a Safe Return to Sport.

ERIC Educational Resources Information Center

MacKnight, John M.

2002-01-01

Clinical properties of infectious mononucleosis include prolonged fatigue, spleen enlargement and fragility, and risk for spleen rupture. Sports medicine practitioners must recognize and manage these clinical features and promote safe, timely return of athletes to sports. Safeguarding against splenic injury and minimizing the duration of…

High-fidelity nursing simulation: impact on student self-confidence and clinical competence.

PubMed

Blum, Cynthia A; Borglund, Susan; Parcells, Dax

2010-01-01

Development of safe nursing practice in entry-level nursing students requires special consideration from nurse educators. The paucity of data supporting high-fidelity patient simulation effectiveness in this population informed the development of a quasi-experimental, quantitative study of the relationship between simulation and student self-confidence and clinical competence. Moreover, the study reports a novel approach to measuring self-confidence and competence of entry-level nursing students. Fifty-three baccalaureate students, enrolled in either a traditional or simulation-enhanced laboratory, participated during their first clinical rotation. Student self-confidence and faculty perception of student clinical competence were measured using selected scale items of the Lasater Clinical Judgment Rubric. The results indicated an overall improvement in self-confidence and competence across the semester, however, simulation did not significantly enhance these caring attributes. The study highlights the need for further examination of teaching strategies developed to promote the transfer of self-confidence and competence from the laboratory to the clinical setting.

Enhancing Critical Thinking Via a Clinical Scholar Approach.

PubMed

Simpson, Vicki; McComb, Sara A; Kirkpatrick, Jane M

2017-11-01

Safety, quality improvement, and a systems perspective are vital for nurses to provide quality evidence-based care. Responding to the call to prepare nurses with these perspectives, one school of nursing used a clinical scholar approach, enhanced by systems engineering to more intentionally develop the ability to clinically reason and apply evidence-based practice. A two-group, repeated-measures control trial was used to determine the effects of systems engineering content and support on nursing students' clinical judgment and critical thinking skills. Findings indicated this approach had a positive effects on student's clinical judgment and clinical reasoning skills. This approach helped students view health care issues from a broader perspective and use evidence to guide solution development, enhancing the focus on evidence-based practice, and quality improvement. Intentional integration of an evidence-based, systems perspective by nursing faculty supports development of nurses who can function safely and effectively in the current health care system. [J Nurs Educ. 2017;56(11):679-682.]. Copyright 2017, SLACK Incorporated.

Hyper- and viscoelastic modeling of needle and brain tissue interaction.

PubMed

Lehocky, Craig A; Yixing Shi; Riviere, Cameron N

2014-01-01

Deep needle insertion into brain is important for both diagnostic and therapeutic clinical interventions. We have developed an automated system for robotically steering flexible needles within the brain to improve targeting accuracy. In this work, we have developed a finite element needle-tissue interaction model that allows for the investigation of safe parameters for needle steering. The tissue model implemented contains both hyperelastic and viscoelastic properties to simulate the instantaneous and time-dependent responses of brain tissue. Several needle models were developed with varying parameters to study the effects of the parameters on tissue stress, strain and strain rate during needle insertion and rotation. The parameters varied include needle radius, bevel angle, bevel tip fillet radius, insertion speed, and rotation speed. The results will guide the design of safe needle tips and control systems for intracerebral needle steering.

Clinical simulation practise framework.

PubMed

Khalili, Hossein

2015-02-01

Historically, simulation has mainly been used to teach students hands-on skills in a relatively safe environment. With changes in the patient population, professional regulations and clinical environments, clinical simulation practise (CSP) must assist students to integrate and apply their theoretical knowledge and skills with their critical thinking, clinical judgement, prioritisation, problem solving, decision making, and teamwork skills to provide holistic care and treatment to their patients. CSP holds great potential to derive a positive transformation in students' transition into the workplace, by associating and consolidating learning from classrooms to clinical settings, and creating bridges between theory and practice. For CSP to be successful in filling the gap, the design and management of the simulation is crucial. In this article a new framework called 'Clinical simulation practise framework: A knowledge to action strategy in health professional education' is being introduced that aims to assist educators and curriculum developers in designing and managing their simulations. This CSP framework theorises that simulation as an experiential educational tool could improve students' competence, confidence and collaboration in performing professional practice in real settings if the CSP provides the following three dimensions: (1) a safe, positive, reflective and fun simulated learning environment; (2) challenging, but realistic, and integrated simulated scenarios; and (3) interactive, inclusive, interprofessional patient-centred simulated practise. © 2015 John Wiley & Sons Ltd.

The First Cut Is the Deepest: The History and Development of Safe Treatments for Wound Healing and Tissue Repair.

PubMed

Hobson, David W; Schuh, JoAnn C L; Zurawski, Daniel V; Wang, Jianyong; Arbabi, Sam; McVean, Maralee; Funk, Kathleen A

2016-09-01

As the skin is the primary barrier to infection, the importance of wound healing has been understood since ancient times. This article provides a synopsis on the symposium presentations focusing on how wounds were traditionally treated, what models and pathology endpoints exist to study wound healing, special considerations for wound healing studies, an overview of regulatory aspects of new pharmaceutical and medical device development, and the clinical relevance of such models. The clinical treatment of small and large wounds is also considered. © The Author(s) 2016.

Achieving the World Health Organization's vision for clinical pharmacology

PubMed Central

Henry, David; Gray, Jean; Day, Richard; Bochner, Felix; Ferro, Albert; Pirmohamed, Munir; Mörike, Klaus; Schwab, Matthias

2015-01-01

Clinical pharmacology is a medical specialty whose practitioners teach, undertake research, frame policy, give information and advice about the actions and proper uses of medicines in humans and implement that knowledge in clinical practice. It involves a combination of several activities: drug discovery and development, training safe prescribers, providing objective and evidence‐based therapeutic information to ethics, regulatory and pricing bodies, supporting patient care in an increasingly subspecialized arena where co‐morbidities, polypharmacy, altered pharmacokinetics and drug interactions are common and developing and contributing to medicines policies for Governments. Clinical pharmacologists must advocate drug quality and they must also advocate for sustainability of the Discipline. However for this they need appropriate clinical service and training support. This Commentary discusses strategies to ensure the Discipline is supported by teaching, training and policy organizations, to communicate the full benefits of clinical pharmacology services, put a monetary value on clinical pharmacology services and to grow the clinical pharmacology workforce to support a growing clinical, academic and regulatory need. PMID:26466826

The Program Cost of a Brief Video Intervention Shown in Sexually Transmitted Disease Clinic Waiting Rooms.

PubMed

Gift, Thomas L; OʼDonnell, Lydia N; Rietmeijer, Cornelis A; Malotte, Kevin C; Klausner, Jeffrey D; Margolis, Andrew D; Borkowf, Craig B; Kent, Charlotte K; Warner, Lee

2016-01-01

Patients in sexually transmitted disease (STD) clinic waiting rooms represent a potential audience for delivering health messages via video-based interventions. A controlled trial at 3 sites found that patients exposed to one intervention, Safe in the City, had a significantly lower incidence of STDs compared with patients in the control condition. An evaluation of the intervention's cost could help determine whether such interventions are programmatically viable. The cost of producing the Safe in the City intervention was estimated using study records, including logs, calendars, and contract invoices. Production costs were divided by the 1650 digital video kits initially fabricated to get an estimated cost per digital video. Clinic costs for showing the video in waiting rooms included staff time costs for equipment operation and hardware depreciation and were estimated for the 21-month study observation period retrospectively. The intervention cost an estimated $416,966 to develop, equaling $253 per digital video disk produced. Per-site costs to show the video intervention were estimated to be $2699 during the randomized trial. The cost of producing and implementing Safe in the City intervention suggests that similar interventions could potentially be produced and made available to end users at a price that would both cover production costs and be low enough that the end users could afford them.

OR.NET: a service-oriented architecture for safe and dynamic medical device interoperability.

PubMed

Kasparick, Martin; Schmitz, Malte; Andersen, Björn; Rockstroh, Max; Franke, Stefan; Schlichting, Stefan; Golatowski, Frank; Timmermann, Dirk

2018-02-23

Modern surgical departments are characterized by a high degree of automation supporting complex procedures. It recently became apparent that integrated operating rooms can improve the quality of care, simplify clinical workflows, and mitigate equipment-related incidents and human errors. Particularly using computer assistance based on data from integrated surgical devices is a promising opportunity. However, the lack of manufacturer-independent interoperability often prevents the deployment of collaborative assistive systems. The German flagship project OR.NET has therefore developed, implemented, validated, and standardized concepts for open medical device interoperability. This paper describes the universal OR.NET interoperability concept enabling a safe and dynamic manufacturer-independent interconnection of point-of-care (PoC) medical devices in the operating room and the whole clinic. It is based on a protocol specifically addressing the requirements of device-to-device communication, yet also provides solutions for connecting the clinical information technology (IT) infrastructure. We present the concept of a service-oriented medical device architecture (SOMDA) as well as an introduction to the technical specification implementing the SOMDA paradigm, currently being standardized within the IEEE 11073 service-oriented device connectivity (SDC) series. In addition, the Session concept is introduced as a key enabler for safe device interconnection in highly dynamic ensembles of networked medical devices; and finally, some security aspects of a SOMDA are discussed.

Successful use of nitrous oxide during lumbar punctures: A call for nitrous oxide in pediatric oncology clinics.

PubMed

Livingston, Mylynda; Lawell, Miranda; McAllister, Nancy

2017-11-01

Numerous reports describe the successful use of nitrous oxide for analgesia in children undergoing painful procedures. Although shown to be safe, effective, and economical, nitrous oxide use is not yet common in pediatric oncology clinics and few reports detail its effectiveness for children undergoing repeated lumbar punctures. We developed a nitrous oxide clinic, and undertook a review of pediatric oncology lumbar puncture records for those patients receiving nitrous oxide in 2011. No major complications were noted. Minor complications were noted in 2% of the procedures. We offer guidelines for establishing such a clinic. © 2017 Wiley Periodicals, Inc.

A novel pretreatment method combining sealing technique with direct injection technique applied for improving biosafety.

PubMed

Wang, Xinyu; Gao, Jing-Lin; Du, Chaohui; An, Jing; Li, MengJiao; Ma, Haiyan; Zhang, Lina; Jiang, Ye

2017-01-01

People today have a stronger interest in the risk of biosafety in clinical bioanalysis. A safe, simple, effective method of preparation is needed urgently. To improve biosafety of clinical analysis, we used antiviral drugs of adefovir and tenofovir as model drugs and developed a safe pretreatment method combining sealing technique with direct injection technique. The inter- and intraday precision (RSD %) of the method were <4%, and the extraction recoveries ranged from 99.4 to 100.7%. Meanwhile, the results showed that standard solution could be used to prepare calibration curve instead of spiking plasma, acquiring more accuracy result. Compared with traditional methods, the novel method not only improved biosecurity of the pretreatment method significantly, but also achieved several advantages including higher precision, favorable sensitivity and satisfactory recovery. With these highly practical and desirable characteristics, the novel method may become a feasible platform in bioanalysis.

Salmonella and cancer: from pathogens to therapeutics.

PubMed

Chorobik, Paulina; Czaplicki, Dominik; Ossysek, Karolina; Bereta, Joanna

2013-01-01

Bacterial cancer therapy is a concept more than 100 years old - yet, all things considered, it is still in early development. While the use of many passive therapeutics is hindered by the complexity of tumor biology, bacteria offer unique features that can overcome these limitations. Microbial metabolism, motility and sensitivity can lead to site-specific treatment, highly focused on the tumor and safe to other tissues. Activation of tumor-specific immunity is another important mechanism of such therapies. Several bacterial strains have been evaluated as cancer therapeutics so far, Salmonella Typhimurium being one of the most promising. S. Typhimurium and its derivatives have been used both as direct tumoricidal agents and as cancer vaccine vectors. VNP20009, an attenuated mutant of S. Typhimurium, shows significant native toxicity against murine tumors and was studied in a first-in-man phase I clinical trial for toxicity and anticancer activity. While proved to be safe in cancer patients, insufficient tumor colonization of VNP20009 was identified as a major limitation for further clinical development. Antibody-fragment-based targeting of cancer cells is one of the few approaches proposed to overcome this drawback.

Vaccine development for allergen-specific immunotherapy based on recombinant allergens and synthetic allergen peptides: Lessons from the past and novel mechanisms of action for the future

PubMed Central

Valenta, Rudolf; Campana, Raffaela; Focke-Tejkl, Margit; Niederberger, Verena

2016-01-01

In the past, the development of more effective, safe, convenient, broadly applicable, and easy to manufacture vaccines for allergen-specific immunotherapy (AIT) has been limited by the poor quality of natural allergen extracts. Progress made in the field of molecular allergen characterization has now made it possible to produce defined vaccines for AIT and eventually for preventive allergy vaccination based on recombinant DNA technology and synthetic peptide chemistry. Here we review the characteristics of recombinant and synthetic allergy vaccines that have reached clinical evaluation and discuss how molecular vaccine approaches can make AIT more safe and effective and thus more convenient. Furthermore, we discuss how new technologies can facilitate the reproducible manufacturing of vaccines of pharmaceutical grade for inhalant, food, and venom allergens. Allergy vaccines in clinical trials based on recombinant allergens, recombinant allergen derivatives, and synthetic peptides allow us to target selectively different immune mechanisms, and certain of those show features that might make them applicable not only for therapeutic but also for prophylactic vaccination. PMID:26853127

Gaining Control of Occupational Injury and Illness in the U.S. Navy Civilian Work Force

DTIC Science & Technology

1990-01-16

caring for the back. Also monitored by the supervisor is a work -hardening program developed by the clinic physical therapist and physician that... development of a work -hardening program for the returning injured employee to ensure a safe re-entry to the workplace. e. "Green Table" and Medical...physical therapist work closely in developing effective programs for the treatment of occupational injuries. Having an onsite physical therapist available

Maintenance of peripheral venous access and its impact on the development of phlebitis: a survey of 186 catheters in a general surgery department in Portugal.

PubMed

do Rego Furtado, Luís Carlos

2011-01-01

This article reports the results of a clinical audit conducted to assess the minimum requirements for safe maintenance of peripheral intravenous catheters. The audit also determined the incidence of phlebitis and attempted to establish a causal relationship between some of the variables used to assess a catheter's maintenance status and the development of phlebitis.

An exploration of undergraduate nursing and physiotherapy students' views regarding education for patient handling.

PubMed

Kneafsey, Rosie; Ramsay, Jill; Edwards, Helen; Callaghan, Helen

2012-12-01

To ascertain the views of undergraduate student nurses and physiotherapists regarding their education in patient handling. Musculo-skeletal injuries are an important cause of staff sickness absence and attrition from the nursing profession and are a recognised problem within the physiotherapy profession. Nurses and physiotherapists are at risk of musculo-skeletal injuries as a result of their role in assisting patients with movement. A questionnaire survey was undertaken of undergraduate nursing and physiotherapy students (n = 371) at one university. Most students agreed that university teaching about moving and handling prepared them for clinical practice (64%). Over a third reported that they had never undertaken a written moving and handling risk assessment in clinical practice (38%). Almost half of the sample (40%) admitted undertaking unsafe moving and handling activities. Half (50%) also stated that they would rather 'fit' into the team than challenge unsafe practice. Almost a third (29%) stated that they had begun to experience pain since becoming a student. There were significant differences between nursing and physiotherapy students. Physiotherapy students were more likely to report being supervised when moving and handling and reported being more assertive about adhering to safe practice. The well-being of both nursing and physiotherapy undergraduate students is threatened when students undertake work placements in clinical settings. University-based education in safe patient handling, though important, can be undermined by workplace settings where unsafe practices occur. Collaboration is needed between university educators, managers and practice-based mentors to support students to maintain safe approaches to moving and handling patients. A third of students reported developing pain since becoming a healthcare student. Students entering their professions already injured may leave the workforce owing to poor physical well-being. It is vital that the clinical workplace supports safe systems of working. © 2012 Blackwell Publishing Ltd.

Plant-made vaccines against West Nile virus are potent, safe, and economically feasible

PubMed Central

Chen, Qiang

2015-01-01

The threat of West Nile virus (WNV) epidemics with increasingly severe neuroinvasive infections demands the development and licensing of effective vaccines. To date, vaccine candidates based on inactivated, live-attenuated, or chimeric virus, and viral DNA and WNV protein subunits have been developed. Some have been approved for veterinary use or are under clinical investigation, yet no vaccine has been licensed for human use. Reaching the milestone of a commercialized human vaccine, however, may largely depend on the economics of vaccine production. Analysis suggests that currently only novel low-cost production technologies would allow vaccination to outcompete the cost of surveillance and clinical treatment. Here, we review progress using plants to address the economic challenges of WNV vaccine production. The advantages of plants as hosts for vaccine production in cost, speed and scalability, especially those of viral vector-based transient expression systems, are discussed. The progress in developing WNV subunit vaccines in plants is reviewed within the context of their expression, characterization, downstream processing, and immunogenicity in animal models. The development of vaccines based on enveloped and non-enveloped virus-like particles is also discussed. These advancements suggest that plants may provide a production platform that offers potent, safe and affordable human vaccines against WNV. PMID:25676782

Plant-made vaccines against West Nile virus are potent, safe, and economically feasible.

PubMed

Chen, Qiang

2015-05-01

The threat of West Nile virus (WNV) epidemics with increasingly severe neuroinvasive infections demands the development and licensing of effective vaccines. To date, vaccine candidates based on inactivated, live-attenuated, or chimeric virus, and viral DNA and WNV protein subunits have been developed. Some have been approved for veterinary use or are under clinical investigation, yet no vaccine has been licensed for human use. Reaching the milestone of a commercialized human vaccine, however, may largely depend on the economics of vaccine production. Analysis suggests that currently only novel low-cost production technologies would allow vaccination to outcompete the cost of surveillance and clinical treatment. Here, we review progress using plants to address the economic challenges of WNV vaccine production. The advantages of plants as hosts for vaccine production in cost, speed and scalability, especially those of viral vector-based transient expression systems, are discussed. The progress in developing WNV subunit vaccines in plants is reviewed within the context of their expression, characterization, downstream processing, and immunogenicity in animal models. The development of vaccines based on enveloped and non-enveloped virus-like particles is also discussed. These advancements suggest that plants may provide a production platform that offers potent, safe and affordable human vaccines against WNV. Copyright © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Safe Use of Acoustic Vestibular-Evoked Myogenic Potential Stimuli: Protocol and Patient-Specific Considerations.

PubMed

Portnuff, Cory D F; Kleindienst, Samantha; Bogle, Jamie M

2017-09-01

Vestibular-evoked myogenic potentials (VEMPs) are commonly used clinical assessments for patients with complaints of dizziness. However, relatively high air-conducted stimuli are required to elicit the VEMP, and ultimately may compromise safe noise exposure limits. Recently, research has reported the potential for noise-induced hearing loss (NIHL) from VEMP stimulus exposure through studies of reduced otoacoustic emission levels after VEMP testing, as well as a recent case study showing permanent sensorineural hearing loss associated with VEMP exposure. The purpose of this report is to review the potential for hazardous noise exposure from VEMP stimuli and to suggest clinical parameters for safe VEMP testing. Literature review with presentation of clinical guidelines and a clinical tool for estimating noise exposure. The literature surrounding VEMP stimulus-induced hearing loss is reviewed, including several cases of overexposure. The article then presents a clinical calculation tool for the estimation of a patient's safe noise exposure from VEMP stimuli, considering stimulus parameters, and includes a discussion of how varying stimulus parameters affect a patient's noise exposure. Finally, recommendations are provided for recognizing and managing specific patient populations who may be at higher risk for NIHL from VEMP stimulus exposure. A sample protocol is provided that allows for safe noise exposure. VEMP stimuli have the potential to cause NIHL due to high sound exposure levels. However, with proper safety protocols in place, clinicians may reduce or eliminate this risk to their patients. Use of the tools provided, including the noise exposure calculation tool and sample protocols, may help clinicians to understand and ensure safe use of VEMP stimuli. American Academy of Audiology

Ultrasonography in gastroenterology.

PubMed

Ødegaard, Svein; Nesje, Lars B; Hausken, Trygve; Gilja, Odd Helge

2015-06-01

Ultrasonography (US) is a safe and available real-time, high-resolution imaging method, which during the last decades has been increasingly integrated as a clinical tool in gastroenterology. New US applications have emerged with enforced data software and new technical solutions, including strain evaluation, three-dimensional imaging and use of ultrasound contrast agents. Specific gastroenterologic applications have been developed by combining US with other diagnostic or therapeutic methods, such as endoscopy, manometry, puncture needles, diathermy and stents. US provides detailed structural information about visceral organs without hazard to the patients and can play an important clinical role by reducing the need for invasive procedures. This paper presents different aspects of US in gastroenterology, with a special emphasis on the contribution from Nordic scientists in developing clinical applications.

The development and evaluation of online stories to enhance clinical learning experiences across health professions in rural Australia.

PubMed

Paliadelis, Penny Susan; Stupans, Leva; Parker, Vicki; Piper, Donella; Gillan, Pauline; Lea, Jackie; Jarrott, Helen Mary; Wilson, Rhonda; Hudson, Judith N; Fagan, Anthea

2015-01-01

Clinical placement learning experiences are integral to all health and medical curricula as a means of integrating theory into practice and preparing graduates to deliver safe, high-quality care to health consumers. A growing challenge for education providers is to access sufficient clinical placements with experienced supervisors who are skilled at maximising learning opportunities for students. This paper reports on the development and evaluation of an innovative online learning program aimed at enhancing student and clinical supervisors' preparedness for effective workplace-based learning. The evidence-based learning program used 'story-telling' as the learning framework. The stories, which were supported by a range of resources, aimed to engage the learners in understanding student and supervisor responsibilities, as well as the expectations and competencies needed to support effective learning in the clinical environment. Evaluation of this program by the learners and stakeholders clearly indicated that they felt authentically 'connected' with the characters in the stories and developed insights that suggested effective learning had occurred.

Application of ET-Kyoto solution in clinical lung transplantation.

PubMed

Omasa, Mitsugu; Hasegawa, Seiki; Bando, Toru; Hanaoka, Nobuharu; Yoshimura, Takashi; Nakamura, Takayuki; Wada, Hiromi

2004-01-01

We have developed a new organ preservation solution called extracellular-type trehalose-containing Kyoto (ET-Kyoto) solution. ET-Kyoto solution has been applied in clinical lung transplantation. The patient was a 49-year-old woman with diffuse panbronchiolitis. She underwent bilateral lobar lung transplantation from living donors. Each lobe was flushed with ET-Kyoto solution. After reperfusion, PaO(2) with inhalation of 100% oxygen was more than 500 Torr. Posttransplantation course was uneventful. Despite the relatively short ischemic time of this case report, ET-Kyoto solution may be feasible and safely applied in clinical lung transplantation.

Choice of Insulin in Type 2 Diabetes: A Southeast Asian Perspective

PubMed Central

Kalra, Sanjay; Thai, Hong Quang; Deerochanawong, Chaicharn; Su-Yen, Goh; Mohamed, Mafauzy; Latt, Tint Swe; Aye, Than Than; Latif, Zafar Ahmed; Katulanda, Prasad; Khun, Touch; Satha, Sum; Vongvandy, Vadsana

2017-01-01

Southeast Asia faces a diabetes epidemic, which has created significant challenges for health care. The unique Asian diabetes phenotype, coupled with peculiar lifestyle, diet, and healthcare-seeking behavior, makes it imperative to develop clinical pathways and guidelines which address local needs and requirements. From an insulin-centric viewpoint, the preparations prescribed in such pathways should be effective, safe, well tolerated, nonintrusive, and suitable for the use in multiple clinical situations including initiation and intensification. This brief communication describes the utility of premixed or dual action insulin in such clinical pathways and guidelines. PMID:28553609

Nurses' experiences and perspectives on medication safety practices: an explorative qualitative study.

PubMed

Smeulers, Marian; Onderwater, Astrid T; van Zwieten, Myra C B; Vermeulen, Hester

2014-04-01

To explore nurses' experiences with and perspectives on preventing medication administration errors. Insight into nurses' experiences with and perspectives on preventing medication administration errors is important and can be utilised to tailor and implement safety practices. A qualitative interview study of 20 nurses in an academic medical centre was conducted between March and December of 2011. Three themes emerged from this study: (1) nurses' roles and responsibilities in medication safety: aside from safe preparation and administration, the clinical reasoning of nurses is essential for medication safety; (2) nurses' ability to work safely: knowledge of risks and nurses' work circumstances influence their ability to work safely; and (3) nurses' acceptance of safety practices: advantages, feasibility and appropriateness are important incentives for acceptance of a safety practice. Nurses' experiences coincide with the assumption that they are in a pre-eminent position to enable safe medication management; however, their ability to adequately perform this role depends on sufficient knowledge to assess the risks of medication administration and on the circumstances in which they work. Safe medication management requires a learning climate and professional practice environment that enables further development of professional nursing skills and knowledge. © 2014 John Wiley & Sons Ltd.

Engineering stem cells for future medicine.

PubMed

Ricotti, Leonardo; Menciassi, Arianna

2013-03-01

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

Immunotherapies: Exploiting the Immune System for Cancer Treatment

PubMed Central

Cato, Caleb; Geiger, Joseph; Henry, Denise; Hernandez, Jennifer; Kaur, Preet; Teskey, Garrett; Tran, Andrew

2018-01-01

Cancer is a condition that has plagued humanity for thousands of years, with the first depictions dating back to ancient Egyptian times. However, not until recent decades have biological therapeutics been developed and refined enough to safely and effectively combat cancer. Three unique immunotherapies have gained traction in recent decades: adoptive T cell transfer, checkpoint inhibitors, and bivalent antibodies. Each has led to clinically approved therapies, as well as to therapies in preclinical and ongoing clinical trials. In this review, we outline the method by which these 3 immunotherapies function as well as any major immunotherapeutic drugs developed for treating a variety of cancers. PMID:29725606

New responsibilities in purchasing and developing services.

PubMed

Jerram, Soline; Fox, Ann

2014-06-01

The role of nursing in the NHS commissioning structure in England is developing. Since April 2013 more than 200 clinical commissioning groups (CCGs), which comprise all GP practices in the locality, have taken on responsibility for health budgets in their areas. This article describes the challenges ahead and nurses' responsibilities in CCGs when working with local citizens and across the health and social care system to assure the delivery of high quality, safe services.

The Effect of a High-Fidelity Home Health Simulations on Nursing Students' Clinical Performance

ERIC Educational Resources Information Center

Crytzer, Michele Leigh

2011-01-01

With an increasing number of patients receiving nursing care in outpatient settings, it is the responsibility of nursing education programs to provide students with adequate training to enable them to develop the skills necessary to provide safe, effective care in diverse environments, including the home. Providing care to patients in their own…

Safe abortion: WHO technical and policy guidance.

PubMed

Cook, R J; Dickens, B M; Horga, M

2004-07-01

In 2003, the World Health Organization published its well referenced handbook Safe Abortion: Technical and Policy Guidance for Health Systems to address the estimated almost 20 million induced abortions each year that are unsafe, imposing a burden of approximately 67 thousand deaths annually. It is a global injustice that 95% of unsafe abortions occur in developing countries. The focus of guidance is on abortion procedures that are lawful within the countries in which they occur, noting that in almost all countries, the law permits abortion to save a woman's life. The guidance treats unsafe abortion as a public health challenge, and responds to the problem through strategies concerning improved clinical care for women undergoing procedures, and the appropriate placement of necessary services. Legal and policy considerations are explored, and annexes present guidance to further reading, international consensus documents on safe abortion, and on manual vacuum aspiration and post-abortion contraception.

[Definition of the Diagnosis Osteomyelitis-Osteomyelitis Diagnosis Score (ODS)].

PubMed

Schmidt, H G K; Tiemann, A H; Braunschweig, R; Diefenbeck, M; Bühler, M; Abitzsch, D; Haustedt, N; Walter, G; Schoop, R; Heppert, V; Hofmann, G O; Glombitza, M; Grimme, C; Gerlach, U-J; Flesch, I

2011-08-01

The disease "osteomyelitis" is characterised by different symptoms and parameters. Decisive roles in the development of the disease are played by the causative bacteria, the route of infection and the individual defense mechanisms of the host. The diagnosis is based on different symptoms and findings from the clinical history, clinical symptoms, laboratory results, diagnostic imaging, microbiological and histopathological analyses. While different osteomyelitis classifications have been published, there is to the best of our knowledge no score that gives information how sure the diagnosis "osteomyelitis" is in general. For any scientific study of a disease a valid definition is essential. We have developed a special osteomyelitis diagnosis score for the reliable classification of clinical, laboratory and technical findings. The score is based on five diagnostic procedures: 1) clinical history and risk factors, 2) clinical examination and laboratory results, 3) diagnostic imaging (ultrasound, radiology, CT, MRI, nuclear medicine and hybrid methods), 4) microbiology, and 5) histopathology. Each diagnostic procedure is related to many individual findings, which are weighted by a score system, in order to achieve a relevant value for each assessment. If the sum of the five diagnostic criteria is 18 or more points, the diagnosis of osteomyelitis can be viewed as "safe" (diagnosis class A). Between 8-17 points the diagnosis is "probable" (diagnosis class B). Less than 8 points means that the diagnosis is "possible, but unlikely" (class C diagnosis). Since each parameter can score six points at a maximum, a reliable diagnosis can only be achieved if at least 3 parameters are scored with 6 points. The osteomyelitis diagnosis score should help to avoid the false description of a clinical presentation as "osteomyelitis". A safe diagnosis is essential for the aetiology, treatment and outcome studies of osteomyelitis. © Georg Thieme Verlag KG Stuttgart · New York.

Future of Treatment for Nonalcoholic Steatohepatitis: Can the Use of Safe, Evidence-Based, Clinically Proven Supplements Provide the Answer to the Unmet Need?

PubMed

Ilan, Yaron

2018-04-20

The epidemic of nonalcoholic fatty liver disease (NAFLD) has created a real and unmet therapeutic need. The long regulatory pathway and the focus on selected subsets of patients with established and advanced disease are some of the current obstacles to providing effective treatment for the majority of NAFLD patients. The complexity of the disease pathogenesis, which involves multiple mechanisms, requires targeting of more than one pathway or a combination-based therapy. Although the drugs being developed may prevent progression to cirrhosis or may decrease negative liver outcomes, their effects on cardiometabolic health and cancer prevention remain unknown. Providing expensive compounds to a large proportion of the population for long-term use would place an economic burden on health care providers. Thus, there is a missed opportunity for early intervention in the course of the disease, by providing agents that improve cardiometabolic status and the progression of fatty liver toward steatohepatitis. Several natural supplements have the potential to meet these needs. This review discusses some of the major obstacles to drug development for NASH treatment. Milestones in bringing evidenced-based, scientifically proven, patent-protected, clinically tested, safe compounds to patients with NAFLD or NASH within a relatively short period of time are presented. The regulatory, intellectual property, manufacturing, and clinical development steps, along with applicable timelines, are discussed. These compounds may provide a possible solution to the challenges associated with the treatment of the majority of patients.

Responsible innovation in human germline gene editing: Background document to the recommendations of ESHG and ESHRE.

PubMed

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

2018-04-01

Technological developments in gene editing raise high expectations for clinical applications, including editing of the germline. The European Society of Human Reproduction and Embryology (ESHRE) and the European Society of Human Genetics (ESHG) together developed a Background document and Recommendations to inform and stimulate ongoing societal debates. This document provides the background to the Recommendations. Germline gene editing is currently not allowed in many countries. This makes clinical applications in these countries impossible now, even if germline gene editing would become safe and effective. What were the arguments behind this legislation, and are they still convincing? If a technique could help to avoid serious genetic disorders, in a safe and effective way, would this be a reason to reconsider earlier standpoints? This Background document summarizes the scientific developments and expectations regarding germline gene editing, legal regulations at the European level, and ethics for three different settings (basic research, preclinical research and clinical applications). In ethical terms, we argue that the deontological objections (e.g., gene editing goes against nature) do not seem convincing while consequentialist objections (e.g., safety for the children thus conceived and following generations) require research, not all of which is allowed in the current legal situation in European countries. Development of this Background document and Recommendations reflects the responsibility to help society understand and debate the full range of possible implications of the new technologies, and to contribute to regulations that are adapted to the dynamics of the field while taking account of ethical considerations and societal concerns.

Modified Vaccinia Virus Ankara: History, Value in Basic Research, and Current Perspectives for Vaccine Development.

PubMed

Volz, A; Sutter, G

2017-01-01

Safety tested Modified Vaccinia virus Ankara (MVA) is licensed as third-generation vaccine against smallpox and serves as a potent vector system for development of new candidate vaccines against infectious diseases and cancer. Historically, MVA was developed by serial tissue culture passage in primary chicken cells of vaccinia virus strain Ankara, and clinically used to avoid the undesirable side effects of conventional smallpox vaccination. Adapted to growth in avian cells MVA lost the ability to replicate in mammalian hosts and lacks many of the genes orthopoxviruses use to conquer their host (cell) environment. As a biologically well-characterized mutant virus, MVA facilitates fundamental research to elucidate the functions of poxvirus host-interaction factors. As extremely safe viral vectors MVA vaccines have been found immunogenic and protective in various preclinical infection models. Multiple recombinant MVA currently undergo clinical testing for vaccination against human immunodeficiency viruses, Mycobacterium tuberculosis or Plasmodium falciparum. The versatility of the MVA vector vaccine platform is readily demonstrated by the swift development of experimental vaccines for immunization against emerging infections such as the Middle East Respiratory Syndrome. Recent advances include promising results from the clinical testing of recombinant MVA-producing antigens of highly pathogenic avian influenza virus H5N1 or Ebola virus. This review summarizes our current knowledge about MVA as a unique strain of vaccinia virus, and discusses the prospects of exploiting this virus as research tool in poxvirus biology or as safe viral vector vaccine to challenge existing and future bottlenecks in vaccinology. © 2017 Elsevier Inc. All rights reserved.

Producing Competent Doctors - The Art and Science of Teaching Clinical Skills.

PubMed

Dhaliwal, Upreet; Supe, Avinash; Gupta, Piyush; Singh, Tejinder

2017-05-15

For a doctor to provide medical care with competence, he must not only have knowledge but must also be able to translate that knowledge into action. It is his competence in clinical skills that will enable him to practice safely and effectively in the real world. To ensure acquisition of clinical skills, medical teachers must adopt teaching methods that prioritise observation, practice, feedback; and more practice. We try to elucidate the meaning of clinical skills, the challenges inherent in clinical skills training in India, training models that have shown success in practice and can be adopted in the Indian context, and various techniques to enhance skill-training, including the giving of feedback, which is a critically important component of skills development.

Risk and Safety of Probiotics

PubMed Central

Doron, Shira; Snydman, David R.

2015-01-01

Probiotics have been used safely for years. Safety outcomes are inconsistently reported in published clinical trials. In 2011, a report released by the Agency for Healthcare Research and Quality concluded that, although the existing probiotic clinical trials reveal no evidence of increased risk, “the current literature is not well equipped to answer questions on the safety of probiotics in intervention studies with confidence.” Critics point out that the preponderance of evidence, including the long history of safe probiotic use as well as data from clinical trials, and animal and in vitro studies all support the assumption that probiotics are generally safe for most populations. Theoretical risks have been described in case reports, clinical trial results and experimental models, include systemic infections, deleterious metabolic activities, excessive immune stimulation in susceptible individuals, gene transfer and gastrointestinal side effects. More research is needed to properly describe the incidence and severity of adverse events related to probiotics. PMID:25922398

Dengue vaccines: recent developments, ongoing challenges and current candidates

PubMed Central

McArthur, Monica A.; Sztein, Marcelo B.; Edelman, Robert

2013-01-01

Summary Dengue is among the most prevalent and important arbovirus diseases of humans. In order to effectively control this rapidly spreading disease, control of the vector mosquito and a safe and efficacious vaccine are critical. Despite considerable efforts, the development of a successful vaccine has remained elusive. Multiple factors have complicated the creation of a successful vaccine, not the least of which are the complex, immune-mediated responses against four antigenically distinct serotypes necessitating a tetravalent vaccine providing long lasting protective immunity. Despite the multiple impediments, there are currently many promising vaccine candidates in pre-clinical and clinical development. Here we review the recent advances in dengue virus vaccine development and briefly discuss the challenges associated with the use of these vaccines as a public health tool. PMID:23984962

Developing professional attributes in critical care nurses using Team-Based Learning.

PubMed

Currey, Judy; Eustace, Paula; Oldland, Elizabeth; Glanville, David; Story, Ian

2015-05-01

Australian nurses prepare for specialty practice by undertaking postgraduate theoretical and clinical education in partnership models between universities and hospitals. In our global healthcare system, nurses require advanced critical thinking and strong communication skills to provide safe, high quality patient care. Yet, few education programs focus on developing these skills. Team-Based Learning (TBL) is a specific educational strategy that encourages and rewards students to think critically and solve clinical problems individually and in teams. The aim of this study was to investigate critical care nursing students' perceptions and experiences of TBL after it was introduced into the second half of their postgraduate specialty course. Following Ethics Committee approval, thirty-two students were invited to participate in an extended response questionnaire on their perceptions of TBL as part of a larger study. Data were analyzed thematically. Postgraduate students perceived their professional growth was accelerated due to the skills and knowledge acquired through TBL. Four themes underpinned the development and accelerated acquisition of specialty nurse attributes due to TBL: Engagement, Learning Effectiveness, Critical Thinking, and Motivation to Participate. Team-Based Learning offered deep and satisfying learning experiences for students. The early acquisition of advanced critical thinking, teamwork and communication skills, and specialty practice knowledge empowered nurses to provide safe patient care with confidence. Copyright © 2015 Elsevier Ltd. All rights reserved.

Steering teens safe: a randomized trial of a parent-based intervention to improve safe teen driving.

PubMed

Peek-Asa, Corinne; Cavanaugh, Joseph E; Yang, Jingzhen; Chande, Vidya; Young, Tracy; Ramirez, Marizen

2014-07-31

Crashes are the leading cause of death for teens, and parent-based interventions are a promising approach. We assess the effectiveness of Steering Teens Safe, a parent-focused program to increase safe teen driving. Steering Teens Safe aimed to improve parental communication with teens about safe driving using motivational interviewing techniques in conjunction with 19 safe driving lessons. A randomized controlled trial involved 145 parent-teen dyads (70 intervention and 75 control). Intervention parents received a 45-minute session to learn the program with four follow-up phone sessions, a DVD, and a workbook. Control parents received a standard brochure about safe driving. Scores were developed to measure teen-reported quantity and quality of parental communication about safe driving. The main outcome measure was a previously validated Risky Driving Score reported by teens. Because the Score was highly skewed, a generalized linear model based on a gamma distribution was used for analysis. Intervention teens ranked their parent's success in talking about driving safety higher than control teens (p = 0.035) and reported that their parents talked about more topics (non-significant difference). The Risky Driving Score was 21% lower in intervention compared to control teens (85% CI = 0.60, 1.00). Interaction between communication quantity and the intervention was examined. Intervention teens who reported more successful communication had a 42% lower Risky Driving Score (95% CI = 0.37, 0.94) than control parents with less successful communication. This program had a positive although not strong effect, and it may hold the most promise in partnership with other programs, such as Driver's Education or Graduated Driver's License policies. ClinicalTrials.gov NCT01014923. Registered Nov. 16, 2009.

Current nonclinical testing paradigm enables safe entry to First-In-Human clinical trials: The IQ consortium nonclinical to clinical translational database.

PubMed

Monticello, Thomas M; Jones, Thomas W; Dambach, Donna M; Potter, David M; Bolt, Michael W; Liu, Maggie; Keller, Douglas A; Hart, Timothy K; Kadambi, Vivek J

2017-11-01

The contribution of animal testing in drug development has been widely debated and challenged. An industry-wide nonclinical to clinical translational database was created to determine how safety assessments in animal models translate to First-In-Human clinical risk. The blinded database was composed of 182 molecules and contained animal toxicology data coupled with clinical observations from phase I human studies. Animal and clinical data were categorized by organ system and correlations determined. The 2×2 contingency table (true positive, false positive, true negative, false negative) was used for statistical analysis. Sensitivity was 48% with a 43% positive predictive value (PPV). The nonhuman primate had the strongest performance in predicting adverse effects, especially for gastrointestinal and nervous system categories. When the same target organ was identified in both the rodent and nonrodent, the PPV increased. Specificity was 84% with an 86% negative predictive value (NPV). The beagle dog had the strongest performance in predicting an absence of clinical adverse effects. If no target organ toxicity was observed in either test species, the NPV increased. While nonclinical studies can demonstrate great value in the PPV for certain species and organ categories, the NPV was the stronger predictive performance measure across test species and target organs indicating that an absence of toxicity in animal studies strongly predicts a similar outcome in the clinic. These results support the current regulatory paradigm of animal testing in supporting safe entry to clinical trials and provide context for emerging alternate models. Copyright © 2017 Elsevier Inc. All rights reserved.

Midwifery students' experiences of simulation- and skills training.

PubMed

Lendahls, Lena; Oscarsson, Marie G

2017-03-01

In Sweden, simulation- and skills training are implemented in midwifery education in order to prepare students for clinical practice. Research regarding the use of both low to high levels of fidelity in simulation in midwifery programme is limited. The aim of this study was to explore midwifery students' experiences of simulation- and skills training. Midwifery students (n=61), at advanced level, were interviewed in 13 group interviews from 2011 to 2105. A semi-structured interview guide was used, and data were analysed by content analysis. The results are presented in four main categories: develops hands on skills and communication, power of collaborative learning, highly valued learning environment and facilitates clinical practice. The majority of students felt that the simulation- and skills training were necessary to become familiar with hands on skills. Having repetitive practices in a safe and secure environment was viewed as important, and students highly valued that mistakes could be made without fear of comprising patient safety. Student's collaboration, reflections and critical thinking increased learning ability. Simulation- and skills training created links between theory and practice, and the lecturer had an important role in providing instructions and feedback. Students felt prepared and confident before their clinical practice, and simulation- and skills training increased safety for all involved, resulting in students being more confident, as patients in clinical practice became less exposed. Furthermore, mentors were satisfied with students' basic skills. Simulation- and skills training support the development of midwifery skills. It creates links between theory and practice, which facilitates students' learning ability. Training needs to include reflections and critical thinking in order to develop their learning. The lecturer has an important role in encouraging time for reflections and creating safe environment during the skills and simulation training. Copyright © 2016 Elsevier Ltd. All rights reserved.

Special care dentistry for general dental practice.

PubMed

Greig, Vicki; Sweeney, Petrina

2013-01-01

Although special care dentistry (SCD) is a fairly recent specialty, the principles and practice of SCD have been developed since the 1980s. Shared care of these patients with general dental practitioners remains vital to ensure that comprehensive care is provided. This article aims to discuss some of the patient groups commonly seen in SCD clinics and give an insight into the varied complex medical and social aspects of care which are managed as part of providing appropriate, safe and holistic care. Many patients who currently fall under the remit of special care dentistry could be treated safely in general dental practice. This article acts as an introduction to special care dentistry for general dental practitioners.

Vitamin K antagonists and direct thrombin inhibitors: present and future.

PubMed

Pineo, Graham F; Hull, Russell D

2005-02-01

Warfarin and related compounds are efficacious and safe in a variety of clinical thrombotic disorders; however, these drugs have a narrow therapeutic window, whereby inadequate therapy is associated with an increased thrombotic risk and overanticoagulation is associated with bleeding. Therefore, attempts have been made to develop alternatives to warfarin. Ximelagatran, an oral direct thrombin inhibitor, has been shown to be as efficacious and safe as warfarin for the prevention and treatment of different thrombotic disorders. This article reviews the pharmacology of the coumarins, the most commonly used vitamin K antagonists, and the practical aspects regarding their use in the management of thrombotic disorders. The future role of the oral direct thrombin inhibitor ximelagatran also is reviewed.

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

PubMed

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

2014-01-01

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

A study to derive a clinical decision rule for triage of emergency department patients with chest pain: design and methodology

PubMed Central

Hess, Erik P; Wells, George A; Jaffe, Allan; Stiell, Ian G

2008-01-01

Background Chest pain is the second most common chief complaint in North American emergency departments. Data from the U.S. suggest that 2.1% of patients with acute myocardial infarction and 2.3% of patients with unstable angina are misdiagnosed, with slightly higher rates reported in a recent Canadian study (4.6% and 6.4%, respectively). Information obtained from the history, 12-lead ECG, and a single set of cardiac enzymes is unable to identify patients who are safe for early discharge with sufficient sensitivity. The 2007 ACC/AHA guidelines for UA/NSTEMI do not identify patients at low risk for adverse cardiac events who can be safely discharged without provocative testing. As a result large numbers of low risk patients are triaged to chest pain observation units and undergo provocative testing, at significant cost to the healthcare system. Clinical decision rules use clinical findings (history, physical exam, test results) to suggest a diagnostic or therapeutic course of action. Currently no methodologically robust clinical decision rule identifies patients safe for early discharge. Methods/design The goal of this study is to derive a clinical decision rule which will allow emergency physicians to accurately identify patients with chest pain who are safe for early discharge. The study will utilize a prospective cohort design. Standardized clinical variables will be collected on all patients at least 25 years of age complaining of chest pain prior to provocative testing. Variables strongly associated with the composite outcome acute myocardial infarction, revascularization, or death will be further analyzed with multivariable analysis to derive the clinical rule. Specific aims are to: i) apply standardized clinical assessments to patients with chest pain, incorporating results of early cardiac testing; ii) determine the inter-observer reliability of the clinical information; iii) determine the statistical association between the clinical findings and the composite outcome; and iv) use multivariable analysis to derive a highly sensitive clinical decision rule to guide triage decisions. Discussion The study will derive a highly sensitive clinical decision rule to identify low risk patients safe for early discharge. This will improve patient care, lower healthcare costs, and enhance flow in our busy and overcrowded emergency departments. PMID:18254973

Challenges in translating vascular tissue engineering to the pediatric clinic.

PubMed

Duncan, Daniel R; Breuer, Christopher K

2011-10-14

The development of tissue-engineered vascular grafts for use in cardiovascular surgery holds great promise for improving outcomes in pediatric patients with complex congenital cardiac anomalies. Currently used synthetic grafts have a number of shortcomings in this setting but a tissue engineering approach has emerged in the past decade as a way to address these limitations. The first clinical trial of this technology showed that it is safe and effective but the primary mode of graft failure is stenosis. A variety of murine and large animal models have been developed to study and improve tissue engineering approaches with the hope of translating this technology into routine clinical use, but challenges remain. The purpose of this report is to address the clinical problem and review recent advances in vascular tissue engineering for pediatric applications. A deeper understanding of the mechanisms of neovessel formation and stenosis will enable rational design of improved tissue-engineered vascular grafts.

The clinical trials supporting benzyl alcohol lotion 5% (Ulesfia): a safe and effective topical treatment for head lice (pediculosis humanus capitis).

PubMed

Meinking, Terri L; Villar, Maria E; Vicaria, Maureen; Eyerdam, Debbie H; Paquet, Diane; Mertz-Rivera, Kamara; Rivera, Hector F; Hiriart, Javier; Reyna, Susan

2010-01-01

Benzyl alcohol lotion 5% (BAL 5%) is a non-neurotoxic topical head lice treatment that is safe and effective in children as young as 6 months of age. The safety and efficacy of this pediculicide has been studied in 695 (confirm number) subjects in all phases of clinical development. Scanning electron micrographs (SEM) demonstrated that the active agent appears to stun the breathing spiracles open, enabling the vehicle to penetrate the respiratory mechanism (spiracles), therefore asphyxiating the lice. Initial phase II trials compared this novel product to RID using identical volumes of treatment (4 oz/application) and yielding, almost, identical efficacy. This outcome pointed to the significant importance of completely saturating the hair with the product in order to achieve maximum treatment success. A second phase II trial, which allowed the use of sufficient product to saturate the hair, resulted in 100% efficacy after both 10 and 30 minute treatments. A third phase II trial verified an effective dose. Phase III trials compared BAL 5% to vehicle placebo for two 10-minute applications. It proved to be safe and effective (p < 0.001) for treatment of head lice and is the first FDA-approved non-neurotoxic lice treatment, now available in the United States as Ulesfia lotion.

Toward the development of a one-dose classical swine fever subunit vaccine: antigen titration, immunity onset, and duration of immunity

PubMed Central

Madera, Rachel F.; Wang, Lihua; Gong, Wenjie; Burakova, Yulia; Buist, Sterling; Nietfeld, Jerome; Henningson, Jamie; Cino-Ozuna, Ada G.; Tu, Changchun

2018-01-01

Highly contagious classical swine fever (CSF) remains a major trade and health problem in the pig industry, resulting in large economic losses worldwide. In CSF-endemic countries, attenuated CSF virus (CSFV) vaccines have been routinely used to control the disease. However, eradication of CSFV in a geographical area would require permanent reduction to zero presence of the virus. It is therefore of paramount importance to develop a safe, potent, and non-infectious CSF vaccine. We have previously reported on a cost-effective CSF E2 subunit vaccine, KNB-E2, which can protect against CSF symptoms in a single dose containing 75 µg of recombinant CSFV glycoprotein E2. In this study, we report on a series of animal studies undertaken to elucidate further the efficacy of KNB-E2. We found that pigs vaccinated with a single KNB-E2 dose containing 25 µg of recombinant CSFV glycoprotein E2 were protected from clinical symptoms of CSF. In addition, KNB-E2-mediated reduction of CSF symptoms was observed at two weeks post-vaccination and the vaccinated pigs continued to exhibit reduced CSF clinical signs when virus challenged at two months and four months post-vaccination. These results suggest that KNB-E2 effectively reduces CSF clinical signs, indicating the potential of this vaccine for safely minimizing CSF-related losses. PMID:29510474

Advanced Technologies in Safe and Efficient Operating Rooms

DTIC Science & Technology

2009-02-01

parameters and sitting strategies to determine car seat design that is both comfortable and ergonomically sound.8 The study of ergonomics in the surgical...off stereo into a prototype endoscope and developed design concepts for visualization techniques based on principles of cognitive ergonomics ...results from simultaneous task performance—is typical of knowledge ascertained through ergonomic clinical research.6 Ergonomic theory, design , and

Theranostic gas-generating nanoparticles for targeted ultrasound imaging and treatment of neuroblastoma.

PubMed

Lee, Jangwook; Min, Hyun-Su; You, Dong Gil; Kim, Kwangmeyung; Kwon, Ick Chan; Rhim, Taiyoun; Lee, Kuen Yong

2016-02-10

The development of safe and efficient diagnostic/therapeutic agents for treating cancer in clinics remains challenging due to the potential toxicity of conventional agents. Although the annual incidence of neuroblastoma is not that high, the disease mainly occurs in children, a population vulnerable to toxic contrast agents and therapeutics. We demonstrate here that cancer-targeting, gas-generating polymeric nanoparticles are useful as a theranostic tool for ultrasound (US) imaging and treating neuroblastoma. We encapsulated calcium carbonate using poly(d,l-lactide-co-glycolide) and created gas-generating polymer nanoparticles (GNPs). These nanoparticles release carbon dioxide bubbles under acidic conditions and enhance US signals. When GNPs are modified using rabies virus glycoprotein (RVG) peptide, a targeting moiety to neuroblastoma, RVG-GNPs effectively accumulate at the tumor site and substantially enhance US signals in a tumor-bearing mouse model. Intravenous administration of RVG-GNPs also reduces tumor growth in the mouse model without the use of conventional therapeutic agents. This approach to developing theranostic agents with disease-targeting ability may provide useful strategy for the detection and treatment of cancers, allowing safe and efficient clinical applications with fewer side effects than may occur with conventional agents. Copyright © 2015 Elsevier B.V. All rights reserved.

Corporate Culture Assessments in Integrative Oncology: A Qualitative Case Study of Two Integrative Oncology Centers

PubMed Central

Mittring, Nadine; Pérard, Marion; Witt, Claudia M.

2013-01-01

The offer of “integrative oncology” is one option for clinics to provide safe and evidence-based complementary medicine treatments to cancer patients. As known from merger theories, corporate culture and integration models have a strong influence on the success of such integration. To identify relevant corporate culture aspects that might influence the success in two highly visible integrative oncology clinics, we interviewed physicians, nurses, practitioners, and managers. All interviews (11 in a German breast cancer clinic and 9 in an integrative medicine cancer service in the USA) were audio-recorded, transcribed and analyzed with content analysis. According to the theoretical framework of mergers, each clinic selected a different integration type (“best of both worlds” and “linking”). Nonetheless, each developed a similar corporate culture that has a strong focus on research and safe and evidence-based treatments, and fosters a holistic and patient-centered approach. Structured communication within the team and with other departments had high relevance. Research was highlighted as a way to open doors and to facilitate a more general acceptance within the hospital. Conventional physicians felt unburdened by the provision of integrative medicine service but also saw problems in the time required for scheduled treatments, which often resulted in long waiting lists. PMID:23818923

Corporate culture assessments in integrative oncology: a qualitative case study of two integrative oncology centers.

PubMed

Mittring, Nadine; Pérard, Marion; Witt, Claudia M

2013-01-01

The offer of "integrative oncology" is one option for clinics to provide safe and evidence-based complementary medicine treatments to cancer patients. As known from merger theories, corporate culture and integration models have a strong influence on the success of such integration. To identify relevant corporate culture aspects that might influence the success in two highly visible integrative oncology clinics, we interviewed physicians, nurses, practitioners, and managers. All interviews (11 in a German breast cancer clinic and 9 in an integrative medicine cancer service in the USA) were audio-recorded, transcribed and analyzed with content analysis. According to the theoretical framework of mergers, each clinic selected a different integration type ("best of both worlds" and "linking"). Nonetheless, each developed a similar corporate culture that has a strong focus on research and safe and evidence-based treatments, and fosters a holistic and patient-centered approach. Structured communication within the team and with other departments had high relevance. Research was highlighted as a way to open doors and to facilitate a more general acceptance within the hospital. Conventional physicians felt unburdened by the provision of integrative medicine service but also saw problems in the time required for scheduled treatments, which often resulted in long waiting lists.

Safety in numbers 3: Authenticity, Building knowledge & skills and Competency development & assessment: the ABC of safe medication dosage calculation problem-solving pedagogy.

PubMed

Weeks, Keith W; Meriel Hutton, B; Coben, Diana; Clochesy, John M; Pontin, David

2013-03-01

When designing learning and assessment environments it is essential to articulate the underpinning education philosophy, theory, model and learning style support mechanisms that inform their structure and content. We elaborate on original PhD research that articulates the design rationale of authentic medication dosage calculation problem-solving (MDC-PS) learning and diagnostic assessment environments. These environments embody the principles of authenticity, building knowledge and skills and competency assessment and are designed to support development of competence and bridging of the theory-practice gap. Authentic learning and diagnostic assessment environments capture the features and expert practices that are located in real world practice cultures and recreate them in authentic virtual clinical environments. We explore how this provides students with a safe virtual authentic environment to actively experience, practice and undertake MDC-PS learning and assessment activities. We argue that this is integral to the construction and diagnostic assessment of schemata validity (mental constructions and frameworks that are an individual's internal representation of their world), bridging of the theory-practice gap and cognitive and functional competence development. We illustrate these principles through the underpinning pedagogical design of two online virtual authentic learning and diagnostic assessment environments (safeMedicate and eDose™). Copyright © 2012. Published by Elsevier Ltd.

Developmental procedures for the clinical practice guidelines for conscious sedation in dentistry for the Korean Academy of Dental Sciences.

PubMed

An, So-Youn; Seo, Kwang-Suk; Kim, Seungoh; Kim, Jongbin; Lee, Deok-Won; Hwang, Kyung-Gyun; Kim, Hyun Jeong

2016-12-01

Evidence-based clinical practice guidelines (CPGs) are defined as "statements that are scientifically reviewed about evidence and systematically developed to assist in the doctors' and patients' decision making in certain clinical situations." This recommendation aims to promote good clinical practice for the provision of safe and effective practices of conscious sedation in dentistry. The development of this clinical practice guideline was conducted by performing a systematic search of the literature for evidence-based CPGs. Existing guidelines, relevant systematic reviews, policy documents, legislation, or other recommendations were reviewed and appraised. To supplement this information, key questions were formulated by the Guideline Development Group and used as the basis for designing systematic literature search strategies to identify literature that may address these questions. Guideline documents were evaluated through a review of domestic and international databases for the development of a renewing of existing conscious sedation guidelines for dentistry. Clinical practice guidelines were critically appraised for their methodologies using Appraisal of guidelines for research and evaluation (AGREE) II. A total of 12 existing CPGs were included and 13 recommendations were made in a range of general, adult, and pediatric areas. The clinical practice guidelines for conscious sedation will be reviewed in 5 years' time for further updates to reflect significant changes in the field.

'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.

A Knowledge-Modeling Approach to Integrate Multiple Clinical Practice Guidelines to Provide Evidence-Based Clinical Decision Support for Managing Comorbid Conditions.

PubMed

Abidi, Samina

2017-10-26

Clinical management of comorbidities is a challenge, especially in a clinical decision support setting, as it requires the safe and efficient reconciliation of multiple disease-specific clinical procedures to formulate a comorbid therapeutic plan that is both effective and safe for the patient. In this paper we pursue the integration of multiple disease-specific Clinical Practice Guidelines (CPG) in order to manage co-morbidities within a computerized Clinical Decision Support System (CDSS). We present a CPG integration framework-termed as COMET (Comorbidity Ontological Modeling & ExecuTion) that manifests a knowledge management approach to model, computerize and integrate multiple CPG to yield a comorbid CPG knowledge model that upon execution can provide evidence-based recommendations for handling comorbid patients. COMET exploits semantic web technologies to achieve (a) CPG knowledge synthesis to translate a paper-based CPG to disease-specific clinical pathways (CP) that include specialized co-morbidity management procedures based on input from domain experts; (b) CPG knowledge modeling to computerize the disease-specific CP using a Comorbidity CPG ontology; (c) CPG knowledge integration by aligning multiple ontologically-modeled CP to develop a unified comorbid CPG knowledge model; and (e) CPG knowledge execution using reasoning engines to derive CPG-mediated recommendations for managing patients with comorbidities. We present a web-accessible COMET CDSS that provides family physicians with CPG-mediated comorbidity decision support to manage Atrial Fibrillation and Chronic Heart Failure. We present our qualitative and quantitative analysis of the knowledge content and usability of COMET CDSS.

Exploring the sociotechnical intersection of patient safety and electronic health record implementation

PubMed Central

Meeks, Derek W; Takian, Amirhossein; Sittig, Dean F; Singh, Hardeep; Barber, Nick

2014-01-01

Objective The intersection of electronic health records (EHR) and patient safety is complex. To examine the applicability of two previously developed conceptual models comprehensively to understand safety implications of EHR implementation in the English National Health Service (NHS). Methods We conducted a secondary analysis of interview data from a 30-month longitudinal, prospective, case study-based evaluation of EHR implementation in 12 NHS hospitals. We used a framework analysis approach to apply conceptual models developed by Sittig and Singh to understand better EHR implementation and use: an eight-dimension sociotechnical model and a three-phase patient safety model (safe technology, safe use of technology, and use of technology to improve safety). Results The intersection of patient safety and EHR implementation and use was characterized by risks involving technology (hardware and software, clinical content, and human–computer interfaces), the interaction of technology with non-technological factors, and improper or unsafe use of technology. Our data support that patient safety improvement activities as well as patient safety hazards change as an organization evolves from concerns about safe EHR functionality, ensuring safe and appropriate EHR use, to using the EHR itself to provide ongoing surveillance and monitoring of patient safety. Discussion We demonstrate the face validity of two models for understanding the sociotechnical aspects of safe EHR implementation and the complex interactions of technology within a healthcare system evolving from paper to integrated EHR. Conclusions Using sociotechnical models, including those presented in this paper, may be beneficial to help stakeholders understand, synthesize, and anticipate risks at the intersection of patient safety and health information technology. PMID:24052536

Ensuring safe access to medication for palliative care while preventing prescription drug abuse: innovations for American inner cities, rural areas, and communities overwhelmed by addiction

PubMed Central

Francoeur, Richard B

2011-01-01

This article proposes and develops novel components of community-oriented programs for creating and affording access to safe medication dispensing centers in existing retail pharmacies and in permanent or travelling pharmacy clinics that are guarded by assigned or off-duty police officers. Pharmacists at these centers would work with police, medical providers, social workers, hospital administrators, and other professionals in: planning and overseeing the safe storage of controlled substance medications in off-site community safe-deposit boxes; strengthening communication and cooperation with the prescribing medical provider; assisting the prescribing medical provider in patient monitoring (checking the state prescription registry, providing pill counts and urine samples); expanding access to lower-cost, and in some cases, abuse-resistant formulations of controlled substance medications; improving transportation access for underserved patients and caregivers to obtain prescriptions; and integrating community agencies and social networks as resources for patient support and monitoring. Novel components of two related community-oriented programs, which may be hosted outside of safe medication dispensing centers, are also suggested and described: (1) developing medication purchasing cooperatives (ie, to help patients, families, and health institutions afford the costs of medications, including tamper-or abuse-resistant/deterrent drug formulations); and (2) expanding the role of inner-city methadone maintenance treatment programs in palliative care (ie, to provide additional patient monitoring from a second treatment team focusing on narcotics addiction, and potentially, to serve as an untapped source of opioid medication for pain that is less subject to abuse, misuse, or diversion). PMID:22312232

Exploring the sociotechnical intersection of patient safety and electronic health record implementation.

PubMed

Meeks, Derek W; Takian, Amirhossein; Sittig, Dean F; Singh, Hardeep; Barber, Nick

2014-02-01

The intersection of electronic health records (EHR) and patient safety is complex. To examine the applicability of two previously developed conceptual models comprehensively to understand safety implications of EHR implementation in the English National Health Service (NHS). We conducted a secondary analysis of interview data from a 30-month longitudinal, prospective, case study-based evaluation of EHR implementation in 12 NHS hospitals. We used a framework analysis approach to apply conceptual models developed by Sittig and Singh to understand better EHR implementation and use: an eight-dimension sociotechnical model and a three-phase patient safety model (safe technology, safe use of technology, and use of technology to improve safety). The intersection of patient safety and EHR implementation and use was characterized by risks involving technology (hardware and software, clinical content, and human-computer interfaces), the interaction of technology with non-technological factors, and improper or unsafe use of technology. Our data support that patient safety improvement activities as well as patient safety hazards change as an organization evolves from concerns about safe EHR functionality, ensuring safe and appropriate EHR use, to using the EHR itself to provide ongoing surveillance and monitoring of patient safety. We demonstrate the face validity of two models for understanding the sociotechnical aspects of safe EHR implementation and the complex interactions of technology within a healthcare system evolving from paper to integrated EHR. Using sociotechnical models, including those presented in this paper, may be beneficial to help stakeholders understand, synthesize, and anticipate risks at the intersection of patient safety and health information technology.

Ensuring safe access to medication for palliative care while preventing prescription drug abuse: innovations for American inner cities, rural areas, and communities overwhelmed by addiction.

PubMed

Francoeur, Richard B

2011-01-01

This article proposes and develops novel components of community-oriented programs for creating and affording access to safe medication dispensing centers in existing retail pharmacies and in permanent or travelling pharmacy clinics that are guarded by assigned or off-duty police officers. Pharmacists at these centers would work with police, medical providers, social workers, hospital administrators, and other professionals in: planning and overseeing the safe storage of controlled substance medications in off-site community safe-deposit boxes; strengthening communication and cooperation with the prescribing medical provider; assisting the prescribing medical provider in patient monitoring (checking the state prescription registry, providing pill counts and urine samples); expanding access to lower-cost, and in some cases, abuse-resistant formulations of controlled substance medications; improving transportation access for underserved patients and caregivers to obtain prescriptions; and integrating community agencies and social networks as resources for patient support and monitoring. Novel components of two related community-oriented programs, which may be hosted outside of safe medication dispensing centers, are also suggested and described: (1) developing medication purchasing cooperatives (ie, to help patients, families, and health institutions afford the costs of medications, including tamper-or abuse-resistant/deterrent drug formulations); and (2) expanding the role of inner-city methadone maintenance treatment programs in palliative care (ie, to provide additional patient monitoring from a second treatment team focusing on narcotics addiction, and potentially, to serve as an untapped source of opioid medication for pain that is less subject to abuse, misuse, or diversion).

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

PubMed

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

2016-03-01

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

Challenges and opportunities in clinical translation of biomedical optical spectroscopy and imaging

NASA Astrophysics Data System (ADS)

Wilson, Brian C.; Jermyn, Michael; Leblond, Frederic

2018-03-01

Medical devices face many hurdles before they enter routine clinical practice to address unmet clinical needs. This is also the case for biomedical optical spectroscopy and imaging systems that are used here to illustrate the opportunities and challenges involved. Following initial concept, stages in clinical translation include instrument development, preclinical testing, clinical prototyping, clinical trials, prototype-to-product conversion, regulatory approval, commercialization, and finally clinical adoption and dissemination, all in the face of potentially competing technologies. Optical technologies face additional challenges from their being extremely diverse, often targeting entirely different diseases and having orders-of-magnitude differences in resolution and tissue penetration. However, these technologies can potentially address a wide variety of unmet clinical needs since they provide rich intrinsic biochemical and structural information, have high sensitivity and specificity for disease detection and localization, and are practical, safe (minimally invasive, nonionizing), and relatively affordable.

New parenteral lipid emulsions for clinical use.

PubMed

Waitzberg, Dan L; Torrinhas, Raquel Susana; Jacintho, Thiago Manzoni

2006-01-01

Routine use of parenteral lipid emulsions (LE) in clinical practice began in 1961, with the development of soybean oil (SO) - based LE. Although clinically safe, experimental reports indicated that SO-based LE could exert a negative influence on immunological functions. Those findings were related to its absolute and relative excess of omega-6 polyunsaturated fatty acids (PUFA) and the low amount of omega-3 PUFA and also to its high PUFA content with an increased peroxidation risk. This motivated the development of new LE basically designed along the reduction of omega-6 PUFA and the omega-3 PUFA addition in order to obtain balanced levels of the omega-6/omega-3 ratio. The new LE for clinical use (available in Europe and South America) are differentiated by their content in polyunsaturated (omega-6 and omega-3), monounsaturated, and saturated fatty acids (FA), as well as FA source of their origin, including soy, coconut, olive, and fish oil. This article presents the new LE nutrition and energy functions but also its biochemical, metabolic, and immunomodulating aspects, according to their FA content. LE at 20% when infused from 1.0 to 2.0 g/kg body weight/day rates, either alone or in association with amino acids and glucose, are safe and well tolerated in routine clinical practice. LE combining SO with medium-chain triglycerides and/or olive oil have less omega-6 PUFA and are better metabolized, with less inflammatory and immunosuppressive effects than in relation to pure SO-based LE. The omega-3 PUFA used alone or as component of a new and complex LE (soy, MCT, olive and fish oil) has demonstrated anti-inflammatory and immunomodulatory effects.

Development of a measure for the assessment of peer-related positive emotional memories.

PubMed

Ferreira, Cláudia; Cunha, Marina; Marta-Simões, Joana; Duarte, Cristiana; Matos, Marcela; Pinto-Gouveia, José

2018-03-01

Previous research has demonstrated a link between early experiences of warmth, safeness, and soothing, and positive feelings, health, and well-being outcomes. Although the impact of positive parent-related early relationships and its posterior recall is well documented, research on the recall of warmth and safeness experiences within early peer relationships remains scarce. In fact, it is considered that the protective role of early positive peer relationships deserves intensive research; however, a specific measure that assesses this construct is still to be created. This study describes the development and validation of a new measure designed to assess the recall of early experiences of warmth, safeness, and affection in relation to peers (EMWSS-peers). Distinct samples, comprising individuals of both genders aged between 18 and 68 years old, were used to test the EMWSS-peers factorial structure through principal axis factoring (PAF) and confirmatory factor analysis (CFA), and to examine its psychometric properties. Principal axis factoring's results indicated that the 12-item scale presents a one-factor structure explaining a total of 71.50% of the variance. The CFA confirmed the plausibility of this structure. The EMWSS-peers also presented excellent internal consistency and construct, concurrent, and divergent validities. The EMWSS-peers seems to be a new avenue for the study of memories of early experiences with friends and colleagues and may entail a relevant contribution to clinical and research fields, particularly for upcoming investigations on the relationship of peer-related affiliative memories with well-being and mental health. The EMWSS-peers is a specific measure to assess the recall of warmth and safeness in early peer relationships. The EMWSS-peers is a brief, robust, and reliable self-report instrument. The EMWSS-peers presented excellent internal consistency and construct, concurrent, and divergent validities. The EMWSS-peers may open a new avenue for the study of memories of early peer-related experiences, with potential clinical and research implications. © 2017 The British Psychological Society.

Clinical Decision-Making Tool for Safe and Effective Prescription of Exercise in Acute Exacerbations of Chronic Obstructive Pulmonary Disease: Results From an Interdisciplinary Delphi Survey and Focus Groups.

PubMed

Camp, Pat G; Reid, W Darlene; Chung, Frank; Kirkham, Ashley; Brooks, Dina; Goodridge, Donna; Marciniuk, Darcy D; Hoens, Alison M

2015-10-01

Exercise is recommended for people with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD), yet there is little information to guide safe and effective mobilization and exercise for these patients. The purpose of this study was to develop a clinical decision-making tool to guide health care professionals in the assessment, prescription, monitoring, and progression of mobilization and therapeutic exercise for patients with AECOPD. A 3-round interdisciplinary Delphi panel identified and selected items based on a preselected consensus of 80%. These items were summarized in a paper-based tool titled Mobilization in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD-Mob). Focus groups and questionnaires were subsequently used to conduct a sensibility evaluation of the tool. Nine researchers, 13 clinicians, and 7 individuals with COPD identified and approved 110 parameters for safe and effective exercise in AECOPD. These parameters were grouped into 5 categories: (1) "What to Assess Prior to Mobilization," (2) "When to Consider Not Mobilizing or to Discontinue Mobilization," (3) "What to Monitor During Mobilization for Patient Safety," (4) "How to Progress Mobilization to Enhance Effectiveness," and (5) "What to Confirm Prior to Discharge." The tool was evaluated in 4 focus groups of 18 health care professionals, 90% of whom reported the tool was easy to use, was concise, and would guide a health care professional who is new to the acute care setting and working with patients with AECOPD. The tool was developed based on published evidence and expert opinion, so the applicability of the items to patients in all settings cannot be guaranteed. The Delphi panel consisted of health care professionals from Canada, so items may not be generalizable to other jurisdictions. The AECOPD-Mob provides practical and concise information on safe and effective exercise for the AECOPD population for use by the new graduate or novice acute care practitioner. © 2015 American Physical Therapy Association.

Fostering EMA's transparency policy.

PubMed

Banzi, Rita; Bertele', Vittorio; Demotes-Mainard, Jacques; Garattini, Silvio; Gluud, Christian; Kubiak, Christine; Ohmann, Christian

2014-10-01

The European Medicines Agency has opened a window to access clinical trial data. This is an important step forward which deserves attention, support, and advice from all the stakeholders. Regulatory agencies are the most comprehensive repositories of clinical trial data on drugs and can also promote and develop standard practices for data sharing. The release of the EMA draft policy on publication and access to clinical trial data in 2013 has fueled a lively debate among academia, industry, and the public in general that is still ongoing. As clinical researchers and producers and users of clinical trial data, we endorse the European Medicines Agency's opening and offer a few suggestions for complete, safe, and effective data sharing. Copyright © 2014 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

Progress and pitfalls in Shigella vaccine research

PubMed Central

Barry, Eileen M.; Pasetti, Marcela F.; Sztein, Marcelo B.; Fasano, Alessio; Kotloff, Karen L.; Levine, Myron M.

2013-01-01

Renewed awareness of the significant morbidity and mortality that Shigella causes among young children in developing countries combined with technological innovations in vaccinology has led to the development of novel vaccine strategies in the past five years. Along with advancement of classical vaccines in clinical trials and new sophisticated measurements of immunological responses, much new data has been produced lending promise to the potential for production of safe and effective Shigella vaccines. Herein we review the recent progress in Shigella vaccine development within the framework of persistent obstacles. PMID:23419287

MO-DE-BRA-04: Hands-On Fluoroscopy Safety Training with Real-Time Patient and Staff Dosimetry

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

Vanderhoek, M; Bevins, N

Purpose: Fluoroscopically guided interventions (FGI) are routinely performed across many different hospital departments. However, many involved staff members have minimal training regarding safe and optimal use of fluoroscopy systems. We developed and taught a hands-on fluoroscopy safety class incorporating real-time patient and staff dosimetry in order to promote safer and more optimal use of fluoroscopy during FGI. Methods: The hands-on fluoroscopy safety class is taught in an FGI suite, unique to each department. A patient equivalent phantom is set on the patient table with an ion chamber positioned at the x-ray beam entrance to the phantom. This provides a surrogatemore » measure of patient entrance dose. Multiple solid state dosimeters (RaySafe i2 dosimetry systemTM) are deployed at different distances from the phantom (0.1, 1, 3 meters), which provide surrogate measures of staff dose. Instructors direct participating clinical staff to operate the fluoroscopy system as they view live fluoroscopic images, patient entrance dose, and staff doses in real-time. During class, instructors work with clinical staff to investigate how patient entrance dose, staff doses, and image quality are affected by different parameters, including pulse rate, magnification, collimation, beam angulation, imaging mode, system geometry, distance, and shielding. Results: Real-time dose visualization enables clinical staff to directly see and learn how to optimize their use of their own fluoroscopy system to minimize patient and staff dose, yet maintain sufficient image quality for FGI. As a direct result of the class, multiple hospital departments have implemented changes to their imaging protocols, including reduction of the default fluoroscopy pulse rate and increased use of collimation and lower dose fluoroscopy modes. Conclusion: Hands-on fluoroscopy safety training substantially benefits from real-time patient and staff dosimetry incorporated into the class. Real-time dose display helps clinical staff visualize, internalize, and ultimately utilize the safety techniques learned during the training. RaySafe/Unfors/Fluke lent us a portable version of their RaySafe i2 Dosimetry System for 6 months.« less

Targeting Recovery in Persistent Persecutory Delusions: A Proof of Principle Study of a New Translational Psychological Treatment (the Feeling Safe Programme).

PubMed

Freeman, Daniel; Bradley, Jonathan; Waite, Felicity; Sheaves, Bryony; DeWeever, Natalie; Bourke, Emilie; McInerney, Josephine; Evans, Nicole; Černis, Emma; Lister, Rachel; Garety, Philippa; Dunn, Graham

2016-09-01

Many patients do not respond adequately to current pharmacological or psychological treatments for psychosis. Persistent persecutory delusions are common in clinical services, and cause considerable patient distress and impairment. Our aim has been to build a new translational personalized treatment, with the potential for wide use, that leads to high rates of recovery in persistent persecutory delusions. We have been developing, and evaluating individually, brief modular interventions, each targeting a key causal factor identified from our cognitive model. These modules are now combined in "The Feeling Safe Programme". To test the feasibility of a new translational modular treatment for persistent persecutory delusions and provide initial efficacy data. 12 patients with persistent persecutory delusions in the context of non-affective psychosis were offered the 6-month Feeling Safe Programme. After assessment, patients chose from a personalized menu of treatment options. Four weekly baseline assessments were carried out, followed by monthly assessments. Recovery in the delusion was defined as conviction falling below 50% (greater doubt than certainty). 11 patients completed the intervention. One patient withdrew before the first monthly assessment due to physical health problems. An average of 20 sessions (SD = 4.4) were received. Posttreatment, 7 out of 11 (64%) patients had recovery in their persistent delusions. Satisfaction ratings were high. The Feeling Safe Programme is feasible to use and was associated with large clinical benefits. To our knowledge this is the first treatment report focused on delusion recovery. The treatment will be tested in a randomized controlled trial.

Sit Up Straight

NASA Technical Reports Server (NTRS)

1998-01-01

BioMetric Systems has an exclusive license to the Posture Video Analysis Tool (PVAT) developed at Johnson Space Center. PVAT uses videos from Space Shuttle flights to identify limiting posture and other human factors in the workplace that could be limiting. The software also provides data that recommends appropriate postures for certain tasks and safe duration for potentially harmful positions. BioMetric Systems has further developed PVAT for use by hospitals, physical rehabilitation facilities, insurance companies, sports medicine clinics, oil companies, manufacturers, and the military.

Appropriate management of special situations in Crohn's disease (upper gastro-intestinal; extra-intestinal manifestations; drug safety during pregnancy and breastfeeding): Results of a multidisciplinary international expert panel-EPACT II.

PubMed

Mottet, Christian; Vader, John-Paul; Felley, Christian; Froehlich, Florian; Gonvers, Jean-Jacques; Juillerat, Pascal; Stockbrügger, Reinhold; Angelucci, Erika; Seibold, Frank; Michetti, Pierre; Pittet, Valérie

2009-12-01

High-grade evidence is lacking for most therapeutic decisions in Crohn's disease. Appropriateness criteria were developed for upper gastro-intestinal, extra-intestinal manifestations and drug safety during conception, pregnancy and breastfeeding in patients with Crohn's disease, to assist the physician in clinical decision making. The European Panel on the Appropriateness of Crohn's Disease Therapy (EPACT II), a multidisciplinary international European expert panel, rated clinical scenarios based on evidence from the published literature and panelists' own clinical expertise. Median ratings (on a 9-point scale) were stratified into three categories: appropriate (7-9), uncertain (4-6 with or without disagreement) and inappropriate (1-3). Experts were also asked to rank appropriate medications by priority. Proton pump inhibitors, steroids, azathioprine/6-mercaptopurine and infliximab are appropriate for upper gastro-duodenal Crohn's disease; for stenosis, endoscopic balloon dilation is the first-line therapy, although surgery is also appropriate. Ursodeoxycholic acid is the only appropriate treatment for primary sclerosing cholangitis. Infliximab is appropriate for Pyoderma gangrenosum, ankylosing spondylitis and uveitis, steroids for Pyoderma gangrenosum and ankylosing spondylitis, adalimumab for Pyoderma gangrenosum and ankylosing spondylitis, cyclosporine-A/tacrolimus for Pyoderma gangrenosum. Mesalamine, sulfasalazine, prednisone, azathioprine/6-mercaptopurine, ciprofloxacin, and probiotics, may be administered safely during pregnancy or for patients wishing to conceive, with the exception that male patients considering conception should avoid sulfasalazine. Metronidazol is considered safe in the 2nd and 3rd trimesters whereas infliximab is rated safe in the 1st trimester but uncertain in the 2nd and 3rd trimesters. Methotrexate is always contraindicated at conception, during pregnancy or during breastfeeding, due to its known teratogenicity. Mesalamine, prednisone, probiotics and infliximab are considered safe during breastfeeding. EPACT II recommendations are freely available online (www.epact.ch). The validity of these criteria should now be tested by prospective evaluation.

Clinical-Grade Manufacturing of Therapeutic Human Mesenchymal Stem/Stromal Cells in Microcarrier-Based Culture Systems.

PubMed

Fernandes-Platzgummer, Ana; Carmelo, Joana G; da Silva, Cláudia Lobato; Cabral, Joaquim M S

2016-01-01

The therapeutic potential of mesenchymal stem/stromal cells (MSC) has triggered the need for high cell doses in a vast number of clinical applications. This demand requires the development of good manufacturing practices (GMP)-compliant ex vivo expansion protocols that should be effective to deliver a robust and reproducible supply of clinical-grade cells in a safe and cost-effective manner. Controlled stirred-tank bioreactor systems under xenogeneic (xeno)-free culture conditions offer ideal settings to develop and optimize cell manufacturing to meet the standards and needs of human MSC for cellular therapies. Herein we describe two microcarrier-based stirred culture systems using spinner flasks and controlled stirred-tank bioreactors under xeno-free conditions for the efficient ex vivo expansion of human bone marrow and adipose tissue-derived MSC.

Simulation-based medical education: time for a pedagogical shift.

PubMed

Kalaniti, Kaarthigeyan; Campbell, Douglas M

2015-01-01

The purpose of medical education at all levels is to prepare physicians with the knowledge and comprehensive skills, required to deliver safe and effective patient care. The traditional 'apprentice' learning model in medical education is undergoing a pedagogical shift to a 'simulation-based' learning model. Experiential learning, deliberate practice and the ability to provide immediate feedback are the primary advantages of simulation-based medical education. It is an effective way to develop new skills, identify knowledge gaps, reduce medical errors, and maintain infrequently used clinical skills even among experienced clinical teams, with the overall goal of improving patient care. Although simulation cannot replace clinical exposure as a form of experiential learning, it promotes learning without compromising patient safety. This new paradigm shift is revolutionizing medical education in the Western world. It is time that the developing countries embrace this new pedagogical shift.

Teaching clinical skills in developing countries: are clinical skills centres the answer?

PubMed

Stark, Patsy; Fortune, F

2003-11-01

There is growing international interest in teaching clinical skills in a variety of contexts, one of which is Clinical Skills Centres. The drivers for change making Skills Centres an important adjunct to ward and ambulatory teaching come both from within and outside medical education. Educationally, self-directed learning is becoming the accepted norm, encouraging students to seek and maximize learning opportunities. There are global changes in health care practice, increased consumerism and increasing student numbers. In some countries, professional recommendations influence what is taught. Increasingly, core skills curricula and outcome objectives are being defined. This explicit definition encourages assessment of the core skills. In turn, all students require equal opportunities to learn how to practise the skills safely and competently. The moves towards interprofessional education make joint learning in a"neutral" setting, like a Clinical Skills Centre, appear particularly attractive. To discuss the potential role of Clinical Skills Centres in skills training in developing countries and to consider alternative options. Many developing countries seek to establish Clinical Skills Centres to ensure effective and reliable skills teaching. However, the model may not be appropriate,because fully equipped Clinical Skills Centres are expensive to set up, staff; and run. They are not the only way to achieve high quality clinical teaching. Suggested options are based on the philosophy and teaching methods successfully developed in Clinical Skills Centres that may fulfil the local needs to achieve low cost and high quality clinical teaching which is reflective of the local health needs and cultural expectations.

Development of the Huddle Observation Tool for structured case management discussions to improve situation awareness on inpatient clinical wards

PubMed Central

Edbrooke-Childs, Julian; Hayes, Jacqueline; Sharples, Evelyn; Gondek, Dawid; Stapley, Emily; Lachman, Peter; Deighton, Jessica

2018-01-01

Background ‘Situation Awareness For Everyone’ (SAFE) was a 3-year project which aimed to improve situation awareness in clinical teams in order to detect potential deterioration and other potential risks to children on hospital wards. The key intervention was the ‘huddle’, a structured case management discussion which is central to facilitating situation awareness. This study aimed to develop an observational assessment tool to assess the team processes occurring during huddles, including the effectiveness of the huddle. Methods A cross-sectional observational design was used to psychometrically develop the ‘Huddle Observation Tool’ (HOT) over three phases using standardised psychometric methodology. Huddles were observed across four NHS paediatric wards participating in SAFE by five researchers; two wards within specialist children hospitals and two within district general hospitals, with location, number of beds and length of stay considered to make the sample as heterogeneous as possible. Inter-rater reliability was calculated using the weighted kappa and intraclass correlation coefficient. Results Inter-rater reliability was acceptable for the collaborative culture (weighted kappa=0.32, 95% CI 0.17 to 0.42), environment items (weighted kappa=0.78, 95% CI 0.52 to 1) and total score (intraclass correlation coefficient=0.87, 95% CI 0.68 to 0.95). It was lower for the structure and risk management items, suggesting that these were more variable in how observers rated them. However, agreement on the global score for huddles was acceptable. Conclusion We developed an observational assessment tool to assess the team processes occurring during huddles, including the effectiveness of the huddle. Future research should examine whether observational evaluations of huddles are associated with other indicators of safety on clinical wards (eg, safety climate and incidents of patient harm), and whether scores on the HOT are associated with improved situation awareness and reductions in deterioration and adverse events in clinical settings, such as inpatient wards. PMID:28928167

[Ego-state Therapy: Psychotherapy for Multiple Personality Disorders].

PubMed

Sugiyama, Toshiro

2018-01-01

The author describes ego-state therapy. This psychotherapy is used for treating multiple personality disorders. The author mentions the theoretical background of this method, and practical points. Initially, ego-state therapy was developed as a type of hypnotherapy, but it evolved as a safe therapeutic method in combination with trauma processing therapies. The author presents a case study, and discusses the clinical significance of this treatment.

Animal models for microbicide studies.

PubMed

Veazey, Ronald S; Shattock, Robin J; Klasse, Per Johan; Moore, John P

2012-01-01

There have been encouraging recent successes in the development of safe and effective topical microbicides to prevent vaginal or rectal HIV-1 transmission, based on the use of anti-retroviral drugs. However, much work remains to be accomplished before a microbicide becomes a standard element of prevention science strategies. Animal models should continue to play an important role in pre-clinical testing, with emphasis on safety, pharmacokinetic and efficacy testing.

[Development and clinical evaluation of an anesthesia information management system].

PubMed

Feng, Jing-yi; Chen, Hua; Zhu, Sheng-mei

2010-09-21

To study the design, implementation and clinical evaluation of an anesthesia information management system. To record, process and store peri-operative patient data automatically, all kinds of bedside monitoring equipments are connected into the system based on information integrating technology; after a statistical analysis of those patient data by data mining technology, patient status can be evaluated automatically based on risk prediction standard and decision support system, and then anesthetist could perform reasonable and safe clinical processes; with clinical processes electronically recorded, standard record tables could be generated, and clinical workflow is optimized, as well. With the system, kinds of patient data could be collected, stored, analyzed and archived, kinds of anesthesia documents could be generated, and patient status could be evaluated to support clinic decision. The anesthesia information management system is useful for improving anesthesia quality, decreasing risk of patient and clinician, and aiding to provide clinical proof.

Carbohydrate-based vaccine adjuvants - discovery and development.

PubMed

Hu, Jing; Qiu, Liying; Wang, Xiaoli; Zou, Xiaopeng; Lu, Mengji; Yin, Jian

2015-10-01

The addition of a suitable adjuvant to a vaccine can generate significant effective adaptive immune responses. There is an urgent need for the development of novel po7tent and safe adjuvants for human vaccines. Carbohydrate molecules are promising adjuvants for human vaccines due to their high biocompatibility and good tolerability in vivo. The present review covers a few promising carbohydrate-based adjuvants, lipopolysaccharide, trehalose-6,6'-dibehenate, QS-21 and inulin as examples, which have been extensively studied in human vaccines in a number of preclinical and clinical studies. The authors discuss the current status, applications and strategies of development of each adjuvant and different adjuvant formulation systems. This information gives insight regarding the exciting prospect in the field of carbohydrate-based adjuvant research. Carbohydrate-based adjuvants are promising candidates as an alternative to the Alum salts for human vaccines development. Furthermore, combining two or more adjuvants in one formulation is one of the effective strategies in adjuvant development. However, further research efforts are needed to study and develop novel adjuvants systems, which can be more stable, potent and safe. The development of synthetic carbohydrate chemistry can improve the study of carbohydrate-based adjuvants.

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.

Guidelines and Recommendations for Developing Interactive eHealth Apps for Complex Messaging in Health Promotion.

PubMed

Heffernan, Kayla Joanne; Chang, Shanton; Maclean, Skye Tamara; Callegari, Emma Teresa; Garland, Suzanne Marie; Reavley, Nicola Jane; Varigos, George Andrew; Wark, John Dennis

2016-02-09

The now ubiquitous catchphrase, "There's an app for that," rings true owing to the growing number of mobile phone apps. In excess of 97,000 eHealth apps are available in major app stores. Yet the effectiveness of these apps varies greatly. While a minority of apps are developed grounded in theory and in conjunction with health care experts, the vast majority are not. This is concerning given the Hippocratic notion of "do no harm." There is currently no unified formal theory for developing interactive eHealth apps, and development is especially difficult when complex messaging is required, such as in health promotion and prevention. This paper aims to provide insight into the creation of interactive eHealth apps for complex messaging, by leveraging the Safe-D case study, which involved complex messaging required to guide safe but sufficient UV exposure for vitamin D synthesis in users. We aim to create recommendations for developing interactive eHealth apps for complex messages based on the lessons learned during Safe-D app development. For this case study we developed an Apple and Android app, both named Safe-D, to safely improve vitamin D status in young women through encouraging safe ultraviolet radiation exposure. The app was developed through participatory action research involving medical and human computer interaction researchers, subject matter expert clinicians, external developers, and target users. The recommendations for development were created from analysis of the development process. By working with clinicians and implementing disparate design examples from the literature, we developed the Safe-D app. From this development process, recommendations for developing interactive eHealth apps for complex messaging were created: (1) involve a multidisciplinary team in the development process, (2) manage complex messages to engage users, and (3) design for interactivity (tailor recommendations, remove barriers to use, design for simplicity). This research has provided principles for developing interactive eHealth apps for complex messaging as guidelines by aggregating existing design concepts and expanding these concepts and new learnings from our development process. A set of guidelines to develop interactive eHealth apps generally, and specifically those for complex messaging, was previously missing from the literature; this research has contributed these principles. Safe-D delivers complex messaging simply, to aid education, and explicitly, considering user safety.

Guidelines and Recommendations for Developing Interactive eHealth Apps for Complex Messaging in Health Promotion

PubMed Central

Heffernan, Kayla Joanne; Maclean, Skye Tamara; Callegari, Emma Teresa; Garland, Suzanne Marie; Reavley, Nicola Jane; Varigos, George Andrew; Wark, John Dennis

2016-01-01

Background The now ubiquitous catchphrase, “There’s an app for that,” rings true owing to the growing number of mobile phone apps. In excess of 97,000 eHealth apps are available in major app stores. Yet the effectiveness of these apps varies greatly. While a minority of apps are developed grounded in theory and in conjunction with health care experts, the vast majority are not. This is concerning given the Hippocratic notion of “do no harm.” There is currently no unified formal theory for developing interactive eHealth apps, and development is especially difficult when complex messaging is required, such as in health promotion and prevention. Objective This paper aims to provide insight into the creation of interactive eHealth apps for complex messaging, by leveraging the Safe-D case study, which involved complex messaging required to guide safe but sufficient UV exposure for vitamin D synthesis in users. We aim to create recommendations for developing interactive eHealth apps for complex messages based on the lessons learned during Safe-D app development. Methods For this case study we developed an Apple and Android app, both named Safe-D, to safely improve vitamin D status in young women through encouraging safe ultraviolet radiation exposure. The app was developed through participatory action research involving medical and human computer interaction researchers, subject matter expert clinicians, external developers, and target users. The recommendations for development were created from analysis of the development process. Results By working with clinicians and implementing disparate design examples from the literature, we developed the Safe-D app. From this development process, recommendations for developing interactive eHealth apps for complex messaging were created: (1) involve a multidisciplinary team in the development process, (2) manage complex messages to engage users, and (3) design for interactivity (tailor recommendations, remove barriers to use, design for simplicity). Conclusions This research has provided principles for developing interactive eHealth apps for complex messaging as guidelines by aggregating existing design concepts and expanding these concepts and new learnings from our development process. A set of guidelines to develop interactive eHealth apps generally, and specifically those for complex messaging, was previously missing from the literature; this research has contributed these principles. Safe-D delivers complex messaging simply, to aid education, and explicitly, considering user safety. PMID:26860623

Human factors in anaesthesia: lessons from aviation.

PubMed

Toff, N J

2010-07-01

Aviation safety has evolved over more than a century and has achieved remarkable results. Applying some of the lessons learned may help make healthcare safer. From the perspective of an anaesthetic background and some thousands of hours of airline flying, I offer a personal perspective, try to give a sense of the place of human factors in airline operations and some of the current problems, and make some suggestions as to what the NHS and anaesthesia might learn from this. Although many of the ingredients for safe operation are frequently already present in our hospitals, and some individual clinical areas and departments achieve high levels of reliability and safety, I will emphasize my firm belief that we cannot expect improvements in human factors training and awareness to be fully effective in the healthcare setting without the parallel development of a simple and strong safety system across organizations. In the process, we may find that the safe hospital turns out somewhat differently to the safe airline.

[The ISP (Safe Insertion of PICCs) protocol: a bundle of 8 recommendations to minimize the complications related to the peripherally inserted central venous catheters (PICC)].

PubMed

Emoli, Alessandro; Cappuccio, Serena; Marche, Bruno; Musarò, Andrea; Scoppettuolo, Giancarlo; Pittiruti, Mauro

2014-01-01

The ISP (Safe Insertion of PICCs) protocol: a bundle of 8 recommendations to minimize the complications related to the peripherally inserted central venous catheters (PICC). The insertion of a peripherally inserted central venous catheter (PICC) is not without risks. The Italian Group for the Study of Long-Term Central Venous Access Devices (GAVeCeLT) has developed a protocol (SIP: Safe Implantation of PICCs) with the aim of minimizing the risks which may be associated with the placement of PICCs. The protocol is based on recommendations available in the literature and on the main clinical practice guidelines. The SIP protocol, a bundle of evidence-based recommendations, it is is easy to use, inexpensive, and cost-effective. If routinely used and carefully inplemented, it greatly reduces complications such as failure of venipuncture, accidental arterial puncture, damage of median nerve, infection and catheter related venous thrombosis.

A safe-by-design approach to the development of gold nanoboxes as carriers for internalization into cancer cells.

PubMed

Movia, Dania; Gerard, Valerie; Maguire, Ciaran Manus; Jain, Namrata; Bell, Alan P; Nicolosi, Valeria; O'Neill, Tiina; Scholz, Dimitri; Gun'ko, Yurii; Volkov, Yuri; Prina-Mello, Adriele

2014-03-01

Gold nanomaterials are currently raising a significant interest for human welfare in the field of clinical diagnosis, therapeutics for chronic pathologies, as well as of many other biomedical applications. In particular, gold nanomaterials are becoming a promising technology for developing novel approaches and treatments against widespread societal diseases such as cancer. In this study, we investigated the potential of proprietary gold nanoboxes (AuNBs) as carriers for their perspective translation into multifunctional, pre-clinical nano-enabled systems for personalized medicine approaches against lung cancer. A safe-by-design, tiered approach, with systematic tests conducted in the early phases on uncoated AuNBs and more focused testing on the coated, drug-loaded nanomaterial toward the end, was adopted. Our results showed that uncoated AuNBs could effectively penetrate into human lung adenocarcinoma (A549) cells when in simple (mono-cultures) or complex (co- and three-dimensional-cultures) in vitro microenvironments mimicking the alveolar region of human lungs. Uncoated AuNBs were biologically inert in A549 cells and demonstrated signs of biodegradability. Concurrently, preliminary data revealed that coated, drug-loaded AuNBs could efficiently deliver a chemotherapeutic agent to A549 cells, corroborating the hypothesis that AuNBs could be used in the future for the development of personalized nano-enabled systems for lung cancer treatment. Copyright © 2013 Elsevier Ltd. All rights reserved.

Pre-departure preparation for international clinical work: a handbook.

PubMed

Edwardson, Jill; Owens, Lauren; Moran, Dane; Aluri, James; Kironji, Antony; Chen, Chi Chiung Grace

2015-08-01

International clinical experiences are increasingly popular among medical students, residents, fellows, and practitioners. Adequate pre-departure training is an integral part of a meaningful, productive, and safe international experience. At Johns Hopkins University School of Medicine, we have developed a pre-departure handbook to assist practitioners in preparing for global health work. The handbook draws from current global health education literature, existing handbooks, and expert experiences, and includes information about logistical and cultural preparations. While a pre-departure handbook cannot serve as a substitute for a comprehensive pre-departure training program, it can be a useful introduction to the pre-departure process.

Factoring nonviral gene therapy into a cure for hemophilia A.

PubMed

Gabrovsky, Vanessa; Calos, Michele P

2008-10-01

Gene therapy for hemophilia A has fallen short of success despite several clinical trials conducted over the past decade. Challenges to its success include vector immunogenicity, insufficient transgene expression levels of Factor VIII, and inhibitor antibody formation. Gene therapy has been dominated by the use of viral vectors, as well as the immunogenic and oncogenic concerns that accompany these strategies. Because of the complexity of viral vectors, the development of nonviral DNA delivery methods may provide an efficient and safe alternative for the treatment of hemophilia A. New types of nonviral strategies, such as DNA integrating vectors, and the success of several nonviral animal studies, suggest that nonviral gene therapy has curative potential and justifies its clinical development.

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.

Automatic discrimination between safe and unsafe swallowing using a reputation-based classifier

PubMed Central

2011-01-01

Background Swallowing accelerometry has been suggested as a potential non-invasive tool for bedside dysphagia screening. Various vibratory signal features and complementary measurement modalities have been put forth in the literature for the potential discrimination between safe and unsafe swallowing. To date, automatic classification of swallowing accelerometry has exclusively involved a single-axis of vibration although a second axis is known to contain additional information about the nature of the swallow. Furthermore, the only published attempt at automatic classification in adult patients has been based on a small sample of swallowing vibrations. Methods In this paper, a large corpus of dual-axis accelerometric signals were collected from 30 older adults (aged 65.47 ± 13.4 years, 15 male) referred to videofluoroscopic examination on the suspicion of dysphagia. We invoked a reputation-based classifier combination to automatically categorize the dual-axis accelerometric signals into safe and unsafe swallows, as labeled via videofluoroscopic review. From these participants, a total of 224 swallowing samples were obtained, 164 of which were labeled as unsafe swallows (swallows where the bolus entered the airway) and 60 as safe swallows. Three separate support vector machine (SVM) classifiers and eight different features were selected for classification. Results With selected time, frequency and information theoretic features, the reputation-based algorithm distinguished between safe and unsafe swallowing with promising accuracy (80.48 ± 5.0%), high sensitivity (97.1 ± 2%) and modest specificity (64 ± 8.8%). Interpretation of the most discriminatory features revealed that in general, unsafe swallows had lower mean vibration amplitude and faster autocorrelation decay, suggestive of decreased hyoid excursion and compromised coordination, respectively. Further, owing to its performance-based weighting of component classifiers, the static reputation-based algorithm outperformed the democratic majority voting algorithm on this clinical data set. Conclusion Given its computational efficiency and high sensitivity, reputation-based classification of dual-axis accelerometry ought to be considered in future developments of a point-of-care swallow assessment where clinical informatics are desired. PMID:22085802

Developing new products in cystic fibrosis: needs and obstacles for activities of small and middle-sized companies.

PubMed

Schlangen, Miriam; Reimann, Andreas L G

2011-06-01

Small and middle-sized enterprises (SMEs) can make important contributions to medical progress through the development of new safe and effective drugs that address the greatest unmet needs of patients. Regulatory inconsistencies across agencies in various countries, however, remain major challenges in cystic fibrosis (CF) drug development. Clear and consistent treatment guidelines, well educated clinical trial sites, a patient registry and grant funding for early development programs are important success-factors for an efficient development process. SMEs developing products for CF need partners in the CF community to assist with disease education and awareness for ongoing clinical trials. SMEs should collaborate and communicate with the CF community in a legally compliant way to take a patient-centric approach to drug design, development and administration. Furthermore, they can help to develop educational tools and fund medical education activities to increase the understanding of the underlying defects and mechanisms of CF disease. Copyright © 2011 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

Practical considerations in clinical strategy to support the development of injectable drug-device combination products for biologics.

PubMed

Li, Zhaoyang; Easton, Rachael

2018-01-01

The development of an injectable drug-device combination (DDC) product for biologics is an intricate and evolving process that requires substantial investments of time and money. Consequently, the commercial dosage form(s) or presentation(s) are often not ready when pivotal trials commence, and it is common to have drug product changes (manufacturing process or presentation) during clinical development. A scientifically sound and robust bridging strategy is required in order to introduce these changes into the clinic safely. There is currently no single developmental paradigm, but a risk-based hierarchical approach has been well accepted. The rigor required of a bridging package depends on the level of risk associated with the changes. Clinical pharmacokinetic/pharmacodynamic comparability or outcome studies are only required when important changes occur at a late stage. Moreover, an injectable DDC needs to be user-centric, and usability assessment in real-world clinical settings may be required to support the approval of a DDC. In this review, we discuss the common issues during the manufacturing process and presentation development of an injectable DDC and practical considerations in establishing a clinical strategy to address these issues, including key elements of clinical studies. We also analyze the current practice in the industry and review relevant and status of regulatory guidance in the DDC field.

Practical considerations in clinical strategy to support the development of injectable drug-device combination products for biologics

PubMed Central

Easton, Rachael

2018-01-01

ABSTRACT The development of an injectable drug-device combination (DDC) product for biologics is an intricate and evolving process that requires substantial investments of time and money. Consequently, the commercial dosage form(s) or presentation(s) are often not ready when pivotal trials commence, and it is common to have drug product changes (manufacturing process or presentation) during clinical development. A scientifically sound and robust bridging strategy is required in order to introduce these changes into the clinic safely. There is currently no single developmental paradigm, but a risk-based hierarchical approach has been well accepted. The rigor required of a bridging package depends on the level of risk associated with the changes. Clinical pharmacokinetic/pharmacodynamic comparability or outcome studies are only required when important changes occur at a late stage. Moreover, an injectable DDC needs to be user-centric, and usability assessment in real-world clinical settings may be required to support the approval of a DDC. In this review, we discuss the common issues during the manufacturing process and presentation development of an injectable DDC and practical considerations in establishing a clinical strategy to address these issues, including key elements of clinical studies. We also analyze the current practice in the industry and review relevant and status of regulatory guidance in the DDC field. PMID:29035675

Medicinal plants and natural products in amelioration of arsenic toxicity: a short review.

PubMed

Bhattacharya, Sanjib

2017-12-01

Chronic arsenic toxicity (arsenicosis) is considered a serious public health menace worldwide, as there is no specific, safe, and efficacious therapeutic management of arsenicosis. To collate the studies on medicinal plants and natural products with arsenic toxicity ameliorative effect, active pre-clinically and/or clinically. Literature survey was carried out by using Google, Scholar Google and Pub-Med. Only the scientific journal articles found on the internet for last two decades were considered. Minerals and semi-synthetic or synthetic analogs of natural products were excluded. Literature study revealed that 34 medicinal plants and 14 natural products exhibited significant protection from arsenic toxicity, mostly in preclinical trials and a few in clinical studies. This research could lead to development of a potentially useful agent in clinical management of arsenicosis in humans.

Dexmedetomidine inhibits activation of the MAPK pathway and protects PC12 and NG108-15 cells from lidocaine-induced cytotoxicity at its maximum safe dose.

PubMed

Wang, Qiong; Tan, Yonghong; Zhang, Na; Xu, Yingyi; Wei, Wei; She, Yingjun; Bi, Xiaobao; Zhao, Baisong; Ruan, Xiangcai

2017-07-01

The developing brains of pediatric patients are highly vulnerable to anesthetic regimen (e.g., lidocaine), potentially causing neurological impairment. Recently, dexmedetomidine (DEX) has been used as an adjunct for sedation, and was shown to exert dose-dependent neuroprotective effects during brain injury. However, the maximum safe dose of DEX is unclear, and its protective effects against lidocaine-related neurotoxicity need to be confirmed. In this study, PC12 and NG108-15 cells were used to estimate safe, non-cytotoxic doses of DEX. We found that 100 and 60μM are the maximum safe dose of DEX for PC12 and NG108-15 cells, respectively, with no significant cytotoxicity. Lidocaine was found to remarkably inhibit cell vitality, but could be reversed by different doses of DEX, especially its maximum safe dose. Furthermore, the apoptosis induced by lidocaine was also assessed, and 100 and 60μM DEX showed optimal protective effects in PC12 and NG108-15 cells, respectively. Mechanistically, DEX activated the mitogen-activated protein kinase (MAPK) pathway, impaired caspase-3 expression, and enhanced anti-apoptotic factor Bcl-2 to resist lidocaine-induced apoptosis, indicating that the optimal dose of DEX alleviates lidocaine-induced cytotoxicity and should be considered in clinical application. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Recent Developments in Cellular Immunotherapy for HSCT-Associated Complications

PubMed Central

Reis, Monica; Ogonek, Justyna; Qesari, Marsela; Borges, Nuno M.; Nicholson, Lindsay; Preußner, Liane; Dickinson, Anne Mary; Wang, Xiao-nong; Weissinger, Eva M.; Richter, Anne

2016-01-01

Allogeneic hematopoietic stem cell transplantation is associated with serious complications, and improvement of the overall clinical outcome of patients with hematological malignancies is necessary. During the last decades, posttransplant donor-derived adoptive cellular immunotherapeutic strategies have been progressively developed for the treatment of graft-versus-host disease (GvHD), infectious complications, and tumor relapses. To date, the common challenge of all these cell-based approaches is their implementation for clinical application. Establishing an appropriate manufacturing process, to guarantee safe and effective therapeutics with simultaneous consideration of economic requirements is one of the most critical hurdles. In this review, we will discuss the recent scientific findings, clinical experiences, and technological advances for cell processing toward the application of mesenchymal stromal cells as a therapy for treatment of severe GvHD, virus-specific T cells for targeting life-threating infections, and of chimeric antigen receptors-engineered T cells to treat relapsed leukemia. PMID:27895644

Animal models for microbicide studies

PubMed Central

Veazey, Ronald S.; Shattock, Robin J; Klasse, Per Johan; Moore, John P.

2013-01-01

There have been encouraging recent successes in the development of safe and effective topical microbicides to prevent vaginal or rectal HIV-1 transmission, based on the use of anti-retroviral drugs. However, much work remains to be accomplished before a microbicide becomes a standard element of prevention science strategies. Animal models should continue to play an important role in pre-clinical testing, with emphasis on safety, pharmacokinetic and efficacy testing. PMID:22264049

Laser safety: regulations, standards, and recommendations

NASA Astrophysics Data System (ADS)

Smalley, Penny J.

1993-07-01

All healthcare professionals involved in the delivery of laser technology to patients, must develop and monitor clinical laser safety programs that ensure compliance with national, state, and local regulations, professional standards of practice, and national consensus standards. Laser safe treatment environments for patients and for personnel can be established and maintained through understanding the impact of both regulatory and advisory guidelines, comprehensive program planning, appropriate continuing education, and routine safety audits.

Empowerment in a model of outreach undergraduate dental education.

PubMed

Radford, D R; Hellyer, P

2017-01-13

Aim To undertake a quantitative and qualitative examination into what aspects of the students' experience in outreach at University of Portsmouth Dental Academy (UPDA) are encouraging their empowerment as autonomous practitioners, ready to graduate as 'safe beginners'.Methods The study was devised as part of the educational service evaluation of outreach education at the UPDA. For the two most recent cohorts of 160 students (2014-16) an additional domain was added specifically investigating the students' sense of how their experience of outreach at the UPDA has impacted on their development to be ready for independent practice (safe beginner). The questionnaire was completed anonymously in their last week of attendance just before graduation.Results A 91% response rate for the questionnaire was achieved. To the question about 'being given an opportunity to become an independent dentist', 83% of the respondents strongly agreed. Two themes with seven subthemes were identified from the free text responses. The two themes were 'self-actualisation: developing self-awareness and self-confidence' and 'delivery of care as a dentist'.Conclusion Within the limitations of this educational evaluation, students enjoyed the increase of autonomy they gained during the year-long placement and felt that the clinical teachers empowered, encouraged and supported them to develop as autonomous dental practitioners and as 'safe beginners', to deliver holistic care in the National Health Service.

[RESEARCH PROGRESS OF THREE-DIMENSIONAL PRINTING TECHNIQUE FOR SPINAL IMPLANTS].

PubMed

Lu, Qi; Yu, Binsheng

2016-09-08

To summarize the current research progress of three-dimensional (3D) printing technique for spinal implants manufacture. The recent original literature concerning technology, materials, process, clinical applications, and development direction of 3D printing technique in spinal implants was reviewed and analyzed. At present, 3D printing technologies used to manufacture spinal implants include selective laser sintering, selective laser melting, and electron beam melting. Titanium and its alloys are mainly used. 3D printing spinal implants manufactured by the above materials and technology have been successfully used in clinical. But the problems regarding safety, related complications, cost-benefit analysis, efficacy compared with traditional spinal implants, and the lack of relevant policies and regulations remain to be solved. 3D printing technique is able to provide individual and customized spinal implants for patients, which is helpful for the clinicians to perform operations much more accurately and safely. With the rapid development of 3D printing technology and new materials, more and more 3D printing spinal implants will be developed and used clinically.

Medical students call for national standards in anatomical education.

PubMed

Farey, John E; Sandeford, Jonathan C; Evans-McKendry, Greg D

2014-11-01

The diminishing number of hours dedicated to formal instruction in anatomy has led to a debate within medical education as to the level required for safe clinical practice. We provide a review of the current state of anatomical education in Australian medical schools and state the case for national standards. In light of the review presented, council members of the Australian Medical Students' Association voted to affirm that consideration should be given to developing undergraduate learning goals for anatomy, providing a codified medical student position on the teaching of anatomy in Australian medical schools. Crucially, the position states that time-intensive methods of instruction such as dissection should be a rite of passage for medical students in the absence of evidence demonstrating the superiority of modern teaching methods. We believe the bodies with a vested interest in the quality of medical graduates, namely the Australian Medical Council, Medical Deans Australia & New Zealand, and the postgraduate colleges should collaborate and develop clear guidelines that make explicit the core knowledge of anatomy expected of medical graduates at each stage of their career with a view to safe clinical practice. In addition, Australian universities have a role to play in conducting further research into contemporary learning styles and the most efficacious methods of delivering anatomical education. © 2014 Royal Australasian College of Surgeons.

The Microphysiology Systems Database for Analyzing and Modeling Compound Interactions with Human and Animal Organ Models

PubMed Central

Vernetti, Lawrence; Bergenthal, Luke; Shun, Tong Ying; Taylor, D. Lansing

2016-01-01

Abstract Microfluidic human organ models, microphysiology systems (MPS), are currently being developed as predictive models of drug safety and efficacy in humans. To design and validate MPS as predictive of human safety liabilities requires safety data for a reference set of compounds, combined with in vitro data from the human organ models. To address this need, we have developed an internet database, the MPS database (MPS-Db), as a powerful platform for experimental design, data management, and analysis, and to combine experimental data with reference data, to enable computational modeling. The present study demonstrates the capability of the MPS-Db in early safety testing using a human liver MPS to relate the effects of tolcapone and entacapone in the in vitro model to human in vivo effects. These two compounds were chosen to be evaluated as a representative pair of marketed drugs because they are structurally similar, have the same target, and were found safe or had an acceptable risk in preclinical and clinical trials, yet tolcapone induced unacceptable levels of hepatotoxicity while entacapone was found to be safe. Results demonstrate the utility of the MPS-Db as an essential resource for relating in vitro organ model data to the multiple biochemical, preclinical, and clinical data sources on in vivo drug effects. PMID:28781990

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.

A fresh look at the anatomy and physiology of equine mastication.

PubMed

Dixon, Padraic M; du Toit, Nicole; Staszyk, Carsten

2013-08-01

There have been many significant and interesting developments in equine dental anatomy during the past 20 years that are of major clinical significance in better understanding the physiology of equine mastication, the etiopathogenesis of some dental disorders, and their safe treatment. The many recent significant developments include descriptions of the enamel infolding of cheek teeth and of infundibular anatomy, including the frequent absence of cementum infilling in many infundibulae, which can lead to infundibular caries. Many important developments in equine dental anatomy are summarized in this article. Copyright © 2013 Elsevier Inc. All rights reserved.

Nanoparticles for Retinal Gene Therapy

PubMed Central

Conley, Shannon M.; Naash, Muna I.

2010-01-01

Ocular gene therapy is becoming a well-established field. Viral gene therapies for the treatment of Leber’s congentinal amaurosis (LCA) are in clinical trials, and many other gene therapy approaches are being rapidly developed for application to diverse ophthalmic pathologies. Of late, development of non-viral gene therapies has been an area of intense focus and one technology, polymer-compacted DNA nanoparticles, is especially promising. However, development of pharmaceutically and clinically viable therapeutics depends not only on having an effective and safe vector but also on a practical treatment strategy. Inherited retinal pathologies are caused by mutations in over 220 genes, some of which contain over 200 individual disease-causing mutations, which are individually very rare. This review will focus on both the progress and future of nanoparticles and also on what will be required to make them relevant ocular pharmaceutics. PMID:20452457

Developing a contextual consciousness: learning to address gender, societal power, and culture in clinical practice.

PubMed

Esmiol, Elisabeth E; Knudson-Martin, Carmen; Delgado, Sarah

2012-10-01

Despite the growing number of culturally sensitive training models and considerable literature on the importance of training clinicians in larger contextual issues, research examining how students learn to apply these issues is limited. In this participatory action research project, we systematically studied our own process as marriage and family therapy (MFT) practicum students developing a contextual consciousness. Using grounded theory, we identified a three-stage process: (a) raised awareness through clinical experimentation and developing a theoretical rationale, (b) reflective questioning involving challenging old perspectives and experiencing positive client-therapist interactions, and (c) an intentional new lens based on personal responsibility and commitment. Creating and maintaining a contextual lens required a safe, empowering group dynamic and accessing other forms of support and accountability after the practicum. © 2012 American Association for Marriage and Family Therapy.

Quality requirements for EHR archetypes.

PubMed

Kalra, Dipak; Tapuria, Archana; Austin, Tony; De Moor, Georges

2012-01-01

The realisation of semantic interoperability, in which any EHR data may be communicated between heterogeneous systems and fully understood by computers as well as people on receipt, is a challenging goal. Despite the use of standardised generic models for the EHR and standard terminology systems, too much optionality and variability exists in how particular clinical entries may be represented. Clinical archetypes provide a means of defining how generic models should be shaped and bound to terminology for specific kinds of clinical data. However, these will only contribute to semantic interoperability if libraries of archetypes can be built up consistently. This requires the establishment of design principles, editorial and governance policies, and further research to develop ways for archetype authors to structure clinical data and to use terminology consistently. Drawing on several years of work within communities of practice developing archetypes and implementing systems from them, this paper presents quality requirements for the development of archetypes. Clinical engagement on a wide scale is also needed to help grow libraries of good quality archetypes that can be certified. Vendor and eHealth programme engagement is needed to validate such archetypes and achieve safe, meaningful exchange of EHR data between systems.

SafeNet: a methodology for integrating general-purpose unsafe devices in safe-robot rehabilitation systems.

PubMed

Vicentini, Federico; Pedrocchi, Nicola; Malosio, Matteo; Molinari Tosatti, Lorenzo

2014-09-01

Robot-assisted neurorehabilitation often involves networked systems of sensors ("sensory rooms") and powerful devices in physical interaction with weak users. Safety is unquestionably a primary concern. Some lightweight robot platforms and devices designed on purpose include safety properties using redundant sensors or intrinsic safety design (e.g. compliance and backdrivability, limited exchange of energy). Nonetheless, the entire "sensory room" shall be required to be fail-safe and safely monitored as a system at large. Yet, sensor capabilities and control algorithms used in functional therapies require, in general, frequent updates or re-configurations, making a safety-grade release of such devices hardly sustainable in cost-effectiveness and development time. As such, promising integrated platforms for human-in-the-loop therapies could not find clinical application and manufacturing support because of lacking in the maintenance of global fail-safe properties. Under the general context of cross-machinery safety standards, the paper presents a methodology called SafeNet for helping in extending the safety rate of Human Robot Interaction (HRI) systems using unsafe components, including sensors and controllers. SafeNet considers, in fact, the robotic system as a device at large and applies the principles of functional safety (as in ISO 13489-1) through a set of architectural procedures and implementation rules. The enabled capability of monitoring a network of unsafe devices through redundant computational nodes, allows the usage of any custom sensors and algorithms, usually planned and assembled at therapy planning-time rather than at platform design-time. A case study is presented with an actual implementation of the proposed methodology. A specific architectural solution is applied to an example of robot-assisted upper-limb rehabilitation with online motion tracking. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Clinical Practice Guideline: Safe Medication Use in the ICU.

PubMed

Kane-Gill, Sandra L; Dasta, Joseph F; Buckley, Mitchell S; Devabhakthuni, Sandeep; Liu, Michael; Cohen, Henry; George, Elisabeth L; Pohlman, Anne S; Agarwal, Swati; Henneman, Elizabeth A; Bejian, Sharon M; Berenholtz, Sean M; Pepin, Jodie L; Scanlon, Mathew C; Smith, Brian S

2017-09-01

To provide ICU clinicians with evidence-based guidance on safe medication use practices for the critically ill. PubMed, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, CINAHL, Scopus, and ISI Web of Science for relevant material to December 2015. Based on three key components: 1) environment and patients, 2) the medication use process, and 3) the patient safety surveillance system. The committee collectively developed Population, Intervention, Comparator, Outcome questions and quality of evidence statements pertaining to medication errors and adverse drug events addressing the key components. A total of 34 Population, Intervention, Comparator, Outcome questions, five quality of evidence statements, and one commentary on disclosure was developed. Subcommittee members were assigned selected Population, Intervention, Comparator, Outcome questions or quality of evidence statements. Subcommittee members completed their Grading of Recommendations Assessment, Development, and Evaluation of the question with his/her quality of evidence assessment and proposed strength of recommendation, then the draft was reviewed by the relevant subcommittee. The subcommittee collectively reviewed the evidence profiles for each question they developed. After the draft was discussed and approved by the entire committee, then the document was circulated among all members for voting on the quality of evidence and strength of recommendation. The committee followed the principles of the Grading of Recommendations Assessment, Development, and Evaluation system to determine quality of evidence and strength of recommendations. This guideline evaluates the ICU environment as a risk for medication-related events and the environmental changes that are possible to improve safe medication use. Prevention strategies for medication-related events are reviewed by medication use process node (prescribing, distribution, administration, monitoring). Detailed considerations to an active surveillance system that includes reporting, identification, and evaluation are discussed. Also, highlighted is the need for future research for safe medication practices that is specific to critically ill patients.

Concise Review: Process Development Considerations for Cell Therapy

PubMed Central

Brieva, Thomas; Raviv, Lior; Rowley, Jon; Niss, Knut; Brandwein, Harvey; Oh, Steve; Karnieli, Ohad

2015-01-01

The development of robust and well-characterized methods of production of cell therapies has become increasingly important as therapies advance through clinical trials toward approval. A successful cell therapy will be a consistent, safe, and effective cell product, regardless of the cell type or application. Process development strategies can be developed to gain efficiency while maintaining or improving safety and quality profiles. This review presents an introduction to the process development challenges of cell therapies and describes some of the tools available to address production issues. This article will provide a summary of what should be considered to efficiently advance a cellular therapy from the research stage through clinical trials and finally toward commercialization. The identification of the basic questions that affect process development is summarized in the target product profile, and considerations for process optimization are discussed. The goal is to identify potential manufacturing concerns early in the process so they may be addressed effectively and thus increase the probability that a therapy will be successful. Significance The present study contributes to the field of cell therapy by providing a resource for those transitioning a potential therapy from the research stage to clinical and commercial applications. It provides the necessary steps that, when followed, can result in successful therapies from both a clinical and commercial perspective. PMID:26315572

An evaluation of learning clinical decision-making for early rehabilitation in the ICU via interactive education with audience response system.

PubMed

Toonstra, Amy L; Nelliot, Archana; Aronson Friedman, Lisa; Zanni, Jennifer M; Hodgson, Carol; Needham, Dale M

2017-06-01

Knowledge-related barriers to safely implement early rehabilitation programs in intensive care units (ICUs) may be overcome via targeted education. The purpose of this study was to evaluate the effectiveness of an interactive educational session on short-term knowledge of clinical decision-making for safe rehabilitation of patients in ICUs. A case-based teaching approach, drawing from published safety recommendations for initiation of rehabilitation in ICUs, was used with a multidisciplinary audience. An audience response system was incorporated to promote interaction and evaluate knowledge before vs. after the educational session. Up to 175 audience members, of 271 in attendance (129 (48%) physical therapists, 51 (19%) occupational therapists, 31 (11%) nursing, 14 (5%) physician, 46 (17%) other), completed both the pre- and post-test questions for each of the six unique patient cases. In four of six patient cases, there was a significant (p< 0.001) increase in identifying the correct answer regarding initiation of rehabilitation activities. This learning effect was similar irrespective of participants' years of experience and clinical discipline. An interactive, case-based, educational session may be effective for increasing short-term knowledge, and identifying knowledge gaps, regarding clinical decision-making for safe rehabilitation of patients in ICUs. Implications for Rehabilitation Lack of knowledge regarding the safety considerations for early rehabilitation of ICU patients is a barrier to implementing early rehabilitation. Interactive educational formats, such as the use of audience response systems, offer a new method of teaching and instantly assessing learning of clinically important information. In a small study, we have shown that an interactive, case-based educational format may be used to effectively teach clinical decision-making for the safe rehabilitation of ICU patients to a diverse audience of clinicians.

Report of a workshop on ensuring sustainable access to safe blood in developing countries: International Blood Safety Forum, March 24, 2017.

PubMed

Katz, Louis M; Donnelly, John J; Gresens, Christopher J; Holmberg, Jerry A; MacPherson, James; Zacharias, Peter J K; Stanley, Jean; Bales, Christine

2018-05-01

On March 24, 2017, more than 90 experts in blood safety and international development from blood centers, industry, government, and international and nongovernmental organizations gathered in Arlington, Virginia, for the Third International Blood Safety Forum, cosponsored by America's Blood Centers and Global Healing. This report summarizes presentations and major conclusions. The meeting explored ways to increase access to affordable, safe blood for low- and lower-middle-income countries (LMICs) in an era when funding from the US President's Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund has been redirected from preventing the spread of human immunodeficiency virus (HIV) to diagnosing and treating the 25 million-plus people living with HIV in LMICs. More effective management systems must be developed to improve cost recovery for blood. While blood systems become more sustainable, continued investment is required to keep them operating. The traditional model of large grants from bilateral and multilateral donors will need to be supplemented (or replaced) with public-private partnerships and nongovernmental investment. A continued emphasis on quality is fundamental. Blood systems must build quality programs, based on accepted standards, including hospitals, clinics, and rural health care providers to ensure proper and safe use of blood. Proposals to resolve health care inequities between LMICs and high-income countries (HICs) must include helping LMICs to define sustainable national policies and practices for blood availability and utilization to suit local contexts. The blood safety lexicon should be revised to include availability, accessibility, and affordability of safe blood and blood products as the goal of all blood safety initiatives. © 2018 AABB.

A national cross-sectional study on effects of fluoride-safe water supply on the prevalence of fluorosis in China.

PubMed

Wang, Cheng; Gao, Yanhui; Wang, Wei; Zhao, Lijun; Zhang, Wei; Han, Hepeng; Shi, Yuxia; Yu, Guangqian; Sun, Dianjun

2012-01-01

To assess the effects of provided fluoride-safe drinking-water for the prevention and control of endemic fluorosis in China. A national cross-sectional study in China. In 1985, randomly selected villages in 27 provinces (or cities and municipalities) in 5 geographic areas all over China. Involved 81 786 children aged from 8 to 12 and 594 698 adults aged over 16. The prevalence of dental fluorosis and clinical skeletal fluorosis, the fluoride concentrations in the drinking-water in study villages and in the urine of subjects. The study showed that in the villages where the drinking-water fluoride concentrations were higher than the government standard of 1.2 mg/l, but no fluoride-safe drinking-water supply scheme was provided (FNB areas), the prevalence rate and index of dental fluorosis in children, and prevalence rate of clinical skeletal fluorosis in adults were all significantly higher than those in the historical endemic fluorosis villages after the fluoride-safe drinking-water were provided (FSB areas). Additionally, the prevalence rate of dental fluorosis as well as clinical skeletal fluorosis, and the concentration of fluoride in urine were found increased with the increase of fluoride concentration in drinking-water, with significant positive correlations in the FNB areas. While, the prevalence rate of dental fluorosis and clinical skeletal fluorosis in different age groups and their degrees of prevalence were significantly lower in the FSB areas than those in the FNB areas. The provision of fluoride-safe drinking-water supply schemes had significant effects on the prevention and control of dental fluorosis and skeletal fluorosis. The study also indicated that the dental and skeletal fluorosis is still prevailing in the high-fluoride drinking-water areas in China.

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.

Development of an alcohol withdrawal protocol: CNS collaborative exemplar.

PubMed

Phillips, Susan; Haycock, Camille; Boyle, Deborah

2006-01-01

The purpose of this process improvement project was to develop an Alcohol Withdrawal Syndrome (AWS) management protocol for acute care. The prevalence of alcohol abuse in our society presents challenges for health professionals, and few nurses have received formal education on the identification and treatment of AWS, which has frequently resulted in ineffective, nonstandardized care. However, nurses practicing in medical-surgical, emergency, trauma, and critical care settings must be astute in the assessment and management of AWS. DESIGN/BACKGROUND/RATIONALE: Following an analysis of existing management protocols, a behavioral health clinical nurse specialist was asked to lead a work team composed of physicians, pharmacists, and nurses to develop a new evidence-based alcohol withdrawal protocol for acute care. By implementing a standardized assessment tool and treatment protocol, clinical nurse specialists empowered nursing staff with strategies to prevent the serious medical complications associated with AWS. FINDINGS/OUTCOMES: The development and integration of a safe and effective treatment protocol to manage AWS was facilitated by collaborative, evidence-based decision making. Clinical experience and specialty expertise were integrated by clinical nurse specialists skilled in group dynamics, problem-solving, and the implementation of change. Improving care of patients in AWS is an exemplar for clinical nurse specialist roles as change agent and patient advocate.

Clinical Trials: More than an Assessment of Treatment Effect – LXV Edward Jackson Memorial Lecture

PubMed Central

Ferris, Frederick L.

2008-01-01

Purpose To review the development of clinical trials and demonstrate their value beyond the assessment of the treatment effect. Design Retrospective literature review Methods Retrospective literature review Results There has been a rapid increase in the number of clinical trials in ophthalmology as assessed by the number of ophthalmic publications and the number of ongoing National Eye Institute (NEI) sponsored clinical trials over the last four decades. The public health significance of the results of these NEI clinical trials goes beyond the demonstration of treatment effects and side effects. From these trials we learn about the clinical course and risk factors of disease allowing us to better determine who and when to treat. Furthermore, the collaboration of investigators, as they develop and carry out protocols, facilitates incorporation of new ideas into the practice of medicine. Conclusions The practice of medicine is increasingly dependent on the results of carefully designed clinical trials. The determination as to whether a new treatment is safe and effective is important, but the additional information we can obtain regarding natural history, risk factors, and patient satisfaction adds immeasurably to our ability to care for our patients. PMID:19100353

Photodynamic Therapy: Occupational Hazards and Preventative Recommendations for Clinical Administration by Healthcare Providers

PubMed Central

Lacey, Steven E.; Vesper, Benjamin J.; Paradise, William A.; Radosevich, James A.; Colvard, Michael D.

2013-01-01

Abstract Objective: Photodynamic therapy (PDT) as a medical treatment for cancers is an increasing practice in clinical settings, as new photosensitizing chemicals and light source technologies are developed and applied. PDT involves dosing patients with photosensitizing drugs, and then exposing them to light using a directed energy device in order to manifest a therapeutic effect. Healthcare professionals providing PDT should be aware of potential occupational health and safety hazards posed by these treatment devices and photosensitizing agents administered to patients. Materials and methods: Here we outline and identify pertinent health and safety considerations to be taken by healthcare staff during PDT procedures. Results: Physical hazards (for example, non-ionizing radiation generated by the light-emitting device, with potential for skin and eye exposure) and chemical hazards (including the photosensitizing agents administered to patients that have the potential for exposure via skin, subcutaneous, ingestion, or inhalation routes) must be considered for safe use of PDT by the healthcare professional. Conclusions: Engineering, administrative, and personal protective equipment controls are recommendations for the safe use and handling of PDT agents and light-emitting technologies. PMID:23859750

Driving and dementia

PubMed Central

Lee, Linda; Molnar, Frank

2017-01-01

Abstract Objective To provide primary care physicians with an approach to driving safety concerns when older persons present with memory difficulties. Sources of information The approach is based on an accredited memory clinic training program developed by the Centre for Family Medicine Primary Care Collaborative Memory Clinic. Main message One of the most challenging aspects of dementia care is the assessment of driving safety. Drivers with dementia are at higher risk of motor vehicle collisions, yet many drivers with mild dementia might be safely able to continue driving for several years. Because safe driving is dependent on multiple cognitive and functional skills, clinicians should carefully consider many factors when determining if cognitive concerns affect driving safety. Specific findings on corroborated history and office-based cognitive testing might aid in the physician’s decisions to refer for comprehensive on-road driving evaluation and whether to notify transportation authorities in accordance with provincial reporting requirements. Sensitive communication and a person-centred approach are essential. Conclusion Primary care physicians must consider many factors when determining if cognitive concerns might affect driving safety in older drivers. PMID:28115437

Driving and dementia: Efficient approach to driving safety concerns in family practice.

PubMed

Lee, Linda; Molnar, Frank

2017-01-01

To provide primary care physicians with an approach to driving safety concerns when older persons present with memory difficulties. The approach is based on an accredited memory clinic training program developed by the Centre for Family Medicine Primary Care Collaborative Memory Clinic. One of the most challenging aspects of dementia care is the assessment of driving safety. Drivers with dementia are at higher risk of motor vehicle collisions, yet many drivers with mild dementia might be safely able to continue driving for several years. Because safe driving is dependent on multiple cognitive and functional skills, clinicians should carefully consider many factors when determining if cognitive concerns affect driving safety. Specific findings on corroborated history and office-based cognitive testing might aid in the physician's decisions to refer for comprehensive on-road driving evaluation and whether to notify transportation authorities in accordance with provincial reporting requirements. Sensitive communication and a person-centred approach are essential. Primary care physicians must consider many factors when determining if cognitive concerns might affect driving safety in older drivers. Copyright© the College of Family Physicians of Canada.

An update on anesthetics and impact on the brain.

PubMed

Fodale, Vincenzo; Tripodi, Vincenzo F; Penna, Olivia; Famà, Fausto; Squadrito, Francesco; Mondello, Epifanio; David, Antonio

2017-09-01

While anesthetics are indispensable clinical tools and generally considered safe and effective, a growing concern over the potential neurotoxicity of anesthesia or specific anesthetic agents has called into question the safety of general anesthetics, especially when administered at extremes of age. Areas covered: This article reviews and updates research findings on the safety of anesthesia and anesthetics in terms of long-term neurotoxicity, with particular focus on postoperative cognitive dysfunctions, Alzheimer's disease and dementias, developing brain, post-operative depression and autism spectrum disorder. Expert opinion: Exposure to general anesthetics is potentially harmful to the human brain, and the consequent long-term cognitive deficits should be classified as an iatrogenic pathology, and considered a public health problem. The fact that in laboratory and clinical research only certain anesthetic agents and techniques, but not others, appear to be involved, raises the problem on what is the safest and the least safe anesthetic to maximize anesthesia efficiency, avoid occurrence of adverse events, and ensure patient safety. New trends in research are moving toward the theory that neuroinflammation could be the hallmark of, or could have a pivotal role in, several neurological disorders.

Competent Psychopharmacology

PubMed Central

Gardner, David M

2014-01-01

There is little doubt that undergraduate and post-graduate training of physicians, pharmacists, and nurses is insufficient to prepare them to use psychotropics safely and effectively, especially in the context of their expanded off-label uses. Therefore, the development of competencies in psychotropic prescribing needs to be approached as a long-term, practice-based learning commitment. Proposed are the abilities and knowledge components necessary for safe and effective use of psychotropics. Typical challenges in prescribing for chronic and recurrent illnesses include highly variable responses and tolerability, drug interactions, and adverse effects that can be serious, irreversible, and even fatal. Prescribing psychotropics is further complicated by negative public and professional reports and growing patient concerns about the quality of care, and questions about the efficacy, safety, and addictive risks of psychotropics. Increased efforts are needed to enhance clinical training and knowledge in psychopharmacology among trainees and practising clinicians, with more comprehensive and sustained attention to the assessment of individual patients, and greater reliance on patient education and collaboration. Improved competence in psychotropic prescribing should lead to more informed, thoughtful, and better-targeted applications as one component of more comprehensive clinical care. PMID:25161064

Acetaminophen use and asthma in children.

PubMed

Sakulchit, Teeranai; Goldman, Ran D

2017-03-01

Question A child with a history of asthma came to my clinic with acute fever. I have heard that acetaminophen might be associated with exacerbation of asthma. Is it safe if I recommend acetaminophen for this child? Answer Most studies suggest an association between acetaminophen use in children and development of asthma later in childhood. However, several confounding factors in study design might contribute to this positive correlation, and without a prospective controlled trial, confirming this finding is challenging. If children have a known history of asthma, it is likely safe to administer a single dose of acetaminophen without concern of precipitating adverse respiratory symptoms. Regular use of acetaminophen to relieve fever or pain does not seem to exacerbate asthma in children more than ibuprofen does. Copyright© the College of Family Physicians of Canada.

Strategic priorities for respiratory syncytial virus (RSV) vaccine development

PubMed Central

Anderson, L.J.; Dormitzer, P.R.; Nokes, D.J.; Rappuoli, R.; Roca, A.; Graham, B.S.

2013-01-01

Although RSV has been a high priority for vaccine development, efforts to develop a safe and effective vaccine have yet to lead to a licensed product. Clinical and epidemiologic features of RSV disease suggest there are at least 4 distinct target populations for vaccines, the RSV naïve young infant, the RSV naïve child ≥6 months of age, pregnant women (to provide passive protection to newborns), and the elderly. These target populations raise different safety and efficacy concerns and may require different vaccination strategies. The highest priority target population is the RSV naïve child. The occurrence of serious adverse events associated with the first vaccine candidate for young children, formalin inactivated RSV (FI-RSV), has focused vaccine development for the young RSV naïve child on live virus vaccines. Enhanced disease is not a concern for persons previously primed by a live virus infection. A variety of live-attenuated viruses have been developed with none yet achieving licensure. New live-attenuated RSV vaccines are being developed and evaluated that maybe sufficiently safe and efficacious to move to licensure. A variety of subunit vaccines are being developed and evaluated primarily for adults in whom enhanced disease is not a concern. An attenuated parainfluenza virus 3 vector expressing the RSV F protein was evaluated in RSV naïve children. Most of these candidate vaccines have used the RSV F protein in various vaccine platforms including virus-like particles, nanoparticles, formulated with adjuvants, and expressed by DNA or virus vectors. The other surface glycoprotein, the G protein, has also been used in candidate vaccines. We now have tools to make and evaluate a wide range of promising vaccines. Costly clinical trials in the target population are needed to evaluate and select candidate vaccines for advancement to efficacy trials. Better data on RSV-associated mortality in developing countries, better estimates of the risk of long term sequelae such as wheezing after infection, better measures of protection in target populations, and data on the costs and benefits of vaccines for target populations are needed to support and justify funding this process. Addressing these challenges and needs should improve the efficiency and speed of achieving a safe and effective, licensed RSV vaccine. PMID:23598484

Clinical Research and Clinical Trials

MedlinePlus

... NICHD News Videos OUTREACH Safe to Sleep® National Child & Maternal Health Education Program RELATED WEBSITES NIH.gov HHS.gov USA.gov ClinicalTrials.gov WEBSITE POLICIES Disclaimer FOIA Privacy Policy Accessibility NIH...Turning Discovery Into Health ®

A community-based cluster randomised trial of safe storage to reduce pesticide self-poisoning in rural Sri Lanka: study protocol

PubMed Central

2011-01-01

Background The WHO recognises pesticide poisoning to be the single most important means of suicide globally. Pesticide self-poisoning is a major public health and clinical problem in rural Asia, where it has led to case fatality ratios 20-30 times higher than self-poisoning in the developed world. One approach to reducing access to pesticides is for households to store pesticides in lockable "safe-storage" containers. However, before this approach can be promoted, evidence is required on its effectiveness and safety. Methods/Design A community-based cluster randomised controlled trial has been set up in 44,000 households in the North Central Province, Sri Lanka. A census is being performed, collecting baseline demographic data, socio-economic status, pesticide usage, self-harm and alcohol. Participating villages are then randomised and eligible households in the intervention arm given a lockable safe storage container for agrochemicals. The primary outcome will be incidence of pesticide self-poisoning over three years amongst individuals aged 14 years and over. 217,944 person years of follow-up are required in each arm to detect a 33% reduction in pesticide self-poisoning with 80% power at the 5% significance level. Secondary outcomes will include the incidence of all pesticide poisoning and total self-harm. Discussion This paper describes a large effectiveness study of a community intervention to reduce the burden of intentional poisoning in rural Sri Lanka. The study builds on a strong partnership between provincial health services, local and international researchers, and local communities. We discuss issues in relation to randomisation and contamination, engaging control villages, the intervention, and strategies to improve adherence. Trial Registritation The trial is registered on ClinicalTrials.gov ref: NCT1146496 (http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01146496). PMID:22104027

The Effect of Aroma Hand Massage Therapy for People with Dementia.

PubMed

Yoshiyama, Kazuyo; Arita, Hideko; Suzuki, Jinichi

2015-12-01

Clinical aromatherapy is a complementary therapy that may be very helpful for elderly dementia care. Aromatherapy may reduce the behavioral and psychological symptoms of dementia (BPSD), improve quality of care, and thus improve the quality of life for people with dementia. In this pilot study, aroma hand massage therapy was used for elderly patients in a medical institution in Japan. The study assessed the effectiveness and safety of clinical aromatherapy as part of routine integrative care among people with dementia in a clinical care setting. The randomized, crossover pilot trials were performed among 14 patients with mild-to-moderate dementia older than age 65 years living in a nursing home in Nara, Japan. Participants were divided into two groups and offered, alternately, control therapy and clinical aromatherapy 3 times a week for the 4-week trials. The effects on BPSD and activities of daily living (ADLs) were evaluated quantitatively before and after the study and 4 weeks after the study ended as a follow-up. Observation records were also collected to obtain qualitative data. The quantitative data showed that neither therapy significantly improved the BPSD or ADL results. The qualitative data were classified into four main categories-mood, behavior, verbal communication, and nonverbal communication-reflecting the positive experiences of participants during both therapies. No harmful reactions or changes in medication occurred during the study. This pilot study demonstrated that clinical aromatherapy was clinically safe but did not lead to statistically significant improvements in BPSD or ADL among people with dementia. Further research on therapeutic effects is needed to develop high-quality care with clinical aromatherapy for elderly patients with dementia in Japan and to fully establish evidence for effective and safe practice in health care institutions.

Safety of meropenem in patients reporting penicillin allergy: lack of allergic cross reactions.

PubMed

Cunha, B A; Hamid, N S; Krol, V; Eisenstein, L

2008-04-01

Over the years, meropenem has become the mainstay of empiric therapy for serious systemic infections in critically ill patients. Although we have had extensive clinical experience since 1996 using meropenem safely in treating hundreds of patients with reported allergic reactions to penicillin without any adverse events, we have not published our experience. This study was conducted to document our clinical practice experience. Accordingly, over a 12-month period we prospectively monitored 110 patients treated with meropenem reporting penicillin allergic reactions for that 12-month period. Since early empiric therapy in such patients is essential, there is often no time for penicillin skin testing. Penicillin skin testing was not done in this "real world" clinical study. Patients were divided into two groups, depending on the nature of their penicillin allergic reactions. During a 12-month period, 110 patients with non-anaphylactic (59) and anaphylactic (51) penicillin allergic reactions tolerated prolonged meropenem therapy (1-4 weeks) safely without any allergic reactions. Based on these data and our previous clinical experience, there appears to be little/no potential cross reactivity between meropenem and penicillins even in patients with a definite history of anaphylactic reactions to penicillins. To the best of our knowledge, this is the first prospective clinical study demonstrating that meropenem may be safely given to patients with known/unknown allergic reactions to penicillin, including those with anaphylactic reactions, without penicillin skin testing. We conclude that meropenem may be given safely to patients reporting a history of non-anaphylactic or anaphylactic allergic reactions to penicillins without penicillin skin testing.

[COMBINED IMMUNOTHERAPY OF RECONDITIONAL CHRONIC NON-SPECIFIC VULVOVAGINITIS IN IMMUNOCOMPROMISED GIRLS].

PubMed

Nesterova, I; Kovaleva, S; Chudilova, G; Lomtatidze, L; Krutova, V; Aslanian, I; Tulendinova, A; Malinovskaya, V

2017-05-01

Nonspecific chronic vulvovaginitis (CNV) is often a clinical indicator of immune deficiency, especially in young girls. The established violations of the functioning of various parts of the immune system (IS) in this pathology dictate the need to include in the complex of immunomodulatory therapy. The developed program of combined immunotherapy for immunocompromised girls allows to reduce the severity and duration of exacerbation of CNV, their frequency against the background of a significant reduction in the incidence of ARVI. Positive clinical effects were observed against the background of the restoration of the functioning of the IS. A protective effect was obtained (observation in a catamnesis for 1 year) - the duration of a clinically safe period increased from 6 to 11-11,5 months per year.

RNAi therapeutics and applications of microRNAs in cancer treatment.

PubMed

Uchino, Keita; Ochiya, Takahiro; Takeshita, Fumitaka

2013-06-01

RNA interference-based therapies are proving to be powerful tools for combating various diseases, including cancer. Scientists are researching the development of safe and efficient systems for the delivery of small RNA molecules, which are extremely fragile in serum, to target organs and cells in the human body. A dozen pre-clinical and clinical trials have been under way over the past few years involving biodegradable nanoparticles, lipids, chemical modification and conjugation. On the other hand, microRNAs, which control the balance of cellular biological processes, have been studied as attractive therapeutic targets in cancer treatment. In this review, we provide an overview of RNA interference-based therapeutics in clinical trials and discuss the latest technology for the systemic delivery of nucleic acid drugs. Furthermore, we focus on dysregulated microRNAs in human cancer, which have progressed in pre-clinical trials as therapeutic targets, and describe a wide range of strategies to control the expression levels of endogenous microRNAs. Further development of RNA interference technologies and progression of clinical trials will contribute to the achievement of practical applications of nucleic acid drugs.

Viral Vector-Based Innovative Approaches to Directly Abolishing Tumorigenic Pluripotent Stem Cells for Safer Regenerative Medicine.

PubMed

Mitsui, Kaoru; Ide, Kanako; Takahashi, Tomoyuki; Kosai, Ken-Ichiro

2017-06-16

Human pluripotent stem cells (hPSCs) are a promising source of regenerative material for clinical applications. However, hPSC transplant therapies pose the risk of teratoma formation and malignant transformation of undifferentiated remnants. These problems underscore the importance of developing technologies that completely prevent tumorigenesis to ensure safe clinical application. Research to date has contributed to establishing safe hPSC lines, improving the efficiency of differentiation induction, and indirectly ensuring the safety of products. Despite such efforts, guaranteeing the clinical safety of regenerative medicine products remains a key challenge. Given the intrinsic genome instability of hPSCs, selective growth advantage of cancer cells, and lessons learned through failures in previous attempts at hematopoietic stem cell gene therapy, conventional strategies are unlikely to completely overcome issues related to hPSC tumorigenesis. Researchers have recently embarked on studies aimed at locating and directly treating hPSC-derived tumorigenic cells. In particular, novel approaches to directly killing tumorigenic cells by transduction of suicide genes and oncolytic viruses are expected to improve the safety of hPSC-based therapy. This article discusses the current status and future perspectives of methods aimed at directly eradicating undifferentiated tumorigenic hPSCs, with a focus on viral vector transduction.

Determination of a safe INR for joint injections in patients taking warfarin.

PubMed

Bashir, M A; Ray, R; Sarda, P; Li, S; Corbett, S

2015-11-01

With an increase in life expectancy in 'developed' countries, the number of elderly patients receiving joint injections for arthritis is increasing. There are legitimate concerns about an increased risk of thromboembolism if anticoagulation is stopped or reversed for such an injection. Despite being a common dilemma, the literature on this issue is scarce. We undertook 2,084 joint injections of the knee and shoulder in 1,714 patients between August 2008 and December 2013. Within this cohort, we noted 41 patients who were taking warfarin and followed them immediately after joint injection in the clinic or radiology department, looking carefully for complications. Then, we sought clinical follow-up, correspondence, and imaging evidence for 4 weeks, looking for complications from these joint injections. We recorded International Normalised Ratio (INR) values before injection. No complications were associated with the procedure after any joint injection. The radiologists who undertook ultrasound-guided injections to shoulders re-scanned the joints looking for haemarthroses: they found none. A similar outcome was noted clinically after injections in the outpatient setting. With a mean INR of 2.77 (range, 1.7-5.5) and a maximum INR within this group of 5.5, joint injections to the shoulder and knee can be undertaken safely in primary or secondary care settings despite the patient taking warfarin.

Irreversible electroporation of the pancreas is feasible and safe in a porcine survival model.

PubMed

Fritz, Stefan; Sommer, Christof M; Vollherbst, Dominik; Wachter, Miguel F; Longerich, Thomas; Sachsenmeier, Milena; Knapp, Jürgen; Radeleff, Boris A; Werner, Jens

2015-07-01

Use of thermal tumor ablation in the pancreatic parenchyma is limited because of the risk of pancreatitis, pancreatic fistula, or hemorrhage. This study aimed to evaluate the feasibility and safety of irreversible electroporation (IRE) in a porcine model. Ten pigs were divided into 2 study groups. In the first group, animals received IRE of the pancreatic tail and were killed after 60 minutes. In the second group, animals received IRE at the head of the pancreas and were followed up for 7 days. Clinical parameters, computed tomography imaging, laboratory results, and histology were obtained. All animals survived IRE ablation, and no cardiac adverse effects were noted. Sixty minutes after IRE, a hypodense lesion on computed tomography imaging indicated the ablation zone. None of the animals developed clinical signs of acute pancreatitis. Only small amounts of ascites fluid, with a transient increase in amylase and lipase levels, were observed, indicating that no pancreatic fistula occurred. This porcine model shows that IRE is feasible and safe in the pancreatic parenchyma. Computed tomography imaging reveals significant changes at 60 minutes after IRE and therefore might serve as an early indicator of therapeutic success. Clinical studies are needed to evaluate the efficacy of IRE in pancreatic cancer.

Lumacaftor/ivacaftor, a novel agent for the treatment of cystic fibrosis patients who are homozygous for the F580del CFTR mutation.

PubMed

Bulloch, Marilyn N; Hanna, Cameron; Giovane, Richard

2017-10-01

Cystic Fibrosis (CF) is an autosomal recessive disease affecting up to 90,000 people worldwide. Approximately 73% of patients are homozygous for the F508del cystic fibrosis transmembrane conductance regulator [CFTR] mutation. Traditionally treatment has only included supportive care. Therefore, there is a need for safe and effective novel therapies targeting the underlying molecular defects seen with CF. Areas covered: In 2016, the Food and Drug Administration and the European Commission approved LUM/IVA (Orkambi), a CFTR modulator that includes both a CFTR corrector and potentiator, for CF patients homozygous for the F508del CFTR mutation. This article reviews the pharmacologic features, clinical efficacy, and safety of LUM/IVA and summarize the available pre-clinical and clinical data of LUM/IVA use. Expert commentary: LUM/IVA showed modest, but significant improvements from baseline in percent predicted FEV 1 (ppFEV 1 ) as well as a reduction in pulmonary exacerbations by 35% It was shown to be safe for short- and long-term use. Currently, LUM/IVA is the only oral agent in its class available and represents a milestone the development of therapies for the management of CF. Nonetheless, pharmacoeconomic data are necessary to justify its high cost before is use becomes standard of care.

[Clinical evaluation of Engström's electrically controlled ELSA for low flow closed circuit anesthesia].

PubMed

Igarashi, M; Nakae, Y; Ichimiya, N; Watanabe, H; Iwasaki, H; Namiki, A

1993-02-01

Many anesthesiologists are now interested in low flow, closed circuit anesthesia from an economical and environmental point of view. In order to evaluate clinically a newly developed electronically controlled anesthesia machine Engström's ELSA, we compared low flow, closed circuit anesthesia on 38 ASA I-II patients using ELSA, with high flow anesthesia on 12 ASA I-II patients using a conventional anesthesia machine. The results were as follows; 1. We could perform safe and economical low flow, closed circuit anesthesia using ELSA's injection vaporizer and accurate monitoring devices for O2, N2O, CO2 and concentrations of various volatile anesthetic agents. 2. Under low flow anesthesia, isoflurane consumption was 5.3 +/- 1.1 ml.h-1 x Vol.%-1 (mean +/- SE) with ELSA, which is about one fourth of the high flow anesthesia consumption (22.6 +/- 2.1 ml.h-1 x Vol.%-1 (mean +/- SE). 3. Low flow closed circuit anesthesia could maintain significantly higher temperature and humidity compared with high flow anesthesia. 4. Under low flow anesthesia of more than 7hrs, color of soda lime becomes blue, but this does not affect FIO2 nor PaCO2, and the method is clinically safe for patients.

Strategies and challenges for safe injection practice in developing countries.

PubMed

Gyawali, Sudesh; Rathore, Devendra Singh; Shankar, P Ravi; Kumar, Kc Vikash

2013-01-01

Injection is one of the important health care procedures used globally to administer drugs. Its unsafe use can transmit various blood borne pathogens. This article aims to review the history and status of injection practices, its importance, interventions and the challenges for safe injection practice in developing countries. The history of injections started with the discovery of syringe in the early nineteenth century. Safe injection practice in developed countries was initiated in the early twentieth century but has not received adequate attention in developing countries. The establishment of "Safe Injection Global Network (SIGN)" was an milestone towards safe injection practice globally. In developing countries, people perceive injection as a powerful healing tool and do not hesitate to pay more for injections. Unsafe disposal and reuse of contaminated syringe is common. Ensuring safe injection practice is one of the greatest challenges for healthcare system in developing countries. To address the problem, interventions with active involvement of a number of stakeholders is essential. A combination of educational, managerial and regulatory strategies is found to be effective and economically viable. Rational and safe use of injections can save many lives but unsafe practice threatens life. Safe injection practice is crucial in developing countries. Evidence based interventions, with honest commitment and participation from the service provider, recipient and community with aid of policy makers are required to ensure safe injection practice.

Strategies and challenges for safe injection practice in developing countries

PubMed Central

Gyawali, Sudesh; Rathore, Devendra Singh; Shankar, P Ravi; Kumar, KC Vikash

2013-01-01

Injection is one of the important health care procedures used globally to administer drugs. Its unsafe use can transmit various blood borne pathogens. This article aims to review the history and status of injection practices, its importance, interventions and the challenges for safe injection practice in developing countries. The history of injections started with the discovery of syringe in the early nineteenth century. Safe injection practice in developed countries was initiated in the early twentieth century but has not received adequate attention in developing countries. The establishment of “Safe Injection Global Network (SIGN)” was an milestone towards safe injection practice globally. In developing countries, people perceive injection as a powerful healing tool and do not hesitate to pay more for injections. Unsafe disposal and reuse of contaminated syringe is common. Ensuring safe injection practice is one of the greatest challenges for healthcare system in developing countries. To address the problem, interventions with active involvement of a number of stakeholders is essential. A combination of educational, managerial and regulatory strategies is found to be effective and economically viable. Rational and safe use of injections can save many lives but unsafe practice threatens life. Safe injection practice is crucial in developing countries. Evidence based interventions, with honest commitment and participation from the service provider, recipient and community with aid of policy makers are required to ensure safe injection practice. PMID:23662018

77 FR 23105 - Supporting Safe and Responsible Development of Unconventional Domestic Natural Gas Resources

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-17

... Safe and Responsible Development of Unconventional Domestic Natural Gas Resources #0; #0; #0..., 2012 Supporting Safe and Responsible Development of Unconventional Domestic Natural Gas Resources By... and responsible development of unconventional domestic natural gas resources and associated...

Optimizing real time fMRI neurofeedback for therapeutic discovery and development

PubMed Central

Stoeckel, L.E.; Garrison, K.A.; Ghosh, S.; Wighton, P.; Hanlon, C.A.; Gilman, J.M.; Greer, S.; Turk-Browne, N.B.; deBettencourt, M.T.; Scheinost, D.; Craddock, C.; Thompson, T.; Calderon, V.; Bauer, C.C.; George, M.; Breiter, H.C.; Whitfield-Gabrieli, S.; Gabrieli, J.D.; LaConte, S.M.; Hirshberg, L.; Brewer, J.A.; Hampson, M.; Van Der Kouwe, A.; Mackey, S.; Evins, A.E.

2014-01-01

While reducing the burden of brain disorders remains a top priority of organizations like the World Health Organization and National Institutes of Health, the development of novel, safe and effective treatments for brain disorders has been slow. In this paper, we describe the state of the science for an emerging technology, real time functional magnetic resonance imaging (rtfMRI) neurofeedback, in clinical neurotherapeutics. We review the scientific potential of rtfMRI and outline research strategies to optimize the development and application of rtfMRI neurofeedback as a next generation therapeutic tool. We propose that rtfMRI can be used to address a broad range of clinical problems by improving our understanding of brain–behavior relationships in order to develop more specific and effective interventions for individuals with brain disorders. We focus on the use of rtfMRI neurofeedback as a clinical neurotherapeutic tool to drive plasticity in brain function, cognition, and behavior. Our overall goal is for rtfMRI to advance personalized assessment and intervention approaches to enhance resilience and reduce morbidity by correcting maladaptive patterns of brain function in those with brain disorders. PMID:25161891

Using Simulation in a Psychiatric Mental Health Nurse Practitioner Doctoral Program.

PubMed

Calohan, Jess; Pauli, Eric; Combs, Teresa; Creel, Andrea; Convoy, Sean; Owen, Regina

The use and effectiveness of simulation with standardized patients in undergraduate and graduate nursing education programs is well documented. Simulation has been primarily used to develop health assessment skills. Evidence supports using simulation and standardized patients in psychiatric-mental health nurse practitioner (PMHNP) programs is useful in developing psychosocial assessment skills. These interactions provide individualized and instantaneous clinical feedback to the student from faculty, peers, and standardized patients. Incorporating simulation into advanced practice psychiatric-mental health nursing curriculum allows students to develop the necessary requisite skills and principles needed to safely and effectively provide care to patients. There are no documented standardized processes for using simulation throughout a doctor of nursing practice PMHNP curriculum. The purpose of this article is to describe a framework for using simulation with standardized patients in a PMHNP curriculum. Students report high levels of satisfaction with the simulation experience and believe that they are more prepared for clinical rotations. Faculty feedback indicates that simulated clinical scenarios are a method to ensure that each student experiences demonstrate a minimum standard of competency ahead of clinical rotations with live patients. Initial preceptor feedback indicates that students are more prepared for clinical practice and function more independently than students that did not experience this standardized clinical simulation framework. Published by Elsevier Inc.

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.

Towards a Rational Design of an Asymptomatic Clinical Herpes Vaccine: The Old, the New, and the Unknown

PubMed Central

Alami Chentoufi, Aziz; Kritzer, Elizabeth; Yu, David M.; Nesburn, Anthony B.; BenMohamed, Lbachir

2012-01-01

The best hope of controlling the herpes simplex virus type 1 and type 2 (HSV-1 and HSV-2) pandemic is the development of an effective vaccine. However, in spite of several clinical trials, starting as early as 1920s, no vaccine has been proven sufficiently safe and efficient to warrant commercial development. In recent years, great strides in cellular and molecular immunology have stimulated creative efforts in controlling herpes infection and disease. However, before moving towards new vaccine strategy, it is necessary to answer two fundamental questions: (i) why past herpes vaccines have failed? (ii) Why the majority of HSV seropositive individuals (i.e., asymptomatic individuals) are naturally “protected” exhibiting few or no recurrent clinical disease, while other HSV seropositive individuals (i.e., symptomatic individuals) have frequent ocular, orofacial, and/or genital herpes clinical episodes? We recently discovered several discrete sets of HSV-1 symptomatic and asymptomatic epitopes recognized by CD4+ and CD8+ T cells from seropositive symptomatic versus asymptomatic individuals. These asymptomatic epitopes will provide a solid foundation for the development of novel herpes epitope-based vaccine strategy. Here we provide a brief overview of past clinical vaccine trials, outline current progress towards developing a new generation “asymptomatic” clinical herpes vaccines, and discuss future mucosal “asymptomatic” prime-boost vaccines that could optimize local protective immunity. PMID:22548113

Accelerating the development of a safe and effective HIV vaccine: HIV vaccine case study for the Decade of Vaccines.

PubMed

Koff, Wayne C; Russell, Nina D; Walport, Mark; Feinberg, Mark B; Shiver, John W; Karim, Salim Abdool; Walker, Bruce D; McGlynn, Margaret G; Nweneka, Chidi Victor; Nabel, Gary J

2013-04-18

Human immunodeficiency virus (HIV), the etiologic agent that causes AIDS, is the fourth largest killer in the world today. Despite the remarkable achievements in development of anti-retroviral therapies against HIV, and the recent advances in new prevention technologies, the rate of new HIV infections continue to outpace efforts on HIV prevention and control. Thus, the development of a safe and effective vaccine for prevention and control of AIDS remains a global public health priority and the greatest opportunity to eventually end the AIDS pandemic. Currently, there is a renaissance in HIV vaccine development, due in large part to the first demonstration of vaccine induced protection, albeit modest, in human efficacy trials, a generation of improved vaccine candidates advancing in the clinical pipeline, and newly defined targets on HIV for broadly neutralizing antibodies. The main barriers to HIV vaccine development include the global variability of HIV, lack of a validated animal model, lack of correlates of protective immunity, lack of natural protective immune responses against HIV, and the reservoir of infected cells conferred by integration of HIV's genome into the host. Some of these barriers are not unique to HIV, but generic to other variable viral pathogens such as hepatitis C and pandemic influenza. Recommendations to overcome these barriers are presented in this document, including but not limited to expansion of efforts to design immunogens capable of eliciting broadly neutralizing antibodies against HIV, expansion of clinical research capabilities to assess multiple immunogens concurrently with comprehensive immune monitoring, increased support for translational vaccine research, and engaging industry as full partners in vaccine discovery and development. Copyright © 2012 Elsevier Ltd. All rights reserved.

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.

Electroconvulsive therapy after maxillofacial metallic implants.

PubMed

Freeman, G Mark; Perry, Matthew T; Manatt, George S; Cristancho, Pilar

2014-03-01

A growing body of literature suggests that electroconvulsive therapy (ECT) can be safely utilized in patients with craniofacial metallic implants. Here we provide radiographic images and the clinical course of a 49-year-old woman with both maxillary and mandibular metallic implants who safely received ECT.

Dizziness Can Be a Drag: Coping with Balance Disorders

MedlinePlus

... now in clinical trials, scientists have created a “virtual reality” grocery store. It allows people with balance disorders to walk safely on a treadmill through computer-generated store aisles. While ... reach for items on virtual shelves. By doing this, they safely learn how ...

Laser Tattoo Removal: A Clinical Update

PubMed Central

Ho, Stephanie GY; Goh, Chee Leok

2015-01-01

Techniques for tattoo removal have evolved significantly over the years. The commonly used Quality-switched (QS) ruby, alexandrite, and Nd:YAG lasers are the traditional workhorses for tattoo removal. Newer strategies using combination laser treatments, multi-pass treatments, and picosecond lasers offer promising results. The tattoo color and skin type of the patient are important considerations when choosing the appropriate laser. Standard protocols can be developed for the effective and safe treatment of tattoos. PMID:25949017

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

PubMed Central

Elfeddali, Iman; van der Feltz-Cornelis, Christina M.; van Os, Jim; Knappe, Susanne; Vieta, Eduard; Wittchen, Hans-Ulrich; Obradors-Tarragó, Carla; Haro, Josep Maria

2014-01-01

Within the ROAMER project, which aims to provide a Roadmap for Mental Health Research in Europe, a two-stage Delphi survey among 86 European experts was conducted in order to identify research priorities in clinical mental health research. Expert consensus existed with regard to the importance of three challenges in the field of clinical mental health research: (1) the development of new, safe and effective interventions for mental disorders; (2) understanding the mechanisms of disease in order to be able to develop such new interventions; and (3) defining outcomes (an improved set of outcomes, including alternative outcomes) to use for clinical mental health research evaluation. Proposed actions involved increasing the utilization of tailored approaches (personalized medicine), developing blended eHealth/mHealth decision aids/guidance tools that help the clinician to choose between various treatment modalities, developing specific treatments in order to better target comorbidity and (further) development of biological, psychological and psychopharmacological interventions. The experts indicated that addressing these priorities will result in increased efficacy and impact across Europe; with a high probability of success, given that Europe has important strengths, such as skilled academics and a long research history. Finally, the experts stressed the importance of creating funding and coordinated networking as essential action needed in order to target the variety of challenges in clinical mental health research. PMID:25337940

From POEM to POET: Applications and perspectives for submucosal tunnel endoscopy.

PubMed

Chiu, Philip W Y; Inoue, Haruhiro; Rösch, Thomas

2016-12-01

Recent advances in submucosal endoscopy have unlocked a new horizon for potential development in diagnostic and therapeutic endoscopy. Increasing evidence has demonstrated that peroral endoscopic myotomy (POEM) is not only clinically feasible and safe, but also has excellent results in symptomatic relief of achalasia. The success of submucosal endoscopy in performance of tumor resection has confirmed the potential of this new area in diagnostic and therapeutic endoscopy. This article reviews the current applications and evidence, from POEM to peroral endoscopic tunnel resection (POET), while exploring the possible future clinical applications in this field. © Georg Thieme Verlag KG Stuttgart · New York.

Diagnosis and Management of Acute Concussion.

PubMed

McCrea, Michael A; Nelson, Lindsay D; Guskiewicz, Kevin

2017-05-01

Over the past 2 decades, there have been major advances in the basic and clinical science of concussion and mild traumatic brain injury. These advances now provide a more evidence-informed approach to the definition, diagnosis, assessment, and management of acute concussion. Standardized clinical tools have been developed and validated for assessment of acute concussion across injury settings (eg, civilian, sport, military). Consensus guidelines now provide guidance regarding injury management and approaches to ensure safe return to activity after acute concussion. This article provides a brief, high-level overview of approaches to best practice in diagnosis, assessment, and management of acute concussion. Copyright © 2017 Elsevier Inc. All rights reserved.

Improving Small Interfering RNA Delivery In Vivo Through Lipid Conjugation.

PubMed

Osborn, Maire F; Khvorova, Anastasia

2018-05-10

RNA interference (RNAi)-based therapeutics are approaching clinical approval for genetically defined diseases. Current clinical success is a result of significant innovations in the development of chemical architectures that support sustained, multi-month efficacy in vivo following a single administration. Conjugate-mediated delivery has established itself as the most promising platform for safe and targeted small interfering RNA (siRNA) delivery. Lipophilic conjugates represent a major class of modifications that improve siRNA pharmacokinetics and enable efficacy in a broad range of tissues. Here, we review current literature and define key features and limitations of this approach for in vivo modulation of gene expression.

"Heidelberg standard examination" and "Heidelberg standard procedures" - Development of faculty-wide standards for physical examination techniques and clinical procedures in undergraduate medical education.

PubMed

Nikendei, C; Ganschow, P; Groener, J B; Huwendiek, S; Köchel, A; Köhl-Hackert, N; Pjontek, R; Rodrian, J; Scheibe, F; Stadler, A-K; Steiner, T; Stiepak, J; Tabatabai, J; Utz, A; Kadmon, M

2016-01-01

The competent physical examination of patients and the safe and professional implementation of clinical procedures constitute essential components of medical practice in nearly all areas of medicine. The central objective of the projects "Heidelberg standard examination" and "Heidelberg standard procedures", which were initiated by students, was to establish uniform interdisciplinary standards for physical examination and clinical procedures, and to distribute them in coordination with all clinical disciplines at the Heidelberg University Hospital. The presented project report illuminates the background of the initiative and its methodological implementation. Moreover, it describes the multimedia documentation in the form of pocketbooks and a multimedia internet-based platform, as well as the integration into the curriculum. The project presentation aims to provide orientation and action guidelines to facilitate similar processes in other faculties.

Clinical Safety and Tolerability of Vildagliptin - Insights from Randomised Trials, Observational Studies and Post-marketing Surveillance.

PubMed

Mathieu, Chantal; Kozlovski, Plamen; Paldánius, Päivi M; Foley, James E; Modgill, Vikas; Evans, Marc; Serban, Carmen

2017-08-01

Vildagliptin is one of the most extensively studied dipeptidyl peptidase-4 (DPP-4) inhibitors in terms of its clinical utility. Over the last decade, a vast panorama of evidence on the benefit-risk profile of vildagliptin has been generated in patients with type 2 diabetes mellitus (T2DM). In this article, we review the cumulative evidence on the safety of vildagliptin from the clinical development programme, as well as reports of rare adverse drug reactions detected during the post-marketing surveillance of the drug. Across clinical studies, the overall safety and tolerability profile of vildagliptin was similar to placebo, and it was supported by real-world data in a broad population of patients with T2DM, making DPP-4 inhibitors, like vildagliptin, a safe option for managing patients with T2DM.

From bench to almost bedside: the long road to a licensed Ebola virus vaccine.

PubMed

Wong, Gary; Mendoza, Emelissa J; Plummer, Francis A; Gao, George F; Kobinger, Gary P; Qiu, Xiangguo

2018-02-01

The Ebola virus (EBOV) disease epidemic during 2014-16 in West Africa has accelerated the clinical development of several vaccine candidates that have demonstrated efficacy in the gold standard nonhuman primate (NHP) model, namely cynomolgus macaques. Areas covered: This review discusses the pre-clinical research and if available, clinical evaluation of the currently available EBOV vaccine candidates, while emphasizing the translatability of pre-clinical data generated in the NHP model to clinical data in humans. Expert opinion: Despite the existence of many successful EBOV vaccine candidates in the pre-clinical stages, only two platforms became the focus of Phase 2/3 efficacy trials in Liberia, Sierra Leone, and Guinea near the peak of the epidemic: the Vesicular stomatitis virus (VSV)-vectored vaccine and the chimpanzee adenovirus type 3 (ChAd3)-vectored vaccine. The results of three distinct clinical trials involving these candidates may soon pave the way for a licensed, safe and efficacious EBOV vaccine to help combat future epidemics.

From bench to almost bedside: The long road to a licensed Ebola virus vaccine

PubMed Central

Wong, Gary; Mendoza, Emelissa J.; Plummer, Francis A.; Gao, George F.; Kobinger, Gary P.; Qiu, Xiangguo

2018-01-01

Introduction The Ebola virus (EBOV) disease epidemic during 2014-16 in West Africa has accelerated the clinical development of several vaccine candidates that have demonstrated efficacy in the gold standard nonhuman primate (NHP) model, namely cynomolgus macaques. Areas covered This review discusses the pre-clinical research and if available, clinical evaluation of the currently available EBOV vaccine candidates, while emphasizing the translatability of pre-clinical data generated in the NHP model to clinical data in humans. Expert opinion Despite the existence of many successful EBOV vaccine candidates in the pre-clinical stages, only two platforms became the focus of Phase 2/3 efficacy trials in Liberia, Sierra Leone, and Guinea near the peak of the epidemic: the Vesicular stomatitis virus (VSV)-vectored vaccine and the chimpanzee adenovirus type 3 (ChAd3)-vectored vaccine. The results of three distinct clinical trials involving these candidates may soon pave the way for a licensed, safe and efficacious EBOV vaccine to help combat future epidemics. PMID:29148858

Salient Features and Outline of the Joint Japanese Guidelines for Safe Handling of Cancer Chemotherapy Drugs

PubMed Central

Kanda, Kiyoko; Hirai, Kazue; Iino, Keiko; Nomura, Hisanaga; Yasui, Hisateru; Kano, Taro; Ichikawa, Chisato; Hiura, Sumiko; Morita, Tomoko; Mitsuma, Ayako; Komatsu, Hiroko

2017-01-01

The purpose of this paper is to introduce the outline and describe the salient features of the “Joint Guidelines for Safe Handling of Cancer Chemotherapy Drugs” (hereinafter, “Guideline”), which were published in July 2015. The purpose of this Guideline is to provide guidance to protect against occupational exposure to hazardous drugs (HDs) to all medical personnel involved in cancer chemotherapy, including physicians, pharmacists, and nurses and home health-care providers. The Guideline was developed according to the Medical Information Network Distribution Service guidance for developing clinical practice guidelines, with reference to five authoritative guidelines used worldwide. PubMed, Cumulative Index to Nursing and Allied Health Literature, Ichushi-Web, and Cochrane Central Register of Controlled Trials were used for a systematic search of the literature. Eight clinical questions (CQs) were eventually established, and the strength of recommendation for each CQ is presented based on 867 references. The salient features of the Guideline are that it was jointly developed by three societies (Japanese Society of Cancer Nursing, Japanese Society of Medical Oncology, and Japanese Society of Pharmaceutical Oncology), contains descriptions including the definition of HDs and the concept of hierarchy of controls, and addresses exposure control measures during handling of chemotherapy drugs. Our future task is to collect additional evidence for the recommended exposure control measures and to assess whether publication of the Guideline has led to adherence of measures to prevent occupational exposure. PMID:28966958

Patient safety competencies in undergraduate nursing students: a rapid evidence assessment.

PubMed

Bianchi, Monica; Bressan, Valentina; Cadorin, Lucia; Pagnucci, Nicola; Tolotti, Angela; Valcarenghi, Dario; Watson, Roger; Bagnasco, Annamaria; Sasso, Loredana

2016-12-01

To identify patient safety competencies, and determine the clinical learning environments that facilitate the development of patient safety competencies in nursing students. Patient safety in nursing education is of key importance for health professional environments, settings and care systems. To be effective, safe nursing practice requires a good integration between increasing knowledge and the different clinical practice settings. Nurse educators have the responsibility to develop effective learning processes and ensure patient safety. Rapid Evidence Assessment. MEDLINE, CINAHL, SCOPUS and ERIC were searched, yielding 500 citations published between 1 January 2004-30 September 2014. Following the Rapid Evidence Assessment process, 17 studies were included in this review. Hawker's (2002) quality assessment tool was used to assess the quality of the selected studies. Undergraduate nursing students need to develop competencies to ensure patient safety. The quality of the pedagogical atmosphere in the clinical setting has an important impact on the students' overall level of competence. Active student engagement in clinical processes stimulates their critical reasoning, improves interpersonal communication and facilitates adequate supervision and feedback. Few studies describe the nursing students' patient safety competencies and exactly what they need to learn. In addition, studies describe only briefly which clinical learning environments facilitate the development of patient safety competencies in nursing students. Further research is needed to identify additional pedagogical strategies and the specific characteristics of the clinical learning environments that encourage the development of nursing students' patient safety competencies. © 2016 John Wiley & Sons Ltd.

Good practice statements on safe laboratory testing: A mixed methods study by the LINNEAUS collaboration on patient safety in primary care.

PubMed

Bowie, Paul; Forrest, Eleanor; Price, Julie; Verstappen, Wim; Cunningham, David; Halley, Lyn; Grant, Suzanne; Kelly, Moya; Mckay, John

2015-09-01

The systems-based management of laboratory test ordering and results handling is a known source of error in primary care settings worldwide. The consequences are wide-ranging for patients (e.g. avoidable harm or poor care experience), general practitioners (e.g. delayed clinical decision making and potential medico-legal implications) and the primary care organization (e.g. increased allocation of resources to problem-solve and dealing with complaints). Guidance is required to assist care teams to minimize associated risks and improve patient safety. To identify, develop and build expert consensus on 'good practice' guidance statements to inform the implementation of safe systems for ordering laboratory tests and managing results in European primary care settings. Mixed methods studies were undertaken in the UK and Ireland, and the findings were triangulated to develop 'good practice' statements. Expert consensus was then sought on the findings at the wider European level via a Delphi group meeting during 2013. We based consensus on 10 safety domains and developed 77 related 'good practice' statements (≥ 80% agreement levels) judged to be essential to creating safety and minimizing risks in laboratory test ordering and subsequent results handling systems in international primary care. Guidance was developed for improving patient safety in this important area of primary care practice. We need to consider how this guidance can be made accessible to frontline care teams, utilized by clinical educators and improvement advisers, implemented by decision makers and evaluated to determine acceptability, feasibility and impacts on patient safety.

32 CFR 105.12 - SAFE Kit collection and preservation.

Code of Federal Regulations, 2014 CFR

2014-07-01

... response, to include mental healthcare. The SAFE of a sexual assault victim should be conducted by a healthcare provider who has specialized education and clinical experience in the collection of forensic... under this reporting option. The healthcare provider shall encourage the victim to obtain referrals for...

14 CFR 67.113 - General medical condition.

Code of Federal Regulations, 2010 CFR

2010-01-01

... established medical history or clinical diagnosis of diabetes mellitus that requires insulin or any other... relating to the condition involved, finds— (1) Makes the person unable to safely perform the duties or... relating to the medication or other treatment involved, finds— (1) Makes the person unable to safely...

14 CFR 67.213 - General medical condition.

Code of Federal Regulations, 2010 CFR

2010-01-01

... established medical history or clinical diagnosis of diabetes mellitus that requires insulin or any other... relating to the condition involved, finds— (1) Makes the person unable to safely perform the duties or... relating to the medication or other treatment involved, finds— (1) Makes the person unable to safely...

14 CFR 67.313 - General medical condition.

Code of Federal Regulations, 2010 CFR

2010-01-01

... established medical history or clinical diagnosis of diabetes mellitus that requires insulin or any other... relating to the condition involved, finds— (1) Makes the person unable to safely perform the duties or... relating to the medication or other treatment involved, finds— (1) Makes the person unable to safely...

Co-creating Emotionally Safe Environments at Camp: Training Staff To Facilitate Adventure Activities.

ERIC Educational Resources Information Center

Brownlee, Matt; Yerkes, Rita

2003-01-01

An emotionally safe environment helps campers participate in adventure activities. Staff development tips for creating a safe environment include using cooperative goal setting; using parallel training processes; developing working lesson plans that outline facilitation techniques for creating emotionally safe environments; and using co-created…

Prediction of coronary artery disease in patients undergoing operations for mitral valve degeneration

NASA Technical Reports Server (NTRS)

Lin, S. S.; Lauer, M. S.; Asher, C. R.; Cosgrove, D. M.; Blackstone, E.; Thomas, J. D.; Garcia, M. J.

2001-01-01

OBJECTIVES: We sought to develop and validate a model that estimates the risk of obstructive coronary artery disease in patients undergoing operations for mitral valve degeneration and to demonstrate its potential clinical utility. METHODS: A total of 722 patients (67% men; age, 61 +/- 12 years) without a history of myocardial infarction, ischemic electrocardiographic changes, or angina who underwent routine coronary angiography before mitral valve prolapse operations between 1989 and 1996 were analyzed. A bootstrap-validated logistic regression model on the basis of clinical risk factors was developed to identify low-risk (< or =5%) patients. Obstructive coronary atherosclerosis was defined as 50% or more luminal narrowing in one or more major epicardial vessels, as determined by means of coronary angiography. RESULTS: One hundred thirty-nine (19%) patients had obstructive coronary atherosclerosis. Independent predictors of coronary artery disease include age, male sex, hypertension, diabetes mellitus,and hyperlipidemia. Two hundred twenty patients were designated as low risk according to the logistic model. Of these patients, only 3 (1.3%) had single-vessel disease, and none had multivessel disease. The model showed good discrimination, with an area under the receiver-operating characteristic curve of 0.84. Cost analysis indicated that application of this model could safely eliminate 30% of coronary angiograms, corresponding to cost savings of $430,000 per 1000 patients without missing any case of high-risk coronary artery disease. CONCLUSION: A model with standard clinical predictors can reliably estimate the prevalence of obstructive coronary atherosclerosis in patients undergoing mitral valve prolapse operations. This model can identify low-risk patients in whom routine preoperative angiography may be safely avoided.

Large-scale Isolation of Highly Pure "Untouched" Regulatory T Cells in a GMP Environment for Adoptive Cell Therapy.

PubMed

Haase, Doreen; Puan, Kia Joo; Starke, Mireille; Lai, Tuck Siong; Soh, Melissa Yan Ling; Karunanithi, Iyswariya; San Luis, Boris; Poh, Tuang Yeow; Yusof, Nurhashikin; Yeap, Chun Hsien; Phang, Chew Yen; Chye, Willis Soon Yuan; Chan, Marieta; Koh, Mickey Boon Chai; Goh, Yeow Tee; Bertin-Maghit, Sebastien; Nardin, Alessandra; Ho, Liam Pock; Rotzschke, Olaf

2015-01-01

Adoptive cell therapy is an emerging treatment strategy for a number of serious diseases. Regulatory T (Treg) cells represent 1 cell type of particular interest for therapy of inflammatory conditions, as they are responsible for controlling unwanted immune responses. Initial clinical trials of adoptive transfer of Treg cells in patients with graft-versus-host disease were shown to be safe. However, obtaining sufficient numbers of highly pure and functional Treg cells with minimal contamination remains a challenge. We developed a novel approach to isolate "untouched" human Treg cells from healthy donors on the basis of negative selection using the surface markers CD49d and CD127. This procedure, which uses an antibody cocktail and magnetic beads for separation in an automated system (RoboSep), was scaled up and adapted to be compatible with good manufacturing practice conditions. With this setup we performed 9 Treg isolations from large-scale leukapheresis samples in a good manufacturing practice facility. These runs yielded sufficient numbers of "untouched" Treg cells for immediate use in clinical applications. The cell preparations consisted of viable highly pure FoxP3-positive Treg cells that were functional in suppressing the proliferation of effector T cells. Contamination with CD4 effector T cells was <10%. All other cell types did not exceed 2% in the final product. Remaining isolation reagents were reduced to levels that are considered safe. Treg cells isolated with this procedure will be used in a phase I clinical trial of adoptive transfer into leukemia patients developing graft-versus-host disease after stem cell transplantation.

Does a too risk-averse approach to the implementation of new radiotherapy technologies delay their clinical use?

PubMed

Garcia, R; Nyström, H; Fiorino, C; Thwaites, D

2015-07-01

Radiotherapy is a generally safe treatment modality in practice; nevertheless, recent well-reported accidents also confirm its potential risks. However, this may obstruct or delay the introduction of new technologies and treatment strategies/techniques into clinical practice. Risks must be addressed and judged in a realistic context: risks must be assessed realistically. Introducing new technology may introduce new possibilities of errors. However, delaying the introduction of such new technology therefore means that patients are denied the potentially better treatment opportunities. Despite the difficulty in quantitatively assessing the risks on both sides of the possible choice of actions, including the "lost opportunity", the best estimates should be included in the overall risk-benefit and cost-benefit analysis. Radiotherapy requires a sufficiently high level of support for the safety, precision and accuracy required: radiotherapy development and implementation is exciting. However, it has been anxious with a constant awareness of the consequences of mistakes or misunderstandings. Recent history can be used to show that for introduction of advanced radiotherapy, the risk-averse medical physicist can act as an electrical fuse in a complex circuit. The lack of sufficient medical physics resource or expertise can short out this fuse and leave systems unsafe. Future technological developments will continue to present further safety and risk challenges. The important evolution of radiotherapy brings different management opinions and strategies. Advanced radiotherapy technologies can and should be safely implemented in as timely a manner as possible for the patient groups where clinical benefit is indicated.

TU-A-BRD-01: Outcomes of Hypofractionated Treatments - Initial Results of the WGSBRT

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

Li, X; Lee, P; Ohri, N

2014-06-15

Stereotactic Body Radiation Therapy (SBRT) has emerged in recent decades as a treatment paradigm that is becoming increasingly important in clinical practice. Clinical outcomes data are rapidly accumulating. Although published relations between outcomes and dose distributions are still sparse, the field has progressed to the point where evidence-based normal tissue dose-volume constraints, prescription strategies, and Tumor Control Probability (TCP) and Normal Tissue Complication Probability (NTCP) models can be developed. The Working Group on SBRT (WGSBRT), under the Biological Effects Subcommittee of AAPM, is a group of physicists and physicians working in the area of SBRT. It is currently performing criticalmore » literature reviews to extract and synthesize usable data and to develop guidelines and models to aid with safe and effective treatment. The group is investigating clinically relevant findings from SBRT in six anatomical regions: Cranial, Head and Neck, Thoracic, Abdominal, Pelvic, and Spinal. In this session of AAPM 2014, interim results are presented on TCP for lung and liver, NTCP for thoracic organs, and radiobiological foundations:• Lung TCP: Detailed modeling of TCP data from 118 published studies on early stage lung SBRT investigates dose response and hypothesized mechanisms to explain the improved outcomes of SBRT. This is presented from the perspective of a physicist, a physician, and a radiobiologist.• Liver TCP: For primary and metastatic liver tumors, individual patient data were extracted from published reports to examine the effects of biologically effective dose on local control.• Thoracic NTCP: Clinically significant SBRT toxicity of lung, rib / chest wall and other structures are evaluated and compared among published clinical data, in terms of risk, risk factors, and safe practice.• Improving the clinical utility of published toxicity reports from SBRT and Hypofractionated treatments. What do we want, and how do we get it? Methods and problems of synthesizing data from published reports. Learning Objectives: Common SBRT fractionation schemes and current evidence for efficacy. Evidence for normal tissue tolerances in hypofractionated treatments. Clinically relevant radiobiological effects at large fraction sizes.« less

Safer obstetric anesthesia through education and mentorship: a model for knowledge translation in Rwanda.

PubMed

Livingston, Patricia; Evans, Faye; Nsereko, Etienne; Nyirigira, Gaston; Ruhato, Paulin; Sargeant, Joan; Chipp, Megan; Enright, Angela

2014-11-01

High rates of maternal mortality remain a widespread problem in the developing world. Skilled anesthesia providers are required for the safe conduct of Cesarean delivery and resuscitation during obstetrical crises. Few anesthesia providers in low-resource settings have access to continuing education. In Rwanda, anesthesia technicians with only three years of post-secondary training must manage complex maternal emergencies in geographically isolated areas. The purpose of this special article is to describe implementation of the SAFE (Safer Anesthesia From Education) Obstetric Anesthesia course in Rwanda, a three-day refresher course designed to improve obstetrical anesthesia knowledge and skills for practitioners in low-resource areas. In addition, we describe how the course facilitated the knowledge-to-action (KTA) cycle whereby a series of steps are followed to promote the uptake of new knowledge into clinical practice. The KTA cycle requires locally relevant teaching interventions and continuation of knowledge post intervention. In Rwanda, this meant carefully considering educational needs, revising curricula to suit the local context, employing active experiential learning during the SAFE Obstetric Anesthesia course, encouraging supportive relationships with peers and mentors, and using participant action plans for change, post-course logbooks, and follow-up interviews with participants six months after the course. During those interviews, participants reported improvements in clinical practice and greater confidence in coordinating team activities. Anesthesia safety remains challenged by resource limitations and resistance to change by health care providers who did not attend the course. Future teaching interventions will address the need for team training.

A pharmacokinetic-pharmacodynamic model for intrathecal baclofen in patients with severe spasticity.

PubMed

Heetla, H W; Proost, J H; Molmans, B H; Staal, M J; van Laar, T

2016-01-01

Intrathecal baclofen (ITB) has proven to be an effective and safe treatment for severe spasticity. However, although ITB is used extensively, clinical decisions are based on very scarce pharmacokinetic-pharmacodynamic (PKPD) data. The aim of this study was to measure baclofen CSF concentrations and clinical effects after administration of various ITB boluses in patients with spasticity and to create a PKPD model for ITB. Twelve patients with severe spasticity received four different bolus doses of ITB (0, 25, 50, 75 μg and an optional dose of 100 μg), administered via a catheter with the tip at thoracic level (Th) 10. After each bolus, 10 CSF samples were taken at fixed time intervals, using a catheter with the tip located at Th12. Clinical effect was assessed by measuring spasticity with the Modified Ashworth Scale (MAS). These data were used to develop a PKPD model. All patients achieved an adequate spasmolytic effect with ITB doses varying from 50 to 100 μg. No serious side effects were observed. CSF baclofen concentrations, as well as the clinical effects, correlated significantly with ITB doses. The PK model predicted a steep spinal concentration gradient of ITB along the spinal axis. The clinical effect could be predicted using a delayed-effect model. ITB is an effective and safe therapy with, however, a steep concentration gradient along the spinal axis. This means that the administered baclofen is staying mainly around the catheter tip, which stresses the importance to position the ITB catheter tip closely to the targeted spinal level. © 2015 The British Pharmacological Society.

Prospective study on laser-assisted laparascopic partial nephrectomy

NASA Astrophysics Data System (ADS)

Sroka, Ronald; Hennig, Georg; Zilinberg, Katja; Khoder, Wael Y.

2012-02-01

Introduction: Developments in laparoscopic partial nephrectomy (LPN) opened a demand for surgical tools compatible with laparoscopic manipulations to make laser assisted technique safe, feasible and reproducible. Warm ischemia and bleeding during laparoscopic partial nephrectomy place technical constraints on surgeons. Therefore it was the aim to develop a safe and effective laser assisted partial nephrectomy technique without need for ischemia. Patients and methods: A diode laser emitting light at 1318nm in cw mode was coupled into a bare fibre (core diameter 600 μm) thus able to transfer up to 100W to the tissue. After dry lab experience, a total of 10 patients suffering from kidney malformations underwent laparoscopic/retroperitoneoscopic partial nephrectomy. Clinically, postoperative renal function and serum c-reactive protein (CRP) were monitored. Laser induced coagulation depth and effects on resection margins were evaluated. Demographic, clinical and follow-up data are presented. Using a commercial available fibre guidance instrument for lanringeal intervention, the demands on an innovative laser fibre guidance instrument for the laser assisted laparoscopic partial nephrectomy (LLPN) are summarized. Results: Overall, all laparascopic intervention were succesfull and could be performed without conversion to open surgery. Mean operative time and mean blood loss were comparable to conventional open and laparascopic approaches. Laser assisted resection of the kidney tissue took max 15min. After extirpation of the tumours all patients showed clinical favourable outcome during follow up period. Tumour sizes were measured to be up 5cm in diameter. The depth of the coagulation on the removed tissue ranged between <1 to 2mm without effect on histopathological evaluation of tumours or resection margin. As the surface of the remaining kidney surface was laser assisted coagulated after removal. The sealing of the surface was induced by a slightly larger coagulation margin, but could not measured so far. Based on this experiences a simple and easy to use instrument described serving also for suction and rinsing. Conclusion: This prospective in-vivo feasibility study shows that laser assisted partial nephrectomy seems to be a safe and promising medical technique which could be provided either during open surgery as well as laparascopically. This application showed good haemostasis and minimal parenchymal damage. Further investigations and development are needed for on-line detection of the remain coagulation margin. An optimised treatment equipment will support the applicability of laser assisted laparoscopic partial nephrectomy.

Comparative toxicity study on classical and modified version of Jawarish Jalinoos (a traditional Unani formulation) in rats.

PubMed

Husain, Gulam Mohammed; Ahmed, Syed Shoeb; Azhar, Misbahuddin; Siddiqui, Javed Inam; Waheed, Mohammad Abdul; Kazmi, Munawwar Husain

2017-03-01

Jawarish Jalinoos (JJ) is a classical semisolid traditional Unani formulation clinically used for the treatment of weakness of vital organs, liver, and stomach. Although JJ has been widely used clinically for several decades, no scientific report is available for its safety. JJ and its sugar-free tablet version (SFJJ; formulated to target diabetic population) were assessed for safety in rats. Ninety-day repeated dose oral toxicity study was performed as per the Organisation for Economic Co-operation and Development Guideline 408. JJ was orally administered at the dose of 2000 mg/kg bw/d, whereas SFJJ was orally administered at the doses of 506 mg/kg body weight (bw)/d, 1012 mg/kg bw/d, and 2024 mg/kg bw/d for 90 days. The animals were periodically observed for clinical signs of toxicity, mortality, morbidity, body weight changes, and feed consumption. At the end of the study, hematology, clinical biochemistry, electrolytes, gross pathology, relative organ weight, and histological examination were performed. Treatment with SFJJ and JJ showed no significant differences in body weight gain, feed consumption, hematology, clinical biochemistry, and serum electrolytes. No gross pathological findings and differences in relative organ weights were observed between control and drug treated rats. Histological examination revealed no toxicologically significant abnormalities related with SFJJ or JJ treatment. The 90-day repeated dose oral toxicity study demonstrates that the no observed adverse effect level of SFJJ and JJ is greater than 2024 mg/kg bw/d and 2000 mg/kg bw/d (p.o.) in rats, respectively. Both formulations were found to be safe up to the tested dose levels and experimental conditions, and therefore safe for clinical use as specified in the literature.

Development of Uniform Protocol for Alopecia Areata Clinical Trials.

PubMed

Solomon, James A

2015-11-01

Developing a successful treatment for alopecia areata (AA), clearly has not been at the forefront of the agenda for new drug/device development among the pharmaceutical and medical device industry. The National Alopecia Areata Foundation (NAAF), a patient advocacy group, initiated a plan to facilitate and drive clinical research toward finding safe and efficacious treatments for AA. As such, Alopecia Areata Uniform Protocols for clinical trials to test new treatments for AA were developed. The design of the uniform protocol is to accomplish the development of a plug-and-play template as well as to provide a framework wherein data from studies utilizing the uniform protocol can be compared through consistency of inclusions/exclusions, safety, and outcome assessment measures. A core uniform protocol for use by pharmaceutical companies in testing proof of concept for investigational products to treat AA. The core protocol includes standardized title, informed consent, inclusion/exclusion criteria, disease outcome assessments, and safety assessments. The statistical methodology to assess successful outcomes will also be standardized. The protocol as well as the informed consent form has been approved in concept by Liberty IRB and is ready to present to pharmaceutical companies.

Ranking of healthcare programmes based on health outcome, health costs and safe delivery of care in hospital pharmacy practice.

PubMed

Brisseau, Lionel; Bussières, Jean-François; Bois, Denis; Vallée, Marc; Racine, Marie-Claude; Bonnici, André

2013-02-01

To establish a consensual and coherent ranking of healthcare programmes that involve the presence of ward-based and clinic-based clinical pharmacists, based on health outcome, health costs and safe delivery of care. This descriptive study was derived from a structured dialogue (Delphi technique) among directors of pharmacy department. We established a quantitative profile of healthcare programmes at five sites that involved the provision of ward-based and clinic-based pharmaceutical care. A summary table of evidence established a unique quality rating per inpatient (clinic-based) or outpatient (ward-based) healthcare programme. Each director rated the perceived impact of pharmaceutical care per inpatient or outpatient healthcare programme on three fields: health outcome, health costs and safe delivery of care. They agreed by consensus on the final ranking of healthcare programmes. A ranking was assigned for each of the 18 healthcare programmes for outpatient care and the 17 healthcare programmes for inpatient care involving the presence of pharmacists, based on health outcome, health costs and safe delivery of care. There was a good correlation between ranking based on data from a 2007-2008 Canadian report on hospital pharmacy practice and the ranking proposed by directors of pharmacy department. Given the often limited human and financial resources, managers should consider the best evidence available on a profession's impact to plan healthcare services within an organization. Data are few on ranking healthcare programmes in order to prioritize which healthcare programme would mostly benefit from the delivery of pharmaceutical care by ward-based and clinic-based pharmacists. © 2012 The Authors. IJPP © 2012 Royal Pharmaceutical Society.

Penicillin and beta-lactam allergy: epidemiology and diagnosis.

PubMed

Macy, Eric

2014-11-01

Penicillin is the most common beta-lactam antibiotic allergy and the most common drug class allergy, reported in about 8% of individuals using health care in the USA. Only about 1% of individuals using health care in the USA have a cephalosporin allergy noted in their medical record, and other specific non-penicillin, non-cephalosporin beta-lactam allergies are even rarer. Most reported penicillin allergy is not associated with clinically significant IgE-mediated reactions after penicillin rechallenge. Un-verified penicillin allergy is a significant and growing public health problem. Clinically significant IgE-mediated penicillin allergy can be safely confirmed or refuted using skin testing with penicilloyl-poly-lysine and native penicillin G and, if skin test is negative, an oral amoxicillin challenge. Acute tolerance of an oral therapeutic dose of a penicillin class antibiotic is the current gold standard test for a lack of clinically significant IgE-mediated penicillin allergy. Cephalosporins and other non-penicillin beta-lactams are widely, safely, and appropriately used in individuals, even with confirmed penicillin allergy. There is little, if any, clinically significant immunologic cross-reactivity between penicillins and other beta-lactams. Routine cephalosporin skin testing should be restricted to research settings. It is rarely needed clinically to safely manage patients and has unclear predictive value at this time. The use of alternative cephalosporins, with different side chains, is acceptable in the setting of a specific cephalosporin allergy. Carbapenems and monobactams are also safely used in individuals with confirmed penicillin allergy. A certain predictable, but low, rate of adverse reactions will occur with all beta-lactam antibiotic use both pre- and post-beta-lactam allergy evaluations.

Development of the Huddle Observation Tool for structured case management discussions to improve situation awareness on inpatient clinical wards.

PubMed

Edbrooke-Childs, Julian; Hayes, Jacqueline; Sharples, Evelyn; Gondek, Dawid; Stapley, Emily; Sevdalis, Nick; Lachman, Peter; Deighton, Jessica

2018-05-01

'Situation Awareness For Everyone' (SAFE) was a 3-year project which aimed to improve situation awareness in clinical teams in order to detect potential deterioration and other potential risks to children on hospital wards. The key intervention was the 'huddle', a structured case management discussion which is central to facilitating situation awareness. This study aimed to develop an observational assessment tool to assess the team processes occurring during huddles, including the effectiveness of the huddle. A cross-sectional observational design was used to psychometrically develop the 'Huddle Observation Tool' (HOT) over three phases using standardised psychometric methodology. Huddles were observed across four NHS paediatric wards participating in SAFE by five researchers; two wards within specialist children hospitals and two within district general hospitals, with location, number of beds and length of stay considered to make the sample as heterogeneous as possible. Inter-rater reliability was calculated using the weighted kappa and intraclass correlation coefficient. Inter - rater reliability was acceptable for the collaborative culture (weighted kappa=0.32, 95% CI 0.17 to 0.42), environment items (weighted kappa=0.78, 95% CI 0.52 to 1) and total score (intraclass correlation coefficient=0.87, 95% CI 0.68 to 0.95). It was lower for the structure and risk management items, suggesting that these were more variable in how observers rated them. However, agreement on the global score for huddles was acceptable. We developed an observational assessment tool to assess the team processes occurring during huddles, including the effectiveness of the huddle. Future research should examine whether observational evaluations of huddles are associated with other indicators of safety on clinical wards (eg, safety climate and incidents of patient harm), and whether scores on the HOT are associated with improved situation awareness and reductions in deterioration and adverse events in clinical settings, such as inpatient wards. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Sexual Harassment Training and Reporting in Athletic Training Students

ERIC Educational Resources Information Center

Mansell, Jamie; Moffit, Dani M.; Russ, Anne C.; Thorpe, Justin N.

2017-01-01

Context: Sexual harassment is a growing concern in higher education. Athletic training students should feel safe in their programs, whether in the didactic or clinical setting. Though the Commission on Accreditation of Athletic Training Education creates standards to keep the students safe, there are none regarding sexual harassment training for…

The H2 robotic exoskeleton for gait rehabilitation after stroke: early findings from a clinical study.

PubMed

Bortole, Magdo; Venkatakrishnan, Anusha; Zhu, Fangshi; Moreno, Juan C; Francisco, Gerard E; Pons, Jose L; Contreras-Vidal, Jose L

2015-06-17

Stroke significantly affects thousands of individuals annually, leading to considerable physical impairment and functional disability. Gait is one of the most important activities of daily living affected in stroke survivors. Recent technological developments in powered robotics exoskeletons can create powerful adjunctive tools for rehabilitation and potentially accelerate functional recovery. Here, we present the development and evaluation of a novel lower limb robotic exoskeleton, namely H2 (Technaid S.L., Spain), for gait rehabilitation in stroke survivors. H2 has six actuated joints and is designed to allow intensive overground gait training. An assistive gait control algorithm was developed to create a force field along a desired trajectory, only applying torque when patients deviate from the prescribed movement pattern. The device was evaluated in 3 hemiparetic stroke patients across 4 weeks of training per individual (approximately 12 sessions). The study was approved by the Institutional Review Board at the University of Houston. The main objective of this initial pre-clinical study was to evaluate the safety and usability of the exoskeleton. A Likert scale was used to measure patient's perception about the easy of use of the device. Three stroke patients completed the study. The training was well tolerated and no adverse events occurred. Early findings demonstrate that H2 appears to be safe and easy to use in the participants of this study. The overground training environment employed as a means to enhance active patient engagement proved to be challenging and exciting for patients. These results are promising and encourage future rehabilitation training with a larger cohort of patients. The developed exoskeleton enables longitudinal overground training of walking in hemiparetic patients after stroke. The system is robust and safe when applied to assist a stroke patient performing an overground walking task. Such device opens the opportunity to study means to optimize a rehabilitation treatment that can be customized for individuals. This study was registered at ClinicalTrials.gov ( https://clinicaltrials.gov/show/NCT02114450 ).

Microwave and radiofrequency techniques for clinical hyperthermia.

PubMed Central

Cheung, A. Y.

1982-01-01

Biological and practical constraints on the use of clinical hyperthermia for the management of cancer are discussed. Commonly used electromagnetic techniques for producing clinical hyperthermia are reviewed and compared. Innovative engineering designs leading to the realization of an integrated, safe and reliable clinical hyperthermia system are also presented. PMID:6950753

Health and safety in clinical laboratories in developing countries: safety considerations.

PubMed

Ejilemele, A A; Ojule, A C

2004-01-01

Clinical laboratories are potentially hazardous work areas. Health and safety in clinical laboratories is becoming an increasingly important subject as a result of the emergence of highly infectious diseases such as hepatitis and HIV. This is even more so in developing countries where health and safety have traditionally been regarded as low priority issues, considering the more important health problems confronting the health authorities in these countries. We conducted a literature search using the medical subheadings titles on the INTERNET over a period of twenty years and summarized our findings. This article identifies hazards in the laboratories and highlights measures to make the laboratory a safer work place. It also emphasizes the mandatory obligations of employers and employees towards the attainment of acceptable safety standards in clinical laboratories in Third World countries in the face of the current HIV/AIDS epidemic in many of these developing countries especially in the sub-Saharan Africa while accommodating the increasing work load in these laboratories. Both the employer and the employee have major roles to play in the maintenance of a safe working environment. This can be achieved if measures discussed are incorporated into everyday laboratory practice.

SAFE: SPARQL Federation over RDF Data Cubes with Access Control.

PubMed

Khan, Yasar; Saleem, Muhammad; Mehdi, Muntazir; Hogan, Aidan; Mehmood, Qaiser; Rebholz-Schuhmann, Dietrich; Sahay, Ratnesh

2017-02-01

Several query federation engines have been proposed for accessing public Linked Open Data sources. However, in many domains, resources are sensitive and access to these resources is tightly controlled by stakeholders; consequently, privacy is a major concern when federating queries over such datasets. In the Healthcare and Life Sciences (HCLS) domain real-world datasets contain sensitive statistical information: strict ownership is granted to individuals working in hospitals, research labs, clinical trial organisers, etc. Therefore, the legal and ethical concerns on (i) preserving the anonymity of patients (or clinical subjects); and (ii) respecting data ownership through access control; are key challenges faced by the data analytics community working within the HCLS domain. Likewise statistical data play a key role in the domain, where the RDF Data Cube Vocabulary has been proposed as a standard format to enable the exchange of such data. However, to the best of our knowledge, no existing approach has looked to optimise federated queries over such statistical data. We present SAFE: a query federation engine that enables policy-aware access to sensitive statistical datasets represented as RDF data cubes. SAFE is designed specifically to query statistical RDF data cubes in a distributed setting, where access control is coupled with source selection, user profiles and their access rights. SAFE proposes a join-aware source selection method that avoids wasteful requests to irrelevant and unauthorised data sources. In order to preserve anonymity and enforce stricter access control, SAFE's indexing system does not hold any data instances-it stores only predicates and endpoints. The resulting data summary has a significantly lower index generation time and size compared to existing engines, which allows for faster updates when sources change. We validate the performance of the system with experiments over real-world datasets provided by three clinical organisations as well as legacy linked datasets. We show that SAFE enables granular graph-level access control over distributed clinical RDF data cubes and efficiently reduces the source selection and overall query execution time when compared with general-purpose SPARQL query federation engines in the targeted setting.

Hepatic veno-occlusive disease during chemotherapy for nephroblastoma: successful and safe treatment with defibrotide. Report of a clinical case.

PubMed

Cecinati, Valerio; Giordano, Paola; De Leonardis, Francesco; Grassi, Massimo; Arcamone, Giampaolo; De Mattia, Domenico; Santoro, Nicola

2009-01-01

Here we report a case of administration of defibrotide in an 11 months old infant with hepatic veno-occlusive disease during chemotherapy for nephroblastoma. He presented with abdominal distension, a weight gain of 15%, ascites, hepatomegaly with right upper quadrant pain, thrombocytopenia and hypertransaminasemia. Despite therapy, his clinical conditions aggravated, and, therefore intravenous administration of defibrotide on a compassionate-use basis was started. The dosage was 15 mg/kg/day in 4 divided doses, which was increased gradually (in 3 days) to 40 mg/kg/day in 4 divided doses. Defibrotide proved safe and effective in resolving clinical symptoms and normalizing serological findings in the syndrome.

Research Findings on Xylitol and the Development of Xylitol Vehicles to Address Public Health Needs

PubMed Central

Milgrom, P.; Ly, K.A.; Rothen, M.

2013-01-01

Xylitol has been demonstrated to be a safe and effective tooth decay preventive agent when used habitually. Nevertheless, its application has been limited by absence of formulations that demand minimal adherence and are acceptable and safe in settings where chewing gum may not be allowed. A substantial literature suggests that a minimum of five to six grams and three exposures per day from chewing gum or candies are needed for a clinical effect. At the same time there is conflicting evidence in the literature from toothpaste studies suggesting that lower-doses and less frequent exposures might be effective. The growing use of xylitol as a sweetener in low amounts in foods and other consumables is, simultaneously, increasing the overall exposure of the public to xylitol and may have additive benefits. PMID:19710081

Endovascular Neurosurgery: Personal Experience and Future Perspectives.

PubMed

Raymond, Jean

2016-09-01

From Luessenhop's early clinical experience until the present day, experimental methods have been introduced to make progress in endovascular neurosurgery. A personal historical narrative, spanning the 1980s to 2010s, with a review of past opportunities, current problems, and future perspectives. Although the technology has significantly improved, our clinical culture remains a barrier to methodologically sound and safe innovative care and progress. We must learn how to safely practice endovascular neurosurgery in the presence of uncertainty and verify patient outcomes in real time. Copyright © 2016 Elsevier Inc. All rights reserved.

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.

Food allergy diagnosis and therapy: where are we now?

PubMed Central

Syed, Aleena; Kohli, Arunima; Nadeau, Kari C

2014-01-01

Food allergy is a growing worldwide epidemic that adversely effects up to 10% of the population. Causes and risk factors remain unclear and diagnostic methods are imprecise. There is currently no accepted treatment for food allergy. Therefore, there is an imminent need for greater understanding of food allergies, revised diagnostics and development of safe, effective therapies. Oral immunotherapy provides a particularly promising avenue, but is still highly experimental and not ready for clinical use. PMID:23998729

Novel Androgen Deprivation Therapy (ADT) in the Treatment of Advanced Prostate Cancer.

PubMed

Aragon-Ching, Jeanny B; Dahut, William L

2010-07-01

Androgen deprivation therapy has been the mainstay of treatment for advanced and metastatic prostate cancer. The use of novel agents targeting the androgen receptor and its signaling pathways offers a promising approach that is both safe and effective. We describe the rationale behind the use of these compounds in clinical development and the existing challenges as to how best to incorporate these new and emerging therapies in the changing treatment paradigm of metastatic prostate cancer.

Clinical report—the pediatrician’s role in child maltreatment prevention.

PubMed

Flaherty, Emalee G; Stirling, John

2010-10-01

It is the pediatrician’s role to promote the child’s well-being and to help parents raise healthy, well-adjusted children. Pediatricians, therefore, can play an important role in the prevention of child maltreatment. Previous clinical reports and policy statements from the American Academy of Pediatrics have focused on improving the identification and management of child maltreatment. This clinical report outlines how the pediatrician can help to strengthen families and promote safe, stable, nurturing relationships with the aim of preventing maltreatment. After describing some of the triggers and factors that place children at risk for maltreatment, the report describes how pediatricians can identify family strengths, recognize risk factors, provide helpful guidance, and refer families to programs and other resources with the goal of strengthening families, preventing child maltreatment, and enhancing child development.

Safe corridors for K-wiring in phalangeal fractures.

PubMed

Rex, C; Vignesh, R; Javed, M; Balaji, Subba Chandra; Premanand, C; Zakki, Syed Ashfaque

2015-01-01

Unstable phalangeal fractures are commonly treated with K-wire fixation. Operative fixation must be used judiciously and with the expectation that the ultimate outcome should be better than the outcome after nonoperative management. It is necessary to achieve a stable fracture fixation and early mobilization. In order to achieve this goal, one should closely understand the safe portals/corridors in hand for K-wire entry for fractures of the phalanges. Safe corridors were defined and tested using a pilot cadaveric and a clinical case study by assessing the outcome. In our prospective case series, 50 patients with 64 phalangeal fractures were treated with closed reduction and K-wires were inserted through safe portals identified by a pilot cadaveric study. On table active finger movement test was done and the results were analyed using radiology, disabilities of the arm, shoulder, and hand (DASH) score and total active motion (TAM). In our study, little finger (n = 28) was the most commonly involved digit. In fracture pattern, transverse (n = 20) and spiral (n = 20) types were common. Proximal phalanx (n = 38) was commonly involved and the common site being the base of the phalanx (n = 28). 47 (95%) patients had excellent TAM and the mean postoperative DASH score was 58.05. All patients achieved excellent and good scores proving the importance of the safe corridor concept. K-wiring through the safe corridor has proved to yield the best clinical results because of least tethering of soft tissues as evidenced by performing "on-table active finger movement test" at the time of surgery. We strongly recommend K-wiring through safe portals in all phalangeal fractures.

Infant Choking: How to Keep Your Baby Safe

MedlinePlus

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Exercising with Osteoporosis: Stay Active the Safe Way

MedlinePlus

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Pharmacological intervention of HIV-1 maturation.

PubMed

Wang, Dan; Lu, Wuxun; Li, Feng

2015-11-01

Despite significant advances in antiretroviral therapy, increasing drug resistance and toxicities observed among many of the current approved human immunodeficiency virus (HIV) drugs indicate a need for discovery and development of potent and safe antivirals with a novel mechanism of action. Maturation inhibitors (MIs) represent one such new class of HIV therapies. MIs inhibit a late step in the HIV-1 Gag processing cascade, causing defective core condensation and the release of non-infectious virus particles from infected cells, thus blocking the spread of the infection to new cells. Clinical proof-of-concept for the MIs was established with betulinic acid derived bevirimat, the prototype HIV-1 MI. Despite the discontinuation of its further clinical development in 2010 due to a lack of uniform patient response caused by naturally occurring drug resistance Gag polymorphisms, several second-generation MIs with improved activity against viruses exhibiting Gag polymorphism mediated resistance have been recently discovered and are under clinical evaluation in HIV/AID patients. In this review, current understanding of HIV-1 MIs is described and recent progress made toward elucidating the mechanism of action, target identification and development of second-generation MIs is reviewed.

Reviving Lonidamine and 6-Diazo-5-oxo-L-norleucine to Be Used in Combination for Metabolic Cancer Therapy

PubMed Central

Cervantes-Madrid, Diana; Romero, Yair; Dueñas-González, Alfonso

2015-01-01

Abnormal metabolism is another cancer hallmark. The two most characterized altered metabolic pathways are high rates of glycolysis and glutaminolysis, which are natural targets for cancer therapy. Currently, a number of newer compounds to block glycolysis and glutaminolysis are being developed; nevertheless, lonidamine and 6-diazo-5-oxo-L-norleucine (DON) are two old drugs well characterized as inhibitors of glycolysis and glutaminolysis, respectively, whose clinical development was abandoned years ago when the importance of cancer metabolism was not fully appreciated and clinical trial methodology was less developed. In this review, a PubMed search using the words lonidamine and 6-diazo-5-oxo-L-norleucine (DON) was undertaken to analyse existing information on the preclinical and clinical studies of these drugs for cancer treatment. Data show that they exhibit antitumor effects; besides there is also the suggestion that they are synergistic. We conclude that lonidamine and DON are safe and potentially effective drugs that need to be reevaluated in combination as metabolic therapy of cancer. PMID:26425550

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.

Professional excellence and career advancement in nursing: a conceptual framework for clinical leadership development.

PubMed

Adeniran, Rita Kudirat; Bhattacharya, Anand; Adeniran, Anthony A

2012-01-01

Increasingly, stakeholders in the health care community are recognizing nursing as key to solving the nation's health care issues. This acknowledgment provides a unique opportunity for nursing to demonstrate leadership by developing clinical nurse leaders to collaborate with the multidisciplinary care team in driving evidence-based, safe quality, cost-effective health care services. One approach for nursing success is standardizing the entry-level education for nurses and developing a uniform professional development and career advancement trajectory with appropriate incentives to encourage participation. A framework to guide and provide scientific evidence of how frontline nurses can be engaged will be paramount. The model for professional excellence and career advancement provides a framework that offers a clear path for researchers to examine variables influencing nurses' professional development and career advancement in a systematic manner. Professional Excellence and Career Advancement in Nursing underscores professional preparedness of a registered nurse as central to leadership development. It also describes the elements that influence nurses' participation in professional development and career advancement under 4 main categories emphasizing mentorship and self-efficacy as essential variables.

“Heidelberg standard examination” and “Heidelberg standard procedures” – Development of faculty-wide standards for physical examination techniques and clinical procedures in undergraduate medical education

PubMed Central

Nikendei, C.; Ganschow, P.; Groener, J. B.; Huwendiek, S.; Köchel, A.; Köhl-Hackert, N.; Pjontek, R.; Rodrian, J.; Scheibe, F.; Stadler, A.-K.; Steiner, T.; Stiepak, J.; Tabatabai, J.; Utz, A.; Kadmon, M.

2016-01-01

The competent physical examination of patients and the safe and professional implementation of clinical procedures constitute essential components of medical practice in nearly all areas of medicine. The central objective of the projects “Heidelberg standard examination” and “Heidelberg standard procedures”, which were initiated by students, was to establish uniform interdisciplinary standards for physical examination and clinical procedures, and to distribute them in coordination with all clinical disciplines at the Heidelberg University Hospital. The presented project report illuminates the background of the initiative and its methodological implementation. Moreover, it describes the multimedia documentation in the form of pocketbooks and a multimedia internet-based platform, as well as the integration into the curriculum. The project presentation aims to provide orientation and action guidelines to facilitate similar processes in other faculties. PMID:27579354

Is Ear Candling a Safe Way to Remove Earwax?

MedlinePlus

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An elective course on the basic and clinical sciences aspects of vitamins and minerals.

PubMed

Islam, Mohammed A

2013-02-12

Objective. To develop and implement an elective course on vitamins and minerals and their usefulness as dietary supplements. Design. A 2-credit-hour elective course designed to provide students with the most up-to-date basic and clinical science information on vitamins and minerals was developed and implemented in the doctor of pharmacy (PharmD) curriculum. In addition to classroom lectures, an active-learning component was incorporated in the course in the form of group discussion. Assessment. Student learning was demonstrated by examination scores. Performance on pre- and post-course surveys administered in 2011 demonstrated a significant increase in students' knowledge of the basic and clinical science aspects of vitamins and minerals, with average scores increasing from 61% to 86%. At the end of the semester, students completed a standard course evaluation. Conclusion. An elective course on vitamin and mineral supplements was well received by pharmacy students and helped them to acquire knowledge and competence in patient counseling regarding safe, appropriate, effective, and economical use of these products.

Development of Novel Faster-Dissolving Microneedle Patches for Transcutaneous Vaccine Delivery

PubMed Central

Ono, Akihiko; Ito, Sayami; Sakagami, Shun; Saito, Mio; Quan, Ying-Shu; Kamiyama, Fumio; Hirobe, Sachiko; Okada, Naoki

2017-01-01

Microneedle (MN) patches are promising for transcutaneous vaccination because they enable vaccine antigens to physically penetrate the stratum corneum via low-invasive skin puncturing, and to be effectively delivered to antigen-presenting cells in the skin. In second-generation MN patches, the dissolving MNs release the loaded vaccine antigen into the skin. To shorten skin application time for clinical practice, this study aims to develop novel faster-dissolving MNs. We designed two types of MNs made from a single thickening agent, carboxymethylcellulose (CMC) or hyaluronan (HN). Both CMC-MN and HN-MN completely dissolved in rat skin after a 5-min application. In pre-clinical studies, both MNs could demonstrably increase antigen-specific IgG levels after vaccination and prolong antigen deposition compared with conventional injections, and deliver antigens into resected human dermal tissue. In clinical research, we demonstrated that both MNs could reliably and safely puncture human skin without any significant skin irritation from transepidermal water loss measurements and ICDRG (International Contact Dermatitis Research Group) evaluation results. PMID:28771172

Convection-Enhanced Delivery.

PubMed

Mehta, A M; Sonabend, A M; Bruce, J N

2017-04-01

Convection-enhanced delivery (CED) is a promising technique that generates a pressure gradient at the tip of an infusion catheter to deliver therapeutics directly through the interstitial spaces of the central nervous system. It addresses and offers solutions to many limitations of conventional techniques, allowing for delivery past the blood-brain barrier in a targeted and safe manner that can achieve therapeutic drug concentrations. CED is a broadly applicable technique that can be used to deliver a variety of therapeutic compounds for a diversity of diseases, including malignant gliomas, Parkinson's disease, and Alzheimer's disease. While a number of technological advances have been made since its development in the early 1990s, clinical trials with CED have been largely unsuccessful, and have illuminated a number of parameters that still need to be addressed for successful clinical application. This review addresses the physical principles behind CED, limitations in the technique, as well as means to overcome these limitations, clinical trials that have been performed, and future developments.

Design and development of a sensorized wireless toy for measuring infants' manual actions.

PubMed

Serio, Stefano Marco; Cecchi, Francesca; Assaf, Tareq; Laschi, Cecilia; Dario, Paolo

2013-05-01

The development of grasping is an important milestone that infants encounter during the first months of life. Novel approaches for measuring infants' manual actions are based on sensorized platform usable in natural settings, such as instrumented wireless toys that could be exploited for diagnosis and rehabilitation purposes. A new sensorized wireless toy has been designed and developed with embedded pressure sensors and audio-visual feedback. The fulfillment of clinical specifications has been proved through mechanical and electrical characterization. Infants showed a good grade of acceptance to such kind of tools, as confirmed by the results of preliminary tests that involved nine healthy infants: the dimensions fulfill infants' anthropometrics, the device is robust and safe, the acquired signals are in the expected range and the wireless communication is stable. Although achieved only through preliminary tests, such results confirm the hypothesis that this typology of instrumented toys could be useful for quantitative monitoring and measuring infants' motor development and ready to be evaluated for assessing motor skills through appropriate clinical trials.

Zika vaccines and therapeutics: landscape analysis and challenges ahead.

PubMed

Wilder-Smith, Annelies; Vannice, Kirsten; Durbin, Anna; Hombach, Joachim; Thomas, Stephen J; Thevarjan, Irani; Simmons, Cameron P

2018-06-06

Various Zika virus (ZIKV) vaccine candidates are currently in development. Nevertheless, unique challenges in clinical development and regulatory pathways may hinder the licensure of high-quality, safe, and effective ZIKV vaccines. Implementing phase 3 efficacy trials will be difficult given the challenges of the spatio-temporal heterogeneity of ZIKV transmission, the unpredictability of ZIKV epidemics, the broad spectrum of clinical manifestations making a single definite endpoint difficult, a lack of sensitive and specific diagnostic assays, and the need for inclusion of vulnerable target populations. In addition to a vaccine, drugs for primary prophylaxis, post-exposure prophylaxis, or treatment should also be developed to prevent or mitigate the severity of congenital Zika syndrome. Establishing the feasibility of immune correlates and/or surrogates are a priority. Given the challenges in conducting phase 3 trials at a time of waning incidence, human challenge trials should be considered to evaluate efficacy. Continued financial support and engagement of industry partners will be essential to the successful development, licensure, and accessibility of Zika vaccines or therapeutics.

The utility of ductal lavage in breast cancer detection and risk assessment

PubMed Central

Domchek, Susan M

2002-01-01

Ductal lavage (DL) permits noninvasive retrieval of epithelial cells from the breast. Clinical development of this technique has been fueled largely by its potential, as yet unproven, to improve detection of breast cancer and definition of individual risk for development of breast cancer. Early studies demonstrate the feasibility of performing this technique, provide data on cellular yield and findings, and demonstrate the ability to measure molecular markers in DL fluid. However, the sensitivity and specificity of DL for the detection of breast cancer remains unknown, as does the significance of atypia, particularly mild atypia, when found in DL fluid. Although DL appears safe and the device is approved by the US Food and Drug Administration, DL is still best utilized in the setting of clinical trials designed to resolve issues of sensitivity, specificity, and localization. PMID:11879562

Five un-easy pieces of pharmaceutical policy reform.

PubMed

Rodwin, Marc A

2013-01-01

Improper dependencies slant policy over a drug's life span, biasing the development of new drugs, the testing and marketing approval for new drugs, and the monitoring of patient safety after drugs are marketed. This article examines five ways in which the public improperly depends on pharmaceutical firms that compromise the integrity of pharmaceutical policy. Today the public relies on pharmaceutical firms: (1) to set priorities on drug research and development; (2) to conduct clinical trials to test whether drugs are safe and effective; (3) to decide what clinical trial data to disclose to the public; (4) to monitor post marketing drug safety; (5) to supply product information to physicians and to finance continuing medical education and other professional activities. The article suggests options to overcome each of these dependencies. © 2013 American Society of Law, Medicine & Ethics, Inc.

Clinical trials in neonates and children: Report of the pulmonary hypertension academic research consortium pediatric advisory committee

PubMed Central

Adatia, Ian; Haworth, Sheila G.; Wegner, Max; Barst, Robyn J.; Ivy, Dunbar; Stenmark, Kurt R.; Karkowsky, Abraham; Rosenzweig, Erika; Aguilar, Christopher

2013-01-01

Drug trials in neonates and children with pulmonary hypertensive vascular disease pose unique but not insurmountable challenges. Childhood is defined by growth and development. Both may influence disease and outcomes of drug trials. The developing pulmonary vascular bed and airways may be subjected to maldevelopment, maladaptation, growth arrest, or dysregulation that influence the disease phenotype. Drug therapy is influenced by developmental changes in renal and hepatic blood flow, as well as in metabolic systems such as cytochrome P450. Drugs may affect children differently from adults, with different clearance, therapeutic levels and toxicities. Toxicity may not be manifested until the child reaches physical, endocrine and neurodevelopmental maturity. Adverse effects may be revealed in the next generation, should the development of ova or spermatozoa be affected. Consideration of safe, age-appropriate tablets and liquid formulations is an obvious but often neglected prerequisite to any pediatric drug trial. In designing a clinical trial, precise phenotyping and genotyping of disease is required to ensure appropriate and accurate inclusion and exclusion criteria. We need to explore physiologically based pharmacokinetic modeling and simulations together with statistical techniques to reduce sample size requirements. Clinical endpoints such as exercise capacity, using traditional classifications and testing cannot be applied routinely to children. Many lack the necessary neurodevelopmental skills and equipment may not be appropriate for use in children. Selection of endpoints appropriate to encompass the developmental spectrum from neonate to adolescent is particularly challenging. One possible solution is the development of composite outcome scores that include age and a developmentally specific functional classification, growth and development scores, exercise data, biomarkers and hemodynamics with repeated evaluation throughout the period of growth and development. In addition, although potentially costly, we recommend long-term continuation of blinded dose ranging after completion of the short-term, double-blind, placebo-controlled trial for side-effect surveillance, which should include neurodevelopmental and peripubertal monitoring. The search for robust evidence to guide safe therapy of children and neonates with pulmonary hypertensive vascular disease is a crucial and necessary goal. PMID:23662203

The Development and Application of Airway Devices in China

PubMed Central

Chen, Xiangdong; Ma, Wuhua; Liu, Renyu; Yao, Shanglong

2017-01-01

Airway management is one of the most important tasks for anesthesiologists. Anesthesiologists are experts in airway management and have made tremendous contribution to the development of the airway devices. Chinese anesthesiologists have made significant contribution in introducing advanced airway management and developing innovative techniques and devices for airway management in China. This article overviews the development and application of airway devices in China as well as the dedication and contribution of Chinese experts in the development of novel airway devices. With the development of science and technology accompanied by the advanced knowledge in airway management, more effective and safe artificial airways will be developed for clinical practice. The authors believe that Chinese experts will continue their outstanding contribution to the development of innovative airway devices, systems and knowledge. PMID:28191485

Amorphous Silica Based Nanomedicine with Safe Carrier Excretion and Enhanced Drug Efficacy

NASA Astrophysics Data System (ADS)

Zhang, Silu

With recent development of nanoscience and nanotechnology, a great amount of efforts have been devoted to nanomedicine development. Among various nanomaterials, silica nanoparticle (NP) is generally accepted as non-toxic, and can provide a versatile platform for drug loading. In addition, the surface of the silica NP is hydrophilic, being favorable for cellular uptake. Therefore, it is considered as one of the most promising candidates to serve as carriers for drugs. The present thesis mainly focuses on the design of silica based nanocarrier-drug systems, aiming at achieving safe nanocarrier excretion from the biological system and enhanced drug efficacy, which two are considered as most important issues in nanomedicine development. To address the safe carrier excretion issue, we have developed a special type of selfdecomposable SiO2-drug composite NPs. By creating a radial concentration gradient of drug in the NP, the drug release occurred simultaneously with the silica carrier decomposition. Such unique characteristic was different from the conventional dense SiO2-drug NP, in which drug was uniformly distributed and can hardly escape the carrier. We found that the controllable release of the drug was primarily determined by diffusion, which was caused by the radial drug concentration gradient in the NP. Escape of the drug molecules then triggered the silica carrier decomposition, which started from the center of the NP and eventually led to its complete fragmentation. The small size of the final carrier fragments enabled their easy excretion via renal systems. Apart from the feature of safe carrier excretion, we also found the controlled release of drugs contribute significantly to the drug efficacy enhancement. By loading an anticancer drug doxorubicin (Dox) to the decomposable SiO 2-methylene blue (MB) NPs, we achieved a self-decomposable SiO 2(MB)-Dox nanomedicine. The gradual escape of drug molecules from NPs and their enabled cytosolic release by optical switch, led to not only high but also stable drug concentration in cytosol within a sustained period. This resulted in enhanced drug efficacy, which is especially manifested in multidrug resistant (MDR) cancer cells, due to the fact that the NP-carrier drug can efficiently bypass the efflux mechanisms and increase drug availability. Together with its feature of spontaneous carrier decomposition and safe excretion, this type of nanomedicine's high drug efficacy highlights its potential for low dose anticancer drug treatment and reduced adverse effect to biological system, holding great promise for clinical translation. The enhanced drug efficacy by employing the self-decomposable silica nanocarrier is also demonstrated in photodynamic therapy (PDT). The loose and fragmentable features of the self-decomposable SiO2-photosensitizer (PS) NPs promoted the outdiffusion of the generated ROS, which resulted in a higher efficacy than that of dense SiO2-PS NPs. On the other hand, we also explored another nanocarrier configuration of Au nanorods decorated SiO2 NP, with PS drug embedded into dense SiO2 matrix. A different mechanism of drug efficacy enhancement was presented as the Au's surface plasmon resonance enhanced the ROS production. Although the drug efficacy of such SiO2(PS)-Au NPs was similar to that of self-decomposable SiO2-PS NPs, their potential for clinical applications was limited without the feature of safe carrier excretion. In summary, the self-decomposable SiO2 based NP developed is a most promising system to serve as safe and effective carriers for drugs. Together with the known biocompatibility of silica, the feature of controllable drug release and simultaneous carrier decomposition achieved in the self-decomposable SiO2-drug NPs make it ideal for a wide range of therapeutic applications.

A national cross-sectional study on effects of fluoride-safe water supply on the prevalence of fluorosis in China

PubMed Central

Wang, Cheng; Gao, Yanhui; Wang, Wei; Zhao, Lijun; Zhang, Wei; Han, Hepeng; Shi, Yuxia; Yu, Guangqian; Sun, Dianjun

2012-01-01

Objective To assess the effects of provided fluoride-safe drinking-water for the prevention and control of endemic fluorosis in China. Design A national cross-sectional study in China. Setting In 1985, randomly selected villages in 27 provinces (or cities and municipalities) in 5 geographic areas all over China. Participants Involved 81 786 children aged from 8 to 12 and 594 698 adults aged over 16. Main outcome measure The prevalence of dental fluorosis and clinical skeletal fluorosis, the fluoride concentrations in the drinking-water in study villages and in the urine of subjects. Results The study showed that in the villages where the drinking-water fluoride concentrations were higher than the government standard of 1.2 mg/l, but no fluoride-safe drinking-water supply scheme was provided (FNB areas), the prevalence rate and index of dental fluorosis in children, and prevalence rate of clinical skeletal fluorosis in adults were all significantly higher than those in the historical endemic fluorosis villages after the fluoride-safe drinking-water were provided (FSB areas). Additionally, the prevalence rate of dental fluorosis as well as clinical skeletal fluorosis, and the concentration of fluoride in urine were found increased with the increase of fluoride concentration in drinking-water, with significant positive correlations in the FNB areas. While, the prevalence rate of dental fluorosis and clinical skeletal fluorosis in different age groups and their degrees of prevalence were significantly lower in the FSB areas than those in the FNB areas. Conclusions The provision of fluoride-safe drinking-water supply schemes had significant effects on the prevention and control of dental fluorosis and skeletal fluorosis. The study also indicated that the dental and skeletal fluorosis is still prevailing in the high-fluoride drinking-water areas in China. PMID:23015601

NLX-P101, an adeno-associated virus gene therapy encoding glutamic acid decarboxylase, for the potential treatment of Parkinson's disease.

PubMed

Diaz-Nido, Javier

2010-07-01

Parkinson's disease (PD) is a neurodegenerative disease affecting nigrostriatal dopaminergic neurons. Dopamine depletion in the striatum leads to functional changes in several deep brain nuclei, including the subthalamic nucleus (STN), which becomes disinhibited and perturbs the control of body movement. Although there is no cure for PD, some pharmacological and surgical treatments can significantly improve the functional ability of patients, particularly in the early stages of the disease. Among neurodegenerative diseases, PD is a particularly suitable target for gene therapy because the neuropathology is largely confined to a relatively small region of the brain. Neurologix Inc is developing NLX-P101 (AAV2-GAD), an adeno-associated viral vector encoding glutamic acid decarboxylase (GAD), for the potential therapy of PD. As GAD potentiates inhibitory neurotransmission from the STN, sustained expression of GAD in the STN by direct delivery of NLX-P101 decreases STN overactivation. This procedure was demonstrated to be a safe and efficient method of reducing motor deficits in animal models of PD. A phase I clinical trial has demonstrated that NLX-P101 was safe and indicated the efficacy of this approach in patients with PD. Results from an ongoing phase II clinical trial of NLX-P101 are awaited to establish the clinical efficacy of this gene therapy.

Investigational Notch and Hedgehog Inhibitors – Therapies for Cardiovascular disease

PubMed Central

Redmond, EM; Guha, S; Walls, D; Cahill, PA

2011-01-01

Importance to the field During the past decade a variety of Notch and Hedgehog pathway inhibitors have been developed for the treatment of several cancers. An emerging paradigm suggests that these same gene regulatory networks are often recapitulated in the context of cardiovascular disease and may now offer an attractive target for therapeutic intervention. Areas Covered This article briefly reviews the profile of Notch and Hedgehog inhibitors that have reached the pre-clinic and clinic for cancer treatment and discusses the clinical issues surrounding targeted use of these inhibitors in the treatment of vascular disorders. Expert Opinion Pre-clinical and clinical data using pan-Notch inhibitors (γ-secretase inhibitors) and selective antibodies to preferentially target notch receptors and ligands has proven successful but concerns remain over normal organ homeostasis and significant pathology in multiple organs. In contrast, the Hedgehog based drug pipeline is rich with more than a dozen Smoothened (SMO) inhibitors at various stages of development. Overall, refined strategies will be necessary to harness these pathways safely as a powerful tool to disrupt angiogenesis and vascular proliferative phenomena without causing prohibitive side effects already seen with cancer models and patients. PMID:22007748

Drugs for solid cancer: the productivity crisis prompts a rethink

PubMed Central

Rösel, Daniel; Brábek, Jan; Veselý, Pavel; Fernandes, Michael

2013-01-01

Despite remarkable progress in cancer-drug discovery, the delivery of novel, safe, and sustainably effective products to the clinic has stalled. Using Src as a model, we examine key steps in drug development. The preclinical evidence on the relationship between Src and solid cancer is in sharp contrast with the modest anticancer effect noted in conventional clinical trials. Here, we consider Src inhibitors as an example of a promising drug class directed to invasion and metastasis and identify roadblocks in translation. We question the assumption that a drug-induced tumor shrinkage in preclinical and clinical studies predicts a successful outcome. Our analysis indicates that the key areas requiring attention are related, and include preclinical models (in vitro and mouse models), meaningful clinical trial end points, and an appreciation of the role of metastasis in morbidity and mortality. Current regulations do not reflect the natural history of the disease, and may be unrelated to the key complications: local invasion, metastasis, and the development of resistance. Alignment of preclinical and clinical studies and regulations based on mechanistic trial end points and platforms may help in overcoming these roadblocks. Viewed kaleidoscopically, most elements necessary and sufficient for a novel translational paradigm are in place. PMID:23836990

New treatment options in the management of hypertension: appraising the potential role of azilsartan medoxomil

PubMed Central

Volpe, Massimo; Savoia, Carmine

2012-01-01

Renin–angiotensin–system (RAS) activation plays a key role in the development of hypertension and cardiovascular disease. Drugs that antagonize the RAS (angiotensin-converting enzyme [ACE] inhibitors and angiotensin receptor blockers [ARBs]) have proven clinical efficacy in reducing blood pressure values and cardiovascular morbidity and mortality. ACE inhibitors partially inhibit plasma ACE, and angiotensin II generation. Thus, ARBs, which block selectively type 1 angiotensin II receptor (AT1R), have been developed and used in the clinical management of hypertension and cardiovascular disease. Experimental and clinical trials with ARBs indicate that this class of drug represents an effective, safe and well tolerated therapeutic option for the prevention and care of hypertension, even though there is no proven superiority as compared to ACE inhibitors except for the better tolerability. Most ARBs may not completely inhibit the AT1R at the approved clinical doses. Azilsartan medoxomil is a newly approved ARB for the management of hypertension. This ARB induces a potent and long-lasting antihypertensive effect and may have cardioprotective properties. This article reviews the current evidence on the clinical effectiveness of azilsartan in hypertension. PMID:22457601

[Hyperhydrosis update].

PubMed

Callejas, M A; Grimalt, R; Cladellas, E

2010-03-01

Nearly 3% of the population has hyperhidrosis. Quality of life is affected, impacting on social relationships and professional activity, and social anxiety disorder can sometime develop. We review the definition and causes of hyperhidrosis and the clinical evaluation of patients. After describing the different clinical aspects of the condition, we discuss the medical and surgical treatments. Of such treatments currently available, particular mention is made of the use of botulinum toxin in some forms of hyperhidrosis as an intermediate option between the traditional treatments and surgery. We also draw attention to the use of minimal access surgical techniques (videothoracoscopy), which, over the past decade, have become established as an effective, safe, and permanent approach for the treatment of hyperhidrosis when indicated.

Management of Anterior Cruciate Ligament Injury: What's In and What's Out?

PubMed Central

Raines, Benjamin Todd; Naclerio, Emily; Sherman, Seth L

2017-01-01

Sports medicine physicians have a keen clinical and research interest in the anterior cruciate ligament (ACL). The biomechanical, biologic, and clinical data researchers generate, help drive injury management and prevention practices globally. The current concepts in ACL injury and surgery are being shaped by technological advances, expansion in basic science research, resurging interest in ACL preservation, and expanding efforts regarding injury prevention. As new methods are being developed in this field, the primary goal of safely improving patient outcomes will be a unifying principle. With this review, we provide an overview of topics currently in controversy or debate, and we identify paradigm shifts in the understanding, management, and prevention of ACL tears. PMID:28966380

Complementary and Alternative Medicine and Osteoarthritis.

PubMed

Wang, Chenchen

2013-01-01

Patients with osteoarthritis experience high levels of pain, psychological distress and have limited therapeutic options. Emerging evidence from clinical trials suggests that both acupuncture and Tai Chi mind-body therapies are safe and effective treatments for osteoarthritis. Acupuncture has effects over and above those of 'sham acupuncture' and the most robust evidence to date demonstrates that acupuncture does have short-term benefits and is a reasonable referral option for patients with symptomatic osteoarthritis. Tai Chi is a mind-body exercise that enhances cardiovascular fitness, muscular strength, balance, and physical function. It also appears to be associated with reduced stress and anxiety and depression, as well as improved quality of life. Thus, Tai Chi may be safely recommended to patients with osteoarthritis as a complementary and alternative medical approach to affect patient well-being. Integrative approaches combine the best of conventional medicine and complementary and alternative medicine to ultimately improve patient care. These modalities may lead to the development of better disease modifying strategies that could improve symptoms and decrease the progression of osteoarthritis. This overview synthesizes the current body of knowledge about Chinese mind-body medicine to better inform clinical decision-making for our rheumatic patients.

Development of Polysorbate 80/Phospholipid mixed micellar formation for docetaxel and assessment of its in vivo distribution in animal models

NASA Astrophysics Data System (ADS)

Song, Hua; Geng, Hongquan; Ruan, Jing; Wang, Kan; Bao, Chenchen; Wang, Juan; Peng, Xia; Zhang, Xueqing; Cui, Daxiang

2011-04-01

Docetaxel (DTX) is a very important member of taxoid family. Despite several alternative delivery systems reported recently, DTX formulated by Polysorbate 80 and alcohol (Taxotere®) is still the most frequent administration in clinical practice. In this study, we incorporated DTX into Polysorbate 80/Phospholipid mixed micelles and compared its structural characteristics, pharmacokinetics, biodistribution, and blood compatibility with its conventional counterparts. Results showed that the mixed micelles loaded DTX possessed a mean size of approximately 13 nm with narrow size distribution and a rod-like micelle shape. In the pharmacokinetics assessment, there was no significant difference between the two preparations ( P > 0.05), which demonstrated that the DTX in the two preparations may share a similar pharmacokinetic process. However, the Polysorbate 80/Phospholipid mixed micelles can increase the drug residence amount of DTX in kidney, spleen, ovary and uterus, heart, and liver. The blood compatibility assessment study revealed that the mixed micelles were safe for intravenous injection. In conclusion, Polysorbate 80/Phospholipid mixed micelle is safe, can improve the tumor therapeutic effects of DTX in the chosen organs, and may be a potential alternative dosage form for clinical intravenous administration of DTX.

In-Human Robot-Assisted Retinal Vein Cannulation, A World First.

PubMed

Gijbels, Andy; Smits, Jonas; Schoevaerdts, Laurent; Willekens, Koen; Vander Poorten, Emmanuel B; Stalmans, Peter; Reynaerts, Dominiek

2018-05-24

Retinal Vein Occlusion (RVO) is a blinding disease caused by one or more occluded retinal veins. Current treatment methods only focus on symptom mitigation rather than targeting a solution for the root cause of the disorder. Retinal vein cannulation is an experimental eye surgical procedure which could potentially cure RVO. Its goal is to dissolve the occlusion by injecting an anticoagulant directly into the blocked vein. Given the scale and the fragility of retinal veins on one end and surgeons' limited positioning precision on the other, performing this procedure manually is considered to be too risky. The authors have been developing robotic devices and instruments to assist surgeons in performing this therapy in a safe and successful manner. This work reports on the clinical translation of the technology, resulting in the world-first in-human robot-assisted retinal vein cannulation. Four RVO patients have been treated with the technology in the context of a phase I clinical trial. The results show that it is technically feasible to safely inject an anticoagulant into a [Formula: see text]-thick retinal vein of an RVO patient for a period of 10 min with the aid of the presented robotic technology and instrumentation.

Effectiveness of short-term, enhanced, infection control support in improving compliance with infection control guidelines and practice in nursing homes: a cluster randomized trial.

PubMed

Gopal Rao, G; Jeanes, A; Russell, H; Wilson, D; Atere-Roberts, E; O'Sullivan, D; Donaldson, N

2009-10-01

In this prospective cluster randomized controlled trial we evaluated the impact of short-term provision of enhanced infection control support on infection control practice in nursing homes in South London. Twelve nursing homes were recruited, six each in intervention (300 residents) and control (265 residents) groups. Baseline observations of hand hygiene facilities, environmental cleanliness and safe disposal of clinical waste showed poor compliance in both groups. Post-intervention observations showed improvement in both groups. There was no statistical difference between the two groups in the compliance for hand hygiene facilities (P=0.69); environmental cleanliness (P=0.43) and safe disposal of clinical waste (P=0.96). In both groups, greatest improvement was in compliance with safe disposal of clinical waste and the least improvement was in hand hygiene facilities. Since infection control practice improved in intervention and control groups, we could not demonstrate that provision of short-term, enhanced, infection control support in nursing homes had a significant impact in infection control practice.

Driving Safety after Spinal Surgery: A Systematic Review

PubMed Central

Alkhalili, Kenan; Hannallah, Jack; Ibeche, Bashar; Bajammal, Sohail; Baco, Abdul Moeen

2017-01-01

This study aimed to assess driving reaction times (DRTs) after spinal surgery to establish a timeframe for safe resumption of driving by the patient postoperatively. The MEDLINE and Google Scholar databases were analyzed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) Statement for clinical studies that investigated changes in DRTs following cervical and lumbar spinal surgery. Changes in DRTs and patients' clinical presentation, pathology, anatomical level affected, number of spinal levels involved, type of intervention, pain level, and driving skills were assessed. The literature search identified 12 studies that investigated postoperative DRTs. Six studies met the inclusion criteria; five studies assessed changes in DRT after lumbar spine surgery and two studies after cervical spina surgery. The spinal procedures were selective nerve root block, anterior cervical discectomy and fusion, and lumbar fusion and/ordecompression. DRTs exhibited variable responses to spinal surgery and depended on the patients' clinical presentation, spinal level involved, and type of procedure performed. The evidence regarding the patients' ability to resume safe driving after spinal surgery is scarce. Normalization of DRT or a return of DRT to pre-spinal intervention level is a widely accepted indicator for safe driving, with variable levels of statistical significance owing to multiple confounding factors. Considerations of the type of spinal intervention, pain level, opioid consumption, and cognitive function should be factored in the assessment of a patient's ability to safely resume driving. PMID:28443178

Driving Safety after Spinal Surgery: A Systematic Review.

PubMed

Alhammoud, Abduljabbar; Alkhalili, Kenan; Hannallah, Jack; Ibeche, Bashar; Bajammal, Sohail; Baco, Abdul Moeen

2017-04-01

This study aimed to assess driving reaction times (DRTs) after spinal surgery to establish a timeframe for safe resumption of driving by the patient postoperatively. The MEDLINE and Google Scholar databases were analyzed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) Statement for clinical studies that investigated changes in DRTs following cervical and lumbar spinal surgery. Changes in DRTs and patients' clinical presentation, pathology, anatomical level affected, number of spinal levels involved, type of intervention, pain level, and driving skills were assessed. The literature search identified 12 studies that investigated postoperative DRTs. Six studies met the inclusion criteria; five studies assessed changes in DRT after lumbar spine surgery and two studies after cervical spina surgery. The spinal procedures were selective nerve root block, anterior cervical discectomy and fusion, and lumbar fusion and/ordecompression. DRTs exhibited variable responses to spinal surgery and depended on the patients' clinical presentation, spinal level involved, and type of procedure performed. The evidence regarding the patients' ability to resume safe driving after spinal surgery is scarce. Normalization of DRT or a return of DRT to pre-spinal intervention level is a widely accepted indicator for safe driving, with variable levels of statistical significance owing to multiple confounding factors. Considerations of the type of spinal intervention, pain level, opioid consumption, and cognitive function should be factored in the assessment of a patient's ability to safely resume driving.

Clinical software development for the Web: lessons learned from the BOADICEA project

PubMed Central

2012-01-01

Background In the past 20 years, society has witnessed the following landmark scientific advances: (i) the sequencing of the human genome, (ii) the distribution of software by the open source movement, and (iii) the invention of the World Wide Web. Together, these advances have provided a new impetus for clinical software development: developers now translate the products of human genomic research into clinical software tools; they use open-source programs to build them; and they use the Web to deliver them. Whilst this open-source component-based approach has undoubtedly made clinical software development easier, clinical software projects are still hampered by problems that traditionally accompany the software process. This study describes the development of the BOADICEA Web Application, a computer program used by clinical geneticists to assess risks to patients with a family history of breast and ovarian cancer. The key challenge of the BOADICEA Web Application project was to deliver a program that was safe, secure and easy for healthcare professionals to use. We focus on the software process, problems faced, and lessons learned. Our key objectives are: (i) to highlight key clinical software development issues; (ii) to demonstrate how software engineering tools and techniques can facilitate clinical software development for the benefit of individuals who lack software engineering expertise; and (iii) to provide a clinical software development case report that can be used as a basis for discussion at the start of future projects. Results We developed the BOADICEA Web Application using an evolutionary software process. Our approach to Web implementation was conservative and we used conventional software engineering tools and techniques. The principal software development activities were: requirements, design, implementation, testing, documentation and maintenance. The BOADICEA Web Application has now been widely adopted by clinical geneticists and researchers. BOADICEA Web Application version 1 was released for general use in November 2007. By May 2010, we had > 1200 registered users based in the UK, USA, Canada, South America, Europe, Africa, Middle East, SE Asia, Australia and New Zealand. Conclusions We found that an evolutionary software process was effective when we developed the BOADICEA Web Application. The key clinical software development issues identified during the BOADICEA Web Application project were: software reliability, Web security, clinical data protection and user feedback. PMID:22490389

Clinical software development for the Web: lessons learned from the BOADICEA project.

PubMed

Cunningham, Alex P; Antoniou, Antonis C; Easton, Douglas F

2012-04-10

In the past 20 years, society has witnessed the following landmark scientific advances: (i) the sequencing of the human genome, (ii) the distribution of software by the open source movement, and (iii) the invention of the World Wide Web. Together, these advances have provided a new impetus for clinical software development: developers now translate the products of human genomic research into clinical software tools; they use open-source programs to build them; and they use the Web to deliver them. Whilst this open-source component-based approach has undoubtedly made clinical software development easier, clinical software projects are still hampered by problems that traditionally accompany the software process. This study describes the development of the BOADICEA Web Application, a computer program used by clinical geneticists to assess risks to patients with a family history of breast and ovarian cancer. The key challenge of the BOADICEA Web Application project was to deliver a program that was safe, secure and easy for healthcare professionals to use. We focus on the software process, problems faced, and lessons learned. Our key objectives are: (i) to highlight key clinical software development issues; (ii) to demonstrate how software engineering tools and techniques can facilitate clinical software development for the benefit of individuals who lack software engineering expertise; and (iii) to provide a clinical software development case report that can be used as a basis for discussion at the start of future projects. We developed the BOADICEA Web Application using an evolutionary software process. Our approach to Web implementation was conservative and we used conventional software engineering tools and techniques. The principal software development activities were: requirements, design, implementation, testing, documentation and maintenance. The BOADICEA Web Application has now been widely adopted by clinical geneticists and researchers. BOADICEA Web Application version 1 was released for general use in November 2007. By May 2010, we had > 1200 registered users based in the UK, USA, Canada, South America, Europe, Africa, Middle East, SE Asia, Australia and New Zealand. We found that an evolutionary software process was effective when we developed the BOADICEA Web Application. The key clinical software development issues identified during the BOADICEA Web Application project were: software reliability, Web security, clinical data protection and user feedback.

Cellular Therapies Clinical Research Roadmap: Lessons learned on how to move a cellular therapy into a clinical trial

PubMed Central

Ouseph, Stacy; Tappitake, Darah; Armant, Myriam; Wesselschmidt, Robin; Derecho, Ivy; Draxler, Rebecca; Wood, Deborah; Centanni, John M.

2014-01-01

A clinical research roadmap has been developed as a resource for researchers to identify critical areas and potential pitfalls when transitioning a cellular therapy product from the research laboratory, via and Investigational New Drug (IND) application, into early phase clinical trials. The roadmap describes four key areas; basic and preclinical research, resource development, translational research and good manufacturing practice (GMP), and IND assembly and submission. Basic and preclinical research identifies a new therapeutic concept and demonstrates its potential value using a model of the relevant disease. During resource development the appropriate specialists and the required expertise to bring this product into the clinic are identified (e.g., researchers, regulatory specialists, GMP manufacturing staff, clinicians, and clinical trials staff, etc.). Additionally, the funds required to achieve this goal (or a plan to procure them) are identified. In the next phase the plan to translate the research product into a clinical grade therapeutic is developed. Finally regulatory approval to start the trial must be obtained. In the United States this is done by filing an IND application with the Food and Drug Administration. The NHLBI-funded Production Assistance for Cellular Therapies (PACT) program has facilitated the transition of a variety of cellular therapy products from the laboratory into Phase1/2 trials. The five PACT facilities have assisted investigators by performing translational studies and GMP manufacturing to ensure that cellular products met release specifications and were manufactured safely, reproducibly, and at the appropriate scale. The roadmap resulting from this experience is the focus of this article. PMID:25484311

Novel Androgen Deprivation Therapy (ADT) in the Treatment of Advanced Prostate Cancer

PubMed Central

Aragon-Ching, Jeanny B.; Dahut, William L.

2011-01-01

Androgen deprivation therapy has been the mainstay of treatment for advanced and metastatic prostate cancer. The use of novel agents targeting the androgen receptor and its signaling pathways offers a promising approach that is both safe and effective. We describe the rationale behind the use of these compounds in clinical development and the existing challenges as to how best to incorporate these new and emerging therapies in the changing treatment paradigm of metastatic prostate cancer. PMID:21922023

Inter-departmental dosimetry audits – development of methods and lessons learned

PubMed Central

Eaton, David J.; Bolton, Steve; Thomas, Russell A. S.; Clark, Catharine H.

2015-01-01

External dosimetry audits give confidence in the safe and accurate delivery of radiotherapy. In the United Kingdom, such audits have been performed for almost 30 years. From the start, they included clinically relevant conditions, as well as reference machine output. Recently, national audits have tested new or complex techniques, but these methods are then used in regional audits by a peer-to-peer approach. This local approach builds up the radiotherapy community, facilitates communication, and brings synergy to medical physics. PMID:26865753

Current Options for the Treatment of Food Allergy

PubMed Central

Lanser, Bruce J.; Wright, Benjamin L.; Orgel, Kelly A.; Vickery, Brian P.; Fleischer, David M.

2016-01-01

Food allergy is increasing in prevalence; as a result, there is intense focus on developing safe and effective therapies. Current methods of specific immunotherapy include oral, sublingual, and epicutaneous, while nonspecific methods that have been investigated include: Chinese herbal medicine, probiotics, and anti-IgE antibodies. Although some studies have demonstrated efficacy in inducing desensitization, questions regarding safety and the potential for achieving immune tolerance remain. Although some of these therapies demonstrate promise, further investigation is required before their incorporation into routine clinical practice. PMID:26456449

The future of radiology augmented with Artificial Intelligence: A strategy for success.

PubMed

Liew, Charlene

2018-05-01

The rapid development of Artificial Intelligence/deep learning technology and its implementation into routine clinical imaging will cause a major transformation to the practice of radiology. Strategic positioning will ensure the successful transition of radiologists into their new roles as augmented clinicians. This paper describes an overall vision on how to achieve a smooth transition through the practice of augmented radiology where radiologists-in-the-loop ensure the safe implementation of Artificial Intelligence systems. Copyright © 2018 Elsevier B.V. All rights reserved.

Implementation of legal abortion in Nepal: a model for rapid scale-up of high-quality care

PubMed Central

2012-01-01

Unsafe abortion's significant contribution to maternal mortality and morbidity was a critical factor leading to liberalization of Nepal's restrictive abortion law in 2002. Careful, comprehensive planning among a range of multisectoral stakeholders, led by Nepal's Ministry of Health and Population, enabled the country subsequently to introduce and scale up safe abortion services in a remarkably short timeframe. This paper examines factors that contributed to rapid, successful implementation of legal abortion in this mountainous republic, including deliberate attention to the key areas of policy, health system capacity, equipment and supplies, and information dissemination. Important elements of this successful model of scaling up safe legal abortion include: the pre-existence of postabortion care services, through which health-care providers were already familiar with the main clinical technique for safe abortion; government leadership in coordinating complementary contributions from a wide range of public- and private-sector actors; reliance on public-health evidence in formulating policies governing abortion provision, which led to the embrace of medical abortion and authorization of midlevel providers as key strategies for decentralizing care; and integration of abortion care into existing Safe Motherhood and the broader health system. While challenges remain in ensuring that all Nepali women can readily exercise their legal right to early pregnancy termination, the national safe abortion program has already yielded strong positive results. Nepal's experience making high-quality abortion care widely accessible in a short period of time offers important lessons for other countries seeking to reduce maternal mortality and morbidity from unsafe abortion and to achieve Millennium Development Goals. PMID:22475782

Attenuation and efficacy of live-attenuated Rift Valley fever virus vaccine candidates in non-human primates.

PubMed

Smith, Darci R; Johnston, Sara C; Piper, Ashley; Botto, Miriam; Donnelly, Ginger; Shamblin, Joshua; Albariño, César G; Hensley, Lisa E; Schmaljohn, Connie; Nichol, Stuart T; Bird, Brian H

2018-05-09

Rift Valley fever virus (RVFV) is an important mosquito-borne veterinary and human pathogen that has caused large outbreaks of severe disease throughout Africa and the Arabian Peninsula. Currently, no licensed vaccine or therapeutics exists to treat this potentially deadly disease. The explosive nature of RVFV outbreaks and the severe consequences of its accidental or intentional introduction into RVFV-free areas provide the impetus for the development of novel vaccine candidates for use in both livestock and humans. Rationally designed vaccine candidates using reverse genetics have been used to develop deletion mutants of two known RVFV virulence factors, the NSs and NSm genes. These recombinant viruses were demonstrated to be protective and immunogenic in rats, mice, and sheep, without producing clinical illness in these animals. Here, we expand upon those findings and evaluate the single deletion mutant (ΔNSs rRVFV) and double deletion mutant (ΔNSs-ΔNSm rRVFV) vaccine candidates in the common marmoset (Callithrix jacchus), a non-human primate (NHP) model resembling severe human RVF disease. We demonstrate that both the ΔNSs and ΔNSs-ΔNSm rRVFV vaccine candidates were found to be safe and immunogenic in the current study. The vaccinated animals received a single dose of vaccine that led to the development of a robust antibody response. No vaccine-induced adverse reactions, signs of clinical illness or infectious virus were detected in the vaccinated marmosets. All vaccinated animals that were subsequently challenged with RVFV were protected against viremia and liver disease. In summary, our results provide the basis for further development of the ΔNSs and ΔNSs-ΔNSm rRVFV as safe and effective human RVFV vaccines for this significant public health threat.

Development of operationalized intravenous to oral antibiotic switch criteria.

PubMed

Akhloufi, H; Hulscher, M; Melles, D C; Prins, J M; van der Sijs, H; Verbon, A

2017-02-01

Despite huge overlap in suggested criteria for a safe intravenous (iv)-to-oral antibiotic switch, there is considerable variation in their operationalization. The objective of this study was to develop a set of measurable conditions that should be met in adult hospitalized patients for a safe iv-to-oral switch. A RAND-modified Delphi procedure was performed to develop a set of operationalized iv-to-oral switch criteria. Switch criteria and their accompanying suggested measurable conditions were extracted from the literature and appraised by a multidisciplinary expert panel during two questionnaire rounds with a face-to-face meeting between these two rounds. In a final step, the experts could approve the set of developed operationalized switch criteria. Seven switch criteria and 41 accompanying measurable conditions extracted from the literature were appraised. Sixteen measurable conditions that operationalize six switch criteria were selected: (i) stable systolic blood pressure; and the absence of (ii) fever, (iii) temperature <36°C, (iv) malabsorption syndrome, (v) short bowel syndrome, (vi) severe gastroparesis, (vii) ileus, (viii) continuous nasogastric suction, (ix) vomiting, (x) (severe) sepsis, (xi) fasciitis necroticans, (xii) CNS infection, (xiii) Staphylococcus aureus bacteraemia, and (xiv) endovascular infection. In addition, (xv) the patient should be cooperative and (xvi) adequate antimicrobial concentration should be achievable at the site of infection by oral administration. These operationalized criteria can be used in daily clinical practice. Future use of these criteria in audits and as rules in clinical decision support systems will facilitate the performance and evaluation of iv-oral switch programmes. © The Author 2016. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

A discharge summary adapted to the frail elderly to ensure transfer of relevant information from the hospital to community settings: a model

PubMed Central

2010-01-01

Background Elderly patients admitted to Geriatric Assessment Units (GAU) typically have complex health problems that require multi-professional care. Considering the scope of human and technological resources solicited during hospitalization, as well as the many risks and discomforts incurred by the patient, it is important to ensure the communication of pertinent information for quality follow-up care in the community setting. Conventional discharge summaries do not adequately incorporate the elements specific to an aging clientele. Objective To develop a discharge summary adapted to the frail elderly patient (D-SAFE) in order to communicate relevant information from hospital to community services. Methods The items to be included in the D-SAFE have been determined by means of a modified Delphi method through consultation with clinical experts from GAUs (11 physicians and 5 pharmacists) and the community (10 physicians and 5 pharmacists). The consensus analysis and the level of agreement among the experts were reached using a modified version of the RAND®/University of California at Los Angeles appropriateness method. Results A consensus was reached after two rounds of consultation for all the items evaluated, where none was judged «inappropriate». Among the items proposed, four were judged to be « uncertain » and were eliminated from the final D-SAFE, which was divided into two sections: the medical discharge summary (22 main items) and the discharge prescription (14 main items). Conclusions The D-SAFE was developed as a more comprehensive tool specifically designed for GAU inpatients. Additional research to validate its acceptability and practical impact on the continuity of care is needed before it can be recommended for use on a broader scale. PMID:20863405

A Survey of Established Veterinary Clinical Skills Laboratories from Europe and North America: Present Practices and Recent Developments.

PubMed

Dilly, Marc; Read, Emma K; Baillie, Sarah

Developing competence in clinical skills is important if graduates are to provide entry-level care, but it is dependent on having had sufficient hands-on practice. Clinical skills laboratories provide opportunities for students to learn on simulators and models in a safe environment and to supplement training with animals. Interest in facilities for developing veterinary clinical skills has increased in recent years as many veterinary colleges face challenges in training their students with traditional methods alone. For the present study, we designed a survey to gather information from established veterinary clinical skills laboratories with the aim of assisting others considering opening or expanding their own facility. Data were collated from 16 veterinary colleges in North America and Europe about the uses of their laboratory, the building and associated facilities, and the staffing, budgets, equipment, and supporting learning resources. The findings indicated that having a dedicated veterinary clinical skills laboratory is a relatively new initiative and that colleges have adopted a range of approaches to implementing and running the laboratory, teaching, and assessments. Major strengths were the motivation and positive characteristics of the staff involved, providing open access and supporting self-directed learning. However, respondents widely recognized the increasing demands placed on the facility to provide more space, equipment, and staff. There is no doubt that veterinary clinical skills laboratories are on the increase and provide opportunities to enhance student learning, complement traditional training, and benefit animal welfare.

Effects of Clinical Pilates Exercises on Patients Developing Lymphedema after Breast Cancer Treatment: A Randomized Clinical Trial.

PubMed

Şener, Hülya Özlem; Malkoç, Mehtap; Ergin, Gülbin; Karadibak, Didem; Yavuzşen, Tuğba

2017-01-01

The aim of the present study was to compare the effects of clinical Pilates exercises with those of the standard lymphedema exercises on lymphedema developing after breast cancer treatment. The study comprised 60 female patients with a mean age of 53.2±7.7 years who developed lymphedema after having breast cancer treatment. The patients were randomized into two groups: the clinical Pilates exercise group (n=30), and the control group (n=30). Before, and at the 8th week of treatment, the following parameters were measured: the severity of lymphedema, limb circumferences, body image using the Social Appearance Anxiety Scale, quality of life with the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-BR23), and upper extremity function using the Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure. Both groups performed one-hour exercises three days a week for 8 weeks. After treatment, the symptoms recovered significantly in both groups. Reductions in the severity of lymphedema, improvements in the social appearance anxiety scale scores, quality of life scores, and upper extremity functions scores in the clinical Pilates exercise group were greater than those in the control group. Clinical Pilates exercises were determined to be more effective on the symptoms of patients with lymphedema than were standard lymphedema exercises. Clinical Pilates exercises could be considered a safe model and would contribute to treatment programs.

Effects of Clinical Pilates Exercises on Patients Developing Lymphedema after Breast Cancer Treatment: A Randomized Clinical Trial

PubMed Central

Şener, Hülya Özlem; Malkoç, Mehtap; Ergin, Gülbin; Karadibak, Didem; Yavuzşen, Tuğba

2017-01-01

Objective The aim of the present study was to compare the effects of clinical Pilates exercises with those of the standard lymphedema exercises on lymphedema developing after breast cancer treatment. Materials and Methods The study comprised 60 female patients with a mean age of 53.2±7.7 years who developed lymphedema after having breast cancer treatment. The patients were randomized into two groups: the clinical Pilates exercise group (n=30), and the control group (n=30). Before, and at the 8th week of treatment, the following parameters were measured: the severity of lymphedema, limb circumferences, body image using the Social Appearance Anxiety Scale, quality of life with the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-BR23), and upper extremity function using the Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure. Both groups performed one-hour exercises three days a week for 8 weeks. Results After treatment, the symptoms recovered significantly in both groups. Reductions in the severity of lymphedema, improvements in the social appearance anxiety scale scores, quality of life scores, and upper extremity functions scores in the clinical Pilates exercise group were greater than those in the control group. Clinical Pilates exercises were determined to be more effective on the symptoms of patients with lymphedema than were standard lymphedema exercises. Conclusions Clinical Pilates exercises could be considered a safe model and would contribute to treatment programs. PMID:28331763

MRI: Is Gadolinium Safe for People with Kidney Problems?

MedlinePlus

... M.D. It depends on the type of magnetic resonance imaging (MRI) scan you're scheduled to ... org," "Mayo Clinic Healthy Living," and the triple-shield Mayo Clinic logo are trademarks of Mayo Foundation ...

Exploring nurses' reactions to a novel technology to support acute health care delivery.

PubMed

Kent, Bridie; Redley, Bernice; Wickramasinghe, Nilmini; Nguyen, Lemai; Taylor, Nyree J; Moghimi, Hoda; Botti, Mari

2015-08-01

To explore nurses' reactions to new novel technology for acute health care. Past failures of technology developers to deliver products that meet nurses' needs have led to resistance and reluctance in the technology adoption process. Thus, involving nurses in a collaborative process from early conceptualisation serves to inform design reflective upon current clinical practice, facilitating the cementing of 'vision' and expectations of the technology. An exploratory descriptive design to capture nurses' immediate impressions. Four focus groups (52 nurses from medical and surgical wards at two hospitals in Australia; one private and one public). Nursing reactions towards the new technology illustrated a variance in barrier and enabler comments across multiple domains of the Theoretical Domains Framework. Most challenging for nurses were the perceived threat to their clinical skill, and the potential capability of the novel technology to capture their clinical workflow. Enabling reactions included visions that this could help integrate care between departments; help management and support of nursing processes; and coordinating their patients care between clinicians. Nurses' reactions differed across hospital sites, influenced by their experiences of using technology. For example, Site 1 nurses reported wide variability in their distribution of barrier and enabling comments and nurses at Site 2, where technology was prevalent, reported mostly positive responses. This early involvement offered nursing input and facilitated understanding of the potential capabilities of novel technology to support nursing work, particularly the characteristics seen as potentially beneficial (enabling technology) and those conflicting (barrier technology) with the delivery of both safe and effective patient care. Collaborative involvement of nurses from the early conceptualisation of technology development brings benefits that increase the likelihood of successful use of a tool intended to support the delivery of safe and efficient patient care. © 2015 John Wiley & Sons Ltd.

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.

Enhancing clinical learning in the workplace: a qualitative study.

PubMed

Magnier, K; Wang, R; Dale, V H M; Murphy, R; Hammond, R A; Mossop, L; Freeman, S L; Anderson, C; Pead, M J

Workplace learning (WPL) is seen as an essential component of clinical veterinary education by the veterinary profession. This study sought to understand this type of learning experience more deeply. This was done utilising observations of students on intramural rotations (IMR) and interviews with students and clinical staff. WPL was seen as an opportunity for students to apply knowledge and develop clinical and professional skills in what is generally regarded as a safe, authentic environment. Clinical staff had clear ideas of what they expected from students in terms of interest, engagement, professionalism, and active participation, where this was appropriate. In contrast, students often did not know what to expect and sometimes felt under-prepared when entering the workplace, particularly in a new species area. With the support of staff acting as mentors, students learned to identify gaps in their knowledge and skills, which could then be addressed during specific IMR work placements. Findings such as these illustrate both the complexities of WPL and the diversity of different workplace settings encountered by the students.

Enhancing clinical learning in the workplace: a qualitative study

PubMed Central

Magnier, K.; Wang, R.; Dale, V. H. M.; Murphy, R.; Hammond, R. A.; Mossop, L.; Freeman, S. L.; Anderson, C.; Pead, M. J.

2011-01-01

Workplace learning (WPL) is seen as an essential component of clinical veterinary education by the veterinary profession. This study sought to understand this type of learning experience more deeply. This was done utilising observations of students on intramural rotations (IMR) and interviews with students and clinical staff. WPL was seen as an opportunity for students to apply knowledge and develop clinical and professional skills in what is generally regarded as a safe, authentic environment. Clinical staff had clear ideas of what they expected from students in terms of interest, engagement, professionalism, and active participation, where this was appropriate. In contrast, students often did not know what to expect and sometimes felt under-prepared when entering the workplace, particularly in a new species area. With the support of staff acting as mentors, students learned to identify gaps in their knowledge and skills, which could then be addressed during specific IMR work placements. Findings such as these illustrate both the complexities of WPL and the diversity of different workplace settings encountered by the students. PMID:22090156

Access to safe legal abortion in Malaysia: women's insights and health sector response.

PubMed

Low, Wah-Yun; Tong, Wen-Ting; Wong, Yut-Lin; Jegasothy, Ravindran; Choong, Sim-Poey

2015-01-01

Malaysia has an abortion law, which permits termination of pregnancy to save a woman's life and to preserve her physical and mental health (Penal Code Section 312, amended in 1989). However, lack of clear interpretation and understanding of the law results in women facing difficulties in accessing abortion information and services. Some health care providers were unaware of the legalities of abortion in Malaysia and influenced by their personal beliefs with regard to provision of abortion services. Accessibility to safer abortion techniques is also an issue. The development of the 2012 Guidelines on Termination of Pregnancy and Guidelines for Management of Sexual and Reproductive Health among Adolescents in Health Clinics by the Ministry of Health, Malaysia, is a step forward toward increasing women's accessibility to safe abortion services in Malaysia. This article provides an account of women's accessibility to abortion in Malaysia and the health sector response in addressing the barriers. © 2014 APJPH.

A conceptual framework for a sports knee injury performance profile (SKIPP) and return to activity criteria (RTAC).

PubMed

Logerstedt, David; Arundale, Amelia; Lynch, Andrew; Snyder-Mackler, Lynn

2015-01-01

Injuries to the knee, including intra-articular fractures, ligamentous ruptures, and meniscal and articular cartilage lesions, are commonplace within sports. Despite advancements in surgical techniques and enhanced rehabilitation, athletes returning to cutting, pivoting, and jumping sports after a knee injury are at greater risk of sustaining a second injury. The clinical utility of objective criteria presents a decision-making challenge to ensure athletes are fully rehabilitated and safe to return to sport. A system centered on specific indicators that can be used to develop a comprehensive profile to monitor rehabilitation progression and to establish return to activity criteria is recommended to clear athletes to begin a progressive and systematic approach to activities and sports. Integration of a sports knee injury performance profile with return to activity criteria can guide clinicians in facilitating an athlete's safe return to sport, prevention of subsequent injury, and life-long knee joint health.

Subcutaneous injections: preventing needlestick injuries in the community.

PubMed

Aziz, Ann-Marie

2012-06-01

Community nurses provide care to patients in a variety of settings, for example health centres, community hospitals, patients' homes, residential and nursing homes. Administering subcutaneous injections to patients in the community is an everyday activity for many nurses in clinical practice. Many problems related to being 'sharps safe' are common to both community nurses and hospital staff. The majority of subcutaneous injections administered in the community are for patients with diabetes. Reducing needlestick injuries after the administration of subcutaneous injections in the community remains paramount to all NHS staff. This article provides information on what national standards to employ when administrating subcutaneous injections and what safety practices should be undertaken for good sharps management. Staff administering subcutaneous injections in the community need to ensure that they are updated on the latest developments in safety needle devices in order to prevent needlestick injuries and provide safe, effective and individualised care for their patients.

The concept of treatment-free remission in chronic myeloid leukemia

PubMed Central

Saußele, S; Richter, J; Hochhaus, A; Mahon, F-X

2016-01-01

The advent of tyrosine kinase inhibitors (TKI) into the management of patients with chronic myeloid leukemia (CML) has profoundly improved prognosis. Survival of responders is approaching that of the general population but lifelong treatment is still recommended. In several trials, TKI treatment has been stopped successfully in approximately half of the patients with deep molecular response. This has prompted the development of a new concept in the evaluation of CML patients known as ‘treatment-free remission'. The future in CML treatment will be to define criteria for the safe and most promising discontinuation of TKI on one hand, and, on the other, to increase the number of patients available for such an attempt. Until safe criteria have been defined, discontinuation of therapy is still experimental and should be restricted to clinical trials or registries. This review will provide an overview of current knowledge as well as an outlook on future challenges. PMID:27133824

Clinical use of methadone.

PubMed

Layson-Wolf, Cherokee; Goode, Jean-Venable; Small, Ralph E

2002-01-01

Methadone hydrochloride is a mu-opioid agonist that has been used for the treatment of pain and for the management and maintenance of opioid withdrawal for over 50 years. Several characteristics make methadone a useful drug. However, these same characteristics and wide interpatient variability can make methadone difficult to use safely. A MEDLINE search was conducted on publications between January 1996 and May 2001 to identify literature relevant to this subject. Those publications were reviewed, and from them, other literature was identified and reviewed. Published studies demonstrate methadone's efficacy in pain management and in opioid withdrawal. However, interpatient variability in pharmacokinetic variables of methadone produces difficulties in developing guidelines for methadone use. Clinicians should not be deterred from use of this drug which has been shown to benefit patients in both pain management and methadone maintenance, but an individualized patient approach must be taken to use methadone safely.

Allergy Medications During Pregnancy.

PubMed

Gonzalez-Estrada, Alexei; Geraci, Stephen A

2016-09-01

Allergic diseases are common in women of childbearing age. Both asthma and atopic conditions may worsen, improve or remain the same during pregnancy. Primary care physicians commonly encounter women receiving multiple medications for pre-existing atopic conditions, who then become pregnant and require medication changes to avoid potential fetal injury or congenital malformations. Each medication should be evaluated; intranasal and inhaled steroids are relatively safe to continue during pregnancy (budesonide is the drug of choice), second-generation antihistamines of choice are cetirizine and loratadine, leukotriene receptor antagonists are safe, sparing use of oral decongestants during the first trimester and omalizumab may be used for both uncontrolled asthma and for antihistamine-resistant urticaria. Medications to avoid during pregnancy include intranasal antihistamines, first-generation antihistamines, mycophenolate mofetil, methotrexate, cyclosporine, azathioprine and zilueton. Common allergic diseases may develop de novo during pregnancy, such as anaphylaxis. Copyright © 2016 Southern Society for Clinical Investigation. Published by Elsevier Inc. All rights reserved.

Are we pharmacovigilant enough in ophthalmic practice?

PubMed Central

Dubey, Ashok; Handu, Shailendra S

2013-01-01

No drug is absolutely safe. Pharmacovigilance is the science related to detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. The ocular medications and devices can cause localized and systemic adverse effects. Not all adverse effects are known when a drug or device is launched in market because of limitations of clinical trials. Many adverse effects are recognized due to the spontaneous reporting of the vigilant doctors who observe and report such events encountered in their practice. Despite a large ophthalmic patient population base, India does not have robust adverse drug reaction (ADR) database because of lack of reporting culture. Government of India recently launched the Pharmacovigilance Programme of India (PvPI) to monitor ADRs and create awareness among the healthcare professionals about the importance of ADRs. Suspecting and reporting a possible drug reaction is very important in developing a safe and rational ophthalmic practice. PMID:23571233

Safety assessment of lepidopteran insect-protected transgenic rice with cry2A* gene.

PubMed

Zou, Shiying; Huang, Kunlun; Xu, Wentao; Luo, Yunbo; He, Xiaoyun

2016-04-01

Numerous genetically modified (GM) crops expressing proteins for insect resistance have been commercialized following extensive testing demonstrating that the foods obtained from them are as safe as that obtained from their corresponding non-GM varieties. In this paper, we report the outcome of safety studies conducted on a newly developed insect-resistant GM rice expressing the cry2A* gene by a subchronic oral toxicity study on rats. GM rice and non-GM rice were incorporated into the diet at levels of 30, 50, and 70% (w/w), No treatment-related adverse or toxic effects were observed based on an examination of the daily clinical signs, body weight, food consumption, hematology, serum biochemistry, and organ weight or based on gross and histopathological examination. These results demonstrate that the GM rice with cry2A* gene is as safe for food as conventional non-GM rice.

Kidney Transplantation From Donors with Hepatitis B

PubMed Central

Veroux, Massimiliano; Ardita, Vincenzo; Corona, Daniela; Giaquinta, Alessia; Ekser, Burcin; Sinagra, Nunziata; Zerbo, Domenico; Patanè, Marco; Gozzo, Cecilia; Veroux, Pierfrancesco

2016-01-01

The growing demand for organ donors to supply the increasing number of patients on kidney waiting lists has led most transplant centers to develop protocols that allow safe use of organs from donors with special clinical situations previously regarded as contraindications. Deceased donors with previous hepatitis B may be a safe resource to increase the donor pool even if there is still controversy among transplantation centers regarding the use of hepatitis B surface antigen-positive donors for renal transplantation. However, when allocated to serology-matched recipients, kidney transplantation from donors with hepatitis B may result in excellent short-term outcome. Many concerns may arise in the long-term outcome, and studies must address the evaluation of the progression of liver disease and the rate of reactivation of liver disease in the recipients. Accurate selection and matching of both donor and recipient and correct post-transplant management are needed to achieve satisfactory long-term outcomes. PMID:27123988

A conceptual framework for a sports knee injury performance profile (SKIPP) and return to activity criteria (RTAC)

PubMed Central

Logerstedt, David; Arundale, Amelia; Lynch, Andrew; Snyder-Mackler, Lynn

2015-01-01

Injuries to the knee, including intra-articular fractures, ligamentous ruptures, and meniscal and articular cartilage lesions, are commonplace within sports. Despite advancements in surgical techniques and enhanced rehabilitation, athletes returning to cutting, pivoting, and jumping sports after a knee injury are at greater risk of sustaining a second injury. The clinical utility of objective criteria presents a decision-making challenge to ensure athletes are fully rehabilitated and safe to return to sport. A system centered on specific indicators that can be used to develop a comprehensive profile to monitor rehabilitation progression and to establish return to activity criteria is recommended to clear athletes to begin a progressive and systematic approach to activities and sports. Integration of a sports knee injury performance profile with return to activity criteria can guide clinicians in facilitating an athlete's safe return to sport, prevention of subsequent injury, and life-long knee joint health. PMID:26537805

A clinical decision rule and D-dimer testing to rule out upper extremity deep vein thrombosis in high-risk patients.

PubMed

van Es, Nick; Bleker, Suzanne M; Di Nisio, Marcello; Kleinjan, Ankie; Beyer-Westendorf, Jan; Camporese, Giuseppe; Kamphuisen, Pieter W; Büller, Harry R; Bossuyt, Patrick M

2016-12-01

In a management study, a diagnostic algorithm consisting of a clinical decision rule, D-dimer, and ultrasonography was shown to safely exclude upper extremity deep vein thrombosis (UEDVT). Efficiency may be lower in high-risk subgroups: those with a central venous catheter or pacemaker, inpatients, cancer, and elderly patients. Data of 406 patients with suspected UEDVT enrolled in a prospective management study were used for the present analysis. The aim was to evaluate the efficiency of the algorithm in subgroups, defined as the proportion of patients in whom imaging could be safely withheld based on the combination of a decision rule result indicating "UEDVT unlikely" and a normal D-dimer result. The strategy excluded UEDVT in 87 of 406 patients (21%); ultrasonography was withheld in these patients and none developed UEDVT during 3months of follow-up. In contrast, ultrasonography could be withheld in only 4 of 92 patients with a catheter or pacemaker (4.3%; 95% CI: 1.7% to 11%) and in 4 of 83 inpatients (4.8%; 95% CI: 1.9% to 12%). The efficiency was 11% in patients with cancer and 13% in those older than 75years. Although the combination of a decision rule and D-dimer testing is safe in excluding UEDVT in the overall population of patients with suspected UEDVT, its efficiency appears limited in some subgroups, in particular those with a central venous catheter or pacemaker, and inpatients. Copyright © 2016 Elsevier Ltd. All rights reserved.

The Role of Vitamin D in Uterine Fibroid Biology

PubMed Central

Brakta, Soumia; Diamond, Justin S.; Al-Hendy, Ayman; Diamond, Michael P.; Halder, Sunil K.

2015-01-01

Objective To provide a detailed summary of current scientific knowledge on uterine fibroids (leiomyomas) in vitro and in in vivo animal models, as well as to postulate the potential role of vitamin D3 as an effective, inexpensive, safe long-term treatment option for uterine fibroids. Design PubMed search articles were used to identify the most relevant studies on uterine fibroids as well as effects of vitamin D3 on uterine fibroid cells and fibroid tumor growth in in vivo animal models. Setting University research laboratory - affiliated infertility clinic. Patient(s) Not applicable. Intervention(s) None Main Outcome Measure(s) Not applicable. Results Despite numerous publications available on uterine fibroids, information about the role that vitamin D3 plays in the regulation of uterine fibroids are limited. Most of the recent vitamin D3-related studies on uterine fibroids were published from our group. Recent studies have demonstrated that vitamin D deficiency plays a significant role in the development of uterine fibroids. Our recent studies have demonstrated that vitamin D3 reduces leiomyoma cell proliferation in vitro, and leiomyoma tumor growth in in vivo animal models. These results postulate the potential role of vitamin D3 for an effective, safe non-surgical medical treatment option for uterine fibroids. Conclusions This article reviews human and animal studies and uncover new possibilities for understanding the vitamin D-based therapeutic option for an effective, safe long-term treatment of uterine fibroids. Based on these results, a clinical trial with vitamin D3 or a hypocalcemic analog, paricalcitol may be warranted for non-surgical medical treatment of uterine fibroids. PMID:26079694

Perinatal staff perceptions of safety and quality in their service.

PubMed

Sinni, Suzanne V; Wallace, Euan M; Cross, Wendy M

2014-11-28

Ensuring safe and appropriate service delivery is central to a high quality maternity service. With this in mind, over recent years much attention has been given to the development of evidence-based clinical guidelines, staff education and risk reporting systems. Less attention has been given to assessing staff perceptions of a service's safety and quality and what factors may influence that. In this study we set out to assess staff perceptions of safety and quality of a maternity service and to explore potential influences on service safety. The study was undertaken within a new low risk metropolitan maternity service in Victoria, Australia with a staffing profile comprising midwives (including students), neonatal nurses, specialist obstetricians, junior medical staff and clerical staff. In depth open-ended interviews using a semi-structured questionnaire were conducted with 23 staff involved in the delivery of perinatal care, including doctors, midwives, nurses, nursing and midwifery students, and clerical staff. Data were analyzed using naturalistic interpretive inquiry to identify emergent themes. Staff unanimously reported that there were robust systems and processes in place to maintain safety and quality. Three major themes were apparent: (1) clinical governance, (2) dominance of midwives, (3) inter-professional relationships. Overall, there was a strong sense that, at least in this midwifery-led service, midwives had the greatest opportunity to be an influence, both positively and negatively, on the safe delivery of perinatal care. The importance of understanding team dynamics, particularly mutual respect, trust and staff cohesion, were identified as key issues for potential future service improvement. Senior staff, particularly midwives and neonatal nurses, play central roles in shaping team behaviors and attitudes that may affect the safety and quality of service delivery. We suggest that strategies targeting senior staff to enhance their performance in their roles, particularly in the training and teamwork role-modeling of the transitory junior workforce, are important for the development and maintenance of a high quality and safe maternity service.

Description and student self-evaluation of a pilot integrated small group learning and simulation programme for medical students in the first clinical year.

PubMed

Levinson, Michele; Kelly, Diane; Zahariou, Krisoula; Johnson, Matthew; Jackman, Christine; Mackenzie, Sara

2017-02-01

Contemporary education for medical students should be student-centred, integrated and contextualised. Small group learning promotes clinical reasoning and skills for lifelong learning. Simulation can provide experiential learning in a safe and controlled environment. We developed a weekly integrated problem-based learning and simulation programme (IPS) over two semesters in the first clinical year to augment clinical placement experience and contextualise theory into work-relevant practice. To evaluate the new programme at Kirkpatrick level 1. An anonymous survey of participating students. The programme was well liked. Students found the programme relevant and that they had a better understanding of patient safety and the assessment of the deteriorating patient. They felt it contributed to integration of theory and practice, clinical reasoning and the acquisition of non-technical skills, particularly affective and communication elements. This IPS programme in the first clinical year can deliver a student-centred curriculum to complement clinical placement that delivers the important requirements of contemporary medical student education. © 2016 Royal Australasian College of Physicians.

Microbial contamination of autologous peripheral blood stem cell products: incidence, clinical outcome, quality control and management strategies.

PubMed

Cheah, Poh Lin; Ong, Chong Wei; Crispin, Philip

2011-06-01

Microbial screening is part of quality control for autologous peripheral blood stem cell (PBSC) manipulation. The incidence of culture positive products varies widely. The clinical significance of infusing culture positive products is uncertain, with no consensus on the interventions required. Microbial cultures of 606 consecutive autologous PBSC products from 278 patients between 1995 and 2005 were retrospectively analysed to determine the incidence of culture positivity and classified according to likely clinical significance. Clinical outcomes of patients who received culture positive products were reviewed. Using the baseline probability of contamination, a quality control method to detect a systematic source of contamination during product manipulation was developed. Eleven (1.8%) of 606 products were culture positive in eight (2.9%) patients. Ten products yielded coagulase negative Staphylococcus species and one Corynebacterium accolens. One patient had catheter sepsis during collection. Five patients received culture positive products, with prophylactic antibiotics when there was known coagulase negative Staphylococcus species. None had clinical evidence of infection following product infusion. The incidence of culture positive products was comparable to published series. Only skin commensals were isolated. Infusion of skin commensal positive products appears safe with antibiotic prophylaxis. Using local and published experience, clinical and laboratory policies were developed for culture positive products.

Collaborative Approach in the Development of High‐Performance Brain–Computer Interfaces for a Neuroprosthetic Arm: Translation from Animal Models to Human Control

PubMed Central

Collinger, Jennifer L.; Kryger, Michael A.; Barbara, Richard; Betler, Timothy; Bowsher, Kristen; Brown, Elke H. P.; Clanton, Samuel T.; Degenhart, Alan D.; Foldes, Stephen T.; Gaunt, Robert A.; Gyulai, Ferenc E.; Harchick, Elizabeth A.; Harrington, Deborah; Helder, John B.; Hemmes, Timothy; Johannes, Matthew S.; Katyal, Kapil D.; Ling, Geoffrey S. F.; McMorland, Angus J. C.; Palko, Karina; Para, Matthew P.; Scheuermann, Janet; Schwartz, Andrew B.; Skidmore, Elizabeth R.; Solzbacher, Florian; Srikameswaran, Anita V.; Swanson, Dennis P.; Swetz, Scott; Tyler‐Kabara, Elizabeth C.; Velliste, Meel; Wang, Wei; Weber, Douglas J.; Wodlinger, Brian

2013-01-01

Abstract Our research group recently demonstrated that a person with tetraplegia could use a brain–computer interface (BCI) to control a sophisticated anthropomorphic robotic arm with skill and speed approaching that of an able‐bodied person. This multiyear study exemplifies important principles in translating research from foundational theory and animal experiments into a clinical study. We present a roadmap that may serve as an example for other areas of clinical device research as well as an update on study results. Prior to conducting a multiyear clinical trial, years of animal research preceded BCI testing in an epilepsy monitoring unit, and then in a short‐term (28 days) clinical investigation. Scientists and engineers developed the necessary robotic and surgical hardware, software environment, data analysis techniques, and training paradigms. Coordination among researchers, funding institutes, and regulatory bodies ensured that the study would provide valuable scientific information in a safe environment for the study participant. Finally, clinicians from neurosurgery, anesthesiology, physiatry, psychology, and occupational therapy all worked in a multidisciplinary team along with the other researchers to conduct a multiyear BCI clinical study. This teamwork and coordination can be used as a model for others attempting to translate basic science into real‐world clinical situations. PMID:24528900

"Combo" nanomedicine: Co-delivery of multi-modal therapeutics for efficient, targeted, and safe cancer therapy.

PubMed

Kemp, Jessica A; Shim, Min Suk; Heo, Chan Yeong; Kwon, Young Jik

2016-03-01

The dynamic and versatile nature of diseases such as cancer has been a pivotal challenge for developing efficient and safe therapies. Cancer treatments using a single therapeutic agent often result in limited clinical outcomes due to tumor heterogeneity and drug resistance. Combination therapies using multiple therapeutic modalities can synergistically elevate anti-cancer activity while lowering doses of each agent, hence, reducing side effects. Co-administration of multiple therapeutic agents requires a delivery platform that can normalize pharmacokinetics and pharmacodynamics of the agents, prolong circulation, selectively accumulate, specifically bind to the target, and enable controlled release in target site. Nanomaterials, such as polymeric nanoparticles, gold nanoparticles/cages/shells, and carbon nanomaterials, have the desired properties, and they can mediate therapeutic effects different from those generated by small molecule drugs (e.g., gene therapy, photothermal therapy, photodynamic therapy, and radiotherapy). This review aims to provide an overview of developing multi-modal therapies using nanomaterials ("combo" nanomedicine) along with the rationale, up-to-date progress, further considerations, and the crucial roles of interdisciplinary approaches. Copyright © 2015 Elsevier B.V. All rights reserved.

Adapting Certified Safe Farm to North Carolina Agriculture: An Implementation Study.

PubMed

Storm, Julia F; LePrevost, Catherine E; Tutor-Marcom, Robin; Cope, W Gregory

2016-01-01

Certified Safe Farm (CSF) is a multimodal safety and health program developed and assessed through multiple controlled intervention studies in Iowa. Although developed with the intent to be broadly applicable to agriculture, CSF has not been widely implemented outside the midwestern United States. This article describes the CSF implementation process in North Carolina (NC), as piloted on a large-scale in three agriculturally diverse and productive counties of NC, and reports its effectiveness using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework. Implementation involved (1) capacity building through safety and health training, (2) adaptation of components of Iowa's CSF model to NC agriculture, (3) marketing and recruitment, and (4) formative evaluation, including an online survey and focus group discussion. From 2009 to 2012, 113 farms participated in at least one component of the CSF intervention, representing a NC farm participation rate of 3.1% in the study area. A major adaptation of NC implementation was the utilization of NC Cooperative Extension as the local driver of implementation in contrast to local AgriSafe clinics in Iowa. The most innovative adaptation to CSF components was the development of a defined economic incentive in the form of a cost-share program. The RE-AIM framework was found to be useful and relevant to the field of agricultural health and safety translational research. This study provides effectiveness measures and implementation alternatives useful for those considering implementing CSF. It informs current efforts to move CSF from research to practice through the National Sustainable Model CSF Program initiative.

Plitidepsin Has a Safe Cardiac Profile: A Comprehensive Analysis

PubMed Central

Soto-Matos, Arturo; Szyldergemajn, Sergio; Extremera, Sonia; Miguel-Lillo, Bernardo; Alfaro, Vicente; Coronado, Cinthya; Lardelli, Pilar; Roy, Elena; Corrado, Claudia Silvia; Kahatt, Carmen

2011-01-01

Plitidepsin is a cyclic depsipeptide of marine origin in clinical development in cancer patients. Previously, some depsipeptides have been linked to increased cardiac toxicity. Clinical databases were searched for cardiac adverse events (CAEs) that occurred in clinical trials with the single-agent plitidepsin. Demographic, clinical and pharmacological variables were explored by univariate and multivariate logistic regression analysis. Forty-six of 578 treated patients (8.0%) had at least one CAE (11 patients (1.9%) with plitidepsin-related CAEs), none with fatal outcome as a direct consequence. The more frequent CAEs were rhythm abnormalities (n = 31; 5.4%), mostly atrial fibrillation/flutter (n = 15; 2.6%). Of note, life-threatening ventricular arrhythmias did not occur. Myocardial injury events (n = 17; 3.0%) included possible ischemic-related and non-ischemic events. Other events (miscellaneous, n = 6; 1.0%) were not related to plitidepsin. Significant associations were found with prostate or pancreas cancer primary diagnosis (p = 0.0017), known baseline cardiac risk factors (p = 0.0072), myalgia present at baseline (p = 0.0140), hemoglobin levels lower than 10 g/dL (p = 0.0208) and grade ≥2 hypokalemia (p = 0.0095). Treatment-related variables (plitidepsin dose, number of cycles, schedule and/or total cumulative dose) were not associated. Electrocardiograms performed before and after plitidepsin administration (n = 136) detected no relevant effect on QTc interval. None of the pharmacokinetic parameters analyzed had a significant impact on the probability of developing a CAE. In conclusion, the most frequent CAE type was atrial fibrillation/atrial flutter, although its frequency was not different to that reported in the age-matched healthy population, while other CAEs types were rare. No dose-cumulative pattern was observed, and no treatment-related variables were associated with CAEs. Relevant risk factors identified were related to the patient’s condition and/or to disease-related characteristics rather than to drug exposure. Therefore, the current analysis supports a safe cardiac risk profile for single-agent plitidepsin in cancer patients. PMID:21747745

Assessment of bio-safety of low-cost polyurethane urologic stents used in developing countries.

PubMed

Roy, Nobhojit; Waingankar, Santosh; Aggarwal, Gaurav

2012-04-01

Ureteral stents, despite their ubiquitous use, have not been evaluated for their safety and strength after removal from the patient. While literature is available from the industry with regards to manufacturing and specifications of stents, what happens to a stent after it is inserted into the body, still needs to be explored. We conducted a methodical study of 153 consecutive patients with urological problems who were stented with inexpensive polyurethane stents. Once removed from the patients, the stents were analyzed for breakload, tensile strength, elongation, pH, decomposition temperature, residue as well as diameter change. There was no significant change in the physical and mechanical properties of the stent after clinical use and the variance was within the acceptable range of biomaterials. There was minimal leaching of material and color change in all stents. The cheap polyurethane stents were found to be safe for use in patients, for the short time periods of in situ stenting. The degradation of physical and chemical properties of the stent was not significant. Thus it can be safely said that the stents currently in widespread use are cost-effective and physically safe for short spans of time.

Feasibility and safety of adenosine cardiovascular magnetic resonance in patients with MR conditional pacemaker systems at 1.5 Tesla.

PubMed

Klein-Wiele, Oliver; Garmer, Marietta; Urbien, Rhyan; Busch, Martin; Kara, Kaffer; Mateiescu, Serban; Grönemeyer, Dietrich; Schulte-Hermes, Michael; Garbrecht, Marc; Hailer, Birgit

2015-12-22

Cardiovascular Magnetic Resonance (CMR) with adenosine stress is a valuable diagnostic tool in coronary artery disease (CAD). However, despite the development of MR conditional pacemakers CMR is not yet established in clinical routine for pacemaker patients with known or suspected CAD. A possible reason is that adenosine stress perfusion for ischemia detection in CMR has not been studied in patients with cardiac conduction disease requiring pacemaker therapy. Other than under resting conditions it is unclear whether MR safe pacing modes (paused pacing or asynchronous mode) can be applied safely because the effect of adenosine on heart rate is not precisely known in this entity of patients. We investigate for the first time feasibility and safety of adenosine stress CMR in pacemaker patients in clinical routine and evaluate a pacing protocol that considers heart rate changes under adenosine. We retrospectively analyzed CMR scans of 24 consecutive patients with MR conditional pacemakers (mean age 72.1 ± 11.0 years) who underwent CMR in clinical routine for the evaluation of known or suspected CAD. MR protocol included cine imaging, adenosine stress perfusion and late gadolinium enhancement. Pacemaker indications were sinus node dysfunction (n = 18) and second or third degree AV block (n = 6). Under a pacing protocol intended to avoid competitive pacing on the one hand and bradycardia due to AV block on the other no arrhythmia occurred. Pacemaker stimulation was paused to prevent competitive pacing in sinus node dysfunction with resting heart rate >45 bpm. Sympatho-excitatory effect of adenosine led to a significant acceleration of heart rate by 12.3 ± 8.3 bpm (p < 0.001), no bradycardia occurred. On the contrary in AV block heart rate remained constant; asynchronous pacing above resting heart rate did not interfere with intrinsic rhythm. Adenosine stress CMR appears to be feasible and safe in patients with MR conditional pacemakers. Heart rate response to adenosine has to be considered for the choice of pacing modes during CMR.

Pediatric primary care to help prevent child maltreatment: the Safe Environment for Every Kid (SEEK) Model.

PubMed

Dubowitz, Howard; Feigelman, Susan; Lane, Wendy; Kim, Jeongeun

2009-03-01

Effective strategies for preventing child maltreatment are needed. Few primary care-based programs have been developed, and most have not been well evaluated. Our goal was to evaluate the efficacy of the Safe Environment for Every Kid model of pediatric primary care in reducing the occurrence of child maltreatment. A randomized trial was conducted from June 2002 to November 2005 in a university-based resident continuity clinic in Baltimore, Maryland. The study population consisted of English-speaking parents of children (0-5 years) brought in for child health supervision. Of the 1118 participants approached, 729 agreed to participate, and 558 of them completed the study protocol. Resident continuity clinics were cluster randomized by day of the week to the model (intervention) or standard care (control) groups. Model care consisted of (1) residents who received special training, (2) the Parent Screening Questionnaire, and (3) a social worker. Risk factors for child maltreatment were identified and addressed by the resident physician and/or social worker. Standard care involved routine pediatric primary care. A subset of the clinic population was sampled for the evaluation. Child maltreatment was measured in 3 ways: (1) child protective services reports using state agency data; (2) medical chart documentation of possible abuse or neglect; and (3) parental report of harsh punishment via the Parent-Child Conflict Tactics scale. Model care resulted in significantly lower rates of child maltreatment in all the outcome measures: fewer child protective services reports, fewer instances of possible medical neglect documented as treatment nonadherence, fewer children with delayed immunizations, and less harsh punishment reported by parents. One-tailed testing was conducted in accordance with the study hypothesis. The Safe Environment for Every Kid (SEEK) model of pediatric primary care seems promising as a practical strategy for helping prevent child maltreatment. Replication and additional evaluation of the model are recommended.

Residential tornado safe room from commodity wood products – design and development

Treesearch

Robert H. Falk; James J. Bridwell

2018-01-01

In the United States, tornadoes cause significant damage and result in many injuries and deaths. Although the development and use of tornado safe rooms have helped decrease the human toll associated with these events, the cost of these structures is often too high for many that could benefit from their use. The development of a nonproprietary residential tornado safe...

Development of dapivirine vaginal ring for HIV prevention.

PubMed

Devlin, Bríd; Nuttall, Jeremy; Wilder, Susan; Woodsong, Cynthia; Rosenberg, Zeda

2013-12-01

In the continuing effort to develop effective HIV prevention methods for women, a vaginal ring containing the non-nucleoside reverse transcriptase inhibitor dapivirine is currently being tested in two safety and efficacy trials. This paper reviews dapivirine ring's pipeline development process, including efforts to determine safe and effective dosing levels as well as identify delivery platforms with the greatest likelihood of success for correct and consistent use. Dapivirine gel and other formulations were developed and tested in preclinical and clinical studies. Multiple vaginal ring prototypes were also tested, resulting in the current ring design as well as additional designs under consideration for future testing. Efficacy results from clinical trials are expected in 2015. Through ongoing consultations with national regulatory authorities, licensure requirements for dapivirine vaginal ring approval have been defined. This article is based on a presentation at the "Product Development Workshop 2013: HIV and Multipurpose Prevention Technologies," held in Arlington, Virginia on February 21-22, 2013. It forms part of a special supplement to Antiviral Research. Copyright © 2013 Elsevier B.V. All rights reserved.

Translating New Science Into the Drug Review Process

PubMed Central

Rouse, Rodney; Kruhlak, Naomi; Weaver, James; Burkhart, Keith; Patel, Vikram; Strauss, David G.

2017-01-01

In 2011, the US Food and drug Administration (FDA) developed a strategic plan for regulatory science that focuses on developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. In line with this, the Division of Applied Regulatory Science was created to move new science into the Center for Drug Evaluation and Research (CDER) review process and close the gap between scientific innovation and drug review. The Division, located in the Office of Clinical Pharmacology, is unique in that it performs mission-critical applied research and review across the translational research spectrum including in vitro and in vivo laboratory research, in silico computational modeling and informatics, and integrated clinical research covering clinical pharmacology, experimental medicine, and postmarket analyses. The Division collaborates with Offices throughout CDER, across the FDA, other government agencies, academia, and industry. The Division is able to rapidly form interdisciplinary teams of pharmacologists, biologists, chemists, computational scientists, and clinicians to respond to challenging regulatory questions for specific review issues and for longer-range projects requiring the development of predictive models, tools, and biomarkers to speed the development and regulatory evaluation of safe and effective drugs. This article reviews the Division’s recent work and future directions, highlighting development and validation of biomarkers; novel humanized animal models; translational predictive safety combining in vitro, in silico, and in vivo clinical biomarkers; chemical and biomedical informatics tools for safety predictions; novel approaches to speed the development of complex generic drugs, biosimilars, and antibiotics; and precision medicine. PMID:29568713

Newcastle disease virus vectored vaccines as bivalent or antigen delivery vaccines

PubMed Central

2017-01-01

Recent advances in reverse genetics techniques make it possible to manipulate the genome of RNA viruses such as Newcastle disease virus (NDV). Several NDV vaccine strains have been used as vaccine vectors in poultry, mammals, and humans to express antigens of different pathogens. The safety, immunogenicity, and protective efficacy of these NDV-vectored vaccines have been evaluated in pre-clinical and clinical studies. The vaccines are safe in mammals, humans, and poultry. Bivalent NDV-vectored vaccines against pathogens of economic importance to the poultry industry have been developed. These bivalent vaccines confer solid protective immunity against NDV and other foreign antigens. In most cases, NDV-vectored vaccines induce strong local and systemic immune responses against the target foreign antigen. This review summarizes the development of NDV-vectored vaccines and their potential use as a base for designing other effective vaccines for veterinary and human use. PMID:28775971

Implementation of clinical decision rules in the emergency department.

PubMed

Stiell, Ian G; Bennett, Carol

2007-11-01

Clinical decision rules (CDRs) are tools designed to help clinicians make bedside diagnostic and therapeutic decisions. The development of a CDR involves three stages: derivation, validation, and implementation. Several criteria need to be considered when designing and evaluating the results of an implementation trial. In this article, the authors review the results of implementation studies evaluating the effect of four CDRs: the Ottawa Ankle Rules, the Ottawa Knee Rule, the Canadian C-Spine Rule, and the Canadian CT Head Rule. Four implementation studies demonstrated that the implementation of CDRs in the emergency department (ED) safely reduced the use of radiography for ankle, knee, and cervical spine injuries. However, a recent trial failed to demonstrate an impact on computed tomography imaging rates. Well-developed and validated CDRs can be successfully implemented into practice, efficiently standardizing ED care. However, further research is needed to identify barriers to implementation in order to achieve improved uptake in the ED.

Remarks spoken before the audience at the final conference plenary session, entitled: "Future directions," at the International Conference on Advances in AIDS Vaccine Development. Fourth annual meeting of the National Cooperative Vaccine Development Groups for AIDS.

PubMed

Nzila, N

1992-08-01

Nzilambi Nzila, Visiting Scientist at the Johns Hopkins University Center for Immunization Research, responds to frequently asked questions about AIDS vaccine clinical trials in Africa. Conference attendees had asked him if the thinks the time is right to begin AIDS vaccine clinical trials in Africa; if African populations and decision makers want to be involved in the trials; and if he thinks that Africans will be used as guinea pigs. Given the magnitude of the AIDS pandemic in Africa and the general population desire for effective responses, Nzila feels that clinical trials could commence. Yes, Africans want to be involved in the early phases of clinical trials to both share their experiences and reap the benefits of an effective and safe vaccine should one be developed. Large IEC campaigns will simply not suffice to stem the spread of HIV. Further, decision makers in Africa should be involved as early as possible to allow then time to recruit HIV-negative volunteers for trials. Finally, Nzila does not equate involvement in vaccine trials with laboratory test animal status, especially since the target population is aware of its participation.

A Software Safety Risk Taxonomy for Use in Retrospective Safety Cases

NASA Technical Reports Server (NTRS)

Hill, Janice L.

2007-01-01

Safety standards contain technical and process-oriented safely requirements. The best time to include these requirements is early in the development lifecycle of the system. When software safety requirements are levied on a legacy system after the fact, a retrospective safety case will need to be constructed for the software in the system. This can be a difficult task because there may be few to no art facts available to show compliance to the software safely requirements. The risks associated with not meeting safely requirements in a legacy safely-critical computer system must be addressed to give confidence for reuse. This paper introduces a proposal for a software safely risk taxonomy for legacy safely-critical computer systems, by specializing the Software Engineering Institute's 'Software Development Risk Taxonomy' with safely elements and attributes.

Now That You Want to Take Your HIV/AIDS Vaccine/Biological Product Research Concept into the Clinic: What are “cGMP”?

PubMed Central

Sheets, Rebecca L.; Rangavajhula, Vijaya; Pullen, Jeffrey K.; Butler, Chris; Mehra, Vijay; Shapiro, Stuart

2015-01-01

The Division of AIDS Vaccine Research Program funds the discovery and development of HIV/AIDS vaccine candidates. Basic researchers, having discovered a potential vaccine in the laboratory, next want to take that candidate into the clinic to test the concept in humans, to see if it translates. Many of them have heard of “cGMP” and know that they are supposed to make a “GMP product” to take into the clinic, but often they are not very familiar with what “cGMP” means and why these good practices are so important. As members of the Vaccine Translational Research Branch, we frequently get asked “can’t we use the material we made in the lab in the clinic?” or “aren’t Phase 1 studies exempt from cGMP?” Over the years, we have had many experiences where researchers or their selected contract manufacturing organizations have not applied an appropriate degree of compliance with cGMP suitable for the clinical phase of development. We share some of these experiences and the lessons learned, along with explaining the importance of cGMP, just what cGMP means, and what they can assure, in an effort to de-mystify this subject and facilitate the rapid and safe translational development of HIV vaccines. PMID:25698494

Now that you want to take your HIV/AIDS vaccine/biological product research concept into the clinic: what are the "cGMP"?

PubMed

Sheets, Rebecca L; Rangavajhula, Vijaya; Pullen, Jeffrey K; Butler, Chris; Mehra, Vijay; Shapiro, Stuart; Pensiero, Michael

2015-04-08

The Division of AIDS Vaccine Research Program funds the discovery and development of HIV/AIDS vaccine candidates. Basic researchers, having discovered a potential vaccine in the laboratory, next want to take that candidate into the clinic to test the concept in humans, to see if it translates. Many of them have heard of "cGMP" and know that they are supposed to make a "GMP product" to take into the clinic, but often they are not very familiar with what "cGMP" means and why these good practices are so important. As members of the Vaccine Translational Research Branch, we frequently get asked "can't we use the material we made in the lab in the clinic?" or "aren't Phase 1 studies exempt from cGMP?" Over the years, we have had many experiences where researchers or their selected contract manufacturing organizations have not applied an appropriate degree of compliance with cGMP suitable for the clinical phase of development. We share some of these experiences and the lessons learned, along with explaining the importance of cGMP, just what cGMP means, and what they can assure, in an effort to de-mystify this subject and facilitate the rapid and safe translational development of HIV vaccines. Published by Elsevier Ltd.

Submucosal Tunneling Endoscopic Resection (STER) and Other Novel Applications of Submucosal Tunneling in Humans.

PubMed

Liu, Bing-Rong; Song, Ji-Tao

2016-04-01

The submucosal tunneling technique was originally developed to provide safe access to the peritoneal cavity for natural orifice transluminal endoscopic surgery procedures. With this technique, the submucosal tunnel becomes the working space for partial myotomy and tumor resection. The submucosal space has come to represent the "third space" distinguished from gastrointestinal lumen (first space) and peritoneal cavity (second space). New applications continue to be developed and further clinical applications in the future are anticipated. This article summarizes the current applications of submucosal tunneling endoscopic resection for subepithelial tumors and describes other related uses of submucosal tunneling. Copyright © 2016 Elsevier Inc. All rights reserved.

Companion diagnostics: a regulatory perspective from the last 5 years of molecular companion diagnostic approvals.

PubMed

Roscoe, Donna M; Hu, Yun-Fu; Philip, Reena

2015-01-01

Companion diagnostics are essential for the safe and effective use of the corresponding therapeutic products. The US FDA has approved a number of companion diagnostics used to select cancer patients for treatment with contemporaneously approved novel therapeutics. The processes of co-development and co-approval of a therapeutic product and its companion diagnostic have been a learning experience that continues to evolve. Using several companion diagnostics as examples, this article describes the challenges associated with the scientific, clinical and regulatory hurdles faced by FDA and industry alike. Taken together, this discussion is intended to assist manufacturers toward a successful companion diagnostics development plan.

Development of Device to Evoke Stretch Reflexes by Use of Electromagnetic Force for the Rehabilitation of the Hemiplegic Upper Limb after Stroke

NASA Astrophysics Data System (ADS)

Hayashi, Ryota; Ishimine, Tomoyasu; Kawahira, Kazumi; Yu, Yong; Tsujio, Showzow

In this research, we focus on the method of rehabilitation with stretch reflexes for the hemiplegic upper limb in stroke patients. We propose a new device which utilizes electromagnetic force to evoke stretch reflexes. The device can exert an assisting force safely, because the electromagnetic force is non contact force. In this paper, we develop a support system applying the proposed device for the functional recovery training of the hemiplegic upper limb. The results obtained from several clinical tests with and without our support system are compared. Then we discuss the validity of our support system.

Vaccination policies and programs: the federal government's role in making the system work.

PubMed

Schwartz, B; Orenstein, W A

2001-12-01

Government agencies play a key role, from preclinical development to postlicensure monitoring, in making vaccinations one of the leading public health interventions. Important steps in this process include development and testing of vaccine antigens, evaluation of clinical and manufacturing data leading to licensure, formulation of recommendations, vaccine purchase, defining strategies to improve coverage, compensation of those injured by vaccine adverse reactions, and monitoring vaccine impact and safety. Using examples of newly recommended vaccines, this article describes the infrastructure that underlies a safe and effective program and highlights some of the opportunities and threats likely to impact the system in coming years.

Genetic and epigenetic instability of stem cells.

PubMed

Rajamani, Karthyayani; Li, Yuan-Sheng; Hsieh, Dean-Kuo; Lin, Shinn-Zong; Harn, Horng-Jyh; Chiou, Tzyy-Wen

2014-01-01

Recently, research on stem cells has been receiving an increasing amount of attention, both for its advantages and disadvantages. Genetic and epigenetic instabilities among stem cells have been a recurring obstacle to progress in regenerative medicine using stem cells. Various reports have stated that these instabilities can transform stem cells when transferred in vivo and thus have the potential to develop tumors. Previous research has shown that various extrinsic and intrinsic factors can contribute to the stability of stem cells. The extrinsic factors include growth supplements, growth factors, oxygen tension, passage technique, and cryopreservation. Controlling these factors based on previous reports may assist researchers in developing strategies for the production and clinical application of "safe" stem cells. On the other hand, the intrinsic factors can be unpredictable and uncontrollable; therefore, to ensure the successful use of stem cells in regenerative medicine, it is imperative to develop and implement appropriate strategies and technique for culturing stem cells and to confirm the genetic and epigenetic safety of these stem cells before employing them in clinical trials.

Cross-boundary rotational working for neonatal nurses.

PubMed

Kane, Tina

2007-05-01

Neonatal services in England and Wales are undergoing significant changes as a result of technological advances as well as the development of new networks. These changes have had a dramatic effect on the neonatal workforce. The skills of the available staff govern the level of activity of neonatal units: many units have had to re-evaluate the services they can safely deliver with the available workforce. This has resulted in the re-configuration of some neonatal units and changes in the dependency levels of many. Units have had to undertake reviews of the patterns of working of their staff to ensure that a skilled and competent workforce is available to provide the level of care each neonatal service requires. Shortages in some areas have meant that units have had to find new ways to retain and update skilled staff. This article describes a rotational programme developed with the aim of providing a continued clinical development pathway for neonatal nursing staff. The programme incorporates competency assessments of emergency skills and clinical and technological advances in neonatal care.

Teamwork and patient safety in dynamic domains of healthcare: a review of the literature.

PubMed

Manser, T

2009-02-01

This review examines current research on teamwork in highly dynamic domains of healthcare such as operating rooms, intensive care, emergency medicine, or trauma and resuscitation teams with a focus on aspects relevant to the quality and safety of patient care. Evidence from three main areas of research supports the relationship between teamwork and patient safety: (1) Studies investigating the factors contributing to critical incidents and adverse events have shown that teamwork plays an important role in the causation and prevention of adverse events. (2) Research focusing on healthcare providers' perceptions of teamwork demonstrated that (a) staff's perceptions of teamwork and attitudes toward safety-relevant team behavior were related to the quality and safety of patient care and (b) perceptions of teamwork and leadership style are associated with staff well-being, which may impact clinician' ability to provide safe patient care. (3) Observational studies on teamwork behaviors related to high clinical performance have identified patterns of communication, coordination, and leadership that support effective teamwork. In recent years, research using diverse methodological approaches has led to significant progress in team research in healthcare. The challenge for future research is to further develop and validate instruments for team performance assessment and to develop sound theoretical models of team performance in dynamic medical domains integrating evidence from all three areas of team research identified in this review. This will help to improve team training efforts and aid the design of clinical work systems supporting effective teamwork and safe patient care.

Safe and efficient method for cryopreservation of human induced pluripotent stem cell-derived neural stem and progenitor cells by a programmed freezer with a magnetic field.

PubMed

Nishiyama, Yuichiro; Iwanami, Akio; Kohyama, Jun; Itakura, Go; Kawabata, Soya; Sugai, Keiko; Nishimura, Soraya; Kashiwagi, Rei; Yasutake, Kaori; Isoda, Miho; Matsumoto, Morio; Nakamura, Masaya; Okano, Hideyuki

2016-06-01

Stem cells represent a potential cellular resource in the development of regenerative medicine approaches to the treatment of pathologies in which specific cells are degenerated or damaged by genetic abnormality, disease, or injury. Securing sufficient supplies of cells suited to the demands of cell transplantation, however, remains challenging, and the establishment of safe and efficient cell banking procedures is an important goal. Cryopreservation allows the storage of stem cells for prolonged time periods while maintaining them in adequate condition for use in clinical settings. Conventional cryopreservation systems include slow-freezing and vitrification both have advantages and disadvantages in terms of cell viability and/or scalability. In the present study, we developed an advanced slow-freezing technique using a programmed freezer with a magnetic field called Cells Alive System (CAS) and examined its effectiveness on human induced pluripotent stem cell-derived neural stem/progenitor cells (hiPSC-NS/PCs). This system significantly increased cell viability after thawing and had less impact on cellular proliferation and differentiation. We further found that frozen-thawed hiPSC-NS/PCs were comparable with non-frozen ones at the transcriptome level. Given these findings, we suggest that the CAS is useful for hiPSC-NS/PCs banking for clinical uses involving neural disorders and may open new avenues for future regenerative medicine. Copyright © 2015 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Evidence-based guideline summary: Evaluation, diagnosis, and management of facioscapulohumeral muscular dystrophy

PubMed Central

Tawil, Rabi; Kissel, John T.; Heatwole, Chad; Pandya, Shree; Gronseth, Gary; Benatar, Michael

2015-01-01

Objective: To develop recommendations for the evaluation, diagnosis, prognostication, and treatment of facioscapulohumeral muscular dystrophy (FSHD) from a systematic review and analysis of the evidence. Methods: Relevant articles were analyzed in accordance with the American Academy of Neurology classification of evidence schemes for diagnostic, prognostic, and treatment studies. Recommendations were linked to the strength of the evidence and other factors. Results and recommendations: Available genetic testing for FSHD type 1 is highly sensitive and specific. Although respiratory insufficiency occurs rarely in FSHD, patients with severe FSHD should have routine pulmonary function testing. Routine cardiac screening is not necessary in patients with FSHD without cardiac symptoms. Symptomatic retinal vascular disease is very rare in FSHD. Exudative retinopathy, however, is potentially preventable, and patients with large deletions should be screened through dilated indirect ophthalmoscopy. The prevalence of clinically relevant hearing loss is not clear. In clinical practice, patients with childhood-onset FSHD may have significant hearing loss. Because undetected hearing loss may impair language development, screening through audiometry is recommended for such patients. Musculoskeletal pain is common in FSHD and treating physicians should routinely inquire about pain. There is at present no effective pharmacologic intervention in FSHD. Available studies suggest that scapular fixation is safe and effective. Surgical scapular fixation might be cautiously offered to selected patients. Aerobic exercise in FSHD appears to be safe and potentially beneficial. On the basis of the evidence, patients with FSHD might be encouraged to engage in low-intensity aerobic exercises. PMID:26215877

MO-A-16A-01: QA Procedures and Metrics: In Search of QA Usability

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

Sathiaseelan, V; Thomadsen, B

Radiation therapy has undergone considerable changes in the past two decades with a surge of new technology and treatment delivery methods. The complexity of radiation therapy treatments has increased and there has been increased awareness and publicity about the associated risks. In response, there has been proliferation of guidelines for medical physicists to adopt to ensure that treatments are delivered safely. Task Group recommendations are copious, and clinical physicists' hours are longer, stretched to various degrees between site planning and management, IT support, physics QA, and treatment planning responsibilities.Radiation oncology has many quality control practices in place to ensure themore » delivery of high-quality, safe treatments. Incident reporting systems have been developed to collect statistics about near miss events at many radiation oncology centers. However, tools are lacking to assess the impact of these various control measures. A recent effort to address this shortcoming is the work of Ford et al (2012) who recently published a methodology enumerating quality control quantification for measuring the effectiveness of safety barriers. Over 4000 near-miss incidents reported from 2 academic radiation oncology clinics were analyzed using quality control quantification, and a profile of the most effective quality control measures (metrics) was identified.There is a critical need to identify a QA metric to help the busy clinical physicists to focus their limited time and resources most effectively in order to minimize or eliminate errors in the radiation treatment delivery processes. In this symposium the usefulness of workflows and QA metrics to assure safe and high quality patient care will be explored.Two presentations will be given:Quality Metrics and Risk Management with High Risk Radiation Oncology ProceduresStrategies and metrics for quality management in the TG-100 Era Learning Objectives: Provide an overview and the need for QA usability metrics: Different cultures/practices affecting the effectiveness of methods and metrics. Show examples of quality assurance workflows, Statistical process control, that monitor the treatment planning and delivery process to identify errors. To learn to identify and prioritize risks and QA procedures in radiation oncology. Try to answer the question: Can a quality assurance program aided by quality assurance metrics help minimize errors and ensure safe treatment delivery. Should such metrics be institution specific.« less

Residential Tornado Safe Rooms from Commodity Wood Products: Wall Development and Impact Testing

Treesearch

Robert H. Falk; James J. Bridwell; John C. Hermanson

2015-01-01

In the United States, tornadoes cause significant damage and result in many injuries and deaths. Although the development and use of tornado safe rooms and shelters have helped reduce the human toll associated with these events, the cost of these structures is often too high for many that could benefit from their use. The development of a residential tornado safe room...

Femtosecond laser eye surgery: the first clinical experience

NASA Astrophysics Data System (ADS)

Juhasz, Tibor; Kurtz, Ron M.; Horvath, Christopher; Suarez, Carlos G.; Nordan, Lee; Slade, Steven

2002-04-01

A brief review of commercial applications of femtosecond lasers in a clinical setting with emphasis on applications to corneal surgery is presented. The first clinical results of 208 procedures conducted from June to November 2000 is reported. The results show that femtosecond lasers may be safely used as keratome for use in LASIK procedures.

Why Physics in Medicine?

PubMed

Samei, Ehsan; Grist, Thomas M

2018-05-18

Despite its crucial role in the development of new medical imaging technologies, in clinical practice, physics has primarily been involved in the technical evaluation of technologies. However, this narrow role is no longer adequate. New trajectories in medicine call for a stronger role for physics in the clinic. The movement toward evidence-based, quantitative, and value-based medicine requires physicists to play a more integral role in delivering innovative precision care through the intentional clinical application of physical sciences. There are three aspects of this clinical role: technology assessment based on metrics as they relate to expected clinical performance, optimized use of technologies for patient-centered clinical outcomes, and retrospective analysis of imaging operations to ensure attainment of expectations in terms of quality and variability. These tasks fuel the drive toward high-quality, consistent practice of medical imaging that is patient centered, evidence based, and safe. While this particular article focuses on imaging, this trajectory and paradigm is equally applicable to the multitudes of the applications of physics in medicine. Copyright © 2018 American College of Radiology. Published by Elsevier Inc. All rights reserved.

[Gadolinium-based contrast agents for magnetic resonance imaging].

PubMed

Carrasco Muñoz, S; Calles Blanco, C; Marcin, Javier; Fernández Álvarez, C; Lafuente Martínez, J

2014-06-01

Gadolinium-based contrast agents are increasingly being used in magnetic resonance imaging. These agents can improve the contrast in images and provide information about function and metabolism, increasing both sensitivity and specificity. We describe the gadolinium-based contrast agents that have been approved for clinical use, detailing their main characteristics based on their chemical structure, stability, and safety. In general terms, these compounds are safe. Nevertheless, adverse reactions, the possibility of nephrotoxicity from these compounds, and the possibility of developing nephrogenic systemic fibrosis will be covered in this article. Lastly, the article will discuss the current guidelines, recommendations, and contraindications for their clinical use, including the management of pregnant and breast-feeding patients. Copyright © 2014 SERAM. Published by Elsevier Espana. All rights reserved.

Evolution of rational vaccine designs for genital herpes immunotherapy.

PubMed

Kaufmann, Johanna Katharina; Flechtner, Jessica Baker

2016-04-01

Immunotherapeutic vaccines have emerged as a novel treatment modality for genital herpes, a sexually transmitted disease mainly caused by herpes simplex virus type 2. The approaches to identify potential vaccine antigens have evolved from classic virus attenuation and characterization of antibody and T cell responses in exposed, but seronegative individuals, to systematic screens for novel T cell antigens. Combined with implementation of novel vaccine concepts revolving around immune evasion and local recruitment of immune effectors, the development of a safe and effective therapeutic vaccine is within reach. Here, we describe the vaccine approaches that currently show promise at clinical and pre-clinical stages and link them to the evolving scientific strategies that led to their identification. Copyright © 2016 Elsevier B.V. All rights reserved.

FDA: Evidentiary Standards for Drug Development and Approval

PubMed Central

Katz, Russell

2004-01-01

Summary: The United States Food and Drug Administration is charged with approving drug treatments that have been shown to be safe and effective. Relevant statutes and regulations provide a legal framework for establishing safety and effectiveness that is sufficiently flexible to ensure that appropriate scientific data are collected for specific treatments targeted to particular diseases. Nonetheless, all clinical trials proposed to establish effectiveness must incorporate common elements in order for the appropriate legal and scientific standards of drug approval to be met. This article will discuss the relevant laws and regulations pertaining to the current effectiveness standard and will discuss the most important clinical trial design elements currently considered acceptable for applications for treatments of neurologic and psychiatric illness. PMID:15717032

A clinical trial of supervised exercise for adult inpatients with acute myeloid leukemia (AML) undergoing induction chemotherapy☆

PubMed Central

Alibhai, Shabbir M.H.; O’Neill, Sara; Fisher-Schlombs, Karla; Breunis, Henriette; Brandwein, Joseph M.; Timilshina, Narhari; Tomlinson, George A.; Klepin, Heidi D.; Culos-Reed, S. Nicole

2013-01-01

Patients with acute myeloid leukemia (AML) receiving induction chemotherapy (IC) were enrolled in a supervised exercise intervention to determine safety, feasibility, and efficacy. Physical fitness measures, quality of life (QOL) and fatigue were assessed using standardized measures at baseline, post-induction, and post first consolidation. Retention was excellent, the intervention was safe, and efficacy estimates suggested benefits in physical fitness and QOL outcomes. Exercise is a safe, promising intervention for improving fitness and QOL in this patient population. These results provide a foundation for a randomized trial to better understand the impact of exercise during IC on clinically important outcomes. PMID:22726923

Is High Fidelity Simulation the Most Effective Method for the Development of Non-Technical Skills in Nursing? A Review of the Current Evidence

PubMed Central

Lewis, Robin; Strachan, Alasdair; Smith, Michelle McKenzie

2012-01-01

Aim: To review the literature on the use of simulation in the development of non-technical skills in nursing Background: The potential risks to patients associated with learning 'at the bedside' are becoming increasingly unacceptable, and the search for innovative education and training methods that do not expose the patient to preventable errors continues. All the evidence shows that a significant proportion of adverse events in health care is caused by problems relating to the application of the 'non-technical' skills of communication, teamwork, leadership and decision-making. Results: Simulation is positively associated with significantly improved interpersonal communication skills at patient handover, and it has also been clearly shown to improve team behaviours in a wide variety of clinical contexts and clinical personnel, associated with improved team performance in the management of crisis situations. It also enables the effective development of transferable, transformational leadership skills, and has also been demonstrated to improve students' critical thinking and clinical reasoning in complex care situations, and to aid in the development of students' self-efficacy and confidence in their own clinical abilities. Conclusion: High fidelity simulation is able to provide participants with a learning environment in which to develop non-technical skills, that is safe and controlled so that the participants are able to make mistakes, correct those mistakes in real time and learn from them, without fear of compromising patient safety. Participants in simulation are also able to rehearse the clinical management of rare, complex or crisis situations in a valid representation of clinical practice, before practising on patients. PMID:22893783

Development of an Ultra-Safe Rechargeable Lithium-Ion Battery.

DTIC Science & Technology

1994-11-15

34 DEVELOPMENT OF AN ULTRA-SAFE RECHARGEABLE LITHIUM - ION BATTERY DTIC \\ JANI 0 1995 19941221 079 Contract # N00014-94-C-0141 ARPA Order...DEVELOPMENT OF AN ULTRA-SAFE RECHARGEABLE LITHIUM - ION BATTERY R&D STATUS REPORT 1931-1001/0 ARPA Order No.: 9332004arp01/13APR1994/313ES Program Code...Title of Work: Lithium - ion Battery Development Reporting Period: August 15, 1994 to November 15, 1994 Description of Progress: The project activities had

Safe delivery and newborn care practices in Sindh, Pakistan: a community-based investigation of mothers and health workers.

PubMed

Hassan, Hamid; Jokhio, Abdul Hakeem; Winter, Heather; Macarthur, Christine

2012-08-01

to determine the prevalence of specific intrapartum practices in Sindh province, Pakistan. a cross-sectional, questionnaire based study. 6 health clinics in Mirpurkhas, Sindh province, rural Pakistan. 225 mothers and 82 health workers. outcome measures were indicators of safe delivery practices and referral following an obstetric complication. Prevalence of unhygienic and unsafe practices in deliveries attended by Traditional Birth Attendants (TBAs) was common. Deliveries by skilled attendants were significantly safer but with some failures in hygienic practices. 29% of women who had experienced an obstetric complication had not received emergency obstetric care. safe delivery practices and newborn care needs to be improved in rural Pakistan. This may be achieved by training health workers and TBAs in safe delivery practices, using safe delivery kits and with an effective referral system. Copyright © 2011 Elsevier Ltd. All rights reserved.

MicroRNA therapeutics: towards a new era for the management of cancer and other diseases.

PubMed

Rupaimoole, Rajesha; Slack, Frank J

2017-03-01

In just over two decades since the discovery of the first microRNA (miRNA), the field of miRNA biology has expanded considerably. Insights into the roles of miRNAs in development and disease, particularly in cancer, have made miRNAs attractive tools and targets for novel therapeutic approaches. Functional studies have confirmed that miRNA dysregulation is causal in many cases of cancer, with miRNAs acting as tumour suppressors or oncogenes (oncomiRs), and miRNA mimics and molecules targeted at miRNAs (antimiRs) have shown promise in preclinical development. Several miRNA-targeted therapeutics have reached clinical development, including a mimic of the tumour suppressor miRNA miR-34, which reached phase I clinical trials for treating cancer, and antimiRs targeted at miR-122, which reached phase II trials for treating hepatitis. In this article, we describe recent advances in our understanding of miRNAs in cancer and in other diseases and provide an overview of current miRNA therapeutics in the clinic. We also discuss the challenge of identifying the most efficacious therapeutic candidates and provide a perspective on achieving safe and targeted delivery of miRNA therapeutics.

Self-neglect: adaptation of a clinical tool to the practice of the medical examiner.

PubMed

Sauvageau, Anny; Hunter, Brian C

2012-09-01

Self-neglect is the inability or unwillingness to provide for oneself the goods and services needed to live safely and independently. It is the most common allegation reported to Adult Protective Services agencies throughout the United States. Unfortunately, it seems that most medical examiners and their teams are not trained appropriately on self-neglect and forget to ask pertinent questions and document relevant observations. The most important aspect of self-neglect for the medical examiner is to recognize the diagnosis to avoid confusion with other forms of elder abuse, particularly neglect from a third party. In this context, a self-neglect scale could be a useful tool to assist the death investigation team. In the clinical field, a self-neglect severity scale was developed by the Consortium for Research in Elder Self-Neglect of Texas. It is here proposed that a self-neglect severity scale for medical examiners should be developed, to assist the investigative team in assessing these common cases. This scale is developed by modifying the clinical scale to adapt it to the particular needs of death investigation. This scale can help the medical examiner and his team in approaching these deaths in a systematic and comprehensive way.

Natural orifice translumenal endoscopic surgery: Progress in humans since white paper

PubMed Central

Santos, Byron F; Hungness, Eric S

2011-01-01

Since the first description of the concept of natural orifice translumenal endoscopic surgery (NOTES), a substantial number of clinical NOTES reports have appeared in the literature. This editorial reviews the available human data addressing research questions originally proposed by the white paper, including determining the optimal method of access for NOTES, developing safe methods of lumenal closure, suturing and anastomotic devices, advanced multitasking platforms, addressing the risk of infection, managing complications, addressing challenges with visualization, and training for NOTES procedures. An analysis of the literature reveals that so far transvaginal access and closure appear to be the most feasible techniques for NOTES, with a limited, but growing transgastric, transrectal, and transesophageal NOTES experience in humans. The theoretically increased risk of infection as a result of NOTES procedures has not been substantiated in transvaginal and transgastric procedures so far. Development of suturing and anastomotic devices and advanced platforms for NOTES has progressed slowly, with limited clinical data on their use so far. Data on the optimal management and incidence of intraoperative complications remain sparse, although possible factors contributing to complications are discussed. Finally, this editorial discusses the likely direction of future NOTES development and its possible role in clinical practice. PMID:21483624

Developing a Clinical-Grade Cryopreservation Protocol for Human Testicular Tissue and Cells

PubMed Central

Pacchiarotti, Jason; Ramos, Thomas; Howerton, Kyle; Greilach, Scott; Zaragoza, Karina; Olmstead, Marnie; Izadyar, Fariborz

2013-01-01

Recent work in preservation of female fertility as well as new information on the nature of spermatogonial stem cells has prompted an investigation into the possibility of an effective clinical-grade procedure for the cryopreservation of testicular cells and/or tissue. Clinical-grade reagents, validated equipment, and protocols consistent with cGTP/cGMP standards were used in developing a procedure suitable for the safe and effective cryopreservation of human testicular cells and tissues. These procedures were designed to be compliant with the relevant FDA regulations. The procedure proved to effectively cryopreserve both testicular cells and tissue. The cryopreservation of testicular tissue was comparable in most aspects we measured to the cryopreservation of isolated cells, except that the viability of the cells from cryopreserved testicular tissue was found to be significantly higher. On the other hand, cryopreservation of cells is preferred for cell analysis, quality control, and sterility testing. This study demonstrates that testicular tissue and cells from sexual reassignment patients can be successfully cryopreserved with a clinical-grade procedure and important cell populations are not only preserved but also enriched by the process. Further studies will determine whether these findings from hormone-treated patients can be generalized to other patients. PMID:23509810

Improving clinical handover in a paediatric ward: implications for nursing management.

PubMed

Mannix, Trudi; Parry, Yvonne; Roderick, Allison

2017-04-01

To describe how nursing staff in a paediatric ward improved the conduct of clinical handover, using a practise development approach. ISBAR (Identify, Situation, Background, Assessment and Recommendation) is a mnemonic tool to aid the safe transfer of patient information in clinical handover. The nurses identified the need to improve the use of ISBAR, and other issues related to handover that could compromise patient safety and constrain family-centred care. Sixty-one percent of nurses on the ward contributed to issue identification and the design of the educational material, including a set of written and video resources and incorporating the role of a handover coach. Staff performance was evaluated before and after access to the resources using self-administered Likert scales, observation and a focus group. After the intervention, there was a stronger relationship between the participants' understanding of ISBAR and their application of it in handover. Further, there were statistically significant increases in improved handover practises, including family inclusion and safety checks. A practise development approach is useful in the provision of education to guide clinical performance in patient handover. Nurse managers can use this approach to empower their staff to make positive changes to practise. © 2017 John Wiley & Sons Ltd.

Tanezumab in the treatment of chronic musculoskeletal conditions.

PubMed

Jayabalan, Prakash; Schnitzer, Thomas J

2017-02-01

The management of pain associated with chronic musculoskeletal conditions represents a significant challenge for the clinician. There remains a need for novel medications that have a significant analgesic benefit and are also safe and well tolerated. Both pre-clinical and clinical data have provided evidence of the role of nerve growth factor (NGF) in a multitude of pain eliciting conditions. Therefore, the development of monoclonal antibodies to NGF for chronic painful musculoskeletal conditions has generated interest. Areas covered: This manuscript is a review that examines both the pharmacological properties and clinical studies of tanezumab, the most widely studied antibody to NGF, for management of osteoarthritis (OA) and low back pain. In addition, the safety and tolerability profile and development history of tanezumab are also discussed. Expert opinion: Most studies provide strong support for the ability of tanezumab to provide clinically meaningful pain relief in individuals with these conditions, with longer-term studies suggesting durability of effect. The adverse event profile appears favorable, assuming the risk mitigation strategies are effective at reducing the incidence of joint-related side effects. Further data are being collected to define the optimal dose and dosing strategy in both OA and chronic low back pain.

Cellular Therapies Clinical Research Roadmap: lessons learned on how to move a cellular therapy into a clinical trial.

PubMed

Ouseph, Stacy; Tappitake, Darah; Armant, Myriam; Wesselschmidt, Robin; Derecho, Ivy; Draxler, Rebecca; Wood, Deborah; Centanni, John M

2015-04-01

A clinical research roadmap has been developed as a resource for researchers to identify critical areas and potential pitfalls when transitioning a cellular therapy product from the research laboratory, by means of an Investigational New Drug (IND) application, into early-phase clinical trials. The roadmap describes four key areas: basic and preclinical research, resource development, translational research and Good Manufacturing Practice (GMP) and IND assembly and submission. Basic and preclinical research identifies a new therapeutic concept and demonstrates its potential value with the use of a model of the relevant disease. During resource development, the appropriate specialists and the required expertise to bring this product into the clinic are identified (eg, researchers, regulatory specialists, GMP manufacturing staff, clinicians and clinical trials staff, etc). Additionally, the funds required to achieve this goal (or a plan to procure them) are identified. In the next phase, the plan to translate the research product into a clinical-grade therapeutic is developed. Finally regulatory approval to start the trial must be obtained. In the United States, this is done by filing an IND application with the Food and Drug Administration. The National Heart, Lung and Blood Institute-funded Production Assistance for Cellular Therapies program has facilitated the transition of a variety of cellular therapy products from the laboratory into Phase1/2 trials. The five Production Assistance for Cellular Therapies facilities have assisted investigators by performing translational studies and GMP manufacturing to ensure that cellular products met release specifications and were manufactured safely, reproducibly and at the appropriate scale. The roadmap resulting from this experience is the focus of this article. Copyright © 2015 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Breast Cancer: Treatment Options

MedlinePlus

... A clinical trial is a research study that tests a new approach to treatment. Doctors want to learn whether the new treatment is safe, effective, and possibly better than the standard treatment. Clinical trials can test a new drug and how often it should ...

Undergraduate interprofessional education using high-fidelity paediatric simulation.

PubMed

Stewart, Moira; Kennedy, Neil; Cuene-Grandidier, Hazel

2010-06-01

High-fidelity simulation is becoming increasingly important in the delivery of teaching and learning to health care professionals within a safe environment. Its use in an interprofessional context and at undergraduate level has the potential to facilitate the learning of good communication and teamworking, in addition to clinical knowledge and skills. Interprofessional teaching and learning workshops using high-fidelity paediatric simulation were developed and delivered to undergraduate medical and nursing students at Queen's University Belfast. Learning outcomes common to both professions, and essential in the clinical management of sick children, included basic competencies, communication and teamworking skills. Quantitative and qualitative evaluation was undertaken using published questionnaires. Quantitative results - the 32-item questionnaire was analysed for reliability using spss. Responses were positive for both groups of students across four domains - acquisition of knowledge and skills, communication and teamworking, professional identity and role awareness, and attitudes to shared learning. Qualitative results - thematic content analysis was used to analyse open-ended responses. Students from both groups commented that an interprofessional education (IPE) approach to paediatric simulation improved clinical and practice-based skills, and provided a safe learning environment. Students commented that there should be more interprofessional and simulation learning opportunities. High-fidelity paediatric simulation, used in an interprofessional context, has the potential to meet the requirements of undergraduate medical and nursing curricula. Further research is needed into the long-term benefits for patient care, and its generalisability to other areas within health care teaching and learning. © Blackwell Publishing Ltd 2010.

Expanding choices in intranasal steroid therapy: summary of a roundtable meeting.

PubMed

Blaiss, Michael S; Benninger, Michael S; Fromer, Len; Gross, Gary; Mabry, Richard; Mahr, Todd; Marple, Bradley; Stoloff, Stuart

2006-01-01

Intranasal steroids (INSs) are recommended as first-line treatment for allergic rhinitis (AR) and a wealth of data exist supporting them as safe and effective. Our goal was to develop a consensus to help physicians choose between INSs by focusing on clinical profiles and patient preferences and providing expert advice on choosing the appropriate INS for each patient. Experts from specialties that manage patients with AR attended a roundtable meeting to discuss INS therapy. Besides comparisons with other pharmacologic agents, they examined the effects of INS on nasal anatomy, patient preferences for INS, and benefits of product selection based on patient profile. The literature on INSs in AR was reviewed, examining properties of the various drugs, delivery devices, formulations, and patient preference data. Nasal anatomy and physiology must be considered to optimize INS deposition in the nose. Teaching patients proper technique for using INS devices is important to prevent nasal injury and may help concentrate drug effect on affected tissues. INS therapies differ somewhat in biological properties and specific formulation; however, all are considered safe and effective treatment for AR. Patients exhibit different clinical profiles, which play a role in INS selection. Patients can clearly identify sensory characteristics of INS and therefore establish product preference. Patient preference also can guide physicians in choosing the appropriate agent for each patient. Control of AR requires a systematic approach to treatment selection and follow-up. Treatment selection should be matched with clinical profile and patient preferences.

Email triage is an effective, efficient and safe way of managing new referrals to a neurologist.

PubMed

Patterson, Victor; Humphreys, Jenny; Henderson, Mark; Crealey, Grainne

2010-10-01

Patients referred to secondary care in the UK often wait many months to be seen, and the UK government has announced various initiatives to address this issue. Since 2002, we have developed an email referral system which allows some neurological referrals to be managed by advice and investigations rather than by a conventional hospital clinic appointment. This system has previously been shown to reduce clinic attendances and to be acceptable to patients and their general practitioners (GPs). To analyse the effects of an email triage system on waiting times, cost of care and safety over 5 years. Referral numbers and waiting times for clinics using this system were analysed. Cost was determined by comparing detailed costs with those of conventional care. Safety was analysed by examining the GP records of all patients referred from a single practice who had been dealt with by advice or investigation, noting deaths, re-referrals and changes in diagnosis. Waiting times fell from 72 to 4 weeks, despite an increase in referrals. The cost per patient of email referral was about £100, compared with £152 for conventional care, a 35% reduction. Safety data on 120 individuals showed a minor change in diagnosis in three. This system is safe, effective (in reducing waiting times) and efficient. It enables neurologists to focus on patients with significant neurological disease and, if applied more widely, could reduce costs and waiting times for neurology services in the UK.

Day-case surgery for total hip and knee replacement: How safe and effective is it?

PubMed

Lazic, Stefan; Boughton, Oliver; Kellett, Catherine F; Kader, Deiary F; Villet, Loïc; Rivière, Charles

2018-04-01

Multimodal protocols for pain control, blood loss management and thromboprophylaxis have been shown to benefit patients by being more effective and as safe (fewer iatrogenic complications) as conventional protocols.Proper patient selection and education, multimodal protocols and a well-defined clinical pathway are all key for successful day-case arthroplasty.By potentially being more effective, cheaper than and as safe as inpatient arthroplasty, day-case arthroplasty might be beneficial for patients and healthcare systems. Cite this article: EFORT Open Rev 2018;3:130-135. DOI: 10.1302/2058-5241.3.170031.

TH-D-BRC-01: Panel Member

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

Aydogan, B.

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

TH-D-BRC-02: Panel Member

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

Hahn, S.

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

TH-D-BRC-04: Panel Member

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

Yu, C.

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

TH-D-BRC-03: Panel Member

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

Paganetti, H.

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

HIV-1 Immunogen: an overview of almost 30 years of clinical testing of a candidate therapeutic vaccine.

PubMed

Graziani, Gina M; Angel, Jonathan B

2016-07-01

Although current antiretroviral therapy (ART) has transformed HIV infection into a chronic, manageable disease, ART does not cure HIV infection. Furthermore, the majority of the world's infected individuals live in resource-limited countries in which access to ART is limited. Thus, the development of an effective therapeutic HIV vaccine would be an invaluable treatment alternative. Developed by the late Dr. Jonas Salk, HIV-1 Immunogen (Remune®) is a candidate therapeutic vaccine that has been studied in thousands of HIV-infected individuals in more than a dozen clinical trials during almost three decades. This Drug Evaluation, which summarizes the results of these trials that have shown the vaccine to be safe and immunogenic, also discusses the contradictory and controversial conclusions drawn from the phases 2, 2/3 and 3 trials that assessed the clinical efficacy of this vaccine. Given the lack of unequivocal clinical benefits of HIV-1 Immunogen despite almost 30 years of extensive testing, it does not appear, in our view, that this vaccine is a clinically effective immunotherapy. However, inclusion of this vaccine in the newly proposed 'Kick/Shock and Kill' strategy for HIV eradication, or use as a prophylactic vaccine, could be considered for future trials.

How we used a patient visit tracker tool to advance experiential learning in systems-based practice and quality improvement in a medical student clinic.

PubMed

Chen, Chen Amy; Park, Ryan J; Hegde, John V; Jun, Tomi; Christman, Mitalee P; Yoo, Sun M; Yamasaki, Alisa; Berhanu, Aaron; Vohra-Khullar, Pamela; Remus, Kristin; Schwartzstein, Richard M; Weinstein, Amy R

2016-01-01

Poorly designed healthcare systems increase costs and preventable medical errors. To address these issues, systems-based practice (SBP) education provides future physicians with the tools to identify systemic errors and implement quality improvement (QI) initiatives to enhance the delivery of cost-effective, safe and multi-disciplinary care. Although SBP education is being implemented in residency programs and is mandated by the Accreditation Council for Graduate Medical Education (ACGME) as one of its core competencies, it has largely not been integrated into undergraduate medical education. We propose that Medical Student-Faculty Collaborative Clinics (MSFCCs) may be the ideal environment in which to train medical students in SBPs and QI initiatives, as they allow students to play pivotal roles in project development, administration, and management. Here we describe a process of experiential learning that was developed within a newly established MSFCC, which challenged students to identify inefficiencies, implement interventions, and track the results. After identifying bottlenecks in clinic operations, our students designed a patient visit tracker tool to monitor clinic flow and implemented solutions to decrease patient visit times. Our model allowed students to drive their own active learning in a practical clinical setting, providing early and unique training in crucial QI skills.

Clinical and financial considerations for implementing an ICU telemedicine program.

PubMed

Kruklitis, Robert J; Tracy, Joseph A; McCambridge, Matthew M

2014-06-01

As the population in the United States increases and ages, the need to provide high-quality, safe, and cost-effective care to the most critically ill patients will be of great importance. With the projected shortage of intensivists, innovative changes to improve efficiency and increase productivity will be necessary. Telemedicine programs in the ICUs (tele-ICUs) are a successful strategy to improve intensivist access to critically ill patients. Although significant capital and maintenance costs are associated with tele-ICUs, these costs can be offset by indirect financial benefits, such as decreased length of stay. To achieve the positive clinical outcomes desired, tele-ICUs must be carefully designed and implemented. In this article, we discuss the clinical benefits of tele-ICUs. We review the financial considerations, including direct and indirect reimbursement and development and maintenance costs. Finally, we review design and implementation considerations for tele-ICUs.

25 Years of Proton Pump Inhibitors: A Comprehensive Review.

PubMed

Strand, Daniel S; Kim, Daejin; Peura, David A

2017-01-15

Proton pump inhibitors (PPIs) were clinically introduced more than 25 years ago and have since proven to be invaluable, safe, and effective agents for the management of a variety of acid-related disorders. Although all members in this class act in a similar fashion, inhibiting active parietal cell acid secretion, there are slight differences among PPIs relating to their pharmacokinetic properties, metabolism, and Food and Drug Administration (FDA)-approved clinical indications. Nevertheless, each is effective in managing gastroesophageal reflux disease and uncomplicated or complicated peptic ulcer disease. Despite their overall efficacy, PPIs do have some limitations related to their short plasma half-lives and requirement for meal-associated dosing, which can lead to breakthrough symptoms in some individuals, especially at night. Longer-acting PPIs and technology to prolong conventional PPI activity have been developed to specifically address these limitations and may improve clinical outcomes.

25 Years of Proton Pump Inhibitors: A Comprehensive Review

PubMed Central

Strand, Daniel S.; Kim, Daejin; Peura, David A.

2017-01-01

Proton pump inhibitors (PPIs) were clinically introduced more than 25 years ago and have since proven to be invaluable, safe, and effective agents for the management of a variety of acid-related disorders. Although all members in this class act in a similar fashion, inhibiting active parietal cell acid secretion, there are slight differences among PPIs relating to their pharmacokinetic properties, metabolism, and Food and Drug Administration (FDA)-approved clinical indications. Nevertheless, each is effective in managing gastroesophageal reflux disease and uncomplicated or complicated peptic ulcer disease. Despite their overall efficacy, PPIs do have some limitations related to their short plasma half-lives and requirement for meal-associated dosing, which can lead to breakthrough symptoms in some individuals, especially at night. Longer-acting PPIs and technology to prolong conventional PPI activity have been developed to specifically address these limitations and may improve clinical outcomes. PMID:27840364

Noninvasive neuromodulation in migraine and cluster headache.

PubMed

Starling, Amaal

2018-06-01

The purpose of this narrative review is to provide an overview of the currently available noninvasive neuromodulation devices for the treatment of migraine and cluster headache. Over the last decade, several noninvasive devices have undergone development and clinical trials to evaluate efficacy and safety. Based on this body of work, single-pulse transcranial magnetic stimulation, transcutaneous supraorbital neurostimulation, and noninvasive vagal nerve stimulation devices have been cleared by the United States Food and Drug Administration and are available for clinical use for the treatment of primary headache disorders. Overall, these novel noninvasive devices appear to be safe, well tolerated, and have demonstrated promising results in clinical trials in both migraine and cluster headache. This narrative review will provide a summary and update of the proposed mechanisms of action, evidence, safety, and future directions of various currently available modalities of noninvasive neuromodulation for the treatment of migraine and cluster headache.

Current Status and Perspectives of Hyperthermia in Cancer Therapy

NASA Astrophysics Data System (ADS)

Hiraoka, Masahiro; Nagata, Yasushi; Mitsumori, Michihide; Sakamoto, Masashi; Masunaga, Shin-ichiro

2004-08-01

Clinical trials of hyperthermia in combination with radiation therapy or chemotherapy undertaken over the past decades in Japan have been reviewed. Originally developed heating devices were mostly used for these trials, which include RF (radiofrequency) capacitive heating devices, a microwave heating device with a lens applicator, an RF intracavitary heating device, an RF current interstitial heating device, and ferromagnetic implant heating device. Non-randomized trials for various cancers, demonstrated higher response rate in thermoradiotherapy than in radiotherapy alone. Randomized trials undertaken for esophageal cancers also demonstrated improved local response with the combined use of hyperthermia. Furthermore, the complications associated with treatment were not generally serious. These clinical results indicate the benefit of combined treatment of hyperthermia and radiotherapy for various malignancies. On the other hand, the presently available heating devices are not satisfactory from the clinical viewpoints. With the advancement of heating and thermometry technologies, hyperthermia will be more widely and safely used in the treatment of cancers.

PEGylated Bovine Carboxyhemoglobin (SANGUINATE™): Results of Clinical Safety Testing and Use in Patients.

PubMed

Abuchowski, A

2016-01-01

Oxygen transfer agents have long been sought as a means to treat hypoxia caused by congenital or acquired conditions. Hemoglobin-based oxygen carriers were in clinical development as blood substitutes, but development was halted due to the finding of significant vasoactivity. Rather than develop a blood substitute, a product for indications characterized by hypoxia is in development. PEGylated bovine carboxyhemoglobin (SANGUINATE™) is both a carbon monoxide releasing molecule and an oxygen transfer agent. It is comprised of three functional components that act to inhibit vasoconstriction, reduce inflammation and optimize the delivery of oxygen. SANGUINATE has the potential to reduce or prevent the effects of ischemia by inhibiting vasoconstriction and re-oxygenating tissue. Phase 1 safety trials in healthy volunteers were completed in 2013. SANGUINATE was shown to be safe and well tolerated with no serious adverse effects. Phase Ib studies have been completed in stable patients with Sickle Cell Disease. SANGUINATE has also been administered to two patients under emergency use protocols. Both patients exhibited improved status following treatment with SANGUINATE.

An Elective Course on the Basic and Clinical Sciences Aspects of Vitamins and Minerals

PubMed Central

2013-01-01

Objective. To develop and implement an elective course on vitamins and minerals and their usefulness as dietary supplements. Design. A 2-credit-hour elective course designed to provide students with the most up-to-date basic and clinical science information on vitamins and minerals was developed and implemented in the doctor of pharmacy (PharmD) curriculum. In addition to classroom lectures, an active-learning component was incorporated in the course in the form of group discussion. Assessment. Student learning was demonstrated by examination scores. Performance on pre- and post-course surveys administered in 2011 demonstrated a significant increase in students’ knowledge of the basic and clinical science aspects of vitamins and minerals, with average scores increasing from 61% to 86%. At the end of the semester, students completed a standard course evaluation. Conclusion. An elective course on vitamin and mineral supplements was well received by pharmacy students and helped them to acquire knowledge and competence in patient counseling regarding safe, appropriate, effective, and economical use of these products. PMID:23463149

Canakinumab: a human anti-IL-1β monoclonal antibody for the treatment of cryopyrin-associated periodic syndromes.

PubMed

Church, Leigh D; McDermott, Michael F

2010-11-01

The cryopyrin-associated periodic syndromes (CAPS) are a group of rare inherited inflammatory diseases associated with overproduction of IL-1β. Canakinumab, developed by Novartis AG (Basel, Switzerland), is an intravenously or subcutaneously administered, fully human monoclonal antibody that neutralizes the bioactivity of human IL-1β. Canakinumab has promising clinical safety and pharmacokinetic properties, and has demonstrated potential for the treatment of CAPS. Canakinumab was recently granted EU orphan drug status for systemic-onset juvenile idiopathic arthritis, and early clinical trials have established that administration of canakinumab every 2 weeks is both safe and effective. Subcutaneous canakinumab (approved formulation) offers some advantages over the existing IL-1β-blocking treatment, anakinra, which must be injected daily and is often not well tolerated by patients. The long-term safety of all targeted anti-IL-1 therapies in CAPS remains an unanswered question owing to the relatively short clinical experience with these agents; as canakinumab produces sustained IL-1 suppression, vigilance is necessary to diagnose the development of adverse events, especially any associated infections.

Critical thinking: the development of an essential skill for nursing students.

PubMed

Papathanasiou, Ioanna V; Kleisiaris, Christos F; Fradelos, Evangelos C; Kakou, Katerina; Kourkouta, Lambrini

2014-08-01

Critical thinking is defined as the mental process of actively and skillfully perception, analysis, synthesis and evaluation of collected information through observation, experience and communication that leads to a decision for action. In nursing education there is frequent reference to critical thinking and to the significance that it has in daily clinical nursing practice. Nursing clinical instructors know that students face difficulties in making decisions related to clinical practice. The main critical thinking skills in which nursing students should be exercised during their studies are critical analysis, introductory and concluding justification, valid conclusion, distinguish of facts and opinions, evaluation the credibility of information sources, clarification of concepts and recognition of conditions. Specific behaviors are essentials for enhancing critical thinking. Nursing students in order to learn and apply critical thinking should develop independence of thought, fairness, perspicacity in personal and social level, humility, spiritual courage, integrity, perseverance, self-confidence, interest for research and curiosity. Critical thinking is an essential process for the safe, efficient and skillful nursing practice. The nursing education programs should adopt attitudes that promote critical thinking and mobilize the skills of critical reasoning.

A research review on clinical needs, technical requirements, and normativity in the design of surgical robots.

PubMed

Díaz, Carlos Eduardo; Fernández, Roemi; Armada, Manuel; García, Felipe

2017-12-01

Nowadays robots play an important role in society, mainly due to the significant benefits they provide when utilized for assisting human beings in the execution of dangerous or repetitive tasks. Medicine is one of the fields in which robots are gaining greater use and development, especially those employed in minimally invasive surgery (MIS). However, due to the particular conditions of the human body where robots have to act, the design of these systems is complex, not only from a technical point of view, but also because the clinical needs and the normativity aspects are important considerations that have to be taken into account in order to achieve better performances and more secure systems for patients and surgeons. Thus, this paper explores the clinical needs and the technical requirements that will trace the roadmap for the next scientific and technological advances in the field of robotic surgery, the metrics that should be defined for safe technology development and the standards that are being elaborated for boosting the industry and facilitating systems integration. Copyright © 2017 John Wiley & Sons, Ltd.

Critical Thinking: The Development of an Essential Skill for Nursing Students

PubMed Central

Papathanasiou, Ioanna V.; Kleisiaris, Christos F.; Fradelos, Evangelos C.; Kakou, Katerina; Kourkouta, Lambrini

2014-01-01

Critical thinking is defined as the mental process of actively and skillfully perception, analysis, synthesis and evaluation of collected information through observation, experience and communication that leads to a decision for action. In nursing education there is frequent reference to critical thinking and to the significance that it has in daily clinical nursing practice. Nursing clinical instructors know that students face difficulties in making decisions related to clinical practice. The main critical thinking skills in which nursing students should be exercised during their studies are critical analysis, introductory and concluding justification, valid conclusion, distinguish of facts and opinions, evaluation the credibility of information sources, clarification of concepts and recognition of conditions. Specific behaviors are essentials for enhancing critical thinking. Nursing students in order to learn and apply critical thinking should develop independence of thought, fairness, perspicacity in personal and social level, humility, spiritual courage, integrity, perseverance, self-confidence, interest for research and curiosity. Critical thinking is an essential process for the safe, efficient and skillful nursing practice. The nursing education programs should adopt attitudes that promote critical thinking and mobilize the skills of critical reasoning. PMID:25395733

Gadolinium-based contrast agent toxicity: a review of known and proposed mechanisms.

PubMed

Rogosnitzky, Moshe; Branch, Stacy

2016-06-01

Gadolinium chelates are widely used as contrast media for magnetic resonance imaging. The approved gadolinium-based contrast agents (GBCAs) have historically been considered safe and well tolerated when used at recommended dosing levels. However, for nearly a decade, an association between GBCA administration and the development of nephrogenic systemic fibrosis (NSF) has been recognized in patients with severe renal impairment. This has led to modifications in clinical practices aimed at reducing the potential and incidence of NSF development. Newer reports have emerged regarding the accumulation of gadolinium in various tissues of patients who do not have renal impairment, including bone, brain, and kidneys. Despite the observations of gadolinium accumulation in tissues regardless of renal function, very limited clinical data regarding the potential for and mechanisms of toxicity is available. This significant gap in knowledge warrants retrospective cohort study efforts, as well as prospective studies that involve gadolinium ion (Gd(3+)) testing in patients exposed to GBCA. This review examines the potential biochemical and molecular basis of gadolinium toxicity, possible clinical significance of gadolinium tissue retention and accumulation, and methods that can limit gadolinium body burden.

Safety Assurance Factors for Electronic Health Record Resilience (SAFER): study protocol

PubMed Central

2013-01-01

Background Implementation and use of electronic health records (EHRs) could lead to potential improvements in quality of care. However, the use of EHRs also introduces unique and often unexpected patient safety risks. Proactive assessment of risks and vulnerabilities can help address potential EHR-related safety hazards before harm occurs; however, current risk assessment methods are underdeveloped. The overall objective of this project is to develop and validate proactive assessment tools to ensure that EHR-enabled clinical work systems are safe and effective. Methods/Design This work is conceptually grounded in an 8-dimension model of safe and effective health information technology use. Our first aim is to develop self-assessment guides that can be used by health care institutions to evaluate certain high-risk components of their EHR-enabled clinical work systems. We will solicit input from subject matter experts and relevant stakeholders to develop guides focused on 9 specific risk areas and will subsequently pilot test the guides with individuals representative of likely users. The second aim will be to examine the utility of the self-assessment guides by beta testing the guides at selected facilities and conducting on-site evaluations. Our multidisciplinary team will use a variety of methods to assess the content validity and perceived usefulness of the guides, including interviews, naturalistic observations, and document analysis. The anticipated output of this work will be a series of self-administered EHR safety assessment guides with clear, actionable, checklist-type items. Discussion Proactive assessment of patient safety risks increases the resiliency of health care organizations to unanticipated hazards of EHR use. The resulting products and lessons learned from the development of the assessment guides are expected to be helpful to organizations that are beginning the EHR selection and implementation process as well as those that have already implemented EHRs. Findings from our project, currently underway, will inform future efforts to validate and implement tools that can be used by health care organizations to improve the safety of EHR-enabled clinical work systems. PMID:23587208

Raman Shifted Nd:YAG Class I Eye-Safe Laser Development 21 January 1986

NASA Astrophysics Data System (ADS)

Nichols, R. W.; Ng, W. K.

1986-07-01

Hughes Aircraft has been developing a hand-held eye-safe laser rangefinder fo1r the Army utilizing Stimulated Raman Scattering technology. The device uses the 2915 cm-1 vibrational mode of methane (CH4) to wavelength shift the Nd:YAG pump laser's 1.064 micron to an eye-safe 1.543 micron. The result is a lightweight BRH Class I eye-safe tactical device. A brief description of Raman wavelength shifting basics is followed by description of the Hughes system.

Investigative safety science as a competitive advantage for Pharma.

PubMed

Moggs, Jonathan; Moulin, Pierre; Pognan, Francois; Brees, Dominique; Leonard, Michele; Busch, Steve; Cordier, Andre; Heard, David J; Kammüller, Michael; Merz, Michael; Bouchard, Page; Chibout, Salah-Dine

2012-09-01

Following a US National Academy of Sciences report in 2007 entitled "Toxicity Testing of the 21st Century: a Vision and a Strategy," significant advances within translational drug safety sciences promise to revolutionize drug discovery and development. The purpose of this review is to outline why investigative safety science is a competitive advantage for the pharmaceutical industry. The article discusses the essential goals for modern investigative toxicologists including: cross-species target biology; molecular pathways of toxicity; and development of predictive tools, models and biomarkers that allow discovery researchers and clinicians to anticipate safety problems and plan ways to address them, earlier than ever before. Furthermore, the article emphasizes the importance of investigating unanticipated clinical safety signals through a combination of mechanistic preclinical studies and/or molecular characterization of clinical samples from affected organs. The traditional boundaries between pharma industry teams focusing on safety/efficacy and preclinical/clinical development are rapidly disappearing in favor of translational safety science-centric organizations with a vision of bringing more effective medicines forward safely and quickly. Comparative biology and mechanistic toxicology approaches facilitate: i) identifying translational safety biomarkers; ii) identifying new drug targets/indications; and iii) mitigating off-target toxicities. These value-adding safety science contributions will change traditional toxicologists from side-effect identifiers to drug development enablers.

History of Right Heart Catheterization: 100 Years of Experimentation and Methodology Development

PubMed Central

Nossaman, Bobby D.; Scruggs, Brittni A.; Nossaman, Vaughn E.; Murthy, Subramanyam N.; Kadowitz, Philip J.

2010-01-01

The development of right heart catheterization has provided the clinician the ability to diagnose patients with congenital and acquired right heart disease, and to monitor patients in the ICU with significant cardiovascular illnesses. The development of bedside pulmonary artery catheterization has become a standard of care for the critically ill patient since its introduction into the ICU almost 40 years ago. However, adoption of this procedure into the mainstream of clinical practice occurred without prior evaluation or demonstration of its clinical or cost-effectiveness. Moreover, current randomized, controlled trials provide little evidence in support of the clinical utility of pulmonary artery catheterization in the management of critically ill patients. Nevertheless, the right heart catheter is an important diagnostic tool to assist the clinician in the diagnosis of congenital heart disease and acquired right heart disease, and moreover, when catheter placement is proximal to the right auricle (atria), this catheter provides an important and safe route for administration of fluids, medications, and parenteral nutrition. The purpose of this manuscript is to review the development of right heart catheterization that led to the ability to conduct physiologic studies in cardiovascular dynamics in normal individuals and in patients with cardiovascular diseases, and to review current controversies of the extension of the right heart catheter, the pulmonary artery catheter. PMID:20160536

Recommendations regarding technical standards for follow-on biologics: comparability, similarity, interchangeability.

PubMed

Davis, Gregory C; Beals, John M; Johnson, Craig; Mayer, Mark H; Meiklejohn, Bruce I; Mitlak, Bruce H; Roth, Jody L; Towns, John K; Veenhuizen, Melissa

2009-07-01

Policy makers around the world are currently considering the creation of a regulatory pathway for follow-on biologics (FOB), which will have to account for the substantial technical challenges associated with FOB development. These challenges will likely involve more complexity than comparability assessments of process changes made by the same manufacturer. The history of industry-regulator comparability discussions helps explain why the same degree of testing and flexibility now applied to change-control within a manufacturer's own process, at this time, cannot be extrapolated to the observed and possibly unknown differences between two manufacturing processes that are independently developed by different (non-collaborating) parties. This commentary provides recommendations on the technical aspects that should be considered in the creation of an approval pathway for FOB products. In the authors' view, analytical methodology in its current state cannot alone provide full assurance that the FOB is sufficiently similar to the innovator product. Moreover, the FOB manufacturer will not have access to the extensive knowledge accumulated by the innovator manufacturer from early development through marketing. Thus, extensive clinical evaluation will likely be necessary to provide assurance that the FOB is safe and efficacious. If such testing demonstrates the FOB is safe and efficacious per existing regulatory standards, the product should receive marketing approval as a 'similar' product. Since 'similarity' is a fundamentally different determination than establishing interchangeability between the two products, an interchangeability determination must be based on additional testing and market experience to ensure patient safety. Post-marketing surveillance of the FOB should be conducted to ensure that the approved molecule has similar clinical safety and efficacy as the innovator product, prior to any consideration of interchangeability.

IMOJEV(®): a Yellow fever virus-based novel Japanese encephalitis vaccine.

PubMed

Appaiahgari, Mohan Babu; Vrati, Sudhanshu

2010-12-01

Japanese encephalitis (JE) is a disease of the CNS caused by Japanese encephalitis virus (JEV). The disease appears in the form of frequent outbreaks in most south- and southeast Asian countries and the virus has become endemic in several areas. There is no licensed therapy available and disease control by vaccination is considered to be most effective. Mouse brain-derived inactivated JE vaccines, although immunogenic, have several limitations in terms of safety, availability and requirement for multiple doses. Owing to these drawbacks, the WHO called for the development of novel, safe and more efficacious JE vaccines. Several candidate vaccines have been developed and at least three of them that demonstrated strong immunogenicity after one or two doses of the vaccine in animal models were subsequently tested in various clinical trials. One of these vaccines, IMOJEV(®) (JE-CV and previously known as ChimeriVax™-JE), is a novel recombinant chimeric virus vaccine, developed using the Yellow fever virus (YFV) vaccine vector YFV17D, by replacing the cDNA encoding the envelope proteins of YFV with that of an attenuated JEV strain SA14-14-2. IMOJEV was found to be safe, highly immunogenic and capable of inducing long-lasting immunity in both preclinical and clinical trials. Moreover, a single dose of IMOJEV was sufficient to induce protective immunity, which was similar to that induced in adults by three doses of JE-VAX(®), a mouse brain-derived inactivated JE vaccine. Recently, Phase III trials evaluating the immunogenicity and safety of the chimeric virus vaccine have been successfully completed in some JE-endemic countries and the vaccine manufacturers have filed an application for vaccine registration. IMOJEV may thus be licensed for use in humans as an improved alternative to the currently licensed JE vaccines.

Evidence-based guideline summary: Evaluation, diagnosis, and management of facioscapulohumeral muscular dystrophy: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology and the Practice Issues Review Panel of the American Association of Neuromuscular & Electrodiagnostic Medicine.

PubMed

Tawil, Rabi; Kissel, John T; Heatwole, Chad; Pandya, Shree; Gronseth, Gary; Benatar, Michael

2015-07-28

To develop recommendations for the evaluation, diagnosis, prognostication, and treatment of facioscapulohumeral muscular dystrophy (FSHD) from a systematic review and analysis of the evidence. Relevant articles were analyzed in accordance with the American Academy of Neurology classification of evidence schemes for diagnostic, prognostic, and treatment studies. Recommendations were linked to the strength of the evidence and other factors. Available genetic testing for FSHD type 1 is highly sensitive and specific. Although respiratory insufficiency occurs rarely in FSHD, patients with severe FSHD should have routine pulmonary function testing. Routine cardiac screening is not necessary in patients with FSHD without cardiac symptoms. Symptomatic retinal vascular disease is very rare in FSHD. Exudative retinopathy, however, is potentially preventable, and patients with large deletions should be screened through dilated indirect ophthalmoscopy. The prevalence of clinically relevant hearing loss is not clear. In clinical practice, patients with childhood-onset FSHD may have significant hearing loss. Because undetected hearing loss may impair language development, screening through audiometry is recommended for such patients. Musculoskeletal pain is common in FSHD and treating physicians should routinely inquire about pain. There is at present no effective pharmacologic intervention in FSHD. Available studies suggest that scapular fixation is safe and effective. Surgical scapular fixation might be cautiously offered to selected patients. Aerobic exercise in FSHD appears to be safe and potentially beneficial. On the basis of the evidence, patients with FSHD might be encouraged to engage in low-intensity aerobic exercises. © 2015 American Academy of Neurology.

New era of biologic therapeutics in atopic dermatitis.

PubMed

Guttman-Yassky, Emma; Dhingra, Nikhil; Leung, Donald Y M

2013-04-01

Atopic dermatitis (AD) is a common inflammatory skin disease regulated by genetic and environmental factors. Both skin barrier defects and aberrant immune responses are believed to drive cutaneous inflammation in AD. Existing therapies rely largely on allergen avoidance, emollients and topical and systemic immune-suppressants, some with significant toxicity and transient efficacy; no specific targeted therapies are in clinical use today. As our specific understanding of the immune and molecular pathways that cause different subsets of AD increases, a variety of experimental agents, particularly biologic agents that target pathogenic molecules bring the promise of safe and effective therapeutics for long-term use. This paper discusses the molecular pathways characterizing AD, the contributions of barrier and immune abnormalities to its pathogenesis, and development of new treatments that target key molecules in these pathways. In this review, we will discuss a variety of biologic therapies that are in development or in clinical trials for AD, perhaps revolutionizing treatment of this disease. Biologic agents in moderate to severe AD offer promise for controlling a disease that currently lacks good and safe therapeutics posing a large unmet need. Unfortunately, existing treatments for AD aim to decrease cutaneous inflammation, but are not specific for the pathways driving this disease. An increasing understanding of the immune mechanisms underlying AD brings the promise of narrow targeted therapies as has occurred for psoriasis, another inflammatory skin disease, for which specific biologic agents have been demonstrated to both control the disease and prevent occurrence of new skin lesions. Although no biologic is yet approved for AD, these are exciting times for active therapeutic development in AD that might lead to revolutionary therapeutics for this disease.

Nursing students' perceptions of learning in practice environments: a review.

PubMed

Henderson, Amanda; Cooke, Marie; Creedy, Debra K; Walker, Rachel

2012-04-01

Effective clinical learning requires integration of nursing students into ward activities, staff engagement to address individual student learning needs, and innovative teaching approaches. Assessing characteristics of practice environments can provide useful insights for development. This study identified predominant features of clinical learning environments from nursing students' perspectives across studies using the same measure in different countries over the last decade. Six studies, from three different countries, using the Clinical Leaning Environment Inventory (CLEI) were reviewed. Studies explored consistent trends about learning environment. Students rated sense of task accomplishment high. Affiliation also rated highly though was influenced by models of care. Feedback measuring whether students' individual needs and views were accommodated consistently rated lower. Across different countries students report similar perceptions about learning environments. Clinical learning environments are most effective in promoting safe practice and are inclusive of student learners, but not readily open to innovation and challenges to routine practices. Crown Copyright © 2011. Published by Elsevier Ltd. All rights reserved.

CAR T-cell therapy for glioblastoma: ready for the next round of clinical testing?

PubMed

Prinzing, Brooke L; Gottschalk, Stephen M; Krenciute, Giedre

2018-05-01

The outcome for patients with glioblastoma (GBM) remains poor, and there is an urgent need to develop novel therapeutic approaches. T cells genetically modified with chimeric antigen receptors (CARs) hold the promise to improve outcomes since they recognize and kill cells through different mechanisms than conventional therapeutics. Areas covered: This article reviews CAR design, tumor associated antigens expressed by GBMs that can be targeted with CAR T cells, preclinical and clinical studies conducted with CAR T cells, and genetic approaches to enhance their effector function. Expert commentary: While preclinical studies have highlighted the potent anti-GBM activity of CAR T cells, the initial foray of CAR T-cell therapies into the clinic resulted only in limited benefits for GBM patients. Additional genetic modification of CAR T cells has resulted in a significant increase in their anti-GBM activity in preclinical models. We are optimistic that clinical testing of these enhanced CAR T cells will be safe and result in improved anti-glioma activity in GBM patients.

Undergraduate community health nursing education in a neighborhood settlement house.

PubMed

Nettle, C; Jones, S

2001-01-01

Undergraduate community health nursing faculty are continually challenged to find appropriate clinical placements. Prior to using an inner-city neighborhood settlement house as a clinical site, traditional public health and home-care agencies provided clinical placements for senior baccalaureate nursing students. The settlement house had several programs but did not have a traditional nursing department. A 14-item questionnaire was developed to examine student (N = 30) perceptions of the opportunities for course objectives to be met and student attitudes and beliefs regarding the settlement-house placement. The majority of the students agreed that the learning experiences at the settlement house provided opportunities to meet course objectives. Findings indicated that students who considered the neighborhood safe are more apt to recommend the clinical placement to other students (p < .01). Those students who believe that professional nursing services can help improve the health of people who live in the inner city are more apt to say, "This experience changed my beliefs regarding people who live in an inner-city neighborhood" (p < .01).

Rotary powered device for bone marrow aspiration and biopsy yields excellent specimens quickly and efficiently.

PubMed

Swords, Ronan T; Kelly, Kevin R; Cohen, Stephen C; Miller, Larry J; Philbeck, Thomas E; Hacker, Sander O; Spadaccini, Cathy J; Giles, Francis J; Brenner, Andrew J

2010-06-01

Recently, a new FDA-cleared battery powered bone marrow biopsy system was developed to allow operators access to the bone marrow space quickly and efficiently. A pre-clinical evaluation of the device (OnControl, Vidacare Corporation, San Antonio, TX, USA) on anesthetized pigs was conducted, in addition to a clinical evaluation in hematology clinic patients requiring a bone marrow biopsy. Twenty-six samples were collected from the swine model. No cellular artifact or thermal damage was reported in any of the samples obtained. For the clinical evaluation of the device, 16 patients were recruited. Mean time from needle contact with skin to needle removal was 38.5 +/- 13.94 seconds. No complications were reported. In this study, the manual and powered samples were equivalent in specimen quality. In the patients evaluated, the device was safe, easy to use and the mean procedural time was significantly faster than previously reported with a manual technique.

Skin Barrier Restoration and Moisturization Using Horse Oil-Loaded Dissolving Microneedle Patches.

PubMed

Lee, Chisong; Eom, Younghyon Andrew; Yang, Huisuk; Jang, Mingyu; Jung, Sang Uk; Park, Ye Oak; Lee, Si Eun; Jung, Hyungil

2018-01-01

Horse oil (HO) has skin barrier restoration and skin-moisturizing effects. Although cream formulations have been used widely and safely, their limited penetration through the stratum corneum is a major obstacle to maximizing the cosmetic efficacy of HO. Therefore, we aimed to encapsulate HO in a cosmetic dissolving microneedle (DMN) for efficient transdermal delivery. To overcome these limitations of skin permeation, HO-loaded DMN (HO-DMN) patches were developed and evaluated for their efficacy and safety using in vitro and clinical studies. Despite the lipophilic nature of HO, the HO-DMN patches had a sharp shape and uniform array, with an average length and tip diameter of 388.36 ± 16.73 and 38.54 ± 5.29 µm, respectively. The mechanical strength of the HO-DMN patches was sufficient (fracture force of 0.29 ± 0.01 N), and they could successfully penetrate pig skin. During the 4-week clinical evaluation, HO-DMN patches caused significant improvements in skin and dermal density, skin elasticity, and moisturization. Additionally, a brief safety assessment showed that the HO-DMN patches induced negligible adverse events. The HO-DMNs are efficient, safe, and convenient for wide use in cosmetic applications for skin barrier restoration and moisturization. © 2018 S. Karger AG, Basel.

Febuxostat: drug review and update.

PubMed

Grewal, Harmanjot K; Martinez, Joseph R; Espinoza, Luis R

2014-05-01

Gouty arthritis and hyperuricemia have ailed humans for centuries. Recent advances in understanding of the mechanism(s) of their development have changed our perception of the disease process. Despite these gains, the treatment options available are limited. The FDA approval of febuxostat for the treatment of hyperuricemia in gout has been a significant step forward. Since its approval in 2009, febuxostat has proven to be safe and efficacious although concerns remain regarding its long-term effects and superiority to other uricosuric agents, such as allopurinol. A comprehensive literature review of PubMed and Ovid examining clinical trials and post-marketing studies yielded congruent findings on efficacy and safety in elderly populations and those with mild-to-moderate renal/hepatic impairment. A lack of literature and clinical studies was found with regard to comparison of febuxostat to FDA-approved high-dose allopurinol (> 300 mg), the safety of febuxostat in the treatment of severe renal/hepatic impairment and the benefit in the treatment of secondary cases of hyperuricemia. Febuxostat is effective in the treatment of mild-to-moderate renal/hepatic impairment with dramatic effects on the serum urate level. It can be used safely in patients with hypersensitivity reactions to allopurinol. Further research is needed to determine the long-term benefits and risks.

Commissioning of a conformal irradiation system for heavy-ion radiotherapy using a layer-stacking method.

PubMed

Kanai, Tatsuaki; Kanematsu, Nobuyuki; Minohara, Shinichi; Komori, Masataka; Torikoshi, Masami; Asakura, Hiroshi; Ikeda, Noritoshi; Uno, Takayuki; Takei, Yuka

2006-08-01

The commissioning of conformal radiotherapy system using heavy-ion beams at the Heavy Ion Medical Accelerator in Chiba (HIMAC) is described in detail. The system at HIMAC was upgraded for a clinical trial using a new technique: large spot uniform scanning with conformal layer stacking. The system was developed to localize the irradiation dose to the target volume more effectively than with the old system. With the present passive irradiation method using a ridge filter, a scatterer, a pair of wobbler magnets, and a multileaf collimator, the width of the spread-out Bragg peak (SOBP) in the radiation field could not be changed. With dynamic control of the beam-modifying devices during irradiation, a more conformal radiotherapy could be achieved. In order to safely perform treatments with this conformal therapy, the moving devices should be watched during irradiation and the synchronousness among the devices should be verified. This system, which has to be safe for patient irradiations, was constructed and tested for safety and for the quality of the dose localization realized. Through these commissioning tests, we were successfully able to prepare the conformal technique using layer stacking for patients. Subsequent to commissioning the technique has been applied to patients in clinical trials.

Improved wound management by regulated negative pressure-assisted wound therapy and regulated, oxygen- enriched negative pressure-assisted wound therapy through basic science research and clinical assessment.

PubMed

Topaz, Moris

2012-05-01

Regulated negative pressure-assisted wound therapy (RNPT) should be regarded as a state-of-the-art technology in wound treatment and the most important physical, nonpharmaceutical, platform technology developed and applied for wound healing in the last two decades. RNPT systems maintain the treated wound's environment as a semi-closed, semi-isolated system applying external physical stimulations to the wound, leading to biological and biochemical effects, with the potential to substantially influence wound-host interactions, and when properly applied may enhance wound healing. RNPT is a simple, safe, and affordable tool that can be utilized in a wide range of acute and chronic conditions, with reduced need for complicated surgical procedures, and antibiotic treatment. This technology has been shown to be effective and safe, saving limbs and lives on a global scale. Regulated, oxygen-enriched negative pressure-assisted wound therapy (RO-NPT) is an innovative technology, whereby supplemental oxygen is concurrently administered with RNPT for their synergistic effect on treatment and prophylaxis of anaerobic wound infection and promotion of wound healing. Understanding the basic science, modes of operation and the associated risks of these technologies through their fundamental clinical mechanisms is the main objective of this review.

Exercise in Pregnancy: A Clinical Review.

PubMed

Hinman, Sally K; Smith, Kristy B; Quillen, David M; Smith, M Seth

2015-01-01

Health professionals who care for pregnant women should discuss potential health benefits and harms of exercise. Although most pregnant women do not meet minimal exercise recommendations, there are a growing number of physically active women who wish to continue training throughout pregnancy. A search of the Web of Science database of articles and reviews available in English through 2014. The search terms exercise pregnancy, strenuous exercise pregnancy, and vigorous exercise pregnancy were used. Clinical review. Level 3. With proper attention to risk stratification and surveillance, exercise is safe for the mother and fetus. Benefits of exercise in pregnancy include reduction in Cesarean section rates, appropriate maternal and fetal weight gain, and managing gestational diabetes. Exercise as a means of preventing gestational diabetes, preeclampsia, or perinatal depression cannot be reliably supported. Overall, the current evidence suffers from a lack of rigorous study design and compliance with physical activity interventions. Research thus far has been unable to consistently demonstrate proposed benefits of exercise in pregnancy, such as preventing gestational diabetes, preeclampsia, or perinatal depression. However, moderate- and high-intensity exercise in normal pregnancies is safe for the developing fetus and clearly has several important benefits. Thus, exercise should be encouraged according to the woman's preconception physical activity level. © 2015 The Author(s).

Bacteriophage-Derived Vectors for Targeted Cancer Gene Therapy

PubMed Central

Pranjol, Md Zahidul Islam; Hajitou, Amin

2015-01-01

Cancer gene therapy expanded and reached its pinnacle in research in the last decade. Both viral and non-viral vectors have entered clinical trials, and significant successes have been achieved. However, a systemic administration of a vector, illustrating safe, efficient, and targeted gene delivery to solid tumors has proven to be a major challenge. In this review, we summarize the current progress and challenges in the targeted gene therapy of cancer. Moreover, we highlight the recent developments of bacteriophage-derived vectors and their contributions in targeting cancer with therapeutic genes following systemic administration. PMID:25606974

Bacteriophage-derived vectors for targeted cancer gene therapy.

PubMed

Pranjol, Md Zahidul Islam; Hajitou, Amin

2015-01-19

Cancer gene therapy expanded and reached its pinnacle in research in the last decade. Both viral and non-viral vectors have entered clinical trials, and significant successes have been achieved. However, a systemic administration of a vector, illustrating safe, efficient, and targeted gene delivery to solid tumors has proven to be a major challenge. In this review, we summarize the current progress and challenges in the targeted gene therapy of cancer. Moreover, we highlight the recent developments of bacteriophage-derived vectors and their contributions in targeting cancer with therapeutic genes following systemic administration.

A New Whooping Cough Vaccine That May Prevent Colonization and Transmission.

PubMed

Brennan, Michael J

2017-11-10

This article is a Letter to the Editor. The major purpose of this Letter is to highlight the development of a new genetically altered whooping cough vaccine. Recently a baboon model has been used to show that this next generation pertussis vaccine can prevent colonization, as well as disease, and elicit antibodies against major pertussis antigens. Two phase I clinical trials have been performed, showing that this new vaccine is safe in humans, and a phase II trial will be performed in the US in 2018.

Strategy in Regulatory Decision-Making for Management of Progressive Multifocal Leukoencephalopathy.

PubMed

Segec, A; Keller-Stanislawski, B; Vermeer, N S; Macchiarulo, C; Straus, S M; Hidalgo-Simon, A; De Bruin, M L

2015-11-01

Progressive multifocal leukoencephalopathy (PML) has been observed after the use of several medicines, including monoclonal antibodies. As these drugs play important roles in the therapeutic armamentarium, it is important to address the challenges that this severe adverse reaction poses to the safe use of medicines. Considering the need for consistent outcomes of regulatory decisions, the European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC) used PML as an example to develop a systematic approach to labeling and risk minimization. © 2015 American Society for Clinical Pharmacology and Therapeutics.

A Unique Approach to Dissemination of Evidence-Based Protocols: A Successful CAUTI Reduction Pilot.

PubMed

Dols, Jean Dowling; White, Sondra K; Timmons, Amy L; Bush, Michelle; Tripp, Joanne; Childers, Amanda Kay; Mathers, Nicholas; Tobias, Maria M

2016-01-01

A unique approach to disseminate an evidence-based protocol for urinary catheter management was led by a staff-driven catheter-associated urinary tract infection (CAUTI) reduction team in one hospital. The nurseeducators, faculty from a local university, and the facility's clinical nurse leader mentored the team. As an approachto reduce CAUTIs in the transplant care and intensive care units, the team developed an interdisciplinary CAUTIEducation Fair, which provided a safe, nonthreateningenvironment to unlearn prior behaviors and showcompetency in new evidence-based ones.

The gonial angle stripper: an instrument for the treatment of prominent gonial angle.

PubMed

Kyutoku, S; Yanagida, A; Kusumoto, K; Ogawa, Y

1994-12-01

In the Orient, a prominent gonial angle, so-called benign masseteric hypertrophy, is rather common and considered unattractive. Therefore, its surgical correction is one of the most popular forms of facial skeletal contouring. For accurate and safe osteotomy of the mandibular angle region, a gonial angle stripper was specially invented. It has a small projection that will ease identification of the osteotomy line in a narrow operative field. The tool has been clinically used in eight patients to prove its usefulness, especially for a posteriorly developed mandibular angle.

Professional Development Strategies to Enhance Nurses' Knowledge and Maintain Safe Practice.

PubMed

Bindon, Susan L

2017-08-01

Maintaining competence is a professional responsibility for nurses. Individual nurses are accountable for their practice, as outlined in the American Nurses Association's Nursing: Scope and Standards of Practice. Nurses across clinical settings face the sometimes daunting challenge of staying abreast of regulatory mandates, practice changes, equipment updates, and other workplace expectations. In the complex, evolving perioperative setting, professional development is a priority, and the need for ongoing education is critical. However, nurses' efforts to engage in their own development can be hampered by a lack of time, limited access to educational resources, or cost concerns. This article provides an overview of nursing professional development and offers some resources to help individual nurses maintain or enhance their knowledge, skills, and attitudes. Copyright © 2017 AORN, Inc. Published by Elsevier Inc. All rights reserved.

Clinical decision support systems: data quality management and governance.

PubMed

Liaw, Siaw-Teng

2013-01-01

This chapter examines data quality management (DQM) and information governance (IG) of electronic decision support (EDS) systems so that they are safe and fit for use by clinicians and patients and their carers. This is consistent with the ISO definition of data quality as being fit for purpose. The scope of DQM & IG should range from data creation and collection in clinical settings, through cleaning and, where obtained from multiple sources, linkage, storage, use by the EDS logic engine and algorithms, knowledge base and guidance provided, to curation and presentation. It must also include protocols and mechanisms to monitor the safety of EDS, which will feedback into DQM & IG activities. Ultimately, DQM & IG must be integrated across the data cycle to ensure that the EDS systems provide guidance that leads to safe and effective clinical decisions and care.

Improving clinical outcomes and patient experience through the use of desloughing.

PubMed

Grothier, Lorraine

2015-09-01

This article focuses on and aims to clarify the role of desloughing as a priority in modern-day wound care. Ambiguity around identification and slough removal has long been a clinical challenge. Effective removal of slough involves the elimination of dead and devitalised tissue as quickly and safely as possible, to enable the wound to return to a healthy state that supports healing. Desloughing is usually associated with typically conservative techniques compared with those used to debride necrotic tissue. More specific and timely targeted action to recognise and remove slough safely will significantly improve the clinical outcomes for patients as well as influence the effective use of scarce resources. The illustrative format of this article will facilitate how clinicians can become familiar with the different types of slough and the appropriate removal techniques.

A Pilot Project Demonstrating that Combat Medics Can Safely Administer Parenteral Medications in the Emergency Department.

PubMed

Schauer, Steven G; Cunningham, Cord W; Fisher, Andrew D; DeLorenzo, Robert A

2017-12-01

Introduction Select units in the military have improved combat medic training by integrating their functions into routine clinical care activities with measurable improvements in battlefield care. This level of integration is currently limited to special operations units. It is unknown if regular Army units and combat medics can emulate these successes. The goal of this project was to determine whether US Army combat medics can be integrated into routine emergency department (ED) clinical care, specifically medication administration. Project Design This was a quality assurance project that monitored training of combat medics to administer parenteral medications and to ensure patient safety. Combat medics were provided training that included direct supervision during medication administration. Once proficiency was demonstrated, combat medics would prepare the medications under direct supervision, followed by indirect supervision during administration. As part of the quality assurance and safety processes, combat medics were required to document all medication administrations, supervising provider, and unexpected adverse events. Additional quality assurance follow-up occurred via complete chart review by the project lead. Data During the project period, the combat medics administered the following medications: ketamine (n=13), morphine (n=8), ketorolac (n=7), fentanyl (n=5), ondansetron (n=4), and other (n=6). No adverse events or patient safety events were reported by the combat medics or discovered during the quality assurance process. In this limited case series, combat medics safely administered parenteral medications under indirect provider supervision. Future research is needed to further develop this training model for both the military and civilian setting. Schauer SG , Cunningham C W, Fisher AD , DeLorenzo RA . A pilot project demonstrating that combat medics can safely administer parenteral medications in the emergency department. Prehosp Disaster Med. 2017;32(6):679-681.

The development and evaluation of a 'blended' enquiry based learning model for mental health nursing students: "making your experience count".

PubMed

Rigby, Lindsay; Wilson, Ian; Baker, John; Walton, Tim; Price, Owen; Dunne, Kate; Keeley, Philip

2012-04-01

To meet the demands required for safe and effective care, nurses must be able to integrate theoretical knowledge with clinical practice (Kohen and Lehman, 2008; Polit and Beck, 2008; Shirey, 2006). This should include the ability to adapt research in response to changing clinical environments and the changing needs of service users. It is through reflective practice that students develop their clinical reasoning and evaluation skills to engage in this process. This paper aims to describe the development, implementation and evaluation of a project designed to provide a structural approach to the recognition and resolution of clinical, theoretical and ethical dilemmas identified by 3rd year undergraduate mental health nursing students. This is the first paper to describe the iterative process of developing a 'blended' learning model which provides students with an opportunity to experience the process of supervision and to become more proficient in using information technology to develop and maintain their clinical skills. Three cohorts of student nurses were exposed to various combinations of face to face group supervision and a virtual learning environment (VLE) in order to apply their knowledge of good practice guidelines and evidenced-based practice to identified clinical issues. A formal qualitative evaluation using independently facilitated focus groups was conducted with each student cohort and thematically analysed (Miles & Huberman, 1994). The themes that emerged were: relevance to practice; facilitation of independent learning; and the discussion of clinical issues. The results of this study show that 'blending' face-to-face groups with an e-learning component was the most acceptable and effective form of delivery which met the needs of students' varied learning styles. Additionally, students reported that they were more aware of the importance of clinical supervision and of their role as supervisees. Copyright © 2011 Elsevier Ltd. All rights reserved.

Virtual gaming to develop students' pediatric nursing skills: A usability test.

PubMed

Verkuyl, Margaret; Atack, Lynda; Mastrilli, Paula; Romaniuk, Daria

2016-11-01

As competition for specialty clinical placements increases, there is an urgent need to create safe, stimulating, alternative learning environments for students. To address that clinical gap, our team developed a virtual game-based simulation to help nursing students develop their pediatric nursing skills. A usability study was conducted using the Technology Acceptance Model as a research framework. The study was conducted at a community college and included nursing students, nursing faculty/clinicians and two gaming experts. The two experts evaluated the game using a heuristic checklist after playing the game. Participants engaged in a think-aloud activity while playing the game and completed a survey and interview based on the Technology Acceptance Model to explore ease of use and utility of the game. We found a high degree of user satisfaction with the game. Students reported that they had learned about pediatric care, they had become immersed in the game and they were keen to keep playing. Several design changes were recommended. Usability testing is critical in the early stages of simulation development and the study provided useful direction for the development team in the next stage of game development. Copyright © 2016 Elsevier Ltd. All rights reserved.

Safe Zones: Creating LGBT Safe Space Ally Programs

ERIC Educational Resources Information Center

Poynter, Kerry John; Tubbs, Nancy Jean

2008-01-01

This article discusses model LGBT Safe Space Ally programs. These programs, often called "Safe Zones," include self selected students, faculty, and employees who publicly show support by displaying stickers, signs, and other identifiable items. Issues covered in the article include history, development, training, membership, assessment, and…

A Strategy to Safely Live and Work in the Space Radiation Environment

NASA Technical Reports Server (NTRS)

Corbin, Barbara J.; Sulzman, Frank M.; Krenek, Sam

2006-01-01

The goal of the National Aeronautics and Space Agency and the Space Radiation Project is to ensure that astronauts can safely live and work in the space radiation environment. The space radiation environment poses both acute and chronic risks to crew health and safety, but unlike some other aspects of space travel, space radiation exposure has clinically relevant implications for the lifetime of the crew. The term safely means that risks are sufficiently understood such that acceptable limits on mission, post-mission and multi-mission consequences (for example, excess lifetime fatal cancer risk) can be defined. The Space Radiation Project strategy has several elements. The first element is to use a peer-reviewed research program to increase our mechanistic knowledge and genetic capabilities to develop tools for individual risk projection, thereby reducing our dependency on epidemiological data and population-based risk assessment. The second element is to use the NASA Space Radiation Laboratory to provide a ground-based facility to study the understanding of health effects/mechanisms of damage from space radiation exposure and the development and validation of biological models of risk, as well as methods for extrapolation to human risk. The third element is a risk modeling effort that integrates the results from research efforts into models of human risk to reduce uncertainties in predicting risk of carcinogenesis, central nervous system damage, degenerative tissue disease, and acute radiation effects. To understand the biological basis for risk, we must also understand the physical aspects of the crew environment. Thus the fourth element develops computer codes to predict radiation transport properties, evaluate integrated shielding technologies and provide design optimization recommendations for the design of human space systems. Understanding the risks and determining methods to mitigate the risks are keys to a successful radiation protection strategy.

Consensus Recommendations for the Clinical Application of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Depression.

PubMed

McClintock, Shawn M; Reti, Irving M; Carpenter, Linda L; McDonald, William M; Dubin, Marc; Taylor, Stephan F; Cook, Ian A; O'Reardon, John; Husain, Mustafa M; Wall, Christopher; Krystal, Andrew D; Sampson, Shirlene M; Morales, Oscar; Nelson, Brent G; Latoussakis, Vassilios; George, Mark S; Lisanby, Sarah H

To provide expert recommendations for the safe and effective application of repetitive transcranial magnetic stimulation (rTMS) in the treatment of major depressive disorder (MDD). Participants included a group of 17 expert clinicians and researchers with expertise in the clinical application of rTMS, representing both the National Network of Depression Centers (NNDC) rTMS Task Group and the American Psychiatric Association Council on Research (APA CoR) Task Force on Novel Biomarkers and Treatments. The consensus statement is based on a review of extensive literature from 2 databases (OvidSP MEDLINE and PsycINFO) searched from 1990 through 2016. The search terms included variants of major depressive disorder and transcranial magnetic stimulation. The results were limited to articles written in English that focused on adult populations. Of the approximately 1,500 retrieved studies, a total of 118 publications were included in the consensus statement and were supplemented with expert opinion to achieve consensus recommendations on key issues surrounding the administration of rTMS for MDD in clinical practice settings. In cases in which the research evidence was equivocal or unclear, a consensus decision on how rTMS should be administered was reached by the authors of this article and is denoted in the article as "expert opinion." Multiple randomized controlled trials and published literature have supported the safety and efficacy of rTMS antidepressant therapy. These consensus recommendations, developed by the NNDC rTMS Task Group and APA CoR Task Force on Novel Biomarkers and Treatments, provide comprehensive information for the safe and effective clinical application of rTMS in the treatment of MDD. © Copyright 2017 Physicians Postgraduate Press, Inc.

Expanded pharmacy technician roles: Accepting verbal prescriptions and communicating prescription transfers.

PubMed

Frost, Timothy P; Adams, Alex J

2017-11-01

As the role of the clinical pharmacist continues to develop and advance, it is critical to ensure pharmacists can operate in a practice environment and workflow that supports the full deployment of their clinical skills. When pharmacy technician roles are optimized, patient safety can be enhanced and pharmacists may dedicate more time to advanced clinical services. Currently, 17 states allow technicians to accept verbal prescriptions called in by a prescriber or prescriber's agent, or transfer a prescription order from one pharmacy to another. States that allow these activities generally put few legal limitations on them, and instead defer to the professional judgment of the supervising pharmacist whether to delegate these tasks or not. These activities were more likely to be seen in states that require technicians to be registered and certified, and in states that have accountability mechanisms (e.g., discipline authority) in place for technicians. There is little evidence to suggest these tasks cannot be performed safely and accurately by appropriately trained technicians, and the track record of success with these tasks spans four decades in some states. Pharmacists can adopt strong practice policies and procedures to mitigate the risk of harm from verbal orders, such as instituting read-back/spell-back techniques, or requiring the indication for each phoned-in medication, among other strategies. Pharmacists may also exercise discretion in deciding to whom to delegate these tasks. As the legal environment becomes more permissive, we foresee investment in more robust education and training of technicians to cover these activities. Thus, with the adoption of robust practice policies and procedures, delegation of verbal orders and prescription transfers can be safe and effective, remove undue stress on pharmacists, and potentially free up pharmacist time for higher-order clinical care. Copyright © 2016 Elsevier Inc. All rights reserved.

Chlamydia vaccine candidates and tools for chlamydial antigen discovery.

PubMed

Rockey, Daniel D; Wang, Jie; Lei, Lei; Zhong, Guangming

2009-10-01

The failure of the inactivated Chlamydia-based vaccine trials in the 1960s has led researchers studying Chlamydia to take cautious and rational approaches to develop safe and effective chlamydial vaccines. Subsequent research efforts focused on three areas. The first is the analysis of the immunobiology of chlamydial infection in animal models, with supporting clinical studies, to identify the immune correlates of both protective immunity and pathological responses. Second, recent radical improvements in genomics, proteomics and associated technologies have assisted in the implementation of creative approaches to search for suitable vaccine candidates. Third, progress in the analysis of host response and adjuvanticity regulating both innate and adaptive immunity at the mucosal site of infection has led to progress in the design of optimal delivery and adjuvant systems for enhancing protective immunity. Considerable progress has been made in the first two areas but research efforts to better define the factors that regulate immunity at mucosal sites of infection and to develop strategies to boost protective immunity via immunomodulation, effective delivery systems and potent adjuvants, have remained elusive. In this article, we will summarize progress in these areas with a focus on chlamydial vaccine antigen discovery, and discuss future directions towards the development of a safe and effective chlamydial vaccine.

NS5B RNA dependent RNA polymerase inhibitors: the promising approach to treat hepatitis C virus infections.

PubMed

Deore, R R; Chern, J-W

2010-01-01

Hepatitis C virus (HCV), a causative agent for non-A and non-B hepatitis, has infected approximately 3% of world's population. The current treatment option of ribavirin in combination with pegylated interferon possesses lower sustained virological response rates, and has serious disadvantages. Unfortunately, no prophylactic vaccine has been approved yet. Therefore, there is an unmet clinical need for more effective and safe anti-HCV drugs. HCV NS5B RNA dependent RNA polymerase is currently pursued as the most popular target to develop safe anti-HCV agents, as it is not expressed in uninfected cells. More than 25 pharmaceutical companies and some research groups have developed ≈50 structurally diverse scaffolds to inhibit NS5B. Here we provide comprehensive account of the drug development process of these scaffolds. NS5B polymerase inhibitors have been broadly classified in nucleoside and non nucleoside inhibitors and are sub classified according to their mechanism of action and structural diversities. With some additional considerations about the inhibitor bound NS5B enzyme X-ray crystal structure information and pharmacological aspects of the inhibitors, this review summarizes the lead identification, structure activity relationship (SAR) studies leading to the most potent NS5B inhibitors with subgenomic replicon activity.

[European Union Network for Patient Safety and Quality of Care (PASQ). Development and preliminary results in Europe and in the Spanish National Health System].

PubMed

Agra-Varela, Y; Fernández-Maíllo, M; Rivera-Ariza, S; Sáiz-Martínez-Acitorez, I; Casal-Gómez, J; Palanca-Sánchez, I; Bacou, J

2015-01-01

The joint action, European Union Network for Patient Safety and Quality of Care: PaSQ, aims to promote patient safety (PS) in the European Union (EU) and to facilitate the exchange of experiences among Member States (MS) and stakeholders on issues related to quality of care, PS, and patient involvement. The development and preliminary results are presented here, especially as regards the Spanish National Health System (SNHS). PaSQ is developed through 7 work packages, primarily aimed at sharing good practices (GP), which were identified using specific questionnaires and selected by means of explicit criteria, as well as to implement safe clinical practices (SCP) of proven effectiveness and agreed among MS. A total of 482 GP (39% provided by Spanish professionals) were identified. The 34 events organised in the EU, 11 including Spanish participation, facilitate sharing these practices. A total of 194 Health Care centres (49% in Spain) are implementing SCP (hand hygiene, safe surgery, medication reconciliation, and paediatric early warning scores) ACHIEVEMENTS AND FUTURE PERSPECTIVES: PaSQ is making it possible to strengthen collaboration between organizations and professionals at EU and SNHS level regarding PS and quality of care. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

Feasibility, safety and cost of outpatient management of acute minor ischaemic stroke: a population-based study.

PubMed

Paul, Nicola L M; Koton, Silvia; Simoni, Michela; Geraghty, Olivia C; Luengo-Fernandez, Ramon; Rothwell, Peter M

2013-03-01

Outpatient management safely and effectively prevents early recurrent stroke after transient ischaemic attack (TIA), but this approach may not be safe in patients with acute minor stroke. To study outcomes of clinic and hospital-referred patients with TIA or minor stroke (National Institute of Health Stroke Scale score ≤3) in a prospective, population-based study (Oxford Vascular Study). Of 845 patients with TIA/stroke, 587 (69%) were referred directly to outpatient clinics and 258 (31%) directly to inpatient services. Of the 250 clinic-referred minor strokes (mean age 72.7 years), 237 (95%) were investigated, treated and discharged on the same day, of whom 16 (6.8%) were subsequently admitted to hospital within 30 days for recurrent stroke (n=6), sepsis (n=3), falls (n=3), bleeding (n=2), angina (n=1) and nursing care (n=1). The 150 patients (mean age 74.8 years) with minor stroke referred directly to hospital (median length-of-stay 9 days) had a similar 30-day readmission rate (9/150; 6.3%; p=0.83) after initial discharge and a similar 30-day risk of recurrent stroke (9/237 in clinic patients vs 8/150, OR=0.70, 0.27-1.80, p=0.61). Rates of prescription of secondary prevention medication after initial clinic/hospital discharge were higher in clinic-referred than in hospital-referred patients for antiplatelets/anticoagulants (p<0.05) and lipid-lowering agents (p<0.001) and were maintained at 1-year follow-up. The mean (SD) secondary care cost was £8323 (13 133) for hospital-referred minor stroke versus £743 (1794) for clinic-referred cases. Outpatient management of clinic-referred minor stroke is feasible and may be as safe as inpatient care. Rates of early hospital admission and recurrent stroke were low and uptake and maintenance of secondary prevention was high.

Simulation workshops with first year midwifery students.

PubMed

Catling, Christine; Hogan, Rosemarie; Fox, Deborah; Cummins, Allison; Kelly, Michelle; Sheehan, Athena

2016-03-01

Simulated teaching methods enable a safe learning environment that are structured, constructive and reflective. We prepared a 2-day simulation project to help prepare students for their first clinical practice. A quasi-experimental pre-test - post-test design was conducted. Qualitative data from the open-ended survey questions were analysed using content analysis. Confidence intervals and p-values were calculated to demonstrate the changes in participants' levels of understanding/ability or confidence in clinical midwifery skills included in the simulation. 71 midwifery students participated. Students rated their understanding, confidence, and abilities as higher after the simulation workshop, and higher still after their clinical experience. There were five main themes arising from the qualitative data: having a learning experience, building confidence, identifying learning needs, developing communication skills and putting skills into practise. First year midwifery students felt well prepared for the clinical workplace following the simulation workshops. Self-rated understanding, confidence and abilities in clinical midwifery skills were significantly higher following consolidation during clinical placement. Longitudinal studies on the relationship between simulation activities and student's overall clinical experience, their intentions to remain in midwifery, and facility feedback, would be desirable. Copyright © 2015 Elsevier Ltd. All rights reserved.

Experimental MERS Treatment Deemed Safe in Phase I Clinical Trial | Frederick National Laboratory for Cancer Research

Cancer.gov

A small clinical study overseen by the National Institute of Allergy and Infectious Diseases (NIAID) with support from the Frederick National Laboratory for Cancer Research has found that an experimental treatment for Middle East Respiratory Syndrome

Ethics and eplerenone.

PubMed

Gupta, Shruti; Fugh-Berman, Adriane J; Scialli, Anthony

2013-02-01

The use of a placebo arm in clinical trials is unethical if there is an active comparator that is acceptably safe and effective. We argue that reasonable evidence of effectiveness and safety of an inexpensive alternative to an expensive therapy is sufficient to require that the inexpensive therapy be included as a comparator when the expensive therapy is tested, and that use of an inactive placebo comparator only is not ethical. For example, studies of the expensive drug eplerenone for congestive heart failure have not included a spironolactone arm, although there is reasonable evidence that spironolactone would be safe and effective, and spironolactone is inexpensive. The requirement to study inexpensive therapies is based on avoidance of unnecessary cost in medical care as an example of non-maleficence. Several ethical actors in the design, conduct, and publication of clinical trials and their results bear responsibility for the appropriate conduct of clinical trials. That responsibility includes protecting study subjects from being asked to participate in clinical trials that serve primarily to promote the use of new and expensive therapies.

Mayo Clinic experience with modified Vecchietti procedure for vaginal agenesis: it is easy, safe, and effective.

PubMed

Nahas, Samar; Yi, Johnny; Magrina, Javier

2013-01-01

To evaluate the surgical outcome and the anatomic and sexual function in 10 women with Rokitansky syndrome who underwent the laparoscopic Vecchietti procedure at our center. Retrospective analysis. Data were analyzed on the basis of short-term and long-term surgical outcome and sexual function. All patients underwent clinical follow-up at 1, 2, and 6 months after surgery. In all 10 patients, the procedure produced anatomic and functional success. The laparoscopic Vecchietti technique is safe, simple, and effective for treatment of vaginal agenesis. Results are comparable to those of all European studies, and the procedure should gain more popularity in North America. Copyright © 2013 AAGL. All rights reserved.

A clinical trial of supervised exercise for adult inpatients with acute myeloid leukemia (AML) undergoing induction chemotherapy.

PubMed

Alibhai, Shabbir M H; O'Neill, Sara; Fisher-Schlombs, Karla; Breunis, Henriette; Brandwein, Joseph M; Timilshina, Narhari; Tomlinson, George A; Klepin, Heidi D; Culos-Reed, S Nicole

2012-10-01

Patients with acute myeloid leukemia (AML) receiving induction chemotherapy (IC) were enrolled in a supervised exercise intervention to determine safety, feasibility, and efficacy. Physical fitness measures, quality of life (QOL) and fatigue were assessed using standardized measures at baseline, post-induction, and post first consolidation. Retention was excellent, the intervention was safe, and efficacy estimates suggested benefits in physical fitness and QOL outcomes. Exercise is a safe, promising intervention for improving fitness and QOL in this patient population. These results provide a foundation for a randomized trial to better understand the impact of exercise during IC on clinically important outcomes. Copyright © 2012 Elsevier Ltd. All rights reserved.

Clinical teaching based on principles of cognitive apprenticeship: views of experienced clinical teachers.

PubMed

Stalmeijer, Renée E; Dolmans, Diana H J M; Snellen-Balendong, Hetty A M; van Santen-Hoeufft, Marijke; Wolfhagen, Ineke H A P; Scherpbier, Albert J J A

2013-06-01

To explore (1) whether an instructional model based on principles of cognitive apprenticeship fits with the practice of experienced clinical teachers and (2) which factors influence clinical teaching during clerkships from an environmental, teacher, and student level as perceived by the clinical teachers themselves. The model was designed to apply directly to teaching behaviors of clinical teachers and consists of three phases, advocating teaching behaviors such as modeling, creating a safe learning environment, coaching, knowledge articulation, and exploration. A purposive sample of 17 experienced clinical teachers from five different disciplines and four different teaching hospitals took part in semistructured individual interviews. Two researchers independently performed a thematic analysis of the interview transcripts. Coding was discussed within the research team until consensus was reached. All participants recognized the theoretical model as a structured picture of the practice of teaching activities during both regular and senior clerkships. According to participants, modeling and creating a safe learning environment were fundamental to the learning process of both regular and senior clerkship students. Division of teaching responsibilities, longer rotations, and proactive behavior of teachers and students ensured that teachers were able to apply all steps in the model. The theoretical model can offer valuable guidance in structuring clinical teaching activities and offers suggestions for the design of effective clerkships.

Effect of Intrafix® SafeSet infusion apparatus on phlebitis in a neurological intensive care unit: a case-control study.

PubMed

Liu, F; Chen, D; Liao, Y; Diao, L; Liu, Y; Wu, M; Xue, X; You, C; Kang, Y

2012-01-01

To investigate the effect of the Intrafix(®) SafeSet infusion apparatus on the incidence of phlebitis in patients being intravenously infused in a neurological intensive care unit (ICU). Patients aged > 12 years, with no history of diabetes mellitus and no existing phlebitis, requiring a daily peripheral intravenous infusion of ≥ 8 h with the total period lasting ≥ 3 days, were enrolled. Infusions were performed using the Intrafix(®) SafeSet or normal infusion apparatus. Incidence of phlebitis (scored according to the Infusion Nursing Standards of Practice of the American Infusion Nurses Society) was analysed. Patients (n = 1545) were allocated to Intrafix(®) SafeSet (n = 709) or normal infusion (n = 836) groups, matched for age, gender and preliminary diagnosis. Incidence of phlebitis was significantly higher using normal infusion apparatus compared with the Intrafix(®) SafeSet (23.4% versus 17.9%, respectively). Intrafix(®) SafeSet infusion apparatus significantly reduced the incidence of phlebitis in patients in the neurological ICU, compared with normal infusion apparatus, and may be suitable for use in routine clinical practice.

DriveSafe and DriveAware Assessment Tools Are a Measure of Driving-Related Function and Predicts Self-Reported Restriction for Older Drivers.

PubMed

Allan, Claire; Coxon, Kristy; Bundy, Anita; Peattie, Laura; Keay, Lisa

2016-06-01

Safety concerns together with aging of the driving population has prompted research into clinic-based driving assessments. This study investigates the relationship between the DriveSafe and DriveAware assessments and restriction of driving. Community-dwelling adults aged more than 75 (n = 380) were recruited in New South Wales, Australia. Questionnaires were administered to assess driving habits and functional assessments to assess driving-related function. Self-reported restriction was prevalent in this cross-sectional sample (62%) and was related to DriveSafe scores and personal circumstances but not DriveAware scores. DriveSafe scores were correlated with better performance on the Trail-Making Test (TMT; β = -2.94, p < .0001) and better contrast sensitivity (β = 48.70, p < .0001). Awareness was associated with better performance on the TMT (β = 0.08, p < .0001). Our data suggest that DriveSafe and DriveAware are sensitive to deficits in vision and cognition, and drivers with worse DriveSafe scores self-report restricting their driving. © The Author(s) 2015.

Towards large-scale, human-based, mesoscopic neurotechnologies.

PubMed

Chang, Edward F

2015-04-08

Direct human brain recordings have transformed the scope of neuroscience in the past decade. Progress has relied upon currently available neurophysiological approaches in the context of patients undergoing neurosurgical procedures for medical treatment. While this setting has provided precious opportunities for scientific research, it also has presented significant constraints on the development of new neurotechnologies. A major challenge now is how to achieve high-resolution spatiotemporal neural recordings at a large scale. By narrowing the gap between current approaches, new directions tailored to the mesoscopic (intermediate) scale of resolution may overcome the barriers towards safe and reliable human-based neurotechnology development, with major implications for advancing both basic research and clinical translation. Copyright © 2015 Elsevier Inc. All rights reserved.

Safe Patient Handling and Mobility: Development and Implementation of a Large-Scale Education Program.

PubMed

Lee, Corinne; Knight, Suzanne W; Smith, Sharon L; Nagle, Dorothy J; DeVries, Lori

This article addresses the development, implementation, and evaluation of an education program for safe patient handling and mobility at a large academic medical center. The ultimate goal of the program was to increase safety during patient mobility/transfer and reduce nursing staff injury from lifting/pulling. This comprehensive program was designed on the basis of the principles of prework, application, and support at the point of care. A combination of online learning, demonstration, skill evaluation, and coaching at the point of care was used to achieve the goal. Specific roles and responsibilities were developed to facilitate implementation. It took 17 master trainers, 88 certified trainers, 176 unit-based trainers, and 98 coaches to put 3706 nurses and nursing assistants through the program. Evaluations indicated both an increase in knowledge about safe patient handling and an increased ability to safely mobilize patients. The challenge now is sustainability of safe patient-handling practices and the growth and development of trainers and coaches.

Development of an orthopedic surgery trauma patient handover checklist.

PubMed

LeBlanc, Justin; Donnon, Tyrone; Hutchison, Carol; Duffy, Paul

2014-02-01

In surgery, preoperative handover of surgical trauma patients is a process that must be made as safe as possible. We sought to determine vital clinical information to be transferred between patient care teams and to develop a standardized handover checklist. We conducted standardized small-group interviews about trauma patient handover. Based on this information, we created a questionnaire to gather perspectives from all Canadian Orthopaedic Association (COA) members about which topics they felt would be most important on a handover checklist. We analyzed the responses to develop a standardized handover checklist. Of the 1106 COA members, 247 responded to the questionnaire. The top 7 topics felt to be most important for achieving patient safety in the handover were comorbidities, diagnosis, readiness for the operating room, stability, associated injuries, history/mechanism of injury and outstanding issues. The expert recommendations were to have handover completed the same way every day, all appropriate radiographs available, adequate time, all appropriate laboratory work and more time to spend with patients with more severe illness. Our main recommendations for safe handover are to use standardized checklists specific to the patient and site needs. We provide an example of a standardized checklist that should be used for preoperative handovers. To our knowledge, this is the first checklist for handover developed by a group of experts in orthopedic surgery, which is both manageable in length and simple to use.

GIFT-Cloud: A data sharing and collaboration platform for medical imaging research.

PubMed

Doel, Tom; Shakir, Dzhoshkun I; Pratt, Rosalind; Aertsen, Michael; Moggridge, James; Bellon, Erwin; David, Anna L; Deprest, Jan; Vercauteren, Tom; Ourselin, Sébastien

2017-02-01

Clinical imaging data are essential for developing research software for computer-aided diagnosis, treatment planning and image-guided surgery, yet existing systems are poorly suited for data sharing between healthcare and academia: research systems rarely provide an integrated approach for data exchange with clinicians; hospital systems are focused towards clinical patient care with limited access for external researchers; and safe haven environments are not well suited to algorithm development. We have established GIFT-Cloud, a data and medical image sharing platform, to meet the needs of GIFT-Surg, an international research collaboration that is developing novel imaging methods for fetal surgery. GIFT-Cloud also has general applicability to other areas of imaging research. GIFT-Cloud builds upon well-established cross-platform technologies. The Server provides secure anonymised data storage, direct web-based data access and a REST API for integrating external software. The Uploader provides automated on-site anonymisation, encryption and data upload. Gateways provide a seamless process for uploading medical data from clinical systems to the research server. GIFT-Cloud has been implemented in a multi-centre study for fetal medicine research. We present a case study of placental segmentation for pre-operative surgical planning, showing how GIFT-Cloud underpins the research and integrates with the clinical workflow. GIFT-Cloud simplifies the transfer of imaging data from clinical to research institutions, facilitating the development and validation of medical research software and the sharing of results back to the clinical partners. GIFT-Cloud supports collaboration between multiple healthcare and research institutions while satisfying the demands of patient confidentiality, data security and data ownership. Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.

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.

Setting the research agenda for induced abortion in Africa and Asia.

PubMed

Scott, Rachel H; Filippi, Veronique; Moore, Ann M; Acharya, Rajib; Bankole, Akinrinola; Calvert, Clara; Church, Kathryn; Cresswell, Jenny A; Footman, Katharine; Gleason, Joanne; Machiyama, Kazuyo; Marston, Cicely; Mbizvo, Mike; Musheke, Maurice; Owolabi, Onikepe; Palmer, Jennifer; Smith, Christopher; Storeng, Katerini; Yeung, Felicia

2018-05-10

Provision of safe abortion is widely recognized as vital to addressing the health and wellbeing of populations. Research on abortion is essential to meet the UN Sustainable Development Goals. Researchers in population health from university, policy, and practitioner contexts working on two multidisciplinary projects on family planning and safe abortion in Africa and Asia were brought together for a workshop to discuss the future research agenda on induced abortion. Research on care-seeking behavior, supply of abortion care services, and the global and national policy context will help improve access to and experiences of safe abortion services. A number of areas have potential in designing intervention strategies, including clinical innovations, quality improvement mechanisms, community involvement, and task sharing. Research on specific groups, including adolescents and young people, men, populations affected by conflict, marginalized groups, and providers could increase understanding of provision, access to and experiences of induced abortion. Methodological and conceptual advances, for example in the measurement of induced abortion incidence, complications, and client satisfaction, conceptualizations of induced abortion access and care, and methods for follow-up of patients who have induced abortions, will improve the accuracy of measurements of induced abortion, and add to understanding of women's experiences of induced abortions and abortion care. © 2018 International Federation of Gynecology and Obstetrics.

Doing the math: A simple approach to topical timolol dosing for infantile hemangiomas.

PubMed

Dalla Costa, Renata; Prindaville, Brea; Wiss, Karen

2018-03-01

Topical timolol maleate has recently gained popularity as a treatment for superficial infantile hemangiomas, but calculating a safe dose of timolol can be time consuming, which may limit the medication's use in fast-paced clinical environments. This report offers a simplified calculation of the maximum daily safe dosage as 1 drop of medication per kilogram of body weight. © 2018 Wiley Periodicals, Inc.

A decade of vaccinating allergic travellers: a clinical audit.

PubMed

McCallum, Andrew D; Duncan, Christopher J A; MacDonald, Rona; Jones, Michael E

2011-09-01

Adverse reactions following vaccination are rare but may include potentially fatal anaphylaxis. This audit is a retrospective review of 38 patients with a history, or potential risk, of 'vaccine allergy' referred to an Infectious Diseases Unit for vaccination over a 10 year period. A total of 59 patient encounters were recorded, of which 89.8% were uneventful. Of the 6 adverse events, 3 patients had a local reaction, 1 patient developed urticaria and 1 patient had a vasovagal episode. Only 1 patient developed anaphylaxis secondary to vaccination, and she had no prior history of vaccine allergy. Of these patients 17 had a history suggesting the need for immunological investigation but only 7 had laboratory evidence of allergy. The differential diagnosis of anaphylaxis includes vasovagal reactions and non-specific mediator release and immunological work-up of such events can help avoid such patients being incorrectly labelled as allergic. The vast majority of immunisations are uncomplicated and patients with a history of allergic reactions to vaccination may be vaccinated safely in a controlled setting. Unduly conservative guidelines risk withholding vaccines providing protection against dangerous pathogens but which can be safely administered. Copyright © 2011 Elsevier Ltd. All rights reserved.

The National Ebola Training and Education Center: Preparing the United States for Ebola and Other Special Pathogens.

PubMed

Kratochvil, Christopher J; Evans, Laura; Ribner, Bruce S; Lowe, John J; Harvey, Melissa Cole; Hunt, Richard C; Tumpey, Abbigail J; Fagan, Ryan P; Schwedhelm, Michelle M; Bell, Sonia; Maher, John; Kraft, Colleen S; Cagliuso, Nicholas V; Vanairsdale, Sharon; Vasa, Angela; Smith, Philip W

The National Ebola Training and Education Center (NETEC) was established in 2015 in response to the 2014-2016 Ebola virus disease outbreak in West Africa. The US Department of Health and Human Services office of the Assistant Secretary for Preparedness and Response and the US Centers for Disease Control and Prevention sought to increase the competency of healthcare and public health workers, as well as the capability of healthcare facilities in the United States, to deliver safe, efficient, and effective care to patients infected with Ebola and other special pathogens nationwide. NYC Health + Hospitals/Bellevue, Emory University, and the University of Nebraska Medical Center/Nebraska Medicine were awarded this cooperative agreement, based in part on their experience in safely and successfully evaluating and treating patients with Ebola virus disease in the United States. In 2016, NETEC received a supplemental award to expand on 3 initial primary tasks: (1) develop metrics and conduct peer review assessments; (2) develop and provide educational materials, resources, and tools, including exercise design templates; (3) provide expert training and technical assistance; and, to add a fourth task, create a special pathogens clinical research network.

Exercise recommendations for childhood cancer survivors exposed to cardiotoxic therapies: an institutional clinical practice initiative.

PubMed

Okada, Maki; Meeske, Kathleen A; Menteer, Jondavid; Freyer, David R

2012-01-01

Childhood cancer survivors who have received treatment with anthracyclines are at risk for developing cardiomyopathy in dose-dependent fashion. Historically, restrictions on certain types of physical activity that were intended to preserve cardiac function have been recommended, based on a mixture of evidence-based and consensus-based recommendations. In the LIFE Cancer Survivorship & Transition Program at Children's Hospital Los Angeles, the authors reevaluated their recommendations for exercise in survivors who were exposed to anthracyclines, with or without irradiation in proximity to the myocardium. The primary goal was to develop consistent, specific, practical, safe, and (where possible) evidence-based recommendations for at-risk survivors in the program. To accomplish this, the authors referred to current exercise guidelines for childhood cancer survivors, consulted recent literature for relevant populations, and obtained input from the program's pediatric cardiology consultant. The resulting risk-based exercise recommendations are designed to complement current published guidelines, maximize safe exercise, and help childhood cancer survivors return to a normal life that emphasizes overall wellness and physical activity. This article describes a single institution's experience in modifying exercise recommendations for at-risk childhood survivors and includes the methods, findings, and current institutional practice recommendations along with sample education materials.

Nurses' Attitudes Regarding the Safe Handling of Patients Who Are Morbidly Obese: Instrument Development and Psychometric Analysis.

PubMed

Bejciy-Spring, Susan; Vermillion, Brenda; Morgan, Sally; Newton, Cheryl; Chucta, Sheila; Gatens, Cindy; Zadvinskis, Inga; Holloman, Christopher; Chipps, Esther

2016-12-01

Nurses' attitudes play an important role in the consistent practice of safe patient handling behaviors. The purposes of this study were to develop and assess the psychometric properties of a newly developed instrument measuring attitudes of nurses related to the care and safe handling of patients who are obese. Phases of instrument development included (a) item generation, (b) content validity assessment, (c) reliability assessment, (d) cognitive interviewing, and (e) construct validity assessment through factor analysis. The final data from the exploratory factor analysis produced a 26-item multidimensional instrument that contains 9 subscales. Based on the factor analysis, a 26-item instrument can be used to examine nurses' attitudes regarding patients who are morbidly obese and related safe handling practices.

Assessment of the viability of skin grafts

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

Wahner, H.W.

1988-07-01

A number of tests are available to monitor the blood flow in free and distant pedicle skin grafts. The information from these tests aids in the development of measures to enhance vascularization and is occasionally needed to make clinical decisions in patients with distant pedicle grafts. Measurements of the disappearance of an intradermally injected small amount of /sup 133/Xe allows determination of a clearance rate and blood flow before and after clamping the original blood supply through the base. With /sup 99m/Tc, which is generally more readily available, a flow index and block index can be determined. Clinically both proceduresmore » give equally good results in determining a safe time for pedicle base separation. The fluorescein test allows assessment of regional blood flow distribution within the pedicle.« less

Proceedings of the Space Station Freedom Clinical Experts Seminar

NASA Technical Reports Server (NTRS)

Billica, Roger P. (Editor); Lloyd, Charles W. (Editor); Doarn, Charles R. (Editor)

1991-01-01

These are the proceedings of the Space Station Freedom Health Maintenance Facility 1990 Clinical Experts Seminar held August 27-29, 1990, at the Nassau Bay Hilton, Houston, Texas. Contained within are the agenda, list of medical consultants, executive summary, individual presentations, and the comments generated from the working groups. Issues include the adequacy of current Health Maintenance Facility for Space Station Freedom; impact of having, or not having, an ACRV or physician on board Space Station Freedom; new and developing technologies, techniques, and medications and their impact on the evolving Space Station Freedom, considerations surrounding x-ray, ultrasound, lab, decontamination, blood transfusion, nutrition, safe-haven, computer/telemedicine; suggestions as to how to train the Crew Medical Officer; and, how the consultant network will interface over the next several years.

Oncolytic Poxviruses

PubMed Central

Chan, Winnie M.; McFadden, Grant

2015-01-01

Current standard treatments of cancer can prolong survival of many cancer patients but usually do not effectively cure the disease. Oncolytic virotherapy is an emerging therapeutic for the treatment of cancer that exploits replication-competent viruses to selectively infect and destroy cancerous cells while sparing normal cells and tissues. Clinical and/or preclinical studies on oncolytic viruses have revealed that the candidate viruses being tested in trials are remarkably safe and offer potential for treating many classes of currently incurable cancers. Among these candidates are vaccinia and myxoma viruses, which belong to the family Poxviridae and possess promising oncolytic features. This article describes poxviruses that are being developed for oncolytic virotherapy and summarizes the outcomes of both clinical and preclinical studies. Additionally, studies demonstrating superior efficacy when poxvirus oncolytic virotherapy is combined with conventional therapies are described. PMID:25839047

Using task analysis in healthcare design to improve clinical efficiency.

PubMed

Lu, Jun; Hignett, Sue

2009-01-01

To review the functionality of the proposed soiled workroom design for efficient and safe clinical activities. As part of a hospital refurbishment program, the planning team of a United Kingdom National Health Service hospital requested a review of a proposed standardized room design. A 7-day observational study was conducted in five clinical departments at three hospitals. Link analysis was used to record and analyze the movements among components, i.e., nursing staff, equipment/devices, and furniture. Fifty-four observations were recorded for 18 clinical tasks. The most frequent tasks were the disposal of urine and used urine bottles, and returning used commode chairs. Minor recommendations were made to improve the proposed design, and major revisions were suggested to address functionality problems. It was found that the proposed design did not offer the optimal layout for efficient and safe clinical activities. Link analysis was found to be effective for plotting the movements of the staff and accounting for the complexity of tasks. This ergonomic method, in combination with observational field studies, provided a simple and effective way to determine functional space requirements for clinical activities and should be used in all healthcare building design projects.

Developing person-centred practice in hip fracture care for older people.

PubMed

Christie, Jane; Macmillan, Maureen; Currie, Colin; Matthews-Smith, Gerardine

2016-12-14

To facilitate a multidisciplinary collaborative approach to developing person-centred practice in hip fracture care for older people. Collaborative inquiry, a form of action research, was used to collect data for this study. It involved exploration of dilemmas, questions and problems that are part of human experience. Clinical leaders from different disciplines (n=16), who work with older people with hip fractures at different stages of the care pathway, participated in a series of facilitated action meetings. The practice development techniques used in this study included: identifying the strengths and limitations of the current service, values clarification, creating a shared vision, sharing clinical stories, reviewing case records, and reflecting on the experiences of three older people and two caregivers. Hip fracture care was based on meeting service targets, national guidelines and audits. Care was fragmented across different service delivery units, with professional groups working independently. This resulted in suboptimal communication between members of the multidisciplinary group of clinical leaders and care that was process-driven rather than person-centred. Spending time away from clinical practice enabled the multidisciplinary group to collaborate to understand care from the patients' and caregivers' perspectives, and to reflect critically on the care experience as a whole. To develop a person-centred workplace culture, the multidisciplinary team requires facilitated time for reflection. Ongoing facilitative leadership would enable the multidisciplinary team to collaborate effectively to deliver safe, effective person-centred practice in hip fracture care for older people.

Development of a national audit tool for juvenile idiopathic arthritis: a BSPAR project funded by the Health Care Quality Improvement Partnership

PubMed Central

McErlane, Flora; Foster, Helen E; Armitt, Gillian; Bailey, Kathryn; Cobb, Joanna; Davidson, Joyce E; Douglas, Sharon; Fell, Andrew; Friswell, Mark; Pilkington, Clarissa; Strike, Helen; Smith, Nicola; Thomson, Wendy; Cleary, Gavin

2018-01-01

Abstract Objective Timely access to holistic multidisciplinary care is the core principle underpinning management of juvenile idiopathic arthritis (JIA). Data collected in national clinical audit programmes fundamentally aim to improve health outcomes of disease, ensuring clinical care is equitable, safe and patient-centred. The aim of this study was to develop a tool for national audit of JIA in the UK. Methods A staged and consultative methodology was used across a broad group of relevant stakeholders to develop a national audit tool, with reference to pre-existing standards of care for JIA. The tool comprises key service delivery quality measures assessed against two aspects of impact, namely disease-related outcome measures and patient/carer reported outcome and experience measures. Results Eleven service-related quality measures were identified, including those that map to current standards for commissioning of JIA clinical services in the UK. The three-variable Juvenile Arthritis Disease Activity Score and presence/absence of sacro-iliitis in patients with enthesitis-related arthritis were identified as the primary disease-related outcome measures, with presence/absence of uveitis a secondary outcome. Novel patient/carer reported outcomes and patient/carer reported experience measures were developed and face validity confirmed by relevant patient/carer groups. Conclusion A tool for national audit of JIA has been developed with the aim of benchmarking current clinical practice and setting future standards and targets for improvement. Staged implementation of this national audit tool should facilitate investigation of variability in levels of care and drive quality improvement. This will require engagement from patients and carers, clinical teams and commissioners of JIA services. PMID:29069424

Development of a national audit tool for juvenile idiopathic arthritis: a BSPAR project funded by the Health Care Quality Improvement Partnership.

PubMed

McErlane, Flora; Foster, Helen E; Armitt, Gillian; Bailey, Kathryn; Cobb, Joanna; Davidson, Joyce E; Douglas, Sharon; Fell, Andrew; Friswell, Mark; Pilkington, Clarissa; Strike, Helen; Smith, Nicola; Thomson, Wendy; Cleary, Gavin

2018-01-01

Timely access to holistic multidisciplinary care is the core principle underpinning management of juvenile idiopathic arthritis (JIA). Data collected in national clinical audit programmes fundamentally aim to improve health outcomes of disease, ensuring clinical care is equitable, safe and patient-centred. The aim of this study was to develop a tool for national audit of JIA in the UK. A staged and consultative methodology was used across a broad group of relevant stakeholders to develop a national audit tool, with reference to pre-existing standards of care for JIA. The tool comprises key service delivery quality measures assessed against two aspects of impact, namely disease-related outcome measures and patient/carer reported outcome and experience measures. Eleven service-related quality measures were identified, including those that map to current standards for commissioning of JIA clinical services in the UK. The three-variable Juvenile Arthritis Disease Activity Score and presence/absence of sacro-iliitis in patients with enthesitis-related arthritis were identified as the primary disease-related outcome measures, with presence/absence of uveitis a secondary outcome. Novel patient/carer reported outcomes and patient/carer reported experience measures were developed and face validity confirmed by relevant patient/carer groups. A tool for national audit of JIA has been developed with the aim of benchmarking current clinical practice and setting future standards and targets for improvement. Staged implementation of this national audit tool should facilitate investigation of variability in levels of care and drive quality improvement. This will require engagement from patients and carers, clinical teams and commissioners of JIA services. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology.

Design and implementation of population-based specialty care programs.

PubMed

Botts, Sheila R; Gee, Michael T; Chang, Christopher C; Young, Iris; Saito, Logan; Lyman, Alfred E

2017-09-15

The development, implementation, and scaling of 3 population-based specialty care programs in a large integrated healthcare system are reviewed, and the role of clinical pharmacy services in ensuring safe, effective, and affordable care is highlighted. The Kaiser Permanente (KP) integrated healthcare delivery model allows for rapid development and expansion of innovative population management programs involving pharmacy services. Clinical pharmacists have assumed integral roles in improving the safety and effectiveness of high-complexity, high-cost care for specialty populations. These roles require an appropriate practice scope and are supported by an advanced electronic health record with disease registries and electronic surveillance tools for care-gap identification. The 3 specialty population programs described were implemented to address variation or unrecognized gaps in care for at-risk specialty populations. The Home Phototherapy Program has leveraged internal partnerships with clinical pharmacists to improve access to cost-effective nonpharmacologic interventions for psoriasis and other skin disorders. The Multiple Sclerosis Care Program has incorporated clinical pharmacists into neurology care in order to apply clinical guidelines in a systematic manner. The KP SureNet program has used clinical pharmacists and data analytics to identify opportunities to prevent drug-related adverse outcomes and ensure timely follow-up. Specialty care programs improve quality, cost outcomes, and the patient experience by appropriating resources to provide systematic and targeted care to high-risk patients. KP leverages an integration of people, processes, and technology to develop and scale population-based specialty care. Copyright © 2017 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Malaria vaccine R&D in the Decade of Vaccines: breakthroughs, challenges and opportunities.

PubMed

Birkett, Ashley J; Moorthy, Vasee S; Loucq, Christian; Chitnis, Chetan E; Kaslow, David C

2013-04-18

While recent progress has been made in reducing malaria mortality with other interventions, vaccines are still urgently needed to further reduce the incidence of clinical disease, including during pregnancy, and to provide "herd protection" by blocking parasite transmission. The most clinically advanced candidate, RTS,S, is presently undergoing Phase 3 evaluation in young African children across 13 clinical sites in eight African countries. In the 12-month period following vaccination, RTS,S conferred approximately 50% protection from clinical Plasmodium falciparum disease in children aged 5-17 months, and approximately 30% protection in children aged 6-12 weeks when administered in conjunction with Expanded Program for Immunization (EPI) vaccines. The development of more highly efficacious vaccines to prevent clinical disease caused by both P. falciparum and Plasmodium vivax, as well as vaccines to support elimination efforts by inducing immunity that blocks malaria parasite transmission, are priorities. Some key barriers to malaria vaccine development include: a paucity of well-characterized target immunogens and an absence of clear correlates of protection to enable vaccine development targeting all stages of the P. falciparum and P. vivax lifecycles; a limited number of safe and effective delivery systems, including adjuvants, that induce potent, long-lived protective immunity, be it by antibody, CD4+, and/or CD8+ T cell responses; and, for vaccines designed to provide "herd protection" by targeting sexual stage and/or mosquito antigens, the lack of a clear clinical and regulatory pathway to licensure using non-traditional endpoints. Recommendations to overcome these, and other key challenges, are suggested in this document. Copyright © 2013 Elsevier Ltd. All rights reserved.

Creating an optical spectroscopy system for use in a primary care clinical setting (Conference Presentation)

NASA Astrophysics Data System (ADS)

Eshein, Adam; Nguyen, The-Quyen; Radosevich, Andrew J.; Gould, Bradley; Wu, Wenli; Konda, Vani; Yang, Leslie W.; Koons, Ann; Feder, Seth; Valuckaite, Vesta; Roy, Hemant K.; Backman, Vadim

2016-03-01

While there are a plethora of in-vivo spectroscopic techniques that have demonstrated the ability to detect a number of diseases in research trials, very few techniques have successfully become a fully realized clinical technology. This is primarily due to the stringent demands on a clinical device for widespread implementation. Some of these demands include: simple operation requiring minimal or no training, safe for in-vivo patient use, no disruption to normal clinic workflow, tracking of system performance, warning for measurement abnormality, and meeting all FDA guidelines for medical use. Previously, our group developed a fiber optic probe-based optical sensing technique known as low-coherence enhanced backscattering spectroscopy (LEBS) to quantify tissue ultrastructure in-vivo. Now we have developed this technique for the application of prescreening patients for colonoscopy in a primary care (PC) clinical setting. To meet the stringent requirements for a viable medical device used in a PC clinical setting, we developed several novel components including an automated calibration tool, optical contact sensor for signal acquisition, and a contamination sensor to identify measurements which have been affected by debris. The end result is a state-of-the-art medical device that can be realistically used by a PC physician to assess a person's risk for harboring colorectal precancerous lesions. The pilot study of this system shows great promise with excellent stability and accuracy in identifying high-risk patients. While this system has been designed and optimized for our specific application, the system and design concepts are universal to most in-vivo fiber optic based spectroscopic techniques.

Recommendations for incorporating biologicals into management of moderate to severe plaque psoriasis: individualized patient approaches.

PubMed

Langley, Richard G; Ho, Vincent; Lynde, Charles; Papp, Kim A; Poulin, Yves; Shear, Neil; Toole, Jack; Zip, Catherine

2006-01-01

Psoriasis is a T-cell mediated skin disease that affects approximately 2% of the population worldwide. Despite the prevalence of the disease and long-standing efforts to develop strategies to treat it, there is a need for safe and effective therapies to treat psoriasis, particularly the more severe forms. Biological agents such as alefacept, efalizumab, etanercept, and infliximab have been recognized as a class of treatment distinct from other forms of therapy in the treatment algorithm of psoriasis. Recent national and international consensus meetings have developed statements that position biological agents as an important addition to the treatment armamentarium for moderate to severe psoriasis, along with phototherapy and traditional systemic agents. There has been consensus that treatment should be individualized to each patient's needs and circumstances. Biological agents offer the hope of safe, effective, long-term management of moderate to severe psoriasis. As new agents receive approval from Health Canada, the available range of therapeutic options for treating this chronic disease will broaden. A Canadian Psoriasis Expert Panel recently convened in February 2005 to analyze, based on a series of clinical case scenarios, the indications, contraindications, and considerations for and against each of the four biological agents, derived from product labelling, where available, and from the efficacy and safety data from phase 3 and earlier clinical trials, as well as post-marketing reports. The Panel has formulated a set of recommendations for incorporating these biological agents into the current treatment paradigm of moderate to severe plaque psoriasis and has identified the preferred biological agents for each patient based on individual needs and circumstances.

Canadian guideline for safe and effective use of opioids for chronic noncancer pain: clinical summary for family physicians. Part 1: general population.

PubMed

Kahan, Meldon; Mailis-Gagnon, Angela; Wilson, Lynn; Srivastava, Anita

2011-11-01

To provide family physicians with a practical clinical summary of the Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain, developed by the National Opioid Use Guideline Group. Researchers for the guideline conducted a systematic review of the literature on the effectiveness and safety of opioids for chronic noncancer pain, and drafted a series of recommendations. A panel of 49 clinicians from across Canada reviewed the draft and achieved consensus on 24 recommendations. Screening for addiction risk is recommended before prescribing opioids. Weak opioids (codeine and tramadol) are recommended for mild to moderate pain that has not responded to first-line treatments. Oxycodone, hydromorphone, and morphine can be tried in patients who have not responded to weaker opioids. A low initial dose and slow upward titration is recommended, with patient education and close monitoring. Physicians should watch for the development of complications such as sleep apnea. The optimal dose is one which improves function or decreases pain ratings by at least 30%. For by far most patients, the optimal dose will be well below a 200-mg morphine equivalent dose per day. Tapering is recommended for patients who have not responded to an adequate opioid trial. Opioids play an important role in the management of chronic noncancer pain, but careful prescribing is needed to limit potential harms. The new Canadian guideline provides much-needed guidance to help physicians achieve a balance between optimal pain control and safety.

An official ATS clinical practice guideline: interpretation of exhaled nitric oxide levels (FENO) for clinical applications.

PubMed

Dweik, Raed A; Boggs, Peter B; Erzurum, Serpil C; Irvin, Charles G; Leigh, Margaret W; Lundberg, Jon O; Olin, Anna-Carin; Plummer, Alan L; Taylor, D Robin

2011-09-01

Measurement of fractional nitric oxide (NO) concentration in exhaled breath (Fe(NO)) is a quantitative, noninvasive, simple, and safe method of measuring airway inflammation that provides a complementary tool to other ways of assessing airways disease, including asthma. While Fe(NO) measurement has been standardized, there is currently no reference guideline for practicing health care providers to guide them in the appropriate use and interpretation of Fe(NO) in clinical practice. To develop evidence-based guidelines for the interpretation of Fe(NO) measurements that incorporate evidence that has accumulated over the past decade. We created a multidisciplinary committee with expertise in the clinical care, clinical science, or basic science of airway disease and/or NO. The committee identified important clinical questions, synthesized the evidence, and formulated recommendations. Recommendations were developed using pragmatic systematic reviews of the literature and the GRADE approach. The evidence related to the use of Fe(NO) measurements is reviewed and clinical practice recommendations are provided. In the setting of chronic inflammatory airway disease including asthma, conventional tests such as FEV(1) reversibility or provocation tests are only indirectly associated with airway inflammation. Fe(NO) offers added advantages for patient care including, but not limited to (1) detecting of eosinophilic airway inflammation, (2) determining the likelihood of corticosteroid responsiveness, (3) monitoring of airway inflammation to determine the potential need for corticosteroid, and (4) unmasking of otherwise unsuspected nonadherence to corticosteroid therapy.

An Official ATS Clinical Practice Guideline: Interpretation of Exhaled Nitric Oxide Levels (FeNO) for Clinical Applications

PubMed Central

Dweik, Raed A.; Boggs, Peter B.; Erzurum, Serpil C.; Irvin, Charles G.; Leigh, Margaret W.; Lundberg, Jon O.; Olin, Anna-Carin; Plummer, Alan L.; Taylor, D. Robin

2011-01-01

Background: Measurement of fractional nitric oxide (NO) concentration in exhaled breath (FeNO) is a quantitative, noninvasive, simple, and safe method of measuring airway inflammation that provides a complementary tool to other ways of assessing airways disease, including asthma. While FeNO measurement has been standardized, there is currently no reference guideline for practicing health care providers to guide them in the appropriate use and interpretation of FeNO in clinical practice. Purpose: To develop evidence-based guidelines for the interpretation of FeNO measurements that incorporate evidence that has accumulated over the past decade. Methods: We created a multidisciplinary committee with expertise in the clinical care, clinical science, or basic science of airway disease and/or NO. The committee identified important clinical questions, synthesized the evidence, and formulated recommendations. Recommendations were developed using pragmatic systematic reviews of the literature and the GRADE approach. Results: The evidence related to the use of FeNO measurements is reviewed and clinical practice recommendations are provided. Conclusions: In the setting of chronic inflammatory airway disease including asthma, conventional tests such as FEV1 reversibility or provocation tests are only indirectly associated with airway inflammation. FeNO offers added advantages for patient care including, but not limited to (1) detecting of eosinophilic airway inflammation, (2) determining the likelihood of corticosteroid responsiveness, (3) monitoring of airway inflammation to determine the potential need for corticosteroid, and (4) unmasking of otherwise unsuspected nonadherence to corticosteroid therapy. PMID:21885636

Abortion law, policy and services in India: a critical review.

PubMed

Hirve, Siddhivinayak S

2004-11-01

Despite 30 years of liberal legislation, the majority of women in India still lack access to safe abortion care. This paper critically reviews the history of abortion law and policy in India since the 1960s and research on abortion service delivery. Amendments in 2002 and 2003 to the 1971 Medical Termination of Pregnancy Act, including devolution of regulation of abortion services to the district level, punitive measures to deter provision of unsafe abortions, rationalisation of physical requirements for facilities to provide early abortion, and approval of medical abortion, have all aimed to expand safe services. Proposed amendments to the MTP Act to prevent sex-selective abortions would have been unethical and violated confidentiality, and were not taken forward. Continuing problems include poor regulation of both public and private sector services, a physician-only policy that excludes mid-level providers and low registration of rural compared to urban clinics; all restrict access. Poor awareness of the law, unnecessary spousal consent requirements, contraceptive targets linked to abortion, and informal and high fees also serve as barriers. Training more providers, simplifying registration procedures, de-linking clinic and provider approval, and linking policy with up-to-date technology, research and good clinical practice are some immediate measures needed to improve women's access to safe abortion care.

How safe is 1% alum irrigation in controlling intractable vesical hemorrhage?

PubMed

Goswami, A K; Mahajan, R K; Nath, R; Sharma, S K

1993-02-01

A prospective study was done to evaluate the efficacy and safety of intravesical instillation of 1% alum solution in 12 cases of hematuria of vesical origin, uncontrolled by saline irrigation for 24 hours via a 3-way Foley catheter. There were 10 cases of transitional cell carcinoma and 2 of radiation cystitis. Complete response was noted in 6 patients and a partial response in 4. Local side effects included suprapubic pain and vesical tenesmus, which were controlled by antispasmodic and/or analgesic drugs. Transient low grade pyrexia (maximum up to 38.2C) was noted in 4 patients. Among the other various clinical and biochemical parameters, serum aluminum level and prothrombin time showed statistically highly significant changes. Serum aluminum increased from an average baseline value of 1.68 to 3.36 mumol./l. without clinical evidence of aluminum toxicity and with levels well below the recommended safe limit. Prothrombin time increased parallel with the increase in serum aluminum level to a maximum of 1 1/2 times the control. Prothrombin values, therefore, can be used clinically, since they are readily obtainable whereas serum aluminum levels are not. Vesical irrigation with 1% alum solution is a safe method to control hematuria of vesical origin in properly selected cases.

Orbital Atherectomy in the Renal Artery: A New Frontier for an Emerging Technology?

PubMed

Valle, Javier A; Armstrong, Ehrin J; Waldo, Stephen W

2017-01-01

Orbital atherectomy has been developed as a method to modify calcified plaque in the peripheral vasculature, with extensive experience and data supporting its use in infrainguinal peripheral arterial disease. However, calcific atherosclerotic disease occurs in other vascular beds and may benefit from the application of this technology. In this case report, we describe the first reported use of orbital atherectomy in a renal artery. A 55-year-old male with severe drug-refractory hypertension was found to have renal artery stenosis, with severe calcification of the right renal artery. Orbital atherectomy was utilized for initial plaque modification, and he underwent stenting of the renal artery lesion with an excellent angiographic and clinical result at follow-up. In conclusion, orbital atherectomy is a safe and effective means of plaque modification for severely calcified lesions. The safe and effective use of orbital atherectomy in the renal vasculature suggests an opportunity for ongoing evaluation into expanded roles for this technology beyond the coronary and lower-extremity arterial beds.

Assessing fear and anxiety in humans using the threat of predictable and unpredictable aversive events (the NPU-threat test)

PubMed Central

Schmitz, Anja; Grillon, Christian

2012-01-01

The threat of predictable and unpredictable aversive events was developed to assess short-duration (fear) and long-duration (anxiety) aversive states in humans. A typical experiment consists of three conditions: a safe condition (neutral (N)), during which participants are safe from aversive stimuli, and two threat conditions—one in which aversive events are administered predictably (P) (i.e., signaled by a threat cue), and one in which aversive stimuli are administered unpredictably (U). During the so-called NPU -threat test, ongoing change in aversive states is measured with the startle reflex. The NPU -threat test has been validated in pharmacological and clinical studies and can be implemented in children and adults. Similar procedures have been applied in animal models, making the NPU -threat test an ideal tool for translational research. The procedure is relatively short (35 min), simple to implement and generates consistent results with large effect sizes. PMID:22362158

Undergraduate nurses' preferred use of mobile devices in healthcare settings.

PubMed

Mather, Carey; Cummings, Elizabeth; Allen, Penny

2015-01-01

The growth of digital technology has created challenges for appropriate and safe use of mobile or portable devices in healthcare environments. There is perceived risk that the use of mobile technology for learning may distract from provision of patient care if used by undergraduate students during work-integrated learning. This paper reports on a study that aimed to identify differences in preferred behavior of student nurses in their use of mobile technology during and away from the clinical practice environment. A previously validated online survey was administered to students during a period of work integrated learning in a range of healthcare settings in two Australian states. Respondents agreed that mobile devices could be beneficial to patient care. Overall, students proposed they would use mobile devices for accessing information, during work integrated learning, less than when away from the workplace. The development of policy to guide the use of mobile devices, in situ, is important to the provision of safe and competent care and improved health outcomes for patients.

Rehabilitation after anterior cruciate ligament reconstruction: criteria-based progression through the return-to-sport phase.

PubMed

Myer, Gregory D; Paterno, Mark V; Ford, Kevin R; Quatman, Carmen E; Hewett, Timothy E

2006-06-01

Rehabilitation following anterior cruciate ligament (ACL) reconstruction has undergone a relatively rapid and global evolution over the past 25 years. However, there is an absence of standardized, objective criteria to accurately assess an athlete's ability to progress through the end stages of rehabilitation and safe return to sport. Return-to-sport rehabilitation, progressed by quantitatively measured functional goals, may improve the athlete's integration back into sport participation. The purpose of the following clinical commentary is to introduce an example of a criteria-driven algorithm for progression through return-to-sport rehabilitation following ACL reconstruction. Our criteria-based protocol incorporates a dynamic assessment of baseline limb strength, patient-reported outcomes, functional knee stability, bilateral limb symmetry with functional tasks, postural control, power, endurance, agility, and technique with sport-specific tasks. Although this algorithm has limitations, it serves as a foundation to expand future evidence-based evaluation and to foster critical investigation into the development of objective measures to accurately determine readiness to safely return to sport following injury.

Design and discovery of mushroom tyrosinase inhibitors and their therapeutic applications.

PubMed

Mendes, Eduarda; Perry, Maria de Jesus; Francisco, Ana Paula

2014-05-01

Tyrosinase inhibitors could have a huge importance in medicine, cosmetics and agriculture. Although many tyrosinase inhibitors are available, they have demonstrated only mild efficacy and safety concerns. This has led to the discovery of novel tyrosinase inhibitors that are more safe, potent and efficacious. The authors provide an overview of the recent scientific accounts describing the design of new molecules. These compounds belong to different chemical families. The review emphasizes the rationale behind the discovery, the study of structure-activity relationships, the study of the mechanism and kinetic of inhibition and the cellular effect of the inhibitors. The article is based on the literature published from 2007 onward related with the development of synthetic tyrosinase inhibitors. Although a great number of tyrosinase inhibitors have been published in the literature, none, as of yet, have reached the potency and safety requirements needed to enter clinical trials. The emergence of new in vitro and in vivo tests will finally allow the arrival of new compounds that are more potent and safe.

Consistent Safety and Infectivity in Sporozoite Challenge Model of Plasmodium vivax in Malaria-Naive Human Volunteers

PubMed Central

Herrera, Sócrates; Solarte, Yezid; Jordán-Villegas, Alejandro; Echavarría, Juan Fernando; Rocha, Leonardo; Palacios, Ricardo; Ramírez, Óscar; Vélez, Juan D.; Epstein, Judith E.; Richie, Thomas L.; Arévalo-Herrera, Myriam

2011-01-01

A safe and reproducible Plasmodium vivax infectious challenge method is required to evaluate the efficacy of malaria vaccine candidates. Seventeen healthy Duffy (+) and five Duffy (−) subjects were randomly allocated into three (A–C) groups and were exposed to the bites of 2–4 Anopheles albimanus mosquitoes infected with Plasmodium vivax derived from three donors. Duffy (−) subjects were included as controls for each group. Clinical manifestations of malaria and parasitemia were monitored beginning 7 days post-challenge. All Duffy (+) volunteers developed patent malaria infection within 16 days after challenge. Prepatent period determined by thick smear, was longer for Group A (median 14.5 d) than for Groups B and C (median 10 d/each). Infected volunteers recovered rapidly after treatment with no serious adverse events. The bite of as low as two P. vivax-infected mosquitoes provides safe and reliable infections in malaria-naive volunteers, suitable for assessing antimalarial and vaccine efficacy trials. PMID:21292872

Targeted Vaccination against Human α-Lactalbumin for Immunotherapy and Primary Immunoprevention of Triple Negative Breast Cancer

PubMed Central

Tuohy, Vincent K.; Jaini, Ritika; Johnson, Justin M.; Loya, Matthew G.; Wilk, Dennis; Downs-Kelly, Erinn; Mazumder, Suparna

2016-01-01

We have proposed that safe and effective protection against the development of adult onset cancers may be achieved by vaccination against tissue-specific self-proteins that are “retired” from expression at immunogenic levels in normal tissues as we age, but are overexpressed in emerging tumors. α-Lactalbumin is an example of a “retired” self-protein because its expression in normal tissues is confined exclusively to the breast during late pregnancy and lactation, but is also expressed in the vast majority of human triple negative breast cancers (TNBC)—the most aggressive and lethal form of breast cancer and the predominant form that occurs in women at high genetic risk including those with mutated BRCA1 genes. In anticipation of upcoming clinical trials, here we provide preclinical data indicating that α-lactalbumin has the potential as a vaccine target for inducing safe and effective primary immunoprevention as well as immunotherapy against TNBC. PMID:27322324

Subscale Validation of the Subsurface Active Filtration of Exhaust (SAFE) Approach to the NTP Ground Testing

NASA Technical Reports Server (NTRS)

Marshall, William M.; Borowski, Stanley K.; Bulman, Mel; Joyner, Russell; Martin, Charles R.

2015-01-01

Nuclear thermal propulsion (NTP) has been recognized as an enabling technology for missions to Mars and beyond. However, one of the key challenges of developing a nuclear thermal rocket is conducting verification and development tests on the ground. A number of ground test options are presented, with the Sub-surface Active Filtration of Exhaust (SAFE) method identified as a preferred path forward for the NTP program. The SAFE concept utilizes the natural soil characteristics present at the Nevada National Security Site to provide a natural filter for nuclear rocket exhaust during ground testing. A validation method of the SAFE concept is presented, utilizing a non-nuclear sub-scale hydrogen/oxygen rocket seeded with detectible radioisotopes. Additionally, some alternative ground test concepts, based upon the SAFE concept, are presented. Finally, an overview of the ongoing discussions of developing a ground test campaign are presented.

Update On Emerging Antivirals For The Management Of Herpes Simplex Virus Infections: A Patenting Perspective

PubMed Central

Vadlapudi, Aswani D.; Vadlapatla, Ramya K.; Mitra, Ashim K.

2015-01-01

Herpes simplex virus (HSV) infections can be treated efficiently by the application of antiviral drugs. The herpes family of viruses is responsible for causing a wide variety of diseases in humans. The standard therapy for the management of such infections includes acyclovir (ACV) and penciclovir (PCV) with their respective prodrugs valaciclovir and famciclovir. Though effective, long term prophylaxis with the current drugs leads to development of drug-resistant viral isolates, particularly in immunocompromised patients. Moreover, some drugs are associated with dose-limiting toxicities which limit their further utility. Therefore, there is a need to develop new antiherpetic compounds with different mechanisms of action which will be safe and effective against emerging drug resistant viral isolates. Significant advances have been made towards the design and development of novel antiviral therapeutics during the last decade. As evident by their excellent antiviral activities, pharmaceutical companies are moving forward with several new compounds into various phases of clinical trials. This review provides an overview of structure and life cycle of HSV, progress in the development of new therapies, update on the advances in emerging therapeutics under clinical development and related recent patents for the treatment of Herpes simplex virus infections. PMID:23331181

Varicella and herpes zoster vaccine development: lessons learned.

PubMed

Warren-Gash, Charlotte; Forbes, Harriet; Breuer, Judith

2017-12-01

Before vaccination, varicella zoster virus (VZV), which is endemic worldwide, led to almost universal infection. This neurotropic virus persists lifelong by establishing latency in sensory ganglia, where its reactivation is controlled by VZV-specific T-cell immunity. Lifetime risk of VZV reactivation (zoster) is around 30%. Vaccine development was galvanised by the economic and societal burden of VZV, including debilitating zoster complications that largely affect older individuals. Areas covered: We describe the story of development, licensing and implementation of live attenuated vaccines against varicella and zoster. We consider the complex backdrop of VZV virology, pathogenesis and immune responses in the absence of suitable animal models and examine the changing epidemiology of VZV disease. We review the vaccines' efficacy, safety, effectiveness and coverage using evidence from trials, observational studies from large routine health datasets and clinical post-marketing surveillance studies and outline newer developments in subunit and inactivated vaccines. Expert commentary: Safe and effective, varicella and zoster vaccines have already made major inroads into reducing the burden of VZV disease globally. As these live vaccines have the potential to reactivate and cause clinical disease, developing alternatives that do not establish latency is an attractive prospect but will require better understanding of latency mechanisms.

Varicella and herpes zoster vaccine development: lessons learned

PubMed Central

Warren-Gash, Charlotte; Forbes, Harriet; Breuer, Judith

2017-01-01

ABSTRACT Introduction: Before vaccination, varicella zoster virus (VZV), which is endemic worldwide, led to almost universal infection. This neurotropic virus persists lifelong by establishing latency in sensory ganglia, where its reactivation is controlled by VZV-specific T-cell immunity. Lifetime risk of VZV reactivation (zoster) is around 30%. Vaccine development was galvanised by the economic and societal burden of VZV, including debilitating zoster complications that largely affect older individuals. Areas covered: We describe the story of development, licensing and implementation of live attenuated vaccines against varicella and zoster. We consider the complex backdrop of VZV virology, pathogenesis and immune responses in the absence of suitable animal models and examine the changing epidemiology of VZV disease. We review the vaccines’ efficacy, safety, effectiveness and coverage using evidence from trials, observational studies from large routine health datasets and clinical post-marketing surveillance studies and outline newer developments in subunit and inactivated vaccines. Expert commentary: Safe and effective, varicella and zoster vaccines have already made major inroads into reducing the burden of VZV disease globally. As these live vaccines have the potential to reactivate and cause clinical disease, developing alternatives that do not establish latency is an attractive prospect but will require better understanding of latency mechanisms. PMID:29047317

Questioning skills of clinical facilitators supporting undergraduate nursing students.

PubMed

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

2017-12-01

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

The feasibility of implementing recovery, psychosocial and pharmacological interventions for psychosis: comparison study.

PubMed

van der Krieke, Lian; Bird, Victoria; Leamy, Mary; Bacon, Faye; Dunn, Rebecca; Pesola, Francesca; Janosik, Monika; Le Boutillier, Clair; Williams, Julie; Slade, Mike

2015-05-23

Clinical guidelines for the treatment of people experiencing psychosis have existed for over a decade, but implementation of recommended interventions is limited. Identifying influences on implementation may help to reduce this translational gap. The Structured Assessment of Feasibility (SAFE) measure is a standardised assessment of implementation blocks and enablers. The aim of this study was to characterise and compare the implementation blocks and enablers for recommended psychosis interventions. SAFE was used to evaluate and compare three groups of interventions recommended in the 2014 NICE psychosis guideline: pharmacological (43 trials testing 5 interventions), psychosocial (65 trials testing 5 interventions), and recovery (19 trials testing 5 interventions). The 127 trial reports rated with SAFE were supplemented by published intervention manuals, research protocols, trial registrations and design papers. Differences in the number of blocks and enablers across the three interventions were tested statistically, and feasibility profiles were generated. There was no difference between psychosocial and recovery interventions in the number of blocks or enablers to implementation. Pharmacological interventions (a) had fewer blocks than both psychosocial interventions (χ (2)(3) = 133.77, p < 0.001) and recovery interventions (χ (2)(3) = 104.67, p < 0.001) and (b) did not differ in number of enablers from recovery interventions (χ (2)(3) = 0.74, p = 0.863) but had fewer enablers than psychosocial interventions (χ (2)(3) = 28.92, p < 0.001). Potential adverse events associated with the intervention tend to be a block for pharmacological interventions, whereas complexity of the intervention was the most consistent block for recovery and psychosocial interventions. Feasibility profiles show that pharmacological interventions are relatively easy to implement but can sometimes involve risks. Psychosocial and recovery interventions are relatively complex but tend to be more flexible and more often manualised. SAFE ratings can contribute to tackling the current implementation challenges in mental health services, by providing a reporting guideline structure for researchers to maximise the potential for implementation and by informing prioritisation decisions by clinical guideline developers and service managers.

Feeling safe during an inpatient hospitalization: a concept analysis.

PubMed

Mollon, Deene

2014-08-01

This paper aims to explore the critical attributes of the concept feeling safe. The safe delivery of care is a high priority; however; it is not really known what it means to the patient to 'feel safe' during an inpatient hospitalization. This analysis explores the topic of safety from the patient's perspective. Concept analysis. The data bases of CINAHL, Medline, PsychInfo and Google Scholar for the years 1995-2012 were searched using the terms safe and feeling safe. The eight-step concept analysis method of Walker and Avant was used to analyse the concept of feeling safe. Uses and defining attributes, as well as identified antecedents, consequences and empirical referents, are presented. Case examples are provided to assist in the understanding of defining attributes. Feeling safe is defined as an emotional state where perceptions of care contribute to a sense of security and freedom from harm. Four attributes were identified: trust, cared for, presence and knowledge. Relationship, environment and suffering are the antecedents of feeling safe, while control, hope and relaxed or calm are the consequences. Empirical referents and early development of a theory of feeling safe are explored. This analysis begins the work of synthesizing qualitative research already completed around the concept of feeling safe by defining the key attributes of the concept. Support for the importance of developing patient-centred models of care and creating positive environments where patients receive high-quality care and feel safe is provided. © 2014 John Wiley & Sons Ltd.

Safety, efficacy and clinical generalization of the STAR protocol: a retrospective analysis.

PubMed

Stewart, Kent W; Pretty, Christopher G; Tomlinson, Hamish; Thomas, Felicity L; Homlok, József; Noémi, Szabó Némedi; Illyés, Attila; Shaw, Geoffrey M; Benyó, Balázs; Chase, J Geoffrey

2016-12-01

The changes in metabolic pathways and metabolites due to critical illness result in a highly complex and dynamic metabolic state, making safe, effective management of hyperglycemia and hypoglycemia difficult. In addition, clinical practices can vary significantly, thus making GC protocols difficult to generalize across units.The aim of this study was to provide a retrospective analysis of the safety, performance and workload of the stochastic targeted (STAR) glycemic control (GC) protocol to demonstrate that patient-specific, safe, effective GC is possible with the STAR protocol and that it is also generalizable across/over different units and clinical practices. Retrospective analysis of STAR GC in the Christchurch Hospital Intensive Care Unit (ICU), New Zealand (267 patients), and the Gyula Hospital, Hungary (47 patients), is analyzed (2011-2015). STAR Christchurch (BG target 4.4-8.0 mmol/L) is also compared to the Specialized Relative Insulin and Nutrition Tables (SPRINT) protocol (BG target 4.4-6.1 mmol/L) implemented in the Christchurch Hospital ICU, New Zealand (292 patients, 2005-2007). Cohort mortality, effectiveness and safety of glycemic control and nutrition delivered are compared using nonparametric statistics. Both STAR implementations and SPRINT resulted in over 86 % of time per episode in the blood glucose (BG) band of 4.4-8.0 mmol/L. Patients treated using STAR in Christchurch ICU spent 36.7 % less time on protocol and were fed significantly more than those treated with SPRINT (73 vs. 86 % of caloric target). The results from STAR in both Christchurch and Gyula were very similar, with the BG distributions being almost identical. STAR provided safe GC with very few patients experiencing severe hypoglycemia (BG < 2.2 mmol/L, <5 patients, 1.5 %). STAR outperformed its predecessor, SPRINT, by providing higher nutrition and equally safe, effective control for all the days of patient stay, while lowering the number of measurements and interventions required. The STAR protocol has the ability to deliver high performance and high safety across patient types, time, clinical practice culture (Christchurch and Gyula) and clinical resources.

Light curing in orthodontics; should we be concerned?

PubMed

McCusker, Neil; Lee, Siu Man; Robinson, Stephen; Patel, Naresh; Sandy, Jonathan R; Ireland, Anthony J

2013-06-01

Light cured materials are increasingly used in orthodontic clinical practice and concurrent with developments in materials have been developments in light curing unit technology. In recent years the irradiances of these units have increased. The aim of this study was to determine the safe exposure times to both direct and reflected light. The weighted irradiance and safe exposure times of 11 dental curing lights (1 plasma arc, 2 halogen and 8 LED lights) were determined at 6 distances (2-60 cm) from the light guide tip using a spectroradiometer. In addition, using the single most powerful light, the same two parameters were determined for reflected light. This was done at a distance of 10 cm from the reflected light, but during simulated bonding of 8 different orthodontic brackets of three material types, namely stainless steel, ceramic and composite. The results indicate that the LED Fusion lamp had the highest weighted irradiance and the shortest safe exposure time. With this light the maximum safe exposure time without additional eye protection for the patient (at 10 cm), the operator (at 30 cm) and the assistant (at 60 cm) ranged from 2.5 min, 22.1 min and 88.8 min respectively. This indicates a relatively low short term risk during normal operation of dental curing lights. For reflected light at a distance of 10 cm the risk was even lower, but was affected by the material and shape of the orthodontic bracket under test. The short term risks associated with the use of dental curing lights, halogen, LED or plasma, appear to be low, particularly if as is the case adequate safety precautions are employed. The same is true for reflected light from orthodontic brackets during bonding. What is still unclear is the potential long term ocular effects of prolonged exposure to the blue light generated from dental curing lights. Copyright © 2013 Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

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

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

NONE

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

Endocannabinoids in brain plasticity: Cortical maturation, HPA axis function and behavior.

PubMed

Dow-Edwards, Diana; Silva, Lindsay

2017-01-01

Marijuana use during adolescence has reached virtually every strata of society. The general population has the perception that marijuana use is safe for mature people and therefore is also safe for developing adolescents. However, both clinical and preclinical research shows that marijuana use, particularly prior to age 16, could have long-term effects on cognition, anxiety and stress-related behaviors, mood disorders and substance abuse. These effects derive from the role of the endocannabinoid system, the endogenous cannabinoid system, in the development of cortex, amygdala, hippocampus and hypothalamus during adolescence. Endocannabinoids are necessary for normal neuronal excitation and inhibition through actions at glutamate and GABA terminals. Synaptic pruning at excitatory synapses and sparing of inhibitory synapses likely results in changes in the balance of excitation/inhibition in individual neurons and within networks; processes which are necessary for normal cortical development. The interaction between prefrontal cortex (PFC), amygdala and hippocampus is responsible for emotional memory, anxiety-related behaviors and drug abuse and all utilize the endogenous cannabinoid system to maintain homeostasis. Also, endocannabinoids are required for fast and slow feedback in the normal stress response, processes which mature during adolescence. Therefore, exogenous cannabinoids, such as marijuana, have the potential to alter the course of development of each of these major systems (limbic, hypothalamic-pituitary-adrenal (HPA) axis and neocortex) if used during the critical period of brain development, adolescence. This article is part of a Special Issue entitled SI: Adolescent plasticity. Copyright © 2016 Elsevier B.V. All rights reserved.

Development of a test for recording both visual and auditory reaction times, potentially useful for future studies in patients on opioids therapy

PubMed Central

Miceli, Luca; Bednarova, Rym; Rizzardo, Alessandro; Samogin, Valentina; Della Rocca, Giorgio

2015-01-01

Objective Italian Road Law limits driving while undergoing treatment with certain kinds of medication. Here, we report the results of a test, run as a smartphone application (app), assessing auditory and visual reflexes in a sample of 300 drivers. The scope of the test is to provide both the police force and medication-taking drivers with a tool that can evaluate the individual’s capacity to drive safely. Methods The test is run as an app for Apple iOS and Android mobile operating systems and facilitates four different reaction times to be assessed: simple visual and auditory reaction times and complex visual and auditory reaction times. Reference deciles were created for the test results obtained from a sample of 300 Italian subjects. Results lying within the first three deciles were considered as incompatible with safe driving capabilities. Results Performance is both age-related (r>0.5) and sex-related (female reaction times were significantly slower than those recorded for male subjects, P<0.05). Only 21% of the subjects were able to perform all four tests correctly. Conclusion We developed and fine-tuned a test called Safedrive that measures visual and auditory reaction times through a smartphone mobile device; the scope of the test is two-fold: to provide a clinical tool for the assessment of the driving capacity of individuals taking pain relief medication; to promote the sense of social responsibility in drivers who are on medication and provide these individuals with a means of testing their own capacity to drive safely. PMID:25709406

Development of a test for recording both visual and auditory reaction times, potentially useful for future studies in patients on opioids therapy.

PubMed

Miceli, Luca; Bednarova, Rym; Rizzardo, Alessandro; Samogin, Valentina; Della Rocca, Giorgio

2015-01-01

Italian Road Law limits driving while undergoing treatment with certain kinds of medication. Here, we report the results of a test, run as a smartphone application (app), assessing auditory and visual reflexes in a sample of 300 drivers. The scope of the test is to provide both the police force and medication-taking drivers with a tool that can evaluate the individual's capacity to drive safely. The test is run as an app for Apple iOS and Android mobile operating systems and facilitates four different reaction times to be assessed: simple visual and auditory reaction times and complex visual and auditory reaction times. Reference deciles were created for the test results obtained from a sample of 300 Italian subjects. Results lying within the first three deciles were considered as incompatible with safe driving capabilities. Performance is both age-related (r>0.5) and sex-related (female reaction times were significantly slower than those recorded for male subjects, P<0.05). Only 21% of the subjects were able to perform all four tests correctly. We developed and fine-tuned a test called Safedrive that measures visual and auditory reaction times through a smartphone mobile device; the scope of the test is two-fold: to provide a clinical tool for the assessment of the driving capacity of individuals taking pain relief medication; to promote the sense of social responsibility in drivers who are on medication and provide these individuals with a means of testing their own capacity to drive safely.

The interprofessional learning experience: Findings from a qualitative study based in an outpatient setting.

PubMed

Jakobsen, Flemming; Mørcke, Anne Mette; Hansen, Torben Bæk

2017-09-01

Clinical interprofessional education has traditionally taken place in hospital wards, but much diagnosis and treatment have shifted to the outpatient setting. The logical consequence is to shift more students' clinical placements from the "bedside" to outpatient settings. However, it is unclear how we ensure that this shift maximises learning. The purpose of this article is to understand the authentic learning experience in an interprofessional outpatient clinic setting. We performed an exploratory case study with interviews of four nursing students, 13 medical students, and six staff members who worked in an interprofessional outpatient orthopaedic clinic from March 2015 to January 2016. The interviews were transcribed and analysed using systematic text condensation. The students' self-reported learning experience in this outpatient clinic was characterised by direct patient contact and by authentic, interprofessional, task-based learning, and a preference for indirect supervision when conducting uncomplicated patient consultations. The supervisors intended to create this interprofessional outpatient clinic experience by having a clear teaching approach based on adult learning principles in a safe and challenging learning environment. The shift to the outpatient setting was strongly and practically supported by the management. This study indicates that student learning can be shifted to the outpatient clinic setting if there is supportive management and dedicated supervisors who establish a challenging yet safe interprofessional learning environment.

Clinical Oversight: Conceptualizing the Relationship Between Supervision and Safety

PubMed Central

Lingard, Lorelei; Baker, G. Ross; Kitchen, Lisa; Regehr, Glenn

2007-01-01

Background Concern about the link between clinical supervision and safe, quality health care has led to widespread increases in the supervision of medical trainees. The effects of increased supervision on patient care and trainee education are not known, primarily because the current multifacted and poorly operationalized concept of clinical supervision limits the potential for evaluation. Objective To develop a conceptual model of clinical supervision to inform and guide policy and research. Design, Setting, and Participants Observational fieldwork and interviews were conducted in the Emergency Department and General Internal Medicine in-patient teaching wards of two academic health sciences centers associated with an urban Canadian medical school. Members of 12 Internal Medicine and Emergency Medicine teaching teams (n = 88) were observed during regular clinical activities (216 hours). Sixty-five participants (12 physicians, 28 residents, 17 medical students, 8 nurses) also completed interviews about supervision. Field notes and interview transcripts were analyzed for emergent themes using grounded theory methodology. Results The term “clinical oversight” was developed to describe patient care activities performed by supervisors to ensure quality of care. “Routine oversight” (preplanned monitoring of trainees’ clinical work) can expose supervisors to concerns that trigger “responsive oversight” (a double-check or elaboration of trainees’ clinical work). Supervisors sometimes engage in “backstage oversight” (oversight of which the trainee is not directly aware). When supervisors encounter a situation that exceeds a trainee’s competence, they move beyond clinical oversight to “direct patient care”. Conclusions This study elaborates a typology of clinical oversight activities including routine, responsive, and backstage oversight. This new typology provides a framework for clinical supervision policy and for research to evaluate the relationship between supervision and safety. PMID:17557190

Methodology on quantification of sonication duration for safe application of MR guided focused ultrasound for liver tumour ablation.

PubMed

Mihcin, Senay; Karakitsios, Ioannis; Le, Nhan; Strehlow, Jan; Demedts, Daniel; Schwenke, Michael; Haase, Sabrina; Preusser, Tobias; Melzer, Andreas

2017-12-01

Magnetic Resonance Guided Focused Ultrasound (MRgFUS) for liver tumour ablation is a challenging task due to motion caused by breathing and occlusion due the ribcage between the transducer and the tumour. To overcome these challenges, a novel system for liver tumour ablation during free breathing has been designed. The novel TRANS-FUSIMO Treatment System (TTS, EUFP7) interacts with a Magnetic Resonance (MR) scanner and a focused ultrasound transducer to sonicate to a moving target in liver. To meet the requirements of ISO 13485; a quality management system for medical device design, the system needs to be tested for certain process parameters. The duration of sonication and, the delay after the sonication button is activated, are among the parameters that need to be quantified for efficient and safe ablation of tumour tissue. A novel methodology is developed to quantify these process parameters. A computerised scope is programmed in LabVIEW to collect data via hydrophone; where the coordinates of fiber-optic sensor assembly was fed into the TRANS-FUSIMO treatment software via Magnetic Resonance Imaging (MRI) to sonicate to the tip of the sensor, which is synchronised with the clock of the scope, embedded in a degassed water tank via sensor assembly holder. The sonications were executed for 50 W, 100 W, 150 W for 10 s to quantify the actual sonication duration and the delay after the emergency stop by two independent operators for thirty times. The deviation of the system from the predefined specs was calculated. Student's-T test was used to investigate the user dependency. The duration of sonication and the delay after the sonication were quantified successfully with the developed method. TTS can sonicate with a maximum deviation of 0.16 s (Std 0.32) from the planned duration and with a delay of 14 ms (Std 0.14) for the emergency stop. Student's T tests indicate that the results do not depend on operators (p > .05). The evidence obtained via this protocol is crucial for translation- of-research into the clinics for safe application of MRgFUS. The developed protocol could be used for system maintenance in compliance with quality systems in clinics for daily quality assurance routines. Copyright © 2017 Elsevier B.V. All rights reserved.

The Value of Clinical Jazz: Teaching Critical Reflection on, in, and Toward Action.

PubMed

Casapulla, Sharon; Longenecker, Randall; Beverly, Elizabeth A

2016-05-01

Clinical Jazz is a small-group strategy in medical education designed to develop interpersonal skills and improve doctor-patient and interprofessional relationships. The purpose of this study was to explore medical students' and faculty facilitators' perceived value of Clinical Jazz. We conducted a modified Nominal Group Process with participating medical students (n=21), faculty facilitators (n=5), and research team members (n=3). Students and faculty facilitators independently answered the question, "What do you value about Clinical Jazz?" We then conducted content and thematic analyses on the resulting data. Three themes emerged during analysis: (1) students and faculty appreciated the opportunity to learn and practice a thoughtful and structured process for problem solving, (2) students and faculty valued the safety of the group process in sharing a diversity of perspectives on topics in medicine, and (3) students and faculty acknowledged the importance of addressing real and challenging problems that are rarely addressed in formal lectures and other planned small-group settings. Clinical Jazz provides students and faculty with the opportunity to address the hidden and/or informal curriculum in medical education, while providing a safe space and time to solve important clinical and interprofessional problems.

Brain temperature and its fundamental properties: a review for clinical neuroscientists

PubMed Central

Wang, Huan; Wang, Bonnie; Normoyle, Kieran P.; Jackson, Kevin; Spitler, Kevin; Sharrock, Matthew F.; Miller, Claire M.; Best, Catherine; Llano, Daniel; Du, Rose

2014-01-01

Brain temperature, as an independent therapeutic target variable, has received increasingly intense clinical attention. To date, brain hypothermia represents the most potent neuroprotectant in laboratory studies. Although the impact of brain temperature is prevalent in a number of common human diseases including: head trauma, stroke, multiple sclerosis, epilepsy, mood disorders, headaches, and neurodegenerative disorders, it is evident and well recognized that the therapeutic application of induced hypothermia is limited to a few highly selected clinical conditions such as cardiac arrest and hypoxic ischemic neonatal encephalopathy. Efforts to understand the fundamental aspects of brain temperature regulation are therefore critical for the development of safe, effective, and pragmatic clinical treatments for patients with brain injuries. Although centrally-mediated mechanisms to maintain a stable body temperature are relatively well established, very little is clinically known about brain temperature's spatial and temporal distribution, its physiological and pathological fluctuations, and the mechanism underlying brain thermal homeostasis. The human brain, a metabolically “expensive” organ with intense heat production, is sensitive to fluctuations in temperature with regards to its functional activity and energy efficiency. In this review, we discuss several critical aspects concerning the fundamental properties of brain temperature from a clinical perspective. PMID:25339859

Safety and preliminary immunogenicity of Cuban pneumococcal conjugate vaccine candidate in healthy children: a randomized phase I clinical trial.

PubMed

Dotres, Carlos P; Puga, Rinaldo; Ricardo, Yariset; Broño, Carmen R; Paredes, Beatriz; Echemendía, Vladimir; Rosell, Sandra; González, Nadezhda; García-Rivera, Dagmar; Valdés, Yury; Goldblatt, David; Vérez-Bencomo, Vicente

2014-09-15

A new heptavalent conjugate vaccine (PCV7-TT) is under development in Cuba. PCV7-TT contains 2 μg of serotypes 1, 5, 14, 18C, 19F, 23F and 4 μg of 6B, each one conjugated to tetanus toxoid (TT). This vaccine was designed with the serotypes that cause most invasive pneumococcal diseases (IPD) worldwide. In the present study, we investigated the safety and explored the immunogenicity of PCV7-TT during a controlled, randomized and double blind clinical trial phase I in 4-5-year-old children. PCV7-TT was well tolerated and as safe as Synflorix used as control vaccine. Following a single-dose vaccination, all individual serotypes included in PCV7-TT induced statistically significant increase of IgG GMC and OPA GMT. These are the first clinical results of PCV7-TT in children and they pave the way toward next clinical trials in children and infants. This clinical trial was published in the Cuban Public Register of Clinical Trials with code RPCEC00000173. Copyright © 2014 Elsevier Ltd. All rights reserved.

In-home monitoring of persons with dementia: ethical guidelines for technology research and development.

PubMed

Mahoney, Diane F; Purtilo, Ruth B; Webbe, Frank M; Alwan, Majd; Bharucha, Ashok J; Adlam, Tim D; Jimison, Holly B; Turner, Beverly; Becker, S Ann

2007-07-01

Innovative technologies are rapidly emerging that offer caregivers the support and means to assist older adults with cognitive impairment to continue living "at home." Technology research and development efforts applied to older adults with dementia invoke special grant review and institutional review board concerns, to ensure not only safe but also ethically appropriate interventions. Evidence is emerging, however, that tensions are growing between innovators and reviewers. Reviewers with antitechnology biases are in a position to stifle needed innovation. Technology developers who fail to understand the clinical and caregiving aspects of dementia may design applications that are not in alignment with users' capabilities. To bridge this divide, we offer an analysis of the ethical issues surrounding home monitoring, a model framework, and ethical guidelines for technology research and development for persons with Alzheimer's disease and their caregivers.

Functional Nanostructures for Effective Delivery of Small Interfering RNA Therapeutics

PubMed Central

Hong, Cheol Am; Nam, Yoon Sung

2014-01-01

Small interfering RNA (siRNA) has proved to be a powerful tool for target-specific gene silencing via RNA interference (RNAi). Its ability to control targeted gene expression gives new hope to gene therapy as a treatment for cancers and genetic diseases. However, siRNA shows poor pharmacological properties, such as low serum stability, off-targeting, and innate immune responses, which present a significant challenge for clinical applications. In addition, siRNA cannot cross the cell membrane for RNAi activity because of its anionic property and stiff structure. Therefore, the development of a safe, stable, and efficient system for the delivery of siRNA therapeutics into the cytoplasm of targeted cells is crucial. Several nanoparticle platforms for siRNA delivery have been developed to overcome the major hurdles facing the therapeutic uses of siRNA. This review covers a broad spectrum of non-viral siRNA delivery systems developed for enhanced cellular uptake and targeted gene silencing in vitro and in vivo and discusses their characteristics and opportunities for clinical applications of therapeutic siRNA. PMID:25285170

Vaccine Pipeline Has Grown During The Past Two Decades With More Early-Stage Trials From Small And Medium-Size Companies.

PubMed

Hwang, Thomas J; Kesselheim, Aaron S

2016-02-01

Many serious diseases lack safe and effective vaccines. Using a large commercial database, we examined trends in global vaccine research and development and found that the proportion of new vaccine candidates entering all stages of clinical development increased by 3-5 percentage points over the past two decades. Small and medium-size companies accounted for nearly twice as many new Phase I vaccine trials compared to large companies, but late-stage (Phase III) vaccine trials were dominated by large companies. There were no significant differences between vaccines and drugs in the probability of success in clinical trials or in profitability. Small and medium-size companies, including spin-outs from academic research centers, play an important role in innovative research and discovery. Our findings suggest that policy making targeted at smaller companies, such as prizes or opportunities for public-private partnerships, could support the development of new vaccines, particularly those targeting unmet medical needs and emerging public health threats. Project HOPE—The People-to-People Health Foundation, Inc.

Experimental infection of human volunteers with Haemophilus ducreyi: fifteen years of clinical data and experience.

PubMed

Janowicz, Diane M; Ofner, Susan; Katz, Barry P; Spinola, Stanley M

2009-06-01

Haemophilus ducreyi causes chancroid, which facilitates transmission of human immunodeficiency virus type 1. To better understand the biology of H. ducreyi, we developed a human inoculation model. In the present article, we describe clinical outcomes for 267 volunteers who were infected with H. ducreyi. There was a relationship between papule formation and estimated delivered dose. The outcome (either pustule formation or resolution) of infected sites for a given subject was not independent; the most important determinants of pustule formation were sex and host effects. When 41 subjects were infected a second time, their outcomes segregated toward their initial outcome, confirming the host effect. Subjects with pustules developed local symptoms that required withdrawal from the study after a mean of 8.6 days. There were 191 volunteers who had tissue biopsy performed, 173 of whom were available for follow-up analysis; 28 (16.2%) of these developed hypertrophic scars, but the model was otherwise safe. Mutant-parent trials confirmed key features in H. ducreyi pathogenesis, and the model has provided an opportunity to study differential human susceptibility to a bacterial infection.

Clinical Application of Pluripotent Stem Cells: An Alternative Cell-Based Therapy for Treating Liver Diseases?

PubMed

Tolosa, Laia; Pareja, Eugenia; Gómez-Lechón, Maria José

2016-12-01

The worldwide shortage of donor livers for organ and hepatocyte transplantation has prompted the search for alternative therapies for intractable liver diseases. Cell-based therapy is envisaged as a useful therapeutic option to recover and stabilize the lost metabolic function for acute liver failure, end-stage and congenital liver diseases, or for those patients who are not considered eligible for organ transplantation. In recent years, research to identify alternative and reliable cell sources for transplantation that can be derived by reproducible methods has been encouraged. Human pluripotent stem cells (PSCs), which comprise both embryonic and induced PSCs, may offer many advantages as an alternative to hepatocytes for liver cell therapy. Their capacity for expansion, hepatic differentiation and self-renewal make them a promising source of unlimited numbers of hepatocyte-like cells for treating and repairing damaged livers. Immunogenicity and tumorigenicity of human PSCs remain the bottleneck for successful clinical application. However, recent advances made to develop disease-corrected hepatocyte-like cells from patients' human-induced PSCs by gene editing have opened up many potential gateways for the autologous treatment of hereditary liver diseases, which may likely reduce the risk of rejection and the need for lifelong immunosuppression. Well-defined methods to reduce the expression of oncogenic genes in induced PSCs, including protocols for their complete and safe hepatic differentiation, should be established to minimize the tumorigenicity of transplanted cells. On top of this, such new strategies are currently being rigorously tested and validated in preclinical studies before they can be safely transferred to clinical practice with patients.

Sutureless functional end-to-end anastomosis using a linear stapler with polyglycolic acid felt for intestinal anastomoses.

PubMed

Naito, Masanori; Miura, Hirohisa; Nakamura, Takatoshi; Sato, Takeo; Yamanashi, Takahiro; Tsutsui, Atsuko; Watanabe, Masahiko

2017-05-01

Gastrointestinal anastomosis remains associated with a considerable burden of morbidity and, in some cases, mortality. Functional end-to-end anastomosis, whilst extremely efficient, is vulnerable to increased intestinal pressure in the immediate postoperative period, which may predispose to development of anastomotic leakage or bleeding. Therefore, there is a requirement for new techniques that facilitate safe and efficacious anastomotic procedures. This study examined the clinical application of functional end-to-end anastomosis with a stapler that automatically applies a bioabsorbable polyglycolic acid sheet (Endo GIA™ Reinforced Reload with Tri-Staple™ Technology). A porcine model was used to examine functional end-to-end anastomosis with and without application of a bioabsorbable polyglycolic acid sheet. As the crotch of the anastomosis is considered the weakest point, a probe was used to test the integrity of these anastomoses. Furthermore, we performed functional end-to-end anastomosis using the Endo GIA™ Reinforced stapler in a clinical series of 20 patients undergoing gastrointestinal tract resection. In all cases, functional end-to-end anastomosis was performed without suture reinforcement. Small intestine anastomoses in the animal study exhibited no weakness at the crotch of the anastomosis, as tested with a probe, suggesting an increased resiliency to conventional complications of functional end-to-end anastomosis. In the clinical population, no postoperative complications were noted. No adhesive intestinal obstruction was noted. Sutureless functional end-to-end anastomosis using the Endo GIA™ Reinforced appears to be safe, efficacious, and straightforward. Reinforcement of the crotch site with a bioabsorbable polyglycolic acid sheet appears to mitigate conventional problems with crotch-site vulnerability.