Implementation of Point-of-Care Diagnostics in Rural Primary Healthcare Clinics in South Africa: Perspectives of Key Stakeholders

PubMed Central

Mashamba-Thompson, Tivani P.; Jama, Ngcwalisa A.; Sartorius, Benn; Drain, Paul K.; Thompson, Rowan M.

2017-01-01

Introduction: Key stakeholders’ involvement is crucial to the sustainability of quality point-of-care (POC) diagnostics services in low-and-middle income countries. The aim of this study was to explore key stakeholder perceptions on the implementation of POC diagnostics in rural primary healthcare (PHC) clinics in South Africa. Method: We conducted a qualitative study encompassing in-depth interviews with multiple key stakeholders of POC diagnostic services for rural and resource-limited PHC clinics. Interviews were digitally recorded and transcribed verbatim prior to thematic content analysis. Thematic content analysis was conducted using themes guided by the World Health Organisation (WHO) quality-ASSURED (Affordable, Sensitive, Specific, User friendly, Rapid and to enable treatment at first visit and Robust, Equipment free and Delivered to those who need it) criteria for POC diagnostic services in resource-limited settings. Results: 11 key stakeholders participated in the study. All stakeholders perceived the main advantage of POC diagnostics as enabling access to healthcare for rural patients. Stakeholders perceived the current POC diagnostic services to have an ability to meet patients’ needs, but recommended further improvement of the following areas: research on cost-effectiveness; improved quality management systems; development of affordable POC diagnostic and clinic-based monitoring and evaluation. Conclusions: Key stakeholders of POC diagnostics in rural PHC clinics in South Africa highlighted the need to assess affordability and ensure quality assurance of current services before adopting new POC diagnostics and scaling up current POC diagnostics. PMID:28075337

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

PubMed

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

2012-07-01

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

Towards optimised information about clinical trials; identification and validation of key issues in collaboration with cancer patient advocates.

PubMed

Dellson, P; Nilbert, M; Bendahl, P-O; Malmström, P; Carlsson, C

2011-07-01

Clinical trials are crucial to improve cancer treatment but recruitment is difficult. Optimised patient information has been recognised as a key issue. In line with the increasing focus on patients' perspectives in health care, we aimed to study patients' opinions about the written information used in three clinical trials for breast cancer. Primary data collection was done in focus group interviews with breast cancer patient advocates. Content analysis identified three major themes: comprehensibility, emotions and associations, and decision making. Based on the advocates' suggestions for improvements, 21 key issues were defined and validated through a questionnaire in an independent group of breast cancer patient advocates. Clear messages, emotionally neutral expressions, careful descriptions of side effects, clear comparisons between different treatment alternatives and information about the possibility to discontinue treatment were perceived as the most important issues. Patients' views of the information in clinical trials provide new insights and identify key issues to consider in optimising future written information and may improve recruitment to clinical cancer trials. © 2010 Blackwell Publishing Ltd.

Costs of care in a mild-to-moderate Alzheimer clinical trial sample: key resources and their determinants.

PubMed

Gustavsson, Anders; Cattelin, Francoise; Jönsson, Linus

2011-07-01

Costs of care are frequently included as secondary endpoint in Alzheimer clinical trials because payers demand evidence of the budgetary effects of novel therapies. Future clinical trial protocols can be optimized on the basis of the currently available data, including what are the key resources and how are they correlated to disease severity measures. Primary patient-level data from two 18 months clinical trials of a putative disease modifier in mild-to-moderate Alzheimer's disease (n = 2,744) were analyzed to identify key components of costs of care and their determinants in a clinical trial setting. Costs of care were assessed with the resource utilization in dementia Lite (RUD) instrument, which includes patient accommodation, informal care, community care, and hospitalizations. The contribution of each component to total costs of care and their correlation with one another and key disease severity measures (Alzheimer's Disease Assessment Scale--Cognitive Subscale, Mini-Mental State Examination, Clinical Dementia Rating-Sum of Boxes, Alzheimer's Disease Cooperative Study--Activities of Daily Living Inventory, and Neuropsychiatric Inventory Questionnaire) was explored. Informal care constituted 82% to 86% of the total costs of care over the 18-months trial and community care services and patient accommodation contributed 6% to 8% each. Informal care was positively correlated with hospitalizations but negatively to patient accommodation, indicating that these services are supplements. Informal care also had the strongest pair-wise correlation with key disease severity measures, suggesting a higher chance of identifying a treatment effect on this component. ADL-ability (Alzheimer's Disease Cooperative Study--Activities of Daily Living Inventory) was the strongest predictor of costs of care of all disease severity measures. Informal care is the most important component of costs of care in a mild-to-moderate Alzheimer clinical trial sample, and it is primarily

Key Clinical Features to Identify Girls with "CDKL5" Mutations

ERIC Educational Resources Information Center

Bahi-Buisson, Nadia; Nectoux, Juliette; Rosas-Vargas, Haydee; Milh, Mathieu; Boddaert, Nathalie; Girard, Benoit; Cances, Claude; Ville, Dorothee; Afenjar, Alexandra; Rio, Marlene; Heron, Delphine; Morel, Marie Ange N'Guyen; Arzimanoglou, Alexis; Philippe, Christophe; Jonveaux, Philippe; Chelly, Jamel; Bienvenu, Thierry

2008-01-01

Mutations in the human X-linked cyclin-dependent kinase-like 5 ("CDKL5") gene have been shown to cause infantile spasms as well as Rett syndrome (RTT)-like phenotype. To date, less than 25 different mutations have been reported. So far, there are still little data on the key clinical diagnosis criteria and on the natural history of…

Key Elements of Clinical Physician Leadership at an Academic Medical Center

PubMed Central

Dine, C. Jessica; Kahn, Jeremy M; Abella, Benjamin S; Asch, David A; Shea, Judy A

2011-01-01

Background A considerable body of literature in the management sciences has defined leadership and how leadership skills can be attained. There is considerably less literature about leadership within medical settings. Physicians-in-training are frequently placed in leadership positions ranging from running a clinical team or overseeing a resuscitation effort. However, physicians-in-training rarely receive such training. The objective of this study was to discover characteristics associated with effective physician leadership at an academic medical center for future development of such training. Methods We conducted focus groups with medical professionals (attending physicians, residents, and nurses) at an academic medical center. The focus group discussion script was designed to elicit participants' perceptions of qualities necessary for physician leadership. The lead question asked participants to imagine a scenario in which they either acted as or observed a physician leader. Two independent reviewers reviewed transcripts to identify key domains of physician leadership. Results Although the context was not specified, the focus group participants discussed leadership in the context of a clinical team. They identified 4 important themes: management of the team, establishing a vision, communication, and personal attributes. Conclusions Physician leadership exists in clinical settings. This study highlights the elements essential to that leadership. Understanding the physician attributes and behaviors that result in effective leadership and teamwork can lay the groundwork for more formal leadership education for physicians-in-training. PMID:22379520

Key principles for a national clinical decision support knowledge sharing framework: synthesis of insights from leading subject matter experts

PubMed Central

Hongsermeier, Tonya; Wright, Adam; Lewis, Janet; Bell, Douglas S; Middleton, Blackford

2013-01-01

Objective To identify key principles for establishing a national clinical decision support (CDS) knowledge sharing framework. Materials and methods As part of an initiative by the US Office of the National Coordinator for Health IT (ONC) to establish a framework for national CDS knowledge sharing, key stakeholders were identified. Stakeholders' viewpoints were obtained through surveys and in-depth interviews, and findings and relevant insights were summarized. Based on these insights, key principles were formulated for establishing a national CDS knowledge sharing framework. Results Nineteen key stakeholders were recruited, including six executives from electronic health record system vendors, seven executives from knowledge content producers, three executives from healthcare provider organizations, and three additional experts in clinical informatics. Based on these stakeholders' insights, five key principles were identified for effectively sharing CDS knowledge nationally. These principles are (1) prioritize and support the creation and maintenance of a national CDS knowledge sharing framework; (2) facilitate the development of high-value content and tooling, preferably in an open-source manner; (3) accelerate the development or licensing of required, pragmatic standards; (4) acknowledge and address medicolegal liability concerns; and (5) establish a self-sustaining business model. Discussion Based on the principles identified, a roadmap for national CDS knowledge sharing was developed through the ONC's Advancing CDS initiative. Conclusion The study findings may serve as a useful guide for ongoing activities by the ONC and others to establish a national framework for sharing CDS knowledge and improving clinical care. PMID:22865671

Key principles for a national clinical decision support knowledge sharing framework: synthesis of insights from leading subject matter experts.

PubMed

Kawamoto, Kensaku; Hongsermeier, Tonya; Wright, Adam; Lewis, Janet; Bell, Douglas S; Middleton, Blackford

2013-01-01

To identify key principles for establishing a national clinical decision support (CDS) knowledge sharing framework. As part of an initiative by the US Office of the National Coordinator for Health IT (ONC) to establish a framework for national CDS knowledge sharing, key stakeholders were identified. Stakeholders' viewpoints were obtained through surveys and in-depth interviews, and findings and relevant insights were summarized. Based on these insights, key principles were formulated for establishing a national CDS knowledge sharing framework. Nineteen key stakeholders were recruited, including six executives from electronic health record system vendors, seven executives from knowledge content producers, three executives from healthcare provider organizations, and three additional experts in clinical informatics. Based on these stakeholders' insights, five key principles were identified for effectively sharing CDS knowledge nationally. These principles are (1) prioritize and support the creation and maintenance of a national CDS knowledge sharing framework; (2) facilitate the development of high-value content and tooling, preferably in an open-source manner; (3) accelerate the development or licensing of required, pragmatic standards; (4) acknowledge and address medicolegal liability concerns; and (5) establish a self-sustaining business model. Based on the principles identified, a roadmap for national CDS knowledge sharing was developed through the ONC's Advancing CDS initiative. The study findings may serve as a useful guide for ongoing activities by the ONC and others to establish a national framework for sharing CDS knowledge and improving clinical care.

Key design considerations on comparative clinical efficacy studies for biosimilars: adalimumab as an example.

PubMed

Lai, Zhihong; La Noce, Anna

2016-01-01

The global development of a biosimilar product is a methodologically complex affair, lined with potential design pitfalls and operational missteps to be avoided. Without careful attention to experimental design and meticulous execution, a development programme may fail to demonstrate equivalence, as would be anticipated for a biosimilar product, and not receive regulatory approval based on current guidance. In order to demonstrate similarity of a biosimilar product versus the originator (ie, the branded product), based on regulatory guidance, a stepwise approach is usually taken, starting with a comprehensive structural and functional characterisation of the new biological moiety. Given the sequential nature of the review process, the extent and nature of the non-clinical in vivo studies and the clinical studies to be performed depend on the level of evidence obtained in these previous step(s). A clinical efficacy trial is often required to further demonstrate biosimilarity of the two products (biosimilar vs branded) in terms of comparative safety and effectiveness. Owing to the focus on demonstrating biosimilarity and not safety and efficacy de novo, designing an adequate phase III (potentially pivotal) clinical efficacy study of a biosimilar may present some unique challenges. Using adalimumab as an example, we highlight design elements that may deserve special attention.

Qualified nurses' rate new nursing graduates as lacking skills in key clinical areas.

PubMed

Missen, Karen; McKenna, Lisa; Beauchamp, Alison; Larkins, Jo-Ann

2016-08-01

The aim of this study was to explore perceptions of qualified nurses on the abilities of newly registered nursing graduates to perform a variety of clinical skills. Evidence from the literature suggests that undergraduate nursing programmes do not adequately prepare nursing students to be practice-ready on completion of their nursing courses. A descriptive quantitative design was used. Participants were recruited through the Australian Nursing and Midwifery Federation, Victorian branch. A brief explanation of the study and a link to the survey were promoted in their monthly e-newsletter. A total of 245 qualified nurses in the state of Victoria, Australia participated in this study. A survey tool of 51 clinical skills and open-ended questions was used, whereby participants were asked to rate new nursing graduates' abilities using a 5-point Likert scale. Overall participants rated new nursing graduates' abilities for undertaking clinical skills as good or very good in 35·3% of skills, 33·3% were rated as adequate and 31·4% rated as being performed poorly or very poorly. Of concern, essential clinical skills, such as critical thinking and problem solving, working independently and assessment procedures, were found to be poorly executed and affecting new registered nurses graduates' competence. The findings from this study can further serve as a reference for nursing education providers to enhance nursing curricula and work collaboratively with healthcare settings in preparing nurses to be competent, safe practitioners on completion of their studies. Identifying key areas in which new nursing graduates are not yet competent means that educational providers and educators from healthcare settings can focus on these skills in better preparing our nurses to be work ready. © 2016 John Wiley & Sons Ltd.

Key clinical features to identify girls with CDKL5 mutations.

PubMed

Bahi-Buisson, Nadia; Nectoux, Juliette; Rosas-Vargas, Haydeé; Milh, Mathieu; Boddaert, Nathalie; Girard, Benoit; Cances, Claude; Ville, Dorothée; Afenjar, Alexandra; Rio, Marlène; Héron, Delphine; N'guyen Morel, Marie Ange; Arzimanoglou, Alexis; Philippe, Christophe; Jonveaux, Philippe; Chelly, Jamel; Bienvenu, Thierry

2008-10-01

Mutations in the human X-linked cyclin-dependent kinase-like 5 (CDKL5) gene have been shown to cause infantile spasms as well as Rett syndrome (RTT)-like phenotype. To date, less than 25 different mutations have been reported. So far, there are still little data on the key clinical diagnosis criteria and on the natural history of CDKL5-associated encephalopathy. We screened the entire coding region of CDKL5 for mutations in 183 females with encephalopathy with early seizures by denaturing high liquid performance chromatography and direct sequencing, and we identified in 20 unrelated girls, 18 different mutations including 7 novel mutations. These mutations were identified in eight patients with encephalopathy with RTT-like features, five with infantile spasms and seven with encephalopathy with refractory epilepsy. Early epilepsy with normal interictal EEG and severe hypotonia are the key clinical features in identifying patients likely to have CDKL5 mutations. Our study also indicates that these patients clearly exhibit some RTT features such as deceleration of head growth, stereotypies and hand apraxia and that these RTT features become more evident in older and ambulatory patients. However, some RTT signs are clearly absent such as the so called RTT disease profile (period of nearly normal development followed by regression with loss of acquired fine finger skill in early childhood and characteristic intensive eye communication) and the characteristic evolution of the RTT electroencephalogram. Interestingly, in addition to the overall stereotypical symptomatology (age of onset and evolution of the disease) resulting from CDKL5 mutations, atypical forms of CDKL5-related conditions have also been observed. Our data suggest that phenotypic heterogeneity does not correlate with the nature or the position of the mutations or with the pattern of X-chromosome inactivation, but most probably with the functional transcriptional and/or translational consequences of CDKL5

Driving clinical study efficiency by using a productivity breakdown model: comparative evaluation of a global clinical study and a similar Japanese study.

PubMed

Takahashi, K; Sengoku, S; Kimura, H

2011-02-01

A fundamental management imperative of pharmaceutical companies is to contain surging costs of developing and launching drugs globally. Clinical studies are a research and development (R&D) cost driver. The objective of this study was to develop a productivity breakdown model, or a key performance indicator (KPI) tree, for an entire clinical study and to use it to compare a global clinical study with a similar Japanese study. We, thereby, hope to identify means of improving study productivity. We developed the new clinical study productivity breakdown model, covering operational aspects and cost factors. Elements for improving clinical study productivity were assessed from a management viewpoint by comparing empirical tracking data from a global clinical study with a Japanese study with similar protocols. The following unique and material differences, beyond simple international difference in cost of living, that could affect the efficiency of future clinical trials were identified: (i) more frequent site visits in the Japanese study, (ii) head counts at the Japanese study sites more than double those of the global study and (iii) a shorter enrollment time window of about a third that of the global study at the Japanese study sites. We identified major differences in the performance of the two studies. These findings demonstrate the potential of the KPI tree for improving clinical study productivity. Trade-offs, such as those between reduction in head count at study sites and expansion of the enrollment time window, must be considered carefully. © 2010 Blackwell Publishing Ltd.

Key Health Information Technologies and Related Issues for Iran: A Qualitative Study.

PubMed

Hemmat, Morteza; Ayatollahi, Haleh; Maleki, Mohammadreza; Saghafi, Fatemeh

2018-01-01

Planning for the future of Health Information Technology (HIT) requires applying a systematic approach when conducting foresight studies. The aim of this study was to identify key health information technologies and related issues for Iran until 2025. This was a qualitative study and the participants included experts and policy makers in the field of health information technology. In-depth semi-structured interviews were conducted and data were analyzed by using framework analysis and MAXQDA software. The findings revealed that the development of national health information network, electronic health records, patient health records, a cloud-based service center, interoperability standards, patient monitoring technologies, telehealth, mhealth, clinical decision support systems, health information technology and mhealth infrastructure were found to be the key technologies for the future. These technologies could influence the economic, organizational and individual levels. To achieve them, the economic and organizational obstacles need to be overcome. In this study, a number of key technologies and related issues were identified. This approach can help to focus on the most important technologies in the future and to priorities these technologies for better resource allocation and policy making.

Key Health Information Technologies and Related Issues for Iran: A Qualitative Study

PubMed Central

Hemmat, Morteza; Ayatollahi, Haleh; Maleki, Mohammadreza; Saghafi, Fatemeh

2018-01-01

Background and Objective: Planning for the future of Health Information Technology (HIT) requires applying a systematic approach when conducting foresight studies. The aim of this study was to identify key health information technologies and related issues for Iran until 2025. Methods: This was a qualitative study and the participants included experts and policy makers in the field of health information technology. In-depth semi-structured interviews were conducted and data were analyzed by using framework analysis and MAXQDA software. Results: The findings revealed that the development of national health information network, electronic health records, patient health records, a cloud-based service center, interoperability standards, patient monitoring technologies, telehealth, mhealth, clinical decision support systems, health information technology and mhealth infrastructure were found to be the key technologies for the future. These technologies could influence the economic, organizational and individual levels. To achieve them, the economic and organizational obstacles need to be overcome. Conclusion: In this study, a number of key technologies and related issues were identified. This approach can help to focus on the most important technologies in the future and to priorities these technologies for better resource allocation and policy making. PMID:29854016

Public Key Infrastructure Study

DTIC Science & Technology

1994-04-01

commerce. This Public Key Infrastructure (PKI) study focuses on the United States Federal Government operations, but also addresses national and global ... issues in order to facilitate the interoperation of protected electronic commerce among the various levels of government in the U.S., private citizens

The Psychedelic Debriefing in Alcohol Dependence Treatment: Illustrating Key Change Phenomena through Qualitative Content Analysis of Clinical Sessions

PubMed Central

Nielson, Elizabeth M.; May, Darrick G.; Forcehimes, Alyssa A.; Bogenschutz, Michael P.

2018-01-01

Research on the clinical applications of psychedelic-assisted psychotherapy has demonstrated promising early results for treatment of alcohol dependence. Detailed description of the content and methods of psychedelic-assisted psychotherapy, as it is conducted in clinical settings, is scarce. Methods: An open-label pilot (proof-of-concept) study of psilocybin-assisted treatment of alcohol dependence (NCT01534494) was conducted to generate data for a phase 2 RCT (NCT02061293) of a similar treatment in a larger population. The present paper presents a qualitative content analysis of the 17 debriefing sessions conducted in the pilot study, which occurred the day after corresponding psilocybin medication sessions. Results: Participants articulated a series of key phenomena related to change in drinking outcomes and acute subjective effects of psilocybin. Discussion: The data illuminate change processes in patients' own words during clinical sessions, shedding light on potential therapeutic mechanisms of change and how participants express effects of psilocybin. This study is unique in analyzing actual clinical sessions, as opposed to interviews of patients conducted separately from treatment. PMID:29515449

Stem Cells of Dental Origin: Current Research Trends and Key Milestones towards Clinical Application

PubMed Central

About, Imad

2016-01-01

Dental Mesenchymal Stem Cells (MSCs), including Dental Pulp Stem Cells (DPSCs), Stem Cells from Human Exfoliated Deciduous teeth (SHED), and Stem Cells From Apical Papilla (SCAP), have been extensively studied using highly sophisticated in vitro and in vivo systems, yielding substantially improved understanding of their intriguing biological properties. Their capacity to reconstitute various dental and nondental tissues and the inherent angiogenic, neurogenic, and immunomodulatory properties of their secretome have been a subject of meticulous and costly research by various groups over the past decade. Key milestone achievements have exemplified their clinical utility in Regenerative Dentistry, as surrogate therapeutic modules for conventional biomaterial-based approaches, offering regeneration of damaged oral tissues instead of simply “filling the gaps.” Thus, the essential next step to validate these immense advances is the implementation of well-designed clinical trials paving the way for exploiting these fascinating research achievements for patient well-being: the ultimate aim of this ground breaking technology. This review paper presents a concise overview of the major biological properties of the human dental MSCs, critical for the translational pathway “from bench to clinic.” PMID:27818690

Key observations from the NHLBI Asthma Clinical Research Network.

PubMed

Szefler, Stanley J; Chinchilli, Vernon M; Israel, Elliot; Denlinger, Loren Clark; Lemanske, Robert F; Calhoun, William; Peters, Stephen P

2012-05-01

The National Heart, Lung and Blood Institute (NHLBI) Asthma Clinical Research Network (ACRN) recently completed its work after 20 years of collaboration as a multicentre clinical trial network. When formed, its stated mission was to perform multiple controlled clinical trials for treating patients with asthma by dispassionately examining new and existing therapies, and to rapidly communicate its findings to the medical community. The ACRN conducted 15 major clinical trials. In addition, clinical data, manual of operations, protocols and template informed consents from all ACRN trials are available via NHLBI BioLINCC (https://biolincc.nhlbi.nih.gov/studies/). This network contributed major insights into the use of inhaled corticosteroids, short-acting and long-acting ß-adrenergic agonists, leukotriene receptor antagonists, and novel agents (tiotropium, colchicine and macrolide antibiotics). They also pioneered studies of the variability in drug response, predictors of treatment response and pharmacogenetics. This review highlights the major research observations from the ACRN that have impacted the current management of asthma.

[Process and key points of clinical literature evaluation of post-marketing traditional Chinese medicine].

PubMed

Liu, Huan; Xie, Yanming

2011-10-01

The clinical literature evaluation of the post-marketing traditional Chinese medicine is a comprehensive evaluation by the comprehensive gain, analysis of the drug, literature of drug efficacy, safety, economy, based on the literature evidence and is part of the evaluation of evidence-based medicine. The literature evaluation in the post-marketing Chinese medicine clinical evaluation is in the foundation and the key position. Through the literature evaluation, it can fully grasp the information, grasp listed drug variety of traditional Chinese medicines second development orientation, make clear further clinical indications, perfect the medicines, etc. This paper discusses the main steps and emphasis of the clinical literature evaluation. Emphasizing security literature evaluation should attach importance to the security of a comprehensive collection drug information. Safety assessment should notice traditional Chinese medicine validity evaluation in improving syndrome, improveing the living quality of patients with special advantage. The economics literature evaluation should pay attention to reliability, sensitivity and practicability of the conclusion.

The role of health informatics in clinical audit: part of the problem or key to the solution?

PubMed

Georgiou, Andrew; Pearson, Michael

2002-05-01

The concepts of quality assurance (for which clinical audit is an essential part), evaluation and clinical governance each depend on the ability to derive and record measurements that describe clinical performance. Rapid IT developments have raised many new possibilities for managing health care. They have allowed for easier collection and processing of data in greater quantities. These developments have encouraged the growth of quality assurance as a key feature of health care delivery. In the past most of the emphasis has been on hospital information systems designed predominantly for the administration of patients and the management of financial performance. Large, hi-tech information system capacity does not guarantee quality information. The task of producing information that can be confidently used to monitor the quality of clinical care requires attention to key aspects of the design and operation of the audit. The Myocardial Infarction National Audit Project (MINAP) utilizes an IT-based system to collect and process data on large numbers of patients and make them readily available to contributing hospitals. The project shows that IT systems that employ rigorous health informatics methodologies can do much to improve the monitoring and provision of health care.

Biosimilars clinical development program: confirmatory clinical trials: a virtual/simulated case study comparing equivalence and non-inferiority approaches.

PubMed

Fletcher, Mark P

2011-09-01

As part of long term commitment of the Biologicals and Vaccines Committee (B&V) of the International Federation of Pharmaceutical Manufacturers and Association (IFPMA) to provide expert input to the WHO on their recently finalized GUIDELINES ON EVALUATION OF SIMILAR BIOTHERAPEUTIC PRODUCTS (SBPs), and in response to WHO's request, the IFPMA B&V prepared a clinical case study at a recent WHO workshop in Seoul, Korea. The case study, presented by Mark Fletcher on behalf of B&V, involved a model scenario for a clinical efficacy trial to support the approval of a Similar Biotherapeutic Product (SBP) as part of the required comparative clinical program against a Reference Biotherapeutic Product (RBP). A key goal was to understand and illustrate key clinical and statistical principles, and considerations described in the WHO Guidance for regulatory authorities when designing and implementing WHO guidelines and post-approval regulatory oversight for SBPs. Using this model SBP/RBP pair, an interactive discussion was carried out among the workshop participants on the pros and cons of using equivalence vs. non-inferiority designs to assess the two products' similarity. Through discussion of the case, the complexity of demonstrating similar efficacy and safety of a SBP vs. RBP for biotherapeutic products is outlined and discussed in the context of the key principles laid out in the recently published WHO GUIDELINES ON EVALUATION OF SIMILAR BIOTHERAPEUTIC PRODUCTS (SBPs). The exercise illustrates the need for a case-by-case approach when interpreting clinical data from SBP dossiers to adequately assure similar efficacy and safety of SBPs for any studied indication. Copyright © 2011. Published by Elsevier Ltd.

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

PubMed Central

Jordan, Natasha; D’Cruz, David

2015-01-01

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

Clinical supervision in the emergency department: a critical incident study

PubMed Central

Kilroy, D A

2006-01-01

Objectives To identify the key features of effective clinical supervision in the emergency department (ED) from the perspectives of enthusiastic consultants and specialist registrars. To highlight the importance of clinical supervision within emergency medicine, and identify obstructions to its occurrence in everyday practice. Methods A critical incident study was undertaken consisting of structured interviews, conducted by telephone or in person, with 18 consultants and higher level trainees selected for their interest in supervision. Results Direct clinical supervision of key practical skills and patient management steps was considered to be of paramount importance in providing quality patient care and significantly enhancing professional confidence. The adequacy of supervision varied depending upon patient presentation. Trainees were concerned with the competence and skills of their supervisor; consultants were concerned with wider systemic constraints upon the provision of adequate supervision to juniors. Conclusions The value of supervision extends to all patient presentations in the ED. The study raised questions concerning the appropriate attitudes and qualifications for supervisors. Protected supervisory time for those with trainees is mandatory, and must be incorporated within ED consultant job planning. PMID:16439737

Seven Keys to Successful Study.

ERIC Educational Resources Information Center

Edwards, Peter

Written for secondary, technical, and technical and further education (TAFE) students, this book aims to make learning easier and more enjoyable by showing students how to use a series of basic study skills called "keys." The book offers an explanation, examples, graphic illustrations, and activities for each skill. Chapters include: (1)…

Capturing Key NANDA-I Nursing Diagnoses From Actual Clinical Data for Patients With Heart Failure.

PubMed

Park, Hyejin; Tucker, Denise A

2017-01-01

The purpose of the study was to identify key nursing diagnoses with related factors and signs/symptoms using NANDA-I for patients with heart failure (HF). A retrospective descriptive design was used to address the research questions. Data were obtained from the records of patients discharged for 1 year with the medical diagnoses of HF from a Midwestern community hospital. A total of 272 inpatient records were analyzed to describe the frequency and percentage of NANDA-I diagnosis with related factors and signs/symptoms. The top 10 NANDA-I diagnoses associated with related factors and signs/symptoms were identified. Further research related to standardized nursing terminologies such as NANDA-I using large clinical databases from health information systems is needed to support evidence-based nursing diagnosis decision making. © 2015 NANDA International, Inc.

Implementation of renal key performance indicators: promoting improved clinical practice.

PubMed

Toussaint, Nigel D; McMahon, Lawrence P; Dowling, Gregory; Soding, Jenny; Safe, Maria; Knight, Richard; Fair, Kathleen; Linehan, Leanne; Walker, Rowan G; Power, David A

2015-03-01

In the Australian state of Victoria, the Renal Health Clinical Network (RHCN) of the Department of Health Victoria established a Renal Key Performance Indicator (KPI) Working Group in 2011. The group developed four KPIs related to chronic kidney disease and dialysis. A transplant working group of the RHCN developed two additional KPIs. The aim was to develop clinical indicators to measure performance of renal services to drive service improvement. A data collection and benchmarking programme was established, with data provided monthly to the Department using a purpose-designed website portal. The KPI Working Group is responsible for analysing data each quarter and ensuring indicators remain accurate and relevant. Each indicator has clear definitions and targets, and assess (i) patient education, (ii) timely creation of vascular access for haemodialysis, (iii) proportion of patients dialysing at home, (iv) incidence of dialysis-related peritonitis, (v) incidence of pre-emptive renal transplantation, and (vi) timely listing of patients for deceased donor transplantation. Most KPIs have demonstrated improved performance over time with limited gains notably in two: the proportion of patients dialysing at home (KPI 3) and timely listing patients for transplantation (KPI 6). KPI implementation has been established in Victoria for 2 years, providing performance data without additional funding. The six Victorian KPIs are measurable, relevant and modifiable, and implementation relies on enthusiasm and goodwill of physicians and nurses involved in collecting data. The KPIs require further evaluation, but adoption of a similar programme by other jurisdictions could lead to improved national outcomes. © 2014 Asian Pacific Society of Nephrology.

Avanafil for the treatment of erectile dysfunction: initial data and clinical key properties.

PubMed

Kedia, George T; Uckert, Stefan; Assadi-Pour, Farhang; Kuczyk, Markus A; Albrecht, Knut

2013-02-01

Orally active, selective inhibitors of phosphodiesterase type 5 (PDE 5, cyclic GMP PDE), such as sildenafil, tadalafil and vardenafil, are currently the first-choice treatment options for the clinical management of erectile dysfunction (ED) of various etiologies and severities. However, a significant number of patients remain dissatisfied with the available therapies due a lack of efficacy or discomfort arising from adverse events. Several new PDE5 inhibitors, among which are avanafil (TA-1790), lodenafil, mirodenafil, udenafil, SLX-2101, JNJ-10280205 and JNJ-10287069, have recently been approved and introduced into the market or are in the final stages of their clinical development. Avanafil (marketed in the US under the brand name STENDRA(™)) has been developed by VIVUS Inc. (Mountain View, CA, USA) and has recently received approval from the US Food and Drug Administration (FDA) for use in the treatment of male ED. The drug has demonstrated improved selectivity for PDE5, is rapidly absorbed after oral administration with a fast onset of action and a plasma half-life that is comparable to sildenfil and vardenafil. In phase II and phase III clinical trials that included a large number of patients, avanafil has been shown to be effective and well tolerated. Owing to its favorable pharmacodynamic and pharmacokinetic profile, avanafil is considered as a promising new option in the treatment of ED. The present article summarizes the initial data and clinical key properties of avanafil.

Avanafil for the treatment of erectile dysfunction: initial data and clinical key properties

PubMed Central

Ückert, Stefan; Assadi-Pour, Farhang; Kuczyk, Markus A.; Albrecht, Knut

2013-01-01

Orally active, selective inhibitors of phosphodiesterase type 5 (PDE 5, cyclic GMP PDE), such as sildenafil, tadalafil and vardenafil, are currently the first-choice treatment options for the clinical management of erectile dysfunction (ED) of various etiologies and severities. However, a significant number of patients remain dissatisfied with the available therapies due a lack of efficacy or discomfort arising from adverse events. Several new PDE5 inhibitors, among which are avanafil (TA-1790), lodenafil, mirodenafil, udenafil, SLX-2101, JNJ-10280205 and JNJ-10287069, have recently been approved and introduced into the market or are in the final stages of their clinical development. Avanafil (marketed in the US under the brand name STENDRA™) has been developed by VIVUS Inc. (Mountain View, CA, USA) and has recently received approval from the US Food and Drug Administration (FDA) for use in the treatment of male ED. The drug has demonstrated improved selectivity for PDE5, is rapidly absorbed after oral administration with a fast onset of action and a plasma half-life that is comparable to sildenfil and vardenafil. In phase II and phase III clinical trials that included a large number of patients, avanafil has been shown to be effective and well tolerated. Owing to its favorable pharmacodynamic and pharmacokinetic profile, avanafil is considered as a promising new option in the treatment of ED. The present article summarizes the initial data and clinical key properties of avanafil. PMID:23372609

Mental workload as a key factor in clinical decision making.

PubMed

Byrne, Aidan

2013-08-01

The decision making process is central to the practice of a clinician and has traditionally been described in terms of the hypothetico-deductive model. More recently, models adapted from cognitive psychology, such as the dual process and script theories have proved useful in explaining patterns of practice not consistent with purely cognitive based practice. The purpose of this paper is to introduce the concept of mental workload as a key determinant of the type of cognitive processing used by clinicians. Published research appears to be consistent with 'schemata' based cognition as the principle mode of working for those engaged in complex tasks under time pressure. Although conscious processing of factual data is also used, it may be the primary mode of cognition only in situations where time pressure is not a factor. Further research on the decision making process should be based on outcomes which are not dependant on conscious recall of past actions or events and include a measure of mental workload. This further appears to support the concept of the patient, within the clinical environment, as the most effective learning resource.

Impact of duty hour regulations on medical students' education: views of key clinical faculty.

PubMed

Reed, Darcy A; Levine, Rachel B; Miller, Redonda G; Ashar, Bimal H; Bass, Eric B; Rice, Tasha; Cofrancesco, Joseph

2008-07-01

Teaching faculty have valuable perspectives on the impact of residency duty hour regulations on medical students. The objective of this study was to elicit faculty views on the impact of residency duty hour regulations on medical students' educational experience on inpatient medicine rotations. We conducted a National Survey of Key Clinical Faculty (KCF) at 40 internal medicine residency programs affiliated with U.S. medical schools using a random sample stratified by National Institutes of Health funding and program size. This study measures KCF opinions on the effect of duty hour regulations on students' education. Of 154 KCF targeted, 111 responded (72%). Fifty-two percent of KCF reported worsening in the overall quality of students' education compared to just 2.7% reporting improvement (p < 0.001). In multivariate analysis adjusted for gender, academic rank, specialty, and years of teaching experience, faculty who spent >/=15 hours per week teaching were more likely to report worsening in medical students' level of responsibility on inpatient teams [odds ratio (OR) 3.1; 95% confidence interval (CI) 1.3-7.6], ability to follow patients throughout hospitalization (OR 3.2; 95% CI 1.3-7.9), ability to develop working relationships with residents (OR 2.3; 95% CI 1.0-5.2), and the overall quality of students' education (OR 3.3; 95% CI 1.4-8.1) compared to faculty who spent less time teaching. Key clincal faculty report concerns about the impact of duty hour regulations on aspects of medical students' education in internal medicine. Medical schools and residency programs should identify ways to ensure optimal educational experiences for students within duty hour requirements.

Study on changes of clinical indicators and key proteins from fluoride exposure.

PubMed

He, Hong; Wang, Hongmei; Han, Mei; Jiao, Yuguo; Ma, Congli; Zhang, Han; Zhou, Zhou

2014-07-01

Few studies have evaluated the biomarker changes of fluoride exposure. In order to explore early and sensitive indicators, animal experiment was designed. Ninety-six healthy SD rats (48 males and 48 females) weighing approximately 60 g were randomly divided into six groups of 16 animals each by gender average. Control animals were supplied with distilled water only as group 1. Exposure groups' animals were treated with 2, 4, 8, 16, and 32 mg NaF/kg bw, respectively, as groups 2, 3, 4, 5, and 6. Our study found that contents of white blood cell (WBC), lymphocyte percentage (LYMPH%), lymphocyte (LYM), mean platelet volume (MPV), and platelet distribution width (PDW) increased significantly in high-fluoride-exposure groups (p < 0.05), which revealed that immune system may be interfered by high fluoride. Meanwhile, levels of alanine aminotransaminase (ALT), aspartate aminotransaminase (AST), and ALT/AST in groups 5 and 6 decreased significantly compared to those in control group (p < 0.05), as well as the concentration of uric acid (UA) in groups 3, 4, 5, and 6 exhibited the same trends (p < 0.05). On the contrary, the level of blood B2 microglobulin (BB2MG) increased significantly (p < 0.05) in groups 4, 5, and 6. Changes of ALT, AST, UA, and BB2MG suggested the functions of the liver and kidney be altered by fluoride exposure. At the same time, the ATF4 content decreased gradually with the increase of fluoride concentration; furthermore, a highly significant (r = -0.586, p < 0.01) negative relationship between ATF4 content and fluoride exposure level was found. Results meant that clinical indicators cannot act as indicators of high fluoride exposure, and it also suggested that protein ATF4 might be the early and sensitive indicator in epidemiologic study of high fluoride exposure.

A clinical research analytics toolkit for cohort study.

PubMed

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

2012-01-01

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

The ClinicalTrials.gov results database--update and key issues.

PubMed

Zarin, Deborah A; Tse, Tony; Williams, Rebecca J; Califf, Robert M; Ide, Nicholas C

2011-03-03

The ClinicalTrials.gov trial registry was expanded in 2008 to include a database for reporting summary results. We summarize the structure and contents of the results database, provide an update of relevant policies, and show how the data can be used to gain insight into the state of clinical research. We analyzed ClinicalTrials.gov data that were publicly available between September 2009 and September 2010. As of September 27, 2010, ClinicalTrials.gov received approximately 330 new and 2000 revised registrations each week, along with 30 new and 80 revised results submissions. We characterized the 79,413 registry and 2178 results of trial records available as of September 2010. From a sample cohort of results records, 78 of 150 (52%) had associated publications within 2 years after posting. Of results records available publicly, 20% reported more than two primary outcome measures and 5% reported more than five. Of a sample of 100 registry record outcome measures, 61% lacked specificity in describing the metric used in the planned analysis. In a sample of 700 results records, the mean number of different analysis populations per study group was 2.5 (median, 1; range, 1 to 25). Of these trials, 24% reported results for 90% or less of their participants. ClinicalTrials.gov provides access to study results not otherwise available to the public. Although the database allows examination of various aspects of ongoing and completed clinical trials, its ultimate usefulness depends on the research community to submit accurate, informative data.

Key Lessons Learned from Moffitt's Molecular Tumor Board: The Clinical Genomics Action Committee Experience.

PubMed

Knepper, Todd C; Bell, Gillian C; Hicks, J Kevin; Padron, Eric; Teer, Jamie K; Vo, Teresa T; Gillis, Nancy K; Mason, Neil T; McLeod, Howard L; Walko, Christine M

2017-02-01

, many cancer centers are seeking to develop a personalized medicine services and/or molecular tumor board to shepherd precision medicine into clinical practice. This article discusses the key lessons learned through the establishment and development of a molecular tumor board and personalized medicine clinical service. This article highlights practical issues and can serve as an important guide to other centers as they conceive and develop their own personalized medicine services and molecular tumor boards. © AlphaMed Press 2017.

Key Lessons Learned from Moffitt's Molecular Tumor Board: The Clinical Genomics Action Committee Experience

PubMed Central

Knepper, Todd C.; Bell, Gillian C.; Hicks, J. Kevin; Padron, Eric; Teer, Jamie K.; Vo, Teresa T.; Gillis, Nancy K.; Mason, Neil T.; Walko, Christine M.

2017-01-01

of routine clinical practice. Subsequently, many cancer centers are seeking to develop a personalized medicine services and/or molecular tumor board to shepherd precision medicine into clinical practice. This article discusses the key lessons learned through the establishment and development of a molecular tumor board and personalized medicine clinical service. This article highlights practical issues and can serve as an important guide to other centers as they conceive and develop their own personalized medicine services and molecular tumor boards. PMID:28179575

Minor emergency clinic: key to the future of successful hospitals.

PubMed

Chawla, S; Kathawala, Y; Elmuti, D

1992-01-01

This project set out to determine whether there is a relationship between the minor emergency facility an individual uses and their choice of a hospital for in-patient care. In studying this relationship, the factors that are important to persons choosing a clinic or hospital facility, as well as the influence of a physician, were also identified. A structured, undisguised telephone survey was used for interviewing a randomly selected sample population of 189 San Angelo residents. Analysis of the survey data indicated that dependency does exist between minor emergency clinic use and the hospital chosen for in-patient care. The results of this study also suggested that hospitals' marketing strategy should shift the emphasis of their advertising from the hospital itself to their physician association and clinics. In addition, a number of other interesting observations concerning the relative importance of various medical factors to the participants was also explored.

Cost-effectiveness analysis and efficient use of the pharmaceutical budget: the key role of clinical pharmacologists

PubMed Central

Edlin, Richard; Round, Jeff; Hulme, Claire; McCabe, Christopher

2010-01-01

The purpose of this paper is to provide information about cost-effectiveness analysis and the roles of clinical pharmacologists generally in providing efficient health care. The paper highlights the potential consequences of ‘off-label prescribing’ and ‘indication creep’ behaviour given slower growth (or potential cuts) in the NHS budget. This paper highlights the key roles of clinical pharmacologists in delivering an efficient health care system when resources are allocated using cost-effectiveness analyses. It describes what cost-effectiveness analysis (CEA) is and how incremental cost-effectiveness ratios (ICERs) are used to identify efficient options. After outlining the theoretical framework within which using CEA can promote the efficient allocation of the health care budget, it considers the place of disinvestment within achieving efficient resource allocation. Clinical pharmacologists are argued to be critical to providing improved population health under CEA-based resource allocation processes because of their roles in implementation and disinvestment. Given that the challenges facing the United Kingdom National Health Service (NHS) are likely to increase, this paper sets out the stark choices facing clinical pharmacologists. PMID:20716234

Cost-effectiveness analysis and efficient use of the pharmaceutical budget: the key role of clinical pharmacologists.

PubMed

Edlin, Richard; Round, Jeff; Hulme, Claire; McCabe, Christopher

2010-09-01

The purpose of this paper is to provide information about cost-effectiveness analysis and the roles of clinical pharmacologists generally in providing efficient health care. The paper highlights the potential consequences of 'off-label prescribing' and 'indication creep' behaviour given slower growth (or potential cuts) in the NHS budget. This paper highlights the key roles of clinical pharmacologists in delivering an efficient health care system when resources are allocated using cost-effectiveness analyses. It describes what cost-effectiveness analysis (CEA) is and how incremental cost-effectiveness ratios (ICERs) are used to identify efficient options. After outlining the theoretical framework within which using CEA can promote the efficient allocation of the health care budget, it considers the place of disinvestment within achieving efficient resource allocation. Clinical pharmacologists are argued to be critical to providing improved population health under CEA-based resource allocation processes because of their roles in implementation and disinvestment. Given that the challenges facing the United Kingdom National Health Service (NHS) are likely to increase, this paper sets out the stark choices facing clinical pharmacologists.

Effects of additional team-based learning on students' clinical reasoning skills: a pilot study.

PubMed

Jost, Meike; Brüstle, Peter; Giesler, Marianne; Rijntjes, Michel; Brich, Jochen

2017-07-14

In the field of Neurology good clinical reasoning skills are essential for successful diagnosing and treatment. Team-based learning (TBL), an active learning and small group instructional strategy, is a promising method for fostering these skills. The aim of this pilot study was to examine the effects of a supplementary TBL-class on students' clinical decision-making skills. Fourth- and fifth-year medical students participated in this pilot study (static-group comparison design). The non-treatment group (n = 15) did not receive any additional training beyond regular teaching in the neurology course. The treatment group (n = 11) took part in a supplementary TBL-class optimized for teaching clinical reasoning in addition to the regular teaching in the neurology course. Clinical decision making skills were assessed using a key-feature problem examination. Factual and conceptual knowledge was assessed by a multiple-choice question examination. The TBL-group performed significantly better than the non-TBL-group (p = 0.026) in the key-feature problem examination. No significant differences between the results of the multiple-choice question examination of both groups were found. In this pilot study participants of a supplementary TBL-class significantly improved clinical decision-making skills, indicating that TBL may be an appropriate method for teaching clinical decision making in neurology. Further research is needed for replication in larger groups and other clinical fields.

Impact of Duty Hour Regulations on Medical Students’ Education: Views of Key Clinical Faculty

PubMed Central

Levine, Rachel B.; Miller, Redonda G.; Ashar, Bimal H.; Bass, Eric B.; Rice, Tasha; Cofrancesco, Joseph

2008-01-01

BACKGROUND Teaching faculty have valuable perspectives on the impact of residency duty hour regulations on medical students. OBJECTIVE The objective of this study was to elicit faculty views on the impact of residency duty hour regulations on medical students’ educational experience on inpatient medicine rotations. DESIGN AND PARTICIPANTS We conducted a National Survey of Key Clinical Faculty (KCF) at 40 internal medicine residency programs affiliated with U.S. medical schools using a random sample stratified by National Institutes of Health funding and program size. MEASUREMENTS This study measures KCF opinions on the effect of duty hour regulations on students’ education. RESULTS Of 154 KCF targeted, 111 responded (72%). Fifty-two percent of KCF reported worsening in the overall quality of students’ education compared to just 2.7% reporting improvement (p < 0.001). In multivariate analysis adjusted for gender, academic rank, specialty, and years of teaching experience, faculty who spent ≥15 hours per week teaching were more likely to report worsening in medical students’ level of responsibility on inpatient teams [odds ratio (OR) 3.1; 95% confidence interval (CI) 1.3–7.6], ability to follow patients throughout hospitalization (OR 3.2; 95% CI 1.3–7.9), ability to develop working relationships with residents (OR 2.3; 95% CI 1.0–5.2), and the overall quality of students’ education (OR 3.3; 95% CI 1.4–8.1) compared to faculty who spent less time teaching. CONCLUSION Key clincal faculty report concerns about the impact of duty hour regulations on aspects of medical students’ education in internal medicine. Medical schools and residency programs should identify ways to ensure optimal educational experiences for students within duty hour requirements. PMID:18612749

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

PubMed Central

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

2013-01-01

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

Reducing the blame culture through clinical audit in nuclear medicine: a mixed methods study.

PubMed

Ross, P; Hubert, J; Wong, W L

2017-02-01

To identify the barriers and facilitators of doctors' engagement with clinical audit and to explore how and why these factors influenced doctors' decisions to engage with the NHS National Clinical Audit Programme. A single-embedded case study. Mixed methods sequential approach with explorative pilot study and follow-up survey. Pilot study comprised 13 semi-structured interviews with purposefully selected consultant doctors over a six-month period. Interview data coded and analysed using directed thematic content analysis with themes compared against the study's propositions. Themes derived from the pilot study informed the online survey question items. Exploratory factor analysis using STATA and descriptive statistical methods applied to summarise findings. Data triangulation techniques used to corroborate and validate findings across the different methodological techniques. NHS National PET-CT Clinical Audit Programme. Doctors reporting on the Audit Programme. Extent of engagement with clinical audit, factors that influence engagement with clinical audit. Online survey: 58/59 doctors responded (98.3%). Audit was found to be initially threatening (79%); audit was reassuring (85%); audit helped validate professional competence (93%); participation in audit improved reporting skills (76%). Three key factors accounted for 97.6% of the variance in survey responses: (1) perception of audit's usefulness, (2) a common purpose, (3) a supportive blame free culture of trust. Factor 1 influenced medical engagement most. The study documents performance feedback as a key facilitator of medical engagement with clinical audit. It found that medical engagement with clinical audit was associated with reduced levels of professional anxiety and higher levels of perceived self-efficacy.

The clinical role of lecturers in nursing in Ireland: perceptions from key stakeholder groups in nurse education on the role.

PubMed

Meskell, Pauline; Murphy, Kathleen; Shaw, David

2009-10-01

The clinical role of lecturers in nursing has been a focus of debate since the integration of nurse education into higher education institutions. The purpose of this paper is to report the findings from the preliminary phase of a study, undertaken to investigate the perceptions of key stakeholder groups in nurse education, regarding the current clinical role of nurse lecturers in Ireland. A descriptive exploratory design was used involving focus group and individual interviews, soliciting views of purposefully selected educationalists, clinicians, policy formulators and students. The issue was examined from a policy perspective, aiming to collectively represent views of all participant groups. This approach facilitated a more complete picture of perceptions of the role to emerge, to better inform future decision making. Twenty two focus group interviews and twenty one individual interviews were conducted. Content analysis was used to identify themes. All groups were in agreement that role definition was urgently required to dispel ambiguities surrounding what the clinical role should involve. Conflicting views were evident among groups regarding lecturers' clinical credibility, visibility and teaching effectiveness. Findings highlight the essential nature of nurse lecturers engaging with clinical areas to maintain their skills, demonstrate a value for the practice component of the role and provide a link between education and practice.

Uncovering the Rosetta Stone: Report from the First Annual Conference on Key Elements in Translating Stroke Therapeutics from Pre-Clinical to Clinical.

PubMed

Bix, Gregory J; Fraser, Justin F; Mack, William J; Carmichael, S Thomas; Perez-Pinzon, Miguel; Offner, Halina; Sansing, Lauren; Bosetti, Francesca; Ayata, Cenk; Pennypacker, Keith R

2018-06-01

The first annual Stroke Translational Research Advancement Workshop (STRAW), entitled "Uncovering the Rosetta Stone: Key Elements in Translating Stroke Therapeutics from Pre-Clinical to Clinical" was held at the University of Kentucky on October 4-5, 2017. This workshop was organized by the Center for Advanced Translational Stroke Science. The workshop consisted of 2 days of activities. These included three presentations establishing the areas of research in stroke therapeutics, discussing the routes for translation from bench to bedside, and identifying successes and failures in the field. On day 2, grant funding opportunities and goals for the National Institute for Neurological Diseases and Stroke were presented. In addition, the meeting also included break-out sessions designed to connect researchers in areas of stroke, and to foster potential collaborations. Finally, the meeting concluded with an open discussion among attendees led by a panel of experts.

Reducing the blame culture through clinical audit in nuclear medicine: a mixed methods study

PubMed Central

Ross, P; Hubert, J

2017-01-01

Objectives To identify the barriers and facilitators of doctors’ engagement with clinical audit and to explore how and why these factors influenced doctors’ decisions to engage with the NHS National Clinical Audit Programme. Design A single-embedded case study. Mixed methods sequential approach with explorative pilot study and follow-up survey. Pilot study comprised 13 semi-structured interviews with purposefully selected consultant doctors over a six-month period. Interview data coded and analysed using directed thematic content analysis with themes compared against the study’s propositions. Themes derived from the pilot study informed the online survey question items. Exploratory factor analysis using STATA and descriptive statistical methods applied to summarise findings. Data triangulation techniques used to corroborate and validate findings across the different methodological techniques. Setting NHS National PET-CT Clinical Audit Programme. Participants Doctors reporting on the Audit Programme. Main Outcome measures Extent of engagement with clinical audit, factors that influence engagement with clinical audit. Results Online survey: 58/59 doctors responded (98.3%). Audit was found to be initially threatening (79%); audit was reassuring (85%); audit helped validate professional competence (93%); participation in audit improved reporting skills (76%). Three key factors accounted for 97.6% of the variance in survey responses: (1) perception of audit’s usefulness, (2) a common purpose, (3) a supportive blame free culture of trust. Factor 1 influenced medical engagement most. Conclusions The study documents performance feedback as a key facilitator of medical engagement with clinical audit. It found that medical engagement with clinical audit was associated with reduced levels of professional anxiety and higher levels of perceived self-efficacy. PMID:28210493

A systemic study on key parameters affecting nanocomposite coatings on magnesium substrates.

PubMed

Johnson, Ian; Wang, Sebo Michelle; Silken, Christine; Liu, Huinan

2016-05-01

. This study elucidated the key parameters for optimizing nanocomposite coatings on Mg-based substrates for skeletal implant applications, and provided rational design guidelines for the nanocomposite coatings on Mg alloys for potential clinical translation of biodegradable Mg-based implants. This manuscript describes the systemic optimization of nanocomposite coatings to control the degradation and bioactivity of magnesium for skeletal implant applications. The key parameters influencing the integrity and functions of the nanocomposite coatings on magnesium were identified, guidelines for the optimization of the coatings were established, and the benefits of coating optimization were demonstrated through reduced magnesium degradation and increased bone marrow derived mesenchymal stem cell (BMSC) adhesion in vitro. The guidelines developed in this manuscript are valuable for the biometal field to improve the design of bioresorbable implants and devices, which will advance the clinical translation of magnesium-based implants. Copyright © 2016 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.

The ClinicalTrials.gov Results Database — Update and Key Issues

PubMed Central

Zarin, Deborah A.; Tse, Tony; Williams, Rebecca J.; Califf, Robert M.; Ide, Nicholas C.

2011-01-01

BACKGROUND The ClinicalTrials.gov trial registry was expanded in 2008 to include a database for reporting summary results. We summarize the structure and contents of the results database, provide an update of relevant policies, and show how the data can be used to gain insight into the state of clinical research. METHODS We analyzed ClinicalTrials.gov data that were publicly available between September 2009 and September 2010. RESULTS As of September 27, 2010, ClinicalTrials.gov received approximately 330 new and 2000 revised registrations each week, along with 30 new and 80 revised results submissions. We characterized the 79,413 registry and 2178 results of trial records available as of September 2010. From a sample cohort of results records, 78 of 150 (52%) had associated publications within 2 years after posting. Of results records available publicly, 20% reported more than two primary outcome measures and 5% reported more than five. Of a sample of 100 registry record outcome measures, 61% lacked specificity in describing the metric used in the planned analysis. In a sample of 700 results records, the mean number of different analysis populations per study group was 2.5 (median, 1; range, 1 to 25). Of these trials, 24% reported results for 90% or less of their participants. CONCLUSIONS ClinicalTrials.gov provides access to study results not otherwise available to the public. Although the database allows examination of various aspects of ongoing and completed clinical trials, its ultimate usefulness depends on the research community to submit accurate, informative data. PMID:21366476

HnRNPL as a key factor in spermatogenesis: Lesson from functional proteomic studies of azoospermia patients with sertoli cell only syndrome.

PubMed

Li, Jingping; Guo, Wenbin; Li, Fei; He, Jincan; Yu, Qingfeng; Wu, Xiaoqiang; Li, Jianming; Mao, Xiangming

2012-06-06

Sertoli cell only syndrome (SCOS) is one of the main causes leading to the abnormal spermatogenesis. However, the mechanisms for abnormal spermatogenesis in SCOS are still unclear. Here, we analyzed the clinical testis samples of SCOS patients by two-dimensional gel electrophoresis (2-DE) and matrix-assisted laser desorption time-of-flight mass spectrometry (MALDI-TOF/TOF MS) to find the key factors contributing to SCOS. Thirteen differential proteins were identified in clinical testis samples between normal spermatogenesis group and SCOS group. Interestingly, in these differential proteins, Heterogeneous nuclear ribonucleoprotein L(HnRNPL) was suggested as a key regulator involved in apoptosis, death and growth of spermatogenic cells by String and Pubgene bioinformatic programs. Down-regulated HnRNPL in testis samples of SCOS patients was further confirmed by immunohistochemical staining and western blotting. Moreover, in vitro and in vivo experiments demonstrated that knockdown of HnRNPL led to inhibited proliferation, increased apoptosis of spermatogenic cell but decreased apoptosis of sertoli cells. Expression of carcinoembryonic antigen-related cell adhesion molecule 1 in GC-1 cells or expression of inducible nitric oxide synthases in TM4 sertoli cells, was found to be regulated by HnRNPL. Our study first shows HnRNPL as a key factor involved in the spermatogenesis by functional proteomic studies of azoospermia patients with sertoli cell only syndrome. This article is part of a Special Issue entitled: Proteomics: The clinical link. Copyright © 2012 Elsevier B.V. All rights reserved.

The key-features approach to assess clinical decisions: validity evidence to date.

PubMed

Bordage, G; Page, G

2018-05-17

The key-features (KFs) approach to assessment was initially proposed during the First Cambridge Conference on Medical Education in 1984 as a more efficient and effective means of assessing clinical decision-making skills. Over three decades later, we conducted a comprehensive, systematic review of the validity evidence gathered since then. The evidence was compiled according to the Standards for Educational and Psychological Testing's five sources of validity evidence, namely, Content, Response process, Internal structure, Relations to other variables, and Consequences, to which we added two other types related to Cost-feasibility and Acceptability. Of the 457 publications that referred to the KFs approach between 1984 and October 2017, 164 are cited here; the remaining 293 were either redundant or the authors simply mentioned the KFs concept in relation to their work. While one set of articles reported meeting the validity standards, another set examined KFs test development choices and score interpretation. The accumulated validity evidence for the KFs approach since its inception supports the decision-making construct measured and its use to assess clinical decision-making skills at all levels of training and practice and with various types of exam formats. Recognizing that gathering validity evidence is an ongoing process, areas with limited evidence, such as item factor analyses or consequences of testing, are identified as well as new topics needing further clarification, such as the use of the KFs approach for formative assessment and its place within a program of assessment.

Time to be BRAVE: is educating surgeons the key to unlocking the potential of randomised clinical trials in surgery? A qualitative study

PubMed Central

2014-01-01

Background Well-designed randomised clinical trials (RCTs) provide the best evidence to inform decision-making and should be the default option for evaluating surgical procedures. Such trials can be challenging, and surgeons’ preferences may influence whether trials are initiated and successfully conducted and their results accepted. Preferences are particularly problematic when surgeons’ views play a key role in procedure selection and patient eligibility. The bases of such preferences have rarely been explored. Our aim in this qualitative study was to investigate surgeons’ preferences regarding the feasibility of surgical RCTs and their understanding of study design issues using breast reconstruction surgery as a case study. Methods Semistructured qualitative interviews were undertaken with a purposive sample of 35 professionals practicing at 15 centres across the United Kingdom. Interviews were transcribed verbatim and analysed thematically using constant comparative techniques. Sampling, data collection and analysis were conducted concurrently and iteratively until data saturation was achieved. Results Surgeons often struggle with the concept of equipoise. We found that if surgeons did not feel ‘in equipoise’, they did not accept randomisation as a method of treatment allocation. The underlying reasons for limited equipoise were limited appreciation of the methodological weaknesses of data derived from nonrandomised studies and little understanding of pragmatic trial design. Their belief in the value of RCTs for generating high-quality data to change or inform practice was not widely held. Conclusion There is a need to help surgeons understand evidence, equipoise and bias. Current National Institute of Health Research/Medical Research Council investment into education and infrastructure for RCTs, combined with strong leadership, may begin to address these issues or more specific interventions may be required. PMID:24628821

Key clinical benefits of neuroimaging at 7T.

PubMed

Trattnig, Siegfried; Springer, Elisabeth; Bogner, Wolfgang; Hangel, Gilbert; Strasser, Bernhard; Dymerska, Barbara; Cardoso, Pedro Lima; Robinson, Simon Daniel

2018-03-01

The growing interest in ultra-high field MRI, with more than 35.000 MR examinations already performed at 7T, is related to improved clinical results with regard to morphological as well as functional and metabolic capabilities. Since the signal-to-noise ratio increases with the field strength of the MR scanner, the most evident application at 7T is to gain higher spatial resolution in the brain compared to 3T. Of specific clinical interest for neuro applications is the cerebral cortex at 7T, for the detection of changes in cortical structure, like the visualization of cortical microinfarcts and cortical plaques in Multiple Sclerosis. In imaging of the hippocampus, even subfields of the internal hippocampal anatomy and pathology may be visualized with excellent spatial resolution. Using Susceptibility Weighted Imaging, the plaque-vessel relationship and iron accumulations in Multiple Sclerosis can be visualized, which may provide a prognostic factor of disease. Vascular imaging is a highly promising field for 7T which is dealt with in a separate dedicated article in this special issue. The static and dynamic blood oxygenation level-dependent contrast also increases with the field strength, which significantly improves the accuracy of pre-surgical evaluation of vital brain areas before tumor removal. Improvement in acquisition and hardware technology have also resulted in an increasing number of MR spectroscopic imaging studies in patients at 7T. More recent parallel imaging and short-TR acquisition approaches have overcome the limitations of scan time and spatial resolution, thereby allowing imaging matrix sizes of up to 128×128. The benefits of these acquisition approaches for investigation of brain tumors and Multiple Sclerosis have been shown recently. Together, these possibilities demonstrate the feasibility and advantages of conducting routine diagnostic imaging and clinical research at 7T. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights

Clinical trial allocation in multinational pharmaceutical companies - a qualitative study on influential factors.

PubMed

Dombernowsky, Tilde; Haedersdal, Merete; Lassen, Ulrik; Thomsen, Simon F

2017-06-01

Clinical trial allocation in multinational pharmaceutical companies includes country selection and site selection. With emphasis on site selection, the overall aim of this study was to examine which factors pharmaceutical companies value most when allocating clinical trials. The specific aims were (1) to identify key decision makers during country and site selection, respectively, (2) to evaluate by which parameters subsidiaries are primarily assessed by headquarters with regard to conducting clinical trials, and (3) to evaluate which site-related qualities companies value most when selecting trial sites. Eleven semistructured interviews were conducted among employees engaged in trial allocation at 11 pharmaceutical companies. The interviews were analyzed by deductive content analysis, which included coding of data to a categorization matrix containing categories of site-related qualities. The results suggest that headquarters and regional departments are key decision makers during country selection, whereas subsidiaries decide on site selection. Study participants argued that headquarters primarily value timely patient recruitment and quality of data when assessing subsidiaries. The site-related qualities most commonly emphasized during interviews were study population availability, timely patient recruitment, resources at the site, and site personnel's interest and commitment. Costs of running the trials were described as less important. Site personnel experience in conducting trials was described as valuable but not imperative. In conclusion, multinational pharmaceutical companies consider recruitment-related factors as crucial when allocating clinical trials. Quality of data and site personnel's interest and commitment are also essential, whereas costs seem less important. While valued, site personnel experience in conducting clinical trials is not imperative.

Improving Translation from Preclinical Studies to Clinical Trials in Acute Kidney Injury.

PubMed

Fiorentino, Marco; Kellum, John A

2018-05-23

Several cellular and molecular targets and mechanisms have been investigated in preclinical studies of acute kidney injury (AKI), but translation in successful clinical studies has failed to date. This article reviews many issues that have limited this and the potential future perspectives in AKI prevention and treatment. Preclinical models of AKI should closely mimic the complexity of human AKI, considering the importance of several comorbidities in determining the clinical course and outcomes in the human disease. Moreover, studies should test novel interventions in models where AKI is already established, instead of focusing only at primary prevention. AKI definitions and endpoints in animal studies should be similar to those applied in clinical studies; in particular, AKI biomarkers should be implemented to guide patient selection for clinical trials and monitor intervention efficacy. In this scenario, cell-cycle arrest biomarkers have been widely investigated as AKI predictors in both preclinical and clinical studies and they serve as useful tools for future interventional studies. A better understanding of human AKI through a large collection of biological samples and kidney biopsies and omics applications, and an iterative relationship between preclinical and clinical studies are critical steps to improve future preclinical models and clinical trials. Finally, given the great variability in clinical manifestation of AKI, a strong collaboration between research centers and industry is recommended. Key messages: Several methodological issues have hampered the translation of basic research findings in clinical studies, and overcoming these obstacles is necessary to achieve success. © 2018 S. Karger AG, Basel.

[STRATEGY OF USE AND MAINTENANCE OF CLINICAL HOSPITAL CENTER RIJEKA IN ACCORDANCE WITH KEY PERFORMANCE INDICATORS FOR STRATEGIC HEALTHCARE FACILITIES MAINTENANCE].

PubMed

Sjekavica, Mariela; Haller, Herman; Cerić, Anita

2015-01-01

Building usage is the phase in the building life cycle that is most time-consuming, most functional, most significant due to building purpose and often systematically ignored. Maintenance is the set of activities that ensure the planned duration of facility exploitation phase in accordance with the requirements for quality maintenance of a large number of important building features as well as other elements immanent to the nature of facilities' life. The aim of the study is to show the analysis of the current state of organized, planned and comprehensive managerial approach in hospital utilization and maintenance in the Republic of Croatia, given on the case study of Clinical hospital center in Rijeka. The methodology used consists of relevant literature section of theory of facility utilization, maintenance and management in general, hospital buildings especially, display of practice on case study, and comparison of key performance indicators values obtained through interview with those that author Igal M. Shohet defined in his study by field surveys and statistical analyses. Despite many positive indicators of Clinical hospital center Rijeka maintenance, an additional research is needed in order to define a more complete national hospital maintenance strategy.

Community Advisory Boards Guiding Engaged Research Efforts within a Clinical Translational Sciences Award: Key Contextual Factors Explored.

PubMed

Halladay, Jacqueline R; Donahue, Katrina E; Sleath, Betsy; Reuland, Dan; Black, Adina; Mitchell, C Madeline; Breland, Carol E; Coyne-Beasley, Tamera; Mottus, Kathleen; Watson, Sable Noelle; Lewis, Virginia; Wynn, Mysha; Corbie-Smith, Giselle

2017-01-01

Engaging stakeholders in research carries the promise of enhancing the research relevance, transparency, and speed of getting findings into practice. By describing the context and functional aspects of stakeholder groups, like those working as community advisory boards (CABs), others can learn from these experiences and operationalize their own CABs. Our objective is to describe our experiences with diverse CABs affiliated with our community engagement group within our institution's Clinical Translational Sciences Award (CTSA). We identify key contextual elements that are important to administering CABs. A group of investigators, staff, and community members engaged in a 6-month collaboration to describe their experiences of working with six research CABs. We identified the key contextual domains that illustrate how CABS are developed and sustained. Two lead authors, with experience with CABs and identifying contextual domains in other work, led a team of 13 through the process. Additionally, we devised a list of key tips to consider when devising CABs. The final domains include (1) aligned missions among stakeholders (2) resources/support, (3) defined operational processes/shared power, (4) well-described member roles, and (5) understanding and mitigating challenges. The tips are a set of actions that support the domains. Identifying key contextual domains was relatively easy, despite differences in the respective CAB's condition of focus, overall mission, or patient demographics represented. By contextualizing these five domains, other research and community partners can take an informed approach to move forward with CAB planning and engaged research.

Randomized clinical trials and observational studies in the assessment of drug safety.

PubMed

Sawchik, J; Hamdani, J; Vanhaeverbeek, M

2018-05-01

Randomized clinical trials are considered as the preferred design to assess the potential causal relationships between drugs or other medical interventions and intended effects. For this reason, randomized clinical trials are generally the basis of development programs in the life cycle of drugs and the cornerstone of evidence-based medicine. Instead, randomized clinical trials are not the design of choice for the detection and assessment of rare, delayed and/or unexpected effects related to drug safety. Moreover, the highly homogeneous populations resulting from restrictive eligibility criteria make randomized clinical trials inappropriate to describe comprehensively the safety profile of drugs. In that context, observational studies have a key added value when evaluating the benefit-risk balance of the drugs. However, observational studies are more prone to bias than randomized clinical trials and they have to be designed, conducted and reported judiciously. In this article, we discuss the strengths and limitations of randomized clinical trials and of observational studies, more particularly regarding their contribution to the knowledge of medicines' safety profile. In addition, we present general recommendations for the sensible use of observational data. Copyright © 2018 Elsevier Masson SAS. All rights reserved.

Cryopreserved or Fresh Mesenchymal Stromal Cells: Only a Matter of Taste or Key to Unleash the Full Clinical Potential of MSC Therapy?

PubMed

Moll, Guido; Geißler, Sven; Catar, Rusan; Ignatowicz, Lech; Hoogduijn, Martin J; Strunk, Dirk; Bieback, Karen; Ringdén, Olle

2016-01-01

Mesenchymal stromal cells (MSCs) harbor great therapeutic potential for numerous diseases. From early clinical trials, success and failure analysis, bench-to-bedside and back-to-bench approaches, there has been a great gain in knowledge, still leaving a number of questions to be answered regarding optimal manufacturing and quality of MSCs for clinical application. For treatment of many acute indications, cryobanking may remain a prerequisite, but great uncertainty exists considering the therapeutic value of freshly thawed (thawed) and continuously cultured (fresh) MSCs. The field has seen an explosion of new literature lately, outlining the relevance of the topic. MSCs appear to have compromised immunomodulatory activity directly after thawing for clinical application. This may provide a possible explanation for failure of early clinical trials. It is not clear if and how quickly MSCs recover their full therapeutic activity, and if the "cryo stun effect" is relevant for clinical success. Here, we will share our latest insights into the relevance of these observations for clinical practice that will be discussed in the context of the published literature. We argue that the differences of fresh and thawed MSCs are limited but significant. A key issue in evaluating potency differences is the time point of analysis after thawing. To date, prospective double-blinded randomized clinical studies to evaluate potency of both products are lacking, although recent progress was made with preclinical assessment. We suggest refocusing therapeutic MSC development on potency and safety assays with close resemblance of the clinical reality.

Key factors in children's competence to consent to clinical research.

PubMed

Hein, Irma M; Troost, Pieter W; Lindeboom, Robert; Benninga, Marc A; Zwaan, C Michel; van Goudoever, Johannes B; Lindauer, Ramón J L

2015-10-24

Although law is established on a strong presumption that persons younger than a certain age are not competent to consent, statutory age limits for asking children's consent to clinical research differ widely internationally. From a clinical perspective, competence is assumed to involve many factors including the developmental stage, the influence of parents and peers, and life experience. We examined potential determining factors for children's competence to consent to clinical research and to what extent they explain the variation in competence judgments. From January 1, 2012 through January 1, 2014, pediatric patients aged 6 to 18 years, eligible for clinical research studies were enrolled prospectively at various in- and outpatient pediatric departments. Children's competence to consent was assessed by MacArthur Competence Assessment Tool for Clinical Research. Potential determining child variables included age, gender, intelligence, disease experience, ethnicity and socio-economic status (SES). We used logistic regression analysis and change in explained variance in competence judgments to quantify the contribution of a child variable to the total explained variance. Contextual factors included risk and complexity of the decision to participate, parental competence judgment and the child's or parents decision to participate. Out of 209 eligible patients, 161 were included (mean age, 10.6 years, 47.2 % male). Age, SES, intelligence, ethnicity, complexity, parental competence judgment and trial participation were univariately associated with competence (P < 0.05). Total explained variance in competence judgments was 71.5 %. Only age and intelligence significantly and independently explained the variance in competence judgments, explaining 56.6 % and 12.7 % of the total variance respectively. SES, male gender, disease experience and ethnicity each explained less than 1 % of the variance in competence judgments. Contextual factors together explained an extra 2

Video or In-Clinic Consultation? Selection of Attributes as Preparation for a Discrete Choice Experiment Among Key Stakeholders.

PubMed

Chudner, Irit; Goldfracht, Margalit; Goldblatt, Hadass; Drach-Zahavy, Anat; Karkabi, Khaled

2018-06-09

Video consultations (VCs) provide increased accessibility of primary care to remote areas and overall improved care for chronic patients. They also contribute to higher patient satisfaction and improved resource management. Despite these benefits, VC integration into the health system is complex and slow. Understanding the VC-related preferences of three key stakeholders-patients, primary care physicians (PCPs) and policy makers (PMs)-is crucial for achieving optimal implementation. The aim of this study was to select relevant attributes and levels for a discrete choice experiment (DCE) of stakeholders' choice-VC or traditional in-clinic consultation (I-CC) in primary care. Ten semi-structured focus group interviews and 24 semi-structured individual interviews were conducted. Data analysis was performed inductively, using a thematic content analysis method. An attribute-ranking exercise was then conducted based on the results gleaned from the interviews. The most important attributes when choosing either VC or I-CC, for both patients and PMs, were: (1) time to next available appointment; (2) time in line before consultation; (3) relationship to PCP; and (4) quality of consultation. For PCPs, the most important attributes were: (1) time in line before consultation; (2) patient's self-management ability; (3) consultation purpose; (4) quality of consultation. This qualitative study identified attributes and levels for a DCE quantitative stage among three key stakeholder groups. It adds to the literature of examples of developing DCE attributes, and to literature about the stakeholder benefits in the area of telemedicine in healthcare.

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

PubMed

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

2015-11-01

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

Dissemination and implementation of comparative effectiveness evidence: key informant interviews with Clinical and Translational Science Award institutions.

PubMed

Morrato, Elaine H; Concannon, Thomas W; Meissner, Paul; Shah, Nilay D; Turner, Barbara J

2013-03-01

To identify ongoing practices and opportunities for improving national comparative effectiveness research (CER) translation through dissemination and implementation (D&I) via NIH-funded Clinical and Translational Science Award (CTSA) institutions. Key informant interviews were conducted with 18 CTSA grantees sampled to represent a range of D&I efforts. The institutional representatives endorsed fostering CER translation nationally via the CTSA Consortium. However, five themes emerged from the interviews as barriers to CER D&I: lack of institutional awareness, insufficient capacity, lack of established D&I methods, confusion among stakeholders about what CER actually is and limited funding opportunities. Interviewees offered two key recommendations to improve CER translation: development of a centralized clearing house to facilitate the diffusion of CER D&I resources and methods across CTSA institutions; and formalization of the national CTSA network to leverage existing community engagement relationships and resources for the purpose of adapting and disseminating robust CER evidence locally with providers, patients and healthcare systems.

Dissemination and implementation of comparative effectiveness evidence: key informant interviews with Clinical and Translational Science Award institutions

PubMed Central

Morrato, Elaine H; Concannon, Thomas W; Meissner, Paul; Shah, Nilay D; Turner, Barbara J

2014-01-01

Aim To identify ongoing practices and opportunities for improving national comparative effectiveness research (CER) translation through dissemination and implementation (D&I) via NIH-funded Clinical and Translational Science Award (CTSA) institutions. Materials & methods Key informant interviews were conducted with 18 CTSA grantees sampled to represent a range of D&I efforts. Results & conclusions The institutional representatives endorsed fostering CER translation nationally via the CTSA Consortium. However, five themes emerged from the interviews as barriers to CER D&I: lack of institutional awareness, insufficient capacity, lack of established D&I methods, confusion among stakeholders about what CER actually is and limited funding opportunities. Interviewees offered two key recommendations to improve CER translation: development of a centralized clearing house to facilitate the diffusion of CER D&I resources and methods across CTSA institutions; and formalization of the national CTSA network to leverage existing community engagement relationships and resources for the purpose of adapting and disseminating robust CER evidence locally with providers, patients and healthcare systems. PMID:24236560

The Use of Published Clinical Study Reports to Support U.S. Food and Drug Administration Approval of Imaging Agents.

PubMed

Rieves, Dwaine; Jacobs, Paula

2016-12-01

Pharmaceutical companies typically perform prospective, multicenter phase 3 clinical studies to support approval of a new imaging agent by the U.S. Food and Drug Administration (FDA). In uncommon situations, the FDA has approved imaging agents based solely, or in large part, on the clinical study experience described in published reports, including reports of exploratory (i.e., phase 1 or 2) studies performed at a single clinical site. We performed a survey of published reports to assess the potential of the reported information to support FDA approval of a commonly cited investigational imaging agent. Our survey revealed critical data limitations in most publications, all of which reported exploratory clinical studies. Here we summarize the precedent for FDA approval of imaging agents using effectiveness data from publications, FDA guidance, and our experience in reviewing publications. We also present a key-data checklist for investigators to consider in the design, conduct, and reporting of exploratory clinical studies for publication. We encourage editors and peer reviewers to consider requiring these key data when reviewing these reports for publication. © 2016 by the Society of Nuclear Medicine and Molecular Imaging, Inc.

Iranian Clinical Nurses’ Activities for Self-Directed Learning: A Qualitative Study

PubMed Central

Ghiyasvandian, Shahrzad; Malekian, Morteza; Cheraghi, Mohammad Ali

2016-01-01

Background: Clinical nurses need lifelong learning skills for responding to the rapid changes of clinical settings. One of the best strategies for lifelong learning is self-directed learning. The aim of this study was to explore Iranian clinical nurses’ activities for self-directed learning. Methods: In this qualitative study, 23 semi-structured personal interviews were conducted with nineteen clinical nurses working in all four hospitals affiliated to Isfahan Social Security Organization, Isfahan, Iran. Study data were analyzed by using the content analysis approach. The study was conducted from June 2013 to October 2014. Findings: Study participants’ activities for self-directed learning fell into two main categories of striving for knowledge acquisition and striving for skill development. The main theme of the study was ‘Revising personal performance based on intellectual-experiential activities’. Conclusions: Study findings suggest that Iranian clinical nurses continually revise their personal performance by performing self-directed intellectual and experiential activities to acquire expertise. The process of acquiring expertise is a linear process which includes two key steps of knowledge acquisition and knowledge development. In order to acquire and advance their knowledge, nurses perform mental learning activities such as sensory perception, self-evaluation, and suspended judgment step-by-step. Moreover, they develop their skills through doing activities like apprenticeship, masterly performance, and self-regulation. The absolute prerequisite to expertise acquisition is that a nurse needs to follow these two steps in a sequential manner. PMID:26652072

Sequential weighted Wiener estimation for extraction of key tissue parameters in color imaging: a phantom study

NASA Astrophysics Data System (ADS)

Chen, Shuo; Lin, Xiaoqian; Zhu, Caigang; Liu, Quan

2014-12-01

Key tissue parameters, e.g., total hemoglobin concentration and tissue oxygenation, are important biomarkers in clinical diagnosis for various diseases. Although point measurement techniques based on diffuse reflectance spectroscopy can accurately recover these tissue parameters, they are not suitable for the examination of a large tissue region due to slow data acquisition. The previous imaging studies have shown that hemoglobin concentration and oxygenation can be estimated from color measurements with the assumption of known scattering properties, which is impractical in clinical applications. To overcome this limitation and speed-up image processing, we propose a method of sequential weighted Wiener estimation (WE) to quickly extract key tissue parameters, including total hemoglobin concentration (CtHb), hemoglobin oxygenation (StO2), scatterer density (α), and scattering power (β), from wide-band color measurements. This method takes advantage of the fact that each parameter is sensitive to the color measurements in a different way and attempts to maximize the contribution of those color measurements likely to generate correct results in WE. The method was evaluated on skin phantoms with varying CtHb, StO2, and scattering properties. The results demonstrate excellent agreement between the estimated tissue parameters and the corresponding reference values. Compared with traditional WE, the sequential weighted WE shows significant improvement in the estimation accuracy. This method could be used to monitor tissue parameters in an imaging setup in real time.

Preparedness of newly qualified midwives to deliver clinical care: an evaluation of pre-registration midwifery education through an analysis of key events.

PubMed

Skirton, Heather; Stephen, Nicole; Doris, Faye; Cooper, Maggie; Avis, Mark; Fraser, Diane M

2012-10-01

this study was part of a larger project commissioned to ascertain whether midwife teachers bring a unique contribution to the preparation of midwives for practice. The aim of this phase was to determine whether the student midwives' educational programme had equipped them to practise competently after entry to the professional register. this was a prospective, longitudinal qualitative study, using participant diaries to collect data. data were collected from newly qualified midwives during the initial six months after they commenced their first post as a qualified midwife. the potential participants were all student midwives who were completing their education at one of six Universities (three in England, one in Scotland, one in Wales and one in Northern Ireland). Diary data were submitted by 35 newly qualified midwives; 28 were graduates of the three year programme and seven of the shortened programme. diary entries were analysed using thematic analysis (Braun and Clarke, 2006), with a focus on identification of key events in the working lives of the newly qualified midwives. A total of 263 key events were identified, under three main themes: (1) impact of the event on confidence, (2) gaps in knowledge or experience and (3) articulated frustration, conflict or distress. essentially, pre-registration education, delivered largely by midwife teachers and supported by clinical mentors, has been shown to equip newly qualified midwives to work effectively as autonomous practitioners caring for mothers and babies. While newly qualified midwives are able to cope with a range of challenging clinical situations in a safe manner, they lack confidence in key areas. Positive reinforcement by supportive colleagues plays a significant role in enabling them to develop as practitioners. whilst acknowledging the importance of normality in childbearing there is a need within the curriculum to enable midwives to recognise and respond to complex care situations by providing theory

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

PubMed

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

2018-01-29

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

Development of clinical pharmacy key performance indicators for hospital pharmacists using a modified Delphi approach.

PubMed

Fernandes, Olavo; Gorman, Sean K; Slavik, Richard S; Semchuk, William M; Shalansky, Steve; Bussières, Jean-François; Doucette, Douglas; Bannerman, Heather; Lo, Jennifer; Shukla, Simone; Chan, Winnie W Y; Benninger, Natalie; MacKinnon, Neil J; Bell, Chaim M; Slobodan, Jeremy; Lyder, Catherine; Zed, Peter J; Toombs, Kent

2015-06-01

Key performance indicators (KPIs) are quantifiable measures of quality. There are no published, systematically derived clinical pharmacy KPIs (cpKPIs). A group of hospital pharmacists aimed to develop national cpKPIs to advance clinical pharmacy practice and improve patient care. A cpKPI working group established a cpKPI definition, 8 evidence-derived cpKPI critical activity areas, 26 candidate cpKPIs, and 11 cpKPI ideal attributes in addition to 1 overall consensus criterion. Twenty-six clinical pharmacists and hospital pharmacy leaders participated in an internet-based 3-round modified Delphi survey. Panelists rated 26 candidate cpKPIs using 11 cpKPI ideal attributes and 1 overall consensus criterion on a 9-point Likert scale. A meeting was facilitated between rounds 2 and 3 to debate the merits and wording of candidate cpKPIs. Consensus was reached if 75% or more of panelists assigned a score of 7 to 9 on the consensus criterion during the third Delphi round. All panelists completed the 3 Delphi rounds, and 25/26 (96%) attended the meeting. Eight candidate cpKPIs met the consensus definition: (1) performing admission medication reconciliation (including best-possible medication history), (2) participating in interprofessional patient care rounds, (3) completing pharmaceutical care plans, (4) resolving drug therapy problems, (5) providing in-person disease and medication education to patients, (6) providing discharge patient medication education, (7) performing discharge medication reconciliation, and (8) providing bundled, proactive direct patient care activities. A Delphi panel of hospital pharmacists was successful in determining 8 consensus cpKPIs. Measurement and assessment of these cpKPIs will serve to advance clinical pharmacy practice and improve patient care. © The Author(s) 2015.

Pharmacogenetic studies of antidepressant response: how far from the clinic?

PubMed

Perlis, Roy H

2007-03-01

Because the US FDA has begun to focus on disclosure of pharmacogenetic testing results in applications for new drug approval and review of existing drugs (see, eg, http://www.fda.gov/OHRMS/DOCKETS/AC/05/slides/2005-4194S1_Slide-Index.htm), the application of such testing in a clinical setting is likely to increase substantially. Instead of small cohorts of patients, potentially nearly every participant in the large pivotal trials required for drug approval could help inform the future application of that drug. Psychiatry as a whole, and antidepressant prescribing ni particular, stands to benefit in the near term from the identification of newer treatment targets that may overcome some of the limitations of current therapeutics. On the other hand, despite the excitement about the rapid pace of development in psychiatric pharmacogenetics, a number of key issues remain to be addressed before these discoveries are applied in a clinical setting. Close coordination will be required between those who study treatment efficacy and effectiveness and those who study genetic variation in populations to ensure that studies yield results that have scientific importance and clinical importance as well.

A Simplified Approach to Encephalitis and Its Mimics: Key Clinical Decision Points in the Setting of Specific Imaging Abnormalities.

PubMed

McKnight, Colin D; Kelly, Aine M; Petrou, Myria; Nidecker, Anna E; Lorincz, Matthew T; Altaee, Duaa K; Gebarski, Stephen S; Foerster, Bradley

2017-06-01

Infectious encephalitis is a relatively common cause of morbidity and mortality. Treatment of infectious encephalitis with antiviral medication can be highly effective when administered promptly. Clinical mimics of encephalitis arise from a broad range of pathologic processes, including toxic, metabolic, neoplastic, autoimmune, and cardiovascular etiologies. These mimics need to be rapidly differentiated from infectious encephalitis to appropriately manage the correct etiology; however, the many overlapping signs of these various entities present a challenge to accurate diagnosis. A systematic approach that considers both the clinical manifestations and the imaging findings of infectious encephalitis and its mimics can contribute to more accurate and timely diagnosis. Following an institutional review board approval, a health insurance portability and accountability act (HIPAA)-compliant search of our institutional imaging database (teaching files) was conducted to generate a list of adult and pediatric patients who presented between January 1, 1995 and October 10, 2013 for imaging to evaluate possible cases of encephalitis. Pertinent medical records, including clinical notes as well as surgical and pathology reports, were reviewed and correlated with imaging findings. Clinical and imaging findings were combined to generate useful flowcharts designed to assist in distinguishing infectious encephalitis from its mimics. Key imaging features were reviewed and were placed in the context of the provided flowcharts. Four flowcharts were presented based on the primary anatomic site of imaging abnormality: group 1: temporal lobe; group 2: cerebral cortex; group 3: deep gray matter; and group 4: white matter. An approach that combines features on clinical presentation was then detailed. Imaging examples were used to demonstrate similarities and key differences. Early recognition of infectious encephalitis is critical, but can be quite complex due to diverse pathologies and

Review of clinical studies of Polygonum multiflorum Thunb. and its isolated bioactive compounds

PubMed Central

Bounda, Guy-Armel; Feng, YU

2015-01-01

Polygonum multiflorum Thunb. (PMT), officially listed in the Chinese Pharmacopoeia, is one of the most popular perennial Chinese traditional medicines known as He shou wu in China and East Asia, and as Fo-ti in North America. Mounting pharmacological studies have stressed out its key benefice for the treatment of various diseases and medical conditions such as liver injury, cancer, diabetes, alopecia, atherosclerosis, and neurodegenerative diseases as well. International databases such as PubMed/Medline, Science citation Index and Google Scholar were searched for clinical studies recently published on P. multiflorum. Various clinical studies published articles were retrieved, providing information relevant to pharmacokinetics-pharmacodynamics analysis, sleep disorders, dyslipidemia treatment, and neurodegenerative diseases. This review is an effort to update the clinical picture of investigations ever carried on PMT and/or its isolated bio-compounds and to enlighten its therapeutic assessment. PMID:26130933

Paediatricians' opinions of microneedle-mediated monitoring: a key stage in the translation of microneedle technology from laboratory into clinical practice.

PubMed

Mooney, Karen; McElnay, James C; Donnelly, Ryan F

2015-08-01

Microneedle (MN) arrays could offer an alternative method to traditional drug delivery and blood sampling methods. However, acceptance among key end-users is critical for new technologies to succeed. MNs have been advocated for use in children and so, paediatricians are key potential end-users. However, the opinions of paediatricians on MN use have been previously unexplored. The aim of this study was to investigate the views of UK paediatricians on the use of MN technology within neonatal and paediatric care. An online survey was developed and distributed among UK paediatricians to gain their opinions of MN technology and its use in the neonatal and paediatric care settings, particularly for MN-mediated monitoring. A total of 145 responses were obtained, with a completion response rate of 13.7 %. Respondents believed an alternative monitoring technique to blood sampling in children was required. Furthermore, 83 % of paediatricians believed there was a particular need in premature neonates. Overall, this potential end-user group approved of the MN technology and a MN-mediated monitoring approach. Minimal pain and the perceived ease of use were important elements in gaining favour. Concerns included the need for confirmation of correct application and the potential for skin irritation. The findings of this study provide an initial indication of MN acceptability among a key potential end-user group. Furthermore, the concerns identified present a challenge to those working within the MN field to provide solutions to further improve this technology. The work strengthens the rationale behind MN technology and facilitates the translation of MN technology from lab bench into the clinical setting.

International Pediatric MS Study Group Clinical Trials Summit: meeting report.

PubMed

Chitnis, Tanuja; Tardieu, Marc; Amato, Maria Pia; Banwell, Brenda; Bar-Or, Amit; Ghezzi, Angelo; Kornberg, Andrew; Krupp, Lauren B; Pohl, Daniela; Rostasy, Kevin; Tenembaum, Silvia; Waubant, Emmanuelle; Wassmer, Evangeline

2013-03-19

Pediatric studies for new biological agents are mandated by recent legislation, necessitating careful thought to evaluation of emerging multiple sclerosis (MS) therapies in children with MS. Challenges include a small patient population, the lack of prior randomized clinical trials, and ethical concerns. The goal of this meeting was to assess areas of consensus regarding clinical trial design and outcome measures among academic experts involved in pediatric MS care and research. The Steering Committee of the International Pediatric MS Study Group identified key focus areas for discussion. A total of 69 meeting attendees were assembled, including 35 academic experts. Regulatory and pharmaceutical representatives also attended, and provided input, which informed academic expert consensus decisions. The academic experts agreed that clinical trials were necessary in pediatric MS to obtain pharmacokinetic, safety and efficacy data, and regulatory approval allowing for greater medication access. The academic experts agreed that relapse was an appropriate primary outcome measure for phase III pediatric trials. An international standardized cognitive battery was identified. The pros and cons of various trial designs were discussed. Guidelines surrounding MRI studies, pharmacokinetics, pharmacodynamics, and registries were developed. The academic experts agreed that given the limited subject pool, a stepwise approach to the launch of clinical trials for the most promising medications is necessary in order to ensure study completion. Alternative approaches could result in unethical exposure of patients to trial conditions without gaining knowledge. Consensus points for conduct of clinical trials in the rare disease pediatric MS were identified amongst a panel of academic experts, informed by regulatory and industry stakeholders.

Differences in the Implementation of Diagnosis-Related Groups across Clinical Departments: A German Hospital Case Study

PubMed Central

Ridder, Hans-Gerd; Doege, Vanessa; Martini, Susanne

2007-01-01

Objective This article aims to examine the implementation process of diagnosis-related groups (DRGs) in the clinical departments of a German hospital group and to explain why some gain competitive advantage while others do not. Study Setting To investigate this research question, we conducted a qualitative study based on primary data obtained in six clinical departments in a German hospital group between 2003 and 2005. Study Design We chose the case study method in order to gain deep insights into the process dynamics of the implementation of DRGs in the six clinical departments. The dynamic capability approach is used as a theoretical foundation. Employing theory-driven categories we focused on idiosyncratic and common patterns of “successful coders” and “unsuccessful coders.” Data Collection To observe the implementation process of DRGs, we conducted 43 semistructured interviews with key persons, carried out direct observations of the monthly meetings of the DRG project group, and sampled written materials. Principal Findings “Successful coders” invest into change resources, demonstrate a high level of acceptance of innovations, and organize effective processes of coordination and learning. Conclusions All clinical departments only put an emphasis on the coding aspects of the DRGs. There is a lack of vision regarding the optimization of patient treatment processes and specialization. Physicians are the most important key actors, rather than the main barriers. PMID:17995556

Preliminary identification of key clinical domains for outcome evaluation in fibromyalgia using the Delphi method: the Italian experience.

PubMed

Salaffi, F; Ciapetti, A; Sarzi Puttini, P; Atzeni, F; Iannuccelli, C; Di Franco, M; Cazzola, M; Bazzichi, L

2012-03-19

Fibromyalgia (FM) is a complex syndrome that, in Italy, affects at least 2% of the adult population. It is characterized by chronic widespread musculoskeletal pain often accompanied by multiple other symptoms. The aim of this study was to identify a set of clinical domains for FM considered relevant by both clinicians and patients using a consensus process. Consensus was achieved using the Delphi method based on questionnaires and systematic, controlled opinion feedback. The Delphi exercise involved a panel of 252 rheumatologists and 86 patients with FM as defined by the American College of Rheumatology criteria. All of the patients and clinicians were asked to rank the relative different domains of FM in order of priority. The content validity index (CVI) was used to establish the percentage agreement. The importance of each item was ranked on a 0-3 Likert scale. The frequency, mean relevance scores, and frequency importance product were also calculated. The Delphi exercise showed that the domains ranked highest by patients were similar to those of the clinicians, with the exception of tender point intensity (considered relevant by the clinicians but not by the patients) and environmental sensitivity (considered important by the patients but not by the clinicians). A final 8-item model was developed which was considered to demonstrate adequate validity. The Delphi exercises identified and ranked relevant key clinical domains that need to be assessed in FM research. On the basis of these results, a new patient-reported composite outcome index can be developed and used in clinical trials.

[Evidence of pharmacotherapy in COPD--key findings from recently-conducted randomized clinical studies].

PubMed

Shimizu, Kaoruko; Nishimura, Masaharu

2011-10-01

The primary aim of pharmachotherapy in COPD is improvement of exertional dyspnea and quality of life through its bronchodilator effects. However, there is emerging evidence that pharmacotherapy may reduce exacerbations, alleviate annual decline of pulmonary function, and even favorably affect mortality, thus changing natural history of COPD. The large-scaled randomized clinical trials, such as TORCH, UPLIFT, have revealed that combination of long acting beta2 agonist (LABA) and inhaled corticosteroids (ICS), LABA/ICS, and/or tiotropium alone may have such effects. In addition, carbocisteine, which is a mucolytic and anti-oxidant agent, has been shown to reduce exacerbations in COPD. Future directions on pharmacotherapy are personalized medicine based on phenotyping of the disease and development of new agents which may cure airway inflammation in COPD.

Motivational journey of Iranian bachelor of nursing students during clinical education: a grounded theory study.

PubMed

Hanifi, Nasrin; Parvizy, Soroor; Joolaee, Soodabeh

2013-09-01

This study explored how nursing students can be kept motivated throughout their clinical education. Motivation is a key issue in nursing clinical education for student retention. The study was conducted using grounded theory methods, which are appropriate when studying process in a social context. Sixteen students and four instructors, who were purposefully selected, participated in semistructured interviews. Data were analyzed using the constant comparative method. Students' motivational journey occurred in three steps: (i) social condition; (ii) encountering the clinical education challenges; and (iii) looking for an escape from nursing, or simply tolerating nursing. Struggling with professional identity emerged as the core variable. Iran's social context and many other conditions in the clinical education setting affect students' motivation. Identifying motivational process might assist educational authorities in offering solutions to promote motivation among students. © 2013 Wiley Publishing Asia Pty Ltd.

The nature of placebo response in clinical studies of major depressive disorder.

PubMed

Papakostas, George I; Østergaard, Søren D; Iovieno, Nadia

2015-04-01

To review factors influencing placebo response and clinical trial outcome in depression, and suggest ways to optimize trial success in mood disorders. PubMed searches were conducted by cross-referencing the terms depression, depressive with placebo, clinical trial, and clinical trials for studies published in English between 1970 and September 2013. Relevant abstracts were identified in PubMed, including clinical trials, quantitative studies, and qualitative research. We obtained and reviewed relevant articles and utilized their information to synthesize the present review. Included articles were grouped in the following areas of relevance: (1) biological validity of illness, (2) baseline severity of illness, (3) chronicity of the index episode of depression, (4) age of participants, (5) medical and psychiatric comorbidity, (6) probability of receiving placebo, (7) use of prospective treatment phases (lead-in) (8) dosing schedule, (9) trial duration, (10) frequency of follow-up assessments, and (11) study outcome measure. Several key elements emerge as critical to the ultimate success of a clinical trial, including the probability of receiving placebo, study duration, dosing schedule, visit frequency, the use of blinded lead-in phases, the use of centralized raters, illness severity and duration, and comorbid anxiety. Our increasing understanding of the placebo response in clinical trials of major depressive disorder lends to a, gradually, more predictable phenomenon and, hopefully, to one that becomes lesser in magnitude and variability. Several elements have emerged that seem to play a critical role in trial success, gradually reshaping the design of clinical, translational, as well as mechanistic studies in depression. © Copyright 2015 Physicians Postgraduate Press, Inc.

[A Critical Condition of Clinical Studies in Japan -- A Battle of Clinical Study Groups].

PubMed

Furukawa, Hiroshi

2016-04-01

The post-marketing clinical study groups have been losing their activity due to stop of financial support. As the result, clinical study groups cannot achieve any EBM for treatment guidelines. Financial supports should be restarted immediately not to extinguish the post-marketing clinical studies and study groups.

Differences in the implementation of diagnosis-related groups across clinical departments: a German hospital case study.

PubMed

Ridder, Hans-Gerd; Doege, Vanessa; Martini, Susanne

2007-12-01

This article aims to examine the implementation process of diagnosis-related groups (DRGs) in the clinical departments of a German hospital group and to explain why some gain competitive advantage while others do not. To investigate this research question, we conducted a qualitative study based on primary data obtained in six clinical departments in a German hospital group between 2003 and 2005. We chose the case study method in order to gain deep insights into the process dynamics of the implementation of DRGs in the six clinical departments. The dynamic capability approach is used as a theoretical foundation. Employing theory-driven categories we focused on idiosyncratic and common patterns of "successful coders" and "unsuccessful coders." To observe the implementation process of DRGs, we conducted 43 semistructured interviews with key persons, carried out direct observations of the monthly meetings of the DRG project group, and sampled written materials. "Successful coders" invest into change resources, demonstrate a high level of acceptance of innovations, and organize effective processes of coordination and learning. All clinical departments only put an emphasis on the coding aspects of the DRGs. There is a lack of vision regarding the optimization of patient treatment processes and specialization. Physicians are the most important key actors, rather than the main barriers.

Defining the Key Competencies in Radiation Protection for Endovascular Procedures: A Multispecialty Delphi Consensus Study.

PubMed

Doyen, Bart; Maurel, Blandine; Cole, Jonathan; Maertens, Heidi; Mastracci, Tara; Van Herzeele, Isabelle

2018-02-01

Radiation protection training courses currently focus on broad knowledge topics which may not always be relevant in daily practice. The goal of this study was to determine the key competencies in radiation protection that every endovascular team member should possess and apply routinely, through multispecialty clinical content expert consensus. Consensus was obtained through a two round modified Delphi methodology. The expert panel consisted of European vascular surgeons, interventional radiologists, and interventional cardiologists/angiologists experienced in endovascular procedures. An initial list of statements, covering knowledge skills, technical skills and attitudes was created, based on a literature search. Additional statements could be suggested by the experts in the first Delphi round. Each of the statements had to be rated on a 5- point Likert scale. A statement was considered to be a key competency when the internal consistency was greater than alpha = 0.80 and at least 80% of the experts agreed (rating 4/5) or strongly agreed (rating 5/5) with the statement. Questionnaires were emailed to panel members using the Surveymonkey service. Forty-one of 65 (63.1%) invited experts agreed to participate in the study. The response rates were 36 out of 41 (87.8%): overall 38 out of 41(92.6%) in the first round and 36 out of 38 (94.7%) in the second round. The 71 primary statements were supplemented with nine items suggested by the panel. The results showed excellent consensus among responders (Cronbach's alpha = 0.937 first round; 0.958 s round). Experts achieved a consensus that 30 of 33 knowledge skills (90.9%), 23 of 27 technical skills (82.1%), and 15 of 20 attitudes (75.0%) should be considered as key competencies. A multispecialty European endovascular expert panel reached consensus about the key competencies in radiation protection. These results may serve to create practical and relevant radiation protection training courses in the future, enhancing

How do Supervising Clinicians of a University Hospital and Associated Teaching Hospitals Rate the Relevance of the Key Competencies within the CanMEDS Roles Framework in Respect to Teaching in Clinical Clerkships?

PubMed

Jilg, Stefanie; Möltner, Andreas; Berberat, Pascal; Fischer, Martin R; Breckwoldt, Jan

2015-01-01

In German-speaking countries, the physicians' roles framework of the "Canadian Medical Education Directives for Specialists" (CanMEDS) is increasingly used to conceptualize postgraduate medical education. It is however unclear, whether it may also be applied to the final year of undergraduate education within clinical clerkships, called "Practical Year" (PY). Therefore, the aim of this study was to explore how clinically active physicians at a university hospital and at associated teaching hospitals judge the relevance of the seven CanMEDS roles (and their (role-defining) key competencies) in respect to their clinical work and as learning content for PY training. Furthermore, these physicians were asked whether the key competencies were actually taught during PY training. 124 physicians from internal medicine and surgery rated the relevance of the 28 key competencies of the CanMEDS framework using a questionnaire. For each competency, following three aspects were rated: "relevance for your personal daily work", "importance for teaching during PY", and "implementation into actual PY teaching". In respect to the main study objective, all questionnaires could be included into analysis. All seven CanMEDS roles were rated as relevant for personal daily work, and also as important for teaching during PY. Furthermore, all roles were stated to be taught during actual PY training. The roles "Communicator", "Medical Expert", and "Collaborator" were rated as significantly more important than the other roles, for all three sub-questions. No differences were found between the two disciplines internal medicine and surgery, nor between the university hospital and associated teaching hospitals. Participating physicians rated all key competencies of the CanMEDS model to be relevant for their personal daily work, and for teaching during PY. These findings support the suitability of the CanMEDS framework as a conceptual element of PY training.

How do Supervising Clinicians of a University Hospital and Associated Teaching Hospitals Rate the Relevance of the Key Competencies within the CanMEDS Roles Framework in Respect to Teaching in Clinical Clerkships?

PubMed Central

Jilg, Stefanie; Möltner, Andreas; Berberat, Pascal; Fischer, Martin R.; Breckwoldt, Jan

2015-01-01

Background and aim: In German-speaking countries, the physicians’ roles framework of the “Canadian Medical Education Directives for Specialists” (CanMEDS) is increasingly used to conceptualize postgraduate medical education. It is however unclear, whether it may also be applied to the final year of undergraduate education within clinical clerkships, called “Practical Year” (PY). Therefore, the aim of this study was to explore how clinically active physicians at a university hospital and at associated teaching hospitals judge the relevance of the seven CanMEDS roles (and their (role-defining) key competencies) in respect to their clinical work and as learning content for PY training. Furthermore, these physicians were asked whether the key competencies were actually taught during PY training. Methods: 124 physicians from internal medicine and surgery rated the relevance of the 28 key competencies of the CanMEDS framework using a questionnaire. For each competency, following three aspects were rated: “relevance for your personal daily work”, “importance for teaching during PY”, and “implementation into actual PY teaching”. Results: In respect to the main study objective, all questionnaires could be included into analysis. All seven CanMEDS roles were rated as relevant for personal daily work, and also as important for teaching during PY. Furthermore, all roles were stated to be taught during actual PY training. The roles “Communicator”, “Medical Expert”, and “Collaborator” were rated as significantly more important than the other roles, for all three sub-questions. No differences were found between the two disciplines internal medicine and surgery, nor between the university hospital and associated teaching hospitals. Conclusion: Participating physicians rated all key competencies of the CanMEDS model to be relevant for their personal daily work, and for teaching during PY. These findings support the suitability of the Can

Evaluation of a prototype interactive consent program for pediatric clinical trials: a pilot study

PubMed Central

Voepel-Lewis, Terri; McGonegal, Maureen; Levine, Robert

2011-01-01

Standard written methods of presenting research information may be difficult for many parents and children to understand. This pilot study was designed to examine the use of a novel prototype interactive consent program for describing a hypothetical pediatric asthma trial to parents and children. Parents and children were interviewed to examine their baseline understanding of key elements of a clinical trial, eg, randomization, placebo, and blinding. Subjects then reviewed age-appropriate versions of an interactive computer program describing an asthma trial, and their understanding of key research concepts was again tested along with their understanding of the details of the trial. Parents and children also completed surveys to examine their perceptions and satisfaction with the program. Both parents and children demonstrated improved understanding of key research concepts following administration of the consent program. For example, the percentage of parents and children who could correctly define the terms clinical trials and placebo improved from 60% to 80%, and 80% to 100% among parents and 25% to 50% and 0% to 50% among children, respectively, following review of the interactive programs. Parents and children's overall understanding of the details of the asthma trial were 14.2±0.84 and 9.25±4.9 (0–15 scale, where 15 is complete understanding), respectively. Results also suggest that the interactive programs were easy to use and facilitated understanding of the clinical trial among parents and children. Interactive media may offer an effective means of presenting understandable information to parents and children regarding participation in clinical trials. Further work to examine this novel approach appears warranted. PMID:21803924

Quantum exhaustive key search with simplified-DES as a case study.

PubMed

Almazrooie, Mishal; Samsudin, Azman; Abdullah, Rosni; Mutter, Kussay N

2016-01-01

To evaluate the security of a symmetric cryptosystem against any quantum attack, the symmetric algorithm must be first implemented on a quantum platform. In this study, a quantum implementation of a classical block cipher is presented. A quantum circuit for a classical block cipher of a polynomial size of quantum gates is proposed. The entire work has been tested on a quantum mechanics simulator called libquantum. First, the functionality of the proposed quantum cipher is verified and the experimental results are compared with those of the original classical version. Then, quantum attacks are conducted by using Grover's algorithm to recover the secret key. The proposed quantum cipher is used as a black box for the quantum search. The quantum oracle is then queried over the produced ciphertext to mark the quantum state, which consists of plaintext and key qubits. The experimental results show that for a key of n-bit size and key space of N such that [Formula: see text], the key can be recovered in [Formula: see text] computational steps.

Can non‐clinical repolarization assays predict the results of clinical thorough QT studies? Results from a research consortium

PubMed Central

Park, Eunjung; Gintant, Gary A; Bi, Daoqin; Kozeli, Devi; Pettit, Syril D; Skinner, Matthew; Willard, James; Wisialowski, Todd; Koerner, John; Valentin, Jean‐Pierre

2018-01-01

Background and Purpose Translation of non‐clinical markers of delayed ventricular repolarization to clinical prolongation of the QT interval corrected for heart rate (QTc) (a biomarker for torsades de pointes proarrhythmia) remains an issue in drug discovery and regulatory evaluations. We retrospectively analysed 150 drug applications in a US Food and Drug Administration database to determine the utility of established non‐clinical in vitro IKr current human ether‐à‐go‐go‐related gene (hERG), action potential duration (APD) and in vivo (QTc) repolarization assays to detect and predict clinical QTc prolongation. Experimental Approach The predictive performance of three non‐clinical assays was compared with clinical thorough QT study outcomes based on free clinical plasma drug concentrations using sensitivity and specificity, receiver operating characteristic (ROC) curves, positive (PPVs) and negative predictive values (NPVs) and likelihood ratios (LRs). Key Results Non‐clinical assays demonstrated robust specificity (high true negative rate) but poor sensitivity (low true positive rate) for clinical QTc prolongation at low‐intermediate (1×–30×) clinical exposure multiples. The QTc assay provided the most robust PPVs and NPVs (ability to predict clinical QTc prolongation). ROC curves (overall test accuracy) and LRs (ability to influence post‐test probabilities) demonstrated overall marginal performance for hERG and QTc assays (best at 30× exposures), while the APD assay demonstrated minimal value. Conclusions and Implications The predictive value of hERG, APD and QTc assays varies, with drug concentrations strongly affecting translational performance. While useful in guiding preclinical candidates without clinical QT prolongation, hERG and QTc repolarization assays provide greater value compared with the APD assay. PMID:29181850

Use of Key Performance Indicators to Improve Milestone Assessment in Semi-Annual Clinical Competency Committee Meetings.

PubMed

Chen, Fei; Arora, Harendra; Martinelli, Susan M

2017-01-01

The Accreditation Council for Graduate Medical Education's Next Accreditation System requires residency programs to semiannually submit composite milestone data on each resident's performance. This report describes and evaluates a new assessment review procedure piloted in our departmental Clinical Competency Committee (CCC) semi-annual meeting in June 2016. A modified Delphi technique was utilized to develop key performance indicators (KPI) linking milestone descriptors to clinical practice. In addition, the CCC identified six specific milestone sub-competencies that would be prescored with objective data prior to the meeting. Each resident was independently placed on the milestones by 3 different CCC faculty members. Milestone placement data of the same cohort of 42 residents (Clinical Anesthesia Years 1-3) were collected to calculate inter-rater reliability of the assessment procedures before and after the implemented changes. A survey was administrated to collect CCC feedback on the new procedure. The procedure assisted in reducing meeting time from 8 to 3.5 hours. Survey of the CCC members revealed positive perception of the procedure. Higher inter-rater reliability of the milestone placement was obtained using the implemented KPIs (Intraclass correlation coefficient [ICC] single measure range: before=.53-.94, after=.74-.98). We found the new assessment procedure beneficial to the efficiency and transparency of the assessment process. Further improvement of the procedure involves refinement of KPIs and additional faculty development on KPIs to allow non-CCC faculty to provide more accurate resident evaluations.

Use of Key Performance Indicators to Improve Milestone Assessment in Semi-Annual Clinical Competency Committee Meetings

PubMed Central

Arora, Harendra; Martinelli, Susan M.

2017-01-01

Background: The Accreditation Council for Graduate Medical Education's Next Accreditation System requires residency programs to semiannually submit composite milestone data on each resident's performance. This report describes and evaluates a new assessment review procedure piloted in our departmental Clinical Competency Committee (CCC) semi-annual meeting in June 2016. Methods: A modified Delphi technique was utilized to develop key performance indicators (KPI) linking milestone descriptors to clinical practice. In addition, the CCC identified six specific milestone sub-competencies that would be prescored with objective data prior to the meeting. Each resident was independently placed on the milestones by 3 different CCC faculty members. Milestone placement data of the same cohort of 42 residents (Clinical Anesthesia Years 1–3) were collected to calculate inter-rater reliability of the assessment procedures before and after the implemented changes. A survey was administrated to collect CCC feedback on the new procedure. Results: The procedure assisted in reducing meeting time from 8 to 3.5 hours. Survey of the CCC members revealed positive perception of the procedure. Higher inter-rater reliability of the milestone placement was obtained using the implemented KPIs (Intraclass correlation coefficient [ICC] single measure range: before=.53–.94, after=.74–.98). Conclusion: We found the new assessment procedure beneficial to the efficiency and transparency of the assessment process. Further improvement of the procedure involves refinement of KPIs and additional faculty development on KPIs to allow non-CCC faculty to provide more accurate resident evaluations. PMID:29766033

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

PubMed Central

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

2014-01-01

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

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

PubMed

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

2014-01-01

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

The operating room as a clinical learning environment: An exploratory study.

PubMed

Meyer, Rhoda; Van Schalkwyk, Susan C; Prakaschandra, Rosaley

2016-05-01

Students undertake their clinical placement in various clinical settings for the exposure to and acquisition of skills related to that particular context. The operating room is a context that offers the opportunity to develop critical skills related to the perioperative care of the patient. Despite numerous studies that have been undertaken in this field, few have investigated the operating room as a clinical learning environment in the South African private healthcare context. The aim of this study was to determine nursing students' perceptions of the operating room as a clinical learning environment. An exploratory, interpretive and descriptive design generating qualitative data was utilized. Eight nursing students completed an open-ended questionnaire, and twelve nursing students participated in the focus group discussion. Four themes emerged, namely, 'interpersonal factors', 'educational factors', 'private operating room context', and 'recommendations'. The opinion that the operating room offers an opportunity to gain skills unique to this context was expressed. However, despite the potential learning opportunities, the key findings of this study reveal negative perceptions of nursing students regarding learning experiences in the operating room. Exploration into the preparatory needs of students specific to learning outcomes before operating room placement should be considered. It will also be necessary to improve collaboration between lecturers, mentors and theatre managers. Copyright © 2016 Elsevier Ltd. All rights reserved.

An exploration of peer-assisted learning in undergraduate nursing students in paediatric clinical settings: An ethnographic study.

PubMed

Carey, Matthew C; Chick, Anna; Kent, Bridie; Latour, Jos M

2018-06-01

Peer-assisted leaning relates to the acquisition of knowledge and skills through shared learning of matched equals. The concept has been explored within the field of nurse education across a range of learning environments, but its impact in practice is still relatively unknown. This paper reports on findings when observing paediatric undergraduate nursing students who engage in PAL within the clinical practice setting. The aim of this paper is to report the findings of a study undertaken to explore peer-assisted learning in undergraduate nursing students, studying children's health, in the clinical practice setting. A qualitative ethnographic study using non-participant observations. A range of inpatient paediatric clinical settings across two teaching hospitals. First, second and third year paediatric student nurses enrolled on a Bachelor of Nursing Programme. Non-participant observations were used to observe a range of interactions between the participants when engaging in peer-assisted learning within the same clinical area. A total of 67 h of raw data collected across all observations was analysed using framework analysis to draw together key themes. Of the 20 identified students across two hospitals, 17 agreed to take part in the study. Findings were aggregated into three key themes; 1. Peers as facilitators to develop learning when engaging in peer-assisted learning, 2. Working together to develop clinical practice and deliver care, 3. Positive support and interaction from peers to enhance networking and develop working structure. Peer-assisted learning in undergraduate children's nursing students stimulates students in becoming engaged in their learning experiences in clinical practice and enhance collaborative support within the working environment. The benefits of peer-assisted learning in current clinical practice settings can be challenging. Therefore, education and practice need to be aware of the benefits and their contribution towards future

Impact of clinical and health services research projects on decision-making: a qualitative study.

PubMed

Solans-Domènech, Maite; Adam, Paula; Guillamón, Imma; Permanyer-Miralda, Gaietà; Pons, Joan M V; Escarrabill, Joan

2013-05-10

This article reports on the impact assessment experience of a funding program of non-commercial clinical and health services research. The aim was to assess the level of implementation of results from a subgroup of research projects (on respiratory diseases), and to detect barriers (or facilitators) in the translation of new knowledge to informed decision-making. A qualitative study was performed. The sample consisted of six projects on respiratory diseases funded by the Agency for Health Quality and Assessment of Catalonia between 1996 and 2004. Semi-structured interviews to key informants including researchers and healthcare decision-makers were carried out. Interviews were recorded, transcribed verbatim and analysed on an individual (key informant) and group (project) basis. In addition, the differences between achieved and expected impacts were described. Twenty-three semi-structured interviews were conducted. Most participants indicated changes in health services or clinical practice had resulted from research. The channels used to transfer new knowledge were mainly conventional ones, but also in less explicit ways, such as with the involvement of local scientific societies, or via debates and discussions with colleagues and local leaders. The barriers and facilitators identified were mostly organizational (in research management, and clinical and healthcare practice), although there were also some related to the nature of the research as well as personal factors. Both the expected and achieved impacts enabled the identification of the gaps between what is expected and what is truly achieved. In this study and according to key informants, the impact of these research projects on decision-making can be direct (the application of a finding or innovation) or indirect, contributing to a more complex change in clinical practice and healthcare organization, both having other contextual factors. The channels used to transfer this new knowledge to clinical practice

Impact of clinical and health services research projects on decision-making: a qualitative study

PubMed Central

2013-01-01

Background This article reports on the impact assessment experience of a funding program of non-commercial clinical and health services research. The aim was to assess the level of implementation of results from a subgroup of research projects (on respiratory diseases), and to detect barriers (or facilitators) in the translation of new knowledge to informed decision-making. Methods A qualitative study was performed. The sample consisted of six projects on respiratory diseases funded by the Agency for Health Quality and Assessment of Catalonia between 1996 and 2004. Semi-structured interviews to key informants including researchers and healthcare decision-makers were carried out. Interviews were recorded, transcribed verbatim and analysed on an individual (key informant) and group (project) basis. In addition, the differences between achieved and expected impacts were described. Results Twenty-three semi-structured interviews were conducted. Most participants indicated changes in health services or clinical practice had resulted from research. The channels used to transfer new knowledge were mainly conventional ones, but also in less explicit ways, such as with the involvement of local scientific societies, or via debates and discussions with colleagues and local leaders. The barriers and facilitators identified were mostly organizational (in research management, and clinical and healthcare practice), although there were also some related to the nature of the research as well as personal factors. Both the expected and achieved impacts enabled the identification of the gaps between what is expected and what is truly achieved. Conclusions In this study and according to key informants, the impact of these research projects on decision-making can be direct (the application of a finding or innovation) or indirect, contributing to a more complex change in clinical practice and healthcare organization, both having other contextual factors. The channels used to transfer

Assessing the Health-Care Risk: The Clinical-VaR, a Key Indicator for Sound Management.

PubMed

Jiménez-Rodríguez, Enrique; Feria-Domínguez, José Manuel; Sebastián-Lacave, Alonso

2018-03-30

Clinical risk includes any undesirable situation or operational factor that may have negative consequences for patient safety or capable of causing an adverse event (AE). The AE, intentional or unintentionally, may be related to the human factor, that is, medical errors (MEs). Therefore, the importance of the health-care risk management is a current and relevant issue on the agenda of many public and private institutions. The objective of the management has been evolving from the identification of AE to the assessment of cost-effective and efficient measures that improve the quality control through monitoring. Consequently, the goal of this paper is to propose a Key Risk Indicator (KRI) that enhances the advancement of the health-care management system. Thus, the application of the Value at Risk (VaR) concept in combination to the Loss Distribution Approach (LDA) is proved to be a proactive tool, within the frame of balanced scorecard (BSC), in health organizations. For this purpose, the historical events recorded in the Algo-OpData ® database (Algorithmics Inc., Toronto, ON, Canada, IBM, Armonk, NY, USA) have been used. The analysis highlights the importance of risk in the financials outcomes of the sector. The results of paper show the usefulness of the Clinical-VaR to identify and monitor the risk and sustainability of the implemented controls.

Assessing the Health-Care Risk: The Clinical-VaR, a Key Indicator for Sound Management

PubMed Central

Jiménez-Rodríguez, Enrique; Sebastián-Lacave, Alonso

2018-01-01

Clinical risk includes any undesirable situation or operational factor that may have negative consequences for patient safety or capable of causing an adverse event (AE). The AE, intentional or unintentionally, may be related to the human factor, that is, medical errors (MEs). Therefore, the importance of the health-care risk management is a current and relevant issue on the agenda of many public and private institutions. The objective of the management has been evolving from the identification of AE to the assessment of cost-effective and efficient measures that improve the quality control through monitoring. Consequently, the goal of this paper is to propose a Key Risk Indicator (KRI) that enhances the advancement of the health-care management system. Thus, the application of the Value at Risk (VaR) concept in combination to the Loss Distribution Approach (LDA) is proved to be a proactive tool, within the frame of balanced scorecard (BSC), in health organizations. For this purpose, the historical events recorded in the Algo-OpData® database (Algorithmics Inc., Toronto, ON, Canada, IBM, Armonk, NY, USA) have been used. The analysis highlights the importance of risk in the financials outcomes of the sector. The results of paper show the usefulness of the Clinical-VaR to identify and monitor the risk and sustainability of the implemented controls. PMID:29601529

Optimizing prognosis-related key miRNA-target interactions responsible for cancer metastasis.

PubMed

Zhao, Hongying; Yuan, Huating; Hu, Jing; Xu, Chaohan; Liao, Gaoming; Yin, Wenkang; Xu, Liwen; Wang, Li; Zhang, Xinxin; Shi, Aiai; Li, Jing; Xiao, Yun

2017-12-12

Increasing evidence suggests that the abnormality of microRNAs (miRNAs) and their downstream targets is frequently implicated in the pathogenesis of human cancers, however, the clinical benefit of causal miRNA-target interactions has been seldom studied. Here, we proposed a computational method to optimize prognosis-related key miRNA-target interactions by combining transcriptome and clinical data from thousands of TCGA tumors across 16 cancer types. We obtained a total of 1,956 prognosis-related key miRNA-target interactions between 112 miRNAs and 1,443 their targets. Interestingly, these key target genes are specifically involved in tumor progression-related functions, such as 'cell adhesion' and 'cell migration'. Furthermore, they are most significantly correlated with 'tissue invasion and metastasis', a hallmark of metastasis, in ten distinct types of cancer through the hallmark analysis. These results implicated that the prognosis-related key miRNA-target interactions were highly associated with cancer metastasis. Finally, we observed that the combination of these key miRNA-target interactions allowed to distinguish patients with good prognosis from those with poor prognosis both in most TCGA cancer types and independent validation sets, highlighting their roles in cancer metastasis. We provided a user-friendly database named miRNATarget (freely available at http://biocc.hrbmu.edu.cn/miRNATar/), which provides an overview of the prognosis-related key miRNA-target interactions across 16 cancer types.

Leadership for learning: a literature study of leadership for learning in clinical practice.

PubMed

Allan, Helen T; Smith, Pamela A; Lorentzon, Maria

2008-07-01

To report a literature study of leadership for learning in clinical practice in the United Kingdom. Background Previous research in the United Kingdom showed that the ward sister was central to creating a positive learning environment for student nurses. Since the 1990s, the ward mentor has emerged as the key to student nurses' learning in the United Kingdom. A literature study of new leadership roles and their influence on student nurse learning (restricted to the United Kingdom) which includes an analysis of ten qualitative interviews with stakeholders in higher education in the United Kingdom undertaken as part of the literature study. Learning in clinical placements is led by practice teaching roles such as mentors, clinical practice facilitators and practice educators rather than new leadership roles. However, workforce changes in clinical placements has restricted the opportunities for trained nurses to role model caring activities for student nurses and university based lecturers are increasingly distant from clinical practice. Leadership for learning in clinical practice poses three unresolved questions for nurse managers, practitioners and educators - what is nursing, what should student nurses learn and from whom? Leadership for student nurse learning has passed to new learning and teaching roles with Trusts and away from nursing managers. This has implications for workforce planning and role modelling within the profession.

Improving accuracy of clinical coding in surgery: collaboration is key.

PubMed

Heywood, Nick A; Gill, Michael D; Charlwood, Natasha; Brindle, Rachel; Kirwan, Cliona C

2016-08-01

Clinical coding data provide the basis for Hospital Episode Statistics and Healthcare Resource Group codes. High accuracy of this information is required for payment by results, allocation of health and research resources, and public health data and planning. We sought to identify the level of accuracy of clinical coding in general surgical admissions across hospitals in the Northwest of England. Clinical coding departments identified a total of 208 emergency general surgical patients discharged between 1st March and 15th August 2013 from seven hospital trusts (median = 20, range = 16-60). Blinded re-coding was performed by a senior clinical coder and clinician, with results compared with the original coding outcome. Recorded codes were generated from OPCS-4 & ICD-10. Of all cases, 194 of 208 (93.3%) had at least one coding error and 9 of 208 (4.3%) had errors in both primary diagnosis and primary procedure. Errors were found in 64 of 208 (30.8%) of primary diagnoses and 30 of 137 (21.9%) of primary procedure codes. Median tariff using original codes was £1411.50 (range, £409-9138). Re-calculation using updated clinical codes showed a median tariff of £1387.50, P = 0.997 (range, £406-10,102). The most frequent reasons for incorrect coding were "coder error" and a requirement for "clinical interpretation of notes". Errors in clinical coding are multifactorial and have significant impact on primary diagnosis, potentially affecting the accuracy of Hospital Episode Statistics data and in turn the allocation of health care resources and public health planning. As we move toward surgeon specific outcomes, surgeons should increase collaboration with coding departments to ensure the system is robust. Copyright © 2016 Elsevier Inc. All rights reserved.

Antiobesity Effects of Anthocyanins in Preclinical and Clinical Studies

PubMed Central

Giacometti, Jasminka

2017-01-01

The natural phytochemicals present in foods, including anthocyanins, might play a role in attenuating obesity by producing a decrease in weight and adipose tissue. This review focused on current knowledge about anthocyanins' role in obesity and its related comorbidities reported in animal models and humans. We summarized their target identification and mechanism of action through several pathways and their final effects on health and well-being. Into consideration of ongoing researches, we highlighted the following key points: a healthy relationship between anthocyanin supplementation and antiobesity effects suffers of the same pros and cons evidenced when the beneficial responses to other phytochemical treatments towards different degenerative diseases have been considered; the different dosage applied in animal versus clinical studies; the complex metabolism and biotransformation to which anthocyanins and phytochemicals are subjected in the intestine and tissues; the possibility that different components present in the supplemented mixtures can interact generating antagonistic, synergistic, or additive effects difficult to predict, and the difference between prevention and therapy. The evolution of the field must seriously consider the need to establish new and adequate cellular and animal models which may, in turn, allow the design of more efficient and prevention-targeted clinical studies. PMID:28785373

Antiobesity Effects of Anthocyanins in Preclinical and Clinical Studies.

PubMed

Azzini, Elena; Giacometti, Jasminka; Russo, Gian Luigi

2017-01-01

The natural phytochemicals present in foods, including anthocyanins, might play a role in attenuating obesity by producing a decrease in weight and adipose tissue. This review focused on current knowledge about anthocyanins' role in obesity and its related comorbidities reported in animal models and humans. We summarized their target identification and mechanism of action through several pathways and their final effects on health and well-being. Into consideration of ongoing researches, we highlighted the following key points: a healthy relationship between anthocyanin supplementation and antiobesity effects suffers of the same pros and cons evidenced when the beneficial responses to other phytochemical treatments towards different degenerative diseases have been considered; the different dosage applied in animal versus clinical studies; the complex metabolism and biotransformation to which anthocyanins and phytochemicals are subjected in the intestine and tissues; the possibility that different components present in the supplemented mixtures can interact generating antagonistic, synergistic, or additive effects difficult to predict, and the difference between prevention and therapy. The evolution of the field must seriously consider the need to establish new and adequate cellular and animal models which may, in turn, allow the design of more efficient and prevention-targeted clinical studies.

A transcultural study of Jordanian nursing students' care encounters within the context of clinical education.

PubMed

Nahas, V

2000-06-01

Clinical education is an integral part of nursing education. Clinical teachers are the vital link in this teaching-learning process. The quality and quantity of student-teacher interactions in the clinical area can either facilitate or hinder students' learning. This paper presents a part of a larger study that discovered, described, explained and compared Australian and Jordanian nursing students' caring and non-caring encounters with their clinical teachers within the context of clinical education. The study was guided by Leininger's theory of culture care universality and diversity and Leininger's ethnonursing research method was utilised. The informants consisted of 12 key informants and 35 general informants. Three major themes emerged from the analysis of the data: (1) clinical teacher's caring behaviours; (2) student-teacher caring encounters; and (3) caring encounter consequences. Under these themes, care constructs emerged which gave light to the Jordanian nursing students' care meanings, expressions and values within their cultural environment, social structures and world view. The overall findings revealed that Jordanian nursing students found their clinical experiences as beneficial when their encounters with the clinical teacher were conducted through mothering, translating, sustaining, negotiating and transforming processes.

Motives for participating in a clinical research trial: a pilot study in Brazil.

PubMed

Nappo, Solange A; Iafrate, Giovanna B; Sanchez, Zila M

2013-01-10

In the past, clinical study participants have suffered from the experiments that they were subjected to. Study subjects may not understand the study process or may participate in clinical studies because they do not have access to medical care. The objectives of the present study were 1. to analyze the motives that might cause a volunteer to participate as a study subject; 2. to identify the social-demographic profile of this study subjects; and 3. to determine whether the motives to volunteer as a study subject are in accordance with the established legal and ethical principles for research in Brazil. Mixed-methods research was used (a qualitative-quantitative approach). A sample of 80 volunteers underwent a semi-structured interview, which was based on a survey script that was elaborated from discussions with key informants. The sample was randomly selected from a database of clinical study volunteers that was provided by Brazilian clinical study centers. The interviews were recorded and transcribed. Descriptive statistics were used for content analysis, including contingency tables with hypothesis testing. The motivations for clinical study participation were linked to types of benefit. The most frequently encountered motivations were financial gain and therapeutic alternative. Altruism was not a common motivator, and when altruism was present, it was observed as a secondary motivator. All participants reported that they understood the Informed Consent Statement (ICS). However, only two parts of the form were remembered by all of the volunteers: the section on being able to leave the study at any point and the section that stated that there would be some responsible professional at their disposal for the entirety of the study. The present study shows that study participants are primarily motivated by personal benefit when volunteering to participate in clinical studies. Whether these study participants had an integral understanding of the ICS is not clear.

Simple Web-based interactive key development software (WEBiKEY) and an example key for Kuruna (Poaceae: Bambusoideae)1

PubMed Central

Attigala, Lakshmi; De Silva, Nuwan I.; Clark, Lynn G.

2016-01-01

Premise of the study: Programs that are user-friendly and freely available for developing Web-based interactive keys are scarce and most of the well-structured applications are relatively expensive. WEBiKEY was developed to enable researchers to easily develop their own Web-based interactive keys with fewer resources. Methods and Results: A Web-based multiaccess identification tool (WEBiKEY) was developed that uses freely available Microsoft ASP.NET technologies and an SQL Server database for Windows-based hosting environments. WEBiKEY was tested for its usability with a sample data set, the temperate woody bamboo genus Kuruna (Poaceae). Conclusions: WEBiKEY is freely available to the public and can be used to develop Web-based interactive keys for any group of species. The interactive key we developed for Kuruna using WEBiKEY enables users to visually inspect characteristics of Kuruna and identify an unknown specimen as one of seven possible species in the genus. PMID:27144109

Schizoaffective disorder diagnosed according to different diagnostic criteria--systematic literature search and meta-analysis of key clinical characteristics and heterogeneity.

PubMed

Pagel, Tobias; Franklin, Jeremy; Baethge, Christopher

2014-03-01

Schizoaffective disorder is viewed as a heterogeneous diagnosis among psychotic illnesses. Different diagnostic systems differ in their definition with DSM (-IIIR, -IV, and -V) providing a narrower definition than RDC and ICD-10. It is unclear whether this difference is reflected in patient samples diagnosed according to different diagnostic systems. Exploratory study based on a systematic review of studies of schizoaffective disorder samples diagnosed by either RDC and ICD-10 (group of "broad criteria") or DSM-IIIR and -IV ("narrow criteria"); comparison (by Mann-Whitney-U-tests) of key characteristics, such as age, number of hospitalizations, or scores in psychometric tests, between more broadly and more narrowly defined schizoaffective disorder samples using standard deviations as a measurement of heterogeneity as well as weighted means and percentages. To reduce selection bias only studies including schizoaffective patient samples together with affective disorder and schizophrenia samples were selected. 55 studies were included, 14 employing RDC, 4 ICD-10, 20 DSM-IIIR, and 17 DSM-IV. Thirteen characteristics were compared: patients diagnosed according to broader criteria had fewer previous hospitalizations (2.2 vs. 5.4) and were both less often male (42 vs. 51%) and married (21 vs. 40%). Heterogeneity was similar in both groups but slightly higher in RDC and ICD-10 samples than in DSM-IIIR and -IV-samples: +4% regarding demographic and clinical course data and +13% regarding psychometric tests (pooled SD). Secular trends and different designs may have confounded the results and limit generalizability. Some comparisons were underpowered. Differences in diagnostic criteria are reflected in key characteristics of samples. The association of larger heterogeneity with wider diagnostic criteria supports employing standard deviations as a measurement of heterogeneity. Copyright © 2013 Elsevier B.V. All rights reserved.

Key performance indicators to benchmark hospital information systems - a delphi study.

PubMed

Hübner-Bloder, G; Ammenwerth, E

2009-01-01

To identify the key performance indicators for hospital information systems (HIS) that can be used for HIS benchmarking. A Delphi survey with one qualitative and two quantitative rounds. Forty-four HIS experts from health care IT practice and academia participated in all three rounds. Seventy-seven performance indicators were identified and organized into eight categories: technical quality, software quality, architecture and interface quality, IT vendor quality, IT support and IT department quality, workflow support quality, IT outcome quality, and IT costs. The highest ranked indicators are related to clinical workflow support and user satisfaction. Isolated technical indicators or cost indicators were not seen as useful. The experts favored an interdisciplinary group of all the stakeholders, led by hospital management, to conduct the HIS benchmarking. They proposed benchmarking activities both in regular (annual) intervals as well as at defined events (for example after IT introduction). Most of the experts stated that in their institutions no HIS benchmarking activities are being performed at the moment. In the context of IT governance, IT benchmarking is gaining importance in the healthcare area. The found indicators reflect the view of health care IT professionals and researchers. Research is needed to further validate and operationalize key performance indicators, to provide an IT benchmarking framework, and to provide open repositories for a comparison of the HIS benchmarks of different hospitals.

Clinical Laboratory Automation: A Case Study

PubMed Central

Archetti, Claudia; Montanelli, Alessandro; Finazzi, Dario; Caimi, Luigi; Garrafa, Emirena

2017-01-01

Background This paper presents a case study of an automated clinical laboratory in a large urban academic teaching hospital in the North of Italy, the Spedali Civili in Brescia, where four laboratories were merged in a unique laboratory through the introduction of laboratory automation. Materials and Methods The analysis compares the preautomation situation and the new setting from a cost perspective, by considering direct and indirect costs. It also presents an analysis of the turnaround time (TAT). The study considers equipment, staff and indirect costs. Results The introduction of automation led to a slight increase in equipment costs which is highly compensated by a remarkable decrease in staff costs. Consequently, total costs decreased by 12.55%. The analysis of the TAT shows an improvement of nonemergency exams while emergency exams are still validated within the maximum time imposed by the hospital. Conclusions The strategy adopted by the management, which was based on re-using the available equipment and staff when merging the pre-existing laboratories, has reached its goal: introducing automation while minimizing the costs. Significance for public health Automation is an emerging trend in modern clinical laboratories with a positive impact on service level to patients and on staff safety as shown by different studies. In fact, it allows process standardization which, in turn, decreases the frequency of outliers and errors. In addition, it induces faster processing times, thus improving the service level. On the other side, automation decreases the staff exposition to accidents strongly improving staff safety. In this study, we analyse a further potential benefit of automation, that is economic convenience. We study the case of the automated laboratory of one of the biggest hospital in Italy and compare the cost related to the pre and post automation situation. Introducing automation lead to a cost decrease without affecting the service level to patients

Influence of occlusal loading on peri-implant clinical parameters. A pilot study

PubMed Central

Pellicer-Chover, Hilario; Viña-Almunia, José; Romero-Millán, Javier; Peñarrocha-Oltra, David; Peñarrocha-Diago, María

2014-01-01

Objectives: To investigate the relation between occlusal loading and peri-implant clinical parameters (probing depth, bleeding on probing, gingival retraction, width of keratinized mucosa, and crevicular fluid volume) in patients with implant-supported complete fixed prostheses in both arches. Material and Methods: This clinical study took place at the University of Valencia (Spain) dental clinic. It included patients attending the clinic for regular check-ups during at least 12 months after rehabilitation of both arches with implant-supported complete fixed ceramo-metallic prostheses. One study implant and one control implant were established for each patient using the T-Scan®III computerized system (Tesco, South Boston, USA). The maxillary implant closest to the point of maximum occlusal loading was taken as the study implant and the farthest (with least loading) as the control. Occlusal forces were registered with the T-Scan® III and then occlusal adjustment was performed to distribute occlusal forces correctly. Peri-implant clinical parameters were analyzed in both implants before and two and twelve months after occlusal adjustment. Results: Before occlusal adjustment, study group implants presented a higher mean volume of crevicular fluid (51.3±7.4 UP) than the control group (25.8±5.5 UP), with statistically significant difference. Two months after occlusal adjustment, there were no significant differences between groups (24.6±3.8 UP and 26±4.5 UP respectively) (p=0.977). After twelve months, no significant differences were found between groups (24.4±11.1 UP and 22.5±8.9 UP respectively) (p=0.323). For the other clinical parameters, no significant differences were identified between study and control implants at any of the study times (p>0.05). Conclusions: Study group implants receiving higher occlusal loading presented significantly higher volumes of crevicular fluid than control implants. Crevicular fluid volumes were similar in both groups two and

Key features of an EU health information system: a concept mapping study.

PubMed

Rosenkötter, Nicole; Achterberg, Peter W; van Bon-Martens, Marja J H; Michelsen, Kai; van Oers, Hans A M; Brand, Helmut

2016-02-01

Despite the acknowledged value of an EU health information system (EU-HISys) and the many achievements in this field, the landscape is still heavily fragmented and incomplete. Through a systematic analysis of the opinions and valuations of public health stakeholders, this study aims to conceptualize key features of an EU-HISys. Public health professionals and policymakers were invited to participate in a concept mapping procedure. First, participants (N = 34) formulated statements that reflected their vision of an EU-HISys. Second, participants (N = 28) rated the relative importance of each statement and grouped conceptually similar ones. Principal Component and cluster analyses were used to condense these results to EU-HISys key features in a concept map. The number of key features and the labelling of the concept map were determined by expert consensus. The concept map contains 10 key features that summarize 93 statements. The map consists of a horizontal axis that represents the relevance of an 'organizational strategy', which deals with the 'efforts' to design and develop an EU-HISys and the 'achievements' gained by a functioning EU-HISys. The vertical axis represents the 'professional orientation' of the EU-HISys, ranging from the 'scientific' through to the 'policy' perspective. The top ranking statement expressed the need to establish a system that is permanent and sustainable. The top ranking key feature focuses on data and information quality. This study provides insights into key features of an EU-HISys. The results can be used to guide future planning and to support the development of a health information system for Europe. © The Author 2015. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.

Building a semantic web-based metadata repository for facilitating detailed clinical modeling in cancer genome studies.

PubMed

Sharma, Deepak K; Solbrig, Harold R; Tao, Cui; Weng, Chunhua; Chute, Christopher G; Jiang, Guoqian

2017-06-05

Detailed Clinical Models (DCMs) have been regarded as the basis for retaining computable meaning when data are exchanged between heterogeneous computer systems. To better support clinical cancer data capturing and reporting, there is an emerging need to develop informatics solutions for standards-based clinical models in cancer study domains. The objective of the study is to develop and evaluate a cancer genome study metadata management system that serves as a key infrastructure in supporting clinical information modeling in cancer genome study domains. We leveraged a Semantic Web-based metadata repository enhanced with both ISO11179 metadata standard and Clinical Information Modeling Initiative (CIMI) Reference Model. We used the common data elements (CDEs) defined in The Cancer Genome Atlas (TCGA) data dictionary, and extracted the metadata of the CDEs using the NCI Cancer Data Standards Repository (caDSR) CDE dataset rendered in the Resource Description Framework (RDF). The ITEM/ITEM_GROUP pattern defined in the latest CIMI Reference Model is used to represent reusable model elements (mini-Archetypes). We produced a metadata repository with 38 clinical cancer genome study domains, comprising a rich collection of mini-Archetype pattern instances. We performed a case study of the domain "clinical pharmaceutical" in the TCGA data dictionary and demonstrated enriched data elements in the metadata repository are very useful in support of building detailed clinical models. Our informatics approach leveraging Semantic Web technologies provides an effective way to build a CIMI-compliant metadata repository that would facilitate the detailed clinical modeling to support use cases beyond TCGA in clinical cancer study domains.

BCR-ABL1 Compound Mutations Combining Key Kinase Domain Positions Confer Clinical Resistance to Ponatinib in Ph Chromosome-Positive Leukemia

PubMed Central

Zabriskie, Matthew S.; Eide, Christopher A.; Tantravahi, Srinivas K.; Vellore, Nadeem A.; Estrada, Johanna; Nicolini, Franck E.; Khoury, Hanna J.; Larson, Richard A.; Konopleva, Marina; Cortes, Jorge E.; Kantarjian, Hagop; Jabbour, Elias J.; Kornblau, Steven M.; Lipton, Jeffrey H.; Rea, Delphine; Stenke, Leif; Barbany, Gisela; Lange, Thoralf; Hernández-Boluda, Juan-Carlos; Ossenkoppele, Gert J.; Press, Richard D.; Chuah, Charles; Goldberg, Stuart L.; Wetzler, Meir; Mahon, Francois-Xavier; Etienne, Gabriel; Baccarani, Michele; Soverini, Simona; Rosti, Gianantonio; Rousselot, Philippe; Friedman, Ran; Deininger, Marie; Reynolds, Kimberly R.; Heaton, William L.; Eiring, Anna M.; Pomicter, Anthony D.; Khorashad, Jamshid S.; Kelley, Todd W.; Baron, Riccardo; Druker, Brian J.; Deininger, Michael W.; O'Hare, Thomas

2014-01-01

Summary Ponatinib is the only currently approved tyrosine kinase inhibitor (TKI) that suppresses all BCR-ABL1 single mutants in Philadelphia chromosome-positive (Ph+) leukemia, including the recalcitrant BCR-ABL1T315I mutant. However, emergence of compound mutations in a BCR-ABL1 allele may confer ponatinib resistance. We found that clinically reported BCR-ABL1 compound mutants center on 12 key positions and confer varying resistance to imatinib, nilotinib, dasatinib, ponatinib, rebastinib and bosutinib. T315I-inclusive compound mutants confer high-level resistance to TKIs, including ponatinib. In vitro resistance profiling was predictive of treatment outcomes in Ph+ leukemia patients. Structural explanations for compound mutation-based resistance were obtained through molecular dynamics simulations. Our findings demonstrate that BCR-ABL1 compound mutants confer different levels of TKI resistance, necessitating rational treatment selection to optimize clinical outcome. PMID:25132497

Challenges in the clinical education of the nursing profession in Iran: A qualitative study.

PubMed

Jasemi, Madineh; Whitehead, Bill; Habibzadeh, Hosein; Zabihi, Roghaieh Esmaeili; Rezaie, Soheila Ahangarzadeh

2018-04-21

Clinical education is an important part of nurse training. It provides students with the opportunity to gain useful experience and has a key role in their professional preparation. The importance of clinical education in nursing students' professional performance means that identifying the challenges in this field is crucial. The goal of this study is to identify challenges in the field of clinical nurse education. A qualitative content analysis study. A faculty of Nursing and Midwifery, in Iran 2017. Nine student nurses, three qualified nurses and two nursing educators. This study has been applied to various depths of interpretation. Semi-structured interviews were used to collect the data. Nine student nurses, three qualified nurses and two nursing educators were interviewed. The analysis of the interviews generated five categories. Two main themes were extracted as challenges in the clinical training of nursing professionals: 1. Inefficient educational structure and 2. Inefficient professional performance environment. Considering the inadequate professional performance environment and defective educational structure, designing and delivering lessons with clear goals is essential. Using objective and measurable scales for evaluating educational standards, the use of empowered instructors with high communicational skills is useful for increasing students' motivation and interest toward clinical education and solving existing challenges. Copyright © 2018 Elsevier Ltd. All rights reserved.

Clinical Research Informatics: Supporting the Research Study Lifecycle.

PubMed

Johnson, S B

2017-08-01

Objectives: The primary goal of this review is to summarize significant developments in the field of Clinical Research Informatics (CRI) over the years 2015-2016. The secondary goal is to contribute to a deeper understanding of CRI as a field, through the development of a strategy for searching and classifying CRI publications. Methods: A search strategy was developed to query the PubMed database, using medical subject headings to both select and exclude articles, and filtering publications by date and other characteristics. A manual review classified publications using stages in the "research study lifecycle", with key stages that include study definition, participant enrollment, data management, data analysis, and results dissemination. Results: The search strategy generated 510 publications. The manual classification identified 125 publications as relevant to CRI, which were classified into seven different stages of the research lifecycle, and one additional class that pertained to multiple stages, referring to general infrastructure or standards. Important cross-cutting themes included new applications of electronic media (Internet, social media, mobile devices), standardization of data and procedures, and increased automation through the use of data mining and big data methods. Conclusions: The review revealed increased interest and support for CRI in large-scale projects across institutions, regionally, nationally, and internationally. A search strategy based on medical subject headings can find many relevant papers, but a large number of non-relevant papers need to be detected using text words which pertain to closely related fields such as computational statistics and clinical informatics. The research lifecycle was useful as a classification scheme by highlighting the relevance to the users of clinical research informatics solutions. Georg Thieme Verlag KG Stuttgart.

ANALYSIS OF METEOROLOGICAL CONDITIONS DURING THE 1977 ANCLOTE KEYS PLUME STUDY

EPA Science Inventory

Meteorological conditions are described and analyzed for nine experimental observation periods of the Anclote Keys Plume Study, which was conducted near Tampa, Florida during February 1977. The primary objective of the Plume Study was to investigate both the short and long range ...

Clinical application of ICF key codes to evaluate patients with dysphagia following stroke

PubMed Central

Dong, Yi; Zhang, Chang-Jie; Shi, Jie; Deng, Jinggui; Lan, Chun-Na

2016-01-01

Abstract This study was aimed to identify and evaluate the International Classification of Functioning (ICF) key codes for dysphagia in stroke patients. Thirty patients with dysphagia after stroke were enrolled in our study. To evaluate the ICF dysphagia scale, 6 scales were used as comparisons, namely the Barthel Index (BI), Repetitive Saliva Swallowing Test (RSST), Kubota Water Swallowing Test (KWST), Frenchay Dysarthria Assessment, Mini-Mental State Examination (MMSE), and the Montreal Cognitive Assessment (MoCA). Multiple regression analysis was performed to quantitate the relationship between the ICF scale and the other 7 scales. In addition, 60 ICF scales were analyzed by the least absolute shrinkage and selection operator (LASSO) method. A total of 21 ICF codes were identified, which were closely related with the other scales. These included 13 codes from Body Function, 1 from Body Structure, 3 from Activities and Participation, and 4 from Environmental Factors. A topographic network map with 30 ICF key codes was also generated to visualize their relationships. The number of ICF codes identified is in line with other well-established evaluation methods. The network topographic map generated here could be used as an instruction tool in future evaluations. We also found that attention functions and biting were critical codes of these scales, and could be used as treatment targets. PMID:27661012

Interpreting magnesium status to enhance clinical care: key indicators.

PubMed

Costello, Rebecca B; Nielsen, Forrest

2017-11-01

To update advances in identifying factors affecting magnesium (Mg) status that assist in providing improved evidence-based clinical decision-making for assessing Mg status. Findings from recent cohort studies, small randomized control trials, and multiple meta-analyses reinforce earlier work that serum Mg concentrations, urinary Mg excretion, and Mg dietary intakes are inversely associated with cardiovascular disease, chronic kidney disease, and diabetes. These studies indicate that the reference range for serum Mg needs updating, and that individuals with serum Mg in the range of 0.75-0.85 mmol/l and displaying changes in other factors associated with a low Mg status may be Mg deficient. Individuals with serum Mg concentrations below this range most likely are Mg deficient and, above this range, are most likely Mg sufficient. The combined determination of serum Mg concentration, 24-h urinary Mg excretion, and dietary Mg intake is currently the most practical method to obtain a sound assessment of Mg status. The strong correlations of Mg deficiency with increased risk of several chronic diseases, some of which exist as comorbidities, indicate that Mg status should be ascertained in patients presenting such disorder.

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

PubMed

Jessee, Mary Ann

2018-01-01

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

Clinical and Economic Evaluation of Repository Corticotropin Injection: A Narrative Literature Review of Treatment Efficacy and Healthcare Resource Utilization for Seven Key Indications.

PubMed

Philbin, Michael; Niewoehner, John; Wan, George J

2017-08-01

Repository corticotropin injection (RCI; H.P. Acthar ® Gel; Mallinckrodt Pharmaceuticals Inc., Hampton, NJ) is a highly purified, prolonged-release porcine preparation of adrenocorticotropic hormone (ACTH) analogue that is FDA-approved for treatment of 19 autoimmune and inflammatory disorders. The diverse physiological actions of RCI at the melanocortin receptors (MCRs) affect processes involved in inflammation, pigmentation, steroidogenesis, and immunomodulation. Although RCI has been approved to treat inflammatory and autoimmune diseases for more than 60 years, recent progress in understanding both MCRs and the effects of RCI in modulating immune responses has led to increased interest in RCI as a therapeutic choice. The objective of this narrative literature review is to summarize key clinical and economic data on RCI treatment of seven disorders: infantile spasms (IS), multiple sclerosis (MS) relapses, proteinuria in nephrotic syndrome, rheumatoid arthritis (RA), dermatomyositis/polymyositis (DM/PM), systemic lupus erythematosus (SLE), and symptomatic sarcoidosis based on published literature and product information. An extended report is available as the Academy of Managed Care Pharmacy (AMCP) Formulary dossier for H.P. Acthar ® Gel. Key studies of clinical efficacy and healthcare utilization and cost from 1956 to 2016 are summarized. The evidence supports the efficacy of RCI across the seven indications. RCI is effective as a first-line therapy for IS. For the other six conditions, RCI may improve clinical outcomes during exacerbations or when the condition is resistant to conventional treatments. Use of RCI is associated with reduced use of biologics, corticosteroids, and disease-modifying antirheumatic drugs. Initiation of RCI therapy in patients with IS, MS, RA, SLE, or DM/PM has been associated with lower post-therapy healthcare utilization and medical costs, including decreases in hospitalizations, hospital length of stay, outpatient visits, and

Communicating Herschel Key Programs in Solar System Studies to the Public

NASA Astrophysics Data System (ADS)

Rengel, M.; Hartogh, P.; Müller, T.

2011-10-01

The Herschel Space Observatory, one of the cornerstone missions of the European Space Agency (ESA) with participation from NASA, is delivering a wealth of far-infrared and sub-millimeter observations of the cold Universe. A considerable part of the observing time for the nominal three year mission lifetime has been awarded in the form of Key Programs. Between the 42 key programs (guaranteed and open times), only two key programs are dedicated to study the Solar System: "Water and Related Chemistry in the Solar System", also known as Herschel Solar System Observations (HssO) project [1], and "TNOs are Cool: A Survey of the Transneptunian Region" [2]. In the framework of these Programs, a serie of public outreach activities and efforts of its results are being carried out. We present some of the outreach strategies developed (e.g. press releases, web pages, logos, public lectures, exhibitions, interviews, reports, etc.) and some plans in this direction. Our activities introduce people to knowledge and beauty of solar system research and wider the opportunities for the public to become more involved in topics like solar system studies, specially in the times of frequent exo-planet discoveries.

A study on design and development of enterprise-wide concepts for clinical documentation templates.

PubMed

Zhou, Li; Gurjar, Rupali; Regier, Rachel; Morgan, Stephen; Meyer, Theresa; Aroy, Teal; Goldman, Debora Scavone; Hongsermeier, Tonya; Middleton, Blackford

2008-11-06

Structured clinical documents are associated with many potential benefits. Underlying terminologies and structure of information are keys to their successful implementation and use. This paper presents a methodology for design and development of enterprise-wide concepts for clinical documentation templates for an ambulatory Electronic Medical Record (EMR) system.

Practical considerations for estimating clinical trial accrual periods: application to a multi-center effectiveness study

PubMed Central

Carter, Rickey E; Sonne, Susan C; Brady, Kathleen T

2005-01-01

Background Adequate participant recruitment is vital to the conduct of a clinical trial. Projected recruitment rates are often over-estimated, and the time to recruit the target population (accrual period) is often under-estimated. Methods This report illustrates three approaches to estimating the accrual period and applies the methods to a multi-center, randomized, placebo controlled trial undergoing development. Results Incorporating known sources of accrual variation can yield a more justified estimate of the accrual period. Simulation studies can be incorporated into a clinical trial's planning phase to provide estimates for key accrual summaries including the mean and standard deviation of the accrual period. Conclusion The accrual period of a clinical trial should be carefully considered, and the allocation of sufficient time for participant recruitment is a fundamental aspect of planning a clinical trial. PMID:15796782

Key performance indicators score (KPIs-score) based on clinical and laboratorial parameters can establish benchmarks for internal quality control in an ART program.

PubMed

Franco, José G; Petersen, Claudia G; Mauri, Ana L; Vagnini, Laura D; Renzi, Adriana; Petersen, Bruna; Mattila, M C; Comar, Vanessa A; Ricci, Juliana; Dieamant, Felipe; Oliveira, João Batista A; Baruffi, Ricardo L R

2017-06-01

KPIs have been employed for internal quality control (IQC) in ART. However, clinical KPIs (C-KPIs) such as age, AMH and number of oocytes collected are never added to laboratory KPIs (L-KPIs), such as fertilization rate and morphological quality of the embryos for analysis, even though the final endpoint is the evaluation of clinical pregnancy rates. This paper analyzed if a KPIs-score strategy with clinical and laboratorial parameters could be used to establish benchmarks for IQC in ART cycles. In this prospective cohort study, 280 patients (36.4±4.3years) underwent ART. The total KPIs-score was obtained by the analysis of age, AMH (AMH Gen II ELISA/pre-mixing modified, Beckman Coulter Inc.), number of metaphase-II oocytes, fertilization rates and morphological quality of the embryonic lot. The total KPIs-score (C-KPIs+L-KPIs) was correlated with the presence or absence of clinical pregnancy. The relationship between the C-KPIs and L-KPIs scores was analyzed to establish quality standards, to increase the performance of clinical and laboratorial processes in ART. The logistic regression model (LRM), with respect to pregnancy and total KPIs-score (280 patients/102 clinical pregnancies), yielded an odds ratio of 1.24 (95%CI = 1.16-1.32). There was also a significant difference (p<0.0001) with respect to the total KPIs-score mean value between the group of patients with clinical pregnancies (total KPIs-score=20.4±3.7) and the group without clinical pregnancies (total KPIs-score=15.9±5). Clinical pregnancy probabilities (CPP) can be obtained using the LRM (prediction key) with the total KPIs-score as a predictor variable. The mean C-KPIs and L-KPIs scores obtained in the pregnancy group were 11.9±2.9 and 8.5±1.7, respectively. Routinely, in all cases where the C-KPIs score was ≥9, after the procedure, the L-KPIs score obtained was ≤6, a revision of the laboratory procedure was performed to assess quality standards. This total KPIs-score could set up

BCR-ABL1 compound mutations combining key kinase domain positions confer clinical resistance to ponatinib in Ph chromosome-positive leukemia.

PubMed

Zabriskie, Matthew S; Eide, Christopher A; Tantravahi, Srinivas K; Vellore, Nadeem A; Estrada, Johanna; Nicolini, Franck E; Khoury, Hanna J; Larson, Richard A; Konopleva, Marina; Cortes, Jorge E; Kantarjian, Hagop; Jabbour, Elias J; Kornblau, Steven M; Lipton, Jeffrey H; Rea, Delphine; Stenke, Leif; Barbany, Gisela; Lange, Thoralf; Hernández-Boluda, Juan-Carlos; Ossenkoppele, Gert J; Press, Richard D; Chuah, Charles; Goldberg, Stuart L; Wetzler, Meir; Mahon, Francois-Xavier; Etienne, Gabriel; Baccarani, Michele; Soverini, Simona; Rosti, Gianantonio; Rousselot, Philippe; Friedman, Ran; Deininger, Marie; Reynolds, Kimberly R; Heaton, William L; Eiring, Anna M; Pomicter, Anthony D; Khorashad, Jamshid S; Kelley, Todd W; Baron, Riccardo; Druker, Brian J; Deininger, Michael W; O'Hare, Thomas

2014-09-08

Ponatinib is the only currently approved tyrosine kinase inhibitor (TKI) that suppresses all BCR-ABL1 single mutants in Philadelphia chromosome-positive (Ph(+)) leukemia, including the recalcitrant BCR-ABL1(T315I) mutant. However, emergence of compound mutations in a BCR-ABL1 allele may confer ponatinib resistance. We found that clinically reported BCR-ABL1 compound mutants center on 12 key positions and confer varying resistance to imatinib, nilotinib, dasatinib, ponatinib, rebastinib, and bosutinib. T315I-inclusive compound mutants confer high-level resistance to TKIs, including ponatinib. In vitro resistance profiling was predictive of treatment outcomes in Ph(+) leukemia patients. Structural explanations for compound mutation-based resistance were obtained through molecular dynamics simulations. Our findings demonstrate that BCR-ABL1 compound mutants confer different levels of TKI resistance, necessitating rational treatment selection to optimize clinical outcome. Copyright © 2014 Elsevier Inc. All rights reserved.

Association between maternal comorbidity and preterm birth by severity and clinical subtype: retrospective cohort study

PubMed Central

2011-01-01

Background Preterm birth (PTB) is a major cause of infant morbidity and mortality, but the relationship between comorbidity and PTB by clinical subtype and severity of gestational age remains poorly understood. We evaluated associations between maternal comorbidities and PTB by clinical subtype and gestational age. Methods We conducted a retrospective cohort study of 1,329,737 singleton births delivered in hospitals in the province of Québec, Canada, 1989-2006. PTB was classified by clinical subtype (medically indicated, preterm premature rupture of membranes (PPROM), spontaneous preterm labour) and gestational age (< 28, 28-31, 32-36 completed weeks). Odds ratios (OR) of PTB by clinical subtype for systemic and localized maternal comorbidities were estimated using polytomous logistic regression, adjusting for maternal age, grand multiparity, and period. Attributable fractions were calculated. Results PTB rates were higher among mothers with comorbidity (10.9%) compared to those without comorbidity (4.7%). Several comorbidities were associated with greater odds of medically indicated PTB compared with no comorbidity, but only comorbidities localized to the reproductive system were associated with spontaneous PTB. Drug dependence and mental disorders were strongly associated with PPROM and spontaneous PTBs across all gestational ages (OR > 2.0). At the population level, several major comorbidities (placental abruption, chorioamnionitis, oliogohydramnios, structural abnormality, cervical incompetence) were key contributors to all clinical subtypes of PTB, especially at < 32 weeks. Major systemic comorbidities (preeclampsia, anemia) were key contributors to PPROM and medically indicated PTBs. Conclusions The relationship between comorbidity and clinical subtypes of PTB depends on gestational age. Prevention of PPROM and spontaneous PTB may benefit from greater attention to preeclampsia, anemia and comorbidities localized to the reproductive system. PMID:21970736

Association between maternal comorbidity and preterm birth by severity and clinical subtype: retrospective cohort study.

PubMed

Auger, Nathalie; Le, Thi Uyen Nhi; Park, Alison L; Luo, Zhong-Cheng

2011-10-04

Preterm birth (PTB) is a major cause of infant morbidity and mortality, but the relationship between comorbidity and PTB by clinical subtype and severity of gestational age remains poorly understood. We evaluated associations between maternal comorbidities and PTB by clinical subtype and gestational age. We conducted a retrospective cohort study of 1,329,737 singleton births delivered in hospitals in the province of Québec, Canada, 1989-2006. PTB was classified by clinical subtype (medically indicated, preterm premature rupture of membranes (PPROM), spontaneous preterm labour) and gestational age (< 28, 28-31, 32-36 completed weeks). Odds ratios (OR) of PTB by clinical subtype for systemic and localized maternal comorbidities were estimated using polytomous logistic regression, adjusting for maternal age, grand multiparity, and period. Attributable fractions were calculated. PTB rates were higher among mothers with comorbidity (10.9%) compared to those without comorbidity (4.7%). Several comorbidities were associated with greater odds of medically indicated PTB compared with no comorbidity, but only comorbidities localized to the reproductive system were associated with spontaneous PTB. Drug dependence and mental disorders were strongly associated with PPROM and spontaneous PTBs across all gestational ages (OR > 2.0). At the population level, several major comorbidities (placental abruption, chorioamnionitis, oliogohydramnios, structural abnormality, cervical incompetence) were key contributors to all clinical subtypes of PTB, especially at < 32 weeks. Major systemic comorbidities (preeclampsia, anemia) were key contributors to PPROM and medically indicated PTBs. The relationship between comorbidity and clinical subtypes of PTB depends on gestational age. Prevention of PPROM and spontaneous PTB may benefit from greater attention to preeclampsia, anemia and comorbidities localized to the reproductive system.

Pharmacists' Perceptions of the Barriers and Facilitators to the Implementation of Clinical Pharmacy Key Performance Indicators

PubMed Central

Minard, Laura V; Deal, Heidi; Harrison, Megan E; Toombs, Kent; Neville, Heather; Meade, Andrea

2016-01-01

Background In hospitals around the world, there has been no consensus regarding which clinical activities a pharmacist should focus on until recently. In 2011, a Canadian clinical pharmacy key performance indicator (cpKPI) collaborative was formed. The goal of the collaborative was to advance pharmacy practice in order to improve patient outcomes and enhance the quality of care provided to patients by hospital pharmacists. Following a literature review, which indicated that pharmacists can improve patient outcomes by carrying out specific activities, and an evidence-informed consensus process, a final set of eight cpKPIs were established. Canadian hospitals leading the cpKPI initiative are currently in the early stages of implementing these indicators. Objective To explore pharmacists' perceptions of the barriers and facilitators to the implementation of cpKPIs. Methods Clinical pharmacists employed by the Nova Scotia Health Authority were invited to participate in focus groups. Focus group discussions were audio-recorded and transcribed, and data was analyzed using thematic analysis. Findings Three focus groups, including 26 pharmacists, were conducted in February 2015. Three major themes were identified. Resisting the change was comprised of documentation challenges, increased workload, practice environment constraints, and competing priorities. Embracing cpKPIs was composed of seeing the benefit, demonstrating value, and existing supports. Navigating the unknown was made up of quality versus quantity battle, and insights into the future. Conclusions Although pharmacists were challenged by documentation and other changes associated with the implementation of cpKPIs, they demonstrated significant support for cpKPIs and were able to see benefits of the implementation. Pharmacists came up with suggestions for overcoming resistance associated with the implementation of cpKPIs and provided insights into the future of pharmacy practice. The identification of barriers

Pharmacists' Perceptions of the Barriers and Facilitators to the Implementation of Clinical Pharmacy Key Performance Indicators.

PubMed

Minard, Laura V; Deal, Heidi; Harrison, Megan E; Toombs, Kent; Neville, Heather; Meade, Andrea

2016-01-01

In hospitals around the world, there has been no consensus regarding which clinical activities a pharmacist should focus on until recently. In 2011, a Canadian clinical pharmacy key performance indicator (cpKPI) collaborative was formed. The goal of the collaborative was to advance pharmacy practice in order to improve patient outcomes and enhance the quality of care provided to patients by hospital pharmacists. Following a literature review, which indicated that pharmacists can improve patient outcomes by carrying out specific activities, and an evidence-informed consensus process, a final set of eight cpKPIs were established. Canadian hospitals leading the cpKPI initiative are currently in the early stages of implementing these indicators. To explore pharmacists' perceptions of the barriers and facilitators to the implementation of cpKPIs. Clinical pharmacists employed by the Nova Scotia Health Authority were invited to participate in focus groups. Focus group discussions were audio-recorded and transcribed, and data was analyzed using thematic analysis. Three focus groups, including 26 pharmacists, were conducted in February 2015. Three major themes were identified. Resisting the change was comprised of documentation challenges, increased workload, practice environment constraints, and competing priorities. Embracing cpKPIs was composed of seeing the benefit, demonstrating value, and existing supports. Navigating the unknown was made up of quality versus quantity battle, and insights into the future. Although pharmacists were challenged by documentation and other changes associated with the implementation of cpKPIs, they demonstrated significant support for cpKPIs and were able to see benefits of the implementation. Pharmacists came up with suggestions for overcoming resistance associated with the implementation of cpKPIs and provided insights into the future of pharmacy practice. The identification of barriers and facilitators to cpKPI implementation will be

Governance for clinical decision support: case studies and recommended practices from leading institutions

PubMed Central

Sittig, Dean F; Ash, Joan S; Bates, David W; Feblowitz, Joshua; Fraser, Greg; Maviglia, Saverio M; McMullen, Carmit; Nichol, W Paul; Pang, Justine E; Starmer, Jack; Middleton, Blackford

2011-01-01

Objective Clinical decision support (CDS) is a powerful tool for improving healthcare quality and ensuring patient safety; however, effective implementation of CDS requires effective clinical and technical governance structures. The authors sought to determine the range and variety of these governance structures and identify a set of recommended practices through observational study. Design Three site visits were conducted at institutions across the USA to learn about CDS capabilities and processes from clinical, technical, and organizational perspectives. Based on the results of these visits, written questionnaires were sent to the three institutions visited and two additional sites. Together, these five organizations encompass a variety of academic and community hospitals as well as small and large ambulatory practices. These organizations use both commercially available and internally developed clinical information systems. Measurements Characteristics of clinical information systems and CDS systems used at each site as well as governance structures and content management approaches were identified through extensive field interviews and follow-up surveys. Results Six recommended practices were identified in the area of governance, and four were identified in the area of content management. Key similarities and differences between the organizations studied were also highlighted. Conclusion Each of the five sites studied contributed to the recommended practices presented in this paper for CDS governance. Since these strategies appear to be useful at a diverse range of institutions, they should be considered by any future implementers of decision support. PMID:21252052

Evaluating laboratory key performance using quality indicators in Alexandria University Hospital Clinical Chemistry Laboratories.

PubMed

Rizk, Mostafa M; Zaki, Adel; Hossam, Nermine; Aboul-Ela, Yasmin

2014-12-01

The performance of clinical laboratories plays a fundamental role in the quality and effectiveness of healthcare. To evaluate the laboratory performance in Alexandria University Hospital Clinical Laboratories using key quality indicators and to compare the performance before and after an improvement plan based on ISO 15189 standards. The study was carried out on inpatient samples for a period of 7 months that was divided into three phases: phase I included data collection for evaluation of the existing process before improvement (March-May 2012); an intermediate phase, which included corrective, preventive action, quality initiative and steps for improvement (June 2012); and phase II, which included data collection for evaluation of the process after improvement (July 2012-September 2012). In terms of the preanalytical indicators, incomplete request forms in phase I showed that the total number of received requests were 31 944, with a percentage of defected request of 33.66%; whereas in phase II, there was a significant reduction in all defected request items (P<0.001) with a percentage of defected requests of 9.64%. As for the analytical indicators, the proficiency testing accuracy score in phase I showed poor performance of 10 analytes in which total error (TE) exceeded total error allowable (TEa), with a corresponding sigma value of less than 3, which indicates test problems and an unreliable method. The remaining analytes showed an acceptable performance in which TE did not exceed the TEa, with a sigma value of more than 6. Following an intervention of 3 months, the performance showed marked improvement. Error tracking in phase I showed a TE of (5.11%), whereas in phase II it was reduced to 2.48% (P<0.001).For the postanalytical indicators, our results in phase I showed that the percentage of nonreported critical results was 26.07%. In phase II, there was a significant improvement (P<0.001). The percentage of nonreported results was 11.37%, the reasons were

Implementation of clinical governance in hospitals: challenges and the keys for success.

PubMed

Mousavi, Seyed Mohammad Hadi; Agharahimi, Zahra; Daryabeigi, Maede; Rezaei, Nima

2014-01-01

There is a number of models and strategies for improving the quality of care such as total quality management, continuous quality improvement and clinical governance. The policy of clinical governance is part of the governments overall strategy for monitoring, assuring and improving in the national health services organization. Clinical governance has been introduced as a bridge between managerial and clinical approaches to quality. For successful implementing of clinical governance, it is necessary to pay attention to firm foundations of the structure, including equipment, staffing arrangement, supporting specialties, and staff training. Therefore, as clinical governance improves safety and quality in health care services, the current situation in hospitals should be evaluated before any intervention while barriers and blocks on structure and process should be determined to select a method for changing them. Considering these points could guarantee success in implementation of clinical governance; otherwise there would be a little chance to achieve the desired results despite consumption of plenty of time and huge paper works.

Patient engagement in clinical communication: an exploratory study.

PubMed

Chaboyer, Wendy; McMurray, Anne; Marshall, Andrea; Gillespie, Brigid; Roberts, Shelley; Hutchinson, Alison M; Botti, Mari; McTier, Lauren; Rawson, Helen; Bucknall, Tracey

2016-09-01

Existing practice strategies for actively involving patients in care during hospitalisation are poorly understood. The aim of this study was to explore how healthcare professionals engaged patients in communication associated with care transitions. An instrumental, collective case study approach was used to generate empirical data about patient transitions in care. A purposive sample of key stakeholders representing (i) patients and their families; (ii) hospital discharge planning team members; and (iii) healthcare professionals was recruited in five Australian health services. Individual and group semi-structured interviews were conducted to elicit detailed explanations of patient engagement in transition planning. Interviews lasted between 30 and 60 minutes and were digitally recorded and transcribed verbatim. Data collection and analysis were conducted simultaneously and continued until saturation was achieved. Thematic analysis was undertaken. Five themes emerged as follows: (i) organisational commitment to patient engagement; (ii) the influence of hierarchical culture and professional norms on patient engagement; (iii) condoning individual healthcare professionals' orientations and actions; (iv) understanding and negotiating patient preferences; and (v) enacting information sharing and communication strategies. Most themes illustrated how patient engagement was enabled; however, barriers also existed. Our findings show that strong organisational and professional commitment to patient-centred care throughout the organisation was a consistent feature of health services that actively engaged patients in clinical communication. Understanding patients' needs and preferences and having both formal and informal strategies to engage patients in clinical communication were important in how this involvement occurred. © 2016 Nordic College of Caring Science.

Pediatric clinical drug trials in low-income countries: key ethical issues.

PubMed

MacLeod, S M; Knoppert, D C; Stanton-Jean, M; Avard, D

2015-02-01

Potential child participants in clinical research trials in low-income countries are often vulnerable because of poverty, high morbidity and mortality, inadequate education, and varied local cultural norms. However, vulnerability by itself must not be accepted as an obstacle blocking children from the health benefits that may accrue as an outcome of sound clinical research. As greater emphasis is placed on evidence-based treatment of children, it should be anticipated that there will be a growing call for agreement on principles to guide clinical investigations in low-income countries. There is now general acceptance of the view that children must be protected from non-evidence-based interventions and from substandard treatments. The questions remaining relate to how best to stimulate clinical research activity that will serve the needs of infants, children, and youth in developing countries and how best to assign priority to ethically sound research that will meet their clinical requirements. In low-income countries, 39 % of citizens are 13 years of age or younger, and consequently it is certain that clinical investigations of some new therapeutic products will be conducted there more frequently. This review offers some suggestions for approaches that will help to achieve more effective ethical consideration, including (1) improving the quality of research ethics boards; (2) fostering collaborative partnerships among important stakeholders; (3) making concerted efforts to build capacity; (4) improving the quality of the consent and waiver process; and (5) developing improved governance for harmonized ethics platforms. Continuing support by international organizations is required to sustain the establishment and maintenance of stronger research ethics boards to protect children enrolled in clinical trials. This review underscores the importance of developing a culture of solidarity and true partnership between developed and low-income country organizations, which

Thioredoxin: a key regulator of cardiovascular homeostasis.

PubMed

Yamawaki, Hideyuki; Haendeler, Judith; Berk, Bradford C

2003-11-28

The thioredoxin (TRX) system (TRX, TRX reductase, and NADPH) is a ubiquitous thiol oxidoreductase system that regulates cellular reduction/oxidation (redox) status. The oxidation mechanism for disease pathogenesis states that an imbalance in cell redox state alters function of multiple cell pathways. In this study, we review the essential role for TRX to limit oxidative stress directly via antioxidant effects and indirectly by protein-protein interaction with key signaling molecules, such as apoptosis signal-regulating kinase 1. We propose that TRX and its endogenous regulators are important future targets to develop clinical therapies for cardiovascular disorders associated with oxidative stress.

Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the design and operation of multi-center clinical trials: a qualitative research study.

PubMed

Eisenstein, Eric L; Diener, Lawrence W; Nahm, Meredith; Weinfurt, Kevin P

2011-12-01

New technologies may be required to integrate the National Institutes of Health's Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies.

Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the Design and Operation of Multi-center Clinical Trials: a Qualitative Research Study

PubMed Central

Diener, Lawrence W.; Nahm, Meredith; Weinfurt, Kevin P.

2013-01-01

New technologies may be required to integrate the National Institutes of Health’s Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies. PMID:20703765

Finite key analysis for symmetric attacks in quantum key distribution

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

Meyer, Tim; Kampermann, Hermann; Kleinmann, Matthias

2006-10-15

We introduce a constructive method to calculate the achievable secret key rate for a generic class of quantum key distribution protocols, when only a finite number n of signals is given. Our approach is applicable to all scenarios in which the quantum state shared by Alice and Bob is known. In particular, we consider the six state protocol with symmetric eavesdropping attacks, and show that for a small number of signals, i.e., below n{approx}10{sup 4}, the finite key rate differs significantly from the asymptotic value for n{yields}{infinity}. However, for larger n, a good approximation of the asymptotic value is found.more » We also study secret key rates for protocols using higher-dimensional quantum systems.« less

Social Studies Assessment Program: Grade 10 [and] Manual and Scoring Key.

ERIC Educational Resources Information Center

Manitoba Dept. of Education and Training, Winnipeg. Curriculum Development and Implementation Branch.

Designed to assess the success of social studies instruction for students in grade 10 in Manitoba, Canada, this test evaluation instrument contains a manual, a scoring key, and a test. Administered to determine whether students learned important ideas and skills in social studies instruction, the results of the testing will be used to improve…

Anticancer Activity of Curcumin and Its Analogues: Preclinical and Clinical Studies.

PubMed

Allegra, Alessandro; Innao, Vanessa; Russo, Sabina; Gerace, Demetrio; Alonci, Andrea; Musolino, Caterina

2017-01-02

Curcumin has been shown to have a wide variety of therapeutic effects, ranging from anti-inflammatory, chemopreventive, anti-proliferative, and anti-metastatic. This review provides an overview of the recent research conducted to overcome the problems with the bioavailability of curcumin, and of the preclinical and clinical studies that have reported success in combinatorial strategies coupling curcumin with other treatments. Research on the signaling pathways that curcumin treatment targets shows that it potently acts on major intracellular components involved in key processes such as genomic modulations, cell invasion and cell death pathways. Curcumin is a promising molecule for the prevention and treatment of cancer.

Language Learning at Key Stage 2: Findings from a Longitudinal Study

ERIC Educational Resources Information Center

Cable, Carrie; Driscoll, Patricia; Mitchell, Rosamond; Sing, Sue; Cremin, Teresa; Earl, Justine; Eyres, Ian; Holmes, Bernardette; Martin, Cynthia; Heins, Barbara

2012-01-01

This paper discusses some of the findings from a 3-year longitudinal study of language learning in the upper stage of English primary schools, i.e. at Key Stage 2. This largely qualitative study (commissioned by the then Department for Children, Schools and Families) was designed to explore and document developing provision and practice in a…

Review of key concepts in magnetic resonance physics.

PubMed

Moore, Michael M; Chung, Taylor

2017-05-01

MR physics can be a challenging subject for practicing pediatric radiologists. Although many excellent texts provide very comprehensive reviews of the field of MR physics at various levels of understanding, the authors of this paper explain several key concepts in MR physics that are germane to clinical practice in a non-rigorous but practical fashion. With the basic understanding of these key concepts, practicing pediatric radiologists can build on their knowledge of current clinical MR techniques and future advances in MR applications. Given the challenges of both the increased need for rapid imaging in non-sedated children and the rapid physiological cardiovascular and respiratory motion in pediatric patients, many advances in complex MR techniques are being applied to imaging these children. The key concepts are as follows: (1) structure of a pulse sequence, (2) k-space, (3) "trade-off triangle" and (4) fat suppression. This review is the first of five manuscripts in a minisymposium on pediatric MR. The authors' goal for this review is to aid in understanding the MR techniques described in the subsequent manuscripts on brain imaging and body imaging in this minisymposium.

Comparative study of key exchange and authentication methods in application, transport and network level security mechanisms

NASA Astrophysics Data System (ADS)

Fathirad, Iraj; Devlin, John; Jiang, Frank

2012-09-01

The key-exchange and authentication are two crucial elements of any network security mechanism. IPsec, SSL/TLS, PGP and S/MIME are well-known security approaches in providing security service to network, transport and application layers; these protocols use different methods (based on their requirements) to establish keying materials and authenticates key-negotiation and participated parties. This paper studies and compares the authenticated key negotiation methods in mentioned protocols.

Doctors' experience with handheld computers in clinical practice: qualitative study.

PubMed

McAlearney, Ann Scheck; Schweikhart, Sharon B; Medow, Mitchell A

2004-05-15

To examine doctors' perspectives about their experiences with handheld computers in clinical practice. Qualitative study of eight focus groups consisting of doctors with diverse training and practice patterns. Six practice settings across the United States and two additional focus group sessions held at a national meeting of general internists. 54 doctors who did or did not use handheld computers. Doctors who used handheld computers in clinical practice seemed generally satisfied with them and reported diverse patterns of use. Users perceived that the devices helped them increase productivity and improve patient care. Barriers to use concerned the device itself and personal and perceptual constraints, with perceptual factors such as comfort with technology, preference for paper, and the impression that the devices are not easy to use somewhat difficult to overcome. Participants suggested that organisations can help promote handheld computers by providing advice on purchase, usage, training, and user support. Participants expressed concern about reliability and security of the device but were particularly concerned about dependency on the device and over-reliance as a substitute for clinical thinking. Doctors expect handheld computers to become more useful, and most seem interested in leveraging (getting the most value from) their use. Key opportunities with handheld computers included their use as a stepping stone to build doctors' comfort with other information technology and ehealth initiatives and providing point of care support that helps improve patient care.

Strategies to design clinical studies to identify predictive biomarkers in cancer research.

PubMed

Perez-Gracia, Jose Luis; Sanmamed, Miguel F; Bosch, Ana; Patiño-Garcia, Ana; Schalper, Kurt A; Segura, Victor; Bellmunt, Joaquim; Tabernero, Josep; Sweeney, Christopher J; Choueiri, Toni K; Martín, Miguel; Fusco, Juan Pablo; Rodriguez-Ruiz, Maria Esperanza; Calvo, Alfonso; Prior, Celia; Paz-Ares, Luis; Pio, Ruben; Gonzalez-Billalabeitia, Enrique; Gonzalez Hernandez, Alvaro; Páez, David; Piulats, Jose María; Gurpide, Alfonso; Andueza, Mapi; de Velasco, Guillermo; Pazo, Roberto; Grande, Enrique; Nicolas, Pilar; Abad-Santos, Francisco; Garcia-Donas, Jesus; Castellano, Daniel; Pajares, María J; Suarez, Cristina; Colomer, Ramon; Montuenga, Luis M; Melero, Ignacio

2017-02-01

The discovery of reliable biomarkers to predict efficacy and toxicity of anticancer drugs remains one of the key challenges in cancer research. Despite its relevance, no efficient study designs to identify promising candidate biomarkers have been established. This has led to the proliferation of a myriad of exploratory studies using dissimilar strategies, most of which fail to identify any promising targets and are seldom validated. The lack of a proper methodology also determines that many anti-cancer drugs are developed below their potential, due to failure to identify predictive biomarkers. While some drugs will be systematically administered to many patients who will not benefit from them, leading to unnecessary toxicities and costs, others will never reach registration due to our inability to identify the specific patient population in which they are active. Despite these drawbacks, a limited number of outstanding predictive biomarkers have been successfully identified and validated, and have changed the standard practice of oncology. In this manuscript, a multidisciplinary panel reviews how those key biomarkers were identified and, based on those experiences, proposes a methodological framework-the DESIGN guidelines-to standardize the clinical design of biomarker identification studies and to develop future research in this pivotal field. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Doctors' use of mobile devices in the clinical setting: a mixed methods study.

PubMed

Nerminathan, Arany; Harrison, Amanda; Phelps, Megan; Alexander, Shirley; Scott, Karen M

2017-03-01

Mobile device use has become almost ubiquitous in daily life and therefore includes use by doctors in clinical settings. There has been little study as to the patterns of use and impact this has on doctors in the workplace and how negatively or positively it impacts at the point of care. To explore how doctors use mobile devices in the clinical setting and understand drivers for use. A mixed methods study was used with doctors in a paediatric and adult teaching hospital in 2013. A paper-based survey examined mobile device usage data by doctors in the clinical setting. Focus groups explored doctors' reasons for using or refraining from using mobile devices in the clinical setting, and their attitudes about others' use. The survey, completed by 109 doctors, showed that 91% owned a smartphone and 88% used their mobile devices frequently in the clinical setting. Trainees were more likely than consultants to use their mobile devices for learning and accessing information related to patient care, as well as for personal communication unrelated to work. Focus group data highlighted a range of factors that influenced doctors to use personal mobile devices in the clinical setting, including convenience for medical photography, and factors that limited use. Distraction in the clinical setting due to use of mobile devices was a key issue. Personal experience and confidence in using mobile devices affected their use, and was guided by role modelling and expectations within a medical team. Doctors use mobile devices to enhance efficiency in the workplace. In the current environment, doctors are making their own decisions based on balancing the risks and benefits of using mobile devices in the clinical setting. There is a need for guidelines around acceptable and ethical use that is patient-centred and that respects patient privacy. © 2016 Royal Australasian College of Physicians.

Posttraumatic stress disorder and physical illness: results from clinical and epidemiologic studies.

PubMed

Boscarino, Joseph A

2004-12-01

Research indicates that exposure to traumatic stressors and psychological trauma is widespread. The association of such exposures with posttraumatic stress disorder (PTSD) and other mental health conditions is well known. However, epidemiologic research increasingly suggests that exposure to these events is related to increased health care utilization, adverse health outcomes, the onset of specific diseases, and premature death. To date, studies have linked traumatic stress exposures and PTSD to such conditions as cardiovascular disease, diabetes, gastrointestinal disease, fibromyalgia, chronic fatigue syndrome, musculoskeletal disorders, and other diseases. Evidence linking cardiovascular disease and exposure to psychological trauma is particularly strong and has been found consistently across different populations and stressor events. In addition, clinical studies have suggested the biological pathways through which stressor-induced diseases may be pathologically expressed. In particular, recent studies have implicated the hypothalamic-pituitary-adrenal (HPA) and the sympathetic-adrenal-medullary (SAM) stress axes as key in this pathogenic process, although genetic and behavioral/psychological risk factors cannot be ruled out. Recent findings, indicating that victims of PTSD have higher circulating T-cell lymphocytes and lower cortisol levels, are intriguing and suggest that chronic sufferers of PTSD may be at risk for autoimmune diseases. To test this hypothesis, we assessed the association between chronic PTSD in a national sample of 2,490 Vietnam veterans and the prevalence of common autoimmune diseases, including rheumatoid arthritis, psoriasis, insulin-dependent diabetes, and thyroid disease. Our analyses suggest that chronic PTSD, particularly comorbid PTSD or complex PTSD, is associated with all of these conditions. In addition, veterans with comorbid PTSD were more likely to have clinically higher T-cell counts, hyperreactive immune responses on

The experience of adolescents participating in a randomised clinical trial in the field of mental health: a qualitative study.

PubMed

Midgley, Nick; Isaacs, Danny; Weitkamp, Katharina; Target, Mary

2016-07-28

This descriptive study aimed to investigate adolescents' motivations for participating in a randomised controlled trial (RCT), to explore the understanding that the young people had regarding a number of aspects of the trial design, to examine whether or not they found participation in the trial to be acceptable and what affected this, and to identify whether and how the young people felt that their participation in the RCT impacted on their experience of therapy and on therapeutic change. Seventy-six adolescents who were taking part in a large-scale RCT to evaluate the clinical and cost effectiveness of psychological therapies for depression were interviewed at two time-points after completing therapy. The semi-structured interviews, which included a focus on the young people's experience of the research study, were analysed using framework analysis. The vast majority of adolescents found it acceptable to participate in the clinical trial, and many agreed to participate for reasons of 'conditional altruism'. However consent was often given without great understanding of the key elements of the trial, including the difference between treatment arms and the randomisation process. Although the adolescents were largely positive about their experiences from taking part, the study raises questions about whether clinical outcomes may be influenced by participation in the research elements of the trial. Although adolescents are under-represented in clinical trials, those who do participate are generally positive about the experience; however, careful thought needs to be given to key elements of the trial design and the potential impact of the research participation on clinical outcomes. ISRCTN registry, ISRCTN83033550 . Registered on 15 October 2009.

The ECAR Study of Undergraduate Students and Information Technology, 2010. Key Findings

ERIC Educational Resources Information Center

Smith, Shannon D.; Caruso, Judith Borreson

2010-01-01

This document presents the key findings from "The ECAR Study of Undergraduate Students and Information Technology, 2010". Since 2004, the annual ECAR (EDUCAUSE Center for Applied Research) study of undergraduate students and information technology has sought to shed light on how information technology affects the college experience. We…

Expanding syphilis testing: a scoping review of syphilis testing interventions among key populations.

PubMed

Ong, Jason J; Fu, Hongyun; Smith, M Kumi; Tucker, Joseph D

2018-05-01

Syphilis is an important sexually transmitted infection (STI). Despite inexpensive and effective treatment, few key populations receive syphilis testing. Innovative strategies are needed to increase syphilis testing among key populations. Areas covered: This scoping review focused on strategies to increase syphilis testing in key populations (men who have sex with men (MSM), sex workers, people who use drugs, transgender people, and incarcerated individuals). Expert commentary: We identified many promising syphilis testing strategies, particularly among MSM. These innovations are separated into diagnostic, clinic-based, and non-clinic based strategies. In terms of diagnostics, self-testing, dried blood spots, and point-of-care testing can decentralize syphilis testing. Effective syphilis self-testing pilots suggest the need for further attention and research. In terms of clinic-based strategies, modifying default clinical procedures can nudge physicians to more frequently recommend syphilis testing. In terms of non-clinic based strategies, venue-based screening (e.g. in correctional facilities, drug rehabilitation centres) and mobile testing units have been successfully implemented in a variety of settings. Integration of syphilis with HIV testing may facilitate implementation in settings where individuals have increased sexual risk. There is a strong need for further syphilis testing research and programs.

Invited review: study design considerations for clinical research in veterinary radiology and radiation oncology.

PubMed

Scrivani, Peter V; Erb, Hollis N

2013-01-01

High quality clinical research is essential for advancing knowledge in the areas of veterinary radiology and radiation oncology. Types of clinical research studies may include experimental studies, method-comparison studies, and patient-based studies. Experimental studies explore issues relative to pathophysiology, patient safety, and treatment efficacy. Method-comparison studies evaluate agreement between techniques or between observers. Patient-based studies investigate naturally acquired disease and focus on questions asked in clinical practice that relate to individuals or populations (e.g., risk, accuracy, or prognosis). Careful preplanning and study design are essential in order to achieve valid results. A key point to planning studies is ensuring that the design is tailored to the study objectives. Good design includes a comprehensive literature review, asking suitable questions, selecting the proper sample population, collecting the appropriate data, performing the correct statistical analyses, and drawing conclusions supported by the available evidence. Most study designs are classified by whether they are experimental or observational, longitudinal or cross-sectional, and prospective or retrospective. Additional features (e.g., controlled, randomized, or blinded) may be described that address bias. Two related challenging aspects of study design are defining an important research question and selecting an appropriate sample population. The sample population should represent the target population as much as possible. Furthermore, when comparing groups, it is important that the groups are as alike to each other as possible except for the variables of interest. Medical images are well suited for clinical research because imaging signs are categorical or numerical variables that might be predictors or outcomes of diseases or treatments. © 2013 Veterinary Radiology & Ultrasound.

Fibroblasts—a key host cell type in tumor initiation, progression, and metastasis

PubMed Central

Strell, Carina; Rundqvist, Helene

2012-01-01

Tumor initiation, growth, invasion, and metastasis occur as a consequence of a complex interplay between the host environment and cancer cells. Fibroblasts are now recognized as a key host cell type involved in host–cancer signaling. This review discusses some recent studies that highlight the roles of fibroblasts in tumor initiation, early progression, invasion, and metastasis. Some clinical studies describing the prognostic significance of fibroblast-derived markers and signatures are also discussed. PMID:22509805

Master's level education in Jordan: a qualitative study of key motivational factors and perceived impact on practice.

PubMed

Zahran, Zainab

2013-09-01

To explore key motivational factors of Jordanian nurses to undertake a Master's degree and explore perceived impact on practice. In Jordan, there are postgraduate educational programmes offering a Master's degree in clinical nursing for registered nurses. These programmes are intended to prepare nurses to practise at an advanced level as potential clinical nurse specialists. Little is known about the motivation of nurses to undertake such Master's degree preparation programmes and their perceived impact on practice. Using an ethnographic design, narratives from semi-structured interviews with participants (n=37) from five Jordanian hospitals and two public universities were collected and thematically analysed. Four main themes emerged from the data: self development; broadening career opportunities; developing practice; and the perceived impact of Master's level nurses on practice. The majority of Jordanian nurses chose to undertake a Master's degree because of a desire for self and practice development. The majority of participants referred to M-level nurses in terms of knowledge transfer, highlighting their clinical teaching and in-service education activities. M-level nurses were also associated with managerial and supervisory roles in clinical practice. Controversy over the impact of M-level nurses in enhancing patient care is not limited to the Jordanian setting. Future research needs to focus on comparative studies between nurses with M-level qualifications and experienced nurses without either M-level qualifications or specialist courses to establish if there is any significant relationship between practice performance and educational preparation and experience. Evaluation research could be undertaken for the purpose of developing measurable and observable criteria related to educational and skill based outcomes. Copyright © 2012 Elsevier Ltd. All rights reserved.

Healthcare professionals’ perceptions of clinical governance implementation: a qualitative New Zealand study of 3205 open-ended survey comments

PubMed Central

Gauld, Robin; Horsburgh, Simon

2015-01-01

Objectives To investigate healthcare professional perceptions of local implementation of a national clinical governance policy in New Zealand. Design Respondent comments written at the end of a national healthcare professional survey designed to assess implementation of core components of the clinical governance policy. Setting The written comments were provided by respondents to a survey distributed to over 41 000 registered healthcare professionals employed in 19 of New Zealand's government-funded District Health Boards. Comments were analysed and categorised within emerging themes. Results 3205 written comments were received. Five key themes illustrating barriers to clinical governance implementation were found, representing problems with: developing management–clinical relations; clinicians stepping up into clinical governance and leadership activities; interprofessional relations; training needs for governance and leadership; and having insufficient time to get involved. Conclusions Despite a national policy on clinical governance which New Zealand's government launched in 2009, this study found that considerable effort is required to build clinical governance at the local level. This finding parallels with other studies in the field. Two areas demand attention: building systems for organisational governance and leadership; and building professional governance arrangements. PMID:25564142

Stem Cell Therapies for Knee Cartilage Repair: The Current Status of Preclinical and Clinical Studies

PubMed Central

Anderson, John A.; Little, Dianne; Toth, Alison P.; Moorman, Claude T.; Tucker, Bradford S.; Ciccotti, Michael G.; Guilak, Farshid

2014-01-01

Background Articular cartilage damage of the knee is common, causing significant morbidity worldwide. Many adult tissues contain cells that are able to differentiate into multiple cell types, including chondrocytes. These stem cells have gained significant attention over the past decade and may become frontline management for cartilage defects in the very near future. Purpose The role of stem cells in the treatment of knee osteochondral defects was reviewed. Recent animal and clinical studies were reviewed to determine the benefits and potential outcomes of using stem cells for cartilage defects. Study Design Literature review. Methods A PubMed search was undertaken. The key phrase “stem cells and knee” was used. The search included reviews and original articles over an unlimited time period. From this search, articles outlining animal and clinical trials were selected. A search of current clinical trials in progress was performed on the clinicaltrials.gov website, and “stem cells and knee” was used as the search phrase. Results Stem cells have been used in many recent in vitro and animal studies. A number of cell-based approaches for cartilage repair have progressed from preclinical animal studies into clinical trials. Conclusion The use of stem cells for the treatment of cartilage defects is increasing in animal and clinical studies. Methods of delivery of stem cells to the knee’s cartilage vary from direct injection to implantation with scaffolds. While these approaches are highly promising, there is currently limited evidence of a direct clinical benefit, and further research is required to assess the overall outcome of stem cell therapies for knee cartilage repair. PMID:24220016

ClinicalTrials.gov, stem cells and 'pay-to-participate' clinical studies.

PubMed

Turner, Leigh

2017-09-01

Numerous US businesses that engage in direct-to-consumer advertising of stem cell interventions that are not US FDA-approved also recruit clients by listing 'pay-to-participate' studies listed on ClinicalTrials.gov . Individuals considering enrolling in such studies and NIH officials responsible for overseeing the database need to be aware that some businesses are using the registry to promote unapproved stem cell interventions that study subjects are charged to receive. Inclusion of such studies in ClinicalTrials.gov reveals that the database needs better screening tools. In particular, screening should evaluate whether studies submitted to the registry have been reviewed and permitted to proceed by the FDA in the case of clinical studies requiring FDA clearance in addition to institutional review board approval.

Paediatric International Nursing Study: using person-centred key performance indicators to benchmark children's services.

PubMed

McCance, Tanya; Wilson, Val; Kornman, Kelly

2016-07-01

The aim of the Paediatric International Nursing Study was to explore the utility of key performance indicators in developing person-centred practice across a range of services provided to sick children. The objective addressed in this paper was evaluating the use of these indicators to benchmark services internationally. This study builds on primary research, which produced indicators that were considered novel both in terms of their positive orientation and use in generating data that privileges the patient voice. This study extends this research through wider testing on an international platform within paediatrics. The overall methodological approach was a realistic evaluation used to evaluate the implementation of the key performance indicators, which combined an integrated development and evaluation methodology. The study involved children's wards/hospitals in Australia (six sites across three states) and Europe (seven sites across four countries). Qualitative and quantitative methods were used during the implementation process, however, this paper reports the quantitative data only, which used survey, observations and documentary review. The findings demonstrate the quality of care being delivered to children and their families across different international sites. The benchmarking does, however, highlight some differences between paediatric and general hospitals, and between the different key performance indicators across all the sites. The findings support the use of the key performance indicators as a novel method to benchmark services internationally. Whilst the data collected across 20 paediatric sites suggest services are more similar than different, benchmarking illuminates variations that encourage a critical dialogue about what works and why. The transferability of the key performance indicators and measurement framework across different settings has significant implications for practice. The findings offer an approach to benchmarking and celebrating

Key-value store with internal key-value storage interface

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

Bent, John M.; Faibish, Sorin; Ting, Dennis P. J.

A key-value store is provided having one or more key-value storage interfaces. A key-value store on at least one compute node comprises a memory for storing a plurality of key-value pairs; and an abstract storage interface comprising a software interface module that communicates with at least one persistent storage device providing a key-value interface for persistent storage of one or more of the plurality of key-value pairs, wherein the software interface module provides the one or more key-value pairs to the at least one persistent storage device in a key-value format. The abstract storage interface optionally processes one or moremore » batch operations on the plurality of key-value pairs. A distributed embodiment for a partitioned key-value store is also provided.« less

The Use of Intuition in Homeopathic Clinical Decision Making: An Interpretative Phenomenological Study

PubMed Central

Brien, Sarah; Dibb, Bridget; Burch, Alex

2011-01-01

While intuition plays a role in clinical decision making within conventional medicine, little is understood about its use in complementary and alternative medicine (CAM). The aim of this qualitative study was to investigate intuition from the perspective of homeopathic practitioners; its' manifestation, how it was recognized, its origins and when it was used within daily clinical practice. Semi-structured interviews were carried out with clinically experienced non-National Health Service (NHS) UK homeopathic practitioners. Interpretative phenomenological analysis was used to analyze the data. Homeopaths reported many similarities with conventional medical practitioner regarding the nature, perceived origin and manifestation of their intuitions in clinical practice. Intuition was used in two key aspects of the consultation: (i) to enhance the practitioner-patient relationship, these were generally trusted; and (ii) intuitions relating to the prescribing decision. Homeopaths were cautious about these latter intuitions, testing any intuitive thoughts through deductive reasoning before accepting them. Their reluctance is not surprising given the consequences for patient care, but we propose this also reflects homeopaths' sensitivity to the academic and medical mistrust of both homeopathy and intuition. This study is the first to explore the use of intuition in decision making in any form of complementary medicine. The similarities with conventional practitioners may provide confidence in validating intuition as a legitimate part of the decision making process for these specific practitioners. Further work is needed to elucidate if these findings reflect intuitive use in clinical practice of other CAM practitioners in both private and NHS (i.e., time limited) settings. PMID:19773389

Barriers and decisions when answering clinical questions at the point of care: a grounded theory study.

PubMed

Cook, David A; Sorensen, Kristi J; Wilkinson, John M; Berger, Richard A

2013-11-25

Answering clinical questions affects patient-care decisions and is important to continuous professional development. The process of point-of-care learning is incompletely understood. To understand what barriers and enabling factors influence physician point-of-care learning and what decisions physicians face during this process. Focus groups with grounded theory analysis. Focus group discussions were transcribed and then analyzed using a constant comparative approach to identify barriers, enabling factors, and key decisions related to physician information-seeking activities. Academic medical center and outlying community sites. Purposive sample of 50 primary care and subspecialist internal medicine and family medicine physicians, interviewed in 11 focus groups. Insufficient time was the main barrier to point-of-care learning. Other barriers included the patient comorbidities and contexts, the volume of available information, not knowing which resource to search, doubt that the search would yield an answer, difficulty remembering questions for later study, and inconvenient access to computers. Key decisions were whether to search (reasons to search included infrequently seen conditions, practice updates, complex questions, and patient education), when to search (before, during, or after the clinical encounter), where to search (with the patient present or in a separate room), what type of resource to use (colleague or computer), what specific resource to use (influenced first by efficiency and second by credibility), and when to stop. Participants noted that key features of efficiency (completeness, brevity, and searchability) are often in conflict. Physicians perceive that insufficient time is the greatest barrier to point-of-care learning, and efficiency is the most important determinant in selecting an information source. Designing knowledge resources and systems to target key decisions may improve learning and patient care.

Health Clinic Environments in Georgia Elementary Schools

ERIC Educational Resources Information Center

Simpson, Susan Rogers

2005-01-01

Schools seem to be the logical place to serve the health needs of students, since children spend a majority of their time there. Design standards were not available for health clinics in Georgia elementary schools; therefore, this study examined key characteristics of an elementary school clinic in order to determine the importance of each design…

Using clinical indicators to facilitate quality improvement via the accreditation process: an adaptive study into the control relationship.

PubMed

Chuang, Sheuwen; Howley, Peter P; Hancock, Stephen

2013-07-01

The aim of the study was to determine accreditation surveyors' and hospitals' use and perceived usefulness of clinical indicator reports and the potential to establish the control relationship between the accreditation and reporting systems. The control relationship refers to instructional directives, arising from appropriately designed methods and efforts towards using clinical indicators, which provide a directed moderating, balancing and best outcome for the connected systems. Web-based questionnaire survey. Australian Council on Healthcare Standards' (ACHS) accreditation and clinical indicator programmes. Seventy-three of 306 surveyors responded. Half used the reports always/most of the time. Five key messages were revealed: (i) report use was related to availability before on-site investigation; (ii) report use was associated with the use of non-ACHS reports; (iii) a clinical indicator set's perceived usefulness was associated with its reporting volume across hospitals; (iv) simpler measures and visual summaries in reports were rated the most useful; (v) reports were deemed to be suitable for the quality and safety objectives of the key groups of interested parties (hospitals' senior executive and management officers, clinicians, quality managers and surveyors). Implementing the control relationship between the reporting and accreditation systems is a promising expectation. Redesigning processes to ensure reports are available in pre-survey packages and refined education of surveyors and hospitals on how to better utilize the reports will support the relationship. Additional studies on the systems' theory-based model of the accreditation and reporting system are warranted to establish the control relationship, building integrated system-wide relationships with sustainable and improved outcomes.

Clinical risk management.

PubMed

Knowles, D

Managing clinical risk involves all staff with clinical and managerial responsibilities. This article draws attention to some key steps in risk management and ways to deal with the problems when things do go wrong.

Medicinal Mushrooms in Human Clinical Studies. Part I. Anticancer, Oncoimmunological, and Immunomodulatory Activities: A Review.

PubMed

Wasser, Solomon P

2017-01-01

More than 130 medicinal functions are thought to be produced by medicinal mushrooms (MMs) and fungi, including antitumor, immunomodulating, antioxidant, radical scavenging, cardiovascular, antihypercholesterolemic, antiviral, antibacterial, antiparasitic, antifungal, detoxification, hepatoprotective, antidiabetic, and other effects. Many, if not all, higher Basidiomycetes mushrooms contain biologically active compounds in fruit bodies, cultured mycelia, and cultured broth. Special attention has been paid to mushroom polysaccharides. Numerous bioactive polysaccharides or polysaccharide-protein complexes from MMs seem to enhance innate and cell-mediated immune responses, and they exhibit antitumor activities in animals and humans. While the mechanism of their antitumor actions is still not completely understood, stimulation and modulation of key host immune responses by these mushroom compounds seems to be central. Most important for modern medicine are polysaccharides and low-molecular weight secondary metabolites with antitumor and immunostimulating properties. More than 600 studies have been conducted worldwide, and numerous human clinical trials on MMs have been published. Several of the mushroom compounds have proceeded through phase I, II, and III clinical studies and are used extensively and successfully in Asia to treat various cancers and other diseases. The aim of this review is to provide an overview of and analyze the literature on clinical trials using MMs with human anticancer, oncoimmunological, and immunomodulatory activities. High-quality, long-term, randomized, double-blind, placebo-controlled clinical studies of MMs, including well-sized population studies are definitely needed in order to yield statistical power showing their efficacy and safety. Clinical trials must obtain sufficient data on the efficacy and safety of MM-derived drugs and preparations. Discussion of results based on clinical studies of the anticancer, oncoimmunological, and

Usability study of clinical exome analysis software: top lessons learned and recommendations.

PubMed

Shyr, Casper; Kushniruk, Andre; Wasserman, Wyeth W

2014-10-01

New DNA sequencing technologies have revolutionized the search for genetic disruptions. Targeted sequencing of all protein coding regions of the genome, called exome analysis, is actively used in research-oriented genetics clinics, with the transition to exomes as a standard procedure underway. This transition is challenging; identification of potentially causal mutation(s) amongst ∼10(6) variants requires specialized computation in combination with expert assessment. This study analyzes the usability of user interfaces for clinical exome analysis software. There are two study objectives: (1) To ascertain the key features of successful user interfaces for clinical exome analysis software based on the perspective of expert clinical geneticists, (2) To assess user-system interactions in order to reveal strengths and weaknesses of existing software, inform future design, and accelerate the clinical uptake of exome analysis. Surveys, interviews, and cognitive task analysis were performed for the assessment of two next-generation exome sequence analysis software packages. The subjects included ten clinical geneticists who interacted with the software packages using the "think aloud" method. Subjects' interactions with the software were recorded in their clinical office within an urban research and teaching hospital. All major user interface events (from the user interactions with the packages) were time-stamped and annotated with coding categories to identify usability issues in order to characterize desired features and deficiencies in the user experience. We detected 193 usability issues, the majority of which concern interface layout and navigation, and the resolution of reports. Our study highlights gaps in specific software features typical within exome analysis. The clinicians perform best when the flow of the system is structured into well-defined yet customizable layers for incorporation within the clinical workflow. The results highlight opportunities to

Key issues and challenges in developing a pedagogical intervention in the simulation skills center--an action research study.

PubMed

Reierson, Inger Åse; Hvidsten, Anne; Wighus, Marianne; Brungot, Solvor; Bjørk, Ida Torunn

2013-07-01

Simulation skills centers (SSC) are considered important learning arenas for preparing and qualifying nursing students. Limited clinical placements and claims of diminished learning opportunities raise concerns that newly educated nurses lack proficiency in many psychomotor skills. Accordingly, there is an increased focus on learning in the SSC. However, it has been questioned if the pedagogical underpinning of teaching and learning in the SSC is missing or unclear. At a bachelor nursing education in Norway, there was a desire to change practice and enhance learning in the SSC by systematic use of The Model of Practical Skill Performance (Bjørk and Kirkevold, 2000). A participatory action research design was chosen. A pedagogical intervention was developed and implemented in 2010 in a cohort of eighty-seven first year bachelor nursing students during their basic nursing skill course. The intervention is shortly described. This article reports key issues and challenges that emerged during development of the new intervention. Data to inform the study were collected via thorough meeting minutes and the project leader's logbook, and analyzed using fieldnotes analysis. Six key issues and challenges were identified. These are presented and discussed consecutively in light of their importance for development and implementation of the new intervention. Copyright © 2013 Elsevier Ltd. All rights reserved.

Clinical Relevance of Nontuberculous Mycobacteria Isolated from Sputum in a Gold Mining Workforce in South Africa: An Observational, Clinical Study.

PubMed

van Halsema, Clare L; Chihota, Violet N; Gey van Pittius, Nicolaas C; Fielding, Katherine L; Lewis, James J; van Helden, Paul D; Churchyard, Gavin J; Grant, Alison D

2015-01-01

The clinical relevance of nontuberculous mycobacteria (NTM), detected by liquid more than solid culture in sputum specimens from a South African mining workforce, is uncertain. We aimed to describe the current spectrum and relevance of NTM in this population. An observational study including individuals with sputum NTM isolates, recruited at workforce tuberculosis screening and routine clinics. Symptom questionnaires were administered at the time of sputum collection and clinical records and chest radiographs reviewed retrospectively. Of 232 individuals included (228 (98%) male, median age 44 years), M. gordonae (60 individuals), M. kansasii (50), and M. avium complex (MAC: 38) were the commonest species. Of 38 MAC isolates, only 2 (5.3%) were from smear-positive sputum specimens and 30/38 grew in liquid but not solid culture. MAC was especially prevalent among symptomatic, HIV-positive individuals. HIV prevalence was high: 57/74 (77%) among those tested. No differences were found in probability of death or medical separation by NTM species. M. gordonae, M. kansasii, and MAC were the commonest NTM among miners with suspected tuberculosis, with most MAC from smear-negative specimens in liquid culture only. HIV testing and identification of key pathogenic NTM in this setting are essential to ensure optimal treatment.

Clinical Relevance of Nontuberculous Mycobacteria Isolated from Sputum in a Gold Mining Workforce in South Africa: An Observational, Clinical Study

PubMed Central

van Halsema, Clare L.; Chihota, Violet N.; Gey van Pittius, Nicolaas C.; Fielding, Katherine L.; Lewis, James J.; van Helden, Paul D.; Churchyard, Gavin J.; Grant, Alison D.

2015-01-01

Background. The clinical relevance of nontuberculous mycobacteria (NTM), detected by liquid more than solid culture in sputum specimens from a South African mining workforce, is uncertain. We aimed to describe the current spectrum and relevance of NTM in this population. Methods. An observational study including individuals with sputum NTM isolates, recruited at workforce tuberculosis screening and routine clinics. Symptom questionnaires were administered at the time of sputum collection and clinical records and chest radiographs reviewed retrospectively. Results. Of 232 individuals included (228 (98%) male, median age 44 years), M. gordonae (60 individuals), M. kansasii (50), and M. avium complex (MAC: 38) were the commonest species. Of 38 MAC isolates, only 2 (5.3%) were from smear-positive sputum specimens and 30/38 grew in liquid but not solid culture. MAC was especially prevalent among symptomatic, HIV-positive individuals. HIV prevalence was high: 57/74 (77%) among those tested. No differences were found in probability of death or medical separation by NTM species. Conclusions. M. gordonae, M. kansasii, and MAC were the commonest NTM among miners with suspected tuberculosis, with most MAC from smear-negative specimens in liquid culture only. HIV testing and identification of key pathogenic NTM in this setting are essential to ensure optimal treatment. PMID:26180817

Conducting clinical post-conference in clinical teaching: a qualitative study.

PubMed

Hsu, Li-Ling

2007-08-01

The aim of this study was to explore nurse educators' perceptions regarding clinical postconferences. Additional aims included the exploration of interaction characteristics between students and faculty in clinical postconferences. Nursing students are challenged to think and learn in ways that will prepare them for practice in a complex health care environment. Clinical postconferences give students the opportunity to share knowledge gained through transformative learning and provide a forum for discussion and critical thinking. Faculty members must guide students as the latter participate in discussions, develop problem-solving skills and express feedings and attitudes in clinical conferences. The study used qualitative research methods, including participant observation and an open-ended questionnaire. Participant observers watched interaction activities between teachers and students in clinical postconferences. A total of 20 clinical postconferences, two conferences per teacher, were observed. The Non-Numerical Unstructured Data Indexing Searching and Theory-building qualitative software program was used in data analysis. Research findings indicated that, of the six taxonomy questions, lower-level questions (knowledge and comprehensive questions) were mostly asked by faculty members' postclinical conferences. The most frequently used guideline was task orientation, which is related to practice goals and was found in discussions of assignments, reading reports, discussions of clinical experiences, role plays, psychomotor skill practice, quizzes and student evaluations. It is an essential responsibility of nurse educators to employ postconferences to assist students in applying their knowledge in practical situations, in developing professional values and in enhancing their problem solving abilities.

How reliable are clinical systems in the UK NHS? A study of seven NHS organisations

PubMed Central

Franklin, Bryony Dean; Moorthy, Krishna; Cooke, Matthew W; Vincent, Charles

2012-01-01

Background It is well known that many healthcare systems have poor reliability; however, the size and pervasiveness of this problem and its impact has not been systematically established in the UK. The authors studied four clinical systems: clinical information in surgical outpatient clinics, prescribing for hospital inpatients, equipment in theatres, and insertion of peripheral intravenous lines. The aim was to describe the nature, extent and variation in reliability of these four systems in a sample of UK hospitals, and to explore the reasons for poor reliability. Methods Seven UK hospital organisations were involved; each system was studied in three of these. The authors took delivery of the systems' intended outputs to be a proxy for the reliability of the system as a whole. For example, for clinical information, 100% reliability was defined as all patients having an agreed list of clinical information available when needed during their appointment. Systems factors were explored using semi-structured interviews with key informants. Common themes across the systems were identified. Results Overall reliability was found to be between 81% and 87% for the systems studied, with significant variation between organisations for some systems: clinical information in outpatient clinics ranged from 73% to 96%; prescribing for hospital inpatients 82–88%; equipment availability in theatres 63–88%; and availability of equipment for insertion of peripheral intravenous lines 80–88%. One in five reliability failures were associated with perceived threats to patient safety. Common factors causing poor reliability included lack of feedback, lack of standardisation, and issues such as access to information out of working hours. Conclusions Reported reliability was low for the four systems studied, with some common factors behind each. However, this hides significant variation between organisations for some processes, suggesting that some organisations have managed to create

Florida Keys

NASA Image and Video Library

2002-12-13

The Florida Keys are a chain of islands, islets and reefs extending from Virginia Key to the Dry Tortugas for about 309 kilometers (192 miles). The keys are chiefly limestone and coral formations. The larger islands of the group are Key West (with its airport), Key Largo, Sugarloaf Key, and Boca Chica Key. A causeway extends from the mainland to Key West. This image was acquired on October 28, 2001, by the Advanced Spaceborne Thermal Emission and Reflection Radiometer (ASTER) on NASA's Terra satellite. With its 14 spectral bands from the visible to the thermal infrared wavelength region, and its high spatial resolution of 15 to 90 meters (about 50 to 300 feet), ASTER images Earth to map and monitor the changing surface of our planet. http://photojournal.jpl.nasa.gov/catalog/PIA03890

Doctors' experience with handheld computers in clinical practice: qualitative study

PubMed Central

McAlearney, Ann Scheck; Schweikhart, Sharon B; Medow, Mitchell A

2004-01-01

Objective To examine doctors' perspectives about their experiences with handheld computers in clinical practice. Design Qualitative study of eight focus groups consisting of doctors with diverse training and practice patterns. Setting Six practice settings across the United States and two additional focus group sessions held at a national meeting of general internists. Participants 54 doctors who did or did not use handheld computers. Results Doctors who used handheld computers in clinical practice seemed generally satisfied with them and reported diverse patterns of use. Users perceived that the devices helped them increase productivity and improve patient care. Barriers to use concerned the device itself and personal and perceptual constraints, with perceptual factors such as comfort with technology, preference for paper, and the impression that the devices are not easy to use somewhat difficult to overcome. Participants suggested that organisations can help promote handheld computers by providing advice on purchase, usage, training, and user support. Participants expressed concern about reliability and security of the device but were particularly concerned about dependency on the device and over-reliance as a substitute for clinical thinking. Conclusions Doctors expect handheld computers to become more useful, and most seem interested in leveraging (getting the most value from) their use. Key opportunities with handheld computers included their use as a stepping stone to build doctors' comfort with other information technology and ehealth initiatives and providing point of care support that helps improve patient care. PMID:15142920

Tracing the evolution of chiropractic students’ confidence in clinical and patient communication skills during a clinical internship: a multi-methods study

PubMed Central

2012-01-01

Background Anecdotal evidence points to variations in individual students’ evolving confidence in clinical and patient communication skills during a clinical internship. A better understanding of the specific aspects of internships that contribute to increasing or decreasing confidence is needed to best support students during the clinical component of their study. Methods A multi-method approach, combining two large-scale surveys with 269 students and three in-depth individual interviews with a sub-sample of 29 students, was used to investigate the evolution of change in student confidence during a 10-month long internship. Change in levels of confidence in patient communication and clinical skills was measured and relationship to demographic factors were explored. The interviews elicited students’ accounts and reflections on what affected the evolution of their confidence during the internship. Results At the start of their internship, students were more confident in their patient communication skills than their clinical skills but prior experience was significantly related to confidence in both. Initial confidence in patient communication skills was also related to age and prior qualification but not gender whilst confidence in clinical skills was related to gender but not age or prior qualification. These influences were maintained over time. Overall, students’ levels of confidence in patient communication and clinical skills confidence increased significantly over the duration of the internship with evidence that change over time in these two aspects were inter-related. To explore how specific aspects of the internship contributed to changing levels of confidence, two extreme sub-groups of interviewees were identified, those with the least increase and those with the highest increase in professional confidence over time. A number of key factors affecting the development of confidence were identified, including among others, interactions with clinicians

Tracing the evolution of chiropractic students' confidence in clinical and patient communication skills during a clinical internship: a multi-methods study.

PubMed

Hecimovich, Mark; Volet, Simone

2012-06-19

Anecdotal evidence points to variations in individual students' evolving confidence in clinical and patient communication skills during a clinical internship. A better understanding of the specific aspects of internships that contribute to increasing or decreasing confidence is needed to best support students during the clinical component of their study. A multi-method approach, combining two large-scale surveys with 269 students and three in-depth individual interviews with a sub-sample of 29 students, was used to investigate the evolution of change in student confidence during a 10-month long internship. Change in levels of confidence in patient communication and clinical skills was measured and relationship to demographic factors were explored. The interviews elicited students' accounts and reflections on what affected the evolution of their confidence during the internship. At the start of their internship, students were more confident in their patient communication skills than their clinical skills but prior experience was significantly related to confidence in both. Initial confidence in patient communication skills was also related to age and prior qualification but not gender whilst confidence in clinical skills was related to gender but not age or prior qualification. These influences were maintained over time. Overall, students' levels of confidence in patient communication and clinical skills confidence increased significantly over the duration of the internship with evidence that change over time in these two aspects were inter-related. To explore how specific aspects of the internship contributed to changing levels of confidence, two extreme sub-groups of interviewees were identified, those with the least increase and those with the highest increase in professional confidence over time. A number of key factors affecting the development of confidence were identified, including among others, interactions with clinicians and patients, personal agency and

Clinical Evidence in Guardianship of Older Adults Is Inadequate: Findings From a Tri-State Study

PubMed Central

Moye, Jennifer; Wood, Stacey; Edelstein, Barry; Armesto, Jorge C.; Bower, Emily H.; Harrison, Julie A.; Wood, Erica

2014-01-01

Purpose This preliminary study compared clinical evaluations for guardianship in three states with varying levels of statutory reform. Design and Methods Case files for 298 cases of adult guardianship were reviewed in Massachusetts, Pennsylvania, and Colorado, three states with varying degrees of statutory reform. The quality and content of the written clinical evidence for guardianship and the hearing outcome were recorded. Results The quality of the written clinical evidence for guardianship was best in Colorado, the state with the most progressive statutory reform, earning a grade of B in our ratings, and worst in Massachusetts, a state with minimal reform, earning a grade of D – with nearly two thirds of the written evidence illegible. Information on specific functional deficits was frequently missing and conclusory statements were common. Information about the individual’s key values and preferences was almost never provided, and individuals were rarely present at the hearing. Limited orders were used for 34% of the cases in Colorado, associated with more complete clinical testimony, but such orders were used in only 1 case in either Massachusetts or Pennsylvania. Implications In this study, states with progressive statutes that promote functional assessment are associated with increased quality of clinical testimony and use of limited orders. A continuing dialogue between clinical and legal professionals is needed to advance reform in guardianship, and thereby provide for the needs and protect the rights of adults who face guardianship proceedings. PMID:17989402

Clinical Needs Finding: Developing the Virtual Experience, A Case Study

PubMed Central

Mittal, Vaishali; Thompson, Megan; Altman, Stuart M; Taylor, Peter; Summers, Alexander; Goodwin, Kelsey; Louie, Angelique Y

2013-01-01

We describe an innovative program at the University of California, Davis for students to engage in clinical needs finding. Using a team-based approach, students participated in clinical rotations to observe firsthand the needs of clinicians at the university affiliated medical center. The teams were asked to develop documentary-style videos to capture key experiences that would allow future viewers to use the videos as “virtual” clinical rotations. This was conceived as a strategy to allow students in prohibitively large classes, or students in programs at institutions without associated medical or veterinary school programs, to experience clinical rotations and perform needs assessments. The students' perspectives on the experience as well as instructor analysis of best practices for this type of activity are presented and discussed. We found that the internship experience was valuable to the students participating, by not only introducing the practice of needs finding but for increasing the students' confidence in the practice of engineering design and their ability to work independently. The videos produced were of such high quality that instructors from other institutions have requested copies for instructional use. Virtual clinical rotations through video experiences may provide a reasonable substitute for students who do not have the ability to participate in rotations in person. PMID:23483373

A Multicenter Study of Key Stakeholders’ Perspectives on Communicating with Surrogates about Prognosis in Intensive Care Units

PubMed Central

Cimino, Jenica W.; Ernecoff, Natalie C.; Ungar, Anna; Shotsberger, Kaitlin J.; Pollice, Laura A.; Buddadhumaruk, Praewpannarai; Carson, Shannon S.; Curtis, J. Randall; Hough, Catherine L.; Lo, Bernard; Matthay, Michael A.; Peterson, Michael W.; Steingrub, Jay S.; White, Douglas B.

2015-01-01

Rationale: Surrogates of critically ill patients often have inaccurate expectations about prognosis. Yet there is little research on how intensive care unit (ICU) clinicians should discuss prognosis, and existing expert opinion–based recommendations give only general guidance that has not been validated with surrogate decision makers. Objective: To determine the perspectives of key stakeholders regarding how prognostic information should be conveyed in critical illness. Methods: This was a multicenter study at three academic medical centers in California, Pennsylvania, and Washington. One hundred eighteen key stakeholders completed in-depth semistructured interviews. Participants included 47 surrogates of adult patients with acute respiratory distress syndrome; 45 clinicians working in study ICUs, including physicians, nurses, social workers, and spiritual care providers; and 26 experts in health communication, decision science, ethics, family-centered care, geriatrics, healthcare disparities, palliative care, psychology, psychiatry, and critical care. Measurements and Main Results: There was broad support among surrogates for existing expert recommendations, including truthful prognostic disclosure, emotional support, tailoring the disclosure strategy to each family’s needs, and checking for understanding. In addition, stakeholders offered suggestions that add specificity to existing recommendations, including: (1) In addition to conveying prognostic estimates, clinicians should help families “see the prognosis for themselves” by showing families radiographic images and explaining the clinical significance of physical manifestations of severe disease at the bedside. (2) Many physicians did not support using numeric estimates to convey prognosis to families, whereas many surrogates, clinicians from other disciplines, and experts believed numbers could be helpful. (3) Clinicians should conceptualize prognostic communication as an iterative process that

Qualified nurses' perceptions of nursing graduates' abilities vary according to specific demographic and clinical characteristics. A descriptive quantitative study.

PubMed

Missen, Karen; McKenna, Lisa; Beauchamp, Alison; Larkins, Jo-Ann

2016-10-01

Evidence from the literature and anecdotally from clinical settings suggests that newly graduated nurses are not fully prepared to be independent practitioners in healthcare settings. The aim of this study was to explore perceptions of qualified nurses in relation to the practice readiness of newly registered nursing graduates and determine whether these views differ according to specific demographic characteristics, clinical settings, and geographical locations. A descriptive quantitative design was used. An online survey tool was used to assess how qualified nurses (n=201) in Victoria, Australia, rated newly graduated nurses' abilities on 51 individual clinical skills/competencies in eight key skill areas. A composite score was calculated for each skill area and a comparative analysis was undertaken on the various cohorts of participants according to their demographic and clinical characteristics using one-way ANOVA and post hoc tests. Newly graduated nurses were found to be lacking competence in two key skill areas and were rated as performing adequately in the remaining six skill areas assessed. Significant differences (p≤0.05) in performance were found according to the age of the nurse, number of years registered, the educational setting in which they undertook their nurse education, their role, and the clinical area in which they worked. There were no significant differences according to whether the nurse worked in the private or public healthcare sector. Few differences were found between nurses working in a metropolitan vs. regional/rural healthcare setting. This is the first study to quantify the scale of this problem. Our findings serve as a reference for both nurse education providers and healthcare settings in better preparing nursing graduates to be competent, safe practitioners in all clinical areas. Copyright © 2016 Elsevier Ltd. All rights reserved.

Academic Primer Series: Five Key Papers about Study Designs in Medical Education.

PubMed

Gottlieb, Michael; Chan, Teresa M; Fredette, Jenna; Messman, Anne; Robinson, Daniel W; Cooney, Robert; Boysen-Osborn, Megan; Sherbino, Jonathan

2017-06-01

A proper understanding of study design is essential to creating successful studies. This is also important when reading or peer reviewing publications. In this article, we aimed to identify and summarize key papers that would be helpful for faculty members interested in learning more about study design in medical education research. The online discussions of the 2016-2017 Academic Life in Emergency Medicine Faculty Incubator program included a robust and vigorous discussion about education study design, which highlighted a number of papers on that topic. We augmented this list of papers with further suggestions by expert mentors. Via this process, we created a list of 29 papers in total on the topic of medical education study design. After gathering these papers, our authorship group engaged in a modified Delphi approach to build consensus on the papers that were most valuable for the understanding of proper study design in medical education. We selected the top five most highly rated papers on the topic domain of study design as determined by our study group. We subsequently summarized these papers with respect to their relevance to junior faculty members and to faculty developers. This article summarizes five key papers addressing study design in medical education with discussions and applications for junior faculty members and faculty developers. These papers provide a basis upon which junior faculty members might build for developing and analyzing studies.

Reasons for missed appointments with a hepatitis C outreach clinic: A qualitative study.

PubMed

Poll, Ray; Allmark, Peter; Tod, Angela M

2017-01-01

Non-attendance in drug service hepatitis C outreach clinics means clients miss the opportunity of being given lifestyle advice and referral to hospital for assessment and treatment. A similar problem is experienced in other services throughout the UK. A qualitative study was undertaken to investigate the problem. Clients with a history of not attending the outreach clinic were invited to participate during a routine drug clinic appointment. A contact details sheet with a preferred telephone number was completed by those agreeing to take part. Verbal consent was taken and a telephone interview took place. The participants were remunerated for taking part with a five pounds high street voucher. The 'framework method' was used to analyse the data with key themes identified. Twenty-eight telephone interviews were undertaken from April to June 2012. All the clients gave 'prima-facie' reasons for non-attendance including 'not a priority' and 'forgot'. However, the study indicates these are insufficient to explain the various experiences and influences. Underlying reasons that impacted upon attendance were identified. These reasons relate to (i) client characteristics e.g. 'priority' to score drugs and the 'cost of travel' and (ii) clinic service e.g. 'difficult journey' to the clinic and timing of the 'appointment'. The reasons operated within a complex context where other factors had an impact including addiction, welfare policy, stigma and the nature of hepatitis C itself. The study revealed that beneath apparently simple explanations for non-attendance, such as clients' chaotic lifestyle resulting in them forgetting or not being bothered to attend, there were far more complex and varied underlying reasons. This has important implications for drug policy including the need to better incorporate clients' perspectives. Policy that is based only on the simple, surface reasons is unlikely to be effective. Crown Copyright © 2016. Published by Elsevier B.V. All rights

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

PubMed Central

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

2013-01-01

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

[Clinical trials in nursing journals].

PubMed

Di Giulio, Paola; Campagna, Sara; Dimonte, Valerio

2014-01-01

Clinical trials are pivotal for the development of nursing knowledge. To describe the clinical trials published in nursing journals in the last two years and propose some general reflections on nursing research. A search with the key-word trial was done on PubMed (2009-2013) on Cancer Nursing, European Journal of Oncology Nursing, International Journal of Nursing Studies, Journal of Advanced Nursing, Journal of Clinical Nursing and Nursing Research. Of 228 trials identified, 104 (45.8%) were published in the last 2 years. Nurses from Asian countries published the larger number of trials. Educational and supportive interventions were the most studied (61/104 trials), followed by clinical interventions (33/104). Samples were limited and most trials are monocentric. A growing number of trials is published, on issues relevant for the nursing profession, however larger samples and multicentric studies would be necessary.

Embedding clinical interventions into observational studies

PubMed Central

Newman, Anne B.; Avilés-Santa, M. Larissa; Anderson, Garnet; Heiss, Gerardo; Howard, Wm. James; Krucoff, Mitchell; Kuller, Lewis H.; Lewis, Cora E.; Robinson, Jennifer G.; Taylor, Herman; Treviño, Roberto P.; Weintraub, William

2017-01-01

Novel approaches to observational studies and clinical trials could improve the cost-effectiveness and speed of translation of research. Hybrid designs that combine elements of clinical trials with observational registries or cohort studies should be considered as part of a long-term strategy to transform clinical trials and epidemiology, adapting to the opportunities of big data and the challenges of constrained budgets. Important considerations include study aims, timing, breadth and depth of the existing infrastructure that can be leveraged, participant burden, likely participation rate and available sample size in the cohort, required sample size for the trial, and investigator expertise. Community engagement and stakeholder (including study participants) support are essential for these efforts to succeed. PMID:26611435

A case study detailing key considerations for implementing a telehealth approach to office ergonomics.

PubMed

Ritchie, Catherine L W; Miller, Linda L; Antle, David M

2017-01-01

Telehealth approaches to delivering ergonomics assessment hold great potential to improve service delivery in rural and remote settings. This case study describes a telehealth-based ergonomics service delivery process, and compares in-person and telehealth-based ergonomics approaches at an Alberta-based non-profit advocacy group. This project demonstrates that telehealth approaches to ergonomics do not lead to significantly different scoring outcomes for assessment of ergonomics issues, when compared to in-person assessments. This project also outlines the importance of live real-time video conferencing to improving communication, attaining key assessment information, and demonstrating ergonomic adjustments. However, some key considerations of bandwidth and hardware capabilities need to be taken into account. Key communication strategies are outlined to improve rapport, maintain employee confidentiality, and reduce client anxiety around telehealth ergonomics assessments. This project provides further support for telehealth approaches to office ergonomics, and outlines some key implementation strategies and barriers that should be considered.

Function key and shortcut key use in airway facilities.

DOT National Transportation Integrated Search

2003-02-01

This document provides information on the function keys and shortcut keys used by systems in the Federal Aviation Administration : Airway Facilities (AF) work environment. It includes a catalog of the function keys and shortcut keys used by each syst...

Key Issues in an International Clinical Experience for Graduate Students in Education: Implications for Policy and Practice

ERIC Educational Resources Information Center

Gaudino, Ann C.; Moss, David M.; Wilson, Eleanor V.

2012-01-01

This study examines international clinical experiences in England with graduate education students from The University of Connecticut (UConn) and The University of Virginia (UVA) in the United States of America. Limited research available about international clinical experiences in the field of Education focuses primarily to only describe programs…

Clinical ethics revisited

PubMed Central

Singer, Peter A; Pellegrino, Edmund D; Siegler, Mark

2001-01-01

A decade ago, we reviewed the field of clinical ethics; assessed its progress in research, education, and ethics committees and consultation; and made predictions about the future of the field. In this article, we revisit clinical ethics to examine our earlier observations, highlight key developments, and discuss remaining challenges for clinical ethics, including the need to develop a global perspective on clinical ethics problems. PMID:11346456

Academic Primer Series: Five Key Papers about Team Collaboration Relevant to Emergency Medicine.

PubMed

Gottlieb, Michael; Grossman, Catherine; Rose, Emily; Sanderson, William; Ankel, Felix; Swaminathan, Anand; Chan, Teresa M

2017-02-01

Team collaboration is an essential for success both within academics and the clinical environment. Often, team collaboration is not explicitly taught during medical school or even residency, and must be learned during one's early career. In this article, we aim to summarize five key papers about team collaboration for early career clinician educators. We conducted a consensus-building process among the writing team to generate a list of key papers that describe the importance or significance of team collaboration, seeking input from social media sources. The authors then used a three-round voting methodology akin to a Delphi study to determine the most important papers from the initially generated list. The five most important papers on the topic of team collaboration, as determined by this mixed group of junior faculty members and faculty developers, are presented in this paper. For each included publication, a summary was provided along with its relevance to junior faculty members and faculty developers. Five key papers about team collaboration are presented in this publication. These papers provide a foundational background to help junior faculty members with collaborating in teams both clinically and academically. This list may also inform senior faculty and faculty developers about the needs of junior faculty members.

The Future of Clinical Education: Opportunities and Challenges from Allied Health Deans' Perspective.

PubMed

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

2017-01-01

There is limited information and consensus on the future of clinical education and the key factors impacting allied health (AH) clinical training. AH deans identified both opportunities and challenges impacting clinical education based on a proposed educational model. From July 2013 to March 2014, 61 deans whose institutions were 2013 members of the Association of Schools of Allied Health Professions (ASAHP) participated in a three-round Delphi survey. Agreement on the relative importance of and the ability to impact the key factors was analyzed. Impact was evaluated for three groups: individual, collective, and both individual and collective deans. AH deans' responses were summarized and refined; individual items were accepted or rerated until agreement was achieved or study conclusion. Based on the deans' ratings of importance and impact, 159 key factors within 13 clinical education categories emerged as important for the future of clinical education. Agreement was achieved on 107 opportunities and 52 challenges. The Delphi technique generated new information where little existed specific to AH deans' perspectives on AH clinical education. This research supports the Key Factors Impacting Allied Health Clinical Education conceptual model proposed earlier and provides a foundation for AH deans to evaluate opportunities and challenges impacting AH clinical education and to design action plans based on this research.

Embedding clinical interventions into observational studies.

PubMed

Newman, Anne B; Avilés-Santa, M Larissa; Anderson, Garnet; Heiss, Gerardo; Howard, Wm James; Krucoff, Mitchell; Kuller, Lewis H; Lewis, Cora E; Robinson, Jennifer G; Taylor, Herman; Treviño, Roberto P; Weintraub, William

2016-01-01

Novel approaches to observational studies and clinical trials could improve the cost-effectiveness and speed of translation of research. Hybrid designs that combine elements of clinical trials with observational registries or cohort studies should be considered as part of a long-term strategy to transform clinical trials and epidemiology, adapting to the opportunities of big data and the challenges of constrained budgets. Important considerations include study aims, timing, breadth and depth of the existing infrastructure that can be leveraged, participant burden, likely participation rate and available sample size in the cohort, required sample size for the trial, and investigator expertise. Community engagement and stakeholder (including study participants) support are essential for these efforts to succeed. Copyright © 2015. Published by Elsevier Inc.

Educating for health service reform: clinical learning, governance and capability - a case study protocol.

PubMed

Gardner, Anne; Gardner, Glenn; Coyer, Fiona; Gosby, Helen

2016-01-01

The nurse practitioner is a growing clinical role in Australia and internationally, with an expanded scope of practice including prescribing, referring and diagnosing. However, key gaps exist in nurse practitioner education regarding governance of specialty clinical learning and teaching. Specifically, there is no internationally accepted framework against which to measure the quality of clinical learning and teaching for advanced specialty practice. A case study design will be used to investigate educational governance and capability theory in nurse practitioner education. Nurse practitioner students, their clinical mentors and university academic staff, from an Australian university that offers an accredited nurse practitioner Master's degree, will be invited to participate in the study. Semi-structured interviews will be conducted with students and their respective clinical mentors and university academic staff to investigate learning objectives related to educational governance and attributes of capability learning. Limited demographic data on age, gender, specialty, education level and nature of the clinical healthcare learning site will also be collected. Episodes of nurse practitioner student specialty clinical learning will be observed and documentation from the students' healthcare learning sites will be collected. Descriptive statistics will be used to report age groups, areas of specialty and types of facilities where clinical learning and teaching is observed. Qualitative data from interviews, observations and student documents will be coded, aggregated and explored to inform a framework of educational governance, to confirm the existing capability framework and describe any additional characteristics of capability and capability learning. This research has widespread significance and will contribute to ongoing development of the Australian health workforce. Stakeholders from industry and academic bodies will be involved in shaping the framework that

Experimental study on discretely modulated continuous-variable quantum key distribution

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

Shen Yong; Zou Hongxin; Chen Pingxing

2010-08-15

We present a discretely modulated continuous-variable quantum key distribution system in free space by using strong coherent states. The amplitude noise in the laser source is suppressed to the shot-noise limit by using a mode cleaner combined with a frequency shift technique. Also, it is proven that the phase noise in the source has no impact on the final secret key rate. In order to increase the encoding rate, we use broadband homodyne detectors and the no-switching protocol. In a realistic model, we establish a secret key rate of 46.8 kbits/s against collective attacks at an encoding rate of 10more » MHz for a 90% channel loss when the modulation variance is optimal.« less

Key components of a service model providing early childhood support for women attending opioid treatment clinics: an Australian state health service review.

PubMed

Harvey, Susan R; Schmied, Virginia; Nicholls, Daniel; Dahlen, Hannah

2012-09-01

To report the findings of a service review--specifically the strategy to provide early childhood services 'on site' at opioid treatment clinics to address access difficulties. Child and family health nurses are skilled in the assessment and support of families during early childhood. However, women with a history of substance abuse are often cautious when engaging with universal and other health services, with the result that the infant may miss recommended developmental screening and early referral to improve health outcomes. In 2006, an internal review was undertaken of the integration of early childhood and parenting services at opioid treatment clinics in a large Area Health Service of New South Wales, Australia. A qualitative study design, using semi-structured interview questions was used. Data were collected via six focus groups (4-15 participants in each group) and individual interview of child and family health nurses, nurse unit managers and clinical staff (n=58). Three key components of a model for providing early childhood support in collaboration with opioid treatment services were identified. First, the importance of building a trusting relationship between the woman and the child and family health nurses, second, maintaining continuity of care and a multidisciplinary/multiagency approach, and finally the importance of staff education, support and professional development. The provision of early childhood and parenting services on site, as part of a multidisciplinary 'one stop shop' approach to service delivery was a clear recommendation of the review. Reduction of access difficulties to specialised early childhood support is of benefit to clients, community health services attempting to provide a service to this difficult to reach population and to drug and alcohol services seeking to provide a high level of holistic care for clients. © 2012 Blackwell Publishing Ltd.

Clinical intuition in the nursing process and decision-making-A mixed-studies review.

PubMed

Melin-Johansson, Christina; Palmqvist, Rebecca; Rönnberg, Linda

2017-12-01

To review what is characteristic of registered nurses' intuition in clinical settings, in relationships and in the nursing process. Intuition is a controversial concept and nurses believe that there are difficulties in how they should explain their nursing actions or decisions based on intuition. Much of the evidence from the body of research indicates that nurses value their intuition in a variety of clinical settings. More information on how nurses integrate intuition as a core element in daily clinical work would contribute to an improved understanding on how they go about this. Intuition deserves a place in evidence-based activities, where intuition is an important component associated with the nursing process. An integrative review strengthened with a mixed-studies review. Literature searches were conducted in the databases CINAHL, PubMed and PsycINFO, and literature published 1985-2016 were included. The findings in the studies were analysed with content analysis, and the synthesis process entailed a reasoning between the authors. After a quality assessment, 16 studies were included. The analysis and synthesis resulted in three categories. The characteristics of intuition in the nurse's daily clinical activities include application, assertiveness and experiences; in the relationships with patients' intuition include unique connections, mental and bodily responses, and personal qualities; and in the nursing process include support and guidance, component and clues in decision-making, and validating decisions. Intuition is more than simply a "gut feeling," and it is a process based on knowledge and care experience and has a place beside research-based evidence. Nurses integrate both analysis and synthesis of intuition alongside objective data when making decisions. They should rely on their intuition and use this knowledge in clinical practice as a support in decision-making, which increases the quality and safety of patient care. We find that intuition plays a

Optimizing Requirements Decisions with KEYS

NASA Technical Reports Server (NTRS)

Jalali, Omid; Menzies, Tim; Feather, Martin

2008-01-01

Recent work with NASA's Jet Propulsion Laboratory has allowed for external access to five of JPL's real-world requirements models, anonymized to conceal proprietary information, but retaining their computational nature. Experimentation with these models, reported herein, demonstrates a dramatic speedup in the computations performed on them. These models have a well defined goal: select mitigations that retire risks which, in turn, increases the number of attainable requirements. Such a non-linear optimization is a well-studied problem. However identification of not only (a) the optimal solution(s) but also (b) the key factors leading to them is less well studied. Our technique, called KEYS, shows a rapid way of simultaneously identifying the solutions and their key factors. KEYS improves on prior work by several orders of magnitude. Prior experiments with simulated annealing or treatment learning took tens of minutes to hours to terminate. KEYS runs much faster than that; e.g for one model, KEYS ran 13,000 times faster than treatment learning (40 minutes versus 0.18 seconds). Processing these JPL models is a non-linear optimization problem: the fewest mitigations must be selected while achieving the most requirements. Non-linear optimization is a well studied problem. With this paper, we challenge other members of the PROMISE community to improve on our results with other techniques.

What Really Motivates Iranian Nurses to Be Creative in Clinical Settings?: A Qualitative Study

PubMed Central

Isfahani, Sara Shahsavari; Hosseini, Mohammad Ali; Khoshknab, Masoud Fallahi; Peyrovi, Hamid; Khanke, Hamid Reza

2015-01-01

Background: Creativity and innovation are key elements for organization improvement, particularly in nursing, and for finding alternatives for solving nurses’ occupational problems. Nurses’ creativity is affected by motivation. Although, there are many possible sources of motivation, the Iranian nurses’ creativity is seldom clarified, and the most important factors motivating nurses to be creative in clinical settings has rarely been addressed. Objectives: The aim of this study was to explore Iranian nurses’ experiences regarding the most important factors that motivate their creativity in clinical settings. Methods: This qualitative study was conducted using conventional content analysis approach. A purposive sample of sixteen nurses was recruited from two educational hospitals affiliated to Tehran and Jahrom Universities of Medical Sciences in Iran. Data were gathered through conducting face-to-face semi-structured interviews and were analyzed by qualitative content analysis approach. Findings: Five main themes emerged from the data analysis, including: (a) Intrinsic motivators, (b) Extrinsic motivators, (c) Achievement motivators, (d) Relational or altruistic motivators, and (e) Spiritual motivators. Conclusions: Study findings indicated that nurses are creative and innovative individuals. So nurse managers and health policy makers should consider creativity as an integral part of all health and clinical strategies and policies. They should support creative and innovative efforts of nurses and provide a climate in which nurses engage in more creative and productive behaviors. PMID:26156918

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

PubMed

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

2017-01-01

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

Does ventrolateral prefrontal cortex help in searching for the lost key? Evidence from an fNIRS study.

PubMed

Carrieri, Marika; Lancia, Stefania; Bocchi, Alessia; Ferrari, Marco; Piccardi, Laura; Quaresima, Valentina

2018-06-01

The Key Search Task (KST) is a neuropsychological test that requires strategies for searching a lost key in an imaginary field. This request may involve different cognitive processes as mental imagery and navigation planning. This study was aimed at investigating, by a twenty-channel functional near-infrared spectroscopy (fNIRS) system, the hemodynamic response (i.e., oxygenated-hemoglobin (O 2 Hb) and deoxygenated-hemoglobin (HHb) changes) of the prefrontal cortex in navigation planning. A right ventrolateral prefrontal cortex (rVLPFC) activation during the KST was hypothesized. Thirty-eight volunteers performed the KST and a Control Task (CT), the latter requiring the volunteers to mark the X letter. An activation (i.e., increase/decrease in O 2 Hb/HHb) of: 1) rVLPFC during the KST execution, and 2) bilateral dorsolateral prefrontal cortex (DLPFC) during the CT execution was found. The present study provides a contribution in localizing the rVLPFC as the critically active region, within the frontal lobes, that was found maximally activated during mental navigation in the mind's eye of healthy participants while performing the KST. Considering the contribution of rVLPFC in spatial navigation, its activation suggests that the KST could be adopted in the clinical routine for investigating navigation planning. Compared to other neuroimaging techniques, fNIRS (with its relatively low physical constraints) contributes to better clarifying the role of rVLPFC in some aspects of human navigation. Therefore, the combined use of the fNIRS and the KST could be considered as an innovative and valid tool to evaluate fundamental functions for everyday life, such as spatial navigation planning.

Nursing students' viewpoints toward two methods of clinical conference and clinical nursing round.

PubMed

Gheidanzadeh, Maryam; Baghersad, Zahra; Abazari, Parvaneh

2017-01-01

Clinical education provides a chance to combine theoretical knowledge and clinical skills. Students are the key elements in the evaluation of clinical education efficacy. The present study was aimed to define nursing students' viewpoints concerning conformity to the characteristics of clinical conference and clinical round. This descriptive analytical study was conducted on the bachelor's students of the 4 th -6 th semester of nursing. Sampling was conducted using census sampling method during the 2 nd semester of 2014-2015 school year. Data collection tool was a three-section researcher-made questionnaire containing demographic, nursing round, and clinical conference characteristics. Descriptive and inferential statistical tests (independent t -test, ANOVA, and Spearman and Pearson correlation coefficients) were used for data analysis. Participants were 134 bachelor's students of the 4 th -6 th semester of nursing. According to half of the participants, conformity to the characteristics of clinical conference (45.5%, 53%) and clinical round (44%, 51.5%) were poor and medium, respectively. Paired t -test showed a significant difference between students' viewpoints toward the planning of clinical conference and clinical nursing round ( P = 0.006, t = 2.77). According to the results of the present study on students' viewpoints, clinical education faces a serious challenge with regard to clinical education methods. Considering the necessity and importance of clinical education, more investigation should be conducted to detect its relevant factors and plan for its improvement.

A Cross-Continental Study on Children's Drawings of Football Players: Implications for Understanding Key Issues and Controversies in Human Figure Drawings

PubMed Central

Baluch, Bahman; Duffy, Linda J.; Badami, Rokhsareh; Pereira, Elisangela C. Ap

2017-01-01

Professionals examine various aspects of girls’ and boys’ drawings as a way of understanding their intelligence, personality and emotional state. However, the extent to which such measures could be universally generalised or attributed to a specific cultural norm is still a debatable issue. In the present study five key features of children’s drawings namely: the size (height) of the drawings, profile or full face, figure in action or static, shaded or non-shaded and the nature of additional details were examined from a cross-cultural perspective, and by providing a topic (football) for which children’s drawing of a human figure could provide opportunities for the latter indices to manifest and flourish. Children from three countries; England, Iran and Brazil, representing three continents took part in this study. The participants were asked to draw a football player from their own country and from the other participating countries. The results showed that Brazilian children differ from Iranian and English children by drawing significantly smaller figures and putting more football action in the drawings. Shading of the figure drawn was more prevalent amongst English children. Such findings have implications for the interpretation of key aspects of children's drawings in educational, clinical and therapeutic settings and from a universal vs. culturally-specific viewpoint. PMID:28904595

A Cross-Continental Study on Children's Drawings of Football Players: Implications for Understanding Key Issues and Controversies in Human Figure Drawings.

PubMed

Baluch, Bahman; Duffy, Linda J; Badami, Rokhsareh; Pereira, Elisangela C Ap

2017-08-01

Professionals examine various aspects of girls' and boys' drawings as a way of understanding their intelligence, personality and emotional state. However, the extent to which such measures could be universally generalised or attributed to a specific cultural norm is still a debatable issue. In the present study five key features of children's drawings namely: the size (height) of the drawings, profile or full face, figure in action or static, shaded or non-shaded and the nature of additional details were examined from a cross-cultural perspective, and by providing a topic (football) for which children's drawing of a human figure could provide opportunities for the latter indices to manifest and flourish. Children from three countries; England, Iran and Brazil, representing three continents took part in this study. The participants were asked to draw a football player from their own country and from the other participating countries. The results showed that Brazilian children differ from Iranian and English children by drawing significantly smaller figures and putting more football action in the drawings. Shading of the figure drawn was more prevalent amongst English children. Such findings have implications for the interpretation of key aspects of children's drawings in educational, clinical and therapeutic settings and from a universal vs. culturally-specific viewpoint.

Key success factors of health research centers: A mixed method study.

PubMed

Tofighi, Shahram; Teymourzadeh, Ehsan; Heydari, Majid

2017-08-01

In order to achieve success in future goals and activities, health research centers are required to identify their key success factors. This study aimed to extract and rank the factors affecting the success of research centers at one of the medical universities in Iran. This study is a mixed method (qualitative-quantitative) study, which was conducted between May to October in 2016. The study setting was 22 health research centers. In qualitative phase, we extracted the factors affecting the success in research centers through purposeful interviews with 10 experts of centers, and classified them into themes and sub-themes. In the quantitative phase, we prepared a questionnaire and scored and ranked the factors recognized by 54 of the study samples by Friedman test. Nine themes and 42 sub-themes were identified. Themes included: strategic orientation, management, human capital, support, projects, infrastructure, communications and collaboration, paradigm and innovation and they were rated respectively as components of success in research centers. Among the 42 identified factors, 10 factors were ranked respectively as the key factors of success, and included: science and technology road map, strategic plan, evaluation indexes, committed human resources, scientific evaluation of members and centers, innovation in research and implementation, financial support, capable researchers, equipment infrastructure and teamwork. According to the results, the strategic orientation was the most important component in the success of research centers. Therefore, managers and authorities of research centers should pay more attention to strategic areas in future planning, including the science and technology road map and strategic plan.

Key success factors of health research centers: A mixed method study

PubMed Central

Tofighi, Shahram; Teymourzadeh, Ehsan; Heydari, Majid

2017-01-01

Background In order to achieve success in future goals and activities, health research centers are required to identify their key success factors. Objective This study aimed to extract and rank the factors affecting the success of research centers at one of the medical universities in Iran. Methods This study is a mixed method (qualitative-quantitative) study, which was conducted between May to October in 2016. The study setting was 22 health research centers. In qualitative phase, we extracted the factors affecting the success in research centers through purposeful interviews with 10 experts of centers, and classified them into themes and sub-themes. In the quantitative phase, we prepared a questionnaire and scored and ranked the factors recognized by 54 of the study samples by Friedman test. Results Nine themes and 42 sub-themes were identified. Themes included: strategic orientation, management, human capital, support, projects, infrastructure, communications and collaboration, paradigm and innovation and they were rated respectively as components of success in research centers. Among the 42 identified factors, 10 factors were ranked respectively as the key factors of success, and included: science and technology road map, strategic plan, evaluation indexes, committed human resources, scientific evaluation of members and centers, innovation in research and implementation, financial support, capable researchers, equipment infrastructure and teamwork. Conclusion According to the results, the strategic orientation was the most important component in the success of research centers. Therefore, managers and authorities of research centers should pay more attention to strategic areas in future planning, including the science and technology road map and strategic plan. PMID:28979733

Nanoparticles in the clinic

PubMed Central

Anselmo, Aaron C.

2016-01-01

Abstract Nanoparticle/microparticle‐based drug delivery systems for systemic (i.e., intravenous) applications have significant advantages over their nonformulated and free drug counterparts. For example, nanoparticle systems are capable of delivering therapeutics and treating areas of the body that other delivery systems cannot reach. As such, nanoparticle drug delivery and imaging systems are one of the most investigated systems in preclinical and clinical settings. Here, we will highlight the diversity of nanoparticle types, the key advantages these systems have over their free drug counterparts, and discuss their overall potential in influencing clinical care. In particular, we will focus on current clinical trials for nanoparticle formulations that have yet to be clinically approved. Additional emphasis will be on clinically approved nanoparticle systems, both for their currently approved indications and their use in active clinical trials. Finally, we will discuss many of the often overlooked biological, technological, and study design challenges that impact the clinical success of nanoparticle delivery systems. PMID:29313004

Simple Web-based interactive key development software (WEBiKEY) and an example key for Kuruna (Poaceae: Bambusoideae).

PubMed

Attigala, Lakshmi; De Silva, Nuwan I; Clark, Lynn G

2016-04-01

Programs that are user-friendly and freely available for developing Web-based interactive keys are scarce and most of the well-structured applications are relatively expensive. WEBiKEY was developed to enable researchers to easily develop their own Web-based interactive keys with fewer resources. A Web-based multiaccess identification tool (WEBiKEY) was developed that uses freely available Microsoft ASP.NET technologies and an SQL Server database for Windows-based hosting environments. WEBiKEY was tested for its usability with a sample data set, the temperate woody bamboo genus Kuruna (Poaceae). WEBiKEY is freely available to the public and can be used to develop Web-based interactive keys for any group of species. The interactive key we developed for Kuruna using WEBiKEY enables users to visually inspect characteristics of Kuruna and identify an unknown specimen as one of seven possible species in the genus.

Successful Implementation of Clinical Information Technology: Seven Key Lessons from CPOE.

PubMed

Gellert, G A; Hill, V; Bruner, K; Maciaz, G; Saucedo, L; Catzoela, L; Ramirez, R; Jacobs, W J; Nguyen, P; Patel, L; Webster, S L

2015-01-01

To identify and describe the most critical strategic and operational contributors to the successful implementation of clinical information technologies, as deployed within a moderate sized system of U.S. community hospitals. CHRISTUS Health is a multi-state system comprised of more than 350 services and 60 hospitals with over 9 000 physicians. The Santa Rosa region of CHRISTUS Health, located in greater San Antonio, Texas is comprised of three adult community hospital facilities and one Children's hospital each with bed capacities of 142-180. Computerized Patient Order Entry (CPOE) was first implemented in 2012 within a complex market environment. The Santa Rosa region has 2 417 credentialed physicians and 263 mid-level allied health professionals. This report focuses on the seven most valuable strategies deployed by the Health Informatics team in a large four hospital CHRISTUS region to achieve strong CPOE adoption and critical success lessons learned. The findings are placed within the context of the literature describing best practices in health information technology implementation. While the elements described involved discrete de novo process generation to support implementation and operations, collectively they represent the creation of a new customer-centric service culture in our Health Informatics team, which has served as a foundation for ensuring strong clinical information technology adoption beyond CPOE. The seven success factors described are not limited in their value to and impact on CPOE adoption, but generalize to - and can advance success in - varied other clinical information technology implementations across diverse hospitals. A number of these factors are supported by reports in the literature of other institutions' successful implementations of CPOE and other clinical information technologies, and while not prescriptive to other settings, may be adapted to yield value elsewhere.

Psychologists' Clinical Practices in Assessing Dementia in Individuals with Down Syndrome

ERIC Educational Resources Information Center

Auty, Ellen; Scior, Katrina

2008-01-01

There are now ample guidelines for the assessment and diagnosis of possible dementia in individuals with intellectual disabilities (ID) and Down syndrome. However, little is known about their implementation in clinical practice. This study set out to examine the clinical practice of one key professional group, namely clinical psychologists. A…

The views of key stakeholders in Zimbabwe on the introduction of postgraduate family medicine training: A qualitative study.

PubMed

Sururu, Cherifa; Mash, Robert

2017-09-12

Strengthening primary health care (PHC) is a priority for all effective health systems, and family physicians are seen as a key member of the PHC team. Zimbabwe has joined a number of African countries that are seriously considering the introduction of postgraduate family medicine training. Implementation of training, however, has not yet happened. To explore the views of key stakeholders on the introduction of postgraduate family medicine training. Key academic, governmental and professional stakeholders in Zimbabwean health and higher education systems. Twelve semi-structured interviews were conducted with purposively selected key stakeholders. Data were recorded, transcribed and analysed using the framework method. Anticipated benefits: More effective functioning of PHC and district health services with reduced referrals, improved access to more comprehensive services and improved clinical outcomes. Opportunities: International trend towards family medicine training, government support, availability of a small group of local trainers, need to revise PHC policy. Anticipated barriers: Family medicine is unattractive as a career choice because it is largely unknown to newly qualified doctors and may not be recognised in private sector. There is concern that advocacy is mainly coming from the private sector. Threats: Economic conditions, poor remuneration, lack of funding for resources and new initiatives, resistance from other specialists in private sector. Stakeholders anticipated significant benefits from the introduction of family medicine training and identified a number of opportunities that support this, but also recognised the existence of major barriers and threats to successful implementation.

The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--chapter 1: Key ethical requirements and progress toward the definition of an international regulatory framework.

PubMed

Cozzi, Emanuele; Tallacchini, Mariachiara; Flanagan, Enda B; Pierson, Richard N; Sykes, Megan; Vanderpool, Harold Y

2009-01-01

The outstanding results recently obtained in islet xenotransplantation suggest that porcine islet clinical trials may soon be scientifically appropriate. Before the initiation of such clinical studies, however, it is essential that a series of key ethical and regulatory conditions are satisfied. As far as ethics is concerned, the fundamental requirements have been previously reported in a position paper of the Ethics Committee of the International Xenotransplantation Association. These include aspects related to the selection of adequately informed, appropriate recipients; animal breeding and welfare; safety issues and the need for a favorable risk/benefit assessment based on strong efficacy data in relevant xenotransplantation studies in the primate. As most diabetic patients are not at risk of short-term mortality without islet transplantation, only a small subset of patients could currently be considered for any type of islet transplant. However, there are potential advantages to xenotransplantation that could result in a favorable benefit-over-harm determination for islet xenotransplantation in this subpopulation and ultimately in a broader population of diabetic patients. With regard to regulatory aspects, the key concepts underlying the development of the regulatory models in existence in the United States, Europe and New Zealand are discussed. Each of these models provides an example of a well-defined regulatory approach to ensure the initiation of well-regulated and ethically acceptable clinical islet xenotransplantation trials. At this stage, it becomes apparent that only a well-coordinated international effort such as that initiated by the World Health Organization, aimed at harmonizing xenotransplantation procedures according to the highest ethical and regulatory standards on a global scale, will enable the initiation of clinical xenotransplantation trials under the best auspices for its success and minimize any risk of failure.

How do chiropractors manage clinical risk? A questionnaire study.

PubMed

Wangler, Martin; Peterson, Cynthia; Zaugg, Beatrice; Thiel, Haymo; Finch, Rob

2013-06-08

The literature on chiropractic safety tends to focus on adverse events and little is known about how chiropractors ensure safety and manage risk in the course of their daily practice. The purpose of this study was to investigate how chiropractors manage potentially risky clinical scenarios. We also sought to establish how chiropractors perceive the safety climate in their workplace and thus whether there is an observable culture of safety within the profession. An online questionnaire was designed to determine which of nine management options would be chosen by the respondent in response to four defined clinical case scenarios. Safety climate within the respondent's practice setting was measured by seeking the level of agreement with 23 statements relating to six different safety dimensions. 260 licensed chiropractors in Switzerland and 1258 UK members of The Royal College of Chiropractors were invited to complete the questionnaire. Questionnaire responses were analysed quantitatively in respect of the four clinical scenarios and the nine management options to determine the likelihood of each option being undertaken, with results recorded in terms of % likelihood. Gender differences in response to the management options for each scenario were evaluated using the Mann-Whitney U (MWU) test. Positive agreement with elements comprising each of the six safety dimensions contributed to a composite '% positive agreement' score calculated for each dimension. Questionnaire responses were received from 76% (200/260) of Swiss participants and 31% (393/1258) of UK members of The Royal College of Chiropractors. There was a general trend for Swiss and UK chiropractors to manage clinical scenarios where treatment appears not to be successful, not indicated, possibly harmful or where a patient is apparently getting worse, by re-evaluating their care. Stopping treatment and/or incident reporting to a safety incident reporting and learning system were generally found to be unlikely

Lessons learned from implementing service-oriented clinical decision support at four sites: A qualitative study.

PubMed

Wright, Adam; Sittig, Dean F; Ash, Joan S; Erickson, Jessica L; Hickman, Trang T; Paterno, Marilyn; Gebhardt, Eric; McMullen, Carmit; Tsurikova, Ruslana; Dixon, Brian E; Fraser, Greg; Simonaitis, Linas; Sonnenberg, Frank A; Middleton, Blackford

2015-11-01

To identify challenges, lessons learned and best practices for service-oriented clinical decision support, based on the results of the Clinical Decision Support Consortium, a multi-site study which developed, implemented and evaluated clinical decision support services in a diverse range of electronic health records. Ethnographic investigation using the rapid assessment process, a procedure for agile qualitative data collection and analysis, including clinical observation, system demonstrations and analysis and 91 interviews. We identified challenges and lessons learned in eight dimensions: (1) hardware and software computing infrastructure, (2) clinical content, (3) human-computer interface, (4) people, (5) workflow and communication, (6) internal organizational policies, procedures, environment and culture, (7) external rules, regulations, and pressures and (8) system measurement and monitoring. Key challenges included performance issues (particularly related to data retrieval), differences in terminologies used across sites, workflow variability and the need for a legal framework. Based on the challenges and lessons learned, we identified eight best practices for developers and implementers of service-oriented clinical decision support: (1) optimize performance, or make asynchronous calls, (2) be liberal in what you accept (particularly for terminology), (3) foster clinical transparency, (4) develop a legal framework, (5) support a flexible front-end, (6) dedicate human resources, (7) support peer-to-peer communication, (8) improve standards. The Clinical Decision Support Consortium successfully developed a clinical decision support service and implemented it in four different electronic health records and four diverse clinical sites; however, the process was arduous. The lessons identified by the Consortium may be useful for other developers and implementers of clinical decision support services. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Characteristics of effective clinical teachers identified by dental students: a qualitative study.

PubMed

Jahangiri, L; McAndrew, M; Muzaffar, A; Mucciolo, T W

2013-02-01

This qualitative research study identified criteria for clinical teacher quality preferences as perceived by dental students. Third and fourth year dental students at New York University College of Dentistry were given a two question, open-ended survey asking what qualities they liked most and least in a clinical teacher. Responses were collected until data saturation was achieved. A total of 157 respondents provided a total of 995 written comments. Descriptive words within the responses were coded and grouped into key words, according to similar relationships, and further refined into 17 defined categories. Three core themes, Character, Competence and Communication, emerged from these 17 categories, which were validated according to specific references found in the existing educational literature. 'Character' comprised nine of the 17 defined categories: (caring, motivation, empathy, patience, professionalism, available, fairness, happiness, patient-centred) and yielded 59.1% of total student responses; 'Competence' consisted of five categories: knowledgeable, expertise, efficient, skilful, effective (29.2%); and 'Communication' represented the remaining three categories: feedback, approachable and interpersonal communication (11.7%). Positive and negative responses related to the defined category of caring were cited by 59.2% of all students. Motivation was the next highest category, cited by 45.9% of students. Non-cognitive attributes, especially those in the Character theme, comprised the majority of student comments. Because students' perceptions are so critical to understanding clinical teaching effectiveness in dental education, these findings can be used to develop assessments to measure clinical teaching effectiveness, to create criteria for the hiring and promotion of clinical faculty and to plan faculty development programming. © 2012 John Wiley & Sons A/S. Published by Blackwell Publishing Ltd.

Lessons Learned During the Conduct of Clinical Studies in The Dental PBRN

PubMed Central

Gilbert, Gregg H.; Richman, Joshua S.; Gordan, Valeria V.; Rindal, D. Brad; Fellows, Jeffrey L.; Benjamin, Paul L.; Wallace-Dawson, Martha; Williams, O. Dale

2012-01-01

Effectively addressing challenges of conducting research in nonacademic settings is crucial to its success. A dental practice-based research network called The Dental Practice-Based Research Network (DPBRN) is comprised of practitioner-investigators in two health maintenance organizations, several universities, many U.S. states, and three Scandinavian countries. Our objective in this article is to describe lessons learned from conducting studies in this research context; the studies are conducted by clinicians in community settings who may be doing their first research study. To date, twenty-one studies have been completed or are in implementation. These include a broad range of topic areas, enrollment sizes, and study designs. A total of 1,126 practitioner-investigators have participated in at least one study. After excluding one study because it involved electronic records queries only, these studies included more than 70,000 patient/participant units. Because the DPBRN is committed to being both practitioner- and patient-driven, all studies must be approved by its Executive Committee and a formal study section of academic clinical scientists. As a result of interacting with a diverse range of institutional and regulatory entities, funding agencies, practitioners, clinic staff, patients, academic scientists, and geographic areas, twenty-three key lessons have been learned. Patients’ acceptance of these studies has been very high, judging from high participation rates and their completion of data forms. Early studies substantially informed later studies with regard to study design, practicality, forms design, informed consent process, and training and monitoring methods. Although time-intensive and complex, these solutions improved acceptability of practice-based research to patients, practitioners, and university researchers. PMID:21460266

Nurses' Perceptions and Practices Toward Clinical Alarms in a Transplant Cardiac Intensive Care Unit: Exploring Key Issues Leading to Alarm Fatigue

PubMed Central

Tarriela, Albert Fajardo; Gomez, Tiffany Michelle; Reed, Charles Calhoun; Rapp, Kami Marie

2015-01-01

. Around 60% of nurses indicated they received insufficient training on bedside and central cardiac monitors. A correlation also showed the need for training on cardiac monitors, specifically for older nurses (P=.01). Conclusions False and non-actionable alarms continue to desensitize TCICU nurses, perhaps resulting in missing fatal alarms. Nurses’ attitudes and practices related to clinical alarms are key elements for designing contextually sensitive quality initiatives to fight alarm fatigue. Alarm management in ICUs is a multidimensional complex process involving usability of monitoring devices, and unit, clinicians, training, and policy-related factors. This indicates the need for a multi-method approach to decrease alarm fatigue and improve alarm systems safety. PMID:27025940

The structure of contraceptive education and instruction within nurse led family planning clinics: a grounded theory study.

PubMed

Hayter, Mark

2009-09-01

This study aimed to explore and analyse how nurses instruct women in contraceptive use during consultations in family planning clinics to produce a grounded theory of contraceptive education. Nurses play a key role in instructing women how to use contraception in family planning clinic consultations. These one-to-one situations are encounters where women are taught how to use contraceptive methods effectively. However, very little is known about the nature of these consultations. A qualitative study using a grounded theory approach was used. Three linked 'core categories' emerged from the data analysis. Firstly, women are educated about their body and how it responds to contraception: 'reproductive education'. This core category is closely linked to 'surveillance' where women are taught to monitor their reproductive health and to 'contraceptive regimen' where women are instructed in techniques to successfully use a contraceptive method. Together these three core categories present a grounded theory of 'contraceptive education'. Nursing practice in this important area of women's health care is complex and requires skilled practitioners. This study presents unique empirical data into how nurses conduct one-to-one consultations with women - providing a novel insight into how contraception is explained in clinical situations. Key issues for practice from the data were the lack of a balance when discussing side effects, the rigidity of some instructions and the lack of recognition of risk from sexually transmitted infection. Nurses working in sexual health need to ensure that women understand the often complex instructions they provide and that rigid instruction be occasionally amended to enable some flexibility. The manner in which side-effects are discussed should also be balanced. Nurses need to address the risk of sexually transmitted infections more substantially in contraceptive discussions.

Multidrug Resistance in Breast Cancer: From In Vitro Models to Clinical Studies

PubMed Central

Wind, N. S.; Holen, I.

2011-01-01

The development of multidrug resistance (MDR) and subsequent relapse on therapy is a widespread problem in breast cancer, but our understanding of the underlying molecular mechanisms is incomplete. Numerous studies have aimed to establish the role of drug transporter pumps in MDR and to link their expression to response to chemotherapy. The ATP-binding cassette (ABC) transporters are central to breast cancer MDR, and increases in ABC expression levels have been shown to correlate with decreases in response to various chemotherapy drugs and a reduction in overall survival. But as there is a large degree of redundancy between different ABC transporters, this correlation has not been seen in all studies. This paper provides an introduction to the key molecules associated with breast cancer MDR and summarises evidence of their potential roles reported from model systems and clinical studies. We provide possible explanations for why despite several decades of research, the precise role of ABC transporters in breast cancer MDR remains elusive. PMID:22332018

Identifying Opportunities for Vertical Integration of Biochemistry and Clinical Medicine.

PubMed

Wendelberger, Karen J.; Burke, Rebecca; Haas, Arthur L.; Harenwattananon, Marisa; Simpson, Deborah

1998-01-01

Objectives: Retention of basic science knowledge, as judged by National Board of Medical Examiners' (NBME) data, suffers due to lack of apparent relevance and isolation of instruction from clinical application, especially in biochemistry. However, the literature reveals no systematic process for identifying key biochemical concepts and associated clinical conditions. This study systematically identified difficult biochemical concepts and their common clinical conditions as a critical step towards enhancing relevance and retention of biochemistry.Methods: A multi-step/ multiple stakeholder process was used to: (1) identify important biochemistry concepts; (2) determine students' perceptions of concept difficulty; (3) assess biochemistry faculty, student, and clinical teaching scholars' perceived relevance of identified concepts; and (4) identify associated common clinical conditions for relevant and difficult concepts. Surveys and a modified Delphi process were used to gather data, subsequently analyzed using SPSS for Windows.Results: Sixteen key biochemical concepts were identified. Second year medical students rated 14/16 concepts as extremely difficult while fourth year students rated nine concepts as moderately to extremely difficult. On average, each teaching scholar generated common clinical conditions for 6.2 of the 16 concepts, yielding a set of seven critical concepts and associated clinical conditions.Conclusions: Key stakeholders in the instructional process struggle to identify biochemistry concepts that are critical, difficult to learn and associated with common clinical conditions. However, through a systematic process beginning with identification of concepts and associated clinical conditions, relevance of basic science instruction can be enhanced.

Are privacy-enhancing technologies for genomic data ready for the clinic? A survey of medical experts of the Swiss HIV Cohort Study.

PubMed

Raisaro, Jean-Louis; McLaren, Paul J; Fellay, Jacques; Cavassini, Matthias; Klersy, Catherine; Hubaux, Jean-Pierre

2018-03-01

Protecting patient privacy is a major obstacle for the implementation of genomic-based medicine. Emerging privacy-enhancing technologies can become key enablers for managing sensitive genetic data. We studied physicians' attitude toward this kind of technology in order to derive insights that might foster their future adoption for clinical care. We conducted a questionnaire-based survey among 55 physicians of the Swiss HIV Cohort Study who tested the first implementation of a privacy-preserving model for delivering genomic test results. We evaluated their feedback on three different aspects of our model: clinical utility, ability to address privacy concerns and system usability. 38/55 (69%) physicians participated in the study. Two thirds of them acknowledged genetic privacy as a key aspect that needs to be protected to help building patient trust and deploy new-generation medical information systems. All of them successfully used the tool for evaluating their patients' pharmacogenomics risk and 90% were happy with the user experience and the efficiency of the tool. Only 8% of physicians were unsatisfied with the level of information and wanted to have access to the patient's actual DNA sequence. This survey, although limited in size, represents the first evaluation of privacy-preserving models for genomic-based medicine. It has allowed us to derive unique insights that will improve the design of these new systems in the future. In particular, we have observed that a clinical information system that uses homomorphic encryption to provide clinicians with risk information based on sensitive genetic test results can offer information that clinicians feel sufficient for their needs and appropriately respectful of patients' privacy. The ability of this kind of systems to ensure strong security and privacy guarantees and to provide some analytics on encrypted data has been assessed as a key enabler for the management of sensitive medical information in the near future

Prevention or treatment of ARDS with aspirin: a review of preclinical models and meta- analysis of clinical studies

PubMed Central

Panka, Bernardo Amisa; de Grooth, Harm-Jan; Spoelstra–de Man, Angeliquè; Looney, Mark; Tuinman, Pieter-Roel

2016-01-01

Background The acute respiratory distress syndrome (ARDS) is a life-threating disorder that contributes significantly to critical illness. No specific pharmacological interventions directed at lung injury itself, have proven effective in improving outcome of patients with ARDS. Platelet activation was identified as a key component in ARDS pathophysiology and may provide an opportunity for preventive and therapeutic strategies. We hypothesize that use of acetyl salicylic acid (ASA) may prevent and/or attenuate lung injury. Methods We conducted a systematic review of preclinical studies and meta-analysis of clinical studies investigating the efficacy of ASA in the setting of lung injury. MEDLINE, EMBASE AND COCHRANE databases were searched. Results The literature search yielded 1314 unique articles. Fifteen pre-clinical studies and eight clinical studies fulfilled the in- and exclusion criteria. In the animal studies, the overall effect of ASA was positive, e.g. ASA improved survival and attenuated inflammation and pulmonary edema. Mechanisms of actions involved, among others, are interference with the neutrophil-platelets interaction, reduction of leukotrienes, neutrophil extracellular traps and prostaglandins. High dose ASA may be the drug of choice. A meta-analysis of 3 clinical studies showed an association between ASA use and a reduced incidence of ARDS (OR 0.59, 95% CI 0.36–0.98), albeit with substantial between-study heterogeneity. All studies had their own shortcomings in methodological quality. Conclusion This systematic review of preclinical studies and meta-analysis of clinical studies suggests a beneficial role for ASA in ARDS prevention and treatment. However, the currently available data is insufficient to justify an indication for ASA in ARDS. The body of literature does support further studies in humans. We suggest clinical trials in which the mechanisms of action of ASA in lung injury models is being evaluated to guide optimal timing and dose

Implementing clinical guidelines in stroke: a qualitative study of perceived facilitators and barriers.

PubMed

Donnellan, Claire; Sweetman, S; Shelley, E

2013-08-01

Clinical guidelines are frequently used as a mechanism for implementing evidence-based practice. However research indicates that health professionals vary in the extent to which they adhere to these guidelines. This study aimed to study the perceptions of stakeholders and health professionals on the facilitators and barriers to implementing national stroke guidelines in Ireland. Qualitative interviews using focus groups were conducted with stakeholders (n=3) and multidisciplinary team members from hospitals involved in stroke care (n=7). All focus group interviews were semi-structured, using open-ended questions. Data was managed and analysed using NVivo 9 software. The main themes to emerge from the focus groups with stakeholders and hospital multidisciplinary teams were very similar in terms of topics discussed. These were resources, national stroke guidelines as a tool for change, characteristics of national stroke guidelines, advocacy at local level and community stroke care challenges. Facilitators perceived by stakeholders and health professionals included having dedicated resources, user-friendly guidelines relevant at local level and having supportive advocates on the ground. Barriers were inadequate resources, poor guideline characteristics and insufficient training and education. This study highlights health professionals' perspectives regarding many key concepts which may affect the implementation of stroke care guidelines. The introduction of stroke clinical guidelines at a national level is not sufficient to improve health care quality as they should be incorporated in a quality assurance cycle with education programmes and feedback from surveys of clinical practice. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Five keys to real transformation in health care.

PubMed

Senzon, Simon A

2011-11-01

Transformation in health care requires a deeply holistic approach. Natural leaders of such a transformation are the complementary and alternative medicine practitioners who already share a vision of wellness, prevention, and optimal human function. Central to this shared vision is lifestyle change for patients and practitioners. Yet, to change a lifestyle is to change a self. Assisting individuals to transform their very sense of self in order to live healthier, more fulfilling lives centered on flourishing requires several important keys. Visionary and unified leaders are the first key. Structural support through coordination of health clinics locally and nationally is the second key. This can be optimized by utilizing initiatives of the new Affordable Health Care Act, because it provides a potential impetus for deep structural changes. An expanded evidence base for multifactorial approaches to wellness lifestyles is the third key. A reorganizational orientation with an emphasis on the right timing of transformation is the fourth key. The fifth key is an Integral map, which brings together the personal, behavioral, cultural, and social domains. By utilizing such a map, one ensures that no aspect of the transformative revolution at hand slips away due to any misplaced focus, such as emphasizing only on the things we can see with our eyes. By embracing the essence of transformation in terms of a wholeness to all reality, an evolutionary unifying field with interior depth and exterior expression, health care is redefined more authentically. © Mary Ann Liebert, Inc.

Understanding Price Elasticities to Inform Public Health Research and Intervention Studies: Key Issues

PubMed Central

Nghiem, Nhung; Genç, Murat; Blakely, Tony

2013-01-01

Pricing policies such as taxes and subsidies are important tools in preventing and controlling a range of threats to public health. This is particularly so in tobacco and alcohol control efforts and efforts to change dietary patterns and physical activity levels as a means of addressing increases in noncommunicable diseases. To understand the potential impact of pricing policies, it is critical to understand the nature of price elasticities for consumer products. For example, price elasticities are key parameters in models of any food tax or subsidy that aims to quantify health impacts and cost-effectiveness. We detail relevant terms and discuss key issues surrounding price elasticities to inform public health research and intervention studies. PMID:24028228

An evaluative study of clinical preceptorship.

PubMed

Kaviani, N; Stillwell, Y

2000-04-01

Clinical preceptorships, in collaboration between clinical agencies and educational institutions have been documented as an effective and innovative means of facilitating student learning, providing advantages for both the clinical and educational settings. A preceptorship programme of 100 hours duration was developed and delivered by the nurse education institute, in consultation with a health care organization. The objectives of the preceptorship programme were to help registered nurses, in partnership with clinical nurse educators, to effectively integrate, support and assist the development of clinical competence in the undergraduate nursing student. Following the implementation of the preceptorship programme a research study was conducted to evaluate programme effectiveness. The purpose of the study was to examine preceptors, preceptees, and nurse managers' preceptions of the preceptor role and factors which influenced the performance of preceptors. The methods used in this study included those commonly found in evaluation research. That is, participants were drawn from those who were involved, either directly or indirectly, in the preceptorship programme, namely preceptors, preceptees and nurse managers. Using focus groups, they were each asked to identify the outcomes of the programme in practice. Study findings highlighted the importance of formal preceptor preparation, which was shown to enhance teaching and learning opportunities for student preceptees, personal and professional development of the preceptors, and the promotion of positive partnerships between nurse educators and nurse practitioners. The need for formal recognition of the preceptor role in practice, particularly in relation to the provision of adequate time and resources, emerged from the study. The research findings enabled the development of an evaluative model of preceptorship, which highlights the intrinsic and extrinsic factors impacting on the preceptor role.

[About History of Scientific Clinical Schools in Russia: Certain Disputable Issues of Methodology of Studying Problem].

PubMed

Borodulin, V I; Gliantsev, S P

2017-07-01

The article considers particular key methodological aspects of problem of scientific clinical school in national medicine. These aspects have to do with notion of school, its profile, issues of pedagogues, teachings and followers, subsidiary schools and issue of ethical component of scientific school. The article is a polemic one hence one will find no definite answers to specified questions. The reader is proposed to ponder over answers independently adducing examples of pro and contra. The conclusion is made about necessity of studying scientific schools in other areas of medicine and further elaboration of problem.

Treatment of clinical mastitis.

PubMed

Roberson, Jerry R

2012-07-01

In summary, culture-based therapy and severity levels are key to management of clinical mastitis. Antibiotic therapy should be strongly considered for gram-positive clinical mastitis. Antibiotic therapy is not necessary for mild-to-moderate gram-negative clinical mastitis. Antibiotic therapy is warranted for practically all severe clinical mastitis as well as fluids and anti-inflammatory drugs. Clinical mastitis cases due to yeast and fungal pathogens or no growth isolates do not warrant antibiotic therapy.

Developing critical thinking skills from clinical assignments: a pilot study on nursing students' self-reported perceptions.

PubMed

Marchigiano, Gail; Eduljee, Nina; Harvey, Kimberly

2011-01-01

Clinical assignments in nursing education provide opportunities for students to develop thinking skills vital to the effective delivery of patient care. The purpose of the present study was to examine students' perceived levels of confidence for using thinking skills when completing two types of clinical assignments. Clinical educators and managers are challenged to develop teaching and learning strategies that help students think critically and reflectively and transfer these skills into sound nursing practice. This study is based on the theoretical framework of critical thinking within the nursing process framework. Undergraduate nursing students (n=51) completed surveys indicating their confidence in using seven thinking skills for nursing care. Students indicated significantly more confidence when implementing the journal format as compared with the care plan format when analysing information, determining relevance, making connections, selecting appropriate information, applying relevant knowledge and evaluating outcomes. The findings of the present study propose a new approach for enhancing students' thinking skills. Journaling is an effective strategy for enhancing students' thinking skills. Nursing managers are in key organisational positions for supporting and promoting the use of the journal format and building supportive and collaborative learning environments for students to develop thinking skills for managing patient care. © 2010 The Authors. Journal compilation © 2010 Blackwell Publishing Ltd.

GP leadership in clinical commissioning groups: a qualitative multi-case study approach across England.

PubMed

Marshall, Martin; Holti, Richard; Hartley, Jean; Matharu, Tatum; Storey, John

2018-06-01

Clinical commissioning groups (CCGs) were established in England in 2013 to encourage GPs to exert greater influence over the processes of service improvement and redesign in the NHS. Little is known about the extent and the ways in which GPs have assumed these leadership roles. To explore the nature of clinical leadership of GPs in CCGs, and to examine the enablers and barriers to implementing a policy of clinical leadership in the NHS. A qualitative multi-case study approach in six localities across England. The case studies were purposefully sampled to represent different geographical localities and population demographics, and for their commitment to redesigning specified clinical or service areas. Data were collected from the case study CCGs and their partner organisations using a review of relevant documents, semi-structured individual or group interviews, and observations of key meetings. The data were analysed thematically and informed by relevant theories. GPs prefer a collaborative style of leadership that may be unlikely to produce rapid or radical change. Leadership activities are required at all levels in the system from strategy to frontline delivery, and the leadership behaviours of GPs who are not titular leaders are as important as formal leadership roles. A new alliance is emerging between clinicians and managers that draws on their different skillsets and creates new common interests. The uncertain policy environment in the English NHS is impacting on the willingness and the focus of GP leaders. GPs are making an important contribution as leaders of health service improvement and redesign but there are significant professional and political barriers to them optimising a leadership role. © British Journal of General Practice 2018.

PET measurements of myocardial blood flow post myocardial infarction: Relationship to invasive and cardiac magnetic resonance studies and potential clinical applications.

PubMed

Gewirtz, Henry

2017-12-01

This review focuses on clinical studies concerning assessment of coronary microvascular and conduit vessel function primarily in the context of acute and sub acute myocardial infarction (MI). The ability of quantitative PET measurements of myocardial blood flow (MBF) to delineate underlying pathophysiology and assist in clinical decision making in this setting is discussed. Likewise, considered are physiological metrics fractional flow reserve, coronary flow reserve, index of microvascular resistance (FFR, CFR, IMR) obtained from invasive studies performed in the cardiac catheterization laboratory, typically at the time of PCI for MI. The role both of invasive studies and cardiac magnetic resonance (CMR) imaging in assessing microvascular function, a key determinant of prognosis, is reviewed. The interface between quantitative PET MBF measurements and underlying pathophysiology, as demonstrated both by invasive and CMR methodology, is discussed in the context of optimal interpretation of the quantitative PET MBF exam and its potential clinical applications.

Entropy driven key-lock assembly.

PubMed

Odriozola, G; Jiménez-Angeles, F; Lozada-Cassou, M

2008-09-21

The effective interaction between a sphere with an open cavity (lock) and a spherical macroparticle (key), both immersed in a hard sphere fluid, is studied by means of Monte Carlo simulations. As a result, a two-dimensional map of the key-lock effective interaction potential is constructed, which leads to the proposal of a self-assembling mechanism: There exists trajectories through which the key-lock pair could assemble avoiding trespassing potential barriers. Hence, solely the entropic contribution can induce their self-assembling even in the absence of attractive forces. This study points out the solvent contribution within the underlying mechanisms of substrate-protein assemblydisassembly processes, which are important steps of the enzyme catalysis and protein mediated transport.

Entropy driven key-lock assembly

NASA Astrophysics Data System (ADS)

Odriozola, G.; Jiménez-Ángeles, F.; Lozada-Cassou, M.

2008-09-01

The effective interaction between a sphere with an open cavity (lock) and a spherical macroparticle (key), both immersed in a hard sphere fluid, is studied by means of Monte Carlo simulations. As a result, a two-dimensional map of the key-lock effective interaction potential is constructed, which leads to the proposal of a self-assembling mechanism: There exists trajectories through which the key-lock pair could assemble avoiding trespassing potential barriers. Hence, solely the entropic contribution can induce their self-assembling even in the absence of attractive forces. This study points out the solvent contribution within the underlying mechanisms of substrate-protein assembly/disassembly processes, which are important steps of the enzyme catalysis and protein mediated transport.

Quantum key management

DOEpatents

Hughes, Richard John; Thrasher, James Thomas; Nordholt, Jane Elizabeth

2016-11-29

Innovations for quantum key management harness quantum communications to form a cryptography system within a public key infrastructure framework. In example implementations, the quantum key management innovations combine quantum key distribution and a quantum identification protocol with a Merkle signature scheme (using Winternitz one-time digital signatures or other one-time digital signatures, and Merkle hash trees) to constitute a cryptography system. More generally, the quantum key management innovations combine quantum key distribution and a quantum identification protocol with a hash-based signature scheme. This provides a secure way to identify, authenticate, verify, and exchange secret cryptographic keys. Features of the quantum key management innovations further include secure enrollment of users with a registration authority, as well as credential checking and revocation with a certificate authority, where the registration authority and/or certificate authority can be part of the same system as a trusted authority for quantum key distribution.

A cluster randomized trial to assess the effect of clinical pathways for patients with stroke: results of the clinical pathways for effective and appropriate care study

PubMed Central

2012-01-01

Background Clinical pathways (CPs) are used to improve the outcomes of acute stroke, but their use in stroke care is questionable, because the evidence on their effectiveness is still inconclusive. The objective of this study was to evaluate whether CPs improve the outcomes and the quality of care provided to patients after acute ischemic stroke. Methods This was a multicentre cluster-randomized trial, in which 14 hospitals were randomized to the CP arm or to the non intervention/usual care (UC) arm. Healthcare workers in the CP arm received 3 days of training in quality improvement of CPs and in use of a standardized package including information on evidence-based key interventions and indicators. Healthcare workers in the usual-care arm followed their standard procedures. The teams in the CP arm developed their CPs over a 6-month period. The primary end point was mortality. Secondary end points were: use of diagnostic and therapeutic procedures, implementation of organized care, length of stay, re-admission and institutionalization rates after discharge, dependency levels, and complication rates. Results Compared with the patients in the UC arm, the patients in the CP arm had a significantly lower risk of mortality at 7 days (OR = 0.10; 95% CI 0.01 to 0.95) and significantly lower rates of adverse functional outcomes, expressed as the odds of not returning to pre-stroke functioning in their daily life (OR = 0.42; 95 CI 0.18 to 0.98). There was no significant effect on 30-day mortality. Compared with the UC arm, the hospital diagnostic and therapeutic procedures were performed more appropriately in the CP arm, and the evidence-based key interventions and organized care were more applied in the CP arm. Conclusions CPs can significantly improve the outcomes of patients with ischemic patients with stroke, indicating better application of evidence-based key interventions and of diagnostic and therapeutic procedures. This study tested a new hypothesis and provided

Family history in primary care: understanding GPs' resistance to clinical genetics--qualitative study.

PubMed

Mathers, Jonathan; Greenfield, Sheila; Metcalfe, Alison; Cole, Trevor; Flanagan, Sarah; Wilson, Sue

2010-05-01

National and local evaluations of clinical genetics service pilots have experienced difficulty in engaging with GPs. To understand GPs' reluctance to engage with clinical genetics service developments, via an examination of the role of family history in general practice. Qualitative study using semi-structured one-to-one interviews. The West Midlands, UK. Interviews with 21 GPs working in 15 practices, based on a stratified random sample from the Midlands Research Practices Consortium database. Thematic analysis proceeded alongside data generation. Framework grids were constructed for comparative analytical questioning. Interpretation was framed by two explanatory models: a knowledge deficit model, and practice and professional identity model. There is a clear distinction between the routine use and function of family history in GPs' clinical decision making, and contrasting conceptualisations of genetics and 'genetic conditions'. Although genetics is clearly a part of current GP practice, with acknowledgement of genetic components to multifactorial disease, this is distinguished from 'genetic conditions' which are seen as rare, complex single-gene disorders. Importantly, family history takes its place within a broader notion of the 'family doctor' that interviewees identified as a key aspect of their role. In contrast, clinical genetics was not identified as a core component of generalist practice. The likely effectiveness of educational policy interventions aimed at GPs that focus solely on knowledge deficit models, is questionable. There is a need to acknowledge how appropriate practice is constructed by GPs, within the context of accepted generalist roles and related identities.

Molecular Pharmacology of Malignant Pleural Mesothelioma: Challenges and Perspectives From Preclinical and Clinical Studies.

PubMed

Thellung, Stefano; Favoni, Roberto E; Würth, Roberto; Nizzari, Mario; Pattarozzi, Alessandra; Daga, Antonio; Florio, Tullio; Barbieri, Federica

2016-01-01

Malignant pleural mesothelioma (MPM) is one of the deadliest and most heterogeneous tumors, highly refractory to multimodal therapeutic approach, including surgery, chemo- and radiotherapy. Preclinical and clinical studies exploring the efficacy of drugs targeting tyrosine kinases, angiogenesis and histone deacetylases, did not fulfil the expected clinical benefits. Thus, novel molecular targets should be identified from a definite knowledge of the unique biology and most relevant transduction pathways of MPM cells. Cancer stem cells (CSCs) are a subset of malignant precursors responsible for initiation, progression, resistance to cytotoxic drugs, recurrence and metastatic diffusion of tumor cells. CSCs are putative driving factors for MPM development and contribute to its clinical and biological heterogeneity; hence, targeted eradication of CSCs represents an ineludible goal to counteract MPM aggressiveness. In this context, innovative preclinical models could be exploited to identify novel intracellular pathway inhibitors able to target CSC viability. Novel drug targets have been identified among key factors responsible for the oncogenic transformation of mesothelial cells, often directly induced by asbestos. These include mitogenic and anti-apoptotic signaling that may also be activated by autocrine and paracrine cytokine pathways controlling cell plasticity. Both signaling pathways affecting proto-oncogene and transcription factor expression, or genetic and epigenetic alterations, such as mutations in cell cycle genes and silencing of tumor suppressor genes, represent promising disease-specific targets. In this review we describe current knowledge of MPM cell biology, focusing on potential targets to be tested in pharmacological studies, and highlighting results and challenges of clinical translation.

How the World's Best Schools Stay on Top: Study's Key Findings Pinpoint Practices That Align with Learning Forward

ERIC Educational Resources Information Center

Killion, Joellen

2016-01-01

Key findings from a new study highlight how Learning Forward's long-standing position on professional learning correlates with practices in high-performing systems in Singapore, Shanghai, Hong Kong, and British Columbia. The purpose of this article is to share key findings from the study so that educators might apply them to strengthening…

Data capture by digital pen in clinical trials: a qualitative and quantitative study.

PubMed

Estellat, Candice; Tubach, Florence; Costa, Yolande; Hoffmann, Isabelle; Mantz, Jean; Ravaud, Philippe

2008-05-01

To investigate the use of the digital pen (DP) system to collect data in a clinical trial. To assess the accuracy of the system in this setting. Qualitative study based on semistructured interviews and a focus group. Quantitative study comparing the DP system and a double manual data-entry system in accuracy of acquiring data by variable type (tick boxes, dates, numbers, letters). An ongoing randomised multicentric clinical trial in tertiary care in France. 27 investigators involved in the trial (anaesthetists) who did or did not include patients, 4 study monitors and the study coordinator. Six key findings emerged: 1) the DP system was easy to use; its utilisation was intuitive, even for investigators inexperienced in informatics; 2) despite its portability, the DP was not always used in front of patients; 3) the DP system did not affect patient recruitment; 4) most of the technical problems of the system occurred during setup (compatibility, password access, antivirus software); 5) the main advantage was quickness of data availability for the study coordination staff and the main hindrance was the extra time required for online verification; and 6) all investigators were ready to use the system again. The investigators had to check 16% of data obtained by the DP system during the verification step. There is no relevant difference between the number of errors for the DP and the double manual data-entry systems: 8/5022 versus 6/5022 data entries. 5 out of 8 DP-system failures were due to the intelligent character recognition system. The DP system has a good acceptability among all investigators in a clinical setting, whether they are experienced with computers or not, and a good accuracy, as compared with double manual data entry.

Towards Data Value-Level Metadata for Clinical Studies.

PubMed

Zozus, Meredith Nahm; Bonner, Joseph

2017-01-01

While several standards for metadata describing clinical studies exist, comprehensive metadata to support traceability of data from clinical studies has not been articulated. We examine uses of metadata in clinical studies. We examine and enumerate seven sources of data value-level metadata in clinical studies inclusive of research designs across the spectrum of the National Institutes of Health definition of clinical research. The sources of metadata inform categorization in terms of metadata describing the origin of a data value, the definition of a data value, and operations to which the data value was subjected. The latter is further categorized into information about changes to a data value, movement of a data value, retrieval of a data value, and data quality checks, constraints or assessments to which the data value was subjected. The implications of tracking and managing data value-level metadata are explored.

Key Reconciliation for High Performance Quantum Key Distribution

PubMed Central

Martinez-Mateo, Jesus; Elkouss, David; Martin, Vicente

2013-01-01

Quantum Key Distribution is carving its place among the tools used to secure communications. While a difficult technology, it enjoys benefits that set it apart from the rest, the most prominent is its provable security based on the laws of physics. QKD requires not only the mastering of signals at the quantum level, but also a classical processing to extract a secret-key from them. This postprocessing has been customarily studied in terms of the efficiency, a figure of merit that offers a biased view of the performance of real devices. Here we argue that it is the throughput the significant magnitude in practical QKD, specially in the case of high speed devices, where the differences are more marked, and give some examples contrasting the usual postprocessing schemes with new ones from modern coding theory. A good understanding of its implications is very important for the design of modern QKD devices. PMID:23546440

Advances in clinical study of curcumin.

PubMed

Yang, Chunfen; Su, Xun; Liu, Anchang; Zhang, Lin; Yu, Aihua; Xi, Yanwei; Zhai, Guangxi

2013-01-01

Curcumin has been estimated as a potential agent for many diseases and attracted great attention owing to its various pharmacological activities, including anti-cancer, and anti-inflammatory. Now curcumin is being applied to a number of patients with breast cancer, rheumatoid arthritis, Alzheimer's disease, colorectal cancer, psoriatic, etc. Several clinical trials have stated that curcumin is safe enough and effective. The objective of this article was to summarize the clinical studies of curcumin, and give a reference for future studies.

Analysis of causality from observational studies and its application in clinical research in Intensive Care Medicine.

PubMed

Coscia Requena, C; Muriel, A; Peñuelas, O

2018-02-28

Random allocation of treatment or intervention is the key feature of clinical trials and divides patients into treatment groups that are approximately balanced for baseline, and therefore comparable covariates except for the variable treatment of the study. However, in observational studies, where treatment allocation is not random, patients in the treatment and control groups often differ in covariates that are related to intervention variables. These imbalances in covariates can lead to biased estimates of the treatment effect. However, randomized clinical trials are sometimes not feasible for ethical, logistical, economic or other reasons. To resolve these situations, interest in the field of clinical research has grown in designing studies that are most similar to randomized experiments using observational (i.e. non-random) data. Observational studies using propensity score analysis methods have been increasing in the scientific papers of Intensive Care. Propensity score analyses attempt to control for confounding in non-experimental studies by adjusting for the likelihood that a given patient is exposed. However, studies with propensity indexes may be confusing, and intensivists are not familiar with this methodology and may not fully understand the importance of this technique. The objectives of this review are: to describe the fundamentals of propensity index methods; to present the techniques to adequately evaluate propensity index models; to discuss the advantages and disadvantages of these techniques. Copyright © 2018 Elsevier España, S.L.U. y SEMICYUC. All rights reserved.

Barriers and opportunities for enhancing patient recruitment and retention in clinical research: findings from an interview study in an NHS academic health science centre.

PubMed

Adams, Mary; Caffrey, Louise; McKevitt, Christopher

2015-03-12

In the UK, the recruitment of patients into clinical research is a national health research and development policy priority. There has been limited investigation of how national level factors operate as barriers or facilitators to recruitment work, particularly from the perspective of staff undertaking patient recruitment work. The aim of this study is to identify and examine staff views of the key organisational barriers and facilitators to patient recruitment work in one clinical research group located in an NHS Academic Health Science Centre. A qualitative study utilizing in-depth, one-to-one semi-structured interviews with 11 purposively selected staff with particular responsibilities to recruit and retain patients as clinical research subjects. Thematic analysis classified interview data by recurring themes, concepts, and emergent categories for the purposes of establishing explanatory accounts. The findings highlight four key factors that staff perceived to be most significant for the successful recruitment and retention of patients in research and identify how staff located these factors within patients, studies, the research centre, the trust, and beyond the trust. Firstly, competition for research participants at an organisational and national level was perceived to undermine recruitment success. Secondly, the tension between clinical and clinical research workloads was seen to interrupt patient recruitment into studies, despite national funding arrangements to manage excess treatment costs. Thirdly, staff perceived an imbalance between personal patient burden and benefit. Ethical committee regulation, designed to protect patients, was perceived by some staff to detract from clarification and systematisation of incentivisation strategies. Finally, the structure and relationships within clinical research teams, in particular the low tacit status of recruitment skills, was seen as influential. The results of this case-study, conducted in an exemplary NHS

Clinic Workflow Simulations using Secondary EHR Data

PubMed Central

Hribar, Michelle R.; Biermann, David; Read-Brown, Sarah; Reznick, Leah; Lombardi, Lorinna; Parikh, Mansi; Chamberlain, Winston; Yackel, Thomas R.; Chiang, Michael F.

2016-01-01

Clinicians today face increased patient loads, decreased reimbursements and potential negative productivity impacts of using electronic health records (EHR), but have little guidance on how to improve clinic efficiency. Discrete event simulation models are powerful tools for evaluating clinical workflow and improving efficiency, particularly when they are built from secondary EHR timing data. The purpose of this study is to demonstrate that these simulation models can be used for resource allocation decision making as well as for evaluating novel scheduling strategies in outpatient ophthalmology clinics. Key findings from this study are that: 1) secondary use of EHR timestamp data in simulation models represents clinic workflow, 2) simulations provide insight into the best allocation of resources in a clinic, 3) simulations provide critical information for schedule creation and decision making by clinic managers, and 4) simulation models built from EHR data are potentially generalizable. PMID:28269861

Clinically unrecognized miliary tuberculosis: an autopsy study.

PubMed

Savic, Ivana; Trifunovic-Skodric, Vesna; Mitrovic, Dragan

2016-01-01

Miliary tuberculosis (TB) usually presents with atypical clinical manifestations; thus it is often recognized only at autopsy. Our objectives were to study the frequency of MT diagnosed at autopsy and determine clinical diagnoses that masked TB, as well as causes of death and comorbidities. Retrospective study of all autopsies performed between 2008 and 2014. Institute of Pathology, Belgrade, Serbia. in subjects where autopsy showed the presence of MT that was not recognized clinically, we recorded the clinical diagnoses (presumed causes of death) as reported in autopsy request forms, as well as actual cause of death and comorbidities as determined at autopsy. Clinically unrecognized MT. The total number of autopsies in this period was 6206. thirty-five individuals showed clinically unrecognized MT (0.56% of all autopsies, age: 62.2 [17.2] years, M:F=2:3). Common clinical diagnoses masking pulmonary MT were exacerbation of COPD (25%) and pulmonary thromboembolism (25%), with common radiological presentation of diffuse pulmonary infiltrates (56.3%). Dominant clinical diagnoses in patients with generalized MT were adult respiratory distress syndrome, sepsis, gastrointestinal bleeding and meningoencephalitis. Disseminated MT was often associated with secondary anemia or thrombocytopenia (15.8%) and recent surgery (15.8%). Frequent comorbidities included chronic renal failure and malignancies, whereas MT was a dominant cause of death. Greater awareness of MT is needed to improve recognition in clinical settings. In particular, MT should be considered in patients with atypical clinical presentation and diffuse pulmonary infiltrates on chest X-ray, particularly if they have chronic renal failure, malignancy, hematological disorders or a history of recent surgery. None.

Key ingredients of anti-stigma programs for health care providers: a data synthesis of evaluative studies.

PubMed

Knaak, Stephanie; Modgill, Geeta; Patten, Scott B

2014-10-01

As part of its ongoing effort to combat stigma against mental illness among health care providers, the Mental Health Commission of Canada partnered with organizations conducting anti-stigma interventions. Our objective was to evaluate program effectiveness and to better understand what makes some programs more effective than others. Our paper reports the elements of these programs found to be most strongly associated with favourable outcomes. Our study employed a multi-phased, mixed-methods design. First, a grounded theory qualitative study was undertaken to identify key program elements. Next, each program (n = 22) was coded according to the presence or absence of the identified key program ingredients. Then, random-effects, meta-regression modelling was used to examine the association between program outcomes and the key ingredients. The qualitative analysis led to a 6-ingredient model of key program elements. Results of the quantitative analysis showed that programs that included all 6 of these ingredients performed significantly better than those that did not. Individual analyses of each of the 6 ingredients showed that including multiple forms of social contact and emphasizing recovery were characteristics of the most effective programs. The results provide a validation of a 6-ingredient model of key program elements for anti-stigma programming for health care providers. Emphasizing recovery and including multiple types of social contact are of particular importance for maximizing the effectiveness of anti-stigma programs for health care providers.

Algorithms for Lightweight Key Exchange.

PubMed

Alvarez, Rafael; Caballero-Gil, Cándido; Santonja, Juan; Zamora, Antonio

2017-06-27

Public-key cryptography is too slow for general purpose encryption, with most applications limiting its use as much as possible. Some secure protocols, especially those that enable forward secrecy, make a much heavier use of public-key cryptography, increasing the demand for lightweight cryptosystems that can be implemented in low powered or mobile devices. This performance requirements are even more significant in critical infrastructure and emergency scenarios where peer-to-peer networks are deployed for increased availability and resiliency. We benchmark several public-key key-exchange algorithms, determining those that are better for the requirements of critical infrastructure and emergency applications and propose a security framework based on these algorithms and study its application to decentralized node or sensor networks.

[Scientific, practical and educational aspects of clinical epidemiology].

PubMed

Briko, N I

2012-01-01

This article defines clinical epidemiology and describes its goal and objectives. The author claims that clinical epidemiology is a section of epidemiology which underlies the development of evidence-based standards for diagnostics, treatment and prevention and helps to select the appropriate algorithm for each clinical case. The study provides a comprehensive overview of the relationship between clinical epidemiology and evidence-based medicine. Epidemiological research is shown to be methodological basis of clinical epidemiology and evidence-based medicine with randomized controlled trials being the "gold standard" for obtaining reliable data. The key stages in the history of clinical epidemiology are discussed and further development of clinical epidemiology and the integration of courses on clinical epidemiology in education is outlined for progress in medical research and health care practice.

"We're the Mature People": A Study of Masculine Subjectivity and Its Relationship to Key Stage Four Religious Studies

ERIC Educational Resources Information Center

Farrell, Francis

2015-01-01

Critical theory and research has shown that subjects carry gendered meanings. Numbers opting for Religious Studies (RS) have remained skewed towards girls. Drawing from post-structuralism and masculinities theory, this article critically analyses data from interviews with a group of key stage four boys who had opted for Religious Studies in…

The Weiland Medal: Clinical Research in Hand Surgery

PubMed Central

Chung, Kevin C.

2015-01-01

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

Impact of the European clinical trials directive on prospective academic clinical trials associated with BMT.

PubMed

Frewer, L J; Coles, D; van der Lans, I A; Schroeder, D; Champion, K; Apperley, J F

2011-03-01

The European Clinical Trials Directive (EU 2001; 2001/20/EC) was introduced to improve the efficiency of commercial and academic clinical trials. Concerns have been raised by interested organizations and institutions regarding the potential for negative impact of the Directive on non-commercial European clinical research. Interested researchers within the European Group for Blood and Marrow Transplantation (EBMT) were surveyed to determine whether researcher experiences confirmed this view. Following a pilot study, an internet-based questionnaire was distributed to individuals in key research positions in the European haemopoietic SCT community. Seventy-one usable questionnaires were returned from participants in different EU member states. The results indicate that the perceived impact of the European Clinical Trials Directive has been negative, at least in the research areas of interest to the EBMT.

Facilitating Case Studies in Massage Therapy Clinical Education

PubMed Central

Baskwill, Amanda

2013-01-01

The integration of evidence into reflective health care practice has been on the rise in recent years and is a phenomenon that has affected all health care professions, including massage therapy. Clinical case studies are a research design that follows one patient or subject, making the studies ideal for use in clinical practice. They are valuable for communicating information from clinical practice to the broader community. Case studies have face validity that may be more valuable to individual practitioners than homogeneous randomized controlled trials, as the practitioner may recognize a complex patient in the case report. At Humber College, Student Massage Therapists (SMTs) create, conduct, and communicate results of a clinical case study prior to graduation. This article describes the process and experience. PMID:23730397

Translation of nondopaminergic treatments for levodopa-induced dyskinesia from MPTP-lesioned nonhuman primates to phase IIa clinical studies: keys to success and roads to failure.

PubMed

Fox, Susan H; Lang, Anthony E; Brotchie, Jonathan M

2006-10-01

Studies in MPTP-lesioned nonhuman primates have demonstrated the potential of nondopaminergic drugs in reducing the problems of levodopa-induced dyskinesia (LID). Here we review the process of translating findings from the monkey to man. Agents targeting glutamate, adensosine, noradrenaline, 5-hydroxytryptamine, cannabinoid, and opioid transmitter systems have been assessed for antidyskinetic potential in human studies. Eleven nondopaminergic drugs with antidyskinetic efficacy in the MPTP primate have been advanced to proof-of-concept phase IIa trials in PD patients (amantadine, istradefylline, idazoxan, fipamezole, sarizotan, quetiapine, clozapine, nabilone, rimonabant, naloxone, and naltrexone). For all six nondopaminergic transmitter systems reviewed, the MPTP-lesioned primate correctly predicted phase II efficacy of at least one drug. Of the 11 specific molecules tested in both monkeys and humans, 8 showed clear antidyskinetic properties in both human and monkey. In the instances where the primate studies did not, or did not consistently, predict the outcome of the human studies, the discrepancy may reflect limitations in the validity of the model or limitations in the design of either the clinical or the preclinical studies. We find that the major determinant of success in predicting efficacy is to ensure that primate studies are conducted in a statistically rigorous way and incorporate designs and outcome measures with clinical applicability. On the other hand, phase IIa trials should strive to replicate the preclinical study, especially in terms of protocol, drug dose equivalence, and outcome measure, so as to test the same hypothesis. Failure to meet these criteria carries the risk of false negative conclusions in phase IIa trials.

Parents' perceived obstacles to pediatric clinical trial participation: Findings from the clinical trials transformation initiative.

PubMed

Greenberg, Rachel G; Gamel, Breck; Bloom, Diane; Bradley, John; Jafri, Hasan S; Hinton, Denise; Nambiar, Sumathi; Wheeler, Chris; Tiernan, Rosemary; Smith, P Brian; Roberts, Jamie; Benjamin, Daniel K

2018-03-01

Enrollment of children into pediatric clinical trials remains challenging. More effective strategies to improve recruitment of children into trials are needed. This study used in-depth qualitative interviews with parents who were approached to enroll their children in a clinical trial in order to gain an understanding of the barriers to pediatric clinical trial participation. Twenty-four parents whose children had been offered the opportunity to participate in a clinical trial were interviewed: 19 whose children had participated in at least 1 clinical trial and 5 who had declined participation in any trial. Each study aspect, from the initial explanation of the study to the end of the study, can affect the willingness of parents to consent to the proposed study and future studies. Establishing trust, appropriate timing, a transparent discussion of risks and benefits oriented to the layperson, and providing motivation for children to participate were key factors that impacted parents' decisions. In order for clinical trial accrual to be successful, parents' priorities and considerations must be a central focus, beginning with initial trial design. The recommendations from the parents who participated in this study can be used to support budget allocations that ensure adequate training of study staff and improved staffing on nights and weekends. Studies of parent responses in outpatient settings and additional inpatient settings will provide valuable information on the consent process from the child's and parent's perspectives. Further studies are needed to explore whether implementation of such strategies will result in improved recruitment for pediatric clinical trials.

Best practices for clinical pathology testing in carcinogenicity studies.

PubMed

Young, Jamie K; Hall, Robert L; O'Brien, Peter; Strauss, Volker; Vahle, John L

2011-02-01

The Society of Toxicologic Pathology (STP) and American Society for Veterinary Clinical Pathology (ASCVP) convened a Clinical Pathology in Carcinogenicity Studies Working Group to recommend best practices for inclusion of clinical pathology testing in carcinogenicity studies. Regulatory guidance documents and literature were reviewed, and veterinary pathologists from North America, Japan, and Europe were surveyed regarding current practices, perceived value, and recommendations for clinical pathology testing in carcinogenicity studies. For two-year rodent carcinogenicity studies, the Working Group recommends that clinical pathology testing be limited to collection of blood smears at scheduled and unscheduled sacrifices to be examined only if indicated to aid in the diagnosis of possible hematopoietic neoplasia following histopathologic evaluation. Additional clinical pathology testing is most appropriately used to address specific issues from prior toxicity studies or known test article-related class effects. Inadequate data were available to make a recommendation concerning clinical pathology testing for alternative six-month carcinogenicity assays using genetically modified mice, although the Working Group suggests that it may be appropriate to use the same approach as for two-year carcinogenicity studies since the study goal is the same.

A Study of Clinically Related Open Source Software Projects

PubMed Central

Hogarth, Michael A.; Turner, Stuart

2005-01-01

Open source software development has recently gained significant interest due to several successful mainstream open source projects. This methodology has been proposed as being similarly viable and beneficial in the clinical application domain as well. However, the clinical software development venue differs significantly from the mainstream software venue. Existing clinical open source projects have not been well characterized nor formally studied so the ‘fit’ of open source in this domain is largely unknown. In order to better understand the open source movement in the clinical application domain, we undertook a study of existing open source clinical projects. In this study we sought to characterize and classify existing clinical open source projects and to determine metrics for their viability. This study revealed several findings which we believe could guide the healthcare community in its quest for successful open source clinical software projects. PMID:16779056

Asking Questions as a Key Strategy in Guiding a Novice Teacher: A Self-Study

ERIC Educational Resources Information Center

Olsher, Gila; Kantor, Itay-Danny

2012-01-01

This self-study explores the instruction of a novice teacher by an expert mentor teacher, while applying the strategy of asking questions instead of the more common pattern of giving advice and guidance in the form of telling. The study examines the educational potential embedded in the question-asking strategy as a key mentoring resource when…

Identification of the Key Fields and Their Key Technical Points of Oncology by Patent Analysis.

PubMed

Zhang, Ting; Chen, Juan; Jia, Xiaofeng

2015-01-01

This paper aims to identify the key fields and their key technical points of oncology by patent analysis. Patents of oncology applied from 2006 to 2012 were searched in the Thomson Innovation database. The key fields and their key technical points were determined by analyzing the Derwent Classification (DC) and the International Patent Classification (IPC), respectively. Patent applications in the top ten DC occupied 80% of all the patent applications of oncology, which were the ten fields of oncology to be analyzed. The number of patent applications in these ten fields of oncology was standardized based on patent applications of oncology from 2006 to 2012. For each field, standardization was conducted separately for each of the seven years (2006-2012) and the mean of the seven standardized values was calculated to reflect the relative amount of patent applications in that field; meanwhile, regression analysis using time (year) and the standardized values of patent applications in seven years (2006-2012) was conducted so as to evaluate the trend of patent applications in each field. Two-dimensional quadrant analysis, together with the professional knowledge of oncology, was taken into consideration in determining the key fields of oncology. The fields located in the quadrant with high relative amount or increasing trend of patent applications are identified as key ones. By using the same method, the key technical points in each key field were identified. Altogether 116,820 patents of oncology applied from 2006 to 2012 were retrieved, and four key fields with twenty-nine key technical points were identified, including "natural products and polymers" with nine key technical points, "fermentation industry" with twelve ones, "electrical medical equipment" with four ones, and "diagnosis, surgery" with four ones. The results of this study could provide guidance on the development direction of oncology, and also help researchers broaden innovative ideas and discover new

Clinical audit of COPD in outpatient respiratory clinics in Spain: the EPOCONSUL study.

PubMed

Calle Rubio, Myriam; Alcázar Navarrete, Bernardino; Soriano, Joan B; Soler-Cataluña, Juan J; Rodríguez González-Moro, José Miguel; Fuentes Ferrer, Manuel E; López-Campos, José Luis

2017-01-01

Chronic obstructive pulmonary disease (COPD) outpatients account for a large burden of usual care by respirologists. EPOCONSUL is the first national clinical audit conducted in Spain on the medical care for COPD patients delivered in outpatient respiratory clinics. We aimed to evaluate the clinical interventions and the degree of adherence to recommendations in outpatients of current COPD clinical practice guidelines. This is an observational study with prospective recruitment (May 2014-May 2015) of patients with a COPD diagnosis as seen in outpatient respiratory clinics. The information collected was historical in nature as for the clinical data of the last and previous consultations, and the information concerning hospital resources was concurrent. A total of 17,893 clinical records of COPD patients in outpatient respiratory clinics from 59 Spanish hospitals were evaluated. Of the 5,726 patients selected, 4,508 (78.7%) were eligible. Overall, 12.1% of COPD patients did not fulfill a diagnostic spirometry criteria. Considerable variability existed in the available resources and work organization of the hospitals, although the majority were university hospitals with respiratory inpatient units. There was insufficient implementation of clinical guidelines in preventive and educational matters. In contrast, quantitative evaluation of dyspnea grade (81.9%) and exacerbation history (70.9%) were more frequently performed. Only 12.4% had COPD severity calculated according to the Body mass index, airflow Obstruction, Dyspnoea and Exercise capacity (BODE) index. Phenotype characteristics according to Spanish National Guideline for COPD were determined in 46.3% of the audited patients, and the risk evaluation according to Global initiative for chronic Obstructive Lung Disease was estimated only in 21.9%. The EPOCONSUL study reports the current situation of medical care for COPD patients in outpatient clinics in Spain, revealing its variability, strengths, and weaknesses

Behavioral and language variants of frontotemporal dementia: a review of key symptoms.

PubMed

Laforce, Robert

2013-12-01

While recent advances in the development of neuroimaging and molecular biomarkers for studying neurodegenerative conditions have revolutionized the field, dementia remains a clinical diagnosis. No component of the diagnostic process is more crucial than obtaining a good history. Getting to know the first manifestations of the disease, tracking their evolution and functional impact, combined with a targeted neurological examination, further guides differential diagnosis. This paper summarizes the key symptoms of the behavioral and language variants of frontotemporal dementia. The behavioral variant of frontotemporal dementia (bvFTD) is characterized by severe changes in behavior and personality such as disinhibition, apathy, loss of empathy, or stereotypic behavior, leading to a loss of social competence. Executive functions are impaired, while memory and visuospatial skills are relatively better preserved. By contrast, the language variants or primary progressive aphasias (PPAs) are marked by prominent language disturbances that can be subclassified into a non-fluent/agrammatic variant (naPPA), a semantic variant (svPPA), and a logopenic variant (lvPPA). Although combined characterization of clinical, imaging, biological and genetic biomarkers is essential to establish a detailed diagnosis of such heterogeneous conditions, the author emphasizes the importance of accurate recognition of key symptoms that can lead to better identification of underlying neuropathology and appropriate treatment approaches.

Psychological factors mediate key symptoms of fibromyalgia through their influence on stress.

PubMed

Malin, Katrina; Littlejohn, Geoffrey Owen

2016-09-01

The clinical features of fibromyalgia are associated with various psychological factors, including stress. We examined the hypothesis that the path that psychological factors follow in influencing fibromyalgia symptoms is through their direct effect on stress. Ninety-eight females with ACR 1990 classified fibromyalgia completed the following questionnaires: The Big 5 Personality Inventory, Fibromyalgia Impact Questionnaire, Perceived Stress Scale, Profile of Mood States, Mastery Scale, and Perceived Control of Internal States Scale. SPSS (PASW version 22) was used to perform basic t tests, means, and standard deviations to show difference between symptom characteristics. Pathway analysis using structural equation modelling (Laavan) examined the effect of stress on the relationships between psychological factors and the elements that define the fibromyalgia phenotype. The preferred model showed that the identified path clearly linked the psychological variables of anxiety, neuroticism and mastery, but not internal control, to the three key elements of fibromyalgia, namely pain, fatigue and sleep (p < 0.001), via the person's perceived stress. Confusion, however, did not fit the preferred model. This study confirms that stress is a necessary link in the pathway between certain identified, established and significant psychological factors and key fibromyalgia symptoms. This has implications for the understanding of contributing mechanisms and the clinical care of patients with fibromyalgia.

A pilot study of distributed knowledge management and clinical decision support in the cloud.

PubMed

Dixon, Brian E; Simonaitis, Linas; Goldberg, Howard S; Paterno, Marilyn D; Schaeffer, Molly; Hongsermeier, Tonya; Wright, Adam; Middleton, Blackford

2013-09-01

Implement and perform pilot testing of web-based clinical decision support services using a novel framework for creating and managing clinical knowledge in a distributed fashion using the cloud. The pilot sought to (1) develop and test connectivity to an external clinical decision support (CDS) service, (2) assess the exchange of data to and knowledge from the external CDS service, and (3) capture lessons to guide expansion to more practice sites and users. The Clinical Decision Support Consortium created a repository of shared CDS knowledge for managing hypertension, diabetes, and coronary artery disease in a community cloud hosted by Partners HealthCare. A limited data set for primary care patients at a separate health system was securely transmitted to a CDS rules engine hosted in the cloud. Preventive care reminders triggered by the limited data set were returned for display to clinician end users for review and display. During a pilot study, we (1) monitored connectivity and system performance, (2) studied the exchange of data and decision support reminders between the two health systems, and (3) captured lessons. During the six month pilot study, there were 1339 patient encounters in which information was successfully exchanged. Preventive care reminders were displayed during 57% of patient visits, most often reminding physicians to monitor blood pressure for hypertensive patients (29%) and order eye exams for patients with diabetes (28%). Lessons learned were grouped into five themes: performance, governance, semantic interoperability, ongoing adjustments, and usability. Remote, asynchronous cloud-based decision support performed reasonably well, although issues concerning governance, semantic interoperability, and usability remain key challenges for successful adoption and use of cloud-based CDS that will require collaboration between biomedical informatics and computer science disciplines. Decision support in the cloud is feasible and may be a reasonable

Ethnic bias and clinical decision-making among New Zealand medical students: an observational study.

PubMed

Harris, Ricci; Cormack, Donna; Stanley, James; Curtis, Elana; Jones, Rhys; Lacey, Cameron

2018-01-23

Health professional racial/ethnic bias may impact on clinical decision-making and contribute to subsequent ethnic health inequities. However, limited research has been undertaken among medical students. This paper presents findings from the Bias and Decision-Making in Medicine (BDMM) study, which sought to examine ethnic bias (Māori (indigenous peoples) compared with New Zealand European) among medical students and associations with clinical decision-making. All final year New Zealand (NZ) medical students in 2014 and 2015 (n = 888) were invited to participate in a cross-sectional online study. Key components included: two chronic disease vignettes (cardiovascular disease (CVD) and depression) with randomized patient ethnicity (Māori or NZ European) and questions on patient management; implicit bias measures (an ethnicity preference Implicit Association Test (IAT) and an ethnicity and compliant patient IAT); and, explicit ethnic bias questions. Associations between ethnic bias and clinical decision-making responses to vignettes were tested using linear regression. Three hundred and two students participated (34% response rate). Implicit and explicit ethnic bias favoring NZ Europeans was apparent among medical students. In the CVD vignette, no significant differences in clinical decision-making by patient ethnicity were observed. There were also no differential associations by patient ethnicity between any measures of ethnic bias (implicit or explicit) and patient management responses in the CVD vignette. In the depression vignette, some differences in the ranking of recommended treatment options were observed by patient ethnicity and explicit preference for NZ Europeans was associated with increased reporting that NZ European patients would benefit from treatment but not Māori (slope difference 0.34, 95% CI 0.08, 0.60; p = 0.011), although this was the only significant finding in these analyses. NZ medical students demonstrated ethnic bias, although

Evaluation systems for clinical governance development: a comparative study.

PubMed

Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Ebrahimipour, Hossein

2014-01-01

Lack of scientific and confirmed researches and expert knowledge about evaluation systems for clinical governance development in Iran have made studies on different evaluation systems for clinical governance development a necessity. These studies must provide applied strategies to design criteria of implementing clinical governance for hospital's accreditation. This is a descriptive and comparative study on development of clinical governance models all over the world. Data have been gathered by reviewing related articles. Models have been studied in comprehensive review method. The evaluated models of clinical governance development were Australian, NHS, SPOCK and OPTIGOV. The final aspects extracted from these models were Responsiveness, Policies and Strategies, Organizational Structure, Allocating Resources, Education and Occupational Development, Performance Evaluation, External Evaluation, Patient Oriented Approach, Risk Management, Personnel's Participation, Information Technology, Human Resources, Research and Development, Evidence Based Medicine, Clinical Audit, Health Technology Assessment and Quality. These results are applicable for completing the present criteria which evaluating clinical governance application and provide practical framework to evaluate country's hospital on the basis of clinical governance elements.

Social Pharmacy and Clinical Pharmacy-Joining Forces.

PubMed

Almarsdottir, Anna Birna; Granas, Anne Gerd

2015-12-22

This commentary seeks to define the areas of social pharmacy and clinical pharmacy to uncover what they have in common and what still sets them apart. Common threats and challenges of the two areas are reviewed in order to understand the forces in play. Forces that still keep clinical and social pharmacy apart are university structures, research traditions, and the management of pharmacy services. There are key (but shrinking) differences between clinical and social pharmacy which entail the levels of study within pharmaceutical sciences, the location in which the research is carried out, the choice of research designs and methods, and the theoretical foundations. Common strengths and opportunities are important to know in order to join forces. Finding common ground can be developed in two areas: participating together in multi-disciplinary research, and uniting in a dialogue with internal and external key players in putting forth what is needed for the profession of pharmacy. At the end the question is posed, "What's in a name?" and we argue that it is important to emphasize what unifies the families of clinical pharmacy and social pharmacy for the benefit of both fields, pharmacy in general, and society at large.

[Are non-clinical studies predictive of adverse events in humans?].

PubMed

Claude, N

2007-09-01

The predictibility of adverse events induced by drugs in non-clinical safety studies performed on in vitro and/or in vivo models is a key point for the safety of humans exposed to pharmaceuticals. The strength and the weakness of animal studies to predict human toxicity were assessed by an international study on the concordance of the toxicity of 150 pharmaceuticals observed in humans with that observed in experimental animals. The results showed a good correlation (70% of the adverse events in humans were detected in animal studies) and an early time to first appearance of concordant animal toxicity: 94% were first observed in studies of 1 month or less in duration. The highest incidence of overall concordance was seen in hematological and cardiovascular adverse effects and the least was seen in cutaneous and ophthalmological adverse effects. These studies, scientifically and regulatory standardized, need, in some cases to be adapted to specific problems linked to sensitive populations (young, old or with a pathology which could be worsened by the drug), or specific pharmaceuticals (produced by biotechnology). Some severe adverse events are not detected in conventional animal models (immuno-allergy, idiosyncrasy). Taken together, these elements support the value of toxicology studies to predict many human toxic events associated with pharmaceuticals. Nevertheless, a part of human toxicity is not detected by these experimental approaches, and new tools developed through progress in biology and bio-informatics should reduce this uncertainly margin.

Clinical studies in orthodontics--an overview of NIDR-sponsored clinical orthodontic studies in the US.

PubMed

Baumrind, S

1998-11-01

A number of clinical trials sponsored by the National Institutes of Health (NIH) use rigorous methods of data acquisition and analysis previously developed in fundamental biology and the physical sciences. The naive expectation that these trials would lead relatively rapidly to definitive answers concerning the therapeutic strategies and techniques under study is dispelled. This presentation focuses on delineating differences between the study of central tendencies and individual variation, more specifically on the strategy to study this variation: measure additional sources of variance within each patient at more timepoints and perhaps with greater precision. As rigorous orthodontic research is still in its infancy, the problem of defining the proper mix between prospective and retrospective trials is discussed. In view of the high costs of prospective clinical trials, many of the questions germane to orthodontics can be answered by well-conducted retrospective trials, assuming that properly randomized sampling procedures are employed. Definitive clinical trials are likely to require better theoretical constructs, better instrumentation, and better measures than now available. Reasons for concern are the restricted resources available and the fact that current mensurational approaches may not detect many of the individual differences. The task of constructing sharable databases and record bases stored in digital form and available either remotely from servers, or locally from CD-ROMs or optical disks, is crucial to the optimization of future investigations.

Neural Correlates of Intolerance of Uncertainty in Clinical Disorders.

PubMed

Wever, Mirjam; Smeets, Paul; Sternheim, Lot

2015-01-01

Intolerance of uncertainty is a key contributor to anxiety-related disorders. Recent studies highlight its importance in other clinical disorders. The link between its clinical presentation and the underlying neural correlates remains unclear. This review summarizes the emerging literature on the neural correlates of intolerance of uncertainty. In conclusion, studies focusing on the neural correlates of this construct are sparse, and findings are inconsistent across disorders. Future research should identify neural correlates of intolerance of uncertainty in more detail. This may unravel the neurobiology of a wide variety of clinical disorders and pave the way for novel therapeutic targets.

Clinical Impact Research - how to choose experimental or observational intervention study?

PubMed

Malmivaara, Antti

2016-11-01

Interventions directed to individuals by health and social care systems should increase health and welfare of patients and customers. This paper aims to present and define a new concept Clinical Impact Research (CIR) and suggest which study design, either randomized controlled trial (RCT) (experimental) or benchmarking controlled trial (BCT) (observational) is recommendable and to consider the feasibility, validity, and generalizability issues in CIR. The new concept is based on a narrative review of the literature and on author's idea that in intervention studies, there is a need to cover comprehensively all the main impact categories and their respective outcomes. The considerations on how to choose the most appropriate study design (RCT or BCT) were based on previous methodological studies on RCTs and BCTs and on author's previous work on the concepts benchmarking controlled trial and system impact research (SIR). The CIR covers all studies aiming to assess the impact for health and welfare of any health (and integrated social) care or public health intervention directed to an individual. The impact categories are accessibility, quality, equality, effectiveness, safety, and efficiency. Impact is the main concept, and within each impact category, both generic- and context-specific outcome measures are needed. CIR uses RCTs and BCTs. CIR should be given a high priority in medical, health care, and health economic research. Clinicians and leaders at all levels of health care can exploit the evidence from CIR. Key messages The new concept of Clinical Impact Research (CIR) is defined as a research field aiming to assess what are the impacts of healthcare and public health interventions targeted to patients or individuals. The term impact refers to all effects caused by the interventions, with particular emphasis on accessibility, quality, equality, effectiveness, safety, and efficiency. CIR uses two study designs: randomized controlled trials (RCTs) (experimental

Osteoarthritis subpopulations and implications for clinical trial design

PubMed Central

2011-01-01

Treatment guidelines for osteoarthritis have stressed the need for research on clinical predictors of response to different treatments. However, identifying such clinical predictors of response is less easy than it seems, and there is not a given classification of osteoarthritis subpopulations. This review article highlights the key methodical issues when analyzing and designing clinical studies to detect important subgroups with respect to treatment effect. In addition, we discuss the main osteoarthritis subpopulations and give examples of how specific treatment effects in these subpopulations have been assessed. PMID:21470393

Key technique study and application of infrared thermography in hypersonic wind tunnel

NASA Astrophysics Data System (ADS)

LI, Ming; Yang, Yan-guang; Li, Zhi-hui; Zhu, Zhi-wei; Zhou, Jia-sui

2014-11-01

The solutions to some key techniques using infrared thermographic technique in hypersonic wind tunnel, such as temperature measurement under great measurement angle, the corresponding relation between model spatial coordinates and the ones in infrared map, the measurement uncertainty analysis of the test data etc., are studied. The typical results in the hypersonic wind tunnel test are presented, including the comparison of the transfer rates on a thin skin flat plate model with a wedge measured with infrared thermography and thermocouple, the experimental study heating effect on the flat plate model impinged by plume flow and the aerodynamic heating on the lift model.

Computational intelligence for the Balanced Scorecard: studying performance trends of hemodialysis clinics.

PubMed

Cattinelli, Isabella; Bolzoni, Elena; Chermisi, Milena; Bellocchio, Francesco; Barbieri, Carlo; Mari, Flavio; Amato, Claudia; Menzer, Marcus; Stopper, Andrea; Gatti, Emanuele

2013-07-01

The Balanced Scorecard (BSC) is a general, widely employed instrument for enterprise performance monitoring based on the periodic assessment of strategic Key Performance Indicators that are scored against preset targets. The BSC is currently employed as an effective management support tool within Fresenius Medical Care (FME) and is routinely analyzed via standard statistical methods. More recently, the application of computational intelligence techniques (namely, self-organizing maps) to BSC data has been proposed as a way to enhance the quantity and quality of information that can be extracted from it. In this work, additional methods are presented to analyze the evolution of clinic performance over time. Performance evolution is studied at the single-clinic level by computing two complementary indexes that measure the proportion of time spent within performance clusters and improving/worsening trends. Self-organizing maps are used in conjunction with these indexes to identify the specific drivers of the observed performance. The performance evolution for groups of clinics is modeled under a probabilistic framework by resorting to Markov chain properties. These allow a study of the probability of transitioning between performance clusters as time progresses for the identification of the performance level that is expected to become dominant over time. We show the potential of the proposed methods through illustrative results derived from the analysis of BSC data of 109 FME clinics in three countries. We were able to identify the performance drivers for specific groups of clinics and to distinguish between countries whose performances are likely to improve from those where a decline in performance might be expected. According to the stationary distribution of the Markov chain, the expected trend is best in Turkey (where the highest performance cluster has the highest probability, P=0.46), followed by Portugal (where the second best performance cluster dominates

Prevalence of clinical trial status discrepancies: A cross-sectional study of 10,492 trials registered on both ClinicalTrials.gov and the European Union Clinical Trials Register.

PubMed

Fleminger, Jessica; Goldacre, Ben

2018-01-01

Trial registries are a key source of information for clinicians and researchers. While building OpenTrials, an open database of public trial information, we identified errors and omissions in registries, including discrepancies between descriptions of the same trial in different registries. We set out to ascertain the prevalence of discrepancies in trial completion status using a cohort of trials registered on both the European Union Clinical Trials Register (EUCTR) and ClinicalTrials.gov. We used matching titles and registry IDs provided by both registries to build a cohort of dual-registered trials. Completion statuses were compared; we calculated descriptive statistics on the prevalence of discrepancies. 11,988 dual-registered trials were identified. 1,496 did not provide a comparable completion status, leaving 10,492 trials. 16.2% were discrepant on completion status. The majority of discrepancies (90.5%) were a 'completed' trial on ClinicalTrials.gov inaccurately marked as 'ongoing' on EUCTR. Overall, 33.9% of dual-registered trials described as 'ongoing' on EUCTR were listed as 'completed' on ClinicalTrials.gov. Completion status on registries is commonly inaccurate. Previous work on publication bias may underestimate non-reporting. We describe simple steps registry owners and trialists could take to improve accuracy.

Missing clinical information in NHS hospital outpatient clinics: prevalence, causes and effects on patient care.

PubMed

Burnett, Susan J; Deelchand, Vashist; Franklin, Bryony Dean; Moorthy, Krishna; Vincent, Charles

2011-05-23

In Britain over 39,000 reports were received by the National Patient Safety Agency relating to failures in documentation in 2007 and the UK Health Services Journal estimated in 2008 that over a million hospital outpatient visits each year might take place without the full record available. Despite these high numbers, the impact of missing clinical information has not been investigated for hospital outpatients in the UK.Studies in primary care in the USA have found 13.6% of patient consultations have missing clinical information, with this adversely affecting care in about half of cases, and in Australia 1.8% of medical errors were found to be due to the unavailability of clinical information.Our objectives were to assess the frequency, nature and potential impact on patient care of missing clinical information in NHS hospital outpatients and to assess the principal causes. This is the first study to present such figures for the UK and the first to look at how clinicians respond, including the associated impact on patient care. Prospective descriptive study of missing information reported by surgeons, supplemented by interviews on the causes.Data were collected by surgeons in general, gastrointestinal, colorectal and vascular surgical clinics in three teaching hospitals across the UK for over a thousand outpatient appointments. Fifteen interviews were conducted with those involved in collating clinical information for these clinics.The study had ethics approval (Hammersmith and Queen Charlotte's & Chelsea Research Ethics Committee), reference number (09/H0707/27). Participants involved in the interviews signed a consent form and were offered the opportunity to review and agree the transcript of their interview before analysis. No patients were involved in this research. In 15% of outpatient consultations key items of clinical information were missing. Of these patients, 32% experienced a delay or disruption to their care and 20% had a risk of harm. In over half of

Value as the key concept in the health care system: how it has influenced medical practice and clinical decision-making processes.

PubMed

Marzorati, Chiara; Pravettoni, Gabriella

2017-01-01

In the last 10 years, value has played a key role in the health care system. In this concept, innovations in medical practice and the increasing importance of patient centeredness have contributed to draw the attention of the medical community. Nonetheless, a large consensus on the meaning of "value" is still lacking: patients, physicians, policy makers, and other health care professionals have different ideas on which component of value may play a prominent role. Yet, shared clinical decision-making and patient empowerment have been recognized as fundamental features of the concept of value. Different paradigms of health care system embrace different meanings of value, and the absence of common and widely accepted definition does not help to identify a unique model of care in health care system. Our aim is to provide an overview of those paradigms that have considered value as a key theoretical concept and to investigate how the presence of value can influence the medical practice. This article may contribute to draw attention toward patients and propose a possible link between health care system based on "value" and new paradigms such as patient-centered system (PCS), patient empowerment, and P5 medicine, in order to create a predictive, personalized, preventive, participatory, and psycho-cognitive model to treat patients. Indeed, patient empowerment, value-based system, and P5 medicine seem to shed light on different aspects of a PCS, and this allows a better understanding of people under care.

Value as the key concept in the health care system: how it has influenced medical practice and clinical decision-making processes

PubMed Central

Marzorati, Chiara; Pravettoni, Gabriella

2017-01-01

In the last 10 years, value has played a key role in the health care system. In this concept, innovations in medical practice and the increasing importance of patient centeredness have contributed to draw the attention of the medical community. Nonetheless, a large consensus on the meaning of “value” is still lacking: patients, physicians, policy makers, and other health care professionals have different ideas on which component of value may play a prominent role. Yet, shared clinical decision-making and patient empowerment have been recognized as fundamental features of the concept of value. Different paradigms of health care system embrace different meanings of value, and the absence of common and widely accepted definition does not help to identify a unique model of care in health care system. Our aim is to provide an overview of those paradigms that have considered value as a key theoretical concept and to investigate how the presence of value can influence the medical practice. This article may contribute to draw attention toward patients and propose a possible link between health care system based on “value” and new paradigms such as patient-centered system (PCS), patient empowerment, and P5 medicine, in order to create a predictive, personalized, preventive, participatory, and psycho-cognitive model to treat patients. Indeed, patient empowerment, value-based system, and P5 medicine seem to shed light on different aspects of a PCS, and this allows a better understanding of people under care. PMID:28356752

Artifice, Interpretation and Nature: Key Categories in Radiology Work

NASA Astrophysics Data System (ADS)

Nyce, James M.

This paper extends on some prior work on nature, culture and computation. This paper will look at “image work” in a radiology department, i.e, how radiologists use images and other kinds of knowledge in daily clinical work. In particular, the paper will look at the role tacit knowledge and categories have in the work radiologists carry out. How radiologists make use of and contrast analog and digital representations of nature will be explored here because this is key to how radiologists work and think. In other words, the role that computer derived artifacts, correspondence theory and mimesis play in the clinical work of radiology will be discussed.

Vascular Cognitive Impairment in a Memory Clinic Population: Rationale and Design of the "Utrecht-Amsterdam Clinical Features and Prognosis in Vascular Cognitive Impairment" (TRACE-VCI) Study.

PubMed

Boomsma, Jooske Marije Funke; Exalto, Lieza Geertje; Barkhof, Frederik; van den Berg, Esther; de Bresser, Jeroen; Heinen, Rutger; Koek, Huiberdina Lena; Prins, Niels Daniël; Scheltens, Philip; Weinstein, Henry Chanoch; van der Flier, Wiesje Maria; Biessels, Geert Jan

2017-04-19

dementia in 52.4% of patients (451/861), mild cognitive impairment in 24.6% (212/861), and no objective cognitive impairment in the remaining 23.0% (198/861). The TRACE-VCI study represents a large cohort of well-characterized patients with VCI in a memory clinic setting. Data processing and collection for follow-up are currently being completed. The TRACE-VCI study will provide insight into the clinical features of memory clinic patients that meet VCI criteria and establish key prognostic factors for further cognitive decline and (recurrent) major vascular events. ©Jooske Marije Funke Boomsma, Lieza Geertje Exalto, Frederik Barkhof, Esther van den Berg, Jeroen de Bresser, Rutger Heinen, Huiberdina Lena Koek, Niels Daniël Prins, Philip Scheltens, Henry Chanoch Weinstein, Wiesje Maria van der Flier, Geert Jan Biessels. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 19.04.2017.

Clinical audit of COPD in outpatient respiratory clinics in Spain: the EPOCONSUL study

PubMed Central

Calle Rubio, Myriam; Alcázar Navarrete, Bernardino; Soriano, Joan B; Soler-Cataluña, Juan J; Rodríguez González-Moro, José Miguel; Fuentes Ferrer, Manuel E; López-Campos, José Luis

2017-01-01

Background Chronic obstructive pulmonary disease (COPD) outpatients account for a large burden of usual care by respirologists. EPOCONSUL is the first national clinical audit conducted in Spain on the medical care for COPD patients delivered in outpatient respiratory clinics. We aimed to evaluate the clinical interventions and the degree of adherence to recommendations in outpatients of current COPD clinical practice guidelines. Methodology This is an observational study with prospective recruitment (May 2014–May 2015) of patients with a COPD diagnosis as seen in outpatient respiratory clinics. The information collected was historical in nature as for the clinical data of the last and previous consultations, and the information concerning hospital resources was concurrent. Results A total of 17,893 clinical records of COPD patients in outpatient respiratory clinics from 59 Spanish hospitals were evaluated. Of the 5,726 patients selected, 4,508 (78.7%) were eligible. Overall, 12.1% of COPD patients did not fulfill a diagnostic spirometry criteria. Considerable variability existed in the available resources and work organization of the hospitals, although the majority were university hospitals with respiratory inpatient units. There was insufficient implementation of clinical guidelines in preventive and educational matters. In contrast, quantitative evaluation of dyspnea grade (81.9%) and exacerbation history (70.9%) were more frequently performed. Only 12.4% had COPD severity calculated according to the Body mass index, airflow Obstruction, Dyspnoea and Exercise capacity (BODE) index. Phenotype characteristics according to Spanish National Guideline for COPD were determined in 46.3% of the audited patients, and the risk evaluation according to Global initiative for chronic Obstructive Lung Disease was estimated only in 21.9%. Conclusion The EPOCONSUL study reports the current situation of medical care for COPD patients in outpatient clinics in Spain, revealing

Identification of the Key Fields and Their Key Technical Points of Oncology by Patent Analysis

PubMed Central

Zhang, Ting; Chen, Juan; Jia, Xiaofeng

2015-01-01

Background This paper aims to identify the key fields and their key technical points of oncology by patent analysis. Methodology/Principal Findings Patents of oncology applied from 2006 to 2012 were searched in the Thomson Innovation database. The key fields and their key technical points were determined by analyzing the Derwent Classification (DC) and the International Patent Classification (IPC), respectively. Patent applications in the top ten DC occupied 80% of all the patent applications of oncology, which were the ten fields of oncology to be analyzed. The number of patent applications in these ten fields of oncology was standardized based on patent applications of oncology from 2006 to 2012. For each field, standardization was conducted separately for each of the seven years (2006–2012) and the mean of the seven standardized values was calculated to reflect the relative amount of patent applications in that field; meanwhile, regression analysis using time (year) and the standardized values of patent applications in seven years (2006–2012) was conducted so as to evaluate the trend of patent applications in each field. Two-dimensional quadrant analysis, together with the professional knowledge of oncology, was taken into consideration in determining the key fields of oncology. The fields located in the quadrant with high relative amount or increasing trend of patent applications are identified as key ones. By using the same method, the key technical points in each key field were identified. Altogether 116,820 patents of oncology applied from 2006 to 2012 were retrieved, and four key fields with twenty-nine key technical points were identified, including “natural products and polymers” with nine key technical points, “fermentation industry” with twelve ones, “electrical medical equipment” with four ones, and “diagnosis, surgery” with four ones. Conclusions/Significance The results of this study could provide guidance on the development

Career Development Factors for Minority Disability and Health Research Leaders: A Key Informant Study

ERIC Educational Resources Information Center

Manyibe, Edward O.; Moore, Corey L.; Wang, Ningning; Davis, Dytisha; Aref, Fariborz; Washington, Andre L.; Johnson, Jean; Eugene-Cross, Kenyotta; Muhammad, Atashia; Lewis, Allen

2017-01-01

Purpose: This study examined and documented minority disability and health research leaders' experiences and perspectives on career development challenges and success strategies. Methods: A sample of 15 African American, American Indian or Alaskan Native, Latino, and Asian research leaders as key informants participated in the inquiry. Research…

Secret-key expansion from covert communication

NASA Astrophysics Data System (ADS)

Arrazola, Juan Miguel; Amiri, Ryan

2018-02-01

Covert communication allows the transmission of messages in such a way that it is not possible for adversaries to detect that the communication is occurring. This provides protection in situations where knowledge that two parties are talking to each other may be incriminating to them. In this work, we study how covert communication can be used for a different purpose: secret key expansion. First, we show that any message transmitted in a secure covert protocol is also secret and therefore unknown to an adversary. We then propose a covert communication protocol where the amount of key consumed in the protocol is smaller than the transmitted key, thus leading to secure secret key expansion. We derive precise conditions for secret key expansion to occur, showing that it is possible when there are sufficiently low levels of noise for a given security level. We conclude by examining how secret key expansion from covert communication can be performed in a computational security model.

Preclinical and clinical studies on the use of growth factors for bone repair: a systematic review.

PubMed

Fisher, Daniel Mark; Wong, James Min-Leong; Crowley, Conor; Khan, Wasim S

2013-05-01

Bone healing is a complex process. Whilst the majority of fractures heal with conventional treatment, open fractures, large bone defects and non unions still provide great challenges to Orthopaedic Surgeons. Whilst autologous bone graft is seen as the gold standard, the use of growth factors is a growing area of research to find an effective alternative with lower side effects such as donor site morbidity and the finite amount available. This systematic review aims to summarize the pre clinical in-vivo studies and examine the clinical studies on the use of growth factors in bone healing. Databases: PubMed, Medline, OVID, and Cochrane library. The following key words and search terms were used: Growth Factors, Bone Healing, Bone Morphogenic Protein, Transforming Growth Factor Beta, Insulin Like Growth Factor, Platelet Derived Growth Factor, Fracture. All articles were screened based on title with abstracts and full text articles reviewed as appropriate. Reference lists were reviewed from relevant articles to ensure comprehensive and systematic review. Three tables of studies were constructed focussing on Bone Morphogenic Proteins, Platelet Rich Plasma and Growth Factors and Tissue Engineering. Bone Morphogenic Proteins and Platelet Rich Plasma, which contains multiple growth factors, have been shown in preclinical and clinical trials to be an effective alternative to autologous bone graft. Bone Morphogenic Proteins have been shown to be effective in fracture non union, and in open tibial fractures. Platelet Rich Plasma has shown promise in preclinical trials and some small clinical trials, however numbers are limited. Bone Morphogenic Proteins have been shown to be superior to Platelet Rich Protein in one trial. Combining these growth factors with tissue engineering techniques is the focus of ongoing research, and through further clinical trials the most effective techniques for enhancing bone healing will be revealed.

Concept-Based Learning in Clinical Experiences: Bringing Theory to Clinical Education for Deep Learning.

PubMed

Nielsen, Ann

2016-07-01

Concept-based learning is used increasingly in nursing education to support the organization, transfer, and retention of knowledge. Concept-based learning activities (CBLAs) have been used in clinical education to explore key aspects of the patient situation and principles of nursing care, without responsibility for total patient care. The nature of best practices in teaching and the resultant learning are not well understood. The purpose of this multiple-case study research was to explore and describe concept-based learning in the context of clinical education in inpatient settings. Four clinical groups (each a case) were observed while they used CBLAs in the clinical setting. Major findings include that concept-based learning fosters deep learning, connection of theory with practice, and clinical judgment. Strategies used to support learning, major teaching-learning foci, and preconditions for concept-based teaching and learning will be described. Concept-based learning is promising to support integration of theory with practice and clinical judgment through application experiences with patients. [J Nurs Educ. 2016;55(7):365-371.]. Copyright 2016, SLACK Incorporated.

Study on the security of the authentication scheme with key recycling in QKD

NASA Astrophysics Data System (ADS)

Li, Qiong; Zhao, Qiang; Le, Dan; Niu, Xiamu

2016-09-01

In quantum key distribution (QKD), the information theoretically secure authentication is necessary to guarantee the integrity and authenticity of the exchanged information over the classical channel. In order to reduce the key consumption, the authentication scheme with key recycling (KR), in which a secret but fixed hash function is used for multiple messages while each tag is encrypted with a one-time pad (OTP), is preferred in QKD. Based on the assumption that the OTP key is perfect, the security of the authentication scheme has be proved. However, the OTP key of authentication in a practical QKD system is not perfect. How the imperfect OTP affects the security of authentication scheme with KR is analyzed thoroughly in this paper. In a practical QKD, the information of the OTP key resulting from QKD is partially leaked to the adversary. Although the information leakage is usually so little to be neglected, it will lead to the increasing degraded security of the authentication scheme as the system runs continuously. Both our theoretical analysis and simulation results demonstrate that the security level of authentication scheme with KR, mainly indicated by its substitution probability, degrades exponentially in the number of rounds and gradually diminishes to zero.

Development of EULAR recommendations for the reporting of clinical trial extension studies in rheumatology

PubMed Central

Buch, Maya H; Silva-Fernandez, Lucia; Carmona, Loreto; Aletaha, Daniel; Christensen, Robin; Combe, Bernard; Emery, Paul; Ferraccioli, Gianfranco; Guillemin, Francis; Kvien, Tore K; Landewe, Robert; Pavelka, Karel; Saag, Kenneth; Smolen, Josef S; Symmons, Deborah; van der Heijde, Désirée; Welling, Joep; Wells, George; Westhovens, Rene; Zink, Angela; Boers, Maarten

2015-01-01

Objectives Our initiative aimed to produce recommendations on post-randomised controlled trial (RCT) trial extension studies (TES) reporting using European League Against Rheumatism (EULAR) standard operating procedures in order to achieve more meaningful output and standardisation of reports. Methods We formed a task force of 22 participants comprising RCT experts, clinical epidemiologists and patient representatives. A two-stage Delphi survey was conducted to discuss the domains of evaluation of a TES and definitions. A ‘0–10’ agreement scale assessed each domain and definition. The resulting set of recommendations was further refined and a final vote taken for task force acceptance. Results Seven key domains and individual components were evaluated and led to agreed recommendations including definition of a TES (100% agreement), minimal data necessary (100% agreement), method of data analysis (agreement mean (SD) scores ranging between 7.9 (0.84) and 9.0 (2.16)) and reporting of results as well as ethical issues. Key recommendations included reporting of absolute numbers at each stage from the RCT to TES with reasons given for drop-out at each stage, and inclusion of a flowchart detailing change in numbers at each stage and focus (mean (SD) agreement 9.9 (0.36)). A final vote accepted the set of recommendations. Conclusions This EULAR task force provides recommendations for implementation in future TES to ensure a standardised approach to reporting. Use of this document should provide the rheumatology community with a more accurate and meaningful output from future TES, enabling better understanding and more confident application in clinical practice towards improving patient outcomes. PMID:24827533

Key Elements in Successful Training A Comparative Study of Two Workplaces. Project Report, 2000-2001.

ERIC Educational Resources Information Center

Adult Literacy and Numeracy Australian Research Consortium, Alice Springs. Northern Territory Centre.

This publication presents case studies of two sites--one with and one without a history of involvement in Workplace English Language and Literacy (WELL)-funded training programs. Case study 1, "Partnership, Flexibility, and Experience: Key Elements in Successful Training" (Jenny McGuirk), investigates a food processing company in New South Wales…

Contemporary issues in clinical dental teaching.

PubMed

Groenlund, Catherine; Handal, Boris

2013-05-01

This research project sought to explore the issue of what constitutes effective clinical teaching in the minds of both students and teachers. As stakeholders of the dental clinical setting, teachers and students have valuable practical insights to share with the academic and professional community as to what constitutes effective dental teaching. An explorative qualitative study of dental teachers' and students' perceptions of clinical teaching was carried out at the Faculty of Dentistry of Sydney University. Thirty-one clinical teachers and 12 students participated in this case study through an online questionnaire survey and a focus group, respectively. Responses were categorized in three major clusters, namely, instructional, curricular or organizational. The findings reveal that both groups hold similar opinions on what constitutes effective clinical instruction including a shared passion for learning and teaching, being clear and organized, demonstrating clinical competencies as well as engaging in professional self-reflection. Most of the issues fell into the instructional cluster where establishing a positive relationship with students including providing constructive feedback at the clinical session came up as key factors contributing to the student experience. There is a demand from both students and teachers to standardize clinical procedures and protocols as well as having a greater synchronization in time and content between lectures and clinical work.

Key management of the double random-phase-encoding method using public-key encryption

NASA Astrophysics Data System (ADS)

Saini, Nirmala; Sinha, Aloka

2010-03-01

Public-key encryption has been used to encode the key of the encryption process. In the proposed technique, an input image has been encrypted by using the double random-phase-encoding method using extended fractional Fourier transform. The key of the encryption process have been encoded by using the Rivest-Shamir-Adelman (RSA) public-key encryption algorithm. The encoded key has then been transmitted to the receiver side along with the encrypted image. In the decryption process, first the encoded key has been decrypted using the secret key and then the encrypted image has been decrypted by using the retrieved key parameters. The proposed technique has advantage over double random-phase-encoding method because the problem associated with the transmission of the key has been eliminated by using public-key encryption. Computer simulation has been carried out to validate the proposed technique.

Consensus building for interlaboratory studies, key comparisons, and meta-analysis

NASA Astrophysics Data System (ADS)

Koepke, Amanda; Lafarge, Thomas; Possolo, Antonio; Toman, Blaza

2017-06-01

Interlaboratory studies in measurement science, including key comparisons, and meta-analyses in several fields, including medicine, serve to intercompare measurement results obtained independently, and typically produce a consensus value for the common measurand that blends the values measured by the participants. Since interlaboratory studies and meta-analyses reveal and quantify differences between measured values, regardless of the underlying causes for such differences, they also provide so-called ‘top-down’ evaluations of measurement uncertainty. Measured values are often substantially over-dispersed by comparison with their individual, stated uncertainties, thus suggesting the existence of yet unrecognized sources of uncertainty (dark uncertainty). We contrast two different approaches to take dark uncertainty into account both in the computation of consensus values and in the evaluation of the associated uncertainty, which have traditionally been preferred by different scientific communities. One inflates the stated uncertainties by a multiplicative factor. The other adds laboratory-specific ‘effects’ to the value of the measurand. After distinguishing what we call recipe-based and model-based approaches to data reductions in interlaboratory studies, we state six guiding principles that should inform such reductions. These principles favor model-based approaches that expose and facilitate the critical assessment of validating assumptions, and give preeminence to substantive criteria to determine which measurement results to include, and which to exclude, as opposed to purely statistical considerations, and also how to weigh them. Following an overview of maximum likelihood methods, three general purpose procedures for data reduction are described in detail, including explanations of how the consensus value and degrees of equivalence are computed, and the associated uncertainty evaluated: the DerSimonian-Laird procedure; a hierarchical Bayesian

Optical key system

DOEpatents

Hagans, Karla G.; Clough, Robert E.

2000-01-01

An optical key system comprises a battery-operated optical key and an isolated lock that derives both its operating power and unlock signals from the correct optical key. A light emitting diode or laser diode is included within the optical key and is connected to transmit a bit-serial password. The key user physically enters either the code-to-transmit directly, or an index to a pseudorandom number code, in the key. Such person identification numbers can be retained permanently, or ephemeral. When a send button is pressed, the key transmits a beam of light modulated with the password information. The modulated beam of light is received by a corresponding optical lock with a photovoltaic cell that produces enough power from the beam of light to operate a password-screen digital logic. In one application, an acceptable password allows a two watt power laser diode to pump ignition and timing information over a fiberoptic cable into a sealed engine compartment. The receipt of a good password allows the fuel pump, spark, and starter systems to each operate. Therefore, bypassing the lock mechanism as is now routine with automobile thieves is pointless because the engine is so thoroughly disabled.

Key issues in the persistence of poliomyelitis in Nigeria: a case-control study.

PubMed

Mangal, Tara D; Aylward, R Bruce; Mwanza, Michael; Gasasira, Alex; Abanida, Emmanuel; Pate, Muhammed A; Grassly, Nicholas C

2014-02-01

The completion of poliomyelitis eradication is a global emergency for public health. In 2012, more than 50% of the world's cases occurred in Nigeria following an unanticipated surge in incidence. We aimed to quantitatively analyse the key factors sustaining transmission of poliomyelitis in Nigeria and to calculate clinical efficacy estimates for the oral poliovirus vaccines (OPV) currently in use. We used acute flaccid paralysis (AFP) surveillance data from Nigeria collected between January, 2001, and December, 2012, to estimate the clinical efficacies of all four OPVs in use and combined this with vaccination coverage to estimate the effect of the introduction of monovalent and bivalent OPV on vaccine-induced serotype-specific population immunity. Vaccine efficacy was determined using a case-control study with CIs based on bootstrap resampling. Vaccine efficacy was also estimated separately for north and south Nigeria, by age of the children, and by year. Detailed 60-day follow-up data were collected from children with confirmed poliomyelitis and were used to assess correlates of vaccine status. We also quantitatively assessed the epidemiology of poliomyelitis and programme performance and considered the reasons for the high vaccine refusal rate along with risk factors for a given local government area reporting a case. Against serotype 1, both monovalent OPV (median 32.1%, 95% CI 26.1-38.1) and bivalent OPV (29.5%, 20.1-38.4) had higher clinical efficacy than trivalent OPV (19.4%, 16.1-22.8). Corresponding data for serotype 3 were 43.2% (23.1-61.1) and 23.8% (5.3-44.9) compared with 18.0% (14.1-22.1). Combined with increases in coverage, this factor has boosted population immunity in children younger than age 36 months to a record high (64-69% against serotypes 1 and 3). Vaccine efficacy in northern states was estimated to be significantly lower than in southern states (p≤0.05). The proportion of cases refusing vaccination decreased from 37-72% in 2008 to 21

Public-key quantum digital signature scheme with one-time pad private-key

NASA Astrophysics Data System (ADS)

Chen, Feng-Lin; Liu, Wan-Fang; Chen, Su-Gen; Wang, Zhi-Hua

2018-01-01

A quantum digital signature scheme is firstly proposed based on public-key quantum cryptosystem. In the scheme, the verification public-key is derived from the signer's identity information (such as e-mail) on the foundation of identity-based encryption, and the signature private-key is generated by one-time pad (OTP) protocol. The public-key and private-key pair belongs to classical bits, but the signature cipher belongs to quantum qubits. After the signer announces the public-key and generates the final quantum signature, each verifier can verify publicly whether the signature is valid or not with the public-key and quantum digital digest. Analysis results show that the proposed scheme satisfies non-repudiation and unforgeability. Information-theoretic security of the scheme is ensured by quantum indistinguishability mechanics and OTP protocol. Based on the public-key cryptosystem, the proposed scheme is easier to be realized compared with other quantum signature schemes under current technical conditions.

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

PubMed

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

2014-12-12

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

Training oncology and palliative care clinical nurse specialists in psychological skills: evaluation of a pilot study.

PubMed

Clark, Jane E; Aitken, Susan; Watson, Nina; McVey, Joanne; Helbert, Jan; Wraith, Anita; Taylor, Vanessa; Catesby, Sarah

2015-06-01

National guidelines in the United Kingdom recommend training Clinical Nurse Specialists in psychological skills to improve the assessment and intervention with psychological problems experienced by people with a cancer diagnosis (National Institute for Health and Clinical Excellence, 2004). This pilot study evaluated a three-day training program combined with supervision sessions from Clinical Psychologists that focused on developing skills in psychological assessment and intervention for common problems experienced by people with cancer. Questionnaires were developed to measure participants' levels of confidence in 15 competencies of psychological skills. Participants completed these prior to the program and on completion of the program. Summative evaluation was undertaken and results were compared. In addition, a focus group interview provided qualitative data of participants' experiences of the structure, process, and outcomes of the program. Following the program, participants rated their confidence in psychological assessment and skills associated with providing psychological support as having increased in all areas. This included improved knowledge of psychological theories, skills in assessment and intervention and accessing and using supervision appropriately. The largest increase was in providing psycho-education to support the coping strategies of patients and carers. Thematic analysis of interview data identified two main themes including learning experiences and program enhancements. The significance of the clinical supervision sessions as key learning opportunities, achieved through the development of a community of practice, emerged. Although this pilot study has limitations, the results suggest that a combined teaching and supervision program is effective in improving Clinical Nurse Specialists' confidence level in specific psychological skills. Participants' experiences highlighted suggestions for refinement and development of the program

Clinical information transfer and data capture in the acute myocardial infarction pathway: an observational study.

PubMed

Kesavan, Sujatha; Kelay, Tanika; Collins, Ruth E; Cox, Benita; Bello, Fernando; Kneebone, Roger L; Sevdalis, Nick

2013-10-01

Acute myocardial infarctions (MIs) or heart attacks are the result of a complete or an incomplete occlusion of the lumen of the coronary artery with a thrombus. Prompt diagnosis and early coronary intervention results in maximum myocardial salvage, hence time to treat is of the essence. Adequate, accurate and complete information is vital during the early stages of admission of an MI patient and can impact significantly on the quality and safety of patient care. This study aimed to record how clinical information between different clinical teams during the journey of a patient in the MI care pathway is captured and to review the flow of information within this care pathway. A prospective, descriptive, structured observational study to assess (i) current clinical information systems (CIS) utilization and (ii) real-time information availability within an acute cardiac care setting was carried out. Completeness and availability of patient information capture across four key stages of the MI care pathway were assessed prospectively. Thirteen separate information systems were utilized during the four phases of the MI pathway. Observations revealed fragmented CIS utilization, with users accessing an average of six systems to gain a complete set of patient information. Data capture was found to vary between each pathway stage and in both patient cohort risk groupings. The highest level of information completeness (100%) was observed only in the discharge stage of the MI care pathway. The lowest level of information completeness (58%) was observed in the admission stage. The study highlights fragmentation, CIS duplication, and discrepancies in the current clinical information capture and data transfer across the MI care pathway in an acute cardiac care setting. The development of an integrated and user-friendly electronic data capture and transfer system would reduce duplication and would facilitate efficient and complete information provision at the point of care. © 2012

Policies and clinical practices relating to the management of gestational diabetes mellitus in the public health sector, South Africa - a qualitative study.

PubMed

Muhwava, Lorrein Shamiso; Murphy, Katherine; Zarowsky, Christina; Levitt, Naomi

2018-05-10

Women with a prior gestational diabetes have an increased lifetime risk of developing type 2 diabetes. Although post-partum follow-up for GDM women is essential to prevent progression to type 2 diabetes, it is poorly attended. The need for health systems interventions to support postpartum follow-up for GDM women is evident, but there is little knowledge of actual current practice. The aim of this study was to explore current policies and clinical practices relating to antenatal and post-natal care for women with GDM in South Africa, as well as health sector stakeholders' perspectives on the barriers to -- and opportunities for -- delivering an integrated mother - baby health service that extends beyond the first week post-partum, to the infant's first year of life. Following a document review of policy and clinical practice guidelines, in-depth interviews were conducted with 11 key informants who were key policy makers, health service managers and clinicians working in the public health services in South Africa's two major cities (Johannesburg and Cape Town). Data were analysed using qualitative content analysis procedures. The document review and interviews established that it is policy that health services adhere to international guidelines for GDM diagnosis and management, in addition to locally developed guidelines and protocols for clinical practice. All key informants confirmed that lack of postpartum follow-up for GDM women is a significant problem. Health systems barriers include fragmentation of care and the absence of standardised postnatal care for post-GDM women. Key informants also raised patient - related challenges including lack of perceived future risk of developing type 2 diabetes and non-attendance for postpartum follow up, as barriers to postnatal care for GDM women. All participants supported integrated primary health services but cautioned against overloading health workers. Although there is alignment between international guidelines, local

Clinical learning environment at Shiraz Medical School.

PubMed

Rezaee, Rita; Ebrahimi, Sedigheh

2013-01-01

Clinical learning occurs in the context of a dynamic environment. Learning environment found to be one of the most important factors in determining the success of an effective teaching program. To investigate, from the attending and resident's perspective, factors that may affect student leaning in the educational hospital setting at Shiraz University of Medical Sciences (SUMS). This study combined qualitative and quantitative methods to determine factors affecting effective learning in clinical setting. Residents evaluated the perceived effectiveness of the university hospital learning environment. Fifty two faculty members and 132 residents participated in this study. Key determinants that contribute to an effective clinical teaching were autonomy, supervision, social support, workload, role clarity, learning opportunity, work diversity and physical facilities. In a good clinical setting, residents should be appreciated and given appropriate opportunities to study in order to meet their objectives. They require a supportive environment to consolidate their knowledge, skills and judgment. © 2013 Tehran University of Medical Sciences. All rights reserved.

A survey on clinical governance awareness among clinical staff: a cross-sectional study.

PubMed

Ravaghi, Hamid; Zarnaq, Rahim Khodayari; Adel, Amin; Badpa, Mahnaz; Adel, Moein; Abolhassani, Nazanin

2014-06-25

Clinical Governance (CG) program has been raised in Iran in order to improve the quality of clinical care. The purpose of this study is to investigate the awareness of clinical governance program among clinical staff working in selected teaching hospitals in Tehran, Iran. To investigate the CG awareness, a cross-sectional survey was conducted among 345 clinical staff working in 20 selected public hospitals in Tehran. Data were gathered using the standardized clinical governance awareness questionnaire. Descriptive statistics were used to analyze the data. The results showed that the level of staff awareness about the concept of CG was low. They perceived continuous quality improvement, responsibility, medical errors reduction and patient safety as the main concepts of the CG framework. Reaching agreement of standards concepts among staff and positive changes in attitudes were considered as two most observed changes. The main perceived barriers to the implementation of clinical governance included lack of proper management and leadership, lack of full support, inappropriate organizational culture, lack of knowledge, poor communication system and insufficient training. The concepts and goals of clinical governance have not been effectively conveyed to the staff and despite its implementation in the hospitals, there has been low clinical governance awareness among the staff. Clinical Governance must be implemented through comprehensive management support and participation of all staff and health professionals at both hospital and policy making level.

Maintaining a clinical weight loss after intensive lifestyle intervention is the key to cardiometabolic health.

PubMed

Dandanell, Sune; Skovborg, Camilla; Præst, Charlotte Boslev; Kristensen, Kasper Bøgh; Nielsen, Malene Glerup; Lionett, Sofie; Jørgensen, Sofie Drevsholt; Vigelsø, Andreas; Dela, Flemming; Helge, Jørn Wulff

Intensive lifestyle interventions (ILI) are criticised for ineffective obesity treatment because weight loss over time is modest and thus of limited clinical relevance. However, a subgroup (5-30%) maintains a clinical weight loss >10%, but it is not clear if cardiometabolic health follows this pattern. The aim was to study the effect of different magnitudes of weight loss maintenance after ILI on cardiometabolic health. Eighty out of 2420 former participants (age: 36±1, BMI: 38±1, (means ±SE)) in an 11-12-week ILI were recruited into 3 groups; clinical weight loss maintenance (>10% weight loss), moderate maintenance (1-10%), and weight regain based on weight loss at follow-up (5.3±0.4years). Weight loss during the ILI was achieved by increased physical activity and hypo-caloric diet. Dual X-ray Absorptiometry, blood sample, skeletal muscle biopsy and VO 2max test were used to determine cardiometabolic health at follow-up. At follow-up, the clinical weight loss maintenance group scored better in the following variables compared to the other groups: BMI (31±1, 33±2, 43±2kg/m 2 ), composition (34±2, 40±1, 49±1% fat), visceral adipose tissue (0.8±0.2, 1.7±0.5, 2.4±0.4kg), plasma triglycerides (0.8±0.2, 1.3±0.4, 1.6±0.3mmol/L), plasma glucose (4.9±0.1, 5.9±0.4, 5.9±0.1mmol/L), Hb1Ac (5.1±0.0, 5.6±0.2, 5.8±0.2%), protein content in skeletal muscle of GLUT4 (1.5±0.2, 0.9±0.1, 1.0±0.1 AU) and hexokinase II (1.6±0.2, 1.0±0.2, 0.7±0.1 AU), citrate synthase activity (155±6, 130±5, 113±5μmol/g/min) and VO 2max (49±1, 43±1, 41±1mL/min/FFM) (p<0.05). Cardiometabolic health is better in participants who have maintained >10% weight loss compared to moderate weight loss and weight regain. Copyright © 2016 Asia Oceania Association for the Study of Obesity. Published by Elsevier Ltd. All rights reserved.

Three-party authenticated key agreements for optimal communication

PubMed Central

Lee, Tian-Fu; Hwang, Tzonelih

2017-01-01

Authenticated key agreements enable users to determine session keys, and to securely communicate with others over an insecure channel via the session keys. This study investigates the lower bounds on communications for three-party authenticated key agreements and considers whether or not the sub-keys for generating a session key can be revealed in the channel. Since two clients do not share any common secret key, they require the help of the server to authenticate their identities and exchange confidential and authenticated information over insecure networks. However, if the session key security is based on asymmetric cryptosystems, then revealing the sub-keys cannot compromise the session key. The clients can directly exchange the sub-keys and reduce the transmissions. In addition, authenticated key agreements were developed by using the derived results of the lower bounds on communications. Compared with related approaches, the proposed protocols had fewer transmissions and realized the lower bounds on communications. PMID:28355253

PPB | What is a Clinical Study

Cancer.gov

The Pleuropulmonary blastoma (PPB) DICER1 Syndrome Study ‹an observational clinical research study‹is enrolling children with PPB and their families. In an observational study, investigators assess health outcomes in groups of participants according to a protocol or research plan.

Developing clinical practice guidelines for Chinese herbal treatment of polycystic ovary syndrome: A mixed-methods modified Delphi study.

PubMed

Lai, Lily; Flower, Andrew; Moore, Michael; Lewith, George

2015-06-01

Preliminary evidence suggests Chinese herbal medicine (CHM) could be a viable treatment option for polycystic ovary syndrome (PCOS). Prior to conducting a clinical trial it is important to consider the characteristics of good clinical practice. This study aims to use professional consensus to establish good clinical practice guidelines for the CHM treatment of PCOS. CHM practitioners participated in a mixed-methods modified Delphi study involving three rounds of structured group communication. Round 1 involved qualitative interviews with practitioners to generate statements regarding good clinical practice. In round 2, these statements were distributed online to the same practitioners to rate their agreement using a 7-point Likert scale, where group consensus was defined as a median rating of ≥5. Statements reaching consensus were accepted for consideration onto the guideline whilst those not reaching consensus were re-distributed for consideration in round 3. Statements presented in the guidelines were graded from A (strong consensus) to D (no consensus) determined by median score and interquartile range. 11 CHM practitioners in the UK were recruited. After three Delphi rounds, 91 statement items in total had been considered, of which 89 (97.8%) reached consensus and 2 (2.2%) did not. The concluding set of guidelines consists of 85 items representing key features of CHM prescribing for PCOS. These guidelines can be viewed as an initial framework that captures fundamental principles of good clinical practice for CHM. Copyright © 2015 Elsevier Ltd. All rights reserved.

Understanding egorrhea from cultural-clinical psychology

PubMed Central

Sasaki, Jun; Wada, Kaori; Tanno, Yoshihiko

2013-01-01

Based on his observations in Japanese clinical settings, Fujinawa (1972) conceptualized egorrhea syndrome, which includes symptoms such as erythrophobia, fear of eye-to-eye confrontation, olfactory reference syndrome, delusions of soliloquy, delusions of sleep talking, and thought broadcasting. The key feature of this syndrome is self-leakage, a perceived sense that one's personal internal information, such as feelings and thoughts, are leaking out. To reach a more comprehensive understanding of egorrhea, this paper aims to present general overview and reconsider the phenomenon of self-leakage using cultural-clinical psychology as a framework. First, the symptoms of egorrhea are reviewed in relation to other related psychopathologies such as social anxiety disorder (SAD) and taijin kyofusho (TKS), as well as schizophrenia. Second, a series of empirical studies conducted using Japanese non-clinical samples are summarized. The results of these studies form the basis for subsequent discussions, which incorporates the cultural-clinical psychology perspective proposed by Ryder et al. (2011). This paper ends with a general discussion regarding implications for research and clinical practice. PMID:24348445

Finite-key analysis for measurement-device-independent quantum key distribution.

PubMed

Curty, Marcos; Xu, Feihu; Cui, Wei; Lim, Charles Ci Wen; Tamaki, Kiyoshi; Lo, Hoi-Kwong

2014-04-29

Quantum key distribution promises unconditionally secure communications. However, as practical devices tend to deviate from their specifications, the security of some practical systems is no longer valid. In particular, an adversary can exploit imperfect detectors to learn a large part of the secret key, even though the security proof claims otherwise. Recently, a practical approach--measurement-device-independent quantum key distribution--has been proposed to solve this problem. However, so far its security has only been fully proven under the assumption that the legitimate users of the system have unlimited resources. Here we fill this gap and provide a rigorous security proof against general attacks in the finite-key regime. This is obtained by applying large deviation theory, specifically the Chernoff bound, to perform parameter estimation. For the first time we demonstrate the feasibility of long-distance implementations of measurement-device-independent quantum key distribution within a reasonable time frame of signal transmission.

Japan-Specific Key Regulatory Aspects for Development of New Biopharmaceutical Drug Products.

PubMed

Desai, Kashappa Goud; Obayashi, Hirokazu; Colandene, James D; Nesta, Douglas P

2018-03-28

Japan represents the third largest pharmaceutical market in the world. Developing a new biopharmaceutical drug product for the Japanese market is a top business priority for global pharmaceutical companies while aligning with ethical drivers to treat more patients in need. Understanding Japan-specific key regulatory requirements is essential to achieve successful approvals. Understanding the full context of Japan-specific regulatory requirements/expectations is challenging to global pharmaceutical companies due to differences in language and culture. This article summarizes key Japan-specific regulatory aspects/requirements/expectations applicable to new drug development, approval, and postapproval phases. Formulation excipients should meet Japan compendial requirements with respect to the type of excipient, excipient grade, and excipient concentration. Preclinical safety assessments needed to support clinical phases I, II, and III development are summarized. Japanese regulatory authorities have taken appropriate steps to consider foreign clinical data, thereby enabling accelerated drug development and approval in Japan. Other important topics summarized in this article include: Japan new drug application-specific bracketing strategies for critical and noncritical aspects of the manufacturing process, regulatory requirements related to stability studies, release specifications and testing methods, standard processes involved in pre and postapproval inspections, management of postapproval changes, and Japan regulatory authority's consultation services available to global pharmaceutical companies. Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

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.

Poststroke Seizures and Epilepsy: Clinical Studies and Animal Models

PubMed Central

Kelly, Kevin M.

2002-01-01

Poststroke seizures and epilepsy have been described in numerous clinical studies for many years. Most studies are retrospective in design, include relatively small numbers of patients, have limited periods of follow-up, and report a diversity of findings. Well-designed clinical trials and population studies in the recent past addressed several critical clinical issues and generated important findings regarding the occurrence of poststroke seizures and epilepsy. In contrast, the pathophysiologic events of injured brain that establish poststroke epileptogenesis are not well understood, and animal modeling has had limited development. Reviews of several important clinical studies and animal models that hold promise for a better understanding of poststroke epileptogenesis are presented. PMID:15309107

Characteristics of student preparedness for clinical learning: clinical educator perspectives using the Delphi approach

PubMed Central

2012-01-01

Background During clinical placements, clinical educators facilitate student learning. Previous research has defined the skills, attitudes and practices that pertain to an ideal clinical educator. However, less attention has been paid to the role of student readiness in terms of foundational knowledge and attitudes at the commencement of practice education. Therefore, the aim of this study was to ascertain clinical educators’ views on the characteristics that they perceive demonstrate that a student is well prepared for clinical learning. Methods A two round on-line Delphi study was conducted. The first questionnaire was emailed to a total of 636 expert clinical educators from the disciplines of occupational therapy, physiotherapy and speech pathology. Expert clinical educators were asked to describe the key characteristics that indicate a student is prepared for a clinical placement and ready to learn. Open-ended responses received from the first round were subject to a thematic analysis and resulted in six themes with 62 characteristics. In the second round, participants were asked to rate each characteristic on a 7 point Likert Scale. Results A total of 258 (40.56%) responded to the first round of the Delphi survey while 161 clinical educators completed the second (62.40% retention rate). Consensus was reached on 57 characteristics (six themes) using a cut off of greater than 70% positive respondents and an interquartile deviation IQD of equal or less than 1. Conclusions This study identified 57 characteristics (six themes) perceived by clinical educators as indicators of a student who is prepared and ready for clinical learning. A list of characteristics relating to behaviours has been compiled and could be provided to students to aid their preparation for clinical learning and to universities to incorporate within curricula. In addition, the list provides a platform for discussions by professional bodies about the role of placement education. PMID:23145840

Optical key system

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

Hagans, K.G.; Clough, R.E.

2000-04-25

An optical key system comprises a battery-operated optical key and an isolated lock that derives both its operating power and unlock signals from the correct optical key. A light emitting diode or laser diode is included within the optical key and is connected to transmit a bit-serial password. The key user physically enters either the code-to-transmit directly, or an index to a pseudorandom number code, in the key. Such person identification numbers can be retained permanently, or ephemeral. When a send button is pressed, the key transmits a beam of light modulated with the password information. The modulated beam ofmore » light is received by a corresponding optical lock with a photovoltaic cell that produces enough power from the beam of light to operate a password-screen digital logic. In one application, an acceptable password allows a two watt power laser diode to pump ignition and timing information over a fiberoptic cable into a sealed engine compartment. The receipt of a good password allows the fuel pump, spark, and starter systems to each operate. Therefore, bypassing the lock mechanism as is now routine with automobile thieves is pointless because the engine is so thoroughly disabled.« less

Understanding Clinic Practices for Human Papilloma Virus Vaccination Series Completion in Clinics That Provide Primary Care: Survey of Clinic Managers in Iowa.

PubMed

Askelson, Natoshia M; Edmonds, Stephanie W; Momany, Elizabeth T; Tegegne, Mesay A

2016-07-01

Rates for human papilloma virus (HPV) vaccination are low across the United States. Evidence-based-practices to increase immunization coverage have been recommended by public health organizations, yet many primary care clinics do not follow these practices. The purpose of this study was to examine if primary care clinics use these best practices to promote completion of the HPV vaccine series for their adolescent patients. Understanding the prevalence of evidence-based immunization strategies is key to increasing vaccination coverage. We mailed 914 surveys to clinic managers of clinics that provide primary care in Iowa. The survey content was based on immunization strategies related to clinic practice and policies that have been proven effective to promote the completion of the HPV vaccination series. Survey responses from 127 clinics were used in the final analysis. Most clinics always used the state's immunization information system to record HPV vaccinations (89.4%). Over a quarter of clinics (27.6%) did not use any type of reminder or recall system to alert parents or providers that an HPV vaccine was due, and 35.0% did not give the vaccine at sick visits. Clinics need to focus more on the recommended logistics and processes to ensure that patients receive the entire HPV vaccination series. Survey results indicate that clinics are not consistently implementing the recommended best practices to ensure that vaccination series are completed.

An overview of clinical studies on fiber post systems.

PubMed

Dikbas, Idil; Tanalp, Jale

2013-01-01

Intraradicular posts are useful adjuncts in the restoration of endodontically treated teeth. These systems have undergone a significant evolution in recent years, and fiber-reinforced systems have started to be incorporated into routine clinical care more frequently. Despite the high number of laboratory studies pertaining to the characteristics of fiber posts, clinical studies evaluating their general success rates are rather limited. Since clinical investigations are reliable means to achieve information about the general behavior pattern of materials or techniques, assessment of this data will be beneficial to have a better understanding of fiber-reinforced intraradicular post systems. The purpose of this paper was to make a summary of clinical studies regarding various fiber posts. A PubMed search was conducted and articles dating back to 1990 were retrieved. The paper provides an overview of clinical studies on fiber posts specifically in the last decade as well as commentary analysis.

An Overview of Clinical Studies on Fiber Post Systems

PubMed Central

Dikbas, Idil; Tanalp, Jale

2013-01-01

Intraradicular posts are useful adjuncts in the restoration of endodontically treated teeth. These systems have undergone a significant evolution in recent years, and fiber-reinforced systems have started to be incorporated into routine clinical care more frequently. Despite the high number of laboratory studies pertaining to the characteristics of fiber posts, clinical studies evaluating their general success rates are rather limited. Since clinical investigations are reliable means to achieve information about the general behavior pattern of materials or techniques, assessment of this data will be beneficial to have a better understanding of fiber-reinforced intraradicular post systems. The purpose of this paper was to make a summary of clinical studies regarding various fiber posts. A PubMed search was conducted and articles dating back to 1990 were retrieved. The paper provides an overview of clinical studies on fiber posts specifically in the last decade as well as commentary analysis. PMID:24250255

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

PubMed

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

2017-09-11

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

Social Pharmacy and Clinical Pharmacy—Joining Forces

PubMed Central

Almarsdottir, Anna Birna; Granas, Anne Gerd

2015-01-01

This commentary seeks to define the areas of social pharmacy and clinical pharmacy to uncover what they have in common and what still sets them apart. Common threats and challenges of the two areas are reviewed in order to understand the forces in play. Forces that still keep clinical and social pharmacy apart are university structures, research traditions, and the management of pharmacy services. There are key (but shrinking) differences between clinical and social pharmacy which entail the levels of study within pharmaceutical sciences, the location in which the research is carried out, the choice of research designs and methods, and the theoretical foundations. Common strengths and opportunities are important to know in order to join forces. Finding common ground can be developed in two areas: participating together in multi-disciplinary research, and uniting in a dialogue with internal and external key players in putting forth what is needed for the profession of pharmacy. At the end the question is posed, “What’s in a name?” and we argue that it is important to emphasize what unifies the families of clinical pharmacy and social pharmacy for the benefit of both fields, pharmacy in general, and society at large. PMID:28970374

Integration of preclinical and clinical knowledge to predict intravenous PK in human: bilastine case study.

PubMed

Vozmediano, Valvanera; Ortega, Ignacio; Lukas, John C; Gonzalo, Ana; Rodriguez, Monica; Lucero, Maria Luisa

2014-03-01

Modern pharmacometrics can integrate and leverage all prior proprietary and public knowledge. Such methods can be used to scale across species or comparators, perform clinical trial simulation across alternative designs, confirm hypothesis and potentially reduce development burden, time and costs. Crucial yet typically lacking in integration is the pre-clinical stage. Prediction of PK in man, using in vitro and in vivo studies in different animal species, is increasingly well theorized but could still find wider application in drug development. The aim of the present work was to explore methods for bridging pharmacokinetic knowledge from animal species (i.v. and p.o.) and man (p.o.) into i.v. in man using the antihistamine drug bilastine as example. A model, predictive of i.v. PK in man, was developed on data from two pre-clinical species (rat and dog) and p.o. in man bilastine trials performed earlier. In the knowledge application stage, two different approaches were used to predict human plasma concentration after i.v. of bilastine: allometry (several scaling methods) and a semi-physiological method. Both approaches led to successful predictions of key i.v. PK parameters of bilastine in man. The predictive i.v. PK model was validated using later data from a clinical study of i.v. bilastine. Introduction of such knowledge in development permits proper leveraging of all emergent knowledge as well as quantification-based exploration of PK scenario, e.g. in special populations (pediatrics, renal insufficiency, comedication). In addition, the methods permit reduction or elimination and certainly optimization of learning trials, particularly those concerning alternative off-label administration routes.

Work Keys USA.

ERIC Educational Resources Information Center

Work Keys USA, 1998

1998-01-01

"Work Keys" is a comprehensive program for assessing and teaching workplace skills. This serial "special issue" features 18 first-hand reports on Work Keys projects in action in states across North America. They show how the Work Keys is helping businesses and educators solve the challenge of building a world-class work force.…

Maximizing the benefits of antiretroviral therapy for key affected populations.

PubMed

Grubb, Ian R; Beckham, Sarah W; Kazatchkine, Michel; Thomas, Ruth M; Albers, Eliot R; Cabral, Mauro; Lange, Joep; Vella, Stefano; Kurian, Manoj; Beyrer, Chris

2014-01-01

Scientific research has demonstrated the clinical benefits of earlier initiation of antiretroviral treatment (ART), and that ART can markedly reduce HIV transmission to sexual partners. Ensuring universal access to ART for those who need it has long been a core principle of the HIV response, and extending the benefits of ART to key populations is critical to increasing the impact of ART and the overall effectiveness of the HIV response. However, this can only be achieved through coordinated efforts to address political, social, legal and economic barriers that key populations face in accessing HIV services. Recent analyses show that HIV prevalence levels among key populations are far higher than among the general population, and they experience a range of biological and behavioural factors, and social, legal and economic barriers that increase their vulnerability to HIV and have resulted in alarmingly low ART coverage. World Health Organization 2014 consolidated guidance on HIV among key populations offers the potential for increased access to ART by key populations, following the same principles as for the general adult population. However, it should not be assumed that key populations will achieve greater access to ART unless stigma, discrimination and punitive laws, policies and practices that limit access to ART and other HIV interventions in many countries are addressed. Rights-based approaches and investments in critical enablers, such as supportive legal and policy environments, are essential to enable wider access to ART and other HIV interventions for key populations. The primary objective of ART should always be to treat the person living with HIV; prevention is an important, additional benefit. ART should be provided only with informed consent. The preventive benefits of treatment must not be used as a pretext for failure to provide other necessary HIV programming for key populations, including comprehensive harm reduction and other prevention

Barriers to using eHealth data for clinical performance feedback in Malawi: A case study.

PubMed

Landis-Lewis, Zach; Manjomo, Ronald; Gadabu, Oliver J; Kam, Matthew; Simwaka, Bertha N; Zickmund, Susan L; Chimbwandira, Frank; Douglas, Gerald P; Jacobson, Rebecca S

2015-10-01

Sub-optimal performance of healthcare providers in low-income countries is a critical and persistent global problem. The use of electronic health information technology (eHealth) in these settings is creating large-scale opportunities to automate performance measurement and provision of feedback to individual healthcare providers, to support clinical learning and behavior change. An electronic medical record system (EMR) deployed in 66 antiretroviral therapy clinics in Malawi collects data that supervisors use to provide quarterly, clinic-level performance feedback. Understanding barriers to provision of eHealth-based performance feedback for individual healthcare providers in this setting could present a relatively low-cost opportunity to significantly improve the quality of care. The aims of this study were to identify and describe barriers to using EMR data for individualized audit and feedback for healthcare providers in Malawi and to consider how to design technology to overcome these barriers. We conducted a qualitative study using interviews, observations, and informant feedback in eight public hospitals in Malawi where an EMR system is used. We interviewed 32 healthcare providers and conducted seven hours of observation of system use. We identified four key barriers to the use of EMR data for clinical performance feedback: provider rotations, disruptions to care processes, user acceptance of eHealth, and performance indicator lifespan. Each of these factors varied across sites and affected the quality of EMR data that could be used for the purpose of generating performance feedback for individual healthcare providers. Using routinely collected eHealth data to generate individualized performance feedback shows potential at large-scale for improving clinical performance in low-resource settings. However, technology used for this purpose must accommodate ongoing changes in barriers to eHealth data use. Understanding the clinical setting as a complex adaptive

Barriers to using eHealth data for clinical performance feedback in Malawi: A case study

PubMed Central

Landis-Lewis, Zach; Manjomo, Ronald; Gadabu, Oliver J; Kam, Matthew; Simwaka, Bertha N; Zickmund, Susan L; Chimbwandira, Frank; Douglas, Gerald P; Jacobson, Rebecca S

2016-01-01

Introduction Sub-optimal performance of healthcare providers in low-income countries is a critical and persistent global problem. The use of electronic health information technology (eHealth) in these settings is creating large-scale opportunities to automate performance measurement and provision of feedback to individual healthcare providers, to support clinical learning and behavior change. An electronic medical record system (EMR) deployed in 66 antiretroviral therapy clinics in Malawi collects data that supervisors use to provide quarterly, clinic-level performance feedback. Understanding barriers to provision of eHealth-based performance feedback for individual healthcare providers in this setting could present a relatively low-cost opportunity to significantly improve the quality of care. Objective The aims of this study were to identify and describe barriers to using EMR data for individualized audit and feedback for healthcare providers in Malawi and to consider how to design technology to overcome these barriers. Methods We conducted a qualitative study using interviews, observations, and informant feedback in eight public hospitals in Malawi where an EMR is used. We interviewed 32 healthcare providers and conducted seven hours of observation of system use. Results We identified four key barriers to the use of EMR data for clinical performance feedback: provider rotations, disruptions to care processes, user acceptance of eHealth, and performance indicator lifespan. Each of these factors varied across sites and affected the quality of EMR data that could be used for the purpose of generating performance feedback for individual healthcare providers. Conclusion Using routinely collected eHealth data to generate individualized performance feedback shows potential at large-scale for improving clinical performance in low-resource settings. However, technology used for this purpose must accommodate ongoing changes in barriers to eHealth data use. Understanding

Turbulence study in the vicinity of piano key weir: relevance, instrumentation, parameters and methods

NASA Astrophysics Data System (ADS)

Tiwari, Harinarayan; Sharma, Nayan

2017-05-01

This research paper focuses on the need of turbulence, instruments reliable to capture turbulence, different turbulence parameters and some advance methodology which can decompose various turbulence structures at different levels near hydraulic structures. Small-scale turbulence research has valid prospects in open channel flow. The relevance of the study is amplified as we introduce any hydraulic structure in the channel which disturbs the natural flow and creates discontinuity. To recover this discontinuity, the piano key weir (PKW) might be used with sloped keys. Constraints of empirical results in the vicinity of PKW necessitate extensive laboratory experiments with fair and reliable instrumentation techniques. Acoustic Doppler velocimeter was established to be best suited within range of some limitations using principal component analysis. Wavelet analysis is proposed to decompose the underlying turbulence structure in a better way.

Key Largo Limestone revisited: Pleistocene shelf-edge facies, Florida Keys, USA

USGS Publications Warehouse

Gray, Multer H.; Gischler, E.; Lundberg, J.; Simmons, K.R.; Shinn, E.A.

2002-01-01

New dates and analysis of 12 deep and 57 shallow cores allow a more detailed interpretation of the Pleistocene shelf edge of the Florida Platform as found in various facies of the Key Largo Limestone beneath the Florida Keys. In this study a three-phase evolution of the Quaternary units (Q1-Q5) of the Key Largo is presented with new subdivision of the Q5. (1) In the first phase, the Q1 and Q2 (perhaps deposited during oxygen-isotope stage 11) deep-water quartz-rich environment evolved into a shallow carbonate phase. (2) Subsequently, a Q3 (presumably corresponding to oxygen-isotope stage 9) flourishing reef and productive high-platform sediment phase developed. (3) Finally, a Q4 and Q5 (corresponding to oxygen-isotope stages 7 and 5) stabilization phase occured with reefs and leeward productive lagoons, followed by lower sea levels presenting a sequence of younger (isotope substages 5c, 5a) shelf-margin wedges, sediment veneers and outlier reefs. The Key Largo Limestone provides an accessible model of a carbonate shelf edge with fluctuating water depth, bordering a deep seaward basin for a period of at least 300 ka. During this time, at least four onlaps/offlaps, often separated by periods of karst development with associated diagenetic alterations, took place. The story presented by this limestone not only allows a better understanding of the history of south Florida but also aids in the interpretation of similar persistent shelf-edge sites bordering deep basins in other areas.

Are the Keys loved to death? A study of diver specialization levels and preferences in the Florida Keys

Treesearch

Shona Paterson; David K. Loomis

2010-01-01

This paper presents research conducted for the Florida Reef Resilience Program on nonresident recreational SCUBA divers in three zones of the Florida Keys. When divers were segmented into specialization subgroups for analysis, divers in different subgroups tended to use different geographic locations. These results suggest differences in user preferences; yet when...

Algorithms for Lightweight Key Exchange †

PubMed Central

Santonja, Juan; Zamora, Antonio

2017-01-01

Public-key cryptography is too slow for general purpose encryption, with most applications limiting its use as much as possible. Some secure protocols, especially those that enable forward secrecy, make a much heavier use of public-key cryptography, increasing the demand for lightweight cryptosystems that can be implemented in low powered or mobile devices. This performance requirements are even more significant in critical infrastructure and emergency scenarios where peer-to-peer networks are deployed for increased availability and resiliency. We benchmark several public-key key-exchange algorithms, determining those that are better for the requirements of critical infrastructure and emergency applications and propose a security framework based on these algorithms and study its application to decentralized node or sensor networks. PMID:28654006

Partially Key Distribution with Public Key Cryptosystem Based on Error Control Codes

NASA Astrophysics Data System (ADS)

Tavallaei, Saeed Ebadi; Falahati, Abolfazl

Due to the low level of security in public key cryptosystems based on number theory, fundamental difficulties such as "key escrow" in Public Key Infrastructure (PKI) and a secure channel in ID-based cryptography, a new key distribution cryptosystem based on Error Control Codes (ECC) is proposed . This idea is done by some modification on McEliece cryptosystem. The security of ECC cryptosystem obtains from the NP-Completeness of block codes decoding. The capability of generating public keys with variable lengths which is suitable for different applications will be provided by using ECC. It seems that usage of these cryptosystems because of decreasing in the security of cryptosystems based on number theory and increasing the lengths of their keys would be unavoidable in future.

Marketing and clinical trials: a case study

PubMed Central

Francis, David; Roberts, Ian; Elbourne, Diana R; Shakur, Haleema; Knight, Rosemary C; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki A; McDonald, Alison M; Grant, Adrian M; Campbell, Marion K

2007-01-01

Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. Results The case study demonstrates that trials need various categories of people to buy in – hence, to be successful, trialists must embrace marketing strategies to some extent. Conclusion The performance of future clinical trials could be enhanced if trialists routinely considered these factors. PMID:18028537

Marketing and clinical trials: a case study.

PubMed

Francis, David; Roberts, Ian; Elbourne, Diana R; Shakur, Haleema; Knight, Rosemary C; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki A; McDonald, Alison M; Grant, Adrian M; Campbell, Marion K

2007-11-20

Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. The case study demonstrates that trials need various categories of people to buy in - hence, to be successful, trialists must embrace marketing strategies to some extent. The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

American Society of Clinical Oncology Summit on Addressing Obesity Through Multidisciplinary Provider Collaboration: Key Findings and Recommendations for Action.

PubMed

Ligibel, Jennifer A; Alfano, Catherine M; Hershman, Dawn L; Merrill, Janette K; Basen-Engquist, Karen; Bloomgarden, Zachary T; Demark-Wahnefried, Wendy; Dixon, Suzanne; Hassink, Sandra G; Jakicic, John M; Morton, John Magaña; Okwuosa, Tochi M; Powell-Wiley, Tiffany M; Rothberg, Amy E; Stephens, Mark; Streett, Sarah E; Wild, Robert A; Westman, Eric A; Williams, Ronald J; Wollins, Dana S; Hudis, Clifford A

2017-11-01

Given the increasing evidence that obesity increases the risk of developing and dying from malignancy, the American Society of Clinical Oncology (ASCO) launched an Obesity Initiative in 2013 that was designed to increase awareness among oncology providers and the general public of the relationship between obesity and cancer and to promote research in this area. Recognizing that the type of societal change required to impact the obesity epidemic will require a broad-based effort, ASCO hosted the "Summit on Addressing Obesity through Multidisciplinary Collaboration" in 2016. This meeting was held to review current challenges in addressing obesity within the respective health care provider communities and to identify priorities that would most benefit from a collective and cross-disciplinary approach. Efforts focused on four key areas: provider education and training; public education and activation; research; and policy and advocacy. Summit attendees discussed current challenges in addressing obesity within their provider communities and identified priorities that would most benefit from multidisciplinary collaboration. A synopsis of recommendations to facilitate future collaboration, as well as examples of ongoing cooperative efforts, provides a blueprint for multidisciplinary provider collaboration focused on obesity prevention and treatment. © 2017 The Obesity Society.

Clinical stakeholders’ opinions on the use of selective decontamination of the digestive tract in critically ill patients in intensive care units: an international Delphi study

PubMed Central

2013-01-01

Introduction Selective decontamination of the digestive tract (SDD) is a prophylactic antibiotic regimen that is not widely used in practice. We aimed to describe the opinions of key ‘stakeholders’ about the validity of the existing evidence base, likely consequences of implementation, relative importance of their opinions in influencing overall practice, likely barriers to implementation and perceptions of the requirement for further research to inform the decision about whether to embark on a further large randomised controlled trial. Methods This was a Delphi study informed by comprehensive framework of possible determinants of health professionals’ behaviour to study Critical Care practice in four countries. There were four key stakeholder participant groups including ICU physicians, pharmacists, clinical leads, and clinical microbiologists/ infectious disease physicians. Round one comprised participant interviews and Rounds two and three were online questionnaires using Delphi method. Results In this study, 141 participants were recruited of whom 82% were retained. Participants rated themselves as knowledgeable about SDD. Antibiotic resistance was identified as the most important issue. SDD was seen as a low clinical priority but few participants reported strong opposition. There was moderate agreement that research to date has not adequately addressed concerns about antibiotic resistance and lacks generalizability. Participants indicated equipoise with regard to benefits and harms of SDD, and indicated strong support for a further randomised trial. Conclusions Clinicians have clinical equipoise about the effectiveness of SDD. Future research requires longer follow up to assess antibiotic resistance as well as greater validity/generalizability to provide definitive answers on the effectiveness of decontamination and effects on antibiotic resistance. SDD was regarded as not being a high clinical priority, which may limit future trial participation. These

Key Questions for Translation of FFA Receptors: From Pharmacology to Medicines.

PubMed

Suckow, Arthur T; Briscoe, Celia P

2017-01-01

The identification of fatty acids as ligands for the G-protein coupled free fatty acid (FFA) receptor family over 10 years ago led to intensive chemistry efforts to find small-molecule ligands for this class of receptors. Identification of potent, selective modulators of the FFA receptors and their utility in medicine has proven challenging, in part due to their complex pharmacology. Nevertheless, ligands have been identified that are sufficient for exploring the therapeutic potential of this class of receptors in rodents and, in the case of FFA1, FFA2, FFA4, and GPR84, also in humans. Expression profiling, the phenotyping of FFA receptor knockout mice, and the results of studies exploring the effects of these ligands in rodents have uncovered a number of indications where engagement of one or a combination of FFA receptors might provide some clinical benefit in areas including diabetes, inflammatory bowel syndrome, Alzheimer's, pain, and cancer. In this chapter, we will review the clinical potential of modulating FFA receptors based on preclinical and in some cases clinical studies with synthetic ligands. In particular, key aspects and challenges associated with small-molecule ligand identification and FFA receptor pharmacology will be addressed with a view of the hurdles that need to be overcome to fully understand the potential of the receptors as therapeutic targets.

Identifying Signs of Tinea Pedis: A Key to Understanding Clinical Variables.

PubMed

Canavan, Theresa N; Elewski, Boni E

2015-10-01

Tinea pedis is a frequently encountered dermatophytosis affecting the superficial skin of the feet, primarily of adults. The prevalence of tinea pedis has increased over the last several decades due to an increase in multiple risk factors. Infection from dermatophytes is most common, but infection from other fungi can also result in tinea pedis. Four distinct clinical presentations occur: interdigital, moccasin, vesicular, and acute ulcerative types. A variety of physical exam findings can help the clinician identify patients with tinea pedis.

Keys to Scholarship

ERIC Educational Resources Information Center

Hebert, Terri

2011-01-01

Up ahead, a foreboding wooden door showing wear from passage of earlier travelers is spotted. As the old porch light emits a pale yellow glow, a key ring emerges from deep inside the coat pocket. Searching for just the right key, the voyager settles on one that also shows age. As the key enters its receptacle and begins to turn, a clicking noise…

Clinical Impact Research – how to choose experimental or observational intervention study?

PubMed Central

Malmivaara, Antti

2016-01-01

Abstract Background: Interventions directed to individuals by health and social care systems should increase health and welfare of patients and customers. Aims: This paper aims to present and define a new concept Clinical Impact Research (CIR) and suggest which study design, either randomized controlled trial (RCT) (experimental) or benchmarking controlled trial (BCT) (observational) is recommendable and to consider the feasibility, validity, and generalizability issues in CIR. Methods: The new concept is based on a narrative review of the literature and on author’s idea that in intervention studies, there is a need to cover comprehensively all the main impact categories and their respective outcomes. The considerations on how to choose the most appropriate study design (RCT or BCT) were based on previous methodological studies on RCTs and BCTs and on author’s previous work on the concepts benchmarking controlled trial and system impact research (SIR). Results: The CIR covers all studies aiming to assess the impact for health and welfare of any health (and integrated social) care or public health intervention directed to an individual. The impact categories are accessibility, quality, equality, effectiveness, safety, and efficiency. Impact is the main concept, and within each impact category, both generic- and context-specific outcome measures are needed. CIR uses RCTs and BCTs. Conclusions: CIR should be given a high priority in medical, health care, and health economic research. Clinicians and leaders at all levels of health care can exploit the evidence from CIR. Key messagesThe new concept of Clinical Impact Research (CIR) is defined as a research field aiming to assess what are the impacts of healthcare and public health interventions targeted to patients or individuals.The term impact refers to all effects caused by the interventions, with particular emphasis on accessibility, quality, equality, effectiveness, safety, and efficiency. CIR uses two study

Clinical Research with Transcranial Direct Current Stimulation (tDCS): Challenges and Future Directions

PubMed Central

Brunoni, Andre Russowsky; Nitsche, Michael A.; Bolognini, Nadia; Bikson, Marom; Wagner, Tim; Merabet, Lotfi; Edwards, Dylan J.; Valero-Cabre, Antoni; Rotenberg, Alexander; Pascual-Leone, Alvaro; Ferrucci, Roberta; Priori, Alberto; Boggio, Paulo; Fregni, Felipe

2011-01-01

Background Transcranial direct current stimulation (tDCS) is a neuromodulatory technique that delivers low-intensity, direct current to cortical areas facilitating or inhibiting spontaneous neuronal activity. In the past ten years, tDCS physiological mechanisms of action have been intensively investigated giving support for the investigation of its applications in clinical neuropsychiatry and rehabilitation. However, new methodological, ethical, and regulatory issues emerge when translating the findings of preclinical and phase I studies into phase II and III clinical studies. The aim of this comprehensive review is to discuss the key challenges of this process and possible methods to address them. Methods We convened a workgroup of researchers in the field to review, discuss and provide updates and key challenges of neuromodulation use for clinical research. Main Findings/Discussion We reviewed several basic and clinical studies in the field and identified potential limitations, taking into account the particularities of the technique. We review and discuss the findings into four topics: (i) mechanisms of action of tDCS, parameters of use and computer-based human brain modeling investigating electric current fields and magnitude induced by tDCS; (ii) methodological aspects related to the clinical research of tDCS as divided according to study phase (i.e., preclinical, phase I, phase II and phase III studies); (iii) ethical and regulatory concerns; (iv) future directions regarding novel approaches, novel devices, and future studies involving tDCS. Finally, we propose some alternative methods to facilitate clinical research on tDCS. PMID:22037126

Of lamp posts, keys, and fabled drunkards: A perspectival tale of 4 guidelines.

PubMed

Greenhalgh, Trisha

2018-04-15

Evidence-based medicine is the application of research findings to inform individual clinical decisions. There is a tension-both philosophical and practical-between the average result from a population study and the circumstances and needs of an individual patient. This personal account of "evidence-based" trauma care illustrates and explores this tension. The author, a keen athlete, describes her experience of a high-impact cycle accident that led to limb fractures (which were diagnosed and treated according to evidence-based guidelines) and also an occult injury to the cervical spine (which was not diagnosed at the time). Some evidence-based guidelines are reviewed and applied to the case. The clinical record described the cycle accident as a "fall." Initial assessment directed the clinicians' gaze to the obvious injuries, whose treatment was straightforward. On admission, the patient (aged 55 years at the time) was offered "falls prevention" via a guideline-based checklist. Several months later, neurological sequelae indicated possible damage to the cervical spine. But the NICE Guideline recommending cervical spine imaging in cases of high-impact trauma had not been considered-perhaps because the clinical narrative had been prematurely assigned to the script of "older person with fall." Furthermore, the author, who was (appropriately) treated with neurosurgery, was surprised at the response of clinical colleagues, based on application of an irrelevant section of a guideline, that her cervical discectomy was "nonevidence based." Nonsteroidal anti-inflammatory drugs for postoperative pain were indicated in this patient even though they were not recommended for the average patient. As Sir John Grimley Evans' warned, we should avoid using evidence-based guidelines in the manner of the fabled drunkard who searched under the lamp post for his key because that was where the light was, even though he knew he had lost his key somewhere else. © 2018 The Authors Journal

The University Charter School Partnership: A Case Study on the Perspectives of Key Constituencies

ERIC Educational Resources Information Center

DeMinico, Dana

2011-01-01

The following study sought to add to the body of literature on effective charter school models and the role universities play in urban school reform by closely examining one urban elementary university charter school partnership through the eyes of its key participants and in relation to the unique political and social contexts in which it was…

Development of EULAR recommendations for the reporting of clinical trial extension studies in rheumatology.

PubMed

Buch, Maya H; Silva-Fernandez, Lucia; Carmona, Loreto; Aletaha, Daniel; Christensen, Robin; Combe, Bernard; Emery, Paul; Ferraccioli, Gianfranco; Guillemin, Francis; Kvien, Tore K; Landewe, Robert; Pavelka, Karel; Saag, Kenneth; Smolen, Josef S; Symmons, Deborah; van der Heijde, Désirée; Welling, Joep; Wells, George; Westhovens, Rene; Zink, Angela; Boers, Maarten

2015-06-01

Our initiative aimed to produce recommendations on post-randomised controlled trial (RCT) trial extension studies (TES) reporting using European League Against Rheumatism (EULAR) standard operating procedures in order to achieve more meaningful output and standardisation of reports. We formed a task force of 22 participants comprising RCT experts, clinical epidemiologists and patient representatives. A two-stage Delphi survey was conducted to discuss the domains of evaluation of a TES and definitions. A '0-10' agreement scale assessed each domain and definition. The resulting set of recommendations was further refined and a final vote taken for task force acceptance. Seven key domains and individual components were evaluated and led to agreed recommendations including definition of a TES (100% agreement), minimal data necessary (100% agreement), method of data analysis (agreement mean (SD) scores ranging between 7.9 (0.84) and 9.0 (2.16)) and reporting of results as well as ethical issues. Key recommendations included reporting of absolute numbers at each stage from the RCT to TES with reasons given for drop-out at each stage, and inclusion of a flowchart detailing change in numbers at each stage and focus (mean (SD) agreement 9.9 (0.36)). A final vote accepted the set of recommendations. This EULAR task force provides recommendations for implementation in future TES to ensure a standardised approach to reporting. Use of this document should provide the rheumatology community with a more accurate and meaningful output from future TES, enabling better understanding and more confident application in clinical practice towards improving patient outcomes. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Clinical coordination in accountable care organizations: A qualitative study.

PubMed

Lewis, Valerie A; Schoenherr, Karen; Fraze, Taressa; Cunningham, Aleen

2016-12-06

Accountable care organizations (ACOs) are becoming a common payment and delivery model. Despite widespread interest, little empirical research has examined what efforts or strategies ACOs are using to change care and reduce costs. Knowledge of ACOs' clinical efforts can provide important context for understanding ACO performance, particularly to distinguish arenas where ACOs have and have not attempted care transformation. The aim of the study was to understand ACOs' efforts to change clinical care during the first 18 months of ACO contracts. We conducted semistructured interviews between July and December 2013. Our sample includes ACOs that began performance contracts in 2012, including Medicare Shared Savings Program and Pioneer participants, stratified across key factors. In total, we conducted interviews with executives from 30 ACOs. Iterative qualitative analysis identified common patterns and themes. ACOs in the first year of performance contracts are commonly focusing on four areas: first, transforming primary care through increased access and team-based care; second, reducing avoidable emergency department use; third, strengthening practice-based care management; and fourth, developing new boundary spanner roles and activities. ACOs were doing little around transforming specialty care, acute and postacute care, or standardizing care across practices during the first 18 months of ACO performance contracts. Results suggest that cost reductions associated with ACOs in the first years of contracts may be related to primary care. Although in the long term many hope ACOs will achieve coordination across a wide array of care settings and providers, in the short term providers under ACO contracts are focused largely on primary care-related strategies. Our work provides a template of the common areas of clinical activity in the first years of ACO contracts, which may be informative to providers considering becoming an ACO. Further research will be needed to

"You can save time if…"-A qualitative study on internal factors slowing down clinical trials in Sub-Saharan Africa.

PubMed

Vischer, Nerina; Pfeiffer, Constanze; Limacher, Manuela; Burri, Christian

2017-01-01

The costs, complexity, legal requirements and number of amendments associated with clinical trials are rising constantly, which negatively affects the efficient conduct of trials. In Sub-Saharan Africa, this situation is exacerbated by capacity and funding limitations, which further increase the workload of clinical trialists. At the same time, trials are critically important for improving public health in these settings. The aim of this study was to identify the internal factors that slow down clinical trials in Sub-Saharan Africa. Here, factors are limited to those that exclusively relate to clinical trial teams and sponsors. These factors may be influenced independently of external conditions and may significantly increase trial efficiency if addressed by the respective teams. We conducted sixty key informant interviews with clinical trial staff working in different positions in two clinical research centres in Kenya, Ghana, Burkina Faso and Senegal. The study covered English- and French-speaking, and Eastern and Western parts of Sub-Saharan Africa. We performed thematic analysis of the interview transcripts. We found various internal factors associated with slowing down clinical trials; these were summarised into two broad themes, "planning" and "site organisation". These themes were consistently mentioned across positions and countries. "Planning" factors related to budget feasibility, clear project ideas, realistic deadlines, understanding of trial processes, adaptation to the local context and involvement of site staff in planning. "Site organisation" factors covered staff turnover, employment conditions, career paths, workload, delegation and management. We found that internal factors slowing down clinical trials are of high importance to trial staff. Our data suggest that adequate and coherent planning, careful assessment of the setting, clear task allocation and management capacity strengthening may help to overcome the identified internal factors and

[Key informers. When and How?].

PubMed

Martín González, R

2009-03-01

When information obtained through duly designed and developed studies is not available, the solution to certain problems that affect the population or that respond to certain questions may be approached by using the information and experience provided by the so-called key informer. The key informer is defined as a person who is in contact with the community or with the problem to be studied, who is considered to have good knowledge of the situation and therefore who is considered an expert. The search for consensus is the basis to obtain information through the key informers. The techniques used have different characteristics based on whether the experts chosen meet together or not, whether they are guided or not, whether they interact with each other or not. These techniques include the survey, the Delphi technique, the nominal group technique, brainwriting, brainstorming, the Phillips 66 technique, the 6-3-5 technique, the community forum and the community impressions technique. Information provided by key informers through the search for consensus is relevant when this is not available or cannot be obtained by other methods. It has permitted the analysis of the existing neurological care model, elaboration of recommendations on visit times for the out-patient neurological care, and the elaboration of guidelines and recommendations for the management of prevalent neurological problems.

Second Mesiobuccal Canal Treatment in a Predoctoral Dental Clinic: A Retrospective Clinical Study.

PubMed

Coelho, Marcelo Santos; Parker, Jeffrey M; Tawil, Peter Z

2016-06-01

The aim of this retrospective clinical study was to evaluate the location and treatment of second canals in mesiobuccal roots (MB2) of first and second maxillary molars in a predoctoral endodontic clinic by the graduating classes of 2008 to 2015. These results were compared to similar clinical studies. Included in the study were 368 root canal treatments performed by 310 third- and fourth-year dental students at one U.S. dental school. All cases were done under faculty supervision, and the students were instructed to use dental loupe magnification. Students' evaluation sheets were used to deteremine the total MB2 canals treated in first and second maxillary molars. The results showed that, overall, 72.55% of the teeth had an MB2 canal treated. The frequency was higher in first molars (75.91%) than in second molars (56.92%) (p<0.05). Third-year students were able to detect 39 MB2 canals in 57 maxillary molars (68.42%), while fourth-year students detected 228 MB2 canals in 311 teeth (73.31%) (p>0.05). Under proper supervision by experienced endodontists, these dental students were capable of treating MB2 canals in maxillary molars. The frequency of MB2 canals located and treated by dental students with the assistance of experienced professionals was higher in first than in second molars. No significant difference was found between third- and fourth-year students. The incidence of MB2 canals located and treated in this study was found to be similar to that in other clinical studies.

Teaching medical students to discern ethical problems in human clinical research studies.

PubMed

Roberts, Laura Weiss; Warner, Teddy D; Green Hammond, Katherine A; Brody, Janet L; Kaminsky, Alexis; Roberts, Brian B

2005-10-01

Investigators and institutional review boards are entrusted with ensuring the conduct of ethically sound human studies. Assessing ethical aspects of research protocols is a key skill in fulfilling this duty, yet no empirically validated method exists for preparing professionals to attain this skill. The authors performed a randomized controlled educational intervention, comparing a criteria-based learning method, a clinical-research- and experience-based learning method, and a control group. All 300 medical students enrolled at the University of New Mexico School of Medicine in 2001 were invited to participate. After a single half-hour educational session, a written posttest of ability to detect ethical problems in hypothetical protocol vignettes was administered. The authors analyzed responses to ten protocol vignettes that had been evaluated independently by experts. For each vignette, a global assessment of the perceived significance of ethical problems and the identification of specific ethical problems were evaluated. Eighty-three medical students (27%) volunteered: 50 (60%) were women and 55 (66%) were first- and second-year students. On global assessments, the criteria-focused group perceived ethical problems as more significant than did the other two groups (p < .02). Students in the criteria-focused group were better able than students in the control group (p < .03) to discern specific ethical problems, more closely resembling expert assessments. Unexpectedly, the group focused on clinical research participants identified fewer problems than did the control group (p < .05). The criteria-focused intervention produced enhanced ethical evaluation skills. This work supports the potential value of empirically derived methods for preparing professionals to discern ethical aspects of human studies.

[Clinical key points. Gonioscopy].

PubMed

Hamard, P

2007-05-01

Gonioscopy should be performed in all patients with glaucoma or suspected of having glaucoma. Four points are systematically evaluated: the width of the angle, the degree of trabecular pigmentation, the iridotrabecular appositions or synechia, and the level of iris insertion and the shape of the peripheral iris profile.

Electronic health records to facilitate clinical research.

PubMed

Cowie, Martin R; Blomster, Juuso I; Curtis, Lesley H; Duclaux, Sylvie; Ford, Ian; Fritz, Fleur; Goldman, Samantha; Janmohamed, Salim; Kreuzer, Jörg; Leenay, Mark; Michel, Alexander; Ong, Seleen; Pell, Jill P; Southworth, Mary Ross; Stough, Wendy Gattis; Thoenes, Martin; Zannad, Faiez; Zalewski, Andrew

2017-01-01

Electronic health records (EHRs) provide opportunities to enhance patient care, embed performance measures in clinical practice, and facilitate clinical research. Concerns have been raised about the increasing recruitment challenges in trials, burdensome and obtrusive data collection, and uncertain generalizability of the results. Leveraging electronic health records to counterbalance these trends is an area of intense interest. The initial applications of electronic health records, as the primary data source is envisioned for observational studies, embedded pragmatic or post-marketing registry-based randomized studies, or comparative effectiveness studies. Advancing this approach to randomized clinical trials, electronic health records may potentially be used to assess study feasibility, to facilitate patient recruitment, and streamline data collection at baseline and follow-up. Ensuring data security and privacy, overcoming the challenges associated with linking diverse systems and maintaining infrastructure for repeat use of high quality data, are some of the challenges associated with using electronic health records in clinical research. Collaboration between academia, industry, regulatory bodies, policy makers, patients, and electronic health record vendors is critical for the greater use of electronic health records in clinical research. This manuscript identifies the key steps required to advance the role of electronic health records in cardiovascular clinical research.

Clinical and neuropsychological features of violence in schizophrenia: A prospective cohort study.

PubMed

Bulgari, Viola; Iozzino, Laura; Ferrari, Clarissa; Picchioni, Marco; Candini, Valentina; De Francesco, Alessandra; Maggi, Paolo; Segalini, Beatrice; de Girolamo, Giovanni

2017-03-01

The increased risk of violence in schizophrenia has been linked to several environmental, clinical and neuropsychological factors, including executive dysfunction. However, data about the nature of these effects are mixed and controversial. The main aim of this study was to investigate the relationship between clinical and neuropsychological factors with violence risk in patients with schizophrenia, taking into account current psychopathology and lifetime alcohol use. We compared a sample of patients living in Residential Facilities (RFs) with schizophrenia and a past history of interpersonal violence (vSZ, N=50) to patients with schizophrenia matched on age, gender and alcohol abuse/dependence but with no violence history (nvSZ, N=37). We then established the association between the clinical and neuropsychological factors that predicted violence over a 1year follow-up period. The results revealed that vSZ patients living in RFs were characterized by greater compulsory hospital admissions, higher anger and less negative symptoms as compared to nvSZ patients. vSZ patients performed better on executive and motor tasks than nvSZ; however, these differences appeared to be explained by the lower negative psychotic symptom in the vSZ group. Both groups were involved in episodes of violence during the follow-up period; among the two, the vSZ patients were more likely to be violent. Negative symptoms predicted less verbal aggression at 1year follow-up. Overall, these findings support a key role of negative rather than positive symptoms in driving violence risk among SZ patients living in RFs, in a manner that negative symptoms are linked to a lower risk of violence. Copyright © 2016 Elsevier B.V. All rights reserved.

Automated secured cost effective key refreshing technique to enhance WiMAX privacy key management

NASA Astrophysics Data System (ADS)

Sridevi, B.; Sivaranjani, S.; Rajaram, S.

2013-01-01

In all walks of life the way of communication is transformed by the rapid growth of wireless communication and its pervasive use. A wireless network which is fixed and richer in bandwidth is specified as IEEE 802.16, promoted and launched by an industrial forum is termed as Worldwide Interoperability for Microwave Access (WiMAX). This technology enables seamless delivery of wireless broadband service for fixed and/or mobile users. The obscurity is the long delay which occurs during the handoff management in every network. Mobile WiMAX employs an authenticated key management protocol as a part of handoff management in which the Base Station (BS) controls the distribution of keying material to the Mobile Station (MS). The protocol employed is Privacy Key Management Version 2- Extensible Authentication Protocol (PKMV2-EAP) which is responsible for the normal and periodical authorization of MSs, reauthorization as well as key refreshing. Authorization key (AK) and Traffic Encryption key (TEK) plays a vital role in key exchange. When the lifetime of key expires, MS has to request for a new key to BS which in turn leads to repetition of authorization, authentication as well as key exchange. To avoid service interruption during reauthorization , two active keys are transmitted at the same time by BS to MS. The consequences of existing work are hefty amount of bandwidth utilization, time consumption and large storage. It is also endured by Man in the Middle attack and Impersonation due to lack of security in key exchange. This paper designs an automatic mutual refreshing of keys to minimize bandwidth utilization, key storage and time consumption by proposing Previous key and Iteration based Key Refreshing Function (PKIBKRF). By integrating PKIBKRF in key generation, the simulation results indicate that 21.8% of the bandwidth and storage of keys are reduced and PKMV2 mutual authentication time is reduced by 66.67%. The proposed work is simulated with Qualnet model and

Factors that influence career progression among postdoctoral clinical academics: a scoping review of the literature

PubMed Central

Ranieri, Veronica; Barratt, Helen; Fulop, Naomi; Rees, Geraint

2016-01-01

Background The future of academic medicine is uncertain. Concerns regarding the future availability of qualified and willing trainee clinical academics have been raised worldwide. Of significant concern is our failure to retain postdoctoral trainee clinical academics, who are likely to be our next generation of leaders in scientific discovery. Objectives To review the literature about factors that may influence postdoctoral career progression in early career clinical academics. Design This study employed a scoping review method. Three reviewers separately assessed whether the articles found fit the inclusion criteria. Data sources PubMed, Scopus, Web of Science and Google Scholar (1991–2015). Article selection The review encompassed a broad search of English language studies published anytime up to November 2015. All articles were eligible for inclusion, including research papers employing either quantitative or qualitative methods, as well as editorials and other summary articles. Data extraction Data extracted from included publications were charted according to author(s), sample population, study design, key findings, country of origin and year of publication. Results Our review identified 6 key influences: intrinsic motivation, work–life balance, inclusiveness, work environment, mentorship and availability of funding. It also detected significant gaps within the literature about these influences. Conclusions Three key steps are proposed to help support postdoctoral trainee clinical academics. These focus on ensuring that researchers feel encouraged in their workplace, involved in collaborative dialogue with key stakeholders and able to access reliable information regarding their chosen career pathway. Finally, we highlight recommendations for future research. PMID:27798036

IGF1R as a Key Target in High Risk, Metastatic Medulloblastoma

PubMed Central

Svalina, Matthew N.; Kikuchi, Ken; Abraham, Jinu; Lal, Sangeet; Davare, Monika A.; Settelmeyer, Teagan P.; Young, Michael C.; Peckham, Jennifer L.; Cho, Yoon-Jae; Michalek, Joel E.; Hernandez, Brian S.; Berlow, Noah E.; Jackson, Melanie; Guillaume, Daniel J.; Selden, Nathan R.; Bigner, Darell D.; Nazemi, Kellie J.; Green, Sarah C.; Corless, Christopher L.; Gultekin, Sakir; Mansoor, Atiya; Rubin, Brian P.; Woltjer, Randall; Keller, Charles

2016-01-01

Risk or presence of metastasis in medulloblastoma causes substantial treatment-related morbidity and overall mortality. Through the comparison of cytokines and growth factors in the cerebrospinal fluid (CSF) of metastatic medulloblastoma patients with factors also in conditioned media of metastatic MYC amplified medulloblastoma or leptomeningeal cells, we were led to explore the bioactivity of IGF1 in medulloblastoma by elevated CSF levels of IGF1, IGF-sequestering IGFBP3, IGFBP3-cleaving proteases (MMP and tPA), and protease modulators (TIMP1 and PAI-1). IGF1 led not only to receptor phosphorylation but also accelerated migration/adhesion in MYC amplified medulloblastoma cells in the context of appropriate matrix or meningothelial cells. Clinical correlation suggests a peri-/sub-meningothelial source of IGF-liberating proteases that could facilitate leptomeningeal metastasis. In parallel, studies of key factors responsible for cell autonomous growth in MYC amplified medulloblastoma prioritized IGF1R inhibitors. Together, our studies identify IGF1R as a high value target for clinical trials in high risk medulloblastoma. PMID:27255663

IGF1R as a Key Target in High Risk, Metastatic Medulloblastoma.

PubMed

Svalina, Matthew N; Kikuchi, Ken; Abraham, Jinu; Lal, Sangeet; Davare, Monika A; Settelmeyer, Teagan P; Young, Michael C; Peckham, Jennifer L; Cho, Yoon-Jae; Michalek, Joel E; Hernandez, Brian S; Berlow, Noah E; Jackson, Melanie; Guillaume, Daniel J; Selden, Nathan R; Bigner, Darell D; Nazemi, Kellie J; Green, Sarah C; Corless, Christopher L; Gultekin, Sakir; Mansoor, Atiya; Rubin, Brian P; Woltjer, Randall; Keller, Charles

2016-06-03

Risk or presence of metastasis in medulloblastoma causes substantial treatment-related morbidity and overall mortality. Through the comparison of cytokines and growth factors in the cerebrospinal fluid (CSF) of metastatic medulloblastoma patients with factors also in conditioned media of metastatic MYC amplified medulloblastoma or leptomeningeal cells, we were led to explore the bioactivity of IGF1 in medulloblastoma by elevated CSF levels of IGF1, IGF-sequestering IGFBP3, IGFBP3-cleaving proteases (MMP and tPA), and protease modulators (TIMP1 and PAI-1). IGF1 led not only to receptor phosphorylation but also accelerated migration/adhesion in MYC amplified medulloblastoma cells in the context of appropriate matrix or meningothelial cells. Clinical correlation suggests a peri-/sub-meningothelial source of IGF-liberating proteases that could facilitate leptomeningeal metastasis. In parallel, studies of key factors responsible for cell autonomous growth in MYC amplified medulloblastoma prioritized IGF1R inhibitors. Together, our studies identify IGF1R as a high value target for clinical trials in high risk medulloblastoma.

Clinical laboratory studies of disinfection with Sporicidin.

PubMed Central

Isenberg, H D

1985-01-01

The clinical microbiology laboratory evaluation of disinfectants can serve as a guide for their application to reduce hospital-acquired infections. The use of Sporicidin, a glutaraldehyde-phenol formulation, was evaluated by the application of modified MIC and MBC determinations for standard organisms. In addition, the effect of this formulation on bacteria that may proliferate in water at ambient temperatures was studied. This investigation indicated that such studies can help the clinical microbiologist to guide the use of disinfectants and sterilants for the maintenance of a safe hospital environment. PMID:3932457

Clinical disintegration time of orally disintegrating tablets clinically available in Japan in healthy volunteers.

PubMed

Yoshita, Tomohiro; Uchida, Shinya; Namiki, Noriyuki

2013-01-01

Disintegration time is an important characteristic of orally disintegrating tablets (ODTs), and evaluation of disintegration time is a key step in formulation development, manufacturing, and clinical practice. In this study, we aimed to clarify the clinical disintegration time of ODTs that are currently used clinically, and to evaluate its correlation with the in vitro disintegration time of ODTs which was measured using Tricorptester, a newly developed disintegration testing apparatus. The clinical disintegration time of 17 ODT products was measured in healthy volunteers (n=9-10; age range, 21-28 years). A randomized single-blind trial was performed; each tablet was placed on the tongues of the participants, and it disintegrated in their oral cavities. No significant difference was observed in the clinical disintegration time of each ODT among the 3 groups to which the subjects were randomly assigned. The clinical disintegration time of the 17 ODT products was between 17.6 s and 33.8 s. The in vitro disintegration time of 26 clinically used ODT products measured using Tricorptester ranged between 4.40 s and 30.4 s. A significant positive correlation was observed between in vitro and clinical disintegration times (r=0.79; p<0.001). This study shows that all the tested products, which are clinically available in Japan, showed good disintegration and that the disintegration time varied according to the product. In addition, the in vitro disintegration time of ODTs measured using Tricorptester is a good reflection of the disintegration time in the oral cavity.

Reporting Guidelines for Clinical Pharmacokinetic Studies: The ClinPK Statement.

PubMed

Kanji, Salmaan; Hayes, Meghan; Ling, Adam; Shamseer, Larissa; Chant, Clarence; Edwards, David J; Edwards, Scott; Ensom, Mary H H; Foster, David R; Hardy, Brian; Kiser, Tyree H; la Porte, Charles; Roberts, Jason A; Shulman, Rob; Walker, Scott; Zelenitsky, Sheryl; Moher, David

2015-07-01

Transparent reporting of all research is essential for assessing the validity of any study. Reporting guidelines are available and endorsed for many types of research but are lacking for clinical pharmacokinetic studies. Such tools promote the consistent reporting of a minimal set of information for end users, and facilitate knowledge translation of research. The objective of this study was to create a guideline to assist in the transparent and complete reporting of clinical pharmacokinetic studies. Preliminary content to be considered was identified from a systematic search of the literature and regulatory documents. Stakeholders were identified to participate in a modified Delphi exercise and a virtual meeting to generate consensus for items considered essential in the reporting of clinical pharmacokinetic studies. The proposed checklist was pilot tested on 100 recently published clinical pharmacokinetic studies. Overall and itemized compliance with the proposed guidance was determined for each study. Sixty-eight stakeholders from nine countries consented to participate. Four rounds of a modified Delphi survey and a series of small virtual meetings were required to generate consensus for a 24-item checklist considered to be essential to the reporting of clinical pharmacokinetic studies. When applied to the 100 most recently published clinical pharmacokinetic studies, 45 were determined to be compliant with at least 80 % of the checklist items. Explanatory text was prepared using examples of compliant reporting from these and other relevant studies. The reader's ability to judge the validity of pharmacokinetic research can be greatly compromised by the incomplete reporting of study information. Using consensus methods, we have developed a tool to guide transparent and accurate reporting of clinical pharmacokinetic studies. Endorsement and implementation of these guidelines by researchers, clinicians and journals would promote more consistent reporting of these

Eight-step method to build the clinical content of an evidence-based care pathway: the case for COPD exacerbation

PubMed Central

2012-01-01

Background Optimization of the clinical care process by integration of evidence-based knowledge is one of the active components in care pathways. When studying the impact of a care pathway by using a cluster-randomized design, standardization of the care pathway intervention is crucial. This methodology paper describes the development of the clinical content of an evidence-based care pathway for in-hospital management of chronic obstructive pulmonary disease (COPD) exacerbation in the context of a cluster-randomized controlled trial (cRCT) on care pathway effectiveness. Methods The clinical content of a care pathway for COPD exacerbation was developed based on recognized process design and guideline development methods. Subsequently, based on the COPD case study, a generalized eight-step method was designed to support the development of the clinical content of an evidence-based care pathway. Results A set of 38 evidence-based key interventions and a set of 24 process and 15 outcome indicators were developed in eight different steps. Nine Belgian multidisciplinary teams piloted both the set of key interventions and indicators. The key intervention set was judged by the teams as being valid and clinically applicable. In addition, the pilot study showed that the indicators were feasible for the involved clinicians and patients. Conclusions The set of 38 key interventions and the set of process and outcome indicators were found to be appropriate for the development and standardization of the clinical content of the COPD care pathway in the context of a cRCT on pathway effectiveness. The developed eight-step method may facilitate multidisciplinary teams caring for other patient populations in designing the clinical content of their future care pathways. PMID:23190552

Reviewing the evidence for biosimilars: key insights, lessons learned and future horizons

PubMed Central

Goll, Guro L.

2017-01-01

Abstract Biologic therapies have become central to the long-term management of many chronic diseases, including inflammatory rheumatic diseases. Over recent years, the development and licensing pathways for biosimilars have become more standardized, and several biosimilars have been made available for patients with inflammatory rheumatic diseases, such as RA. Pre-licensing requirements for biosimilars mandate the demonstration of comparability with reference products in terms of clinical activity, safety and immunogenicity, whereas post-marketing surveillance and risk minimization requirements are set in place to ensure that long-term, real-world safety data are collected to assess biosimilars in clinical practice. These measures should provide a foundation for physician confidence in biosimilars, which can be established further through clinical experience. Biosimilars may help to fill an unmet need by improving patient access to effective biologic treatments for chronic diseases. Greater access may result in additional clinical benefits, with appropriate use of biologic therapies according to treatment guidelines being associated with improved outcomes and the potential for reduced costs of care. Key challenges for the integration of biosimilars into everyday practice include questions about interchangeability, switching and automatic substitution. Several switching studies have shown that biosimilars can be used in place of reference products while maintaining efficacy and safety. Additional ongoing studies and registries may help to optimize the process of switching, and different funding models are examining the optimal mechanisms to ensure effective uptake of these new treatments. PMID:28903542

Device-independent quantum key distribution

NASA Astrophysics Data System (ADS)

Hänggi, Esther

2010-12-01

In this thesis, we study two approaches to achieve device-independent quantum key distribution: in the first approach, the adversary can distribute any system to the honest parties that cannot be used to communicate between the three of them, i.e., it must be non-signalling. In the second approach, we limit the adversary to strategies which can be implemented using quantum physics. For both approaches, we show how device-independent quantum key distribution can be achieved when imposing an additional condition. In the non-signalling case this additional requirement is that communication is impossible between all pairwise subsystems of the honest parties, while, in the quantum case, we demand that measurements on different subsystems must commute. We give a generic security proof for device-independent quantum key distribution in these cases and apply it to an existing quantum key distribution protocol, thus proving its security even in this setting. We also show that, without any additional such restriction there always exists a successful joint attack by a non-signalling adversary.

Effective, clinically feasible and sustainable: Key design features of psycho-educational and supportive care interventions to promote individualised self-management in cancer care.

PubMed

Schofield, Penelope; Chambers, Suzanne

2015-05-01

As the global burden of cancer increases healthcare services will face increasing challenges in meet the complex needs of these patients, their families and the communities in which they live. This raises the question of how to meet patient need where direct clinical contact may be constrained or not readily available. Patients and families require resources and skills to manage their illness outside of the hospital setting within their own communities. To propose a framework for the development and delivery of psycho-educational and supportive care interventions drawing on theoretical principles of behaviour change and evidence-based interventions, and based on extensive experience in developing and testing complex interventions in oncology. At the core of this intervention framework are considerations of efficiency: interventions are designed to cater for individuals' unique needs; to place minimal demands on the health system infrastructure and to be rapidly disseminated into usual care if successful. There are seven key features: 1) Targeting cancer type and stage; 2) Tailoring to unique individual needs; 3) Promotion of patient self-management of their disease and treatment side effects; 4) Efficient delivery of the intervention; 5) Training and adherence to protocol; 6) Ensuring the intervention is evidence-based; 7) Confirming stakeholder acceptability of the intervention. A case study of a randomised controlled trial which tested psycho-educational oncology interventions using this framework is presented. These interventions were designed to cater for individuals' unique needs and promote self-management while placing minimal demands on the acute health care setting. Innovative ways to realise the potentially major impact that psycho-educational and supportive care interventions can have on psychological morbidity, coping, symptoms and quality of life in serious and chronic illness are needed. This framework, which is driven by theory, evidence, and

Key factors affecting dying children and their families.

PubMed

Hinds, Pamela S; Schum, Lisa; Baker, Justin N; Wolfe, Joanne

2005-01-01

The death of a child alters the life and health of others immediately and for the rest of their lives. How a child dies influences parents' abilities to continue their role functions as well as siblings' abilities to make and maintain friendships, and may be the basis for health care providers' decisions to exit direct care roles. Thus, facilitating a "good death"-an obvious care priority for all involved with the dying child-ought also to be a priority for the health of bereaved families and affected health care providers. Making this a care priority is complicated by a serious lack of data, as details of the last hours or weeks of a dying child or adolescent's life are largely unknown. The purpose of this paper is to identify key factors that affect the course of dying children and adolescents and that of their bereaved survivors, and to link those key factors to needed research that could produce clinically relevant findings to improve the care of these patients. Key factors described here include suffering (physical, psychological, and spiritual), communication, decision making, prognostic ambiguities, ability of the seriously ill child to give assent to research participation, and educational preparation of health care providers to give competent end-of-life care.

Study of Health Outcomes in School Children: Key Challenges and Lessons Learned from the Framingham Schools' Natural History of Nevi Study

ERIC Educational Resources Information Center

Geller, Alan C.; Oliveria, Susan A.; Bishop, Marilyn; Buckminster, Marcia; Brooks, Katie R.; Halpern, Allan C.

2007-01-01

Background: We describe the planning, recruitment, key challenges, and lessons learned in the development of a study of the evolution of nevi (moles) among children in a school setting. Methods: This population-based study of digital photography and dermoscopy of the child's back (overview, close-up, and dermoscopic images) and genetic specimens…

Stress in hospital medicine: a problem for key hospital staff.

PubMed

Allen, I

2001-08-01

Many factors which contribute to stress in the workplace apply to both consultants and ward sisters. Both groups find that their roles have become more complex while they have increasingly lost control of their own clinical and professional territory in a managerial culture. The erosion of the key relationship between consultants and ward sisters is of concern and the need for teamworking is insufficiently recognized.

Unravelling the myotonic dystrophy type 1 clinical spectrum: A systematic registry-based study with implications for disease classification.

PubMed

De Antonio, M; Dogan, C; Hamroun, D; Mati, M; Zerrouki, S; Eymard, B; Katsahian, S; Bassez, G

2016-10-01

The broad clinical spectrum of myotonic dystrophy type 1 (DM1) creates particular challenges for both medical care and design of clinical trials. Clinical onset spans a continuum from birth to late adulthood, with symptoms that are highly variable in both severity and nature of the affected organ systems. In the literature, this complex phenotype is divided into three grades (mild, classic, and severe) and four or five main clinical categories (congenital, infantile/juvenile, adult-onset and late-onset forms), according to symptom severity and age of onset, respectively. However, these classifications are still under discussion with no consensus thus far. While some specific clinical features have been primarily reported in some forms of the disease, there are no clear distinctions. As a consequence, no modifications in the management of healthcare or the design of clinical studies have been proposed based on the clinical form of DM1. The present study has used the DM-Scope registry to assess, in a large cohort of DM1 patients, the robustness of a classification divided into five clinical forms. Our main aim was to describe the disease spectrum and investigate features of each clinical form. The five subtypes were compared by distribution of CTG expansion size, and the occurrence and onset of the main symptoms of DM1. Analyses validated the relevance of a five-grade model for DM1 classification. Patients were classified as: congenital (n=93, 4.5%); infantile (n=303, 14.8%); juvenile (n=628, 30.7%); adult (n=694, 34.0%); and late-onset (n=326, 15.9%). Our data show that the assumption of a continuum from congenital to the late-onset form is valid, and also highlights disease features specific to individual clinical forms of DM1 in terms of symptom occurrence and chronology throughout the disease course. These results support the use of the five-grade model for disease classification, and the distinct clinical profiles suggest that age of onset and clinical form may

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

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

Key barriers to gout care: a systematic review and thematic synthesis of qualitative studies.

PubMed

Rai, Sharan K; Choi, Hyon K; Choi, Sally H J; Townsend, Anne F; Shojania, Kam; De Vera, Mary A

2018-04-17

Gout care remains highly suboptimal, contributing to an increased global disease burden. To understand barriers to gout care, our aim was to provide a systematic review and thematic synthesis of qualitative studies worldwide reporting provider and patient perspectives and experiences with management. We conducted a mapped search of MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, and Social Sciences Citation Index databases and selected qualitative studies of provider and patient perspectives on gout management. We used thematic synthesis to combine the included studies and identify key themes across studies. We included 20 studies that reported the experiences and perspectives of 480 gout patients and 120 providers spanning five different countries across three continents. We identified three predominant provider themes: knowledge gaps and management approaches; perceptions and beliefs about gout patients; and system barriers to optimal gout care (e.g. time constraints and a lack of incentives). We also identified four predominant themes among gout patients: limited gout knowledge; interactions with health-care providers; attitudes towards and experiences with taking medication; and practical barriers to long-term medication use. Our systematic review of worldwide literature consistently identified gaps in gout knowledge among providers, which is likely to contribute to patients' lack of appropriate education about the fundamental causes of and essential treatment approaches for gout. Furthermore, system barriers among providers and day-to-day challenges of taking long-term medications among patients are considerable. These factors provide key targets to improve the widespread suboptimal gout care.

Clinical engagement: improving healthcare together.

PubMed

Riches, E; Robson, B

2014-02-01

Clinical engagement can achieve lasting change in the delivery of healthcare. In October 2011, Healthcare Improvement Scotland formulated a clinical engagement strategy to ensure that a progressive and sustainable approach to engaging healthcare professionals is firmly embedded in its health improvement and public assurance activities. The strategy was developed using a 90-day process, combining an evidence base of best practice and feedback from semi-structured interviews and focus groups. The strategy aims to create a culture where clinicians view working with Healthcare Improvement Scotland as a worthwhile venture, which offers a number of positive benefits such as training, career development and research opportunities. The strategy works towards developing a respectful partnership between Healthcare Improvement Scotland, the clinical community and key stakeholders whereby clinicians' contributions are recognised in a non-financial reward system. To do this, the organisation needs a sustainable infrastructure and an efficient, cost-effective approach to clinical engagement. There are a number of obstacles to achieving successful clinical engagement and these must be addressed as key drivers in its implementation. The implementation of the strategy is supported by an action and resource plan, and its impact will be monitored by a measurement plan to ensure the organisation reviews its approaches towards clinical engagement.

Clinical, Functional, and Biological Correlates of Cognitive Dimensions in Major Depressive Disorder - Rationale, Design, and Characteristics of the Cognitive Function and Mood Study (CoFaM-Study).

PubMed

Baune, Bernhard T; Air, Tracy

2016-01-01

Cross-sectional and longitudinal studies exploring clinical, functional, and biological correlates of major depressive disorder are frequent. In this type of research, depression is most commonly defined as a categorical diagnosis based on studies using diagnostic instruments. Given the phenotypic and biological heterogeneity of depression, we chose to focus the phenotypic assessments on three cognitive dimensions of depression including (a) cognitive performance, (b) emotion processing, and (c) social cognitive functioning. Hence, the overall aim of the study is to investigate the long-term clinical course of these cognitive dimensions in depression and its functional (psychosocial) correlates. We also aim to identify biological "genomic" correlates of these three cognitive dimensions of depression. To address the above overall aim, we created the Cognition and Mood Study (CoFaMS) with the key objective to investigate the clinical, functional, and biological correlates of cognitive dimensions of depression by employing a prospective study design and including a healthy control group. The study commenced in April 2015, including patients with a primary diagnosis of a major depressive episode of major depressive disorder or bipolar disorder according to DSM-IV-TR criteria. The assessments cover the three cognitive dimensions of depression (cognitive performance, emotion processing, and social cognition), cognitive function screening instrument, plus functional scales to assess general, work place, and psychosocial function, depression symptom scales, and clinical course of illness. Blood is collected for comprehensive genomic discovery analyses of biological correlates of cognitive dimensions of depression. The CoFaM-Study represents an innovative approach focusing on cognitive dimensions of depression and its functional and biological "genomic" correlates. The CoFaMS team welcomes collaborations with both national and international researchers.

Merging clinical chemistry biomarker data with a COPD database - building a clinical infrastructure for proteomic studies.

PubMed

Eriksson, Jonatan; Andersson, Simone; Appelqvist, Roger; Wieslander, Elisabet; Truedsson, Mikael; Bugge, May; Malm, Johan; Dahlbäck, Magnus; Andersson, Bo; Fehniger, Thomas E; Marko-Varga, György

2016-01-01

Data from biological samples and medical evaluations plays an essential part in clinical decision making. This data is equally important in clinical studies and it is critical to have an infrastructure that ensures that its quality is preserved throughout its entire lifetime. We are running a 5-year longitudinal clinical study, KOL-Örestad, with the objective to identify new COPD (Chronic Obstructive Pulmonary Disease) biomarkers in blood. In the study, clinical data and blood samples are collected from both private and public health-care institutions and stored at our research center in databases and biobanks, respectively. The blood is analyzed by Mass Spectrometry and the results from this analysis then linked to the clinical data. We built an infrastructure that allows us to efficiently collect and analyze the data. We chose to use REDCap as the EDC (Electronic Data Capture) tool for the study due to its short setup-time, ease of use, and flexibility. REDCap allows users to easily design data collection modules based on existing templates. In addition, it provides two functions that allow users to import batches of data; through a web API (Application Programming Interface) as well as by uploading CSV-files (Comma Separated Values). We created a software, DART (Data Rapid Translation), that translates our biomarker data into a format that fits REDCap's CSV-templates. In addition, DART is configurable to work with many other data formats as well. We use DART to import our clinical chemistry data to the REDCap database. We have shown that a powerful and internationally adopted EDC tool such as REDCap can be extended so that it can be used efficiently in proteomic studies. In our study, we accomplish this by using DART to translate our clinical chemistry data to a format that fits the templates of REDCap.

High key rate continuous-variable quantum key distribution with a real local oscillator.

PubMed

Wang, Tao; Huang, Peng; Zhou, Yingming; Liu, Weiqi; Ma, Hongxin; Wang, Shiyu; Zeng, Guihua

2018-02-05

Continuous-variable quantum key distribution (CVQKD) with a real local oscillator (LO) has been extensively studied recently due to its security and simplicity. In this paper, we propose a novel implementation of a high-key-rate CVQKD with a real LO. Particularly, with the help of the simultaneously generated reference pulse, the phase drift of the signal is tracked in real time and then compensated. By utilizing the time and polarization multiplexing techniques to isolate the reference pulse and controlling the intensity of it, not only the contamination from it is suppressed, but also a high accuracy of the phase compensation can be guaranteed. Besides, we employ homodyne detection on the signal to ensure the high quantum efficiency and heterodyne detection on the reference pulse to acquire the complete phase information of it. In order to suppress the excess noise, a theoretical noise model for our scheme is established. According to this model, the impact of the modulation variance and the intensity of the reference pulse are both analysed theoretically and then optimized according to the experimental data. By measuring the excess noise in the 25km optical fiber transmission system, a 3.14Mbps key rate in the asymptotic regime proves to be achievable. This work verifies the feasibility of the high-key-rate CVQKD with a real LO within the metropolitan area.

Competence of novice nurses: role of clinical work during studying

PubMed Central

Manoochehri, H; Imani, E; Atashzadeh-Shoorideh, F; Alavi-Majd, A

2015-01-01

Aim: Clinical competence is to carry out the tasks with excellent results in a different of adjustments. According to various studies, one of the factors influencing clinical competence is work experience. This experience affects the integrity of students' learning experience and their practical skills. Many nursing students practice clinical work during their full-time studying. The aim of this qualitative research was to clarify the role of clinical work during studying in novice nurses' clinical competence. Methods: This qualitative content analysis performed with the conventional approach. All teaching hospitals of Hormozgan University of Medical Sciences selected as the research environment. To collect data, deep and semi-structured interviews, presence in the scene and manuscripts used. To provide feedback for the next release and the capacity of the data, interviews were transcribed verbatim immediately. Results: 45 newly-graduated nurses and head nurses between 23 and 40 with 1 to 18 years of experience participated in the study. After coding all interviews, 1250 original codes were derived. The themes extracted included: task rearing, personality rearing, knowledge rearing, and profession rearing roles of clinical work during studying. Conclusion: Working during studying can affect performance, personality, knowledge, and professional perspectives of novice nurses. Given the differences that may exist in clinical competencies of novice nurses with and without clinical work experience, it is important to pay more attention to this issue and emphasize on their learning in this period. PMID:28316703

Data Linkage from Clinical to Study Databases via an R Data Warehouse User Interface. Experiences from a Large Clinical Follow-up Study.

PubMed

Kaspar, Mathias; Ertl, Maximilian; Fette, Georg; Dietrich, Georg; Toepfer, Martin; Angermann, Christiane; Störk, Stefan; Puppe, Frank

2016-08-05

Data that needs to be documented for clinical studies has often been acquired and documented in clinical routine. Usually this data is manually transferred to Case Report Forms (CRF) and/or directly into an electronic data capture (EDC) system. To enhance the documentation process of a large clinical follow-up study targeting patients admitted for acutely decompensated heart failure by accessing the data created during routine and study visits from a hospital information system (HIS) and by transferring it via a data warehouse (DWH) into the study's EDC system. This project is based on the clinical DWH developed at the University of Würzburg. The DWH was extended by several new data domains including data created by the study team itself. An R user interface was developed for the DWH that allows to access its source data in all its detail, to transform data as comprehensively as possible by R into study-specific variables and to support the creation of data and catalog tables. A data flow was established that starts with labeling patients as study patients within the HIS and proceeds with updating the DWH with this label and further data domains at a daily rate. Several study-specific variables were defined using the implemented R user interface of the DWH. This system was then used to export these variables as data tables ready for import into our EDC system. The data tables were then used to initialize the first 296 patients within the EDC system by pseudonym, visit and data values. Afterwards, these records were filled with clinical data on heart failure, vital parameters and time spent on selected wards. This solution focuses on the comprehensive access and transformation of data for a DWH-EDC system linkage. Using this system in a large clinical study has demonstrated the feasibility of this approach for a study with a complex visit schedule.

Clinical epidemiology.

PubMed

Martin, S W; Bonnett, B

1987-06-01

Rational clinical practice requires deductive particularization of diagnostic findings, prognoses, and therapeutic responses from groups of animals (herds) to the individual animal (herd) under consideration This process utilizes concepts, skills, and methods of epidemiology, as they relate to the study of the distribution and determinants of health and disease in populations, and casts them in a clinical perspective.We briefly outline diagnostic strategies and introduce a measure of agreement, called kappa, between clinical diagnoses. This statistic is useful not only as a measure of diagnostic accuracy, but also as a means of quantifying and understanding disagreement between diagnosticians. It is disconcerting to many, clinicians included, that given a general deficit of data on sensitivity and specificity, the level of agreement between many clinical diagnoses is only moderate at best with kappa values of 0.3 to 0.6.Sensitivity, specificity, pretest odds, and posttest probability of disease are defined and related to the interpretation of clinical findings and ancillary diagnostic test results. An understanding of these features and how they relate to ruling-in or ruling-out a diagnosis, or minimizzing diagnostic errors will greatly enhance the diagnostic accuracy of the practitioner, and reduce the frequency of clinical disagreement. The approach of running multiple tests on every patient is not only wasteful and expensive, it is unlikely to improve the ability of the clinician to establish the correct diagnosis.We conclude with a discussion of how to decide on the best therapy, a discussion which centers on, and outlines the key features of, the well designed clinical trial. Like a diagnosis, the results from a clinical trial may not always be definitive, nonetheless it is the best available method of gleaning information about treatment efficacy.

Improved key-rate bounds for practical decoy-state quantum-key-distribution systems

NASA Astrophysics Data System (ADS)

Zhang, Zhen; Zhao, Qi; Razavi, Mohsen; Ma, Xiongfeng

2017-01-01

The decoy-state scheme is the most widely implemented quantum-key-distribution protocol in practice. In order to account for the finite-size key effects on the achievable secret key generation rate, a rigorous statistical fluctuation analysis is required. Originally, a heuristic Gaussian-approximation technique was used for this purpose, which, despite its analytical convenience, was not sufficiently rigorous. The fluctuation analysis has recently been made rigorous by using the Chernoff bound. There is a considerable gap, however, between the key-rate bounds obtained from these techniques and that obtained from the Gaussian assumption. Here we develop a tighter bound for the decoy-state method, which yields a smaller failure probability. This improvement results in a higher key rate and increases the maximum distance over which secure key exchange is possible. By optimizing the system parameters, our simulation results show that our method almost closes the gap between the two previously proposed techniques and achieves a performance similar to that of conventional Gaussian approximations.

Numerical approach for unstructured quantum key distribution

PubMed Central

Coles, Patrick J.; Metodiev, Eric M.; Lütkenhaus, Norbert

2016-01-01

Quantum key distribution (QKD) allows for communication with security guaranteed by quantum theory. The main theoretical problem in QKD is to calculate the secret key rate for a given protocol. Analytical formulas are known for protocols with symmetries, since symmetry simplifies the analysis. However, experimental imperfections break symmetries, hence the effect of imperfections on key rates is difficult to estimate. Furthermore, it is an interesting question whether (intentionally) asymmetric protocols could outperform symmetric ones. Here we develop a robust numerical approach for calculating the key rate for arbitrary discrete-variable QKD protocols. Ultimately this will allow researchers to study ‘unstructured' protocols, that is, those that lack symmetry. Our approach relies on transforming the key rate calculation to the dual optimization problem, which markedly reduces the number of parameters and hence the calculation time. We illustrate our method by investigating some unstructured protocols for which the key rate was previously unknown. PMID:27198739

SPIRIT 2013 Statement: defining standard protocol items for clinical trials.

PubMed

Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krle A-Jerić, Karmela; Hrobjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Dore, Caroline J; Parulekar, Wendy R; Summerskill, William S M; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David

2015-12-01

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.

SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials

PubMed Central

Chan, An-Wen; Tetzlaff, Jennifer M.; Altman, Douglas G.; Laupacis, Andreas; Gøtzsche, Peter C.; Krleža-Jerić, Karmela; Hróbjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A.; Doré, Caroline J.; Parulekar, Wendy R.; Summerskill, William S.M.; Groves, Trish; Schulz, Kenneth F.; Sox, Harold C.; Rockhold, Frank W.; Rennie, Drummond; Moher, David

2016-01-01

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol. The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders. PMID:23295957

SPIRIT 2013 statement: defining standard protocol items for clinical trials.

PubMed

Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krleža-Jerić, Karmela; Hróbjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Doré, Caroline J; Parulekar, Wendy R; Summerskill, William S M; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David

2013-02-05

The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.