Sample records for observational controlled clinical

  1. Inter- and intra-observer reliability of clinical movement-control tests for marines

    PubMed Central

    2012-01-01

    Background Musculoskeletal disorders particularly in the back and lower extremities are common among marines. Here, movement-control tests are considered clinically useful for screening and follow-up evaluation. However, few studies have addressed the reliability of clinical tests, and no such published data exists for marines. The present aim was therefore to determine the inter- and intra-observer reliability of clinically convenient tests emphasizing movement control of the back and hip among marines. A secondary aim was to investigate the sensitivity and specificity of these clinical tests for discriminating musculoskeletal pain disorders in this group of military personnel. Methods This inter- and intra-observer reliability study used a test-retest approach with six standardized clinical tests focusing on movement control for back and hip. Thirty-three marines (age 28.7 yrs, SD 5.9) on active duty volunteered and were recruited. They followed an in-vivo observation test procedure that covered both low- and high-load (threshold) tasks relevant for marines on operational duty. Two independent observers simultaneously rated performance as “correct” or “incorrect” following a standardized assessment protocol. Re-testing followed 7–10 days thereafter. Reliability was analysed using kappa (κ) coefficients, while discriminative power of the best-fitting tests for back- and lower-extremity pain was assessed using a multiple-variable regression model. Results Inter-observer reliability for the six tests was moderate to almost perfect with κ-coefficients ranging between 0.56-0.95. Three tests reached almost perfect inter-observer reliability with mean κ-coefficients > 0.81. However, intra-observer reliability was fair-to-moderate with mean κ-coefficients between 0.22-0.58. Three tests achieved moderate intra-observer reliability with κ-coefficients > 0.41. Combinations of one low- and one high-threshold test best discriminated prior back pain, but results

  2. Clinical Research Methodology 2: Observational Clinical Research.

    PubMed

    Sessler, Daniel I; Imrey, Peter B

    2015-10-01

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

  3. From randomized controlled trials to observational studies.

    PubMed

    Silverman, Stuart L

    2009-02-01

    Randomized controlled trials are considered the gold standard in the hierarchy of research designs for evaluating the efficacy and safety of a treatment intervention. However, their results can have limited applicability to patients in clinical settings. Observational studies using large health care databases can complement findings from randomized controlled trials by assessing treatment effectiveness in patients encountered in day-to-day clinical practice. Results from these designs can expand upon outcomes of randomized controlled trials because of the use of larger and more diverse patient populations with common comorbidities and longer follow-up periods. Furthermore, well-designed observational studies can identify clinically important differences among therapeutic options and provide data on long-term drug effectiveness and safety.

  4. Clinically observed chickenpox and the risk of childhood-onset multiple sclerosis.

    PubMed

    Mikaeloff, Yann; Caridade, Guillaume; Suissa, Samy; Tardieu, Marc

    2009-05-15

    The authors conducted a population-based case-control study to investigate whether clinically observed chickenpox, linked with a level of intensity for clinical expression, increases the risk of multiple sclerosis (MS) in childhood. The cases were MS patients whose disease onset occurred between 1994 and 2003, before age 16 years, in France. Each case was matched for age, sex, and geographic origin with as many as 12 controls randomly selected from the general population. Information about clinically observed chickenpox in cases and controls before the index date regarding onset of MS was collected with a standardized questionnaire and was checked against health certificates. Conditional logistic regression was used to estimate the odds ratio for an association between MS and chickenpox. The 137 MS cases were matched with 1,061 controls. Clinically observed chickenpox had occurred in 76.6% of the cases and 84.9% of their matched controls. The adjusted odds ratio of MS onset associated with chickenpox occurrence was 0.58 (95% confidence interval: 0.36, 0.92). The authors concluded that clinically observed chickenpox was associated with a lower risk of childhood-onset MS in a French population.

  5. [Study on clinical effectiveness of acupuncture and moxibustion on acute Bell's facial paralysis: randomized controlled clinical observation].

    PubMed

    Wu, Bin; Li, Ning; Liu, Yi; Huang, Chang-qiong; Zhang, Yong-ling

    2006-03-01

    To investigate the adverse effects of acupuncture on the prognosis, and effectiveness of acupuncture combined with far infrared ray in the patient of acute Bell's facial paralysis within 48 h. Clinically randomized controlled trial was used, and the patients were divided into 3 groups: group A (early acupuncture group), group B (acupuncture combined with far infrared ray) and group C (acupuncture after 7 days). The facial nerve functional classification at the attack, 7 days after the attack and after treatment, the clinically cured rate of following-up of 6 months, and the average cured time, the cured time of complete facial paralysis were observed in the 3 groups. There were no significant differences among the 3 groups in the facial nerve functional classification 7 days after the attack, the clinically cured rate of following-up of 6 months and the average cured time (P > 0.05), but the cured time of complete facial paralysis in the group A and the group B were shorter than that in the group C (P < 0.05). The patient of acute Bell's facial paralysis can be treated with acupuncture and moxibustion, and traditional moxibustion can be replaced by far infrared way.

  6. Positive state observer for the automatic control of the depth of anesthesia-Clinical results.

    PubMed

    Nogueira, Filipa N; Mendonça, T; Rocha, P

    2016-09-13

    The depth of anesthesia (DoA) is a crucial feature in general anesthesia. Nowadays the DoA is usually evaluated by the bispectral index (BIS). According to the surgical procedure, different reference levels for the BIS may be clinically required. This can be achieved by the simultaneous administration of an analgesic (e.g. remifentanil) and an hypnotic (eg propofol). As a contribution to the effort of automating the processes of drug delivery in general anesthesia, in this paper, a positive state observer is designed for the implementation of a control scheme proposed for the automatic administration of propofol and of remifentanil, in order to track a desired level for the BIS. It is proved and illustrated by simulations that the controller-observer scheme has a very good performance. This scheme was implemented, tested and evaluated both by means of simulations and for a set of patients during surgical procedures. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  7. Cautionary tales in the interpretation of observational studies of effects of clinical interventions.

    PubMed

    Scott, I A; Attia, J

    2017-02-01

    Observational studies of the effectiveness of clinical interventions are proliferating as more 'real-world' clinical data (so called 'big data') are gathered from clinical registries, administrative datasets and electronic health records. While well-conducted randomised controlled trials (RCT) remain the scientific standard in assessing the efficacy of clinical interventions, well-designed observational studies may add to the evidence base of effectiveness in situations where RCT are of limited value or very difficult to perform. Rather than dismissing observational studies, we need to determine what circumstances may justify doing an observational study and when the study is sufficiently rigorous to be considered reasonably trustworthy. This article proposes criteria by which users of the literature might make such determinations. © 2016 Royal Australasian College of Physicians.

  8. [Randomized, controlled clinical trials with observational follow-up investigations for evaluating efficacy of antihyperglycaemic treatment. I. Main results of the studies].

    PubMed

    Jermendy, György

    2018-04-01

    The effect of antihyperglycaemic (antidiabetic) treatment on the late diabetic complications is one of the most important research areas in clinical diabetology. The relationship between glycaemic control and late micro- and macrovascular complications was highlighted by the results of the DCCT (Diabetes Control and Complications Trial) with type 1 and by the UKPDS (United Kingdom Prospective Diabetes Study) with type 2 diabetic patients. In these studies, observational follow-up investigations were also performed after the close-out of the randomized phase of the trial. In addition to these landmark studies, other randomized, controlled efficacy trials were also performed with observational follow-up investigations resulting in the development of the concept of metabolic memory or metabolic legacy. In this article, the main results of the studies are summarized. Orv Hetil. 2018; 159(15): 575-582.

  9. 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.

  10. Untapped Potential of Observational Research to Inform Clinical Decision Making: American Society of Clinical Oncology Research Statement.

    PubMed

    Visvanathan, Kala; Levit, Laura A; Raghavan, Derek; Hudis, Clifford A; Wong, Sandra; Dueck, Amylou; Lyman, Gary H

    2017-06-01

    ASCO believes that high-quality observational studies can advance evidence-based practice for cancer care and are complementary to randomized controlled trials (RCTs). Observational studies can generate hypotheses by evaluating novel exposures or biomarkers and by revealing patterns of care and relationships that might not otherwise be discovered. Researchers can then test these hypotheses in RCTs. Observational studies can also answer or inform questions that either have not been or cannot be answered by RCTs. In addition, observational studies can be used for postmarketing surveillance of new cancer treatments, particularly in vulnerable populations. The incorporation of observational research as part of clinical decision making is consistent with the position of many leading institutions. ASCO identified five overarching recommendations to enhance the role of observational research in clinical decision making: (1) improve the quality of electronic health data available for research, (2) improve interoperability and the exchange of electronic health information, (3) ensure the use of rigorous observational research methodologies, (4) promote transparent reporting of observational research studies, and (5) protect patient privacy.

  11. 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

  12. A cluster design controlled trial of arts-based observational skills training in primary care.

    PubMed

    Kirklin, Deborah; Duncan, Jane; McBride, Sandy; Hunt, Sam; Griffin, Mark

    2007-04-01

    To investigate whether the observational skills of doctors and nurses can be improved by arts-based observational skills training. We carried out a cluster design, controlled trial involving 42 general practitioners and 26 primary care nurses in 12 primary care practices in London. Six practices were allocated to the intervention arm and 6 to the control arm. The intervention group received 90 minutes of arts-based observational skills training. The control group received practical training in the management of psoriasis. Before and after this, control and intervention participants were asked to describe 3 dermatological photographs. Descriptions were scored blindly against a predetermined marking key. Participants completed a questionnaire about the intervention, and about their own confidence in diagnosing and referring suspicious pigmented skin lesions. Post-intervention scores were significantly higher in the intervention group compared with the control group (P < 0.001). The majority of participants judged the intervention relevant, enjoyable and valuable. A majority lacked confidence in their dermatological knowledge and skills. This study provides statistically significant evidence that arts-based observational skills training can improve the observational skills of doctors and nurses. It is important not to overstate the clinical significance of these findings, and to recognise that observational skills are just one of many complex and subtle factors affecting the quality of the clinical process. Further research is needed to assess the existence, nature and clinical significance of longer-term benefits, and to identify differences between professional groups.

  13. 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.

  14. Cost-efficiency of knowledge creation: randomized controlled trials vs. observational studies.

    PubMed

    Struck, Rafael; Baumgarten, Georg; Wittmann, Maria

    2014-04-01

    This article reviews traditional and current perspectives on randomized, controlled trials (RCTs) and observational studies relative to the economic implications for public healthcare stakeholders. It takes an average of 17 years to bring 14% of original research into clinical practice. Results from high-quality observational studies may complement limited RCTs in primary and secondary literature bases, and enhance the incorporation of sound evidence-based guidelines. Observational findings from comprehensive medical databases may offer valuable clues on the effectiveness and relevance of public healthcare interventions. Major expenditures associated with RCTs relate to recruitment, inappropriate site selection, conduct and reporting. Application of business strategies and economic evaluation tools, in addition to the planning and conduct of RCTs, may enhance clinical trial site performances. Considering the strengths and limitations of each study type, clinical researchers should explore the contextual worthiness of either design in promulgating knowledge. They should focus on quality of conduct and reporting that may allow for the liberation of limited public and private clinical research funding.

  15. Quantifying peer interactions for research and clinical use: the Manchester Inventory for Playground Observation.

    PubMed

    Gibson, Jenny; Hussain, Jamilla; Holsgrove, Samina; Adams, Catherine; Green, Jonathan

    2011-01-01

    Direct observation of peer relating is potentially a sensitive and ecologically valid measure of child social functioning, but there has been a lack of standardised methods. The Manchester Inventory for Playground Observation (MIPO) was developed as a practical yet rigorous assessment of this kind for 5-11 year olds. We report on the initial reliability and validity of the MIPO and its ability to distinguish social impairments within different psychopathologies. We observed 144 clinically referred children aged 5;00-11;11 (mean 8.8) years with Externalising (n = 44), Internalising (n = 19), Autism Spectrum Disorders (n = 39) or Specific Language Impairment (n = 42), and 44 class-controls, in naturalistic playground interaction. Observers, blind to clinical diagnosis, completed the MIPO and the teacher checklist from the Social Skills Rating System (SSRS). MIPO items showed high internal consistency (alpha = .924; all 'alpha if item deleted' values>.91), inter-observer reliability (mean κ(w) = .77) and test-retest stability (over 2 weeks; mean κ(w) = .58). MIPO totals showed convergence with SSRS (n = 68, r(s) = .78, p<.01) and excellent discrimination between case and control (sensitivity = 0.75 and specificity = 0.88, AUC = .897). Externalising, Autistic Spectrum and Language Impaired groups showed distinct profiles of MIPO impairment consistent with theory:Internalising disorders less so. 65.3% of clinical cases were classified accurately for primary diagnosis. The MIPO shows reliability and validity as a measure of children's social functioning relevant in developmental research and as a clinical tool to aid differential diagnosis and intervention planning. Copyright © 2011 Elsevier Ltd. All rights reserved.

  16. The utility of observational studies in clinical decision making: lessons learned from statin trials.

    PubMed

    Foody, JoAnne M; Mendys, Phillip M; Liu, Larry Z; Simpson, Ross J

    2010-05-01

    Contemporary clinical decision making is well supported by a wide variety of information sources, including clinical practice guidelines, position papers, and insights from randomized controlled trials (RCTs). Much of our fundamental understanding of cardiovascular risk factors is based on multiple observations from major epidemiologic studies, such as The Seven Country Studies and the US-based Framingham Heart Study. These studies provided the framework for the development of clinical practice guidelines, including the National Cholesterol Education Program Adult Treatment Panel series. The objective of this article is to highlight the value of observational studies as a complement to clinical trial data for clinical decision making in real-world practice. Although RCTs are still the benchmark for assessing clinical efficacy and safety of a specific therapeutic approach, they may be of limited utility to practitioners who must then adapt the lessons learned from the trial into the patient care environment. The use of well-structured observational studies can improve our understanding of the translation of clinical trials into clinical practice, as demonstrated here with the example of statins. Although such studies have their own limitations, improved techniques for design and analysis have reduced the impact of bias and confounders. The introduction of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines has provided more uniformity for such studies. When used together with RCTs, observational studies can enhance our understanding of effectiveness and utility in real-world clinical practice. In the examples of statin observational studies, the results suggest that relative effectiveness of different statins and potential impact of switching statins should be carefully considered in treating individual patients by practicing physicians.

  17. [Observation on clinical therapeutic effect of improved thunder-fire miraculous needle on vertigo].

    PubMed

    Zhang, Gong-an; Luo, Jian; Huang, Liu-he

    2008-04-01

    To Compare clinical therapeutic effect of improved thunder-fire miraculous needle and moxibustion on vertigo. One hundred and seventeen cases conformed with the TCM criteria of vertigo were randomly divided into an observation group (n=66) and a control group (n=51). The observation group were treated with improved thunder-fire miraculous needle and the control group with pressing and moxibustion at Baihui (GV 20). After treatment of one therapeutic course, the therapeutic effect was assessed by vertigo symptom rating scores. The total effective rate was 86.4% in the observation group and 66.7% in the control group, with a significant difference between the two groups (P<0.05). The improved thunder-fire miraculous needle can significantly relieve and eliminate symptoms of vertigo, with no adverse effect.

  18. Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics.

    PubMed

    Van Poucke, Sven; Thomeer, Michiel; Heath, John; Vukicevic, Milan

    2016-07-06

    Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers' scientific epistemology of "falsificationism." Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation.

  19. Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics

    PubMed Central

    2016-01-01

    Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers’ scientific epistemology of “falsificationism.” Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation. PMID:27383622

  20. A Randomized Controlled Study of Art Observation Training to Improve Medical Student Ophthalmology Skills.

    PubMed

    Gurwin, Jaclyn; Revere, Karen E; Niepold, Suzannah; Bassett, Barbara; Mitchell, Rebecca; Davidson, Stephanie; DeLisser, Horace; Binenbaum, Gil

    2018-01-01

    Observation and description are critical to the practice of medicine, and to ophthalmology in particular. However, medical education does not provide explicit training in these areas, and medical students are often criticized for deficiencies in these skills. We sought to evaluate the effects of formal observation training in the visual arts on the general and ophthalmologic observational skills of medical students. Randomized, single-masked, controlled trial. Thirty-six first-year medical students, randomized 1:1 into art-training and control groups. Students in the art-training group were taught by professional art educators at the Philadelphia Museum of Art, during 6 custom-designed, 1.5-hour art observation sessions over a 3-month period. All subjects completed pre- and posttesting, in which they described works of art, retinal pathology images, and external photographs of eye diseases. Grading of written descriptions for observational and descriptive abilities by reviewers using an a priori rubric and masked to group assignment and pretesting/posttesting status. Observational skills, as measured by description testing, improved significantly in the training group (mean change +19.1 points) compared with the control group (mean change -13.5 points), P = 0.001. There were significant improvements in the training vs. control group for each of the test subscores. In a poststudy questionnaire, students reported applying the skills they learned in the museum in clinically meaningful ways at medical school. Art observation training for first-year medical students can improve clinical ophthalmology observational skills. Principles from the field of visual arts, which is reputed to excel in teaching observation and descriptive abilities, can be successfully applied to medical training. Further studies can examine the impact of such training on clinical care. Copyright © 2017 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

  1. Inter-Observer and Intra-Observer Reliability of Clinical Assessments in Knee Osteoarthritis

    PubMed Central

    Maricar, Nasimah; Callaghan, Michael J; Parkes, Matthew J; Felson, David T; O’Neill, Terence W

    2016-01-01

    Background Clinical examination of the knee is subject to measurement error. The aim of this analysis was to determine inter- and intra-observer reliability of commonly used clinical tests in patients with knee osteoarthritis(OA). Methods We studied subjects with symptomatic knee OA who were participants in an open-label clinical trial of intra-articular steroid therapy. Following standardisation of the clinical test procedures, two clinicians assessed 25 subjects independently at the same visit, and the same clinician assessed 88 subjects over an interval period of 2–10 weeks; in both cases prior to the steroid intervention. Clinical examination included assessment of bony enlargement, crepitus, quadriceps wasting, knee effusion, joint-line and anserine tenderness and knee range of movement(ROM). Intra-class correlation coefficients(ICC), estimated kappa(κ), weighted kappa(κω) and Bland and Altman plots were used to determine inter- and intra-observer levels of agreement. Results Using Landis and Koch criteria, inter-observer kappa scores were moderate for patellofemoral joint(κ=0.53) and anserine tenderness(κ=0.48); good for bony enlargement(κ=0.66), quadriceps wasting(κ=0.78), crepitus(κ=0.78), medial tibiofemoral joint tenderness(κ=0.76), and effusion assessed by ballottement(κ=0.73) and bulge sign(κω =0.78); and excellent for lateral tibiofemoral joint tenderness(κ=1.00), flexion(ICC=0.97) and extension(ICC=0.87) ROM. Intra-observer kappa scores were moderate for lateral tibiofemoral joint tenderness(κ=0.60), good for crepitus(κ=0.78), effusion assessed by ballottement test(κ=0.77), patellofemoral joint(κ=0.66), medial tibiofemoral joint(κ=0.64) and anserine(κ=0.73) tenderness and excellent for effusion assessed by bulge sign(κω =0.83), bony enlargement(κ=0.98), quadriceps wasting(κ=0.83), flexion(ICC=0.99) and extension(ICC=0.96) ROM. Conclusion Among individuals with symptomatic knee OA, the reliability of clinical examination of the

  2. Controllers, observers, and applications thereof

    NASA Technical Reports Server (NTRS)

    Gao, Zhiqiang (Inventor); Zhou, Wankun (Inventor); Miklosovic, Robert (Inventor); Radke, Aaron (Inventor); Zheng, Qing (Inventor)

    2011-01-01

    Controller scaling and parameterization are described. Techniques that can be improved by employing the scaling and parameterization include, but are not limited to, controller design, tuning and optimization. The scaling and parameterization methods described here apply to transfer function based controllers, including PID controllers. The parameterization methods also apply to state feedback and state observer based controllers, as well as linear active disturbance rejection (ADRC) controllers. Parameterization simplifies the use of ADRC. A discrete extended state observer (DESO) and a generalized extended state observer (GESO) are described. They improve the performance of the ESO and therefore ADRC. A tracking control algorithm is also described that improves the performance of the ADRC controller. A general algorithm is described for applying ADRC to multi-input multi-output systems. Several specific applications of the control systems and processes are disclosed.

  3. A randomised controlled trial of clinics in secondary schools for adolescents with asthma.

    PubMed Central

    Salisbury, Chris; Francis, Caia; Rogers, Chris; Parry, Kate; Thomas, Huw; Chadwick, Stephanie; Turton, Pat

    2002-01-01

    AIM: To compare a nurse-led clinic in schools versus care in general practice for adolescents with asthma. DESIGN OF STUDY: Randomised controlled trial in four schools; parallel observational study in two schools. SETTING: Six comprehensive schools. METHOD: In the randomised trial, pupils were invited to attend asthma review at a nurse-led clinic either in school, or in general practice. The parallel observational study compared pupils invited to practice care within and outside the randomised trial. Primary outcome measures were attendance for asthma review, symptom control, and quality of life. Secondary outcomes were knowledge, attitudes, inhaler technique, use of steroids, school absence, peak flow rate, preference for future care, health service utilisation, and costs. RESULTS: School clinic pupils were more likely to attend an asthma review than those randomised to practice care (90.8% versus 51.0% overall [P < 0.001, not consistent across schools]). No differences were observed in symptom control (P = 0.42) or quality of life (P = 0.63). Pupils attending school clinics had greater knowledge of asthma (difference = +0.38, 95% CI = 0.19 to 0.56), more positive attitudes (difference = +0.21, 95% CI = 0.05 to 0.36), and better inhaler technique (P < 0.001, not consistent across all schools). No differences were observed in school absence or peak flow rate. A majority (63%) of those who had received care at school preferred this model in future. Median costs of providing care at school and at the practice were 32.10 Pounds and 19.80 Pounds, respectively. No differences were observed between the groups in the observational comparison on any outcome. CONCLUSIONS: The schools asthma clinic increased uptake of asthma reviews. There were improvements in various process measures, but not in clinical outcomes. PMID:12528584

  4. Conjugated Equine Estrogens and Breast Cancer Risk in the Women’s Health Initiative Clinical Trial and Observational Study

    PubMed Central

    Prentice, Ross L.; Chlebowski, Rowan T.; Stefanick, Marcia L.; Manson, JoAnn E.; Langer, Robert D.; Pettinger, Mary; Hendrix, Susan L.; Hubbell, F. Allan; Kooperberg, Charles; Kuller, Lewis H.; Lane, Dorothy S.; McTiernan, Anne; O’Sullivan, Mary Jo; Rossouw, Jacques E.; Anderson, Garnet L.

    2009-01-01

    The Women’s Health Initiative randomized controlled trial found a trend (p = 0.09) toward a lower breast cancer risk among women assigned to daily 0.625-mg conjugated equine estrogens (CEEs) compared with placebo, in contrast to an observational literature that mostly reports a moderate increase in risk with estrogenalone preparations. In 1993–2004 at 40 US clinical centers, breast cancer hazard ratio estimates for this CEE regimen were compared between the Women’s Health Initiative clinical trial and observational study toward understanding this apparent discrepancy and refining hazard ratio estimates. After control for prior use of postmenopausal hormone therapy and for confounding factors, CEE hazard ratio estimates were higher from the observational study compared with the clinical trial by 43% (p = 0.12). However, after additional control for time from menopause to first use of postmenopausal hormone therapy, the hazard ratios agreed closely between the two cohorts (p = 0.82). For women who begin use soon after menopause, combined analyses of clinical trial and observational study data do not provide clear evidence of either an overall reduction or an increase in breast cancer risk with CEEs, although hazard ratios appeared to be relatively higher among women having certain breast cancer risk factors or a low body mass index. PMID:18448442

  5. Randomized clinical trial comparing ceftiofur hydrochloride with a positive control protocol for intramammary treatment of nonsevere clinical mastitis in dairy cows.

    PubMed

    Cortinhas, Cristina Simões; Tomazi, Tiago; Zoni, Mário Sérgio Ferreira; Moro, Elio; Veiga Dos Santos, Marcos

    2016-07-01

    The objective of this study was to compare ceftiofur hydrochloride with a positive control protocol for intramammary treatment of nonsevere clinical mastitis in dairy cows. A total of 264 clinical mastitis cases on 11 commercial dairy farms were treated with intramammary infusions, once a day for 4 d using 1 of 2 treatments: (1) ceftiofur hydrochloride 125mg; or (2) control: tetracycline 200mg + neomycin 250mg + bacitracin 28mg + prednisolone 10mg. Streptococcus agalactiae was the most frequently isolated gram-positive pathogen from clinical mastitis, followed by Staphylococcus aureus. Klebsiella spp. and Escherichia coli were the most isolated gram-negative bacteria from clinical mastitis. No significant differences were observed between treatments regarding the overall clinical cure, bacteriological cure, and new infection. No effect of treatment regimen was observed when the bacterial group (gram-positive vs. gram-negative) was evaluated. The overall clinical cure was 0.79 for ceftiofur-treated cows and 0.74 for control-treated cows, whereas the overall bacteriological cure was 0.79 for ceftiofur-treated cows and 0.76 for control-treated cows. Furthermore, the new intramammary infection was 0.10 for cows treated with ceftiofur and 0.11 for cows treated with control. In conclusion, the use of intramammary ceftiofur hydrochloride for treatment of nonsevere clinical mastitis has similar efficacy as a treatment regimen with a combination of antimicrobial agents (tetracycline + neomycin + bacitracin). Copyright © 2016 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

  6. Randomized controlled trials vs. observational studies: why not just live together?

    PubMed

    Faraoni, David; Schaefer, Simon Thomas

    2016-10-21

    Randomized controlled trials (RCTs) are considered the gold standard for clinical research, thus having a high impact on clinical guidelines and our daily patients' care. However, various treatment strategies which we consider "evidence based" have never been subject to a prospective RCT, as we would rate it unethical to withheld an established treatment to individuals in an placebo controlled trial.In a recent BMC Anesthesiology publication, Trentino et al. analyzed the usefulness of observational studies in assessing benefit and risk of different transfusion strategies. The authors nicely reviewed and summarized similarities and differences, advantages and limitations, between different study types frequently used in transfusion medicine. In this interesting article, the authors conclude, that 'when comparing the results of observational studies with RCTs assessing transfusion outcomes, it is important that one consider not only the study method, but also the key elements of the study design'. Thus, in this commentary we now discuss the pro's and con's of different study types, even irrespective of transfusion medicine.

  7. 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

  8. 21 CFR 862.3280 - Clinical toxicology control material.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Clinical toxicology control material. 862.3280... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862.3280 Clinical toxicology control material. (a) Identification. A clinical toxicology control...

  9. 21 CFR 862.3280 - Clinical toxicology control material.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Clinical toxicology control material. 862.3280... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862.3280 Clinical toxicology control material. (a) Identification. A clinical toxicology control...

  10. 21 CFR 862.3280 - Clinical toxicology control material.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Clinical toxicology control material. 862.3280... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862.3280 Clinical toxicology control material. (a) Identification. A clinical toxicology control...

  11. 21 CFR 862.3280 - Clinical toxicology control material.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Clinical toxicology control material. 862.3280... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862.3280 Clinical toxicology control material. (a) Identification. A clinical toxicology control...

  12. 21 CFR 862.3280 - Clinical toxicology control material.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Clinical toxicology control material. 862.3280... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862.3280 Clinical toxicology control material. (a) Identification. A clinical toxicology control...

  13. System/observer/controller identification toolbox

    NASA Technical Reports Server (NTRS)

    Juang, Jer-Nan; Horta, Lucas G.; Phan, Minh

    1992-01-01

    System Identification is the process of constructing a mathematical model from input and output data for a system under testing, and characterizing the system uncertainties and measurement noises. The mathematical model structure can take various forms depending upon the intended use. The SYSTEM/OBSERVER/CONTROLLER IDENTIFICATION TOOLBOX (SOCIT) is a collection of functions, written in MATLAB language and expressed in M-files, that implements a variety of modern system identification techniques. For an open loop system, the central features of the SOCIT are functions for identification of a system model and its corresponding forward and backward observers directly from input and output data. The system and observers are represented by a discrete model. The identified model and observers may be used for controller design of linear systems as well as identification of modal parameters such as dampings, frequencies, and mode shapes. For a closed-loop system, an observer and its corresponding controller gain directly from input and output data.

  14. Diagnosing dehydration? Blend evidence with clinical observations.

    PubMed

    Armstrong, Lawrence E; Kavouras, Stavros A; Walsh, Neil P; Roberts, William O

    2016-11-01

    The purpose of the review is to provide recommendations to improve clinical decision-making based on the strengths and weaknesses of commonly used hydration biomarkers and clinical assessment methods. There is widespread consensus regarding treatment, but not the diagnosis of dehydration. Even though it is generally accepted that a proper clinical diagnosis of dehydration can only be made biochemically rather than relying upon clinical signs and symptoms, no gold standard biochemical hydration index exists. Other than clinical biomarkers in blood (i.e., osmolality and blood urea nitrogen/creatinine) and in urine (i.e., osmolality and specific gravity), blood pressure assessment and clinical symptoms in the eye (i.e., tear production and palpitating pressure) and the mouth (i.e., thirst and mucous wetness) can provide important information for diagnosing dehydration. We conclude that clinical observations based on a combination of history, physical examination, laboratory values, and clinician experience remain the best approach to the diagnosis of dehydration.

  15. Clinical Knowledge from Observational Studies: Everything You Wanted to Know but Were Afraid to Ask.

    PubMed

    Gershon, Andrea S; Jafarzadeh, S Reza; Wilson, Kevin C; Walkey, Allan J

    2018-05-07

    Well-done randomized trials provide accurate estimates of treatment effect by producing groups that are similar on all measures except for the intervention of interest. However, inferences of efficacy in tightly-controlled experimental settings may not translate into similar effectiveness in real-world settings. Observational studies generally enable inferences over a wider range of patient characteristics and evaluation of a broader range of outcomes over a longer period than randomized trials. However, clinicians are often reluctant to incorporate the findings of observational studies into clinical practice. Reason for uncertainty regarding observational studies include a lack of familiarity with observational research methods, occasional disagreements between results of observational studies and randomized trials, the perceived risk of spurious results from systematic bias, and prior teaching that randomized trials are the most reliable source of medical evidence. We propose that a better understanding of observational research will enhance clinicians' ability to distinguish reliable observational studies from those that are subjected to biases and, therefore, provide more confidence to apply observational research results into clinical practice when appropriate. Herein, we explain why observational studies may be perceived as less conclusive than randomized trials, address situations in which observational research and randomized trials produced different findings, and provide information on observational study design so that quality can be evaluated. We conclude that observational research is a valuable source of medical evidence and that clinical action is strongest when supported by both high quality observational studies and randomized trials.

  16. [Clinical observation on acupuncture by stages combined with exercise therapy for treatment of Bell palsy at acute stage].

    PubMed

    Qu, Yong

    2005-08-01

    To find out a method for increasing clinical therapeutic effect on Bell palsy at acute stage. Ninety cases of Bell palsy were randomly divided into an observation group, a control group I and a control group II, 30 cases in each group. They were treated respectively with acupuncture plus exercise therapy, simple acupuncture therapy, and simple exercise therapy, and their therapeutic effects were observed. The cured rate was 66.7% in the observation group, 53.3% in the control group I and 46.70% in the control group II, the observation group being better than the two control groups (P<0.05). Acupuncture by stage combined with exercise therapy can increase the therapeutic effect on Bell palsy at acute stage, and it is a better therapy for Bell palsy.

  17. How clinical observation enhances recruitment and selection.

    PubMed

    Sutherland, Clare

    2012-11-01

    A survey of nurse managers in Derby Hospitals NHS Foundation Trust in 2010 found 51 practitioners working at an advanced clinical level, but there were variations in titles, pay bands, clinical skills and academic qualifications. This prompted the introduction of a local framework to support the development of the advanced nurse practitioner (ANP) role and a review of the interview process to enable managers to assess applicants' skills, competencies and knowledge. The process is now used in practice, with candidates' clinical skills now observed as part of the ANP selection process. This article describes how the new process works.

  18. A software tool to analyze clinical workflows from direct observations.

    PubMed

    Schweitzer, Marco; Lasierra, Nelia; Hoerbst, Alexander

    2015-01-01

    Observational data of clinical processes need to be managed in a convenient way, so that process information is reliable, valid and viable for further analysis. However, existing tools for allocating observations fail in systematic data collection of specific workflow recordings. We present a software tool which was developed to facilitate the analysis of clinical process observations. The tool was successfully used in the project OntoHealth, to build, store and analyze observations of diabetes routine consultations.

  19. Clinical observation on 96 cases of primary osteoporosis treated with kidney-tonifying and bone-strengthening mixture.

    PubMed

    Mingyue, Wang; Ling, Gong; Bei, Xia; Junqing, Cao; Peiqing, Zhou; Jie, Hu

    2005-06-01

    To objectively evaluate the therapeutic effect and safety of Mixture for Nourishing Kidney and Strengthening Bone. Among 160 cases of osteoporosis under clinical observation, 96 patients in the treatment group were treated with Mixture for Nourishing Kidney and Strengthening Bone, 32 patients in the control group were given Shen Gu Capsule and 32 patients in the blank group were given no drug in half a year. Observation and determination were conducted on bone mineral density (BMD), clinical symptoms, bone gla protein (BGP), pyridinoline (PYD), estradiol (E2), testosterone (T), blood urea nitrogen (BUN), transaminase and routine test on blood and urine. The comprehensive effect in the treatment group was remarkably superior to that in the control group. The safe and reliable Chinese drug can enhance BMD, promote osteogenesis and inhibit bone absorption, hence treating osteoporosis with marked effect.

  20. 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

  1. Observation-based training for neuroprosthetic control of grasping by amputees.

    PubMed

    Agashe, Harshavardhan A; Contreras-Vidal, Jose L

    2014-01-01

    Current brain-machine interfaces (BMIs) allow upper limb amputees to position robotic arms with a high degree of accuracy, but lack the ability to control hand pre-shaping for grasping different objects. We have previously shown that low frequency (0.1-1 Hz) time domain cortical activity recorded at the scalp via electroencephalography (EEG) encodes information about grasp pre-shaping. To transfer this technology to clinical populations such as amputees, the challenge lies in constructing BMI models in the absence of overt training hand movements. Here we show that it is possible to train BMI models using observed grasping movements performed by a robotic hand attached to amputees' residual limb. Three transradial amputees controlled the grasping motion of an attached robotic hand via their EEG, following the action-observation training phase. Over multiple sessions, subjects successfully grasped the presented object (a bottle or a credit card) in 53±16 % of trials, demonstrating the validity of the BMI models. Importantly, the validation of the BMI model was through closed-loop performance, which demonstrates generalization of the model to unseen data. These results suggest `mirror neuron system' properties captured by delta band EEG that allows neural representation for action observation to be used for action control in an EEG-based BMI system.

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

    PubMed

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

    2007-04-01

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

  3. Birth Control in Clinical Trials

    PubMed Central

    Stewart, J.; Beyer, B. K.; Chadwick, K.; De Schaepdrijver, L.; Desai, M.; Enright, B.; Foster, W.; Hui, J. Y.; Moffat, G. J.; Tornesi, B.; Van Malderen, K.; Wiesner, L.; Chen, C. L.

    2015-01-01

    The Health and Environmental Sciences Institute (HESI) Developmental and Reproductive Toxicology Technical Committee sponsored a pharmaceutical industry survey on current industry practices for contraception use during clinical trials. The objectives of the survey were to improve our understanding of the current industry practices for contraception requirements in clinical trials, the governance processes set up to promote consistency and/or compliance with contraception requirements, and the effectiveness of current contraception practices in preventing pregnancies during clinical trials. Opportunities for improvements in current practices were also considered. The survey results from 12 pharmaceutical companies identified significant variability among companies with regard to contraception practices and governance during clinical trials. This variability was due primarily to differences in definitions, areas of scientific uncertainty or misunderstanding, and differences in company approaches to enrollment in clinical trials. The survey also revealed that few companies collected data in a manner that would allow a retrospective understanding of the reasons for failure of birth control during clinical trials. In this article, suggestions are made for topics where regulatory guidance or scientific publications could facilitate best practice. These include provisions for a pragmatic definition of women of childbearing potential, guidance on how animal data can influence the requirements for male and female birth control, evidence-based guidance on birth control and pregnancy testing regimes suitable for low- and high-risk situations, plus practical methods to ascertain the risk of drug-drug interactions with hormonal contraceptives. PMID:27042398

  4. Pedagogical strategies used in clinical medical education: an observational study

    PubMed Central

    2010-01-01

    Background Clinical teaching is a complex learning situation influenced by the learning content, the setting and the participants' actions and interactions. Few empirical studies have been conducted in order to explore how clinical supervision is carried out in authentic situations. In this study we explore how clinical teaching is carried out in a clinical environment with medical students. Methods Following an ethnographic approach looking for meaning patterns, similarities and differences in how clinical teachers manage clinical teaching; non-participant observations and informal interviews were conducted during a four month period 2004-2005. The setting was at a teaching hospital in Sweden. The participants were clinical teachers and their 4th year medical students taking a course in surgery. The observations were guided by the aim of the study. Observational notes and notes from informal interviews were transcribed after each observation and all data material was analysed qualitatively. Results Seven pedagogical strategies were found to be applied, namely: 1) Questions and answers, 2) Lecturing, 3) Piloting, 4) Prompting, 5) Supplementing, 6) Demonstrating, and 7) Intervening. Conclusions This study contributes to previous research in describing a repertoire of pedagogical strategies used in clinical education. The findings showed that three superordinate qualitatively different ways of teaching could be identified that fit Ramsden's model. Each of these pedagogical strategies encompass different focus in teaching; either a focus on the teacher's knowledge and behaviour or the student's behaviour and understanding. We suggest that an increased awareness of the strategies in use will increase clinical teachers' teaching skills and the consequences they will have on the students' ability to learn. The pedagogical strategies need to be considered and scrutinized in further research in order to verify their impact on students' learning. PMID:20105340

  5. Observational Studies: Cohort and Case-Control Studies

    PubMed Central

    Song, Jae W.; Chung, Kevin C.

    2010-01-01

    Observational studies are an important category of study designs. To address some investigative questions in plastic surgery, randomized controlled trials are not always indicated or ethical to conduct. Instead, observational studies may be the next best method to address these types of questions. Well-designed observational studies have been shown to provide results similar to randomized controlled trials, challenging the belief that observational studies are second-rate. Cohort studies and case-control studies are two primary types of observational studies that aid in evaluating associations between diseases and exposures. In this review article, we describe these study designs, methodological issues, and provide examples from the plastic surgery literature. PMID:20697313

  6. Family intervention to control type 2 diabetes: a controlled clinical trial.

    PubMed

    García-Huidobro, Diego; Bittner, Marcela; Brahm, Paulina; Puschel, Klaus

    2011-02-01

    Chilean patients with type 2 diabetes mellitus (T2DM) have a low rate of blood sugar control. We studied the effectiveness of a culturally sensitive family oriented intervention designed to improve metabolic control in primary care patients with uncontrolled T2DM. Patients with T2DM from three primary care clinics in Santiago, Chile were randomly selected for inclusion if they had a recent HbA1c ≥7%, were between 18 and 70 years old and lived with a family member. Patients from one clinic received the family oriented intervention; patients from the other two (control) clinics received standard care. The intervention involved family members in care and included family counselling during clinic visits, family meetings and home visits. The primary outcome was HbA1c, measured at 6 and 12 months. A total of 243 patients were enrolled and 209 (86%) completed the study. The intervention was fully administered to only 34% of patients in the intervention clinic. The reduction in the HbA1c from baseline to 12 months was not significantly different between clinics. During the second 6-month period, when the intervention was more intensive, the patients in the intervention clinic significantly improved their HbA1c (P < 0.001) compared to the control patients. A family intervention for the control of T2DM was associated with a significant reduction in HbA1c when the intervention was provided. Incomplete implementation, low statistical power and potential confounding variables between groups could be some of the main factors that explain the lack of difference between clinics in the 12-month period.

  7. Beyond student ratings: peer observation of classroom and clinical teaching.

    PubMed

    Berk, Ronald A; Naumann, Phyllis L; Appling, Susan E

    2004-01-01

    Peer observation of classroom and clinical teaching has received increased attention over the past decade in schools of nursing to augment student ratings of teaching effectiveness. One essential ingredient is the scale used to evaluate performance. A five-step systematic procedure for adapting, writing, and building any peer observation scale is described. The differences between the development of a classroom observation scale and an appraisal scale to observe clinical instructors are examined. Psychometric issues peculiar to observation scales are discussed in terms of content validity, eight types of response bias, and interobserver reliability. The applications of the scales in one school of nursing as part of the triangulation of methods with student ratings and the teaching portfolio are illustrated. Copies of the scales are also provided.

  8. Quality Control of Meteorological Observations

    NASA Technical Reports Server (NTRS)

    Collins, William; Dee, Dick; Rukhovets, Leonid

    1999-01-01

    For the first time, a problem of the meteorological observation quality control (QC) was formulated by L.S. Gandin at the Main Geophysical Observatory in the 70's. Later in 1988 L.S. Gandin began adapting his ideas in complex quality control (CQC) to the operational environment at the National Centers for Environmental Prediction. The CQC was first applied by L.S.Gandin and his colleagues to detection and correction of errors in rawinsonde heights and temperatures using a complex of hydrostatic residuals.Later, a full complex of residuals, vertical and horizontal optimal interpolations and baseline checks were added for the checking and correction of a wide range of meteorological variables. some other of Gandin's ideas were applied and substantially developed at other meteorological centers. A new statistical QC was recently implemented in the Goddard Data Assimilation System. The central component of any quality control is a buddy check which is a test of individual suspect observations against available nearby non-suspect observations. A novel feature of this test is that the error variances which are used for QC decision are re-estimated on-line. As a result, the allowed tolerances for suspect observations can depend on local atmospheric conditions. The system is then better able to accept extreme values observed in deep cyclones, jet streams and so on. The basic statements of this adaptive buddy check are described. Some results of the on-line QC including moisture QC are presented.

  9. Controlled clinical studies of homeopathy.

    PubMed

    Mathie, Robert T

    2015-10-01

    Observations about controlled clinical trials expressed by Max Haidvogl in the book Ultra High Dilution (1994) have been appraised from a perspective two decades later. The present commentary briefly examines changes in homeopathy research evidence since 1994 as regards: the published number of randomised controlled trials (RCTs), the use of individualised homeopathic intervention, the 'proven efficacy of homeopathy', and the quality of the evidence. The commentary reflects the details of RCTs that are available in a recently published literature review and by scrutiny of systematic reviews of RCTs in homeopathy. The homeopathy RCT literature grew by 309 records in the 18 years that immediately followed Haidvogl's article, with more than a doubling of the proportion that investigated individualised homeopathy. Discounting one prior publication, the entire systematic review literature on homeopathy RCTs post-dates 1994. A total of 36 condition-specific systematic reviews have been identified in the peer-reviewed literature: 16 of them reported positive, or tentatively positive, conclusions about homeopathy's clinical effectiveness; the other 20 were negative or non-conclusive. Reviews typically have been restricted in the strength of their conclusions by the low quality of the original RCT evidence. Three comprehensive systematic reviews concluded, cautiously, that homeopathy may differ from placebo; a fourth such review reached negative conclusions. A recent high-quality meta-analysis concluded that medicines prescribed in individualised homeopathic treatment may have small, specific, effects. Despite important growth in research activity since 1994, concerns about study quality limit the interpretation of available RCT data. The question whether homeopathic intervention differs from placebo awaits decisive answer. Copyright © 2015 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

  10. [Clinical observation of modified Da Chaihu decoction in treating essential hypertension with anxiety].

    PubMed

    Zhang, Xiang-Dong; Cheng, Wang-Qiang; Wang, Yong-Gang; Zhang, Zheng

    2017-06-01

    To observe the clinical efficacy of modified Da Chaihu decoction in treating essential hypertension with anxiety, the randomized, controlled, clinical trial was performed in this study. One hundred and twenty-six hypertensive patients with anxiety meeting the inclusive criteria were randomized into the treatment group and the control group. All of the included patients in the above 2 groups were treated by amlodipine besylate tablets. Patients in the treatment group were given Chinese herbal medicine modified Da Chaihu decoction every day. And patients in the control group were given flupentixol and melitracen tablets. The treatment course was 4 weeks. Blood pressure, the score of traditional Chinese medicine syndrome, blood lipids, C reactive protein, the Hamilton anxiety scale score and adverse effects were observed. It has been identified that, both systolic and diastolic blood pressure were significantly reduced (P<0.05). However, no significant difference between the treatment group and the control group was identified. For traditional Chinese medicine syndrome, it was significantly improved in the treatment group (P<0.05). For blood lipids, TC, TG, HDL-C, and LDL-C were significantly improved in the treatment group (P<0.05). After treatment, only TC was significantly reduced in the treatment group when compared to the control group (P<0.05). For C reactive protein, it was significantly reduced in the treatment group after treatment (P<0.05). For anxiety, no significant difference between the treatment group and the control group on the Hamilton anxiety scale score was identified. For adverse effect, no severe adverse effect was identified in this study. The modified Da Chaihu decoction maybe effective in the treatment of essential hypertension with anxiety. In addition to a certain role in lowering blood pressure, the modified Da Chaihu decoction was also effective in improving traditional Chinese medicine syndrome and blood lipids, reducing the level of C

  11. Psychosocial impact of prognostic genetic testing in the care of uveal melanoma patients: protocol of a controlled prospective clinical observational study.

    PubMed

    Erim, Yesim; Scheel, Jennifer; Breidenstein, Anja; Metz, Claudia Hd; Lohmann, Dietmar; Friederich, Hans-Christoph; Tagay, Sefik

    2016-07-07

    Uveal melanoma patients with a poor prognosis can be detected through genetic analysis of the tumor, which has a very high sensitivity. A large number of patients with uveal melanoma decide to receive information about their individual risk and therefore routine prognostic genetic testing is being carried out on a growing number of patients. It is obvious that a positive prediction for recidivism in the future will emotionally burden the respective patients, but research on the psychosocial impact of this innovative method is lacking. The aim of the current study is therefore to investigate the psychosocial impact (psychological distress and quality of life) of prognostic genetic testing in patients with uveal melanoma. This study is a non-randomized controlled prospective clinical observational trial. Subjects are patients with uveal melanoma, in whom genetic testing is possible. Patients who consent to genetic testing are allocated to the intervention group and patients who refuse genetic testing form the observational group. Both groups receive cancer therapy and psycho-oncological intervention when needed. The psychosocial impact of prognostic testing is investigated with the following variables: resilience, social support, fear of tumor progression, depression, general distress, cancer-specific and general health-related quality of life, attitude towards genetic testing, estimation of the perceived risk of metastasis, utilization and satisfaction with psycho-oncological crisis intervention, and sociodemographic data. Data are assessed preoperatively (at initial admission in the clinic) and postoperatively (at discharge from hospital after surgery, 6-12 weeks, 6 and 12 months after initial admission). Genetic test results are communicated 6-12 weeks after initial admission to the clinic. We created optimal conditions for investigation of the psychosocial impact of prognostic genetic testing. This study will provide information on the course of disease and

  12. 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.

  13. [Clinical research XVII. χ(2) test, from the expected to the observed].

    PubMed

    Rivas-Ruiz, Rodolfo; Castelán-Martínez, Osvaldo D; Pérez, Marcela; Talavera, Juan O

    2013-01-01

    When you want to show if there is a statistical association or differences between categorical variables, it is recommended to use the χ(2) test. This nonparametric test is one of the most used in clinical research; it contrasts nominal or ordinal qualitative variables that are observed in clinical practice. This test calculates the p value that determines whether differences between groups are real or due to chance. The χ(2) test is the basis of other tests to analyze qualitative ordinal variables as χ(2) for linear trend, which compares three groups with two outcomes or McNemar test, which contrasts two related samples (a before and afterward comparison) or Mantel-Haenszel χ(2), which controls for potential confounding variables. When using small samples, where the expected results are less than 5, Fisher's exact test should be used. These tests are the most widely used in the medical literature; however, they do not give us the magnitude or the direction of the event and a proper interpretation that requires clinical judgment is needed.

  14. Large Controlled Observational Study on Remote Monitoring of Pacemakers and Implantable Cardiac Defibrillators: A Clinical, Economic, and Organizational Evaluation.

    PubMed

    Dario, Claudio; Delise, Pietro; Gubian, Lorenzo; Saccavini, Claudio; Brandolino, Glauco; Mancin, Silvia

    2016-01-13

    Patients with implantable devices such as pacemakers (PMs) and implantable cardiac defibrillators (ICDs) should be followed up every 3-12 months, which traditionally required in-clinic visits. Innovative devices allow data transmission and technical or medical alerts to be sent from the patient's home to the physician (remote monitoring). A number of studies have shown its effectiveness in timely detection and management of both clinical and technical events, and endorsed its adoption. Unfortunately, in daily practice, remote monitoring has been implemented in uncoordinated and rather fragmented ways, calling for a more strategic approach. The objective of the study was to analyze the impact of remote monitoring for PM and ICD in a "real world" context compared with in-clinic follow-up. The evaluation focuses on how this service is carried out by Local Health Authorities, the impact on the cardiology unit and the health system, and organizational features promoting or hindering its effectiveness and efficiency. A multi-center, multi-vendor, controlled, observational, prospective study was conducted to analyze the impact of remote monitoring implementation. A total of 2101 patients were enrolled in the study: 1871 patients were followed through remote monitoring of PM/ICD (I-group) and 230 through in-clinic visits (U-group). The follow-up period was 12 months. In-clinic device follow-ups and cardiac visits were significantly lower in the I-group compared with the U-group, respectively: PM, I-group = 0.43, U-group = 1.07, P<.001; ICD, I-group = 0.98, U-group = 2.14, P<.001. PM, I-group = 0.37, U-group = 0.85, P<.001; ICD, I-group = 1.58, U-group = 1.69, P=.01. Hospitalizations for any cause were significantly lower in the I-group for PM patients only (I-group = 0.37, U-group = 0.50, P=.005). There were no significant differences regarding use of the emergency department for both PM and ICD patients. In the I-group, 0.30 (PM) and 0.37 (ICD) real clinical events per

  15. Observability of Boolean multiplex control networks

    NASA Astrophysics Data System (ADS)

    Wu, Yuhu; Xu, Jingxue; Sun, Xi-Ming; Wang, Wei

    2017-04-01

    Boolean multiplex (multilevel) networks (BMNs) are currently receiving considerable attention as theoretical arguments for modeling of biological systems and system level analysis. Studying control-related problems in BMNs may not only provide new views into the intrinsic control in complex biological systems, but also enable us to develop a method for manipulating biological systems using exogenous inputs. In this article, the observability of the Boolean multiplex control networks (BMCNs) are studied. First, the dynamical model and structure of BMCNs with control inputs and outputs are constructed. By using of Semi-Tensor Product (STP) approach, the logical dynamics of BMCNs is converted into an equivalent algebraic representation. Then, the observability of the BMCNs with two different kinds of control inputs is investigated by giving necessary and sufficient conditions. Finally, examples are given to illustrate the efficiency of the obtained theoretical results.

  16. [Clinical efficacy observation of acupuncture at suliao (GV 25) on improving regain of consciousness from coma in severe craniocerebral injury].

    PubMed

    Xu, Kai-Sheng; Song, Jian-Hua; Huang, Tiao-Hua; Huang, Zhi-Hua; Yu, Lu-Chang; Zheng, Wei-Ping; Chen, Xiao-Shan; Liu, Chuan

    2014-06-01

    To compare the clinical therapeutic effects differences between acupuncture at Suliao (GV 25) and Shuigou (GV 26) on promoting regain of consciousness from coma in severe craniocerebral injury. Based on regular emergency treatments of neurosurgery, eighty-two cases of craniocerebral injury who were under stable condition were randomly divided into an observation group (42 cases) and a control group (40 cases). Suliao (GV 25) was selected as main aupoint, while Laogong (PC 8) and Yongquan (KI 1), etc. were selected as adjuvant acupoints and Neiguan (PC 6), Sanyinjiao (SP 6), Yifeng (TE 17) and Wangu (GB 12), etc. were selected as matching acupoints in the observation group where a strong needle manipulation was applied to improve the regain of consciousness. The main acupoint of Shuigou (GV 26) along with identical adjuvant acupoints and matching acupoints in the observation group were selected in the control group with identical strong needle manipulation. The treatment was given once a day in both groups, five times per week and ten times were considered as one session. The immediate clinical symptoms after acupuncture at Suliao (GV 25) and Shuigou (GV 26) were observed as well as Glasgow coma scale (GCS) before the treatment, after 45 days and 90 days of treatment to assess the resuscitation time and rate. Also the clinical efficacy was compared between both groups. The occurrence rate of sneezing reflex was 85.7% (36/42) in the observation group, which was higher than 25.0% (10/40) in the control group (P < 0.01). The average resuscitation time was (64.6 +/- 19.4) days in the observation group, which was obviously shorter than (73.8 +/- 14. 6) days in the control group (P < 0.05). The resuscitation rate was 88.1% (37/42) in the observation group, which was similar to 75.0% (30/40) in the control group (P > 0.05). Compared before the treatment, GCS were both improved after the treatment in two groups (both P < 0.01). The 90-day GCS was 9.52 +/- 2.32 in the

  17. 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.

  18. Accuracy of clinical observations of push-off during gait after stroke.

    PubMed

    McGinley, Jennifer L; Morris, Meg E; Greenwood, Ken M; Goldie, Patricia A; Olney, Sandra J

    2006-06-01

    To determine the accuracy (criterion-related validity) of real-time clinical observations of push-off in gait after stroke. Criterion-related validity study of gait observations. Rehabilitation hospital in Australia. Eleven participants with stroke and 8 treating physical therapists. Not applicable. Pearson product-moment correlation between physical therapists' observations of push-off during gait and criterion measures of peak ankle power generation from a 3-dimensional motion analysis system. A high correlation was obtained between the observational ratings and the measurements of peak ankle power generation (Pearson r =.98). The standard error of estimation of ankle power generation was .32W/kg. Physical therapists can make accurate real-time clinical observations of push-off during gait following stroke.

  19. Validation of Clinical Observations of Mastication in Persons with ALS.

    PubMed

    Simione, Meg; Wilson, Erin M; Yunusova, Yana; Green, Jordan R

    2016-06-01

    Amyotrophic lateral sclerosis (ALS) is a progressive neurological disease that can result in difficulties with mastication leading to malnutrition, choking or aspiration, and reduced quality of life. When evaluating mastication, clinicians primarily observe spatial and temporal aspects of jaw motion. The reliability and validity of clinical observations for detecting jaw movement abnormalities is unknown. The purpose of this study is to determine the reliability and validity of clinician-based ratings of chewing performance in neuro-typical controls and persons with varying degrees of chewing impairments due to ALS. Adults chewed a solid food consistency while full-face video were recorded along with jaw kinematic data using a 3D optical motion capture system. Five experienced speech-language pathologists watched the videos and rated the spatial and temporal aspects of chewing performance. The jaw kinematic data served as the gold-standard for validating the clinicians' ratings. Results showed that the clinician-based rating of temporal aspects of chewing performance had strong inter-rater reliability and correlated well with comparable kinematic measures. In contrast, the reliability of rating the spatial and spatiotemporal aspects of chewing (i.e., range of motion of the jaw, consistency of the chewing pattern) was mixed. Specifically, ratings of range of motion were at best only moderately reliable. Ratings of chewing movement consistency were reliable but only weakly correlated with comparable measures of jaw kinematics. These findings suggest that clinician ratings of temporal aspects of chewing are appropriate for clinical use, whereas ratings of the spatial and spatiotemporal aspects of chewing may not be reliable or valid.

  20. Are Common Skin Diseases among Norwegian Dermatological Outpatients Associated with Psychological Problems Compared with Controls? An Observational Study.

    PubMed

    Balieva, Flora; Lien, Lars; Kupfer, Jörg; Halvorsen, Jon Anders; Dalgard, Florence

    2016-02-01

    Dermatological disease has been shown to be associated with psychological comorbidity. The aim of this observational study is to describe the distribution of skin disease and the prevalence of depression, anxiety and stress among Norwegian dermatological outpatients. Thirteen percent of outpatients had clinical anxiety compared with 3.7% of healthy controls, and 5.8% had clinical depression compared with 0.9% of controls. Adjusted odds ratio for clinical anxiety was 4.53 in patients compared with controls, and for clinical depression 6.25, which is much higher than previously described in a larger European study. Patients with tumours had less depression. Chronic inflammatory skin conditions had an especially high impact on patient's psychological wellbeing and should not be undervalued relative to, for instance, skin cancer in health strategies. These results argue strongly for including skin disease prevention and treatment in future health strategies.

  1. Impact of implementing electronic clinical practice guidelines for the diagnosis, control and treatment of cardiovascular risk factors: A pre-post controlled study.

    PubMed

    Comin, Eva; Catalan-Ramos, Arantxa; Iglesias-Rodal, Manuel; Grau, Maria; Del Val, Jose Luis; Consola, Alicia; Amado, Ester; Pons, Angels; Mata-Cases, Manel; Franzi, Alicia; Ciurana, Ramon; Frigola, Eva; Cos, Xavier; Davins, Josep; Verdu-Rotellar, Jose M

    To evaluate the impact of computerized clinical practice guidelines on the management, diagnosis, treatment, control, and follow-up of the main cardiovascular risk factors: hypertension, hypercholesterolaemia, and type 2 diabetes mellitus. Pre-post controlled study. Catalonia, autonomous community located in north-eastern Spain. Individuals aged 35-74 years assigned to general practitioners of the Catalan Health Institute. The intervention group consisted of individuals whose general practitioners had accessed the computerized clinical practice guidelines at least twice a day, while the control group consisted of individuals whose general practitioner had never accessed the computerized clinical practice guidelines platform. The Chi-squared test was used to detect significant differences in the follow-up, control, and treatment variables for all three disorders (hypertension, hypercholesterolaemia, and type 2 diabetes mellitus) between individuals assigned to users and non-users of the computerized clinical practice guidelines, respectively. A total of 189,067 patients were included in this study, with a mean age of 56 years (standard deviation 12), and 55.5% of whom were women. Significant differences were observed in hypertension management, treatment and control; type 2 diabetes mellitus management, treatment and diagnoses, and the management and control of hypercholesterolaemia in both sexes. Computerized clinical practice guidelines are an effective tool for the control and follow-up of patients diagnosed with hypertension, type 2 diabetes mellitus, and hypercholesterolaemia. The usefulness of computerized clinical practice guidelines to diagnose and adequately treat individuals with these disorders remains unclear. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

  2. Large Controlled Observational Study on Remote Monitoring of Pacemakers and Implantable Cardiac Defibrillators: A Clinical, Economic, and Organizational Evaluation

    PubMed Central

    2016-01-01

    Background Patients with implantable devices such as pacemakers (PMs) and implantable cardiac defibrillators (ICDs) should be followed up every 3–12 months, which traditionally required in-clinic visits. Innovative devices allow data transmission and technical or medical alerts to be sent from the patient's home to the physician (remote monitoring). A number of studies have shown its effectiveness in timely detection and management of both clinical and technical events, and endorsed its adoption. Unfortunately, in daily practice, remote monitoring has been implemented in uncoordinated and rather fragmented ways, calling for a more strategic approach. Objective The objective of the study was to analyze the impact of remote monitoring for PM and ICD in a “real world” context compared with in-clinic follow-up. The evaluation focuses on how this service is carried out by Local Health Authorities, the impact on the cardiology unit and the health system, and organizational features promoting or hindering its effectiveness and efficiency. Methods A multi-center, multi-vendor, controlled, observational, prospective study was conducted to analyze the impact of remote monitoring implementation. A total of 2101 patients were enrolled in the study: 1871 patients were followed through remote monitoring of PM/ICD (I-group) and 230 through in-clinic visits (U-group). The follow-up period was 12 months. Results In-clinic device follow-ups and cardiac visits were significantly lower in the I-group compared with the U-group, respectively: PM, I-group = 0.43, U-group = 1.07, P<.001; ICD, I-group = 0.98, U-group = 2.14, P<.001. PM, I-group = 0.37, U-group = 0.85, P<.001; ICD, I-group = 1.58, U-group = 1.69, P=.01. Hospitalizations for any cause were significantly lower in the I-group for PM patients only (I-group = 0.37, U-group = 0.50, P=.005). There were no significant differences regarding use of the emergency department for both PM and ICD patients. In the I-group, 0.30 (PM

  3. Observable phenomena that reveal medical students' clinical reasoning ability during expert assessment of their history taking: a qualitative study.

    PubMed

    Haring, Catharina M; Cools, Bernadette M; van Gurp, Petra J M; van der Meer, Jos W M; Postma, Cornelis T

    2017-08-29

    During their clerkships, medical students are meant to expand their clinical reasoning skills during their patient encounters. Observation of these encounters could reveal important information on the students' clinical reasoning abilities, especially during history taking. A grounded theory approach was used to analyze what expert physicians apply as indicators in their assessment of medical students' diagnostic reasoning abilities during history taking. Twelve randomly selected clinical encounter recordings of students at the end of the internal medicine clerkships were observed by six expert assessors, who were prompted to formulate their assessment criteria in a think-aloud procedure. These formulations were then analyzed to identify the common denominators and leading principles. The main indicators of clinical reasoning ability were abstracted from students' observable acts during history taking in the encounter. These were: taking control, recognizing and responding to relevant information, specifying symptoms, asking specific questions that point to pathophysiological thinking, placing questions in a logical order, checking agreement with patients, summarizing and body language. In addition, patients' acts and the course, result and efficiency of the conversation were identified as indicators of clinical reasoning, whereas context, using self as a reference, and emotion/feelings were identified by the clinicians as variables in their assessment of clinical reasoning. In observing and assessing clinical reasoning during history taking by medical students, general and specific phenomena to be used as indicators for this process could be identified. These phenomena can be traced back to theories on the development and the process of clinical reasoning.

  4. Observation of Couple Conflicts: Clinical Assessment Applications, Stubborn Truths, and Shaky Foundations

    PubMed Central

    Heyman, Richard E.

    2006-01-01

    The purpose of this review is to provide a balanced examination of the published research involving the observation of couples, with special attention toward the use of observation for clinical assessment. All published articles that (a) used an observational coding system and (b) relate to the validity of the coding system are summarized in a table. The psychometric properties of observational systems and the use of observation in clinical practice are discussed. Although advances have been made in understanding couple conflict through the use of observation, the review concludes with an appeal to the field to develop constructs in a psychometrically and theoretically sound manner. PMID:11281039

  5. Observation for clinical effect of phellodendron wet compress in treating the phlebitis caused by infusion.

    PubMed

    Wan, Ying

    2018-05-01

    Aim of the study was to observe and analyze the clinical effect of phellodendron wet compress in treating the phlebitis caused by infusion. The research objects were 600 cases of phlebitis caused by infusion, all of which were treated in our hospital from June 2013 to June 2016. All patients were entitled to the right to know. They were randomly divided into the research group and the control group. Patients in the control group were treated with magnesium sulfate solution wet compress, while patients in the research group were treated with phellodendron wet compress. The effects in these two groups were observed and compared. Compared with the control group, the research group has better overall treatment efficiency, p<0.05; shorter average onset of action, p<0.05; less time in relieving red swelling and pain, p<0.05. Phellodendron wet compress shows a beneficial effect in treating the phlebitis caused by infusion. It can not only obviously shorten the onset of action, but also level up the overall treatment efficiency that helps patients to recover.

  6. Rotigotine transdermal patch in combination therapy for Parkinson's disease--observations in routine clinical practice.

    PubMed

    Ceballos-Baumann, Andres; Häck, Hermann-Josef

    2011-10-01

    The dopamine agonist rotigotine has shown efficacy and safety for the treatment of early and advanced Parkinson's disease (PD) in controlled clinical trials. This observational study evaluated rotigotine administration in combination with other antiparkinsonian medication in routine clinical practice. Data were collected by 688 German practice-based neurologists, initiating rotigotine treatment in patients with idiopathic Parkinson's disease. Assessments included rotigotine maintenance dose, changes in concomitant PD medication, changes in sleep quality, and rotigotine tolerability over an observation period of 12-16 weeks. The median rotigotine maintenance dose was 6 mg/24 h (n = 969, full analysis set). The proportion of all other prescribed PD medications declined over the observation period; combination therapy decreased by 18.7%. Daily levodopa intake was markedly reduced by 87 mg (18.9%) in 47.6% of the patients with levodopa documentation; 7% no longer required levodopa after 12-16 weeks. Mean overall sleep quality (PD Sleep Scale item 1) improved by 21.4 points, the occurrence of nocturias (PDSS item 8) by 13.4 points, and 'turning in bed' (Unified Parkinson's Disease Rating Scale part II) by 0.6 points. Drug-related adverse events were reported for 7.9% of all patients (n = 1152, safety population). Application site reactions were the most common adverse events (2.2%) resulting in early discontinuation in 1.4% of patients. In routine clinical practice, treatment initiation with rotigotine transdermal patch was associated with a reduction of other prescribed PD medications and with an improvement of self-reported sleep quality.

  7. [Clinical observation of preoperative administration of enteral nutrition support in gastric cancer patients at risk of malnutrition].

    PubMed

    Chen, Bo; Zhou, Yong; Yang, Ping; Qin, Xian-peng; Li, Ning-ning; He, Dan; Feng, Jin-yan; Yan, Chuan-jing; Wu, Xiao-ting

    2013-11-01

    To evaluate safety and efficacy of preoperative administration of enteral nutrition support in gastric cancer patients at risk of malnutrition. A single center randomized controlled clinical trial was performed in 60 gastric cancer patients in West China Hospital from May to October 2012. Thirty patients were given enteral nutrition support(Ensure(R)) manufactured by Abbott Laboratories for ten consecutive days before surgical operation in the treatment group, and 30 patients were given an isocaloric and isonitrogenous homogenized diet in the control group for 10 days as well. The laboratory parameters of nutritional status and hepatorenal function were observed and compared between the two groups on admission, preoperative day 1 and postoperative day 3, respectively. Clinical observations, such as nausea and vomiting, were carried out until patients were discharged. Before the intervention, there were no significant differences in the baseline characteristics between the two groups. The levels of serum albumin [(33.9±5.6) g/L vs. (31.0±5.3) g/L, P<0.05], and hemoglobin[(103.4±7.7) g/L vs.(96.6±10.5) g/L, P<0.01] were significantly improved in the treatment group on postoperative day 3. However, the levels of body mass index, lymphocyte count, liver and renal function, serum glucose, sodium, and potassium were not significantly different between the two groups(all P>0.05). Moreover, two patients with nausea and one with vomiting in each group were found. In clinical observation period, no severe treatment-related adverse event were observed. The enteral supplement with Ensure(R) in gastric cancer patients at risk of malnutrition during preoperative period is effective and safe, which is superior to homogenized diet and an appropriate choice for gastric cancer patients with nutritional risk.

  8. Compliance with infection control practices in an university hospital dental clinic

    PubMed Central

    Mutters, Nico T.; Hägele, Ulrike; Hagenfeld, Daniel; Hellwig, Elmar; Frank, Uwe

    2014-01-01

    Aim: Compliance with infection control practices is the key to quality care and excellence in dentistry. Infection control remains one of the most cost-beneficial interventions available. However, implementing control procedures requires full compliance of the whole dental team. The aim of our study was to measure the compliance in daily clinical practice. Methods: The compliance with infection control practices in dentistry by dental health care personnel (DHCP) in a German university dental clinic was observed during clinical work. In addition, a survey was conducted to assess the individual knowledge about infection control procedures. Contamination of the workplace during invasive dental procedures was tested, as well. Results: A total of 58 invasive dental treatments implying close contacts between HCWs and patients were scrutinized. All HCWs (100%) wore gloves during dental work, but in some cases (female dentists: 14.3%; dental assistants: 28.6%) gloves were neither changed nor hands were disinfected between different activities or patient contacts (female dentists: 68.6%; male dentists: 60.9%; dental assistants: 93%). Only 31.4% of female and 39.1% of male dentists carried out adequate hygienic hand disinfection after removing gloves. Male dentists wore significantly more often (100%) protective eyewear compared to 77.1% of female dentists (p<0.05). In addition, most of female dentists (62.9%) and dental assistants (80.7%) wore jewelry during dental procedures. Conclusion: Despite the knowledge of distinct hygiene procedures only a small percentage of dental staff performs hygiene practices according to recommended guidelines. Strict audit is clearly needed in the dental setting to ensure compliance with infection control guidelines to prevent transmission of pathogens. Our results provide insights for the development of a targeted education and training strategy to enhance compliance of dental staff especially of dental assistants with infection control

  9. Compliance with infection control practices in an university hospital dental clinic.

    PubMed

    Mutters, Nico T; Hägele, Ulrike; Hagenfeld, Daniel; Hellwig, Elmar; Frank, Uwe

    2014-01-01

    Compliance with infection control practices is the key to quality care and excellence in dentistry. Infection control remains one of the most cost-beneficial interventions available. However, implementing control procedures requires full compliance of the whole dental team. The aim of our study was to measure the compliance in daily clinical practice. The compliance with infection control practices in dentistry by dental health care personnel (DHCP) in a German university dental clinic was observed during clinical work. In addition, a survey was conducted to assess the individual knowledge about infection control procedures. Contamination of the workplace during invasive dental procedures was tested, as well. A total of 58 invasive dental treatments implying close contacts between HCWs and patients were scrutinized. All HCWs (100%) wore gloves during dental work, but in some cases (female dentists: 14.3%; dental assistants: 28.6%) gloves were neither changed nor hands were disinfected between different activities or patient contacts (female dentists: 68.6%; male dentists: 60.9%; dental assistants: 93%). Only 31.4% of female and 39.1% of male dentists carried out adequate hygienic hand disinfection after removing gloves. Male dentists wore significantly more often (100%) protective eyewear compared to 77.1% of female dentists (p<0.05). In addition, most of female dentists (62.9%) and dental assistants (80.7%) wore jewelry during dental procedures. Despite the knowledge of distinct hygiene procedures only a small percentage of dental staff performs hygiene practices according to recommended guidelines. Strict audit is clearly needed in the dental setting to ensure compliance with infection control guidelines to prevent transmission of pathogens. Our results provide insights for the development of a targeted education and training strategy to enhance compliance of dental staff especially of dental assistants with infection control procedures.

  10. [Randomized, controlled clinical trials with observational follow-up investigations for evaluating efficacy of antihyperglycaemic treatment. II. Features of and lessons from the follow-up investigations].

    PubMed

    Jermendy, György

    2018-04-01

    Although the outcomes of the follow-up investigation period of the randomized clinical studies for evaluating the efficacy of a treatment or an antidiabetic drug may be confounded or potentially biased by several factors, the results are widely accepted by the diabetes community. In line with the theory of metabolic memory or metabolic legacy, early and intensive antihyperglycaemic treatment should be provided for all diabetic patients as this strategy can result in beneficial effects even in the long run. The recent cardiovascular safety trials with new, innovative antidiabetic drugs differ in several aspects from the former efficacy studies. Ten cardiovascular safety trials were completed so far enabling to define their unique and common features. It can be anticipated that the era of randomized, controlled efficacy studies with observational follow-up investigations came to an end in diabetes research. Nowadays, cardiovascular safety trials are in the focus of clinical research in diabetology and results of several ongoing studies are expected with interest in the near future. Orv Hetil. 2018; 159(16): 615-619.

  11. Applying Statistical Process Control to Clinical Data: An Illustration.

    ERIC Educational Resources Information Center

    Pfadt, Al; And Others

    1992-01-01

    Principles of statistical process control are applied to a clinical setting through the use of control charts to detect changes, as part of treatment planning and clinical decision-making processes. The logic of control chart analysis is derived from principles of statistical inference. Sample charts offer examples of evaluating baselines and…

  12. Observability and Controllability of Networks: Symmetry in Representations of Brains and Controllers for Epidemics

    NASA Astrophysics Data System (ADS)

    Schiff, Steven

    Observability and controllability are essential concepts to the design of predictive observer models and feedback controllers of networked systems. We present a numerical and group representational framework, to quantify the observability and controllability of nonlinear networks with explicit symmetries that shows the connection between symmetries and nonlinear measures of observability and controllability. In addition to the topology of brain networks, we have advanced our ability to represent network nodes within the brain using conservation principles and more accurate biophysics that unifies the dynamics of spikes, seizures, and spreading depression. Lastly, we show how symmetries in controller design can be applied to infectious disease epidemics. NIH Grants 1R01EB014641, 1DP1HD086071.

  13. Clinical and microbiological benefits of strict supragingival plaque control as part of the active phase of periodontal therapy.

    PubMed

    Feres, Magda; Gursky, Lauren Christine; Faveri, Marcelo; Tsuzuki, Claudia Ota; Figueiredo, Luciene Cristina

    2009-10-01

    To compare the clinical and microbiological effects of scaling and root planing (SRP) alone or combined with mechanical [professional plaque control (PPC)] or chemical [chlorhexidine rinsing (CHX)] control of supragingival plaque in the treatment of chronic periodontitis. Sixty subjects were randomly assigned to receive SRP alone or combined with PPC (twice a week) or with CHX rinsing (twice a day). The adjunctive treatments began with SRP and were continued for 42 days. Clinical and microbiological examinations were performed at baseline, 2 and 6 months post-therapy. Subgingival plaque samples were analysed for 38 bacterial species by checkerboard DNA-DNA hybridization. The two test treatments were more effective in improving probing depth and clinical attachment level (CAL) than SRP alone, even in intermediate and deep sites. CAL gain was better maintained in the CHX group. The most beneficial microbiological changes were observed in CHX-treated subjects, who showed a significant reduction in the proportions of red and orange complexes, as well as an increase in the proportions of the host-compatible bacterial species. Strict plaque control performed during and after SRP improves periodontal treatment outcomes. The greatest microbiological and clinical benefits were observed with the use of CHX rinsing.

  14. Family Physician Clinical Inertia in Glycemic Control among Patients with Type 2 Diabetes

    PubMed Central

    Lang, Valerija Bralić; Marković, Biserka Bergman; Kranjčević, Ksenija

    2015-01-01

    Background Many patients with diabetes do not achieve target values. One of the reasons for this is clinical inertia. The correct explanation of clinical inertia requires a conjunction of patient with physician and health care system factors. Our aim was to determine the rate of clinical inertia in treating diabetes in primary care and association of patient, physician, and health care setting factors with clinical inertia. Material/Methods This was a national, multicenter, observational, cross-sectional study in primary care in Croatia. Each family physician (FP) provided professional data and collected clinical data on 15–25 type 2 diabetes (T2DM) patients. Clinical inertia was defined as a consultation in which treatment change based on glycated hemoglobin (HbA1c) levels was indicated but did not occur. Results A total of 449 FPs (response rate 89.8%) collected data on 10275 patients. Mean clinical inertia per FP was 55.6% (SD ±26.17) of consultations. All of the FPs were clinically inert with some patients, and 9% of the FPs were clinically inert with all patients. The main factors associated with clinical inertia were: higher percentage of HbA1c, oral anti-diabetic drug initiated by diabetologist, increased postprandial glycemia and total cholesterol, physical inactivity of patient, and administration of drugs other than oral antidiabetics. Conclusions Clinical inertia in treating patients with T2DM is a serious problem. Patients with worse glycemic control and those whose therapy was initiated by a diabetologist experience more clinical inertia. More research on causes of clinical inertia in treating patients with T2DM should be conducted to help achieve more effective diabetes control. PMID:25652941

  15. Family physician clinical inertia in glycemic control among patients with type 2 diabetes.

    PubMed

    Bralić Lang, Valerija; Bergman Marković, Biserka; Kranjčević, Ksenija

    2015-02-05

    Many patients with diabetes do not achieve target values. One of the reasons for this is clinical inertia. The correct explanation of clinical inertia requires a conjunction of patient with physician and health care system factors. Our aim was to determine the rate of clinical inertia in treating diabetes in primary care and association of patient, physician, and health care setting factors with clinical inertia. This was a national, multicenter, observational, cross-sectional study in primary care in Croatia. Each family physician (FP) provided professional data and collected clinical data on 15-25 type 2 diabetes (T2DM) patients. Clinical inertia was defined as a consultation in which treatment change based on glycated hemoglobin (HbA1c) levels was indicated but did not occur. A total of 449 FPs (response rate 89.8%) collected data on 10275 patients. Mean clinical inertia per FP was 55.6% (SD ±26.17) of consultations. All of the FPs were clinically inert with some patients, and 9% of the FPs were clinically inert with all patients. The main factors associated with clinical inertia were: higher percentage of HbA1c, oral anti-diabetic drug initiated by diabetologist, increased postprandial glycemia and total cholesterol, physical inactivity of patient, and administration of drugs other than oral antidiabetics. Clinical inertia in treating patients with T2DM is a serious problem. Patients with worse glycemic control and those whose therapy was initiated by a diabetologist experience more clinical inertia. More research on causes of clinical inertia in treating patients with T2DM should be conducted to help achieve more effective diabetes control.

  16. [Clinical view of toxoplasmosis in children--personal observations].

    PubMed

    Czarnecka-Rudnik, D; Stanek-Bazylko, F

    1997-05-01

    In this work we presented our own experience with recognized and treated toxoplasmosis among children. Treated cases were observed over several years afterwards. We analyzed the frequency and character of clinical changes, evaluated the validity of serological screening and the effectiveness of treatment. The largest age group treated were children 13 months to 5 years old. 13 children had the congenital and 12 the acquired form. The most cases occurred in the nodal, ocular and ocular-cranial forms. Thus, the most common symptoms were enlarged lymphatic nodes, strabismus, febrile seizures, intracranial calcifications. In the acquired forms of the illness a distinct correlation between treatment and the decrease antibody levels, the clinical pictures showed stagnation. The fall in antibody levels occurred earlier with intermediate immunofluorescence than with ELISA method. Among 20 children associated 30-day treatment was implemented (Daraprim, Rovamycine, Biseptol), among 4 with Fansidar and Rovamycine for 2-3 weeks. Few complications occurred at the end of or after treatment and did not require treatment/intervention. Usually it was leukopenia and thrombocytopenia. Long time observation allows to state that both therapeutic models prevent renewal of illness and can be recommended for further use.

  17. Control design based on a linear state function observer

    NASA Technical Reports Server (NTRS)

    Su, Tzu-Jeng; Craig, Roy R., Jr.

    1992-01-01

    An approach to the design of low-order controllers for large scale systems is proposed. The method is derived from the theory of linear state function observers. First, the realization of a state feedback control law is interpreted as the observation of a linear function of the state vector. The linear state function to be reconstructed is the given control law. Then, based on the derivation for linear state function observers, the observer design is formulated as a parameter optimization problem. The optimization objective is to generate a matrix that is close to the given feedback gain matrix. Based on that matrix, the form of the observer and a new control law can be determined. A four-disk system and a lightly damped beam are presented as examples to demonstrate the applicability and efficacy of the proposed method.

  18. Clinical assessment of patients with recalcitrant psoriasis in a randomized, observer-blind, vehicle-controlled trial using indigo naturalis.

    PubMed

    Lin, Yin-Ku; Chang, Chee-Jen; Chang, Ya-Ching; Wong, Wen-Rou; Chang, Shu-Chen; Pang, Jong-Hwei Su

    2008-11-01

    To evaluate the efficacy and safety of treatment with indigo naturalis in patients with recalcitrant plaque-type psoriasis. Randomized, observer-blind, vehicle-controlled, intrapatient comparison study. Ambulatory department of a hospital. Forty-two outpatients with chronic plaque psoriasis were enrolled in the study from May 1, 2004, to April 30, 2005. The patients applied either indigo naturalis ointment or vehicle ointment topically to each of 2 bilaterally symmetrical psoriatic plaque lesions for 12 weeks (depending on the date of enrollment in the study). The outcomes were assessed using the following criteria: the sum of erythema, scaling, and induration scores and the clearing percentage of the target plaque lesion assessed by 2 blinded observers. Significant reductions in the sum of scaling, erythema, and induration scores (P < .001) (mean score, 6.3 after indigo naturalis treatment vs 12.8 in control subjects) and plaque area percentage (P < .001) (mean percentage, 38.5% after indigo naturalis treatment vs 90% in controls) were achieved with topical application of indigo naturalis ointment. Approximately 31 of 42 patients (74%) experienced clearance or near clearance of their psoriasis in the indigo ointment-treated lesion. Topical indigo naturalis ointment was a novel, safe, and effective therapy for plaque-type psoriasis.

  19. A Framework for Control and Observation in Distributed Environments

    NASA Technical Reports Server (NTRS)

    Smith, Warren

    2001-01-01

    As organizations begin to deploy large computational grids, it has become apparent that systems for observation and control of the resources, services, and applications that make up such grids are needed. Administrators must observe the operation of resources and services to ensure that they are operating correctly and they must control the resources and services to ensure that their operation meets the needs of users. Further, users need to observe the performance of their applications so that this performance can be improved and control how their applications execute in a dynamic grid environment. In this paper we describe our software framework for control and observation of resources, services, and applications that supports such uses and we provide examples of how our framework can be used.

  20. Clinical outcomes of immediate/early loading of dental implants. A literature review of recent controlled prospective clinical studies.

    PubMed

    Sennerby, L; Gottlow, J

    2008-06-01

    Two previous reviews have evaluated the clinical outcomes of immediate/early loading of dental implants based on studies published until 2005.(1,2) The aim of the present paper was to review controlled clinical studies on the subject published since 2005 including at least 10 patients in each group followed for at least one year in function. Six comparative studies were found and none of these showed any differences in survival rates or marginal bone loss after one to five years. Most authors used specified inclusion criteria to avoid known risk factors such as soft bone, short implants and bruxism. Data from one randomized study in the edentulous maxilla showed no differences between early and delayed loading in consecutive clinical routine cases including short implants and soft bone. Three additional studies comparing different surfaces or implant designs under immediate loading were reviewed. No differences between implants with a moderately rough or smooth surface topography were observed. The data add to the previous bulk of evidence that various designs of implants can be loaded shortly after their placement in both the mandible and the maxilla. However, one study reported on marginal bone loss around a novel one-piece implant design leading to implant failure which was not seen for control two-piece implants.(3).

  1. A clinical data repository enhances hospital infection control.

    PubMed Central

    Samore, M.; Lichtenberg, D.; Saubermann, L.; Kawachi, C.; Carmeli, Y.

    1997-01-01

    We describe the benefits of a relational database of hospital clinical data (Clinical Data Repository; CDR) for an infection control program. The CDR consists of > 40 Sybase tables, and is directly accessible for ad hoc queries by members of the infection control unit who have been granted privileges for access by the Information Systems Department. The data elements and functional requirements most useful for surveillance of nosocomial infections, antibiotic use, and resistant organisms are characterized. Specific applications of the CDR are presented, including the use of automated definitions of nosocomial infection, graphical monitoring of resistant organisms with quality control limits, and prospective detection of inappropriate antibiotic use. Hospital surveillance and quality improvement activities are significantly benefited by the availability of a querable set of tables containing diverse clinical data. PMID:9357588

  2. [Clinical observation of teacher tablets in treatment of pharyngitis].

    PubMed

    Qin, Dong-yun; Wu, Tie

    2008-07-01

    To evaluate the efficacy of teacher tablets in the treatment of pharyngitis. One hundred and thirty six patients with acute pharyngitis or chronic pharyngitis in attack were randamly divided into two groups: treated group (n=68), the patients were given teacher tablets for 7 days, control group (n=68), the patients were given Qinlian capsule for 7 days. Before and after the experimental medicine-taking test, general condition, clinical symptoms and features of examinations on laryngo-pharynx, throat swab bacterial culture were measured. After 7 day medicine-taking experiment, teacher tablets can improve clinical symptoms (at an efficacy rate of more than 60%) and features (at an efficacy rate of more than 80%) of laryngopharynx, in treated group, the inhibition ratios of alpha streptococcus, neisseria and staphylococcus aureus are more than 50%. There are no significant difference between treated group and control groups in those detected index. Teacher tablets is effective for pharyagitis.

  3. ChronQC: a quality control monitoring system for clinical next generation sequencing.

    PubMed

    Tawari, Nilesh R; Seow, Justine Jia Wen; Perumal, Dharuman; Ow, Jack L; Ang, Shimin; Devasia, Arun George; Ng, Pauline C

    2018-05-15

    ChronQC is a quality control (QC) tracking system for clinical implementation of next-generation sequencing (NGS). ChronQC generates time series plots for various QC metrics to allow comparison of current runs to historical runs. ChronQC has multiple features for tracking QC data including Westgard rules for clinical validity, laboratory-defined thresholds and historical observations within a specified time period. Users can record their notes and corrective actions directly onto the plots for long-term recordkeeping. ChronQC facilitates regular monitoring of clinical NGS to enable adherence to high quality clinical standards. ChronQC is freely available on GitHub (https://github.com/nilesh-tawari/ChronQC), Docker (https://hub.docker.com/r/nileshtawari/chronqc/) and the Python Package Index. ChronQC is implemented in Python and runs on all common operating systems (Windows, Linux and Mac OS X). tawari.nilesh@gmail.com or pauline.c.ng@gmail.com. Supplementary data are available at Bioinformatics online.

  4. Observation of clinical teaching: interest in a faculty development program for surgeons.

    PubMed

    Peyre, Sarah E; Frankl, Susan E; Thorndike, Mary; Breen, Elizabeth M

    2011-01-01

    Observation of clinical teaching is a powerful tool to develop faculty teaching skills. However, the process of being observed can be intimidating for any educator. Our aim is to assess interest in an Observation of Teaching Program within an academic surgical department. An electronic survey asking faculty to indicate interest in participation in a faculty development program that consists of a peer, expert, and/or cross-disciplinary physician observation of teaching was used. Faculty members were also asked whether they would like to observe other faculty as part of a peer-review track. The results were compiled for descriptive statistical analysis. Electronic survey. In all, 46 faculty, all of whom have assigned medical student and resident teaching responsibilities, were introduced to the Observation of Teaching Program and surveyed on their interest in participating. A total of 87% (40/46) of faculty responded after 2 e-mails and 75% (30/40) indicated interest in the Observation of Teaching Program. All faculty who responded positively indicated interest in expert review (30/30), 90% (27/30) in peer review, 87% (26/30) in surgeon review, and 83% (25/30) in cross-disciplinary physician review. A total of 48% (19/40) indicated interest in observing others. Of those who were not interested in the Observation of Teaching Program, restrictions on time (4/10), not enough clinical care responsibilities (2/10), not wanting to be watched (2/10), and program did not seem effective (1/10) were cited as reasons for not participating. Surgical faculty are interested in being observed and receiving feedback about their clinical teaching by experts, peers, colleagues, and cross-disciplinary physicians. Professional development programs for surgeons should consider observation as a teaching methodology. Copyright © 2011 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

  5. Through Clinical Observation: The History of Priapism After Spinal Cord Injuries.

    PubMed

    Turliuc, Mihaela Dana; Turliuc, Serban; Cucu, Andrei Ionut; Tamas, Camelia; Carauleanu, Alexandru; Buzduga, Catalin; Sava, Anca; Dumitrescu, Gabriela Florenta; Costea, Claudia Florida

    2018-01-01

    Since ancient times, physicians of antiquity noted the occurrence of priapism in some spinal cord injuries. Although priests saw it as a consequence of curses and witchcraft, after clinical observations of the Middle Ages and Renaissance, the first medical hypotheses emerged in the 17th-19th centuries completed and argued by neuroscience and neurology developed in the European laboratories and hospitals. This study aims to present a short overview of the history of clinical observations of posttraumatic male priapism after spinal cord injuries since antiquity until the beginning of the 20th century. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

  6. Implementation of a clinical quality control program in a mammography screening service of Brazil.

    PubMed

    DE Souza Sabino, Silvia Maria Prioli; Silva, Thiago Buosi; Watanabe, Anapaula Hidemi Uema; Syrjänen, Kari; Carvalho, André Lopes; Mauad, Edmundo Carvalho

    2014-09-01

    To evaluate the effect of a clinical quality control program on the final quality of a mammography screening service. We conducted retrospective assessment of the clinical quality of 5,000 mammograms taken in a Mammography Screening Program between November 2010 and September 2011, following the implementation of a Clinical Quality Control Program based on the European Guidelines. Among the 105,000 evaluated quality items, there were 8,588 failures (8.2%) - 1.7 failures per examination. Altogether, 89% of the failures were associated with positioning. The recall rate due to a technical error reached a maximum of 0.5% in the early phase of the observation period and subsequently stabilized (0.09%). The ongoing education and monitoring combined with personalized training increased the critical thinking of the involved professionals, reducing the technical failures and unnecessary exposure of patients to radiation, with substantial improvement in the final quality of mammography. Copyright© 2014 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

  7. Conveying Clinical Reasoning Based on Visual Observation via Eye-Movement Modelling Examples

    ERIC Educational Resources Information Center

    Jarodzka, Halszka; Balslev, Thomas; Holmqvist, Kenneth; Nystrom, Marcus; Scheiter, Katharina; Gerjets, Peter; Eika, Berit

    2012-01-01

    Complex perceptual tasks, like clinical reasoning based on visual observations of patients, require not only conceptual knowledge about diagnostic classes but also the skills to visually search for symptoms and interpret these observations. However, medical education so far has focused very little on how visual observation skills can be…

  8. [Two years clinical observation of a kind of castable ceramic--IPS Empress].

    PubMed

    Liu, Y; Li, Y; Nie, Y

    1999-03-01

    We used this material in clinic since 1995. Discussion on the prosthetic effects of the above-mentioned material to spreat it clinically. Through half to two years clinical observations to evaluate the effect of IPS Empress crowns in anterior teeth and inlays in posteriors. and Prosthesis made of this kind of material IPS Empress is one kind of excellent all-ceramic prosthetic material. IPS Empress also could be used in post crowns and the clinical effect was satisfactory.

  9. Observing Behavior and Atypically Restricted Stimulus Control

    ERIC Educational Resources Information Center

    Dube, William V.; Dickson, Chata A.; Balsamo, Lyn M.; O'Donnell, Kristin Lombard; Tomanari, Gerson Y.; Farren, Kevin M.; Wheeler, Emily E.; McIlvane, William J.

    2010-01-01

    Restricted stimulus control refers to discrimination learning with atypical limitations in the range of controlling stimuli or stimulus features. In the study reported here, 4 normally capable individuals and 10 individuals with intellectual disabilities (ID) performed two-sample delayed matching to sample. Sample-stimulus observing was recorded…

  10. A double-blind randomized placebo-controlled clinical trial of squalamine ointment for tinea capitis treatment.

    PubMed

    Coulibaly, Oumar; Thera, Mahamadou A; Koné, Abdoulaye K; Siaka, Goïta; Traoré, Pierre; Djimdé, Abdoulaye A; Brunel, Jean-Michel; Gaudart, Jean; Piarroux, Renaud; Doumbo, Ogobara K; Ranque, Stéphane

    2015-04-01

    Novel treatments against for tinea capitis are needed, and the natural aminosterol squalamine is a potential topical antidermatophyte drug candidate. This phase II randomized double-blind placebo-controlled clinical trial aimed at testing the efficacy and safety of a three-week squalamine ointment regimen for the treatment of tinea capitis. Males aged 6-15 years presenting with tinea capitis were treated with either topical squalamine ointment or placebo for 3 weeks. The primary endpoint was complete clinical cure. The secondary endpoints were the occurrence of local and/or systemic adverse events, mycological cure, and partial clinical response. Prospective follow-up of clinical adverse events was performed daily. Five patients were treated with 1% squalamine ointment and 15 with placebo. No complete cure was observed. No clinical or biological adverse event was recorded. A significantly (p = 0.03) better hair-growth score, indicating a partial clinical improvement of the tinea capitis lesion, was observed in the patients treated with squalamine compared to those treated with placebo. This three-week squalamine ointment regimen was well tolerated and showed an encouraging partial clinical activity for the treatment of tinea capitis. Further studies are needed to evaluate the efficacy of topical squalamine alone against tinea corporis or in combination with a systemic antidermatophyte drug against tinea capitis.

  11. Control of muscle relaxation during anesthesia: a novel approach for clinical routine.

    PubMed

    Stadler, Konrad S; Schumacher, Peter M; Hirter, Sibylle; Leibundgut, Daniel; Bouillon, Thomas W; Glattfelder, Adolf H; Zbinden, Alex M

    2006-03-01

    During general anesthesia drugs are administered to provide hypnosis, ensure analgesia, and skeletal muscle relaxation. In this paper, the main components of a newly developed controller for skeletal muscle relaxation are described. Muscle relaxation is controlled by administration of neuromuscular blocking agents. The degree of relaxation is assessed by supramaximal train-of-four stimulation of the ulnar nerve and measuring the electromyogram response of the adductor pollicis muscle. For closed-loop control purposes, a physiologically based pharmacokinetic and pharmacodynamic model of the neuromuscular blocking agent mivacurium is derived. The model is used to design an observer-based state feedback controller. Contrary to similar automatic systems described in the literature this controller makes use of two different measures obtained in the train-of-four measurement to maintain the desired level of relaxation. The controller is validated in a clinical study comparing the performance of the controller to the performance of the anesthesiologist. As presented, the controller was able to maintain a preselected degree of muscle relaxation with excellent precision while minimizing drug administration. The controller performed at least equally well as the anesthesiologist.

  12. Controllability and observability of Boolean networks arising from biology

    NASA Astrophysics Data System (ADS)

    Li, Rui; Yang, Meng; Chu, Tianguang

    2015-02-01

    Boolean networks are currently receiving considerable attention as a computational scheme for system level analysis and modeling of biological systems. Studying control-related problems in Boolean networks may reveal new insights into the intrinsic control in complex biological systems and enable us to develop strategies for manipulating biological systems using exogenous inputs. This paper considers controllability and observability of Boolean biological networks. We propose a new approach, which draws from the rich theory of symbolic computation, to solve the problems. Consequently, simple necessary and sufficient conditions for reachability, controllability, and observability are obtained, and algorithmic tests for controllability and observability which are based on the Gröbner basis method are presented. As practical applications, we apply the proposed approach to several different biological systems, namely, the mammalian cell-cycle network, the T-cell activation network, the large granular lymphocyte survival signaling network, and the Drosophila segment polarity network, gaining novel insights into the control and/or monitoring of the specific biological systems.

  13. [Clinical observation on nanometer acupoint mounting method for alleviation of myospasm complicated by spinal injury].

    PubMed

    Zhang, Su-Jie; Si, Tong; Li, Zhi

    2008-11-01

    To observe clinical effect of nanometer acupoint mounting method for alleviation of myospasm complicated by spinal injury. Sixty cases were randomly divided into an observation group and a control group, 30 cases in each group. The observation group were treated by nanometer mounting at 4 Jiaji (EX-B 2) points each on both sides of the affected spine and Shenshu (BL 23), Shangliao (BL 31), Ciliao (BL 32), Yang-lingquan (GB 34), Xuanzhong (GB 39); and the control group by mounting zinc oxide sticking tablets at the above acupoints. The mounting was replaced once each two days, 7 times constituting one course. One week and one month after the end of 3 courses, their results were recorded, respectively. Before treatment, there was no significant difference between the two groups in grades of the myospasm degree (P > 0.05). One week after the end of treatment, 15 cases were grade I of myospasm, 9 cases were grade II, 5 cases were grade III and 1 case was grade IV in the observation group, and 1 cases grade I, 7 cases grade II, 14 cases grade III, 8 cases grade IV in the control group. Ridit analysis on the data indicated that there were significant differences before and after treatment in the myospasm degree (P < 0.01) and between the two groups after treatment (P < 0.01). One month after the end of treatment, the results were similar to those one week after the end of treatment. Nanometer acupoint mounting method is a new one for alleviation of myospasm complicated by spinal injury, with convenience, safety and no side effect.

  14. Analysis of clinical observation on acute psychiatric wards.

    PubMed

    Najim, Hellme; Saleem, Khalid; Al Shirbiny, Basil; Ezeasor, Nebo

    2013-09-01

    Clinical observation is very important to manage risk of people who are acutely ill on psychiatric wards. It is always an area of dispute between different specialities and disciplines in serious untoward incidents (SUI). Three levels of observations have been applied on acute psychiatric words. Assessing practice is important to help to identify any area needs improving. A questionnaire was developed by HN to collect demographics. Medical notes on Westley and Grangewater wards were reviewed. Excel Microsoft Office World Computer Programme was used to analyse the results. 57% were men. 62% were above 41 years of age. Majority were suffering from schizophrenia and schizoaffective disorders 61%. 64.28% were admitted as formal patients. 31.42% were on level I observation.62.53 were informal. 54.76% were risk to themselves, 28.57% risk to others. 82.3% were on level II observation, 31.42% formal and 68.50% informal. 21.32% were on level III observation. 66.66% were formal and 66.66% had an incident before this level. This study have shown that patients are assessed properly before they go on any level of care. Some patients need to go on level III as they pose a risk mainly to other people. Regular reviews of patients, especially on high level of observation should be done more promptly, as being on observation is not a comfortable experience to go through and applying the least restrictive practice should always be sought and adopted.

  15. Clinical efficacy of a bleaching enzyme-based toothpaste. A double-blind controlled clinical trial.

    PubMed

    Llena, Carmen; Oteo, Carlos; Oteo, Jesús; Amengual, José; Forner, Leopoldo

    2016-01-01

    To assess the efficacy of a bleaching enzyme-based toothpaste. A randomized clinical trial was carried out, comprising 48 participants with teeth exhibiting color A3 or higher according to the Vita Classical guide. One-half of the sample received the bleaching enzyme-based toothpaste (White Kin(®)), while the other received placebo toothpaste. Both products were supplied in identical containers and had the same composition except for the active components. The teeth color was measured with a spectrophotometer. The patients were instructed to brush their teeth three times a day during 3 min with the assigned product, during 12 weeks. The color measurements were repeated after 3, 6, 9 and 12 weeks of treatment. Color variation was based on the CIE L*a*b* coordinates, ΔE and the EW index. The relationship of these variables at different observation times were performed using a generalized estimating equations model, which evaluated the effect of treatment, time and interaction. The patients using the bleaching enzyme-based toothpaste showed an increase in lightness (80.14 -treatment- versus 79.25 -control group-) and a reduction in component b*. ΔE was found higher in the treatment group (p=0.064), close to statistical significance. The bleaching enzyme-based toothpaste could be potentially efficient in the modification in tooth color progressing from the third to ninth week of treatment, tending to stabilize after the ninth week. A very low carbamide peroxide concentration, with the incorporation of lactoperoxidase, tooth paste, tends to offer clinically satisfactory results, in terms of modifications in tooth color, nevertheless no significant differences were founded when compared to the control group, with an oral hygiene controlled along the study. Copyright © 2015 Elsevier Ltd. All rights reserved.

  16. Comparing Parent-Child Interactions in the Clinic and at Home: An Exploration of the Validity of Clinical Behavior Observations Using Sequential Analysis

    ERIC Educational Resources Information Center

    Shriver, Mark D.; Frerichs, Lynae J.; Williams, Melissa; Lancaster, Blake M.

    2013-01-01

    Direct observation is often considered the "gold standard" for assessing the function, frequency, and intensity of problem behavior. Currently, the literature investigating the construct validity of direct observation conducted in the clinic setting reveals conflicting results. Previous studies on the construct validity of clinic-based…

  17. Clinical impact of negative-pressure wound therapy: a 1,126-patient observational prospective study.

    PubMed

    Téot, Luc; Guillot-Masanovic, Margot; Miquel, Pierre; Truchetet, François; Meaume, Sylvie; Dompmartin, Anne; Charles Kerihuel, Jean; Trial, Chloé; Faure, Christine

    2014-01-01

    Negative-pressure wound therapy (NPWT) was developed in the early 1990s and reported in 1997 by Argenta and Morykwas. Ignored at first, this technique progressively came to be considered as an outstanding advancement in reconstructive surgery. Several randomized controlled studies produced evidence for the effect of NPWT on promotion of granulation tissue formation and prevention of tissue damage and amputation. However, no important longitudinal study has yet produced clinical and economic data on the consequences of integrating NPWT into practice in multiple institutions. This prospective, comparative longitudinal study of NPWT as a clinical-practice innovation was conducted in 1,126 patients between March 2006 and June 2009 in 30 university and nonuniversity public and private hospitals in France. NPWT was proposed in a nonrandomized fashion for various clinical indications, and the patients were divided into two groups, one using NPWT, the second using standard care. Efficacy criteria were spontaneous closure, closure after surgical coverage using skin grafts or flaps, or achievement of 40% wound area regression. The results, observed in a pragmatic but not randomized study, are suggestive of a favorable impact of NPWT in multiple clinical situations. The significance of differences between surgical patients who underwent NPWT and those who did not was unclear, as NPWT had already been adopted by most of the surgical wards. © 2014 by the Wound Healing Society.

  18. Chronic histiocytic intervillositis - Clinical, biochemical and radiological findings: An observational study.

    PubMed

    Koby, Lawrence; Keating, Sarah; Malinowski, Ann Kinga; D'Souza, Rohan

    2018-04-01

    Chronic histiocytic intervillositis (CHI) of the placenta although rare, has a high recurrence rate, is associated with serious adverse pregnancy outcomes and has no available treatment. This study aims to determine clinical, biochemical and radiological factors associated with CHI, to guide management of subsequent pregnancies. This retrospective observational study included consecutive cases with a histopathologic diagnosis of CHI after 18 weeks of gestation, between 2001 and 2014, and no controls. Clinical (maternal, fetal and delivery outcomes), biochemical (first- and second-trimester biomarkers for fetal aneuploidy and serum alkaline phosphatase) and radiological (second- and third-trimester fetal, placental and Doppler ultrasound) factors associated with a histopathological diagnosis of CHI were identified and results presented as percentages. Outcomes of subsequent pregnancies were described. Of 231 identified cases of 'intervillositis', 33 were confirmed to have CHI, of which only 4/33 (12.1%) had prior uncomplicated term deliveries. During pregnancy, 10/18 (55.5%) had abnormal first-trimester screening, 4/16 (25%) had abnormal second-trimester screening, 6/19 (31.6%) had at least one elevated alkaline phosphatase level, and 15/20 (75%) had at least one abnormal feature on mid-trimester placental ultrasound. In subsequent pregnancies that were closely followed with a combination of biochemical and radiologic tests, there were no cases of fetal loss, and lower incidence of fetal growth restriction and preterm birth. No clinical, biochemical or radiological finding is consistently associated with CHI and adverse outcomes thereof. Whether the incorporation of these tests in individualized care-plans could improve outcomes in subsequent pregnancies needs to be studied further. Copyright © 2018 Elsevier Ltd. All rights reserved.

  19. Attitudes toward placebo-controlled clinical trials among depressed patients in Japan.

    PubMed

    Sugawara, Norio; Ishioka, Masamichi; Tsuchimine, Shoko; Tsuruga, Koji; Sato, Yasushi; Tarakita, Natsumi; Furukori, Hanako; Kudo, Shuhei; Tomita, Tetsu; Nakagami, Taku; Yasui-Furukori, Norio

    2018-01-01

    Placebo-controlled clinical trials are the standard in the design of clinical studies for the licensing of new drugs. Medical and ethical concerns regarding placebo use still exist in clinical trials of depressed patients. The aim of this study was to investigate the attitudes toward placebo-controlled clinical trials and to assess factors related to the willingness to participate in such trials among depressed patients in Japan. A total of 206 depressed patients aged 49.5 ± 15.7 years (mean ± SD) who were admitted to three psychiatric hospitals were recruited for a cross-sectional study from June 2015 to March 2016. After a thorough explanation of the placebo, the study participants completed a brief 14-item questionnaire developed to evaluate patients' attitudes regarding possible participation in placebo-controlled clinical trials. The Quick Inventory of Depressive Symptomatology was also administered to assess depressive symptoms. The results indicated that 47% of the patients would be willing to participate in a placebo-controlled clinical trial. Expectations for the improvement of disease, desire to receive more medical care, encouragement by family or friends, and desire to support the development of new drugs were associated with the willingness to participate in such trials, whereas a belief that additional time would be required for medical examinations and fear of exacerbation of symptoms due to placebo use were associated with non-participation. Patients were asked about possible participation in placebo-controlled clinical trials. Less than half of the respondents were willing to participate in placebo-controlled clinical trials. Attitudes toward participation in a placebo-controlled clinical trial need to be considered when deciding whether to conduct such a trial. Copyright © 2017. Published by Elsevier B.V.

  20. Clinical governance and infection control in the United Kingdom.

    PubMed

    Masterson, R G; Teare, E L

    2001-01-01

    The recent organizational changes in the NHS have at their core the concept of clinical governance. Although initially poorly defined and understood this term has now taken on a clear identity, placing quality alongside fiscal probity and corporate governance at the top of NHS priorities. Integral to clinical governance are the basic elements of clear national standards for services and treatments that are to be locally delivered through assured, monitored, high quality healthcare. It is within this framework that workers in infection control must develop their own methods of applying clinical governance. This review explores the implications that the strategy of clinical governance holds for the speciality of infection control, emphasizing the benefits its active adoption can bring and highlighting the key relevance of clinical risk management in this setting. It illustrates clinical governance as a tool to engage colleagues on a multi-disciplinary front, most particularly the crucial link to senior Trust management.

  1. Clinical decision making in dermatology: observation of consultations and the patients' perspectives.

    PubMed

    Hajjaj, F M; Salek, M S; Basra, M K A; Finlay, A Y

    2010-01-01

    Clinical decision making is a complex process and might be influenced by a wide range of clinical and non-clinical factors. Little is known about this process in dermatology. The aim of this study was to explore the different types of management decisions made in dermatology and to identify factors influencing those decisions from observation of consultations and interviews with the patients. 61 patient consultations were observed by a physician with experience in dermatology. The patients were interviewed immediately after each consultation. Consultations and interviews were audio recorded, transcribed and their content analysed using thematic content analysis. The most common management decisions made during the consultations included: follow-up, carrying out laboratory investigation, starting new topical treatment, renewal of systemic treatment, renewal of topical treatment, discharging patients and starting new systemic treatment. Common influences on those decisions included: clinical factors such as ineffectiveness of previous therapy, adherence to prescribing guidelines, side-effects of medications, previous experience with the treatment, deterioration or improvement in the skin condition, and chronicity of skin condition. Non-clinical factors included: patient's quality of life, patient's friends or relatives, patient's time commitment, travel or transportation difficulties, treatment-related costs, availability of consultant, and availability of treatment. The study has shown that patients are aware that management decisions in dermatology are influenced by a wide range of clinical and non-clinical factors. Education programmes should be developed to improve the quality of decision making. Copyright © 2010 S. Karger AG, Basel.

  2. Observing the work of the Clinical Nurse Specialist: a pilot study.

    PubMed

    Darmody, Julie V

    2005-01-01

    The Clinical Nurse Specialist (CNS) is an advanced practice nurse (APN) with graduate preparation as a clinical expert within a specialty area of nursing practice. There is a need for information about the work of the CNS in order to link CNS activities to outcomes and costs of care. To describe the work of the CNS in the acute care setting using the National Association of Clinical Nurse Specialists (NACNS) model as an organizing framework. Descriptive pilot study of the work of the CNS in acute care. A 500-bed academic medical center located in the Midwestern United States. Five masters-prepared APNs in a unit-based CNS role. Direct observation and time study were used to record activities and time for 4 hours with each CNS (n = 5) for a total of 20 hours of observation. CNS activity and time within each practice domain included patient/client (30%), nursing (44%), organization/system (10%), and other activities (16%). Specific activities observed were linked to possible outcomes in the NACNS framework. The NACNS model provided a useful framework for developing a data collection tool that can be used in a larger study that analyzes the work of the acute care CNS. Describing the work of the CNS is an important preliminary step to measuring outcomes and costs of care.

  3. Observer enhanced control for spin-stabilized tethered formation in earth orbit

    NASA Astrophysics Data System (ADS)

    Guang, Zhai; Yuyang, Li; Liang, Bin

    2018-04-01

    This paper addresses the issues relevant to control of spin-stabilized tethered formation in circular orbit. Due to the dynamic complexities and nonlinear perturbations, it is challenging to promote the control precision for the formation deployment and maintenance. In this work, the formation dynamics are derived with considering the spinning rate of the central body, then major attention is dedicated to develop the nonlinear disturbance observer. To achieve better control performance, the observer-enhanced controller is designed by incorporating the disturbance observer into the control loop, benefits from the disturbance compensation are demonstrated, and also, the dependences of the disturbance observer performance on some important parameters are theoretically and numerically analyzed.

  4. ADULTS: A RANDOMIZED CONTROLLED CLINICAL TRIAL

    PubMed Central

    Shah, Krupa N.; Majeed, Zahraa; Yoruk, Yilmaz B.; Yang, Hongmei; Hilton, Tiffany N.; McMahon, James M.; Hall, William J.; Walck, Donna; Luque, Amneris E.; Ryan, Richard M.

    2016-01-01

    Objective HIV-infected older adults (HOA) are at risk of functional decline. Interventions promoting physical activity that can attenuate functional decline and are easily translated into the HOA community are of high priority. We conducted a randomized, controlled clinical trial to evaluate whether a physical activity counseling intervention based on self-determination theory (SDT) improves physical function, autonomous motivation, depression and the quality of life (QOL) in HOA. Methods A total of 67 community-dwelling HOA with mild-to-moderate functional limitations were randomized to one of two groups: a physical activity counseling group or the usual care control group. We used SDT to guide the development of the experimental intervention. Outcome measures that were collected at baseline and final study visits included a battery of physical function tests, levels of physical activity, autonomous motivation, depression, and QOL. Results The study participants were similar in their demographic and clinical characteristics in both the treatment and control groups. Overall physical performance, gait speed, measures of endurance and strength, and levels of physical activity improved in the treatment group compared to the control group (p<0.05). Measures of autonomous regulation such as identified regulation, and measures of depression and QOL improved significantly in the treatment group compared to the control group (p<0.05). Across the groups, improvement in intrinsic regulation and QOL correlated with an improvement in physical function (p<0.05). Conclusion Our findings suggest that a physical activity counseling program grounded in SDT can improve physical function, autonomous motivation, depression, and QOL in HOA with functional limitations. PMID:26867045

  5. Voluntarily controlled but not merely observed visual feedback affects postural sway

    PubMed Central

    Asai, Tomohisa; Hiromitsu, Kentaro; Imamizu, Hiroshi

    2018-01-01

    Online stabilization of human standing posture utilizes multisensory afferences (e.g., vision). Whereas visual feedback of spontaneous postural sway can stabilize postural control especially when observers concentrate on their body and intend to minimize postural sway, the effect of intentional control of visual feedback on postural sway itself remains unclear. This study assessed quiet standing posture in healthy adults voluntarily controlling or merely observing visual feedback. The visual feedback (moving square) had either low or high gain and was either horizontally flipped or not. Participants in the voluntary-control group were instructed to minimize their postural sway while voluntarily controlling visual feedback, whereas those in the observation group were instructed to minimize their postural sway while merely observing visual feedback. As a result, magnified and flipped visual feedback increased postural sway only in the voluntary-control group. Furthermore, regardless of the instructions and feedback manipulations, the experienced sense of control over visual feedback positively correlated with the magnitude of postural sway. We suggest that voluntarily controlled, but not merely observed, visual feedback is incorporated into the feedback control system for posture and begins to affect postural sway. PMID:29682421

  6. Sexual orientations of women with polycystic ovary syndrome: clinical observation in Taiwan.

    PubMed

    Chen, Ching-Hui; Wang, Peng-Hui; Hsieh, Meng-Ti; Tzeng, Chii-Ruey; Wu, Yi-Hsuan; Lee, Chin-San; Chu, Yuan-Hsiang; Chang, Heng-Yu

    2014-12-01

    This study was conducted to explore the association between sexual orientations and polycystic ovary syndrome (PCOS)-related parameters. A cross-sectional study with participants recruited from the regular outpatient clinic at the Department of Obstetrics and Gynecology at Taipei Medical University Hospital, Taipei, Taiwan between July 2012 and December 2013 was carried out. A total of 97 women met the criterion of having been diagnosed with PCOS. Among these 97 women, 89 were heterosexuals and eight were self-identified as lesbians. At the same time, 78 women without PCOS were enrolled to serve as the control group. Participants were given a standard questionnaire and had blood withdrawn for biochemical analysis of androgen parameters--including total testosterone, androstenedione, sex hormone binding globulin, free androgen index, 17β-estradiol (E2), luteinizing hormone, and follicular-stimulating hormone. The biochemical data were measured to compare the PCOS clinical parameters present in people of different sexual orientations (lesbians and heterosexuals). The women with PCOS, regardless of sexual orientation, had higher percentages and serum levels of hyperandrogenism-related clinical parameters than the women without PCOS [acne (87.5% and 60.7% vs. 23.1%), p < 0.001]; hirsutism (62.5% and 57.3% vs. 15.4%, p ≤ 0.001)]; and biochemical parameters (total T, p < 0.05 or p < 0.001, and luteinizing hormone/follicular-stimulating hormone ratio, p ≤ 0.001]. The sexual orientation of women with PCOS affected their body mass index (BMI), because lesbians with PCOS possessed higher BMI than heterosexual women with PCOS (26.5 ± 1.9 vs. 22.5 ± 0.55; p < 0.05). However, hyperandrogenism-related clinical and biochemical parameters were not significantly different statistically between women with PCOS but of different sexual orientations. Our preliminary data showed that sexual orientation influenced the BMI of women with PCOS, but did not affect hyperandrogenism

  7. Identifying Opportunities for Peer Learning: An Observational Study of Medical Students on Clinical Placements.

    PubMed

    Tai, Joanna H; Canny, Benedict J; Haines, Terry P; Molloy, Elizabeth K

    2017-01-01

    Phenomenon: Peer assisted learning (PAL) is frequently employed and researched in preclinical medical education. Fewer studies have examined PAL in the clinical context: These have focused mainly on the accuracy of peer assessment and potential benefits to learner communication and teamwork skills. Research has also examined the positive and negative effects of formal, structured PAL activities in the clinical setting. Given the prevalence of PAL activities during preclinical years, and the unstructured nature of clinical placements, it is likely that nonformal PAL activities are also undertaken. How PAL happens formally and informally and why students find PAL useful in this clinical setting remain poorly understood. This study aimed to describe PAL activities within the context of clinical placement learning and to explore students' perceptions of these activities. An ethnographic study was conducted to gather empirical data on engagement in clinical placement learning activities, including observations and interviews with students in their 1st clinical year, along with their supervising clinicians. Thematic analysis was used to interrogate the data. On average, students used PAL for 5.19 hours per week in a range of activities, of a total of 29.29 hours undertaking placements. PAL was recognized as a means of vicarious learning and had greater perceived value when an educator was present to guide or moderate the learning. Trust between students was seen as a requirement for PAL to be effective. Students found passive observation a barrier to PAL and were able to identify ways to adopt an active stance when observing peers interacting with patients. For example, learners reported that the expectation that they had to provide feedback to peers after task observation, resulted in them taking on a more critical gaze where they were encouraged to consider notions of good practice. Insights: Students use PAL in formal (i.e., tutorial) and nonformal (e.g., peer

  8. Evaluation of inter-observer agreement when using a clinical respiratory scoring system in pre-weaned dairy calves.

    PubMed

    Buczinski, S; Faure, C; Jolivet, S; Abdallah, A

    2016-07-01

    To determine inter-observer agreement for a clinical scoring system for the detection of bovine respiratory disease complex in calves, and the impact of classification of calves as sick or healthy based on different cut-off values. Two third-year veterinary students (Observer 1 and 2) and one post-graduate student (Observer 3) received 4 hours of training on scoring dairy calves for signs of respiratory disease, including rectal temperature, cough, eye and nasal discharge, and ear position. Observers 1 and 2 scored 40 pre-weaning dairy calves 24 hours apart (80 observations) over three visits to a calf-rearing facility, and Observers 1, 2 and 3 scored 20 calves on one visit. Inter-observer agreement was assessed using percentage of agreement (PA) and Kappa statistics for individual clinical signs, comparing Observers 1 and 2. Agreement between the three observers for total clinical score was assessed using cut-off values of ≥4, ≥5 and ≥6 to indicate unhealthy calves. Inter-observer PA for rectal temperature was 0.68, for cough 0.78, for nasal discharge 0.62, for eye discharge 0.63, and for ear position 0.85. Kappa values for all clinical signs indicated slight to fair agreement (<0.4), except temperature that had moderate agreement (0.6). The Fleiss' Kappa for total score, using cut-offs of ≥4, ≥5 and ≥6 to indicate unhealthy calves, was 0.35, 0.06 and 0.13, respectively, indicating slight to fair agreement. There was important inter-observer discrepancies in scoring clinical signs of respiratory disease, using relatively inexperienced observers. These disagreements may ultimately mean increased false negative or false positive diagnoses and incorrect treatment of cases. Visual assessment of clinical signs associated with bovine respiratory disease needs to be thoroughly validated when disease monitoring is based on the use of a clinical scoring system.

  9. Controlled clinical evaluations of chlorine dioxide, chlorite and chlorate in man.

    PubMed Central

    Lubbers, J R; Chauan, S; Bianchine, J R

    1982-01-01

    To assess the relative safety of chronically administered chlorine water disinfectants in man, a controlled study was undertaken. The clinical evaluation was conducted in the three phases common to investigational drug studies. Phase I, a rising dose tolerance investigation, examined the acute effects of progressively increasing single doses of chlorine disinfectants to normal healthy adult male volunteers. Phase II considered the impact on normal subjects of daily ingestion of the disinfectants at a concentration of 5 mg/l. for twelve consecutive weeks. Persons with a low level of glucose-6-phosphate dehydrogenase may be expected to be especially susceptible to oxidative stress; therefore, in Phase III, chlorite at a concentration of 5 mg/l. was administered daily for twelve consecutive weeks to a small group of potentially at-risk glucose-6-phosphate dehydrogenase-deficient subjects. Physiological impact was assessed by evaluation of a battery of qualitative and quantitative tests. The three phases of this controlled double-blind clinical evaluation of chlorine dioxide and its potential metabolites in human male volunteer subjects were completed uneventfully. There were no obvious undesirable clinical sequellae noted by any of the participating subjects or by the observing medical team. In several cases, statistically significant trends in certain biochemical or physiological parameters were associated with treatment; however, none of these trends was judged to have physiological consequence. One cannot rule out the possibility that, over a longer treatment period, these trends might indeed achieve proportions of clinical importance. However, by the absence of detrimental physiological responses within the limits of the study, the relative safety of oral ingestion of chlorine dioxide and its metabolites, chlorite and chlorate, was demonstrated. PMID:6961033

  10. [Critical role of clinical laboratories in hospital infection control].

    PubMed

    Yagi, Tetsuya

    2010-11-01

    The hospital infection control and prevention is recognized to be more and more important according to the advances in modern medical treatment and care. Clinical microbiology laboratory play critical roles in the hospital infection control as a member of infection control team (ICT). They are the first in a hospital to identify outbreak of MRSA in NICU and molecular epidemiological analysis of the isolates lead proper intervention of ICT to the concerned ward. From a viewpoint of infectious disease specialist, rapid and precise microbiological information is essential for the appropriate diagnosis and treatment of infectious diseases. Each medical technologist need to make efforts to understand the characteristics of the examinations for infectious diseases and send out information useful for clinical practices. In our hospital, with the participation of all members of medical technologists, rapid reporting system was developed for blood culture examinations, which greatly contribute to the appropriate treatment of bloodstream infections. Collaborations of clinical microbiology laboratory with other members of ICT realize high quality hospital infection control. They also need to be aware of themselves as good practitioners of infection control measures to prevent hospital infections.

  11. Difficult-to-control hypertension: identification of clinical predictors and use of ICT-based integrated care to facilitate blood pressure control.

    PubMed

    Visco, Valeria; Finelli, Rosa; Pascale, Antonietta Valeria; Mazzeo, Pietro; Ragosa, Nicola; Trimarco, Valentina; Illario, Maddalena; Ciccarelli, Michele; Iaccarino, Guido

    2018-05-01

    Difficult-to-control (DTC) hypertension represents a burden in real life that can be partially solved through identification of the characteristics of clinical patterns and tailoring antihypertensive strategies, including ICT-enabled integrated care (ICT-IC). In the quest for clinical predictors of DTC hypertension, we screened 482 hypertensive patients who were consecutively referred to the departmental hypertension clinic. Following a data quality check, patients were divided into controlled (C, 49.37%) and uncontrolled (UC, 50.63%) groups based on their systolic blood pressure (BP) at follow-up. We then performed statistical analysis on the demographic, clinical, laboratory, and ultrasound data and observed that older age, female sex, higher BP levels, and a family history of hypertension were predictors of DTC hypertension. We then developed a pilot service of ICT-IC, including weekly home visits by nurses and patient education on self-monitoring of BP, heart rate, body weight, and oxygen saturation using 3G-connected devices. Self-monitored data were transmitted to the hospital servers on the electronic chart of the patient for remote assessment by the hospital hypertension specialists. A total of 20 UC patients (M/F = 10/10; age: 72.04 ± 2.17 years) were enrolled to verify the efficacy of BP control without changes in medical treatment. After 1 month of the ICT-IC program, BP was reduced both at the office assessment (systolic BP (SBP): 162.40 ± 2.23 mm Hg, beginning of the program vs. 138.20 ± 4.26 mm Hg at 1 month, p < 0.01) and at home (SBP: 149.83 ± 3.44, beginning of the program vs. 134.16 ± 1.67 mm Hg at 1 month, p < 0.01). We concluded that DTC hypertension can be predicted based on the clinical characteristics at the first visit. For these patients, ICT-IC is a feasible therapeutic strategy to achieve BP control.

  12. Case-controlled clinical and histopathological study of conjunctivochalasis.

    PubMed

    Francis, I C; Chan, D G; Kim, P; Wilcsek, G; Filipic, M; Yong, J; Coroneo, M T

    2005-03-01

    Conjunctivochalasis, a secondary cause of the watery eye, is frequently seen in the older age group as an elevation of the bulbar conjunctiva lying along the lateral or central lower lid margin. A prospective, interventional, case-controlled clinical and histopathological study was conducted. The relevant features of 18 patients (29 eyes) who had their conjunctivochalasis resected as part of the surgical management of their watery eye syndrome were examined. In the control group, tissue was obtained from an age matched series of 24 normal subjects undergoing routine cataract surgery. 24 controls (24 specimens) and 18 patients (29 specimens) had conjunctival strip biopsies, taken from the usual lid margin level bulbar conjunctiva in line with the inferior limbus (controls), and the clinically apparent conjunctivochalasis (patients). These were submitted for histological study. 23 of 24 control sections demonstrated normal conjunctival variation. Four of 29 patient specimens demonstrated a chronic non-granulomatous conjunctivitis, while three eyes of the patient group (two patients) demonstrated features of elastosis. Of the four patients who had the inflammatory infiltrates, three had functional nasolacrimal duct obstructions (FNLDOs) and one had a primary acquired nasolacrimal duct obstruction (PANDO). Of the two patients who had elastosis, one had an FNLDO and the other had normal lacrimal drainage and was Jones 1 positive. Six of 18 patients--that is, seven of 29 specimens of conjunctivochalasis demonstrated signs of elastosis or of chronic non-granulomatous inflammation. Clinically, patients had a spectrum of aetiologies of their watery eye syndrome.

  13. Utilizing visual art to enhance the clinical observation skills of medical students.

    PubMed

    Jasani, Sona K; Saks, Norma S

    2013-07-01

    Clinical observation is fundamental in practicing medicine, but these skills are rarely taught. Currently no evidence-based exercises/courses exist for medical student training in observation skills. The goal was to develop and teach a visual arts-based exercise for medical students, and to evaluate its usefulness in enhancing observation skills in clinical diagnosis. A pre- and posttest and evaluation survey were developed for a three-hour exercise presented to medical students just before starting clerkships. Students were provided with questions to guide discussion of both representational and non-representational works of art. Quantitative analysis revealed that the mean number of observations between pre- and posttests was not significantly different (n=70: 8.63 vs. 9.13, p=0.22). Qualitative analysis of written responses identified four themes: (1) use of subjective terminology, (2) scope of interpretations, (3) speculative thinking, and (4) use of visual analogies. Evaluative comments indicated that students felt the exercise enhanced both mindfulness and skills. Using visual art images with guided questions can train medical students in observation skills. This exercise can be replicated without specially trained personnel or art museum partnerships.

  14. Observed use of standard precautions in Chilean community clinics.

    PubMed

    Ferrer, Lilian Marcela; Cianelli, Rosina; Norr, Kathleen F; Cabieses, Baltica; Araya, Alejandra; Irarrázabal, Lisette; Bernales, Margarita

    2009-01-01

    In Chile, little information about the use of standard precautions (SP) among health care workers (HCWs) exists. As part of a larger study to tailor and test an HIV prevention intervention for community HCWs, this study describes the observed frequency with which appropriate SP were used by HCWs in low-income community clinics of Santiago. Also, the availability of supplies is described. A total of 52 structured observations with potential contamination with body fluids were done. HCWs used SP inconsistently, especially neglecting hand washing, surface cleaning, and cleaning of shared materials. Lack of materials contributed in some instances of failure to use SPs, especially wiping surfaces and safe disposal of sharp instruments, as shown by a positive correlation between use of SP and availability of materials. Essential materials were usually available. Although more education should relate to a better understanding of the importance of SP, no difference was found between professionals and paraprofessionals in the use of SP. It is clear that the initial training, continuing education, and ongoing support for practicing SP are not adequate. Training should be offered to HCWs involved in caring for clients at community clinics to stop the spread of HIV or other infectious diseases in health care settings.

  15. Observing Mode Attitude Controller for the Lunar Reconnaissance Orbiter

    NASA Technical Reports Server (NTRS)

    Calhourn, Philip C.; Garrick, Joseph C.

    2007-01-01

    The Lunar Reconnaissance Orbiter (LRO) mission is the first of a series of lunar robotic spacecraft scheduled for launch in Fall 2008. LRO will spend at least one year in a low altitude polar orbit around the Moon, collecting lunar environment science and mapping data to enable future human exploration. The LRO employs a 3-axis stabilized attitude control system (ACS) whose primary control mode, the "Observing mode", provides Lunar Nadir, off-Nadir, and Inertial fine pointing for the science data collection and instrument calibration. The controller combines the capability of fine pointing with that of on-demand large angle full-sky attitude reorientation into a single ACS mode, providing simplicity of spacecraft operation as well as maximum flexibility for science data collection. A conventional suite of ACS components is employed in this mode to meet the pointing and control objectives. This paper describes the design and analysis of the primary LRO fine pointing and attitude re-orientation controller function, known as the "Observing mode" of the ACS subsystem. The control design utilizes quaternion feedback, augmented with a unique algorithm that ensures accurate Nadir tracking during large angle yaw maneuvers in the presence of high system momentum and/or maneuver rates. Results of system stability analysis and Monte Carlo simulations demonstrate that the observing mode controller can meet fine pointing and maneuver performance requirements.

  16. Effectiveness of cold therapy in reducing pain, trismus, and oedema after impacted mandibular third molar surgery: a randomized, self-controlled, observer-blind, split-mouth clinical trial.

    PubMed

    Zandi, M; Amini, P; Keshavarz, A

    2016-01-01

    Cold therapy is a conventional and widely used modality for reducing pain, trismus, and oedema after dentoalveolar surgeries. However, information reported in the literature on its effectiveness is insufficient and controversial. This study was performed to evaluate the effect of local cold application in reducing pain, trismus, and swelling after impacted mandibular third molar surgery. Thirty patients (seven males and 23 females) with bilateral symmetrical mandibular impacted third molars were enrolled in this randomized, self-controlled, observer-blind clinical trial. The patients were aged between 18 and 30 years. After surgical removal of the tooth on one side (intervention), ice pack therapy was given for 24h after surgery; for the other side (control), no cold therapy was given. The time interval between the two surgeries was at least 4 weeks. The amount of pain, trismus, and facial swelling was measured on days 2 and 7 postoperative, and patient satisfaction with the cold therapy vs. no cold therapy was assessed. The amount of pain, trismus, and facial swelling, and the extent of patient satisfaction were not significantly different between the intervention and control sides. Cold therapy had no beneficial effects on postoperative sequelae after impacted mandibular third molar surgery. Copyright © 2015 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  17. Nonlinear Semigroup for Controlled Partially Observed Diffusions.

    DTIC Science & Technology

    1980-08-21

    REPOTDT Air Force Office of Scientific Research /A-’/7/ Bolling Air Force Base T] DUMER OF PAGES 6 DITRSUIO STATEMENT CLASf thif Report)ort Approved for...block number) In this papaer a "separated"t control problem associated with controlled, LLJ partially observed diffusion processes is considered. The...of Applied Mathematics Brown University Providence, Rhode Island 02912 August 21, 1980 +This research was supported in part by the Air Force Office of

  18. Periodontitis in pregnancy: clinical and serum antibody observations from a baboon model of ligature-induced disease.

    PubMed

    Cappelli, D; Steffen, M J; Holt, S C; Ebersole, J L

    2009-07-01

    Chronic oral infections that elicit host responses leading to periodontal disease are linked with various sequelae of systemic diseases. This report provides seminal information on the clinical and adaptive immunologic characteristics of a baboon model of ligature-induced periodontitis during pregnancy. Female Papio anubis were evaluated for periodontal health at baseline. Ligatures were tied around selected teeth to initiate oral inflammation and periodontitis. Then the animals were bred. At midpregnancy ( approximately 90 days), a clinical evaluation was performed, and additional ligatures were tied on teeth in the contralateral quadrants to maintain progressing periodontitis throughout pregnancy. A final clinical evaluation was done for all experimental teeth after delivery, and ligatures were removed. Serum was collected at all sampling intervals for the determination of antibody levels to a group of 20 oral bacteria. Unligated animals served as controls. At baseline, 16% of animals exhibited minimal plaque and gingival inflammation without periodontal disease. The remaining baboons demonstrated varying levels of inflammation/bleeding, and approximately 20% of the population had periodontal pocketing (>3 mm). Ligated animals expressed increased levels of inflammation and increased probing depths and clinical attachment loss (AL) and could be stratified into multiple subsets postligation based upon changes in clinical parameters at midpregnancy and at delivery. Baboons were categorized into disease susceptibility groups (periodontal disease susceptibility 1 through 4) that described the extent/severity of induced disease during pregnancy. Control animals showed minimal periodontal changes during gestation. Significant differences in serum antibody to multiple oral bacteria were found in animals presenting with periodontitis at baseline and during the 6 months of ligature-induced disease. A significant correlation to antibody to P. gingivalis, which was sustained

  19. Clinical observations with AN-1792 using TAPIR analyses.

    PubMed

    Hock, Christoph; Nitsch, Roger M

    2005-01-01

    Clinical observations with AN-1792 using tissue amyloid plaque immunoreactivity (TAPIR) analyses established for the first time evidence in humans that antibodies against beta-amyloid-related epitopes are capable of slowing progression in Alzheimer's disease. Antibodies derived upon TAPIR assay selection may specifically target the pathologic neoepitopes of aggregated A beta species present in amyloid plaques and some of their aggregated, protofibrillar and low molecular weight oligomeric precursors. We briefly summarize here how the proof of concept was established and why it provides the basis for a potential cure for Alzheimer's disease. Copyright 2005 S. Karger AG, Basel.

  20. Clinical translation of controlled protein delivery systems for tissue engineering.

    PubMed

    Spiller, Kara L; Vunjak-Novakovic, Gordana

    2015-04-01

    Strategies that utilize controlled release of drugs and proteins for tissue engineering have enormous potential to regenerate damaged organs and tissues. The multiple advantages of controlled release strategies merit overcoming the significant challenges to translation, including high costs and long, difficult regulatory pathways. This review highlights the potential of controlled release of proteins for tissue engineering and regenerative medicine. We specifically discuss treatment modalities that have reached preclinical and clinical trials, with emphasis on controlled release systems for bone tissue engineering, the most advanced application with several products already in clinic. Possible strategies to address translational and regulatory concerns are also discussed.

  1. Randomized and controlled clinical study of modified prescriptions of Simiao Pill in the treatment of acute gouty arthritis.

    PubMed

    Shi, Xin-de; Li, Guo-chun; Qian, Zu-xi; Jin, Ze-qiu; Song, Yan

    2008-03-01

    To investigate the compatibility of a modified prescription of Simiao Pill in the treatment of acute gouty arthritis and to verify the clinical efficacy and safety of the drug through a clinical trial. A randomized and controlled clinical trial was designed based on clinical epidemiological principles. A total of 107 patients with acute gouty arthritis were enrolled and randomly assigned to four groups. The first group (Group I) included 27 patients taking gout prescription I; the second group (Group II) included 27 patients taking gout prescription II; the third group (Group III) included 28 patients taking gout prescription III; and the fourth group (control group) included 25 patients taking indomethacin and Benzobromarone as a control group. The duration of the treatment in all 4 groups was two weeks. After the treatment, the index of blood uric acid, blood leukocyte count, score of clinical symptoms, etc. were observed and measured. The total clinical effective rate of the three different modified prescriptions of the Simiao Pill was above 96%, significantly superior to that of the control group (68%, P<0.05). In terms of the improvement of main symptoms, the scores of four symptoms in all TCM treatment and control groups decreased after treatment, with statistically significant differences (P<0.05). Moreover, the scores markedly fell more so in the three Chinese herb groups than in the control group, and especially in Group III (P<0.05). There was a statistically significant difference in blood uric acid values before and after the treatment in the same group but no significant inter-group difference was seen. The modified prescriptions, based on the clinical research, clinical experience and traditional Chinese medicine theory, did show a better effect than Western medicine in this clinical study. Moreover, the prescriptions were precise, with the herbs inexpensive and readily available. The patients had good compliance with less adverse reactions noted. The

  2. Clinical observation of submandibular gland transfer for the prevention of xerostomia after radiotherapy for nasopharyngeal carcinoma: a prospective randomized controlled study of 32 cases

    PubMed Central

    2014-01-01

    Background The aim of this study was to evaluate the clinical efficacy of submandibular gland transfer for the prevention of xerostomia after radiotherapy for nasopharyngeal carcinoma. Methods Using the randomized controlled clinical research method, 65 patients with nasopharyngeal carcinoma were randomly divided into an experimental group consisting of 32 patients and a control group consisting of 33 patients. The submandibular glands were averted to the submental region in 32 patients with nasopharyngeal carcinoma before they received conventional radiotherapy; a lead block was used to shield the submental region during therapy. Prior to radiotherapy, the function of the submandibular glands was assessed using imaging. Submandibular gland function was measured using 99mTc radionuclide scanning at 60 months after radiotherapy. The data in the questionnaire regarding the degree of xerostomia were investigated and saliva secretion was measured at 3, 6, 12, and 60 months after radiotherapy. In addition, the 5-year survival rate was calculated. Results After follow-up for 3, 6, and 12 months, the incidence of moderate to severe xerostomia was significantly lower in the experimental group than in the control group. The average amount of saliva produced by the experimental and control groups was 1.60 g and 0.68 g, respectively (P < 0.001). After follow-up for 60 months, the uptake and secretion functions of the submandibular glands in the experimental group were found to be significantly higher than in the control group (P < 0.001 and P < 0.001, respectively). The incidence of moderate or severe xerostomia was significantly lower than in the control group (15.4% and 76.9%, respectively; P < 0.001). The 5-year survival rates of the experimental group and the control group were 81.3% and 78.8%, respectively, and there was no significant difference between the two groups (P = 0.806). Conclusions After a 5 year follow-up period involving 32

  3. Clinical observation of submandibular gland transfer for the prevention of xerostomia after radiotherapy for nasopharyngeal carcinoma: a prospective randomized controlled study of 32 cases.

    PubMed

    Zhang, Xiangmin; Liu, Folin; Lan, Xiaolin; Yu, Lijiang; Wu, Wei; Wu, Xiuhong; Xiao, Fufu; Li, Shaojin

    2014-02-21

    The aim of this study was to evaluate the clinical efficacy of submandibular gland transfer for the prevention of xerostomia after radiotherapy for nasopharyngeal carcinoma. Using the randomized controlled clinical research method, 65 patients with nasopharyngeal carcinoma were randomly divided into an experimental group consisting of 32 patients and a control group consisting of 33 patients. The submandibular glands were averted to the submental region in 32 patients with nasopharyngeal carcinoma before they received conventional radiotherapy; a lead block was used to shield the submental region during therapy. Prior to radiotherapy, the function of the submandibular glands was assessed using imaging. Submandibular gland function was measured using 99mTc radionuclide scanning at 60 months after radiotherapy. The data in the questionnaire regarding the degree of xerostomia were investigated and saliva secretion was measured at 3, 6, 12, and 60 months after radiotherapy. In addition, the 5-year survival rate was calculated. After follow-up for 3, 6, and 12 months, the incidence of moderate to severe xerostomia was significantly lower in the experimental group than in the control group. The average amount of saliva produced by the experimental and control groups was 1.60 g and 0.68 g, respectively (P<0.001). After follow-up for 60 months, the uptake and secretion functions of the submandibular glands in the experimental group were found to be significantly higher than in the control group (P<0.001 and P<0.001, respectively). The incidence of moderate or severe xerostomia was significantly lower than in the control group (15.4% and 76.9%, respectively; P<0.001). The 5-year survival rates of the experimental group and the control group were 81.3% and 78.8%, respectively, and there was no significant difference between the two groups (P=0.806). After a 5 year follow-up period involving 32 patients who had their submandibular glands transferred for the prevention of

  4. Observing control and data reduction at the UKIRT

    NASA Astrophysics Data System (ADS)

    Bridger, Alan; Economou, Frossie; Wright, Gillian S.; Currie, Malcolm J.

    1998-07-01

    For the past seven years observing with the major instruments at the United Kingdom IR Telescope (UKIRT) has been semi-automated, using ASCII files top configure the instruments and then sequence a series of exposures and telescope movements to acquire the data. For one instrument automatic data reduction completes the cycle. The emergence of recent software technologies has suggested an evolution of this successful system to provide a friendlier and more powerful interface to observing at UKIRT. The Observatory Reduction and Acquisition Control (ORAC) project is now underway to construct this system. A key aim of ORAC is to allow a more complete description of the observing program, including the target sources and the recipe that will be used to provide on-line data reduction. Remote observation preparation and submission will also be supported. In parallel the observatory control system will be upgraded to use these descriptions for more automatic observing, while retaining the 'classical' interactive observing mode. The final component of the project is an improved automatic data reduction system, allowing on-line reduction of data at the telescope while retaining the flexibility to cope with changing observing techniques and instruments. The user will also automatically be provided with the scripts used for the real-time reduction to help provide post-observing data reduction support. The overall project goal is to improve the scientific productivity of the telescope, but it should also reduce the overall ongoing support requirements, and has the eventual goal of supporting the use of queue- scheduled observing.

  5. Impact of locus of control on clinical outcomes in renal dialysis.

    PubMed

    Dec, Elaine

    2006-01-01

    This study focused on the relationship between patients' locus of control and their ability to improve selected clinical outcomes related to kidney dialysis. The main hypothesis of this study stated that patients who viewed themselves as having control over their situation would be more successful at improving targeted clinical outcomes than those who believed someone other than themselves had control over their situation. The study found that interventions aimed at increasing awareness of who has control and reducing the aspect of chance had a more significant positive impact on outcomes than did pure cognitive or educational interventions geared mainly toward emotional issues or educational deficits. Interventions that work with the dominant locus of control to increase awareness of where control lies appeared to be more effective in assisting the patients to improve their targeted clinical outcomes rather than are interventions to change the locus of control between internal and powerful others (external).

  6. Design of control-group conditions in clinical trials of behavioral interventions.

    PubMed

    Lindquist, Ruth; Wyman, Jean F; Talley, Kristine M C; Findorff, Mary J; Gross, Cynthia R

    2007-01-01

    To review considerations in the design of placebo (attention) control conditions for community-based clinical trials of health behavior change interventions and to provide practical strategies for the design of control conditions. A well-designed control condition is an essential component of a clinical trial to foster the unambiguous interpretation of study findings. Pitfalls in the design of control conditions in clinical trials of behavioral interventions are identified and strategies to address them are offered. Types of control conditions that have been used in fall prevention trials are described, along with their strengths and weaknesses. The control condition used in the recent fall evaluation and prevention program (FEPP) was designed to overcome limitations of previous trial designs; it is provided to illustrate how to apply specific design principles. Pitfalls in the design of behavioral intervention studies may be avoided with the application of sound design principles. The FEPP active control condition can be used as a model in the design of future studies.

  7. The efficacy of three-dimensional Schroth exercises in adolescent idiopathic scoliosis: a randomised controlled clinical trial.

    PubMed

    Kuru, Tuğba; Yeldan, İpek; Dereli, E Elçin; Özdinçler, Arzu R; Dikici, Fatih; Çolak, İlker

    2016-02-01

    To compare the efficacy of three-dimensional (3D) Schroth exercises in patients with adolescent idiopathic scoliosis. A randomised-controlled study. An outpatient exercise-unit and in a home setting. Fifty-one patients with adolescent idiopathic scoliosis. Forty-five patients with adolescent idiopathic scoliosis meeting the inclusion criteria were divided into three groups. Schroth's 3D exercises were applied to the first group in the clinic and were given as a home program for the second group; the third group was the control. Scoliosis angle (Cobb method), angle of rotation (scoliometer), waist asymmetry (waist - elbow distance), maximum hump height of the patients and quality of life (QoL) (SRS-23) were assessed pre-treatment and, at the 6(th), 12(th) and 24(th) weeks. The Cobb (-2.53°; P=0.003) and rotation angles (-4.23°; P=0.000) significantly decreased, which indicated an improvement in the clinic exercise group compared to the other groups. The gibbosity (-68.66mm; P=0.000) and waist asymmetry improved only in the clinic exercise group, whereas the results of the other groups worsened. QoL did not change significantly in either group. According to the results of this study the Schroth exercise program applied in the clinic under physiotherapist supervision was superior to the home exercise and control groups; additionally, we observed that scoliosis progressed in the control group, which received no treatment. © The Author(s) 2015.

  8. Epidemiological, clinical and allergological observations on pompholyx.

    PubMed

    Lodi, A; Betti, R; Chiarelli, G; Urbani, C E; Crosti, C

    1992-01-01

    We have studied a group of 104 patients with pompholyx, to investigate the relationship between allergological factors and its etiopathogenesis. The following examinations were performed: blood sampling (routine tests and IgE levels), allergological tests (patch, prick, intradermal, and oral provovation tests with nickel sulphate), skin biopsy to exclude pemphigus vulgaris or bullous pemphigoid. An accurate history of familial and personal allergic diathesis was enquired for and various possible aggravating factors (season, microclimate, perspiration and emotional stress) were considered. The results were age and sex-matched with a healthy control group (208 subjects). We found familial and personal atopic diathesis in 50% of patients versus 11.5% of controls (p less than 0.001); 39 patients (37.49%) also had high levels of IgE. Nickel sulphate was the allergen with the highest positivity on patch testing: 20.19% versus 6.25% of the control group (p less than 0.001). The % of patients allergic to nickel reached 26%, including those (6 patients) reacting to the oral provocation test. Season (43 patients) and hyperhidrosis (38) were the aggravating factors most commonly claimed. We detected no correlation between age, sex, grading of pompholyx and the allergological parameters investigated. Though several different allergological findings have previously been reported in dyshidrosis, their role in its pathogenesis has not yet been fully explained. We think that different haptens or antigens can produce the same clinical and histological picture of pompholyx in predisposed subjects.

  9. Observing how RNs use clinical time in a nursing home: a pilot study.

    PubMed

    Dellefield, Mary Ellen; Harrington, Charlene; Kelly, Ann

    2012-01-01

    Registered nurses (RNs) working in nursing homes (NHs) are a scarce professional resource. Their responsibilities include direct (e.g., assessment, physical care, and medication administration) and indirect care (e.g., documentation, supervision, and other activities performed away from the resident to manage their care environment). The purpose of the study was to describe the direct and indirect care distribution of RNs working day shift in an NH. All RN care was observed, although RN care associated with pressure ulcer prevention as a clinical outcome was highlighted. Work sampling was conducted using a personal data assistant-based RN Observation Measure. RNs spent 59% of their time on indirect care. Little direct care could be linked with specific clinical categories relevant to pressure ulcer prevention. RNs are challenged to use RN clinical time more strategically. Copyright © 2012 Mosby, Inc. All rights reserved.

  10. Clinical translation of controlled protein delivery systems for tissue engineering

    PubMed Central

    Spiller, Kara L.; Vunjak-Novakovic, Gordana

    2013-01-01

    Strategies that utilize controlled release of drugs and proteins for tissue engineering have enormous potential to regenerate damaged organs and tissues. The multiple advantages of controlled release strategies merit overcoming the significant challenges to translation, including high costs and long, difficult regulatory pathways. This review highlights the potential of controlled release of proteins for tissue engineering and regenerative medicine. We specifically discuss treatment modalities that have reached preclinical and clinical trials, with emphasis on controlled release systems for bone tissue engineering, the most advanced application with several products already in clinic. Possible strategies to address translational and regulatory concerns are also discussed. PMID:25787736

  11. Observational studies are complementary to randomized controlled trials.

    PubMed

    Grootendorst, Diana C; Jager, Kitty J; Zoccali, Carmine; Dekker, Friedo W

    2010-01-01

    Randomized controlled trials (RCTs) are considered the gold standard study design to investigate the effect of health interventions, including treatment. However, in some situations, it may be unnecessary, inappropriate, impossible, or inadequate to perform an RCT. In these special situations, well-designed observational studies, including cohort and case-control studies, may provide an alternative to doing nothing in order to obtain estimates of treatment effect. It should be noted that such studies should be performed with caution and correctly. The aims of this review are (1) to explain why RCTs are considered the optimal study design to evaluate treatment effects, (2) to describe the situations in which an RCT is not possible and observational studies are an adequate alternative, and (3) to explain when randomization is not needed and can be approximated in observational studies. Examples from the nephrology literature are used for illustration. Copyright 2009 S. Karger AG, Basel.

  12. Clinical performance of a new blood control peripheral intravenous catheter: A prospective, randomized, controlled study.

    PubMed

    Seiberlich, Laura E; Keay, Vanessa; Kallos, Stephane; Junghans, Tiffany; Lang, Eddy; McRae, Andrew D

    2016-03-01

    The performance of a new safety peripheral intravenous catheter (PIVC) that contains a blood control feature in the hub (blood control) was compared against the current hospital standard without blood control (standard). In this prospective, non-blinded trial, patients were randomized 1:1 to receive either device. Insertions were performed and rated by emergency room nurses. Primary endpoints included clinical acceptability, incidence of blood leakage, and risk of blood exposure. Secondary endpoints were digital compression, insertion success, and usability. 15 clinicians performed 152 PIVC insertions (73 blood control, 79 standard). Clinical acceptability of the blood control device (100%) was non-inferior to the standard (98.7%) (p < 0.0001). The blood control device had a lower incidence of blood leakage (14.1% vs 68.4%), was superior in eliminating the risk of blood exposure (93.9% vs 19.1%) and the need for digital compression (95.3% vs 19.1%), while maintaining non-inferior insertion success rates (95.9% vs 93.7%) and usability ratings (p < 0.0001). In comparison with the hospital-standard, the new safety PIVC with integrated blood control valve had similar clinical acceptability ratings yet demonstrated superior advantages to both clinicians and patients to decrease blood leakage and the clinician's risk of blood exposure, during the insertion process. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  13. Clinical Observed Performance Evaluation: A Prospective Study in Final Year Students of Surgery

    ERIC Educational Resources Information Center

    Markey, G. C.; Browne, K.; Hunter, K.; Hill, A. D.

    2011-01-01

    We report a prospective study of clinical observed performance evaluation (COPE) for 197 medical students in the pre-qualification year of clinical education. Psychometric quality was the main endpoint. Students were assessed in groups of 5 in 40-min patient encounters, with each student the focus of evaluation for 8 min. Each student had a series…

  14. [Nursing students' satisfaction and perception of their first clinical placement: observational study].

    PubMed

    Comparcini, Dania; Simonetti, Valentina; Tomietto, Marco; Galli, Francesco; Fiorani, Catia; Di Labio, Luisa; Cicolini, Giancarlo

    2014-01-01

    Clinical learning environments are defined as an interactive network of forces within the clinical context that influence students' learning outcomes. Nursing students' satisfaction could be strictly related to their learning outcomes. Aim. To analyze the first year nursing students' clinical learning experience and to identify the main determinants of students' satisfaction. The observational study was carried out in five Italian nursing degree courses. 420 students filled out the validated Italian version of the "Clinical Learning Environment and Supervision plus Nurse Teacher (CLES+T) scale" after the conclusion of their first clinical placement. The mean values of the main sub-dimensions of CLES+T varied from 4.02 (pedagogical atmosphere) to 3.30 (supervisory relationship). Students were mainly satisfied with their clinical placement, however the findings showed statistical significantly differences among the five nursing courses. The main determinants of the overall students' satisfaction are the nurse manager's leadership style and the integration between theoretical knowledge and everyday practice of nursing through the relationship among students, clinical tutors and nurse teacher. Our results may contribute to better understand nursing students' perception of their first clinical placement. However, further research are needed to evaluate which organizational factors and clinical training models may enhance the clinical learning experience.

  15. An Evaluation of a Clinical Pharmacy-Directed Intervention on Blood Pressure Control

    PubMed Central

    Kicklighter, Caroline E.; Nelson, Kent M.; Humphries, Tammy L.; Delate, Thomas

    Objective To compare short and long term blood pressure control with clinical pharmacy specialist involvement to traditional physician management. Setting A non-profit health maintenance organization in the United States covering approximately 385,000 lives. Methods This analysis utilized a prospective parallel design. Adult patients with a baseline Blood pressure>140/90 mmHg and receiving at least one antihypertensive medication were eligible for the study. Eligible hypertension management patients at one medical office were referred to the office’s clinical pharmacy specialist (intervention cohort) while at another comparable medical office they received usual physician-directed care (control cohort). The primary outcome measure was achievement of a goal BP (<140/90 mmHg) during a six month follow-up. Medical records were also reviewed approximately 1.5 years post enrollment to assess long-term BP control after clinical pharmacy-managed patients returned to usual care. Multivariate analyses were performed to adjust for baseline cohort differences. Results One hundred-thirteen and 111 subjects in the intervention and control cohorts completed the study, respectively. At the end of the follow-up period, clinical pharmacy-managed subjects were more likely to have achieved goal BP (64.6%) and received a thiazide diuretic (68.1%) compared to control subjects (40.7% and 33.3%, respectively) (adjusted p=0.002 and p<0.001, respectively). The proportion of clinical pharmacy-managed subjects with controlled BP decreased to 22.2% after returning to usual care (p<0.001). Conclusion Clinical pharmacy involvement in hypertension management resulted in increased BP control. Loss of long-term control after discontinuation of clinical pharmacy management supports a change in care processes that prevent patients from being lost to follow-up. PMID:25214896

  16. The impacts of observing flawed and flawless demonstrations on clinical skill learning.

    PubMed

    Domuracki, Kurt; Wong, Arthur; Olivieri, Lori; Grierson, Lawrence E M

    2015-02-01

    Clinical skills expertise can be advanced through accessible and cost-effective video-based observational practice activities. Previous findings suggest that the observation of performances of skills that include flaws can be beneficial to trainees. Observing the scope of variability within a skilled movement allows learners to develop strategies to manage the potential for and consequences associated with errors. This study tests this observational learning approach on the development of the skills of central line insertion (CLI). Medical trainees with no CLI experience (n = 39) were randomised to three observational practice groups: a group which viewed and assessed videos of an expert performing a CLI without any errors (F); a group which viewed and assessed videos that contained a mix of flawless and errorful performances (E), and a group which viewed the same videos as the E group but were also given information concerning the correctness of their assessments (FA). All participants interacted with their observational videos each day for 4 days. Following this period, participants returned to the laboratory and performed a simulation-based insertion, which was assessed using a standard checklist and a global rating scale for the skill. These ratings served as the dependent measures for analysis. The checklist analysis revealed no differences between observational learning groups (grand mean ± standard error: [20.3 ± 0.7]/25). However, the global rating analysis revealed a main effect of group (d.f.2,36 = 4.51, p = 0.018), which describes better CLI performance in the FA group, compared with the F and E groups. Observational practice that includes errors improves the global performance aspects of clinical skill learning as long as learners are given confirmation that what they are observing is errorful. These findings provide a refined perspective on the optimal organisation of skill education programmes that combine physical and observational practice

  17. 10. Credit BG. Interior of control and observation room at ...

    Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

    10. Credit BG. Interior of control and observation room at Control and Recording Center Building 4221/E-22. - Jet Propulsion Laboratory Edwards Facility, Control & Recording Center, Edwards Air Force Base, Boron, Kern County, CA

  18. A span of control tool for clinical managers.

    PubMed

    Morash, Robin; Brintnell, Janet; Rodger, Ginette Lemire

    2005-01-01

    During the second half of the 1990s, healthcare in Canada experienced significant downsizing and reform. One of the consequences of these reorganizations has been a reduction in the number of clinical managers and a significant increase in their span of control, to the point that often their abilities to fulfil their role as clinical managers are hindered (Altaffer 1998; Counsell et al. 2001; Pabst 1993). The first-line manager plays a critical role in the delivery of healthcare, in particular, within nursing services. Therefore, providing support for the professional practice of clinical managers should become a priority.

  19. Public availability of results of observational studies evaluating an intervention registered at ClinicalTrials.gov.

    PubMed

    Baudart, Marie; Ravaud, Philippe; Baron, Gabriel; Dechartres, Agnes; Haneef, Romana; Boutron, Isabelle

    2016-01-28

    Observational studies are essential for assessing safety. The aims of this study were to evaluate whether results of observational studies evaluating an intervention with safety outcome(s) registered at ClinicalTrials.gov were published and, if not, whether they were available through posting on ClinicalTrials.gov or the sponsor website. We identified a cohort of observational studies with safety outcome(s) registered on ClinicalTrials.gov after October 1, 2007, and completed between October 1, 2007, and December 31, 2011. We systematically searched PubMed for a publication, as well as ClinicalTrials.gov and the sponsor website for results. The main outcomes were the time to the first publication in journals and to the first public availability of the study results (i.e. published or posted on ClinicalTrials.gov or the sponsor website). For all studies with results publicly available, we evaluated the completeness of reporting (i.e. reported with the number of events per arm) of safety outcomes. We identified 489 studies; 334 (68%) were partially or completely funded by industry. Results for only 189 (39%, i.e. 65% of the total target number of participants) were published at least 30 months after the study completion. When searching other data sources, we obtained the results for 53% (n = 158; i.e. 93% of the total target number of participants) of unpublished studies; 31% (n = 94) were posted on ClinicalTrials.gov and 21% (n = 64) on the sponsor website. As compared with non-industry-funded studies, industry-funded study results were less likely to be published but not less likely to be publicly available. Of the 242 studies with a primary outcome recorded as a safety issue, all these outcomes were adequately reported in 86% (114/133) when available in a publication, 91% (62/68) when available on ClinicalTrials.gov, and 80% (33/41) when available on the sponsor website. Only 39% of observational studies evaluating an intervention with safety outcome

  20. Clinical importance of achieving biochemical control with medical therapy in adult patients with acromegaly

    PubMed Central

    Christofides, Elena A

    2016-01-01

    In acromegaly, achieving biochemical control (growth hormone [GH] level <1.0 ng/mL and age- and sex-normalized levels of insulin-like growth factor 1 [IGF-1]) through timely diagnosis and appropriate treatment provides an opportunity to improve patient outcomes. Diagnosis of acromegaly is challenging because it is rooted in observing subtle clinical manifestations, and it is typical for acromegaly to evolve for up to 10 years before it is recognized. This results in chronic exposure to elevated levels of GH and IGF-1 and delay in patients receiving appropriate treatment, which consequently increases mortality risk. In this review, the clinical impact of elevated GH and IGF-1 levels, the effectiveness of current therapies, and the potential role of novel treatments for acromegaly will be discussed. Clinical burden of acromegaly and benefits associated with management of GH and IGF-1 levels will be reviewed. Major treatment paradigms in acromegaly include surgery, medical therapy, and radiotherapy. With medical therapies, such as somatostatin analogs, dopamine agonists, and GH receptor antagonists, a substantial proportion of patients achieve reduced GH and normalized IGF-1 levels. In addition, signs and symptoms, quality of life, and comorbidities have also been reported to improve to varying degrees in patients who achieve biochemical control. Currently, there are several innovative therapies in development to improve patient outcomes, patient use, and access. Timely biochemical control of acromegaly ensures that the patient can ultimately improve morbidity and mortality from this disease and its extensive consequences. PMID:27471378

  1. Controlling heat and particle currents in nanodevices by quantum observation

    NASA Astrophysics Data System (ADS)

    Biele, Robert; Rodríguez-Rosario, César A.; Frauenheim, Thomas; Rubio, Angel

    2017-07-01

    We demonstrate that in a standard thermo-electric nanodevice the current and heat flows are not only dictated by the temperature and potential gradient, but also by the external action of a local quantum observer that controls the coherence of the device. Depending on how and where the observation takes place, the direction of heat and particle currents can be independently controlled. In fact, we show that the current and heat flow in a quantum material can go against the natural temperature and voltage gradients. Dynamical quantum observation offers new possibilities for the control of quantum transport far beyond classical thermal reservoirs. Through the concept of local projections, we illustrate how we can create and directionality control the injection of currents (electronic and heat) in nanodevices. This scheme provides novel strategies to construct quantum devices with application in thermoelectrics, spintronic injection, phononics, and sensing among others. In particular, highly efficient and selective spin injection might be achieved by local spin projection techniques.

  2. Management Control Systems and Clinical Experience of Managers in Public Hospitals

    PubMed Central

    Naranjo-Gil, David

    2018-01-01

    Healthcare authorities are encouraging managers in hospitals to acquire clinical experience and knowledge in order to better carry out and coordinate healthcare service delivery. The main objective of this paper is to analyse how the clinical experience of hospital managers is related to public health institutions’ performance. It is proposed that the effect of the clinical experience on operative and financial organizational performance is indirect through the mediating variables of perceived utility of management information and horizontal management control system. This paper analyses how these variables impact hospital performance through the data from a survey sent to 364 hospital managers in Brazil. The results show that managers’ clinical experience is related to higher perceived utility of historical, financial, short-term, and internal information, but not with horizontal control adoption in hospitals. Furthermore, our results show that, in hospitals, perceived utility of forecasted, non-financial, long-term, and external managerial information positively affects hospitals’ financial performance, while adoption of horizontal control management positively affects operational performance. Through showing evidence that clinical background could explain the differences not only in hospital service management but also in information capabilities and management control processes, this study offer meaningful implications for healthcare authorities and hospital managers involved in the development and implementation of strategies in the health sector. PMID:29673192

  3. Prospective clinical observational study evaluating gender-associated differences of preoperative pain intensity.

    PubMed

    Tafelski, Sascha; Kerper, Léonie F; Salz, Anna-Lena; Spies, Claudia; Reuter, Eva; Nachtigall, Irit; Schäfer, Michael; Krannich, Alexander; Krampe, Henning

    2016-07-01

    Previous studies reported conflicting results concerning different pain perceptions of men and women. Recent research found higher pain levels in men after major surgery, contrasted by women after minor procedures. This trial investigates differences in self-reported preoperative pain intensity between genders before surgery.Patients were enrolled in 2011 and 2012 presenting for preoperative evaluation at the anesthesiological assessment clinic at Charité University hospital. Out of 5102 patients completing a computer-assisted self-assessment, 3042 surgical patients with any preoperative pain were included into this prospective observational clinical study. Preoperative pain intensity (0-100 VAS, visual analog scale) was evaluated integrating psychological cofactors into analysis.Women reported higher preoperative pain intensity than men with median VAS scores of 30 (25th-75th percentiles: 10-52) versus 21 (10-46) (P < 0.001). Adjusted multiple regression analysis showed that female gender remained statistically significantly associated with higher pain intensity (P < 0.001). Gender differences were consistent across several subgroups especially with varying patterns in elderly. Women scheduled for minor and moderate surgical procedures showed largest differences in overall pain compared to men.This large clinical study observed significantly higher preoperative pain intensity in female surgical patients. This gender difference was larger in the elderly potentially contradicting the current hypothesis of a primary sex-hormone derived effect. The observed variability in specific patient subgroups may help to explain heterogeneous findings of previous studies.

  4. Predicting out-of-office blood pressure level using repeated measurements in the clinic: an observational cohort study

    PubMed Central

    Sheppard, James P.; Holder, Roger; Nichols, Linda; Bray, Emma; Hobbs, F.D. Richard; Mant, Jonathan; Little, Paul; Williams, Bryan; Greenfield, Sheila; McManus, Richard J.

    2014-01-01

    Objectives: Identification of people with lower (white-coat effect) or higher (masked effect) blood pressure at home compared to the clinic usually requires ambulatory or home monitoring. This study assessed whether changes in SBP with repeated measurement at a single clinic predict subsequent differences between clinic and home measurements. Methods: This study used an observational cohort design and included 220 individuals aged 35–84 years, receiving treatment for hypertension, but whose SBP was not controlled. The characteristics of change in SBP over six clinic readings were defined as the SBP drop, the slope and the quadratic coefficient using polynomial regression modelling. The predictive abilities of these characteristics for lower or higher home SBP readings were investigated with logistic regression and repeated operating characteristic analysis. Results: The single clinic SBP drop was predictive of the white-coat effect with a sensitivity of 90%, specificity of 50%, positive predictive value of 56% and negative predictive value of 88%. Predictive values for the masked effect and those of the slope and quadratic coefficient were slightly lower, but when the slope and quadratic variables were combined, the sensitivity, specificity, positive and negative predictive values for the masked effect were improved to 91, 48, 24 and 97%, respectively. Conclusion: Characteristics obtainable from multiple SBP measurements in a single clinic in patients with treated hypertension appear to reasonably predict those unlikely to have a large white-coat or masked effect, potentially allowing better targeting of out-of-office monitoring in routine clinical practice. PMID:25144295

  5. 11. Credit BG. Interior of control and observation room at ...

    Library of Congress Historic Buildings Survey, Historic Engineering Record, Historic Landscapes Survey

    11. Credit BG. Interior of control and observation room at Control and Recording Center, showing detail of switchboard and closed circuit television monitors. - Jet Propulsion Laboratory Edwards Facility, Control & Recording Center, Edwards Air Force Base, Boron, Kern County, CA

  6. Quality Control in Clinical Laboratory Samples

    DTIC Science & Technology

    2015-01-01

    is able to find and correct flaws in the analytical processes of a lab before potentially incorrect patient resu lts are released. According to...verifi es that the results produced are accurate and precise . Clinical labs use management of documentation as well as inco rporation of a continuous...improvement process to streamline the overall quality control process . QC samples are expected to be identical and tested identically to patient

  7. Stock Versus CAD/CAM Customized Zirconia Implant Abutments - Clinical and Patient-Based Outcomes in a Randomized Controlled Clinical Trial.

    PubMed

    Schepke, Ulf; Meijer, Henny J A; Kerdijk, Wouter; Raghoebar, Gerry M; Cune, Marco

    2017-02-01

    Single-tooth replacement often requires a prefabricated dental implant and a customized crown. The benefits of individualization of the abutment remain unclear. This randomized controlled clinical trial aims to study potential benefits of individualization of zirconia implant abutments with respect to preservation of marginal bone level and several clinical and patient-based outcome measures. Fifty participants with a missing premolar were included and randomly assigned to standard (ZirDesign, DentsplySirona Implants, Mölndal, Sweden) or computer aided design/computer aided manufacturing (CAD/CAM) customized (Atlantis, DentsplySirona Implants, Mölndal, Sweden) zirconia abutment therapy. Peri-implant bone level (primary outcome), Plaque-index, calculus formation, bleeding on probing, gingiva index, probing pocket depth, recession, appearance of soft tissues and patients' contentment were assessed shortly after placement and one year later. No implants were lost and no complications related to the abutments were observed. Statistically significant differences between stock and CAD/CAM customized zirconia abutments could not be demonstrated for any of the operationalized variables. The use of a CAD/CAM customized zirconia abutment in single tooth replacement of a premolar is not associated with an improvement in clinical performance or patients' contentment when compared to the use of a stock zirconia abutment. © 2016 The Authors. Clinical Implant Dentistry and Related Research Published by Wiley Periodicals, Inc.

  8. Ethical considerations in placebo-controlled randomised clinical trials.

    PubMed

    Kaufman, Kenneth R

    2015-06-01

    Ethical considerations in standard medical care and clinical research are underpinnings to quality medicine. Similarly, the placebo-controlled double-blind randomised clinical trial is the gold standard for medical research and fundamental to the development of evidence-based medicine. Researchers and clinicians are challenged by ethical concerns in the informed consent with a need to maximise understanding and minimise therapeutic misconception. This editorial expands on themes raised by Chen et al 's article 'Disclosing the Potential Impact of Placebo Controls in Antidepressant Trials' and serves as an invitation for further submissions to BJPsych Open on ethics, research design and informed consent. None. © The Royal College of Psychiatrists 2015. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) licence.

  9. Clinical and genetic features of diuretic-associated gout: a case-control study.

    PubMed

    Mitnala, Sirisha; Phipps-Green, Amanda; Franklin, Christopher; Horne, Anne; Stamp, Lisa K; Merriman, Tony R; Dalbeth, Nicola

    2016-07-01

    Hyperuricaemia and gout are well-recognized complications of diuretic use. The aim of this study was to examine the clinical and genetic features of diuretic-associated gout. Participants (n = 1365) fulfilling the 1977 ARA gout classification criteria, recruited from primary and secondary care, attended a study visit that included a detailed clinical assessment. Use of diuretic therapy was recorded during the study visit, and was confirmed by electronic dispensing data [n = 426 (31.2%) on diuretics]. Gout-associated single nucleotide polymorphisms were genotyped. Clinical and genetic features of diuretic-associated gout were analysed using a case-control study design (diuretics vs no diuretics). In the diuretic group there were more women, higher rates of comorbid conditions, higher BMI and lower estimated glomerular filtration rate compared with those not taking diuretics. Gout disease duration, frequency of gout flares and presence of tophi were similar in the two groups. Patients on diuretics had higher age of gout presentation and higher recorded serum urate. The ABCG2 rs2231142 risk allele was present less frequently in the diuretic group (36.1%) compared with those not on diuretics (47.6%, P = 1.2 × 10(-4)). The differences in ABCG2 were observed in both men and women with gout. Diuretic-associated gout represents a medically complex condition. Although age of gout onset is later and serum urate concentrations are higher in those on diuretics, other clinical features of gout are similar. The observed differences in the ABCG2 risk allele frequency suggest that some genetic factors play a less dominant role in diuretic-associated gout compared with primary gout. © The Author 2016. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  10. Randomized controlled trial of atorvastatin in clinically isolated syndrome

    PubMed Central

    Waubant, E.; Pelletier, D.; Mass, M.; Cohen, J.A.; Kita, M.; Cross, A.; Bar-Or, A.; Vollmer, T.; Racke, M.; Stüve, O.; Schwid, S.; Goodman, A.; Kachuck, N.; Preiningerova, J.; Weinstock-Guttman, B.; Calabresi, P.A.; Miller, A.; Mokhtarani, M.; Iklé, D.; Murphy, S.; Kopetskie, H.; Ding, L.; Rosenberg, E.; Spencer, C.; Zamvil, S.S.; Waubant, E.; Pelletier, D.; Mass, M.; Bourdette, D.; Egan, R.; Cohen, J.; Stone, L.; Kita, M.; Elliott, M.; Cross, A.; Parks, B.J.; Bar-Or, A.; Vollmer, T.; Campagnolo, D.; Racke, M.; Stüve, O.; Frohman, E.; Schwid, S.; Goodman, A.; Segal, B.; Kachuck, N.; Weiner, L.; Preiningerova, J.; Carrithers, M.; Weinstock-Guttman, B.; Calabresi, P.; Kerr, D.; Miller, A.; Lublin, F.; Sayre, Peter; Hayes, Deborah; Rosenberg, Ellen; Gao, Wendy; Ding, Linna; Adah, Steven; Mokhtarani, Masoud; Neuenburg, Jutta; Bromstead, Carolyn; Olinger, Lynn; Mullen, Blair; Jamison, Ross; Speth, Kelly; Saljooqi, Kerensa; Phan, Peter; Phippard, Deborah; Seyfert-Margolis, Vicki; Bourcier, Katarzyna; Debnam, Tracia; Romaine, Jennifer; Wolin, Stephanie; O'Dale, Brittany; Iklé, David; Murphy, Stacey; Kopetskie, Heather

    2012-01-01

    Objective: To test efficacy and safety of atorvastatin in subjects with clinically isolated syndrome (CIS). Methods: Subjects with CIS were enrolled in a phase II, double-blind, placebo-controlled, 14-center randomized trial testing 80 mg atorvastatin on clinical and brain MRI activity. Brain MRIs were performed quarterly. The primary endpoint (PEP) was development of ≥3 new T2 lesions, or one clinical relapse within 12 months. Subjects meeting the PEP were offered additional weekly interferon β-1a (IFNβ-1a). Results: Due to slow recruitment, enrollment was discontinued after 81 of 152 planned subjects with CIS were randomized and initiated study drug. Median (interquartile range) numbers of T2 and gadolinium-enhancing (Gd) lesions were 15.0 (22.0) and 0.0 (0.0) at baseline. A total of 53.1% of atorvastatin recipients (n = 26/49) met PEP compared to 56.3% of placebo recipients (n = 18/32) (p = 0.82). Eleven atorvastatin subjects (22.4%) and 7 placebo subjects (21.9%) met the PEP by clinical criteria. Proportion of subjects who did not develop new T2 lesions up to month 12 or to starting IFNβ-1a was 55.3% in the atorvastatin and 27.6% in the placebo group (p = 0.03). Likelihood of remaining free of new T2 lesions was significantly greater in the atorvastatin group compared with placebo (odds ratio [OR] = 4.34, p = 0.01). Likelihood of remaining free of Gd lesions tended to be higher in the atorvastatin group (OR = 2.72, p = 0.11). Overall, atorvastatin was well tolerated. No clear antagonistic effect of atorvastatin plus IFNβ-1a was observed on MRI measures. Conclusion: Atorvastatin treatment significantly decreased development of new brain MRI T2 lesion activity, although it did not achieve the composite clinical and imaging PEP. Classification of Evidence: This study provided Class II evidence that atorvastatin did not reduce the proportion of patients with CIS meeting imaging and clinical criteria for starting immunomodulating therapy after 12 months

  11. Shared Mycobacterium avium Genotypes Observed among Unlinked Clinical and Environmental Isolates

    PubMed Central

    Weigel, Kris M.; Yakrus, Mitchell A.; Becker, Annie L.; Chen, Hui-Ling; Fridley, Gina; Sikora, Arthur; Speake, Cate; Hilborn, Elizabeth D.; Pfaller, Stacy

    2013-01-01

    Our understanding of the sources of Mycobacterium avium infection is partially based on genotypic matching of pathogen isolates from cases and environmental sources. These approaches assume that genotypic identity is rare in isolates from unlinked cases or sources. To test this assumption, a high-resolution PCR-based genotyping approach, large-sequence polymorphism (LSP)-mycobacterial interspersed repetitive unit–variable-number tandem repeat (MIRU-VNTR), was selected and used to analyze clinical and environmental isolates of M. avium from geographically diverse sources. Among 127 clinical isolates from seven locations in North America, South America, and Europe, 42 genotypes were observed. Among 12 of these genotypes, matches were seen in isolates from apparently unlinked patients in two or more geographic locations. Six of the 12 were also observed in environmental isolates. A subset of these isolates was further analyzed by alternative strain genotyping methods, pulsed-field gel electrophoresis and MIRU-VNTR, which confirmed the existence of geographically dispersed strain genotypes. These results suggest that caution should be exercised in interpreting high-resolution genotypic matches as evidence for an acquisition event. PMID:23851084

  12. Automated characterization of perceptual quality of clinical chest radiographs: Validation and calibration to observer preference

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

    Samei, Ehsan, E-mail: samei@duke.edu; Lin, Yuan; Choudhury, Kingshuk R.

    Purpose: The authors previously proposed an image-based technique [Y. Lin et al. Med. Phys. 39, 7019–7031 (2012)] to assess the perceptual quality of clinical chest radiographs. In this study, an observer study was designed and conducted to validate the output of the program against rankings by expert radiologists and to establish the ranges of the output values that reflect the acceptable image appearance so the program output can be used for image quality optimization and tracking. Methods: Using an IRB-approved protocol, 2500 clinical chest radiographs (PA/AP) were collected from our clinical operation. The images were processed through our perceptual qualitymore » assessment program to measure their appearance in terms of ten metrics of perceptual image quality: lung gray level, lung detail, lung noise, rib–lung contrast, rib sharpness, mediastinum detail, mediastinum noise, mediastinum alignment, subdiaphragm–lung contrast, and subdiaphragm area. From the results, for each targeted appearance attribute/metric, 18 images were selected such that the images presented a relatively constant appearance with respect to all metrics except the targeted one. The images were then incorporated into a graphical user interface, which displayed them into three panels of six in a random order. Using a DICOM calibrated diagnostic display workstation and under low ambient lighting conditions, each of five participating attending chest radiologists was tasked to spatially order the images based only on the targeted appearance attribute regardless of the other qualities. Once ordered, the observer also indicated the range of image appearances that he/she considered clinically acceptable. The observer data were analyzed in terms of the correlations between the observer and algorithmic rankings and interobserver variability. An observer-averaged acceptable image appearance was also statistically derived for each quality attribute based on the collected individual acceptable

  13. Individualized Quality Control Plan (IQCP): Is It Value-Added for Clinical Microbiology?

    PubMed Central

    Miller, Melissa B.; Hindler, Janet

    2015-01-01

    The Center for Medicaid and Medicare Services (CMS) recently published their Individualized Quality Control Plan (IQCP [https://www.cms.gov/regulations-and-guidance/legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html]), which will be the only option for quality control (QC) starting in January 2016 if laboratories choose not to perform Clinical Laboratory Improvement Act (CLIA) [U.S. Statutes at Large 81(1967):533] default QC. Laboratories will no longer be able to use “equivalent QC” (EQC) or the Clinical and Laboratory Standards Institute (CLSI) standards alone for quality control of their microbiology systems. The implementation of IQCP in clinical microbiology laboratories will most certainly be an added burden, the benefits of which are currently unknown. PMID:26447112

  14. To belong or not to belong: nursing students' interactions with clinical learning environments - an observational study.

    PubMed

    Liljedahl, Matilda; Björck, Erik; Kalén, Susanne; Ponzer, Sari; Bolander Laksov, Klara

    2016-08-05

    Belongingness has been argued to be a prerequisite for students' learning in the clinical setting but making students feel like they belong to the workplace is a challenge. From a sociocultural perspective, workplace participatory practices is a framework that views clinical learning environments to be created in interaction between students and the workplace and hence, are dependent on them both. The aim of this study was to explore the interdependence between affordances and engagement in clinical learning environments. The research question was: How are nursing students influenced in their interactions with clinical learning environments? An observational study with field observations and follow-up interviews was performed. The study setting comprised three academic teaching hospitals. Field observations included shadowing undergraduate nursing students during entire shifts. Fifty-five hours of field observations and ten follow-up interviews with students, supervisors and clinical managers formed the study data. A thematic approach to the analysis was taken and performed iteratively with the data collection. The results revealed that students strived to fill out the role they were offered in an aspirational way but that they became overwhelmed when given the responsibility of care. When students' basic values did not align with those enacted by the workplace, they were not willing to compromise their own values. Workplaces succeeded in inviting students into the community of nurses and the practice of care. Students demonstrated hesitance regarding their desire to belong to the workplace community. The results imply that the challenge for clinical education is not to increase the experience of belongingness but to maintain students' critical and reflective approach to health care practice. Additionally, results suggest students to be included as an important stakeholder in creating clinical learning environments rather than being viewed as consumer of clinical

  15. How to become a better clinical teacher: a collaborative peer observation process.

    PubMed

    Finn, Kathleen; Chiappa, Victor; Puig, Alberto; Hunt, Daniel P

    2011-01-01

    Peer observation of teaching (PoT) is most commonly done as a way of evaluating educators in lecture or small group teaching. Teaching in the clinical environment is a complex and hectic endeavor that requires nimble and innovative teaching on a daily basis. Most junior faculty start their careers with little formal training in education and with limited opportunity to be observed or to observe more experienced faculty. Formal PoT would potentially ameliorate these challenges. This article describes a collaborative peer observation process that a group of 11 clinician educators is using as a longitudinal faculty development program. The process described in this article provides detailed and specific teaching feedback for the observed teaching attending while prompting the observing faculty to reflect on their own teaching style and to borrow effective teaching techniques from the observation. This article provides detailed examples from written feedback obtained during collaborative peer observation to emphasize the richness of this combined experience.

  16. An observational study of socioeconomic and clinical gradients among diabetes patients hospitalized for avoidable causes: evidence of underlying health disparities in China?

    PubMed

    Chen, Brian; Eggleston, Karen; Li, Hong; Shah, Nilay; Wang, Jian

    2014-01-30

    Diabetes is an ambulatory care sensitive condition that can generally be managed in outpatient settings with little or no need for inpatient care. As a preliminary step to investigate whether health disparities can be detected in the inpatient setting in China, we study how diabetic patients hospitalized without prior primary care contact or with greater severity of illness differ from other diabetic inpatients along socioeconomic and clinical dimensions. We conduct an observational study using three years of clinical data for more than 1,800 adult patients with diabetes at two tertiary hospitals in East China. Univariate analysis and probit regression are used to characterize the differences in socioeconomic and clinical factors between patients hospitalized for diabetes with no prior primary care contact and those hospitalized with previous treatment experience. Secondarily, we use ordinary least squares regression to estimate the socioeconomic and clinical differences associated with poor serum glucose control at admission. We find that compared with patients hospitalized after prior treatment experience, inpatients with no previous primary care contact for diabetes have worse clinical laboratory values, are more likely to be young and male, to have lower education attainment, and to have poorer blood sugar control. Insurance, urban residence, and previous use of diabetic medication are in turn negatively correlated with HbA1c levels upon admission. Among hospitalized diabetic patients, socioeconomic factors such as lower education attainment, rural residence and lack of full insurance are associated with avoidable hospitalizations or worse indicators of health. Although we cannot definitively rule out selection bias, these findings are consistent with health disparities observable even at the inpatient level. Future studies should study the underlying mechanism by which traditionally vulnerable groups are more likely to be hospitalized for avoidable causes and

  17. Overview of clinical research design.

    PubMed

    Hartung, Daniel M; Touchette, Daniel

    2009-02-15

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

  18. Clinical and Immunological Changes of Immunotherapy in Patients with Atopic Dermatitis: Randomized Controlled Trial

    PubMed Central

    Sánchez Caraballo, Jorge Mario; Cardona Villa, Ricardo

    2012-01-01

    Background. Immunotherapy has proven to be an useful tool in the management of allergic respiratory diseases; however, little has been studied in atopic dermatitis. Objective. To evaluate the clinical and immunological impact of immunotherapy with mites allergen extracts in atopic dermatitis. Methods. Patients with atopic dermatitis were assigned with computer-generated randomization to either of the following groups: (a) controls received only topical treatment with steroids and/or tacrolimus and (b) actively treated patients received topical treatment plus immunotherapy. Levels of serum total IgE, mites-specific IgE and IgG4 were assessed at study start and after one year of immunotherapy. Results. 31 patients in the active group and 29 in the control group completed the study. Symptoms and medication scores were significantly reduced in the active group after six months. Three patients in the control group showed new sensitizations to mites, while 3 patients in the active group showed neosensitization to shrimp with negative oral food challenge. We observed significant increase of mites-specific IgG4 levels in active group. Conclusion. Specific allergen immunotherapy induced a tolerogenic IgG4 response to mite allergens associated with favorable clinical effects in atopic dermatitis patients. PMID:23724240

  19. Management Control Systems and Clinical Experience of Managers in Public Hospitals.

    PubMed

    Lunkes, Rogério Joao; Naranjo-Gil, David; Lopez-Valeiras, Ernesto

    2018-04-17

    Healthcare authorities are encouraging managers in hospitals to acquire clinical experience and knowledge in order to better carry out and coordinate healthcare service delivery. The main objective of this paper is to analyse how the clinical experience of hospital managers is related to public health institutions’ performance. It is proposed that the effect of the clinical experience on operative and financial organizational performance is indirect through the mediating variables of perceived utility of management information and horizontal management control system. This paper analyses how these variables impact hospital performance through the data from a survey sent to 364 hospital managers in Brazil. The results show that managers’ clinical experience is related to higher perceived utility of historical, financial, short-term, and internal information, but not with horizontal control adoption in hospitals. Furthermore, our results show that, in hospitals, perceived utility of forecasted, non-financial, long-term, and external managerial information positively affects hospitals’ financial performance, while adoption of horizontal control management positively affects operational performance. Through showing evidence that clinical background could explain the differences not only in hospital service management but also in information capabilities and management control processes, this study offer meaningful implications for healthcare authorities and hospital managers involved in the development and implementation of strategies in the health sector.

  20. Evaluating psychiatric case-control studies using the STROBE (STrengthening the Reporting of OBservational Studies in Epidemiology) statement.

    PubMed

    Goi, Pedro Domingues; Goi, Julia Domingues; Cordini, Kariny Larissa; Ceresér, Keila Mendes; Rocha, Neusa Sica da

    2014-01-01

    Case-control studies are important in developing clinical and public health knowledge. The STROBE statement (STrengthening the Reporting of OBservational Studies in Epidemiology) was developed to establish a checklist of items that should be included in articles reporting observational studies. Our aim was to analyze whether the psychiatric case-control articles published in Brazilian journals with CAPES Qualis rating B1/B2 in 2009 conformed with the STROBE statement. Descriptive study on psychiatric papers published in Brazilian journals, within the Postgraduate Medical Program on Psychiatry, at Universidade Federal do Rio Grande do Sul. All psychiatric case-control studies from Brazilian Qualis B1/B2 journals of psychiatry, neurology and public health in 2009 were analyzed. The four most specific items of the STROBE statement were used to evaluate whether these studies fitted within the case-control parameters: 1) selection of cases and controls; 2) controlling for bias; 3) statistical analysis; and 4) presentation of results. Sixteen case-control studies were identified, of which eleven (68.75%) were in psychiatry-focused journals. From analysis using the STROBE statement, all of the articles conformed with item 1; two (12.5%) completely conformed with item 2; none completely conformed with item 3; and only three (18.8%) conformed with item 4. The case-control studies analyzed here did not completely conform with the four STROBE statement items for case-control design. In view of the inadequate methodology of the published studies, these findings justify focusing on research and methodology and expanding the investigations on adherence of studies to their designs.

  1. Individualized Quality Control Plan (IQCP): Is It Value-Added for Clinical Microbiology?

    PubMed

    Sharp, Susan E; Miller, Melissa B; Hindler, Janet

    2015-12-01

    The Center for Medicaid and Medicare Services (CMS) recently published their Individualized Quality Control Plan (IQCP [https://www.cms.gov/regulations-and-guidance/legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html]), which will be the only option for quality control (QC) starting in January 2016 if laboratories choose not to perform Clinical Laboratory Improvement Act (CLIA) [U.S. Statutes at Large 81(1967):533] default QC. Laboratories will no longer be able to use "equivalent QC" (EQC) or the Clinical and Laboratory Standards Institute (CLSI) standards alone for quality control of their microbiology systems. The implementation of IQCP in clinical microbiology laboratories will most certainly be an added burden, the benefits of which are currently unknown. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

  2. OBSERVATIONAL STUDIES VS. RANDOMIZED CONTROLLED TRIALS: AVENUES TO CAUSAL INFERENCE IN NEPHROLOGY

    PubMed Central

    Kovesdy, Csaba P; Kalantar-Zadeh, Kamyar

    2011-01-01

    A common frustration for practicing Nephrologists is the adage that the lack of randomized controlled trials (RCTs) does not allow us to establish causality, but merely associations. The field of Nephrology, like many other disciplines, has been suffering from a lack of RCTs. The view that short of RCTs there is no reliable evidence has hampered our ability to ascertain the best course of action for our patients. However, many clinically important questions in medicine and public health such as the association of smoking and lung cancer are not amenable to RCTs due to ethical or other considerations. Whereas RCTs unquestionably hold many advantages over observational studies, it should be recognized that they also have many flaws that render them fallible under certain circumstances. We provide a description of the various pros and cons of RCTs and of observational studies using examples from the Nephrology literature, and argue that it is simplistic to rank them solely based on pre-conceived notions about the superiority of one over the other. We also discuss methods whereby observational studies can become acceptable tools for causal inferences. Such approaches are especially important in a field like Nephrology where there are myriads of potential interventions based on complex pathophysiologic states, but where properly designed and conducted RCTs for all of these will probably never materialize. PMID:22364796

  3. New definitions of 6 clinical signs of perceptual disorder in children with cerebral palsy: an observational study through reliability measures.

    PubMed

    Ferrari, A; Sghedoni, A; Alboresi, S; Pedroni, E; Lombardi, F

    2014-12-01

    Recently authors have begun to emphasize the non-motor aspects of Cerebral Palsy and their influence on motor control and recovery prognosis. Much has been written about single clinical signs (i.e., startle reaction) but so far no definitions of the six perceptual signs presented in this study have appeared in literature. This study defines 6 signs (startle reaction, upper limbs in startle position, frequent eye blinking, posture freezing, averted eye gaze, grimacing) suggestive of perceptual disorders in children with cerebral palsy and measures agreement on sign recognition among independent observers and consistency of opinions over time. Observational study with both cross-sectional and prospective components. Fifty-six videos presented to observers in random order. Videos were taken from 19 children with a bilateral form of cerebral palsy referred to the Children Rehabilitation Unit in Reggio Emilia. Thirty-five rehabilitation professionals from all over Italy: 9 doctors and 26 physiotherapists. Measure of agreement among 35 independent observers was compiled from a sample of 56 videos. Interobserver reliability was determined using the K index of Fleiss and reliability intra-observer was calculated by the Spearman correlation index between ranks (rho - ρ). Percentage of agreement between observers and Gold Standard was used as criterion validity. Interobserver reliability was moderate for startle reaction, upper limb in startle position, adverted eye gaze and eye-blinking and fair for posture freezing and grimacing. Intraobserver reliability remained consistent over time. Criterion validity revealed very high agreement between independent observer evaluation and gold standard. Semiotics of perceptual disorders can be used as a specific and sensitive instrument in order to identify a new class of patients within existing heterogeneous clinical types of bilateral cerebral palsy forms and could help clinicians in identifying functional prognosis. To provide

  4. Development and Initial Testing of a Structured Clinical Observation Tool to Assess Pharmacotherapy Competence

    ERIC Educational Resources Information Center

    Young, John Q.; Lieu, Sandra; O'Sullivan, Patricia; Tong, Lowell

    2011-01-01

    Objective: The authors developed and tested the feasibility and utility of a new direct-observation instrument to assess trainee performance of a medication management session. Methods: The Psychopharmacotherapy-Structured Clinical Observation (P-SCO) instrument was developed based on multiple sources of expertise and then implemented in 4…

  5. An Optimal Current Observer for Predictive Current Controlled Buck DC-DC Converters

    PubMed Central

    Min, Run; Chen, Chen; Zhang, Xiaodong; Zou, Xuecheng; Tong, Qiaoling; Zhang, Qiao

    2014-01-01

    In digital current mode controlled DC-DC converters, conventional current sensors might not provide isolation at a minimized price, power loss and size. Therefore, a current observer which can be realized based on the digital circuit itself, is a possible substitute. However, the observed current may diverge due to the parasitic resistors and the forward conduction voltage of the diode. Moreover, the divergence of the observed current will cause steady state errors in the output voltage. In this paper, an optimal current observer is proposed. It achieves the highest observation accuracy by compensating for all the known parasitic parameters. By employing the optimal current observer-based predictive current controller, a buck converter is implemented. The converter has a convergently and accurately observed inductor current, and shows preferable transient response than the conventional voltage mode controlled converter. Besides, costs, power loss and size are minimized since the strategy requires no additional hardware for current sensing. The effectiveness of the proposed optimal current observer is demonstrated experimentally. PMID:24854061

  6. Registration practices for observational studies on ClinicalTrials.gov indicated low adherence.

    PubMed

    Boccia, Stefania; Rothman, Kenneth J; Panic, Nikola; Flacco, Maria Elena; Rosso, Annalisa; Pastorino, Roberta; Manzoli, Lamberto; La Vecchia, Carlo; Villari, Paolo; Boffetta, Paolo; Ricciardi, Walter; Ioannidis, John P A

    2016-02-01

    The study aims to assess the status of registration of observational studies. We identified studies on cancer research with prospective recruitment of participants that were registered from February 2000 to December 2011 in ClinicalTrials.gov. We recorded the dates of registration and start of recruitment, outcomes, and description of statistical method. We searched for publications corresponding to the registered studies through May 31, 2014. One thousand one hundred nine registered studies were eligible. Primary and secondary outcomes were reported in 809 (73.0%) and 464 (41.8%) of them. The date of registration preceded the month of the study start in 145 (13.8%) and coincided in 205 (19.5%). A total of 151 publications from 120 (10.8%) registered studies were identified. In 2 (33.3%) of the 6 publications where ClinicalTrials.gov reported that the study started recruitment after registration, and in 9 (50.0%) of 18 publications where ClinicalTrials.gov reported the same date for registration and start of recruitment, the articles showed that the study had actually started recruiting before registration. During the period reviewed, few observational studies have been registered. Registration usually occurred after the study started, and prespecification of outcomes and statistical analysis rarely occurred. Copyright © 2016 Elsevier Inc. All rights reserved.

  7. Structural effects of clinically observed mutations in JAK2 exons 13-15: comparison with V617F and exon 12 mutations

    PubMed Central

    Lee, Tai-Sung; Ma, Wanlong; Zhang, Xi; Kantarjian, Hagop; Albitar, Maher

    2009-01-01

    Background The functional relevance of many of the recently detected JAK2 mutations, except V617F and exon 12 mutants, in patients with chronic myeloproliferative neoplasia (MPN) has been significantly overlooked. To explore atomic-level explanations of the possible mutational effects from those overlooked mutants, we performed a set of molecular dynamics simulations on clinically observed mutants, including newly discovered mutations (K539L, R564L, L579F, H587N, S591L, H606Q, V617I, V617F, C618R, L624P, whole exon 14-deletion) and control mutants (V617C, V617Y, K603Q/N667K). Results Simulation results are consistent with all currently available clinical/experimental evidence. The simulation-derived putative interface, not possibly obtained from static models, between the kinase (JH1) and pseudokinase (JH2) domains of JAK2 provides a platform able to explain the mutational effect for all mutants, including presumably benign control mutants, at the atomic level. Conclusion The results and analysis provide structural bases for mutational mechanisms of JAK2, may advance the understanding of JAK2 auto-regulation, and have the potential to lead to therapeutic approaches. Together with recent mutation profiling results demonstrating the breadth of clinically observed JAK2 mutations, our findings suggest that molecular testing/diagnostics of JAK2 should extend beyond V617F and exon 12 mutations, and perhaps should encompass most of the pseudo-kinase domain-coding region. PMID:19744331

  8. Should we reconsider the routine use of placebo controls in clinical research?

    PubMed

    Avins, Andrew L; Cherkin, Daniel C; Sherman, Karen J; Goldberg, Harley; Pressman, Alice

    2012-04-27

    Modern clinical-research practice favors placebo controls over usual-care controls whenever a credible placebo exists. An unrecognized consequence of this preference is that clinicians are more limited in their ability to provide the benefits of the non-specific healing effects of placebos in clinical practice. We examined the issues in choosing between placebo and usual-care controls. We considered why placebo controls place constraints on clinicians and the trade-offs involved in the choice of control groups. We find that, for certain studies, investigators should consider usual-care controls, even if an adequate placebo is available. Employing usual-care controls would be of greatest value for pragmatic trials evaluating treatments to improve clinical care and for which threats to internal validity can be adequately managed without a placebo-control condition. Intentionally choosing usual-care controls, even when a satisfactory placebo exists, would allow clinicians to capture the value of non-specific therapeutic benefits that are common to all interventions. The result could be more effective, patient-centered care that makes the best use of both specific and non-specific benefits of medical interventions.

  9. Clinical, Bronchographic, Radiological, and Physiological Observations in Ten Cases of Asbestosis

    PubMed Central

    Leathart, G. L.

    1960-01-01

    Ten cases of asbestosis (eight male, two female), aged 45-65 years have been kept under observation for periods of up to eight years. Bronchiectasis was demonstrated bronchographically in six cases. Clubbing of the fingers and coarse crepitations appeared to be signs of bronchiectasis rather than of uncomplicated asbestosis. It is suggested that the prevalence of bronchiectasis is higher than has been reported previously because the patients survived longer. The radiological findings are tabulated and compared with previous descriptions. In these subjects there was no relationship between radiological and clinical state. Nine patients eventually showed clinical deterioration and it often proceeded rapidly. The radiograph however, usually remained unaltered. Pulmonary function tests, including diffusing capacity, arterial blood analysis and estimation of mechanical properties of the lung, were carried out in these 10 cases, and in 11 asbestos workers (aged 35-64 years) without radiological abnormality. The steady state diffusing capacity for carbon monoxide (Dco) at rest was lower in asbestosis than in the control subjects. The pulmonary compliance was remarkably low in asbestosis and related fairly closely to the vital capacity. The maximum voluntary ventilation was also low and was related to increased pulmonary resistance but it cannot be said whether this is in the airways or in the lung tissue. Indirect evidence of inequalities of ventilation/perfusion ratio was obtained in most cases. There is no convincing evidence that pulmonary fibrosis occurs without radiological abnormality, but a defect of diffusion may occur. There is no test of pulmonary function which is diagnostic, but a low pulmonary compliance, especially if combined with a low diffusing capacity, is confirmatory. It is suggested that the demonstration of a progressive decline in vital capacity, or in diffusing capacity, may enable a diagnosis of asbestosis to be made before radiological

  10. Changes in Protein Structure and Distribution Observed at Pre-Clinical Stages of Scrapie Pathogenesis

    PubMed Central

    Kretlow, Ariane; Wang, Qi; Beekes, Michael; Naumann, Dieter; Miller, Lisa M.

    2011-01-01

    Scrapie is a neurodegenerative disorder that involves the misfolding, aggregation and accumulation of the prion protein (PrP). The normal cellular PrP (PrPC) is rich in α-helical secondary structure, whereas the disease-associated pathogenic form of the protein (PrPSc) has an anomalously high β-sheet content. In this study, protein structural changes were examined in situ in the dorsal root ganglia from perorally 263K scrapie-infected and mock-infected hamsters using synchrotron Fourier Transform InfraRed Microspectroscopy (FTIRM) at four time points over the course of the disease (preclinical, 100 & 130 days post-infection (dpi); first clinical signs (~145 dpi); and terminal (~170 dpi)). Results showed clear changes in the total protein content, structure, and distribution as the disease progressed. At pre-clinical time points, the scrapie-infected animals exhibited a significant increase in protein expression, but the β-sheet protein content was significantly lower than controls. Based on these findings, we suggest that the pre-clinical stages of scrapie are characterized by an overexpression of proteins low in β-sheet content. As the disease progressed, the β-sheet content increased significantly. Immunostaining with a PrP-specific antibody, 3F4, confirmed that this increase was partly – but not solely – due to the formation of PrPSc in the tissue and indicated that other proteins high in β-sheet were produced, either by overexpression or misfolding. Elevated β-sheet was observed near the cell membrane at pre-clinical time points and also in the cytoplasm of infected neurons at later stages of infection. At the terminal stage of the disease, the protein expression declined significantly, likely due to degeneration and death of neurons. These dramatic changes in protein content and structure, especially at pre-clinical time points, emphasize the possibility for identifying other proteins involved in early pathogenesis, which are important for further

  11. Reflective Observation in the Clinical Education Setting: A Way to Promote Learning

    ERIC Educational Resources Information Center

    Mazerolle, Stephanie M.; Bowman, Thomas G.; Benes, Sarah S.

    2015-01-01

    Context: Clinical experiences help athletic training students gain real-time learning experiences by engaging in patient care. Observational learning has been identified as important to athletic training student development, yet little is known about its effectiveness. Objective: To explore the athletic training students' perspectives on their…

  12. Reliability Stress-Strength Models for Dependent Observations with Applications in Clinical Trials

    NASA Technical Reports Server (NTRS)

    Kushary, Debashis; Kulkarni, Pandurang M.

    1995-01-01

    We consider the applications of stress-strength models in studies involving clinical trials. When studying the effects and side effects of certain procedures (treatments), it is often the case that observations are correlated due to subject effect, repeated measurements and observing many characteristics simultaneously. We develop maximum likelihood estimator (MLE) and uniform minimum variance unbiased estimator (UMVUE) of the reliability which in clinical trial studies could be considered as the chances of increased side effects due to a particular procedure compared to another. The results developed apply to both univariate and multivariate situations. Also, for the univariate situations we develop simple to use lower confidence bounds for the reliability. Further, we consider the cases when both stress and strength constitute time dependent processes. We define the future reliability and obtain methods of constructing lower confidence bounds for this reliability. Finally, we conduct simulation studies to evaluate all the procedures developed and also to compare the MLE and the UMVUE.

  13. Brief strategic therapy for obsessive–compulsive disorder: a clinical and research protocol of a one-group observational study

    PubMed Central

    Pietrabissa, Giada; Manzoni, Gian Mauro; Gibson, Padraic; Boardman, Donald; Gori, Alessio; Castelnuovo, Gianluca

    2016-01-01

    Introduction Obsessive–compulsive disorder (OCD) is a disabling psychopathology. The mainstay of treatment includes cognitive–behavioural therapy (CBT) and medication management. However, individual suffering, functional impairments as well as the direct and indirect costs associated with the disease remain substantial. New treatment programmes are necessary and the brief strategic therapy (BST) has recently shown encouraging results in clinical practice but no quantitative study has as yet been conducted. Methods and analysis The clinical effectiveness of the OCD-specific BST protocol will be evaluated in a one-group observational study. Participants will be sequentially recruited from a state community psychotherapy clinic in Dublin, Ireland. Outcome measures will be the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and the Beck Depression Inventory-II (BDI-II). Data will be collected at baseline, at treatment termination and at 3 month follow-up. The statistical significance of the post-treatment effect will be assessed by the paired-sample Student t test, while clinical significance will be evaluated by means of the equivalence testing method, which will be also used to assess the maintenance of effect at follow-up. Ethics/dissemination The present study is approved by the Hesed House Ethics Board in Dublin. Findings will enhance the evidence-based knowledge about the clinical effectiveness of BST in treating OCD symptoms, prior to assessing its efficacy in a randomised and controlled clinical trial, and will be disseminated through publication in peer-reviewed journals and conference presentations. PMID:27013594

  14. Randomized controlled clinical trial comparing two dental implants with different neck configurations.

    PubMed

    Sanz-Martín, Ignacio; Sanz-Sánchez, Ignacio; Noguerol, Fernando; Cok, Susy; Ortiz-Vigón, Alberto; Sanz, Mariano

    2017-06-01

    Peri-implant bone levels can vary according to the implant neck macro-design and the implant-abutment interface. To compare the changes in soft and hard tissues when using a one-piece implant with a machined collar (TG) versus a two-piece implant with a progressive platform widening and a platform switching connection (SP). Partially edentulous patients willing to receive one or two implants in the posterior maxilla or mandible were randomized to the control (TG) or to the test group (SP). Final prostheses were delivered after 12 months. Radiographic measurements of interproximal bone levels (primary outcome) were assessed at implant loading and 1-year postloading. Clinical, patient related outcomes and adverse events were assessed at loading and after 6 and 12 months. Sixty-one implants were placed in 47 patients, 37 patients (18 in the TG group and 19 in the SP group), and 47 implants (23 TG and 24 SP) completed the 24-months follow up. At the patient level, a significantly greater bone resorption from baseline to implant loading was observed in the SP group (-0.42 ± 0.45 vs -0.07 ± 0.45; P = .001*), while from loading to the final visit, the TG group had significantly greater bone loss than the SP group (-0.26 ± 0.22 vs -0.11 ± 0.2; P = .020*). At 24 months after surgery, there were no significant differences between both groups (control: 0.33 ± 0.49 vs test: 0.53 ± 0.53; P = .230). Similarly, no significant differences were observed for the secondary outcomes. Both types of implant reported high survival rates and similar bone level changes, clinical parameters, and patient related outcomes after 12 months of loading. © 2017 Wiley Periodicals, Inc.

  15. Pulmonary rehabilitation in lymphangioleiomyomatosis: a controlled clinical trial.

    PubMed

    Araujo, Mariana S; Baldi, Bruno G; Freitas, Carolina S G; Albuquerque, André L P; Marques da Silva, Cibele C B; Kairalla, Ronaldo A; Carvalho, Celso R F; Carvalho, Carlos R R

    2016-05-01

    Lymphangioleiomyomatosis (LAM) is a cystic lung disease frequently associated with reduced exercise capacity. The aim of this study was to assess safety and efficacy of pulmonary rehabilitation in LAM.This controlled clinical trial included 40 patients with LAM and a low physical activity level. The pulmonary rehabilitation programme comprised 24 aerobic and muscle strength training sessions and education. The primary outcome was exercise capacity (endurance time during a constant work rate exercise test). Secondary outcomes included health-related quality of life (St George's Respiratory Questionnaire (SGRQ)), 6-min walking distance (6MWD), dyspnoea, peak oxygen consumption (V'O2 ), daily physical activity (pedometer), symptoms of anxiety and depression, lung function and peripheral muscle strength (one-repetition maximum).The baseline characteristics were well balanced between the groups. The pulmonary rehabilitation group exhibited improvements in the following outcomes versus controls: endurance time (median (interquartile range) 169 (2-303) s versus -33 (-129-39) s; p=0.001), SGRQ (median (interquartile range) -8 (-16-2) versus 2 (-4-5); p=0.002) and 6MWD (median (interquartile range) 59 (13-81) m versus 20 (-12-30) m; p=0.002). Dyspnoea, peak V'O2 , daily physical activity and muscle strength also improved significantly. No serious adverse events were observed.Pulmonary rehabilitation is a safe intervention and improves exercise capacity, dyspnoea, daily physical activity, quality of life and muscle strength in LAM. Copyright ©ERS 2016.

  16. Efficacy and tolerability of rasagiline in daily clinical use--a post-marketing observational study in patients with Parkinson's disease.

    PubMed

    Reichmann, H; Jost, W H

    2010-09-01

    The MAO-B inhibitor rasagiline is indicated for the treatment of idiopathic Parkinson's disease (PD), and its use is supported by evidence from large-scale, controlled clinical studies. The post-marketing observational study presented here investigated the efficacy and tolerability of rasagiline treatment (monotherapy or combination therapy) in daily clinical practice. The study included patients with idiopathic PD who received rasagiline (recommended dose 1 mg, once daily) as monotherapy or combination therapy. The treatment and observation period was approximately 4 months. Outcome measures included the change from baseline in the Columbia University Rating Scale (CURS), the Unified PD Rating Scale fluctuation subscale, daily OFF time (patient home diaries) and the PD Questionnaire-39. Adverse drug reactions/adverse events (ADRs/AEs) and the physician's global judgement of tolerability and efficacy were also examined. Overall, 754 patients received rasagiline during the study. Patients treated with rasagiline (monotherapy or combination therapy) showed significant improvements from baseline in symptom severity (including classical motor and non-classical motor/non-motor symptoms) and quality of life (QoL). Patients receiving combination therapy also experienced significant reductions in daily OFF time. Tolerability was rated as good/very good in over 90% of patients. In daily clinical practice, monotherapy or combination therapy with rasagiline is able to improve PD symptoms, reduce OFF time, and improve QoL, whilst demonstrating favourable tolerability. In addition, rasagiline has a simple dosing schedule of one tablet, once daily, with no titration. These results are consistent with the pivotal rasagiline clinical studies (TEMPO, LARGO and PRESTO).

  17. Knowledge, adherence and control among patients with hypertension attending a peri-urban primary health care clinic, KwaZulu-Natal

    PubMed Central

    2017-01-01

    Background Despite hypertension being a common condition among patients attending primary health care (PHC) clinics, blood pressure (BP) control is often poor. Greater insight into patient-related factors that influence the control of hypertension will assist in the development of an intervention to address the issues identified. Aim The aim of the study was to assess patient-related variables associated with hypertension control among patients attending a peri-urban PHC clinic. Setting The setting for this study was a peri-urban PHC clinic in KwaZulu-Natal. Method This was an observational, descriptive and cross-sectional study with 348 patients selected over a 1-month period. A validated questionnaire was used to collect data on patients’ hypertension knowledge and self-reported adherence, and BP recordings from their medical record were recorded to ascertain control. Results Of the 348 participants, only 49% had good BP control and 44% (152/348) had concurrent diabetes mellitus. The majority of patients had moderate levels of knowledge on hypertension and exhibited moderate adherence. There was a significant relationship between knowledge and reported adherence, between reported adherence and control, but not between reported knowledge and control. Conclusion Despite over 90% of the study population having moderate knowledge, and 62% with moderate reported adherence, BP was well controlled in only less than 50% of the study population. These findings suggest a need to emphasise adherence and explore new ways of approaching adherence. PMID:29113443

  18. Quality of glycaemic control in ambulatory diabetics at the out-patient clinic of Kenyatta National Hospital, Nairobi.

    PubMed

    Otieno, C F; Kariuki, M; Ng'ang'a, L

    2003-08-01

    Treatment of diabetes mellitus is based on the evidence that lowering blood glucose as close to normal range as possible is a primary strategy for reducing or preventing complications or early mortality from diabetes. This suggests poorer glycaemic control would be associated with excess of diabetes-related morbidity and mortality. This presumption is suspected to reach high proportions in developing countries where endemic poverty abets poor glycaemic control. There is no study published on Kenyan patients with diabetes mellitus about their glycaemic control as an audit of diabetes care. To determine the glycaemic control of ambulatory diabetic patients. Cross-sectional study on each clinic day of a randomly selected sample of both type 1 and 2 diabetic patients. Kenyatta National Hospital. Over a period of six months, January 1998 to June 1998. During routine diabetes care in the clinic, mid morning random blood sugar and glycated haemoglobin (HbA1c) were obtained. A total of 305 diabetic patients were included, 52.8% were females and 47.2% were males. 58.3% were on Oral Hypoglycaemic Agent (OHA) only, 22.3% on insulin only; 9.2% on OHA and insulin and 4.6% on diet only. 39.5% had mean HbA1c < or = 8% while 60.5% had HbA1c > or = 8%. Patients on diet-only therapy had the best mean HbA1c = 7.04% while patients on OHA-only had the worst mean HbA1c = 9.06%. This difference was significant (p=0.01). The former group, likely, had better endogenous insulin production. The influence of age, gender and duration of diabetes on the level of glycaemic control observed did not attain statistically significant proportions. The majority of ambulatory diabetic patients attending the out-patient diabetic clinic had poor glycaemic control. The group with the poorest level of glycaemic control were on OHA-only, while best control was observed amongst patients on diet-only, because of possible fair endogenous insulin production. Poor glycaemic control was presumed to be due to sub

  19. Effects of the Non-Nutritive Sweeteners on Glucose Metabolism and Appetite Regulating Hormones: Systematic Review of Observational Prospective Studies and Clinical Trials

    PubMed Central

    Romo-Romo, Alonso; Aguilar-Salinas, Carlos A.; Brito-Córdova, Griselda X.; Gómez Díaz, Rita A.; Vilchis Valentín, David

    2016-01-01

    Background The effects of non-nutritive sweeteners (NNS) on glucose metabolism and appetite regulating hormones are not clear. There is an ongoing debate concerning NNS use and deleterious changes in metabolism. Objectives The aim of this review is to analyze the scientific available evidence regarding the effects of NNS on glucose metabolism and appetite regulating hormones. Data Sources and Study Eligibility Criteria We identified human observational studies evaluating the relation between NNS consumption and obesity, diabetes, and metabolic syndrome, in addition to clinical trials evaluating the effects of NNS in glucose metabolism and appetite regulating hormones. Results Fourteen observational studies evaluating the association between NNS consumption and the development of metabolic diseases and twenty-eight clinical trials studying the effects of NNS on metabolism were included. Finally, two meta-analyses evaluating the association between the consumption of NNS-containing beverages and the development of type 2 diabetes were identified. Conclusions Some observational studies suggest an association between NNS consumption and development of metabolic diseases; however, adiposity is a confounder frequently found in observational studies. The effects of the NNS on glucose metabolism are not clear. The results of the identified clinical trials are contradictory and are not comparable because of the major existing differences between them. Studies evaluating specific NNS, with an adequate sample size, including a homogeneous study group, identifying significant comorbidities, with an appropriate control group, with an appropriate exposure time, and considering adjustment for confounder variables such as adiposity are needed. PMID:27537496

  20. A nonrandomized controlled clinical pilot trial on 8 wk of intermittent fasting (24 h/wk).

    PubMed

    Kessler, Christian S; Stange, Rainer; Schlenkermann, Maike; Jeitler, Michael; Michalsen, Andreas; Selle, Antonia; Raucci, Franca; Steckhan, Nico

    2018-02-01

    The aim of the study was to evaluate whether intermittent fasting (IF) is an effective preventive measure, and whether it is feasible for healthy volunteers under every day conditions. A nonrandomized controlled clinical trial on IF was performed with healthy volunteers over a period of 8 wk, and a subsequent 4-mo follow-up. Outcomes were assessed at baseline, after 8 wk, and after 6 mo. Volunteers who were not interested in fasting served as a control group. Participants in the fasting group were asked to continue their regular nutritional habits on the nonfasting days, whereas the control group maintained their habitual nutrition throughout the whole period. Outcomes included changes of metabolic parameters (insulin, glucose, insulin resistance, insulin-like growth factor-1, brain-derived neurotropic factor, lipids, liver enzymes, hemoglobin A1c) and coagulation markers; bioelectrical impedance analysis; body mass index; abdominal girth; blood pressure; general quality of life (five-item World Health Organization Well-Being Index [WHO-5] questionnaire), as well as mood and anxiety (Hospital Anxiety and Depression Scale [HADS], Profile of Mood States, Flourishing-Scale, visual analog scale, Likert scales). The intervention consisted of a fasting day, which was repeated every week for 8 wk, with abstinence from solid food between 00:00 and 23:59 at minimum and a maximum caloric intake of 300 kcal on each fasting day. A per-protocol analysis was performed. P < 0.05 was considered significant. Thirty-six volunteers were included; 22 allocated themselves to the fasting group, and 14 to the control group. Thirty-three data sets were included in the final analysis. Although significant in-group changes were observed in both groups for a number of outcomes after 8 wk and 6 mo, no significant between-group differences were observed for any outcome other than overall body fat mass after 8 wk as well as for the HADS total score and the WHO-5 total score after 6

  1. 77 FR 14805 - Clinical Laboratory Improvement Advisory Committee, Centers for Disease Control and Prevention...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Clinical Laboratory Improvement Advisory Committee, Centers for Disease Control and Prevention: Notice of Charter..., that the Clinical Laboratory Improvement Advisory Committee, Centers for Disease Control and Prevention...

  2. Sliding mode control-based linear functional observers for discrete-time stochastic systems

    NASA Astrophysics Data System (ADS)

    Singh, Satnesh; Janardhanan, Sivaramakrishnan

    2017-11-01

    Sliding mode control (SMC) is one of the most popular techniques to stabilise linear discrete-time stochastic systems. However, application of SMC becomes difficult when the system states are not available for feedback. This paper presents a new approach to design a SMC-based functional observer for discrete-time stochastic systems. The functional observer is based on the Kronecker product approach. Existence conditions and stability analysis of the proposed observer are given. The control input is estimated by a novel linear functional observer. This approach leads to a non-switching type of control, thereby eliminating the fundamental cause of chatter. Furthermore, the functional observer is designed in such a way that the effect of process and measurement noise is minimised. Simulation example is given to illustrate and validate the proposed design method.

  3. [Observation of Attachment Disorder Symptoms in Middle Childhood].

    PubMed

    Iwanski, Alexandra; Zimmermann, Peter

    2018-05-01

    Observation of Attachment Disorder Symptoms in Middle Childhood Attachment in childhood is mainly assessed by observation. In contrast, assessment of attachment disorder symptoms (RAD) is mainly based on caregiver reports. The present study uses a newly developed observation tool (Coding of Attachment Disorder Behavior in Children; Iwanski u. Zimmermann, 2013) to assess attachment disorder symptoms in a group of school-aged children from a risk group for the development of attachment disorder symptoms and non-clinical controls. In addition, caregiver reports on RAD symptoms are also assessed (Relationship Problems Questionnaire; Minnis, Rabe-Hesketh, Wolkind, 2002; Disturbances of Attachment Interview; Smyke u. Zeanah, 1999). Moreover, associations with children's self-concept (Harter, 2012) were studied. Results reveal that children at risk showed more inhibited and disinhibited attachment disorder symptoms and a more negative self-concept compared to non-clinical controls. RAD symptoms are shown in interaction with both the caregiver and a stranger. The use of a reliable and valid observation tool for the diagnostic of attachment disorder symptoms besides ratings of caregivers is recommended for clinical practice and research.

  4. Clinical and radiographic analysis of an artificial cervical disc: 7-year follow-up from the Prestige prospective randomized controlled clinical trial: Clinical article.

    PubMed

    Burkus, J Kenneth; Traynelis, Vincent C; Haid, Regis W; Mummaneni, Praveen V

    2014-10-01

    The authors assess the long-term safety and efficacy of cervical disc replacement with the Prestige Cervical Disc in a prospective, randomized, multicenter trial at 7 years of follow-up. At 31 investigational sites, 541 patients with single-level cervical disc disease with radiculopathy were randomized to 1 of 2 treatment groups: 276 investigational group patients underwent anterior cervical discectomy and arthroplasty with the Prestige disc, and 265 control group patients underwent anterior cervical discectomy and fusion. Clinical outcomes included Neck Disability Index, the 36-Item Short-Form Health Survey, and neck and arm pain scores. Radiographs were assessed for angle of motion and fusion. Clinical and radiographic outcomes were evaluated preoperatively, intraoperatively, and at 1.5, 3, 6, 12, 24, 36, 60, and 84 months. Of the 541 patients treated, 395 patients (73%; 212 investigational and 183 control patients) completed 7 years of clinical follow-up. Significant improvements achieved by 1.5 months in both groups were sustained at 7 years. In the investigational group, mean Neck Disability Index improvements from preoperative scores were 38.2 and 37.5 at 60 and 84 months, respectively. In the control group, the corresponding means were 33.8 and 31.9. The differences between the investigational and control groups at the 60-month and 84-month periods were significant (p = 0.014 and 0.002, respectively). The overall rates of maintenance or improvement in neurological status in the investigational group were significantly higher: 92.2% and 88.2% at 60 months and 84 months, respectively, compared with 85.7% and 79.7% in the control group (p = 0.017 and 0.011, respectively). At 84 months, the percentage of working patients in the investigational group was 73.9%, and in the control group, 73.1%. Postoperatively, the implant effectively maintained average angular motion of 6.67° at 60 months and 6.75° at 84 months. Cumulative rates for surgery at the index level

  5. Clinical competence of biopsychosocially trained physicians and controls.

    PubMed

    Adler, Rolf H; Minder, Christoph E

    2012-07-25

    To assess and compare clinical observations and interpretations by physicians trained in biopsychosocial internal medicine (group A) and a control group (C) of physicians with no such special training. A verbatim first-interview of a 36-year old woman, seen for consultation by RHA, was presented to both groups (A, trained physicians: n = 30, and C, controls: n = 29). The patient's symptoms included: shaky knees, strange sensations in the abdomen and chest, insecurity and dizziness. The symptoms had begun before her final nursing- exam and exacerbated on her mother's 60th birthday two months later. The patient's mother is the sole caretaker for the patient's sister, who also attended the birthday party. The patient's sister is 19 and had been diagnosed with storage disease and is wheelchair-bound. The doctors were asked to record their observations and interpretations while reviewing the case report. Group A-physicians mentioned and interpreted the physician-patient relationship and the patient's body language as described in the case report more often (p = 0.002, Wilcoxon-Mann-Whitney rank sum test (RS)), mentioned physical symptoms more often (p = 0.0099, Fisher's exact test (FE)) and more often interpreted illness settings with respect to the patient's fear and guilt (Fisher's exact test, p = 0.007 and p = 0.015). A precise integrative diagnosis (life events leading to stress, the latter evoking fear and guilt, leading to symptoms of the fight-flight reaction) was suggested by 7 of group A and 4 of group C. Extensive laboratory work-up and requests for consultations were more frequently asked for by the C group (p = 0.048, RS). Residency training in biopsychosocial medicine in an Internal Medicine Department increased sensitivity to and interpretation of biological and psychosocial data many years after the training and decreased the extent of work-up and consultation costs. However it only tended to enhance psychosomatic conceptualisation with respect to anxiety

  6. [Clinical observation of peptic ulcer treated with acupuncture based on theory of "the compatibility of the five meridians" in Huxiang].

    PubMed

    Li, Cuiying; Li, Jinxiang; Pan, Shimin; Zhang, Xi; Li, Ying

    2017-08-12

    To compare the effects differences for peptic ulcer between acupuncture based on the theory of "the compatibility of the five meridians" in Huxiang and conventional western medication. Sixty patients with peptic ulcer of liver-stomach disharmony type (LSDT) and weakness of spleen and stomach type (WSST) were assigned into an observation group and a control group by block randomization according to syndrome differentiation.Finally,28 cases (17 with LSDT and 11 with WSST) in the observation group,29 cases (18 with LSDT and 11 with WSST) in the control group were included.In the observation group,patients with LSDT were treated with acupuncture at Zhongwan (CV 12),Taichong (LR 3),Xingjian (LR 2),Qimen (LR 14),Zusanli (ST 36),Gongsun (SP 4),Shaofu (HT 8),Jingqu (LU 8),Neiguan (PC 6); those with WSST,at Zhongwan (CV 12),Dadu (SP 2),Taibai (SP 3),Yinlingquan (SP 9),Zusanli (ST 36),Shaofu (HT 8), Taichong (LR 3),Yingu (KI 10),Taixi (KI 3),Taiyuan (LU 9) according to the theory of "the compatibility of the five meridians" in Huxiang .Reinforcing and reducing were according to syndrome differentiation.The treatment was given once a day with needle retained for 30 min,5 days a week,2 days at interval.In the control group,the conventional triple drugs (omeprazole,amoxicillin and clarithromycin) were prescribed orally for Hp positive patients,and omeprazole for Hp negative patients.All the patients were treated for 4 weeks.The clinical syndrome score,ulcer healing under gastroscope,anti-Hp infection and Hp negative conversion ratio rate were observed in the two groups before and after treatment as well as 1 month after treatment.The total effects were evaluated. The syndrome scores after treatment and at 1 month ofter treatment decreased in the two groups (all P <0.05),while without significant difference between the two groups (both P >0.05).The scores within the group between the two syndromes showed no significance in the two groups (both P >0.05).The cure rates under

  7. A controlled evaluation of case clinical effect coding by poison center specialists for detection of WMD scenarios.

    PubMed

    Beuhler, Michael C; Wittler, Mary A; Ford, Marsha; Dulaney, Anna R

    2011-08-01

    Many public health entities employ computer-based syndromic surveillance to monitor for aberrations including possible exposures to weapons of mass destruction (WMD). Often, this is done by screening signs and symptoms reported for cases against syndromic definitions. Poison centers (PCs) may offer significant contributions to public health surveillance because of their detailed clinical effect data field coding and real-time data entry. Because improper clinical effect coding may impede syndromic surveillance, it is important to assess this accuracy for PCs. An AAPCC-certified regional PC assessed the accuracy of clinical effect coding by specialists in poison information (SPIs) listening to audio recordings of standard cases. Eighteen different standardized cases were used, consisting of six cyanide, six botulism, and six control cases. Cases were scripted to simulate clinically relevant telephone conversations and converted to audio recordings. Ten SPIs were randomly selected from the center's staff to listen to and code case information from the recorded cases. Kappa scores and the percentage of correctly coding a present clinical effect were calculated for individual clinical effects summed over all test cases along with corresponding 95% confidence intervals. The rate of the case coding by the SPIs triggering the PC's automated botulism and cyanide alerts was also determined. The kappa scores and the percentage of correctly coding a present clinical effect varied depending on the specific clinical effect, with greater accuracy observed for the clinical effects of vomiting and agitation/irritability, and poor accuracy observed for the clinical effects of visual defect and anion gap increase. Lack of correct coding resulted in only 60 and 86% of the cases that met the botulism and cyanide surveillance definitions, respectively, triggering the corresponding alert. There was no difference observed in the percentage of coding a present clinical effect between

  8. An observation tool to study air traffic control and flightdeck collaboration.

    PubMed

    Cox, Gemma; Sharples, Sarah; Stedmon, Alex; Wilson, John

    2007-07-01

    The complex systems of the flightdeck (FD) and the Air Traffic Control Centre (ATC) are characterised by numerous concurrently operating and interacting communication channels between people and between people and machines/computer systems. This paper describes work in support of investigating the impact of changes to technologies and responsibilities within this system with respect to human factors. It focuses primarily on the introduction of datalink (text-based communication rather than traditional radio communication) and the move towards freeflight (pilot-mediated air traffic control). Air traffic management investigations have outlined these specific changes as strategies to enable further increases in the volume of air traffic. A systems approach was taken and field studies were conducted. Small numbers of domain experts such as air traffic controllers (ATCOs) were involved in the field-based observations of how people interact with systems and each other. This paper summarises the overall research approach taken and then specifically reports on the field-based observations including the justification, development, and findings of the observation tool used. The observation tool examined information propagation through the air traffic control-flightdeck (ATC-FD) system, and resulted in models of possible information trajectories through the system.

  9. Long-term Clinical and Cost Outcomes of a Pharmacist-managed Risk Factor Management Clinic in Singapore: An Observational Study.

    PubMed

    Tan, She Hui; Kng, Kwee Keng; Lim, Sze Mian; Chan, Alexandre; Loh, Jason Kwok Kong; Lee, Joyce Yu-Chia

    2017-12-01

    Few studies have determined the benefits of pharmacist-run clinics within a tertiary institution, and specifically on their capability to improve clinical outcomes as well as reduce the cost of illness. This study was designed to investigate the effectiveness of a pharmacist-managed risk factor management clinic (RFMP) in an acute care setting through the comparison of clinical (improvement in glycosylated hemoglobin level) and cost outcomes with patients receiving usual care. This single-center, observational study included patients aged ≥21 years old and diagnosed with type 2 diabetes mellitus (DM) who received care within the cardiology department of a tertiary institution between January 1, 2014, and December 31, 2015. The intervention group comprised patients who attended the RFMP for 3 to 6 months, and the usual-care group comprised patients who received standard cardiologist care. Univariate analysis and multiple linear regression were conducted to analyze the clinical and cost outcomes. A total of 142 patients with DM (71 patients in the intervention group and 71 patients in the usual-care group) with similar baseline characteristics were included. After adjusting for differences in baseline systolic blood pressure and triglyceride levels, the mean reduction in glycosylated hemoglobin level at 6 months from baseline in the intervention group was significantly lower by 0.78% compared with the usual-care group. Patients in the usual-care group had a significantly higher risk of hospital admissions within the 12 months from baseline compared with the intervention group (odds ratio, 3.84 [95% CI, 1.17-12.57]; P = 0.026). Significantly lower mean annual direct medical costs were also observed in the intervention group (US $8667.03 [$17,416.20] vs US $56,665.02 [$127,250.10]; P = 0.001). The pharmacist-managed RFMP exhibited improved clinical outcomes and reduced health care costs compared with usual care within a tertiary institute. Copyright © 2017 The

  10. Wideband Motion Control by Position and Acceleration Input Based Disturbance Observer

    NASA Astrophysics Data System (ADS)

    Irie, Kouhei; Katsura, Seiichiro; Ohishi, Kiyoshi

    The disturbance observer can observe and suppress the disturbance torque within its bandwidth. Recent motion systems begin to spread in the society and they are required to have ability to contact with unknown environment. Such a haptic motion requires much wider bandwidth. However, since the conventional disturbance observer attains the acceleration response by the second order derivative of position response, the bandwidth is limited due to the derivative noise. This paper proposes a novel structure of a disturbance observer. The proposed disturbance observer uses an acceleration sensor for enlargement of bandwidth. Generally, the bandwidth of an acceleration sensor is from 1Hz to more than 1kHz. To cover DC range, the conventional position sensor based disturbance observer is integrated. Thus, the performance of the proposed Position and Acceleration input based disturbance observer (PADO) is superior to the conventional one. The PADO is applied to position control (infinity stiffness) and force control (zero stiffness). The numerical and experimental results show viability of the proposed method.

  11. Hypoalbuminemia and acute kidney injury: a meta-analysis of observational clinical studies.

    PubMed

    Wiedermann, Christian J; Wiedermann, Wolfgang; Joannidis, Michael

    2010-10-01

    To test the hypothesis that hypoalbuminemia is independently associated with increased risk of acute kidney injury (AKI). A meta-analysis was performed of observational clinical studies evaluating the relationship between serum albumin level and the occurrence of AKI by multivariate methods. Additionally, the impact was assessed of lower serum albumin on mortality in patients who developed AKI. Eligible studies were sought by multiple methods, and adjusted odds ratios (OR) were quantitatively combined using a random effects model. Seventeen clinical studies with 3,917 total patients were included: 11 studies (6 in surgical or intensive care unit patients and 5 in other hospital settings) evaluating the influence of serum albumin on AKI incidence and 6 studies describing the relationship between serum albumin and mortality among patients who had developed AKI. Lower serum albumin was an independent predictor both of AKI and of death after AKI development. With each 10 g L(-1) serum albumin decrement, the odds of AKI increased by 134%. The pooled OR for AKI was 2.34 with a 95% confidence interval (CI) of 1.74-3.14. Among patients who had developed AKI, the odds of death rose 147% (pooled OR 2.47, 95% CI 1.51-4.05) with each 10 g L(-1) serum albumin decrement. This meta-analysis provides evidence that hypoalbuminemia is a significant independent predictor both of AKI and of death following AKI development. Serum albumin determinations may be of utility in identifying patients at increased risk for AKI or for death after AKI. Controlled studies are warranted to assess interventions aimed at correcting hypoalbuminemia.

  12. Clinical outcomes research in gynecologic oncology.

    PubMed

    Melamed, Alexander; Rauh-Hain, J Alejandro; Schorge, John O

    2017-09-01

    Clinical outcomes research seeks to understand the real-world manifestations of clinical care. In particular, outcomes research seeks to reveal the effects of pharmaceutical, procedural, and structural aspects of healthcare on patient outcomes, including mortality, disease control, toxicity, cost, and quality of life. Although outcomes research can utilize interventional study designs, insightful use of observational data is a defining feature of this field. Many questions in gynecologic oncology are not amenable to investigation in randomized clinical trials due to cost, feasibility, or ethical concerns. When a randomized trial is not practical or has not yet been conducted, well-designed observational studies have the potential to provide the best available evidence about the effects of clinical care. Such studies may use surveys, medical records, disease registries, and a variety of administrative data sources. Even when a randomized trial has been conducted, observational studies can be used to estimate the real-world effect of an intervention, which may differ from the results obtained in the controlled setting of a clinical trial. This article reviews the goals, methodologies, data sources, and limitations of clinical outcomes research, with a focus on gynecologic oncology. Copyright © 2017. Published by Elsevier Inc.

  13. Flatness-Based Tracking Control and Nonlinear Observer for a Micro Aerial Quadcopter

    NASA Astrophysics Data System (ADS)

    Rivera, G.; Sawodny, O.

    2010-09-01

    This paper deals with the design of a nonlinear observer and a differential flat based path tracking controller for a mini aerial quadcopter. Taking into account that only the inertial coordinates and the yaw angle are available for measurements, it is shown, that the system is differentially flat, allowing a systematic design of a nonlinear tracking control in open and closed loop. A nonlinear observer is carried out to estimate the roll and pitch angle as well as all the linear and angular velocities. Finally the performance of the feedback controller and observer are illustrated in a computer simulation.

  14. Stock Versus CAD/CAM Customized Zirconia Implant Abutments – Clinical and Patient‐Based Outcomes in a Randomized Controlled Clinical Trial

    PubMed Central

    Meijer, Henny J.A.; Kerdijk, Wouter; Raghoebar, Gerry M.; Cune, Marco

    2016-01-01

    Abstract Background Single‐tooth replacement often requires a prefabricated dental implant and a customized crown. The benefits of individualization of the abutment remain unclear. Purpose This randomized controlled clinical trial aims to study potential benefits of individualization of zirconia implant abutments with respect to preservation of marginal bone level and several clinical and patient‐based outcome measures. Material and Methods Fifty participants with a missing premolar were included and randomly assigned to standard (ZirDesign, DentsplySirona Implants, Mölndal, Sweden) or computer aided design/computer aided manufacturing (CAD/CAM) customized (Atlantis, DentsplySirona Implants, Mölndal, Sweden) zirconia abutment therapy. Peri‐implant bone level (primary outcome), Plaque‐index, calculus formation, bleeding on probing, gingiva index, probing pocket depth, recession, appearance of soft tissues and patients' contentment were assessed shortly after placement and one year later. Results No implants were lost and no complications related to the abutments were observed. Statistically significant differences between stock and CAD/CAM customized zirconia abutments could not be demonstrated for any of the operationalized variables. Conclusion The use of a CAD/CAM customized zirconia abutment in single tooth replacement of a premolar is not associated with an improvement in clinical performance or patients' contentment when compared to the use of a stock zirconia abutment. PMID:27476829

  15. A deep learning model observer for use in alterative forced choice virtual clinical trials

    NASA Astrophysics Data System (ADS)

    Alnowami, M.; Mills, G.; Awis, M.; Elangovanr, P.; Patel, M.; Halling-Brown, M.; Young, K. C.; Dance, D. R.; Wells, K.

    2018-03-01

    Virtual clinical trials (VCTs) represent an alternative assessment paradigm that overcomes issues of dose, high cost and delay encountered in conventional clinical trials for breast cancer screening. However, to fully utilize the potential benefits of VCTs requires a machine-based observer that can rapidly and realistically process large numbers of experimental conditions. To address this, a Deep Learning Model Observer (DLMO) was developed and trained to identify lesion targets from normal tissue in small (200 x 200 pixel) image segments, as used in Alternative Forced Choice (AFC) studies. The proposed network consists of 5 convolutional layers with 2x2 kernels and ReLU (Rectified Linear Unit) activations, followed by max pooling with size equal to the size of the final feature maps and three dense layers. The class outputs weights from the final fully connected dense layer are used to consider sets of n images in an n-AFC paradigm to determine the image most likely to contain a target. To examine the DLMO performance on clinical data, a training set of 2814 normal and 2814 biopsy-confirmed malignant mass targets were used. This produced a sensitivity of 0.90 and a specificity of 0.92 when presented with a test data set of 800 previously unseen clinical images. To examine the DLMOs minimum detectable contrast, a second dataset of 630 simulated backgrounds and 630 images with simulated lesion and spherical targets (4mm and 6mm diameter), produced contrast thresholds equivalent to/better than human observer performance for spherical targets, and comparable (12 % difference) for lesion targets.

  16. A nurse-delivered, clinic-based intervention to address intimate partner violence among low-income women in Mexico City: findings from a cluster randomized controlled trial.

    PubMed

    Gupta, Jhumka; Falb, Kathryn L; Ponta, Oriana; Xuan, Ziming; Campos, Paola Abril; Gomez, Annabel Arellano; Valades, Jimena; Cariño, Gisele; Olavarrieta, Claudia Diaz

    2017-07-12

    Rigorous evaluations of health sector interventions addressing intimate partner violence (IPV) in low- and middle-income countries are lacking. We aimed to assess whether an enhanced nurse-delivered intervention would reduce IPV and improve levels of safety planning behaviors, use of community resources, reproductive coercion, and mental quality of life. We randomized 42 public health clinics in Mexico City to treatment or control arms. In treatment clinics, women received the nurse-delivered session (IPV screening, supportive referrals, health/safety risk assessments) at baseline (T1), and a booster counselling session after 3 months (T2). In control clinics, women received screening and a referral card from nurses. Surveys were conducted at T1, T2, and T3 (15 months from baseline). Our main outcome was past-year physical and sexual IPV. Intent-to-treat analyses were conducted via three-level random intercepts models to evaluate the interaction term for treatment status by time. Between April and October 2013, 950 women (480 in control clinics, 470 in treatment clinics) with recent IPV experiences enrolled in the study. While reductions in IPV were observed for both women enrolled in treatment (OR, 0.40; 95% CI, 0.28-0.55; P < 0.01) and control (OR, 0.51; 95% CI, 0.36-0.72; P < 0.01) clinics at T3 (July to December 2014), no significant treatment effects were observed (OR, 0.78; 95% CI, 0.49-1.24; P = 0.30). At T2 (July to December 2013), women in treatment clinics reported significant improvements, compared to women in control clinics, in mental quality of life (β, 1.45; 95% CI, 0.14-2.75; P = 0.03) and safety planning behaviors (β, 0.41; 95% CI, 0.02-0.79; P = 0.04). While reductions in IPV levels were seen among women in both treatment and control clinics, the enhanced nurse intervention was no more effective in reducing IPV. The enhanced nursing intervention may offer short-term improvements in addressing safety planning and mental

  17. Design control for clinical translation of 3D printed modular scaffolds.

    PubMed

    Hollister, Scott J; Flanagan, Colleen L; Zopf, David A; Morrison, Robert J; Nasser, Hassan; Patel, Janki J; Ebramzadeh, Edward; Sangiorgio, Sophia N; Wheeler, Matthew B; Green, Glenn E

    2015-03-01

    The primary thrust of tissue engineering is the clinical translation of scaffolds and/or biologics to reconstruct tissue defects. Despite this thrust, clinical translation of tissue engineering therapies from academic research has been minimal in the 27 year history of tissue engineering. Academic research by its nature focuses on, and rewards, initial discovery of new phenomena and technologies in the basic research model, with a view towards generality. Translation, however, by its nature must be directed at specific clinical targets, also denoted as indications, with associated regulatory requirements. These regulatory requirements, especially design control, require that the clinical indication be precisely defined a priori, unlike most academic basic tissue engineering research where the research target is typically open-ended, and furthermore requires that the tissue engineering therapy be constructed according to design inputs that ensure it treats or mitigates the clinical indication. Finally, regulatory approval dictates that the constructed system be verified, i.e., proven that it meets the design inputs, and validated, i.e., that by meeting the design inputs the therapy will address the clinical indication. Satisfying design control requires (1) a system of integrated technologies (scaffolds, materials, biologics), ideally based on a fundamental platform, as compared to focus on a single technology, (2) testing of design hypotheses to validate system performance as opposed to mechanistic hypotheses of natural phenomena, and (3) sequential testing using in vitro, in vivo, large preclinical and eventually clinical tests against competing therapies, as compared to single experiments to test new technologies or test mechanistic hypotheses. Our goal in this paper is to illustrate how design control may be implemented in academic translation of scaffold based tissue engineering therapies. Specifically, we propose to (1) demonstrate a modular platform approach

  18. Design Control for Clinical Translation of 3D Printed Modular Scaffolds

    PubMed Central

    Hollister, Scott J.; Flanagan, Colleen L.; Zopf, David A.; Morrison, Robert J.; Nasser, Hassan; Patel, Janki J.; Ebramzadeh, Edward; Sangiorgio, Sophia N.; Wheeler, Matthew B.; Green, Glenn E.

    2015-01-01

    The primary thrust of tissue engineering is the clinical translation of scaffolds and/or biologics to reconstruct tissue defects. Despite this thrust, clinical translation of tissue engineering therapies from academic research has been minimal in the 27 year history of tissue engineering. Academic research by its nature focuses on, and rewards, initial discovery of new phenomena and technologies in the basic research model, with a view towards generality. Translation, however, by its nature must be directed at specific clinical targets, also denoted as indications, with associated regulatory requirements. These regulatory requirements, especially design control, require that the clinical indication be precisely defined a priori, unlike most academic basic tissue engineering research where the research target is typically open-ended, and furthermore requires that the tissue engineering therapy be constructed according to design inputs that ensure it treats or mitigates the clinical indication. Finally, regulatory approval dictates that the constructed system be verified, i.e., proven that it meets the design inputs, and validated, i.e., that by meeting the design inputs the therapy will address the clinical indication. Satisfying design control requires (1) a system of integrated technologies (scaffolds, materials, biologics), ideally based on a fundamental platform, as compared to focus on a single technology, (2) testing of design hypotheses to validate system performance as opposed to mechanistic hypotheses of natural phenomena, and (3) sequential testing using in vitro, in vivo, large preclinical and eventually clinical tests against competing therapies, as compared to single experiments to test new technologies or test mechanistic hypotheses. Our goal in this paper is to illustrate how design control may be implemented in academic translation of scaffold based tissue engineering therapies. Specifically, we propose to (1) demonstrate a modular platform approach

  19. Convergence between observations and interviews in clinical diagnosis of reactive attachment disorder and disinhibited social engagement disorder.

    PubMed

    Giltaij, Hans Peter; Sterkenburg, Paula Sophia; Schuengel, Carlo

    2017-10-01

    A comprehensive approach is needed for diagnosing disordered attachment behavior due to the multifaceted nature of attachment. Differences between various indicators can pose a challenge for deciding on the proper diagnosis. This study assessed the convergence between clinical interview assessment and observation-based clinical diagnosis, and their linkages with inadequate care. Participating children ( N = 55) had intelligence quotients (IQs) between 50 and 85 and were referred for psychiatric consultation. Data were obtained by structured review of medical records, the Disturbances of Attachment Interview (DAI), and the Clinical Observation of Attachment (COA) procedure. Of the 18 children identified using the DAI with Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) diagnosis of reactive attachment disorder (RAD) and/or disinhibited social engagement disorder (DSED), only 7 received a clinical DSM-5 diagnosis of RAD and/or DSED. Observed maladaptive attachment behavior in the COA was strongly associated with DAI scores and with clinical diagnosis of DSM-5 RAD and/or DSED. There was a significantly higher prevalence of extremes of insufficient care in children who were classified with RAD by DAI or DSM-5 and/or with DSED by DSM-5 compared to those with no attachment disorder. Using structured observation and record assessment leads to more conservative identification of RAD or DSED than using the DAI.

  20. Monitoring progression of clinical reasoning skills during health sciences education using the case method - a qualitative observational study.

    PubMed

    Orban, Kristina; Ekelin, Maria; Edgren, Gudrun; Sandgren, Olof; Hovbrandt, Pia; Persson, Eva K

    2017-09-11

    Outcome- or competency-based education is well established in medical and health sciences education. Curricula are based on courses where students develop their competences and assessment is also usually course-based. Clinical reasoning is an important competence, and the aim of this study was to monitor and describe students' progression in professional clinical reasoning skills during health sciences education using observations of group discussions following the case method. In this qualitative study students from three different health education programmes were observed while discussing clinical cases in a modified Harvard case method session. A rubric with four dimensions - problem-solving process, disciplinary knowledge, character of discussion and communication - was used as an observational tool to identify clinical reasoning. A deductive content analysis was performed. The results revealed the students' transition over time from reasoning based strictly on theoretical knowledge to reasoning ability characterized by clinical considerations and experiences. Students who were approaching the end of their education immediately identified the most important problem and then focused on this in their discussion. Practice knowledge increased over time, which was seen as progression in the use of professional language, concepts, terms and the use of prior clinical experience. The character of the discussion evolved from theoretical considerations early in the education to clinical reasoning in later years. Communication within the groups was supportive and conducted with a professional tone. Our observations revealed progression in several aspects of students' clinical reasoning skills on a group level in their discussions of clinical cases. We suggest that the case method can be a useful tool in assessing quality in health sciences education.

  1. Control of linear uncertain systems utilizing mismatched state observers

    NASA Technical Reports Server (NTRS)

    Goldstein, B.

    1972-01-01

    The control of linear continuous dynamical systems is investigated as a problem of limited state feedback control. The equations which describe the structure of an observer are developed constrained to time-invarient systems. The optimal control problem is formulated, accounting for the uncertainty in the design parameters. Expressions for bounds on closed loop stability are also developed. The results indicate that very little uncertainty may be tolerated before divergence occurs in the recursive computation algorithms, and the derived stability bound yields extremely conservative estimates of regions of allowable parameter variations.

  2. The barriers and motivators to learning infection control in clinical placements: interviews with midwifery students.

    PubMed

    Ward, Deborah J

    2013-05-01

    To investigate the barriers to and motivators for learning infection prevention and control as identified by midwifery students. Semi-structured interviews were undertaken with 15 undergraduate midwifery students within one large university. Data were analysed using Framework Analysis. Barriers to good clinical practice were identified by students which were concordant with previous literature related to reasons for non-compliance with infection control precautions. Issues such as competing demands specific to midwifery were also identified. Factors which act as barriers to learning good practice in placements included conflicting information and practices from different staff and placement areas and staff attitudes towards students who tried to comply with precautions. Motivators to good practice included the perceived vulnerability of infants to infection, the role modelling of good practice to new mothers and the monitoring of practice. This study demonstrated that midwifery students perceive barriers and motivators to learning infection prevention and control in their clinical placements. Many of the barriers identified are related to the attitudes and practices of qualified staff. Some of the motivators are related specifically to midwifery practice. Midwives need to be aware of the effects of what is observed in practice on midwifery students and how their practices and attitudes can influence learning both positively and negatively. As healthcare-associated infection and poor compliance with precautions are a global problem, this research should be of benefit to midwives and midwifery educators worldwide in terms of addressing barriers and ensuring better clinical education. Copyright © 2012 Elsevier Ltd. All rights reserved.

  3. Non-fragile observer-based output feedback control for polytopic uncertain system under distributed model predictive control approach

    NASA Astrophysics Data System (ADS)

    Zhu, Kaiqun; Song, Yan; Zhang, Sunjie; Zhong, Zhaozhun

    2017-07-01

    In this paper, a non-fragile observer-based output feedback control problem for the polytopic uncertain system under distributed model predictive control (MPC) approach is discussed. By decomposing the global system into some subsystems, the computation complexity is reduced, so it follows that the online designing time can be saved.Moreover, an observer-based output feedback control algorithm is proposed in the framework of distributed MPC to deal with the difficulties in obtaining the states measurements. In this way, the presented observer-based output-feedback MPC strategy is more flexible and applicable in practice than the traditional state-feedback one. What is more, the non-fragility of the controller has been taken into consideration in favour of increasing the robustness of the polytopic uncertain system. After that, a sufficient stability criterion is presented by using Lyapunov-like functional approach, meanwhile, the corresponding control law and the upper bound of the quadratic cost function are derived by solving an optimisation subject to convex constraints. Finally, some simulation examples are employed to show the effectiveness of the method.

  4. Future enhanced clinical role of pharmacists in Emergency Departments in England: multi-site observational evaluation.

    PubMed

    Hughes, Elizabeth; Terry, David; Huynh, Chi; Petridis, Konstantinos; Aiello, Matthew; Mazard, Louis; Ubhi, Hirminder; Terry, Alex; Wilson, Keith; Sinclair, Anthony

    2017-08-01

    Background There are concerns about maintaining appropriate clinical staffing levels in Emergency Departments. Pharmacists may be one possible solution. Objective To determine if Emergency Department attendees could be clinically managed by pharmacists with or without advanced clinical practice training. Setting Prospective 49 site cross-sectional observational study of patients attending Emergency Departments in England. Method Pharmacist data collectors identified patient attendance at their Emergency Department, recorded anonymized details of 400 cases and categorized each into one of four possible options: cases which could be managed by a community pharmacist; could be managed by a hospital pharmacist independent prescriber; could be managed by a hospital pharmacist independent prescriber with additional clinical training; or medical team only (unsuitable for pharmacists to manage). Impact indices sensitive to both workload and proportion of pharmacist manageable cases were calculated for each clinical group. Main outcome measure Proportion of cases which could be managed by a pharmacist. Results 18,613 cases were observed from 49 sites. 726 (3.9%) of cases were judged suitable for clinical management by community pharmacists, 719 (3.9%) by pharmacist prescribers, 5202 (27.9%) by pharmacist prescribers with further training, and 11,966 (64.3%) for medical team only. Impact Indices of the most frequent clinical groupings were general medicine (13.18) and orthopaedics (9.69). Conclusion The proportion of Emergency Department cases that could potentially be managed by a pharmacist was 36%. Greatest potential for pharmacist management was in general medicine and orthopaedics (usually minor trauma). Findings support the case for extending the clinical role of pharmacists.

  5. Observation and Control of Shock Waves in Individual Nanoplasmas

    DTIC Science & Technology

    2014-03-18

    Observation and Control of Shock Waves in Individual Nanoplasmas Daniel D. Hickstein,1 Franklin Dollar,1 Jim A. Gaffney,2 Mark E. Foord,2 George M...distribution of individual, isolated 100-nm-scale plasmas, we make the first experimental observation of shock waves in nanoplasmas . We demonstrate that...i Nanoscale plasmas ( nanoplasmas ) offer enhanced laser absorption compared to solid or gas targets [1], enabling high-energy physics with tabletop

  6. Boundary control for a flexible manipulator based on infinite dimensional disturbance observer

    NASA Astrophysics Data System (ADS)

    Jiang, Tingting; Liu, Jinkun; He, Wei

    2015-07-01

    This paper focuses on disturbance observer and boundary control design for the flexible manipulator in presence of both boundary disturbance and spatially distributed disturbance. Taking the infinite-dimensionality of the flexural dynamics into account, this study proposes a partial differential equation (PDE) model. Since the spatially distributed disturbance is infinite dimensional, it cannot be compensated by the typical disturbance observer, which is designed by finite dimensional approach. To estimate the spatially distributed disturbance, we propose a novel infinite dimensional disturbance observer (IDDO). Applying the IDDO as a feedforward compensator, a boundary control scheme is designed to regulate the joint position and eliminate the elastic vibration simultaneously. Theoretical analysis validates the stability of both the proposed disturbance observer and the boundary controller. The performance of the closed-loop system is demonstrated by numerical simulations.

  7. The clinical course of low back pain: a meta-analysis comparing outcomes in randomised clinical trials (RCTs) and observational studies

    PubMed Central

    2014-01-01

    Background Evidence suggests that the course of low back pain (LBP) symptoms in randomised clinical trials (RCTs) follows a pattern of large improvement regardless of the type of treatment. A similar pattern was independently observed in observational studies. However, there is an assumption that the clinical course of symptoms is particularly influenced in RCTs by mere participation in the trials. To test this assumption, the aim of our study was to compare the course of LBP in RCTs and observational studies. Methods Source of studies CENTRAL database for RCTs and MEDLINE, CINAHL, EMBASE and hand search of systematic reviews for cohort studies. Studies include individuals aged 18 or over, and concern non-specific LBP. Trials had to concern primary care treatments. Data were extracted on pain intensity. Meta-regression analysis was used to compare the pooled within-group change in pain in RCTs with that in cohort studies calculated as the standardised mean change (SMC). Results 70 RCTs and 19 cohort studies were included, out of 1134 and 653 identified respectively. LBP symptoms followed a similar course in RCTs and cohort studies: a rapid improvement in the first 6 weeks followed by a smaller further improvement until 52 weeks. There was no statistically significant difference in pooled SMC between RCTs and cohort studies at any time point:- 6 weeks: RCTs: SMC 1.0 (95% CI 0.9 to 1.0) and cohorts 1.2 (0.7to 1.7); 13 weeks: RCTs 1.2 (1.1 to 1.3) and cohorts 1.0 (0.8 to 1.3); 27 weeks: RCTs 1.1 (1.0 to 1.2) and cohorts 1.2 (0.8 to 1.7); 52 weeks: RCTs 0.9 (0.8 to 1.0) and cohorts 1.1 (0.8 to 1.6). Conclusions The clinical course of LBP symptoms followed a pattern that was similar in RCTs and cohort observational studies. In addition to a shared ‘natural history’, enrolment of LBP patients in clinical studies is likely to provoke responses that reflect the nonspecific effects of seeking and receiving care, independent of the study design. PMID:24607083

  8. Dextromethorphan/Quinidine in Migraine Prophylaxis: An Open-label Observational Clinical Study.

    PubMed

    Berkovich, Regina R; Sokolov, Alexey Y; Togasaki, Daniel M; Yakupova, Aida A; Cesar, Paul-Henry; Sahai-Srivastava, Soma

    This study aimed to assess potential efficacy and safety of dextromethorphan/quinidine (DMQ) in prophylactic treatment of migraine in patients with multiple sclerosis (MS) with superimposed pseudobulbar affect (PBA). Multiple sclerosis patients with superimposed PBA and comorbid migraine were enrolled into this open-label observational study at the University of Southern California Comprehensive MS Center. The baseline characteristics included, among other data, frequency and severity of acute migraine attacks and use of migraine relievers. The DMQ was used exclusively per its primary indication - PBA symptoms control - 20/10 mg orally, twice a day for the mean of 4.5 months (the shortest exposure registered was 3 months and the longest, 6 months). To determine whether treatment caused an effect on migraine frequency and severity, the baseline and posttreatment values were compared using nonparametric sign test. Thirty-three MS subjects with PBA, who also suffered from migraines, were identified. Twenty-nine subjects had improvement in headache frequency, 4 had no change, and none had worsening (P < 0.001 as compared with the baseline). Twenty-eight subjects had improvement in headache severity, 5 had no change, and none had worsening (P < 0.001). Our pilot study results provide evidence that DMQ shows promise as a candidate for larger clinical studies evaluating its efficacy for the prevention of migraine headaches.

  9. Operational Control Procedures for the Activated Sludge Process, Part I - Observations, Part II - Control Tests.

    ERIC Educational Resources Information Center

    West, Alfred W.

    This is the first in a series of documents developed by the National Training and Operational Technology Center describing operational control procedures for the activated sludge process used in wastewater treatment. Part I of this document deals with physical observations which should be performed during each routine control test. Part II…

  10. Feedback control methods for drug dosage optimisation. Concepts, classification and clinical application.

    PubMed

    Vozeh, S; Steimer, J L

    1985-01-01

    The concept of feedback control methods for drug dosage optimisation is described from the viewpoint of control theory. The control system consists of 5 parts: (a) patient (the controlled process); (b) response (the measured feedback); (c) model (the mathematical description of the process); (d) adaptor (to update the parameters); and (e) controller (to determine optimum dosing strategy). In addition to the conventional distinction between open-loop and closed-loop control systems, a classification is proposed for dosage optimisation techniques which distinguishes between tight-loop and loose-loop methods depending on whether physician's interaction is absent or included as part of the control step. Unlike engineering problems where the process can usually be controlled by fully automated devices, therapeutic situations often require that the physician be included in the decision-making process to determine the 'optimal' dosing strategy. Tight-loop and loose-loop methods can be further divided into adaptive and non-adaptive, depending on the presence of the adaptor. The main application areas of tight-loop feedback control methods are general anaesthesia, control of blood pressure, and insulin delivery devices. Loose-loop feedback methods have been used for oral anticoagulation and in therapeutic drug monitoring. The methodology, advantages and limitations of the different approaches are reviewed. A general feature common to all application areas could be observed: to perform well under routine clinical conditions, which are characterised by large interpatient variability and sometimes also intrapatient changes, control systems should be adaptive. Apart from application in routine drug treatment, feedback control methods represent an important research tool. They can be applied for the investigation of pathophysiological and pharmacodynamic processes. A most promising application is the evaluation of the relationship between an intermediate response (e.g. drug

  11. Quality controls in cellular immunotherapies: rapid assessment of clinical grade dendritic cells by gene expression profiling.

    PubMed

    Castiello, Luciano; Sabatino, Marianna; Zhao, Yingdong; Tumaini, Barbara; Ren, Jiaqiang; Ping, Jin; Wang, Ena; Wood, Lauren V; Marincola, Francesco M; Puri, Raj K; Stroncek, David F

    2013-02-01

    Cell-based immunotherapies are among the most promising approaches for developing effective and targeted immune response. However, their clinical usefulness and the evaluation of their efficacy rely heavily on complex quality control assessment. Therefore, rapid systematic methods are urgently needed for the in-depth characterization of relevant factors affecting newly developed cell product consistency and the identification of reliable markers for quality control. Using dendritic cells (DCs) as a model, we present a strategy to comprehensively characterize manufactured cellular products in order to define factors affecting their variability, quality and function. After generating clinical grade human monocyte-derived mature DCs (mDCs), we tested by gene expression profiling the degrees of product consistency related to the manufacturing process and variability due to intra- and interdonor factors, and how each factor affects single gene variation. Then, by calculating for each gene an index of variation we selected candidate markers for identity testing, and defined a set of genes that may be useful comparability and potency markers. Subsequently, we confirmed the observed gene index of variation in a larger clinical data set. In conclusion, using high-throughput technology we developed a method for the characterization of cellular therapies and the discovery of novel candidate quality assurance markers.

  12. Speed tracking control of pneumatic motor servo systems using observation-based adaptive dynamic sliding-mode control

    NASA Astrophysics Data System (ADS)

    Chen, Syuan-Yi; Gong, Sheng-Sian

    2017-09-01

    This study aims to develop an adaptive high-precision control system for controlling the speed of a vane-type air motor (VAM) pneumatic servo system. In practice, the rotor speed of a VAM depends on the input mass air flow, which can be controlled by the effective orifice area (EOA) of an electronic throttle valve (ETV). As the control variable of a second-order pneumatic system is the integral of the EOA, an observation-based adaptive dynamic sliding-mode control (ADSMC) system is proposed to derive the differential of the control variable, namely, the EOA control signal. In the ADSMC system, a proportional-integral-derivative fuzzy neural network (PIDFNN) observer is used to achieve an ideal dynamic sliding-mode control (DSMC), and a supervisor compensator is designed to eliminate the approximation error. As a result, the ADSMC incorporates the robustness of a DSMC and the online learning ability of a PIDFNN. To ensure the convergence of the tracking error, a Lyapunov-based analytical method is employed to obtain the adaptive algorithms required to tune the control parameters of the online ADSMC system. Finally, our experimental results demonstrate the precision and robustness of the ADSMC system for highly nonlinear and time-varying VAM pneumatic servo systems.

  13. Clinical and scientific importance of source control in abdominal infections: summary of a symposium

    PubMed Central

    Bohnen, John M.A.; Marshall, John C.; Fry, Donald E.; Johnson, Steven B.; Solomkin, Joseph S.

    1999-01-01

    In May 1997, a panel of surgeon-investigators met to discuss the clinical importance and research implications of controlling the source of abdominal infections. It was concluded that source control is critical to therapeutic success and that antimicrobial therapy and other adjunctive interventions will fail if the source of infection is not controlled by resection, exteriorization or other means. The panelists presented different definitions of source control, depending on the scientific purpose of the definition. All participants agreed that failure to consider the adequacy of source control of infection has limited the value of most clinical trials of therapeutic anti-infective agents. Besides recognizing source control as an essential goal of patient care, the panelists emphasized the need for further investigative work to define, record and stratify the adequacy of source control in clinical trials of therapeutic agents for abdominal infections. PMID:10223073

  14. The effect of active video games on cognitive functioning in clinical and non-clinical populations: A meta-analysis of randomized controlled trials.

    PubMed

    Stanmore, Emma; Stubbs, Brendon; Vancampfort, Davy; de Bruin, Eling D; Firth, Joseph

    2017-07-01

    Physically-active video games ('exergames') have recently gained popularity for leisure and entertainment purposes. Using exergames to combine physical activity and cognitively-demanding tasks may offer a novel strategy to improve cognitive functioning. Therefore, this systematic review and meta-analysis was performed to establish effects of exergames on overall cognition and specific cognitive domains in clinical and non-clinical populations. We identified 17 eligible RCTs with cognitive outcome data for 926 participants. Random-effects meta-analyses found exergames significantly improved global cognition (g=0.436, 95% CI=0.18-0.69, p=0.001). Significant effects still existed when excluding waitlist-only controlled studies, and when comparing to physical activity interventions. Furthermore, benefits of exergames where observed for both healthy older adults and clinical populations with conditions associated with neurocognitive impairments (all p<0.05). Domain-specific analyses found exergames improved executive functions, attentional processing and visuospatial skills. The findings present the first meta-analytic evidence for effects of exergames on cognition. Future research must establish which patient/treatment factors influence efficacy of exergames, and explore neurobiological mechanisms of action. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

  15. Involving clinical librarians at the point of care: results of a controlled intervention.

    PubMed

    Aitken, Elizabeth M; Powelson, Susan E; Reaume, Renée D; Ghali, William A

    2011-12-01

    To measure the effect of including a clinical librarian in the health care team on medical residents and clinical clerks. In 2009, medical residents and clinical clerks were preassigned to one of two patient care teams (intervention and control). Each team had a month-long rotation on the general medicine teaching unit. The clinical librarian joined the intervention team for morning intake, clinical rounding, or an afternoon patient list review, providing immediate literature searches, formal group instruction, informal bedside teaching, and/or individual mentoring for use of preappraised resources and evidence-based medicine search techniques. Both intervention and control teams completed pre and post surveys comparing their confidence levels and awareness of resources as well as their self-reported use of evidence for making patient care decisions. The nonintervention team was surveyed as the control group. The clinical librarian intervention had a significant positive effect on medical trainees' self-reported ability to independently locate and evaluate evidence resources to support patient care decisions. Notably, 30 of 34 (88%) reported having changed a treatment plan based on skills taught by the clinical librarian, and 27 of 34 (79%) changed a treatment plan based on the librarian's mediated search support. Clinical librarians on the care team led to positive effects on self-reported provider attitudes, provider information retrieval tendencies, and, notably, clinical decision making. Future research should evaluate economic effects of widespread implementation of on-site clinical librarians.

  16. Clinical observation, pharmacotherapy and referral on discharge of patients with anxiety disorder in a psychiatric emergency service.

    PubMed

    Pailhez, Guillem; Majó, Albert; Córcoles, David; Ginés, José M; Arcega, José M; Castaño, Juan; Merino, Ana; Bulbena, Antonio; Pérez, Víctor

    2015-01-01

    To analyze factors associated with clinical observation, pharmacotherapy and referral on discharge of patients with anxiety disorder (AD) seeking care at a psychiatric emergency unit. A total of 5003 consecutive visits were reviewed over a three-year period at a psychiatric emergency service in a tertiary university hospital. Data collected included sociodemographic and clinical information as well as the Global Assessment of Functioning (GAF) and the Severity Psychiatric Illness (SPI) scale scores. Of all the visits, 992 (19.8%) were diagnosed of AD. Of these, 19.6% required clinical observation and 72.2% were referred to a psychiatrist at discharge. Regression analysis showed that referral to psychiatry was associated with being male, native, psychiatric background, greater severity, lower global functioning, and behavioral disorders. Clinical observation (in a box) was associated with being female, greater severity, and psychotic or behavioral symptoms. Prescription of benzodiazepines was associated with anxiety, no history of addiction, and lower global functioning. Antidepressants were associated with being a native, anxiety with no history of addiction, and lower functioning. Antipsychotics were associated with being native, psychiatric background (not addiction), anxiety, and lower functioning. Behavior, psychiatric background and illness severity were determinants of referral to a specialist. Besides these, psychotic symptoms and non-specific clinical symptoms were determinants of observation. Drug prescription in AD is less frequent if the main complaint is not anxiety and depends more on the level of functioning than on that of severity.

  17. Causal inference from observational data.

    PubMed

    Listl, Stefan; Jürges, Hendrik; Watt, Richard G

    2016-10-01

    Randomized controlled trials have long been considered the 'gold standard' for causal inference in clinical research. In the absence of randomized experiments, identification of reliable intervention points to improve oral health is often perceived as a challenge. But other fields of science, such as social science, have always been challenged by ethical constraints to conducting randomized controlled trials. Methods have been established to make causal inference using observational data, and these methods are becoming increasingly relevant in clinical medicine, health policy and public health research. This study provides an overview of state-of-the-art methods specifically designed for causal inference in observational data, including difference-in-differences (DiD) analyses, instrumental variables (IV), regression discontinuity designs (RDD) and fixed-effects panel data analysis. The described methods may be particularly useful in dental research, not least because of the increasing availability of routinely collected administrative data and electronic health records ('big data'). © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  18. Neural-network-observer-based optimal control for unknown nonlinear systems using adaptive dynamic programming

    NASA Astrophysics Data System (ADS)

    Liu, Derong; Huang, Yuzhu; Wang, Ding; Wei, Qinglai

    2013-09-01

    In this paper, an observer-based optimal control scheme is developed for unknown nonlinear systems using adaptive dynamic programming (ADP) algorithm. First, a neural-network (NN) observer is designed to estimate system states. Then, based on the observed states, a neuro-controller is constructed via ADP method to obtain the optimal control. In this design, two NN structures are used: a three-layer NN is used to construct the observer which can be applied to systems with higher degrees of nonlinearity and without a priori knowledge of system dynamics, and a critic NN is employed to approximate the value function. The optimal control law is computed using the critic NN and the observer NN. Uniform ultimate boundedness of the closed-loop system is guaranteed. The actor, critic, and observer structures are all implemented in real-time, continuously and simultaneously. Finally, simulation results are presented to demonstrate the effectiveness of the proposed control scheme.

  19. Clinical observation of fallopian tube obstruction recanalization by ozone

    PubMed Central

    Sun, Niuniu; Wei, Lequn; Chen, Diansen; Gao, Wanqin; Niu, Huanzhang; He, Chao

    2017-01-01

    Objective: To investigate the clinical effect of fallopian tube obstruction recanalization by ozone. Methods: Total 116 cases of patients undergoing the fallopian tube obstruction were randomly divided into the experimental group and control group, with 58 cases in each group. All patients underwent the interventional fallopian tube recanalization. The patients in the experimental group underwent the fallopian tube perfusion by the ozone water. Meanwhile, the patients in the control group were treated with the conventional anti-inflammatory and anti-adhesion drugs. After the follow-up visit for 6 months, the pregnancy rate and fallopian tube re-occlusion rate were counted and compared between the two groups. Meanwhile, the symptoms were evaluated and compared between the two groups after the operation for two weeks. Results: The success rate of fallopian tube recanalization was 93.1% (54/58), the pregnancy rate was 79.3% (46/58) and the recurrence rate was 5.2% (3/58) in the experimental group. While the success rate of fallopian tube recanalization was 91.4% (53/58), the pregnancy rate was 60.3% (35/58) and the recurrence rate was 17.2% (10/58) in the control group. Analysis showed that there was no significant difference in the recanalization success rate between the two groups (P>0.05). However, the pregnancy rate and re-occlusion rate in the experimental group were significantly lower than those of the control group (P<0.05), and the difference was statistically significant. There was no significant difference in the discomfort symptoms between the experimental group and control group (P>0.05). Conclusion: Fallopian tube recanalization by ozone perfusion can effectively increase the postoperative pregnancy rate and reduce the fallopian tube re-occlusion. PMID:28523024

  20. Switched-Observer-Based Adaptive Neural Control of MIMO Switched Nonlinear Systems With Unknown Control Gains.

    PubMed

    Long, Lijun; Zhao, Jun

    2017-07-01

    In this paper, the problem of adaptive neural output-feedback control is addressed for a class of multi-input multioutput (MIMO) switched uncertain nonlinear systems with unknown control gains. Neural networks (NNs) are used to approximate unknown nonlinear functions. In order to avoid the conservativeness caused by adoption of a common observer for all subsystems, an MIMO NN switched observer is designed to estimate unmeasurable states. A new switched observer-based adaptive neural control technique for the problem studied is then provided by exploiting the classical average dwell time (ADT) method and the backstepping method and the Nussbaum gain technique. It effectively handles the obstacle about the coexistence of multiple Nussbaum-type function terms, and improves the classical ADT method, since the exponential decline property of Lyapunov functions for individual subsystems is no longer satisfied. It is shown that the technique proposed is able to guarantee semiglobal uniformly ultimately boundedness of all the signals in the closed-loop system under a class of switching signals with ADT, and the tracking errors converge to a small neighborhood of the origin. The effectiveness of the approach proposed is illustrated by its application to a two inverted pendulum system.

  1. An autonomous observation and control system based on EPICS and RTS2 for Antarctic telescopes

    NASA Astrophysics Data System (ADS)

    Zhang, Guang-yu; Wang, Jian; Tang, Peng-yi; Jia, Ming-hao; Chen, Jie; Dong, Shu-cheng; Jiang, Fengxin; Wu, Wen-qing; Liu, Jia-jing; Zhang, Hong-fei

    2016-01-01

    For unattended telescopes in Antarctic, the remote operation, autonomous observation and control are essential. An EPICS-(Experimental Physics and Industrial Control System) and RTS2-(Remote Telescope System, 2nd Version) based autonomous observation and control system with remoted operation is introduced in this paper. EPICS is a set of open source software tools, libraries and applications developed collaboratively and used worldwide to create distributed soft real-time control systems for scientific instruments while RTS2 is an open source environment for control of a fully autonomous observatory. Using the advantage of EPICS and RTS2, respectively, a combined integrated software framework for autonomous observation and control is established that use RTS2 to fulfil the function of astronomical observation and use EPICS to fulfil the device control of telescope. A command and status interface for EPICS and RTS2 is designed to make the EPICS IOC (Input/Output Controller) components integrate to RTS2 directly. For the specification and requirement of control system of telescope in Antarctic, core components named Executor and Auto-focus for autonomous observation is designed and implemented with remote operation user interface based on browser-server mode. The whole system including the telescope is tested in Lijiang Observatory in Yunnan Province for practical observation to complete the autonomous observation and control, including telescope control, camera control, dome control, weather information acquisition with the local and remote operation.

  2. [Post-marketing reevaluation for potential quality risk and quality control in clinical application of traditional Chinese medicines].

    PubMed

    Li, Hong-jiao; He, Li-yun; Liu, Bao-yan

    2015-06-01

    The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines (TCM) focuses on the efficacy, adverse reaction, combined medication and effective dose of drugs in the market by expanded clinical trials, and requires a larger sample size and a wider range of patients. Therefore, this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold, researchers in this study reviewed the study purpose, project, scheme design and clinical practice process from an overall point of view, analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks, designed the quality control contents with quality impacting factors, defined key review contents and summarized the precautions in clinical practices, with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs.

  3. Novel disturbance-observer-based control for systems with high-order mismatched disturbances

    NASA Astrophysics Data System (ADS)

    Fang, Xing; Liu, Fei; Wang, Zhiguo; Dong, Na

    2018-01-01

    A novel disturbance-observer-based control method is investigated to attenuate the high-order mismatched disturbances. First, a finite-time disturbance observer (FTDO) is proposed to estimate the disturbances as well as the derivatives. By incorporating the outputs of FTDO, the original system is then reconstructed, where the mismatched disturbances are transformed to the matched ones that are compensated by feed-forward algorithm. Moreover, a feedback control law is developed to achieve the stability and tracking performance requirements for the systems. Finally, the proposed composite control method is applied to an unmanned helicopter system. The simulation results demonstrate that the proposed control method exhibits excellent control performance in the presence of high-order matched and mismatched disturbances.

  4. [Usage of Calendula officinalis in the prevention and treatment of radiodermatitis: a randomized double-blind controlled clinical trial].

    PubMed

    Schneider, Franciane; Danski, Mitzy Tannia Reichembach; Vayego, Stela Adami

    2015-04-01

    To evaluate the efficacy of Calendula officinalis in relation to Essential Fatty Acids for the prevention and treatment of radiodermatitis. This is a randomized double-blind controlled clinical trial with 51 patients with head and neck cancer in radiotherapy treatment divided into two groups: control (27) and experimental (24). There is statistically significant evidence (p-value = 0.0120) that the proportion of radiodermatitis grade 2 in Essential Fatty Acids group is higher than Calendula group. Through the Kaplan-Meier survival curve we observed that Essential Fatty Acids group has always remained below the Calendula group survival curve, due to the lower risk of developing radiodermatitis grade 1, which makes the usage of Calendula more effective, with statistical significance (p-value = 0.00402). Calendula showed better therapeutic response than the Essential Fatty Acids in the prevention and treatment of radiodermatitis. Brazilian Registry of Clinical Trials: RBR-237v4b.

  5. Utilizing measure-based feedback in control-mastery theory: A clinical error.

    PubMed

    Snyder, John; Aafjes-van Doorn, Katie

    2016-09-01

    Clinical errors and ruptures are an inevitable part of clinical practice. Often times, therapists are unaware that a clinical error or rupture has occurred, leaving no space for repair, and potentially leading to patient dropout and/or less effective treatment. One way to overcome our blind spots is by frequently and systematically collecting measure-based feedback from the patient. Patient feedback measures that focus on the process of psychotherapy such as the Patient's Experience of Attunement and Responsiveness scale (PEAR) can be used in conjunction with treatment outcome measures such as the Outcome Questionnaire 45.2 (OQ-45.2) to monitor the patient's therapeutic experience and progress. The regular use of these types of measures can aid clinicians in the identification of clinical errors and the associated patient deterioration that might otherwise go unnoticed and unaddressed. The current case study describes an instance of clinical error that occurred during the 2-year treatment of a highly traumatized young woman. The clinical error was identified using measure-based feedback and subsequently understood and addressed from the theoretical standpoint of the control-mastery theory of psychotherapy. An alternative hypothetical response is also presented and explained using control-mastery theory. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  6. Brief strategic therapy for obsessive-compulsive disorder: a clinical and research protocol of a one-group observational study.

    PubMed

    Pietrabissa, Giada; Manzoni, Gian Mauro; Gibson, Padraic; Boardman, Donald; Gori, Alessio; Castelnuovo, Gianluca

    2016-03-24

    Obsessive-compulsive disorder (OCD) is a disabling psychopathology. The mainstay of treatment includes cognitive-behavioural therapy (CBT) and medication management. However, individual suffering, functional impairments as well as the direct and indirect costs associated with the disease remain substantial. New treatment programmes are necessary and the brief strategic therapy (BST) has recently shown encouraging results in clinical practice but no quantitative study has as yet been conducted. The clinical effectiveness of the OCD-specific BST protocol will be evaluated in a one-group observational study. Participants will be sequentially recruited from a state community psychotherapy clinic in Dublin, Ireland. Outcome measures will be the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and the Beck Depression Inventory-II (BDI-II). Data will be collected at baseline, at treatment termination and at 3 month follow-up. The statistical significance of the post-treatment effect will be assessed by the paired-sample Student t test, while clinical significance will be evaluated by means of the equivalence testing method, which will be also used to assess the maintenance of effect at follow-up. The present study is approved by the Hesed House Ethics Board in Dublin. Findings will enhance the evidence-based knowledge about the clinical effectiveness of BST in treating OCD symptoms, prior to assessing its efficacy in a randomised and controlled clinical trial, and will be disseminated through publication in peer-reviewed journals and conference presentations. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  7. Blood glucose control and quality of health care in non-insulin-treated patients with Type 2 diabetes in Spain: a retrospective and cross-sectional observational study

    PubMed Central

    Rodríguez, A; Calle, A; Vázquez, L; Chacón, F; Polavieja, P; Reviriego, J

    2011-01-01

    Aims To assess blood glucose control and quality of health care provided to non-insulin-treated patients with Type 2 diabetes mellitus in routine clinical practice in Spain. Methods In this observational, retrospective, cross-sectional study, patients were grouped as either having good or suboptimal blood glucose control according to International Diabetes Federation or American Diabetes Association HbA1c goals. Clinical and socio-demographic data and compliance with the main standard level of care recommendations of the International Diabetes Federation were recorded during a routine visit. Correlates of glucose control were analysed by logistic regression. Results Many patients were grouped as having suboptimal control under International Diabetes Federation (61.9%) or American Diabetes Association (45.0%) criteria. The mean number of accomplished International Diabetes Federation recommendations (7.3 out of 11) was higher for endocrinologists (than for internists or primary care physicians), and significantly more patients under their care were in the good glucose control group (than with primary care physicians). More recommendations were associated with blood glucose control using International Diabetes Federation than American Diabetes Association criteria, demanding higher quality of health care for achieving stricter goals. Some recommendations were poorly observed, particularly those concerning patients’ education on diabetes, the prompt prescription of effective treatments and monitoring of complications. Diabetes complications were associated with being in the suboptimal control group. Patients’ education on diabetes and HbA1c monitoring were associated with being in the good control group. Conclusions These results demonstrate the need for improvement in the management of patients with non-insulin-treated Type 2 diabetes in actual clinical practice in Spain. Such improvement would entail a stricter adherence to International Diabetes Federation

  8. 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

  9. [Clinical observation of sleeping disorder in children with encephalopathy treated with acupuncture at head points and seed-pressure at ear points].

    PubMed

    Lai, Shugui; Wu, Qiang; Chen, Lanfang; Huang, Qianru; Zhang, Xuejun

    2015-07-01

    To compare the difference of clinical efficacy on sleeping disorder in the children with encephalopathy between the combined therapy of acupuncture at head points and seed-pressure at ear points and the simple acupuncture at head points. Thirty cases of sleeping disorder induced by encephalopathy werei randomized into an observation group and a control group, 15 cases in each one. In the observation group, the combined therapy of acupuncture at head points and seed-pressure at ear points was adopted. The head points in cluded Sishencong (EX-HN 1), Shenting (GV 24) and Benshen (GB 13). The ear points were the positive reactive sites in the cymba and cavum conchae. In the control group, acupuncture was applied simply to the acupoints on the head. The treatment was given once on every Tuesday and Friday a week separately, 30 min each time. Totally, 16 treatments were required. Children's sleeping habit questionnaire (CSHQ) was used to observe the sleep improvements and the efficacy in the patients of the two groups. In the observation group, the results of sleep resistance, sleep anxiety, night sleep wake, parasomnias, sleep dyspnea, daytime somnolence and the total score after treatment were all improved apparently as compared with those before treatment (all P<0. 05). In the control group, the results of night sleep wake, parasomnias, daytime somnolence and the total score after treatment were improved apparently than those before treatment (all P<0. 05). In the observation group, the results of sleep resistance, sleep dyspnea and the total score after treatment were better than those in the control group (all P<0. 05) and the scores of sleep anxiety and daytime somnolence in the control group were better than those in the observation group after treatment (both P<0. 05). The combined therapy of acupuncture at head points and seed-pressure at the positive reactive sites in the cymba and cavum conchae achieves the superior efficacy on sleep resistance and sleep

  10. Determination of the anaerobic threshold in the pre-operative assessment clinic: inter-observer measurement error.

    PubMed

    Sinclair, R C F; Danjoux, G R; Goodridge, V; Batterham, A M

    2009-11-01

    The variability between observers in the interpretation of cardiopulmonary exercise tests may impact upon clinical decision making and affect the risk stratification and peri-operative management of a patient. The purpose of this study was to quantify the inter-reader variability in the determination of the anaerobic threshold (V-slope method). A series of 21 cardiopulmonary exercise tests from patients attending a surgical pre-operative assessment clinic were read independently by nine experienced clinicians regularly involved in clinical decision making. The grand mean for the anaerobic threshold was 10.5 ml O(2).kg body mass(-1).min(-1). The technical error of measurement was 8.1% (circa 0.9 ml.kg(-1).min(-1); 90% confidence interval, 7.4-8.9%). The mean absolute difference between readers was 4.5% with a typical random error of 6.5% (6.0-7.2%). We conclude that the inter-observer variability for experienced clinicians determining the anaerobic threshold from cardiopulmonary exercise tests is acceptable.

  11. Disturbance observer-based fuzzy control for flexible spacecraft combined attitude & sun tracking system

    NASA Astrophysics Data System (ADS)

    Chak, Yew-Chung; Varatharajoo, Renuganth; Razoumny, Yury

    2017-04-01

    This paper investigates the combined attitude and sun-tracking control problem in the presence of external disturbances and internal disturbances, caused by flexible appendages. A new method based on Pythagorean trigonometric identity is proposed to drive the solar arrays. Using the control input and attitude output, a disturbance observer is developed to estimate the lumped disturbances consisting of the external and internal disturbances, and then compensated by the disturbance observer-based controller via a feed-forward control. The stability analysis demonstrates that the desired attitude trajectories are followed even in the presence of external disturbance and internal flexible modes. The main features of the proposed control scheme are that it can be designed separately and incorporated into the baseline controller to form the observer-based control system, and the combined attitude and sun-tracking control is achieved without the conventional attitude actuators. The attitude and sun-tracking performance using the proposed strategy is evaluated and validated through numerical simulations. The proposed control solution can serve as a fail-safe measure in case of failure of the conventional attitude actuator, which triggered by automatic reconfiguration of the attitude control components.

  12. Clinical and Ultrasonographic Evaluation of Lower-extremity Vein Thrombosis in Behcet Syndrome: An Observational Study.

    PubMed

    Seyahi, Emire; Cakmak, Osman Serdal; Tutar, Burcin; Arslan, Caner; Dikici, Atilla Suleyman; Sut, Necdet; Kantarci, Fatih; Tuzun, Hasan; Melikoglu, Melike; Yazici, Hasan

    2015-11-01

    Vascular involvement can be seen in up to 40% of patients with Behcet syndrome (BS), the lower-extremity vein thrombosis (LEVT) being the most common type. The aim of the current study was to compare venous Doppler findings and clinical features between BS patients with LEVT and control patients diagnosed as having LEVT due to other causes.All consecutive 78 patients (71 men, 7 women; mean age 38.6 ± 10.3 years) with LEVT due to BS and 50 control patients (29 men, 21 women; mean age 42.0 ± 12.5 years) who had LEVT due to other causes, or idiopathic, were studied with the help of a Doppler ultrasonography after a detailed clinical examination. Patterns of venous disease were identified by cluster analyses. Clinical features of chronic venous disease were assessed using 2 classification systems. Venous claudication was also assessed.Patients with BS were more likely to be men, had significantly earlier age of onset of thrombosis, and were treated mainly with immunosuppressives and less frequently with anticoagulants. Furthermore, they had significantly more bilateral involvement, less complete recanalization, and more frequent collateral formation. While control patients had a disorganized pattern of venous involvement, BS patients had a contiguous and symmetric pattern, involving all deep and superficial veins of the lower extremities, with less affinity for crural veins. Clinical assessment, as measured by the 2 classification systems, also indicated a more severe disease among the BS patients. In line, 51% of the BS patients suffered from severe post-thrombotic syndrome (PTS) and 32% from venous claudication, whereas these were present in 8% and 12%, respectively, among the controls. Among BS patients, a longer duration of thrombosis, bilateral femoral vein involvement, and using no anticoagulation along with immunosuppressive treatment when first diagnosed were found to be associated independently with severe PTS.Lower-extremity vein thrombosis

  13. Disturbance observer based pitch control of wind turbines for disturbance rejection

    NASA Astrophysics Data System (ADS)

    Yuan, Yuan; Chen, Xu; Tang, Jiong

    2016-04-01

    In this research, a disturbance observer based (DOB) control scheme is illustrated to reject the unknown low frequency disturbances to wind turbines. Specifically, we aim at maintaining the constant output power but achieving better generator speed regulation when the wind turbine is operated at time-varying and turbulent wind field. The disturbance observer combined with a filter is designed to asymptotically reject the persistent unknown time-varying disturbances. The proposed algorithm is tested in both linearized and nonlinear NREL offshore 5-MW baseline wind turbine. The application of this DOB pitch controller achieves improved power and speed regulation in Region 3 compared with a baseline gain scheduling PID collective controller both in linearized and nonlinear plant.

  14. Final Report for Geometric Observers and Particle Filtering for Controlled Active Vision

    DTIC Science & Technology

    2016-12-15

    code) 15-12-2016 Final Report 01Sep06 - 09May11 Final Report for Geometric Observers & Particle Filtering for Controlled Active Vision 49414-NS.1Allen...Observers and Particle Filtering for Controlled Active Vision by Allen R. Tannenbaum School of Electrical and Computer Engineering Georgia Institute of...7 2.2.4 Conformal Area Minimizing Flows . . . . . . . . . . . . . . . . . . . . . . . 8 2.3 Particle Filters

  15. Scapular positioning and motor control in children and adults: a laboratory study using clinical measures.

    PubMed

    Struyf, Filip; Nijs, Jo; Horsten, Stijn; Mottram, Sarah; Truijen, Steven; Meeusen, Romain

    2011-04-01

    The scapular muscular system is the major determinant of scapular positioning. In addition, strength and muscular endurance develops from childhood through adolescence. It is not known whether differences in scapular positioning and motor control between adults and children may exist. Ninety-two shoulders of 46 adults (mean = 39.4; 18-86 years; SD = 22.5), and 116 shoulders of 59 children (mean = 11.6; 6-17 years; SD = 3.5), were included in the study. Scapular positioning data were collected using a clinical assessment protocol including visual observation of titling and winging, measurement of forward shoulder posture, measurement of scapular upward rotation, and the Kinetic Medial Rotation Test (KMRT). The observation protocol for scapular winging and tilting did not show significant differences between adults and children. After controlling for height, forward shoulder posture (relaxed (0.28 cm/cm (0.06) vs. 0.31 cm/cm (0.07) and retracted (0.15 cm/cm (0.05) vs. 0.20 cm/cm (0.06)) were significantly smaller in children than in adults (P < 0.01). In addition, children showed greater scapular upward rotation (18.6°; SD 9.6°) than adults (14.5°; SD 10.9°) at 90° shoulder abduction. No significant differences were seen between children (19% positive test) and adults (24% positive test) using the KMRT. Children and adults show significant but small differences in scapular upward rotation and forward shoulder posture. These data provide useful reference values using a clinical protocol. Copyright © 2010 Elsevier Ltd. All rights reserved.

  16. Some strategies to address the challenges of collecting observational data in a busy clinical environment.

    PubMed

    Jackson, Debra; McDonald, Glenda; Luck, Lauretta; Waine, Melissa; Wilkes, Lesley

    2016-01-01

    Studies drawing on observational methods can provide vital data to enhance healthcare. However, collecting observational data in clinical settings is replete with challenges, particularly where multiple data-collecting observers are used. Observers collecting data require shared understanding and training to ensure data quality, and particularly, to confirm accurate and consistent identification, discrimination and recording of data. The aim of this paper is to describe strategies for preparing and supporting multiple researchers tasked with collecting observational data in a busy, and often unpredictable, hospital environment. We hope our insights might assist future researchers undertaking research in similar settings.

  17. [Clinical study on the effect of anti-gingivitis IgY toothpaste in control of gingivitis and dental plaque].

    PubMed

    Zhang, Wei; Feng, Xi-Ping; Tao, Dan-Ying; Chen, Jian-Fen

    2016-08-01

    To observe the effect of anti-gingivitis IgY toothpaste in control of gingivitis and plaque. The study was a double-blind, randomized, parallel-controlled clinical trail with a total of 100 subjects who were divided into two groups, experimental group and control group. The subjects in experimental group used anti-gingivitis IgY toothpaste to brush twice daily for 3 minutes, and the subjects in control group used none anti-gingivitis IgY toothpaste. The examiner recorded GI, PI and BOP index of all subjects at the baseline, 6-weeks and 12-weeks. SPSS21.0 software package was used for statistical analysis. Twelve weeks later, there were significant differences in GI and BOP between the two groups. Yet no significant difference was found in PI. Anti-gingivitis IgY toothpaste is effective in control of gingivitis.

  18. Defining a clinically meaningful effect for the design and interpretation of randomized controlled trials.

    PubMed

    Keefe, Richard S E; Kraemer, Helena C; Epstein, Robert S; Frank, Ellen; Haynes, Ginger; Laughren, Thomas P; McNulty, James; Reed, Shelby D; Sanchez, Juan; Leon, Andrew C

    2013-05-01

    This article captures the proceedings of a meeting aimed at defining clinically meaningful effects for use in randomized controlled trials for psychopharmacological agents. Experts from a variety of disciplines defined clinically meaningful effects from their perspectives along with viewpoints about how to design and interpret randomized controlled trials. The article offers relevant, practical, and sometimes anecdotal information about clinically meaningful effects and how to interpret them. The concept for this session was the work of co-chairs Richard Keefe and the late Andy Leon. Faculty included Richard Keefe, PhD; James McNulty, AbScB; Robert S. Epstein, MD, MS; Shelby D. Reed, PhD; Juan Sanchez, MD; Ginger Haynes, PhD; Andrew C. Leon, PhD; Helena Chmura Kraemer, PhD; Ellen Frank, PhD, and Kenneth L. Davis, MD. The term clinically meaningful effect is an important aspect of designing and interpreting randomized controlled trials but can be particularly difficult in the setting of psychopharmacology where effect size may be modest, particularly over the short term, because of a strong response to placebo. Payers, regulators, patients, and clinicians have different concerns about clinically meaningful effects and may describe these terms differently. The use of moderators in success rate differences may help better delineate clinically meaningful effects. There is no clear consensus on a single definition for clinically meaningful differences in randomized controlled trials, and investigators must be sensitive to specific concerns of stakeholders in psychopharmacology in order to design and execute appropriate clinical trials.

  19. An Adaptive Buddy Check for Observational Quality Control

    NASA Technical Reports Server (NTRS)

    Dee, Dick P.; Rukhovets, Leonid; Todling, Ricardo; DaSilva, Arlindo M.; Larson, Jay W.; Einaudi, Franco (Technical Monitor)

    2000-01-01

    An adaptive buddy check algorithm is presented that adjusts tolerances for outlier observations based on the variability of surrounding data. The algorithm derives from a statistical hypothesis test combined with maximum-likelihood covariance estimation. Its stability is shown to depend on the initial identification of outliers by a simple background check. The adaptive feature ensures that the final quality control decisions are not very sensitive to prescribed statistics of first-guess and observation errors, nor on other approximations introduced into the algorithm. The implementation of the algorithm in a global atmospheric data assimilation is described. Its performance is contrasted with that of a non-adaptive buddy check, for the surface analysis of an extreme storm that took place in Europe on 27 December 1999. The adaptive algorithm allowed the inclusion of many important observations that differed greatly from the first guess and that would have been excluded on the basis of prescribed statistics. The analysis of the storm development was much improved as a result of these additional observations.

  20. Final year MBBS students' perception for observed structured clinical examination.

    PubMed

    Siddiqui, Faisal Ghani

    2013-01-01

    To determine perceptions of final year students about observed structured clinical examination (OSCE) and to determine its acceptance among these students. Sequential mixed method design using survey questionnair and in-depth interviews. The study constituted a one-time survey and in-depth interviews conducted over a period of three consecutive days during final year MBBS annual examination at OSCE centre, from April 04, 2010 to April 06, 2010. Three hundred and fifty final year MBBS students, selected through non-probability convenience sampling, were asked to fill the 12-item questionnaire. Three hundred and thirty one students returned the forms. In-depth, structured interviews with 22 students, selected by non-probability purposive sampling, were conducted. The interviews were tape recorded for subsequent transcription. The statistical analysis was done using SPSS 17. The qualitative data was analyzed through content analysis techniques. Three hundred and thirty one final year MBBS students (50.6% females) filled the questionnaire (response rate 94.6%). Fifty three percent respondents agreed that the OSCE tasks were taught during clinical rotations. The experience was stressful for 67.9% respondents. Inadequate prior guidelines, inadequate time for stations, newness of the assessment format and vague instructions were the main causes for stress. Over 70% of the students felt that OSCE helped them identify areas of weakness in their practical and clinical skills; 56.5% felt that the stations dealt with practical skills. Seventy nine percent students were happy with the attitude of the examiners while 19% students felt that the facilitators were uncooperative; failure of the examiners to observe the students during performance of the tasks was the major cause for dissatisfaction. Nearly thirty percent (29.9%) respondent felt that the stations were difficult to understand. Over forty nine percent (49.7%) complained that adequate guidelines were not given prior to

  1. Control Charts When the Observations Are Correlated.

    DTIC Science & Technology

    1987-05-01

    l7 D-AiB6 388 CONTROL CHARTS WHEN THE OBSERVATIONS ARE CORRELATED(J) i/iPITTSBURGH UNIV PA CENTER FOR KULTIVARIATE ANALYSIS P R KRISHNAIAH ET AL MAY... Krishnaiah and B. Q. Miao F-49620-85-C-0008 S. PERFORMING ORGANIZATION NAME AND ADDRESS 10. PROGRAM ELEMENT. PROJECT. TASK AREA II WORK UNIT NUMBERS... Krishnaiah and B.Q. Miao Center for Multivariate Analysis University of Pittsburgh N DTIC E L 1Zk-, -I- OCT0 11987 Play 1987 Technical Report No. 87-09

  2. What Happens After Health Coaching? Observational Study 1 Year Following a Randomized Controlled Trial

    PubMed Central

    Sharma, Anjana E.; Willard-Grace, Rachel; Hessler, Danielle; Bodenheimer, Thomas; Thom, David H.

    2016-01-01

    PURPOSE Health coaching is effective for chronic disease self-management in the primary care safety-net setting, but little is known about the persistence of its benefits. We conducted an observational study evaluating the maintenance of improved cardiovascular risk factors following a health coaching intervention. METHODS We performed a naturalistic follow-up to the Health Coaching in Primary Care Study, a 12-month randomized controlled trial (RCT) comparing health coaching to usual care for patients with uncontrolled diabetes, hypertension, or hyperlipidemia. Participants were followed up 24 months from RCT baseline. The primary outcome was the proportion at goal for at least 1 measure (hemoglobin A1c, systolic blood pressure, or LDL cholesterol) that had been above goal at enrollment; secondary outcomes included each individual clinical goal. Chi-square tests and paired t-tests compared dichotomous and continuous measures. RESULTS 290 of 441 participants (65.8%) participated at both 12 and 24 months. The proportion of patients in the coaching arm of the RCT who achieved the primary outcome dropped only slightly from 47.1% at 12 to 45.9% at 24 months (P = .80). The proportion at goal for hemoglobin A1c dropped from 53.4% to 36.2% (P = .03). All other clinical metrics had small, nonsignificant changes between 12 and 24 months. CONCLUSIONS Results support the conclusion that most improved clinical outcomes persisted 1 year after the completion of the health coaching intervention. PMID:27184989

  3. What Happens After Health Coaching? Observational Study 1 Year Following a Randomized Controlled Trial.

    PubMed

    Sharma, Anjana E; Willard-Grace, Rachel; Hessler, Danielle; Bodenheimer, Thomas; Thom, David H

    2016-05-01

    Health coaching is effective for chronic disease self-management in the primary care safety-net setting, but little is known about the persistence of its benefits. We conducted an observational study evaluating the maintenance of improved cardiovascular risk factors following a health coaching intervention. We performed a naturalistic follow-up to the Health Coaching in Primary Care Study, a 12-month randomized controlled trial (RCT) comparing health coaching to usual care for patients with uncontrolled diabetes, hypertension, or hyperlipidemia. Participants were followed up 24 months from RCT baseline. The primary outcome was the proportion at goal for at least 1 measure (hemoglobin A1c, systolic blood pressure, or LDL cholesterol) that had been above goal at enrollment; secondary outcomes included each individual clinical goal. Chi-square tests and paired t-tests compared dichotomous and continuous measures. 290 of 441 participants (65.8%) participated at both 12 and 24 months. The proportion of patients in the coaching arm of the RCT who achieved the primary outcome dropped only slightly from 47.1% at 12 to 45.9% at 24 months (P = .80). The proportion at goal for hemoglobin A1c dropped from 53.4% to 36.2% (P = .03). All other clinical metrics had small, nonsignificant changes between 12 and 24 months. Results support the conclusion that most improved clinical outcomes persisted 1 year after the completion of the health coaching intervention. © 2016 Annals of Family Medicine, Inc.

  4. Clinical and economic burdens experienced by patients with painful diabetic peripheral neuropathy: An observational study using a Japanese claims database.

    PubMed

    Ebata-Kogure, Nozomi; Nozawa, Kazutaka; Murakami, Aya; Toyoda, Tetsumi; Haga, Yuri; Fujii, Koichi

    2017-01-01

    Diabetic peripheral neuropathy (DPN) may often be painful. Despite the high prevalence of painful DPN (pDPN) among patients with diabetes mellitus (DM), understanding of its clinical and economic burden is limited. This study aimed to describe the clinical and economic burdens faced by patients with pDPN in Japan, and compared them with those experienced by patients with DPN but without painful symptoms (non-pDPN). This retrospective, observational study used data from a large-scale, hospital-based Japanese claims database collected from April 2008 to June 2015. Comorbidities, clinical departments visited, length of hospital stay, and medical costs for the period of ± 6 months from the diagnosis of pDPN or non-pDPN were described for each group. Glycemic control status was examined for each group for patients with glycated hemoglobin data. The data of 8,740 patients with pDPN (mean age 70.0 years, 53.4% male) and 12,592 patients with non-pDPN (mean age 67.7 years, 55.7% male) were analyzed. Patients with pDPN had more comorbidities than patients with non-pDPN; 48.7% and 30.9% of patients in the respective groups had 20 or more comorbidities. The median length of hospital stay was 5 days longer in patients with pDPN. The median total medical costs were higher in patients with pDPN (\\517,762) than in patients with non-pDPN (\\359,909). Patients with pDPN spent higher median costs for medications, but the costs for glycemic control drugs were similar in both groups. For 3,372 patients with glycated hemoglobin data, glycemic control was similar between the two groups. Patients with pDPN experienced greater clinical and economic burdens than patients with non-pDPN, suggesting that patients who develop pDPN may suffer not only from the complications of DM and pain, but also from other comorbid disorders.

  5. Reducing Clinical Inertia in Hypertension Treatment: a Pragmatic Randomized Controlled Trial

    PubMed Central

    Huebschmann, Amy G.; Mizrahi, Trina; Soenksen, Alyssa; Beaty, Brenda L.; Denberg, Thomas D.

    2012-01-01

    Clinical inertia is a major contributor to poor blood pressure (BP) control. We tested the effectiveness of an intervention targeting physician, patient, and office system factors with regard to outcomes of clinical inertia and BP control. We randomized 591 adult primary care patients with elevated BP (mean systolic BP ≥140 or mean diastolic BP ≥90 mm Hg) to intervention or usual care. An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused primary care clinic visits, and furnished providers with treatment decision support. The intervention reduced clinical inertia (−29% vs. −11%, p=0.001). Nonetheless, ΔBP did not differ between intervention and usual care (−10.1/−4.1 vs. −9.1/−4.5 mm Hg, p = 0.50 and 0.71 for systolic and diastolic BP, respectively). Future primary care-focused interventions might benefit from the use of specific medication titration protocols, treatment adherence support, and more sustained patient follow-up visits. PMID:22533659

  6. Randomized, blinded, controlled clinical trial shows no benefit of homeopathic mastitis treatment in dairy cows.

    PubMed

    Ebert, Fanny; Staufenbiel, Rudolf; Simons, Julia; Pieper, Laura

    2017-06-01

    Mastitis is one of the most common diseases in dairy production, and homeopathic remedies have been used increasingly in recent years to treat it. Clinical trials evaluating homeopathy have often been criticized for their inadequate scientific approach. The objective of this triple-blind, randomized controlled trial was to assess the efficacy of homeopathic treatment in bovine clinical mastitis. The study was conducted on a conventionally managed dairy farm between June 2013 and May 2014. Dairy cows with acute mastitis were randomly allocated to homeopathy (n = 70) or placebo (n = 92), for a total of 162 animals. The homeopathic treatment was selected based on clinical symptoms but most commonly consisted of a combination of nosodes with Streptococcinum, Staphylococcinum, Pyrogenium, and Escherichia coli at a potency of 200c. Treatment was administered to cows in the homeopathy group at least once per day for an average of 5 d. The cows in the placebo group were treated similarly, using a placebo preparation instead (lactose globules without active ingredients). If necessary, we also used allopathic drugs (e.g., antibiotics, udder creams, and anti-inflammatory drugs) in both groups. We recorded data relating to the clinical signs of mastitis, treatment, time to recovery, milk yield, somatic cell count at first milk recording after mastitis, and culling. We observed cows for up to 200 d after clinical recovery. Base-level data did not differ between the homeopathy and placebo groups. Mastitis lasted for an average of 6 d in both groups. We observed no significant differences in time to recovery, somatic cell count, risk of clinical cure within 14 d after disease occurrence, mastitis recurrence risk, or culling risk. The results indicated no additional effect of homeopathic treatment compared with placebo. The advantages or disadvantages of homeopathy should be carefully assessed for individual farms. Copyright © 2017 American Dairy Science Association. Published by

  7. [Clinical and pathologic observation of uveal metastatic carcinoma].

    PubMed

    Cong, C X; Lin, J Y; Wang, L H

    2016-10-11

    Objective: To observe the clinical and pathological features of uveal metastatic carcinoma. Methods: It was a retrospective case series study. The clinical manifestation, growth pattern, tumor types and relative pathological features of 13 patients visiting from January 1980 to December 2014 with uveal metastatic carcinoma in Tianjin Eye Hospital were analyzed retrospectively. Results: There were 13 cases, 6 cases of male and 7 of female. Age was from 37.0 to 66.0 years old. The mean age was 52.1 years old. all cases were monocular. There were 5 cases with right eye and 8 cases with left eye. Among 13 cases, 10 tumors were in posterior choroid, one tumor was in anterior choroid and ciliary body, 2 tumors were in the iris. There were 5 patients with lung cancer, 4 patients with breast cancer, 1 patient with prostate cancer, 1 patient with thyroid cancer and 1 patient with esophageal cancer. The primary tumor wasn't found in 1 patient. The rapid decrease of visual acuity showed in 10 patients with posterior choroidal metastatic carcinoma, 8 of them accompanied with extensive retinal detachment and 6 of them had secondary glaucoma. The multiple gray-white nodule or pink cauliflower mass on the papillary margin of iris were showed respectively in 2 patients with iris metastatic carcinoma. The pathological examination found that posterior choroidal metastatic carcinoma mainly located in temporal or nasal side choroids in 10 cases, among them, local or diffuse flat choroidal masses showed in 6cases, extensive mass involving choroid and ciliary body showed in 1 case, large nodular or globular choroidal mass showed in 2 cases, choroidal mass surrounded the optic disc in 1 case, optic nerve invasion showed in 3 cases and extraocular or orbital invasion showed in 3 cases. The scleral and subconjunctival invasion showed in 1 case of anterior choroid and ciliary body metastatic carcinoma. Conclusions: Uveal metastatic carcinoma manifested various growth pattern, the rapid

  8. Observing polymersome dynamics in controlled microscale flows

    NASA Astrophysics Data System (ADS)

    Kumar, Subhalakshmi; Shenoy, Anish; Schroeder, Charles

    2015-03-01

    Achieving an understanding of single particle rheology for large yet deformable particles with controlled membrane viscoelasticity is major challenge in soft materials. In this work, we directly visualize the dynamics of single polymersomes (~ 10 μm in size) in an extensional flow using optical microscopy. We generate polymer vesicular structures composed of polybutadiene-block-polyethylene oxide (PB-b-PEO) copolymers. Single polymersomes are confined near the stagnation point of a planar extensional flow using an automated microfluidic trap, thereby enabling the direct observation of polymersome dynamics under fluid flows with controlled strains and strain rates. In a series of experiments, we investigate the effect of varying elasticity in vesicular membranes on polymersome deformation, along with the impact of decreasing membrane fluidity upon increasing diblock copolymer molecular weight. Overall, we believe that this approach will enable precise characterization of the role of membrane properties on single particle rheology for deformable polymersomes.

  9. Reliability of mercury-in-silastic strain gauge plethysmography curve reading: influence of clinical clues and observer variation.

    PubMed

    Høyer, Christian; Pavar, Susanne; Pedersen, Begitte H; Biurrun Manresa, José A; Petersen, Lars J

    2013-08-01

    Mercury-in-silastic strain gauge pletysmography (SGP) is a well-established technique for blood flow and blood pressure measurements. The aim of this study was to examine (i) the possible influence of clinical clues, e.g. the presence of wounds and color changes during blood pressure measurements, and (ii) intra- and inter-observer variation of curve interpretation for segmental blood pressure measurements. A total of 204 patients with known or suspected peripheral arterial disease (PAD) were included in a diagnostic accuracy trial. Toe and ankle pressures were measured in both limbs, and primary observers analyzed a total of 804 pressure curve sets. The SGP curves were later reanalyzed separately by two observers blinded to clinical clues. Intra- and inter-observer agreement was quantified using Cohen's kappa and reliability was quantified using intra-class correlation coefficients, coefficients of variance, and Bland-Altman analysis. There was an overall agreement regarding patient diagnostic classification (PAD/not PAD) in 202/204 (99.0%) for intra-observer (κ = 0.969, p < 0.001), and 201/204 (98.5%) for inter-observer readings (κ = 0.953, p < 0.001). Reliability analysis showed excellent correlation between blinded versus non-blinded and inter-observer readings for determination of absolute segmental pressures (all intraclass correlation coefficients ≥ 0.984). The coefficient of variance for determination of absolute segmental blood pressure ranged from 2.9-3.4% for blinded/non-blinded data and from 3.8-5.0% for inter-observer data. This study shows a low inter-observer variation among experienced laboratory technicians for reading strain gauge curves. The low variation between blinded/non-blinded readings indicates that SGP measurements are minimally biased by clinical clues.

  10. Sliding mode disturbance observer-based control of a twin rotor MIMO system.

    PubMed

    Rashad, Ramy; El-Badawy, Ayman; Aboudonia, Ahmed

    2017-07-01

    This work proposes a robust tracking controller for a helicopter laboratory setup known as the twin rotor MIMO system (TRMS) using an integral sliding mode controller. To eliminate the discontinuity in the control signal, the controller is augmented by a sliding mode disturbance observer. The actuator dynamics is handled using a backstepping approach which is applicable due to the continuous chattering-free nature of the command signals generated using the disturbance observer based controller. To avoid the complexity of analytically differentiating the command signals, a first order sliding mode differentiator is used. Stability analysis of the closed loop system and the ultimate boundedness of the tracking error is proved using Lyapunov stability arguments. The proposed controller is validated by several simulation studies and is compared to other schemes in the literature. Experimental results using a hardware-in-the-loop system validate the robustness and effectiveness of the proposed controller. Copyright © 2017 ISA. Published by Elsevier Ltd. All rights reserved.

  11. Clinical Characteristics of Impaired Trunk Control in Children with Spastic Cerebral Palsy

    ERIC Educational Resources Information Center

    Heyrman, Lieve; Desloovere, Kaat; Molenaers, Guy; Verheyden, Geert; Klingels, Katrijn; Monbaliu, Elegast; Feys, Hilde

    2013-01-01

    This study aimed to identify clinical characteristics of impaired trunk control in hundred children with spastic CP (mean age 11.4 [plus or minus] 2.1 years, range 8-15 years). Assessment of trunk control was performed with the Trunk Control Measurement Scale (TCMS). Trunk control was clearly impaired, indicated by a median total TCMS score of…

  12. Observations of infection prevention and control practices in primary health care, Kenya.

    PubMed

    Bedoya, Guadalupe; Dolinger, Amy; Rogo, Khama; Mwaura, Njeri; Wafula, Francis; Coarasa, Jorge; Goicoechea, Ana; Das, Jishnu

    2017-07-01

    To assess compliance with infection prevention and control practices in primary health care in Kenya. We used an observational, patient-tracking tool to assess compliance with infection prevention and control practices by 1680 health-care workers during outpatient interactions with 14 328 patients at 935 health-care facilities in 2015. Compliance was assessed in five domains: hand hygiene; protective glove use; injections and blood sampling; disinfection of reusable equipment; and waste segregation. We calculated compliance by dividing the number of correct actions performed by the number of indications and evaluated associations between compliance and the health-care worker's and facility's characteristics. Across 106 464 observed indications for an infection prevention and control practice, the mean compliance was 0.318 (95% confidence interval, CI: 0.315 to 0.321). The compliance ranged from 0.023 (95% CI: 0.021 to 0.024) for hand hygiene to 0.871 (95% CI: 0.866 to 0.876) for injection and blood sampling safety. Compliance was weakly associated with the facility's characteristics (e.g. public or private, or level of specialization) and the health-care worker's knowledge of, and training in, infection prevention and control practices. The observational tool was effective for assessing compliance with infection prevention and control practices across multiple domains in primary health care in a low-income country. Compliance varied widely across infection prevention and control domains. The weak associations observed between compliance and the characteristics of health-care workers and facilities, such as knowledge and the availability of supplies, suggest that a broader focus on behavioural change is required.

  13. Clinical and microbiologic effects of commercially available dentifrice containing aloe vera: a randomized controlled clinical trial.

    PubMed

    Pradeep, A R; Agarwal, Esha; Naik, Savitha B

    2012-06-01

    Certain plants used in folk medicine serve as a source of therapeutic agents that have antimicrobial and other multipotential effects. This prospective, randomized, placebo, and positively controlled clinical trial was designed to evaluate the clinical and microbiologic effects of a commercially available dentifrice containing aloe vera on the reduction of plaque and gingival inflammation in patients with gingivitis. Ninety patients diagnosed with chronic generalized gingivitis were selected and randomly divided into three groups: group 1, placebo toothpaste; group 2, toothpaste containing aloe vera; and group 3, toothpaste with polymer and fluoride containing triclosan. Clinical evaluation was undertaken using a gingival index, plaque was assessed using a modification of the Quigley-Hein index, and microbiologic counts were assessed at baseline, 6 weeks, 12 weeks, and 24 weeks. A subjective evaluation was also undertaken by questionnaire. Toothpaste containing aloe vera showed significant improvement in gingival and plaque index scores as well as microbiologic counts compared with placebo dentifrice. These improvements were comparable to those achieved with toothpaste containing triclosan. Toothpaste containing aloe vera may be a useful herbal formulation for chemical plaque control agents and improvement in plaque and gingival status.

  14. Defining a Clinically Meaningful Effect for the Design and Interpretation of Randomized Controlled Trials

    PubMed Central

    Kraemer, Helena C.; Epstein, Robert S.; Frank, Ellen; Haynes, Ginger; Laughren, Thomas P.; Mcnulty, James; Reed, Shelby D.; Sanchez, Juan; Leon, Andrew C.

    2013-01-01

    Objective: This article captures the proceedings of a meeting aimed at defining clinically meaningful effects for use in randomized controlled trials for psychopharmacological agents. Design: Experts from a variety of disciplines defined clinically meaningful effects from their perspectives along with viewpoints about how to design and interpret randomized controlled trials. Setting: The article offers relevant, practical, and sometimes anecdotal information about clinically meaningful effects and how to interpret them. Participants: The concept for this session was the work of co-chairs Richard Keefe and the late Andy Leon. Faculty included Richard Keefe, PhD; James McNulty, AbScB; Robert S. Epstein, MD, MS; Shelby D. Reed, PhD; Juan Sanchez, MD; Ginger Haynes, PhD; Andrew C. Leon, PhD; Helena Chmura Kraemer, PhD; Ellen Frank, PhD, and Kenneth L. Davis, MD. Results: The term clinically meaningful effect is an important aspect of designing and interpreting randomized controlled trials but can be particularly difficult in the setting of psychopharmacology where effect size may be modest, particularly over the short term, because of a strong response to placebo. Payers, regulators, patients, and clinicians have different concerns about clinically meaningful effects and may describe these terms differently. The use of moderators in success rate differences may help better delineate clinically meaningful effects. Conclusion: There is no clear consensus on a single definition for clinically meaningful differences in randomized controlled trials, and investigators must be sensitive to specific concerns of stakeholders in psychopharmacology in order to design and execute appropriate clinical trials. PMID:23882433

  15. Clinical outcomes of elite controllers, viremic controllers, and long-term nonprogressors in the US Department of Defense HIV natural history study.

    PubMed

    Okulicz, Jason F; Marconi, Vincent C; Landrum, Michael L; Wegner, Scott; Weintrob, Amy; Ganesan, Anuradha; Hale, Braden; Crum-Cianflone, Nancy; Delmar, Judith; Barthel, Vincent; Quinnan, Gerald; Agan, Brian K; Dolan, Matthew J

    2009-12-01

    Durable control of human immunodeficiency virus (HIV) replication and lack of disease progression in the absence of antiretroviral therapy were studied in a military cohort of 4586 subjects. We examined groups of elite controllers (ie, subjects with plasma HIV RNA levels of <50 copies/mL; prevalence, 0.55% [95% confidence interval {CI}, 0.35%-0.80%]), viremic controllers (ie, subjects with plasma HIV RNA levels of 50-2000 copies/mL; prevalence, 3.34% [95% CI, 2.83%-3.91%]), and subjects with a lack of disease progression (ie, long-term nonprogressors [LTNPs]) through 7 years of follow-up (LTNP7s; prevalence, 3.32% [95% CI, 2.70%-4.01%]) or 10 years of follow-up (LTNP10s; prevalence, 2.04% [95% CI, 1.52%-2.68%]). For elite and viremic controllers, spontaneous virologic control was established early and was typically observed when the initial viral load measurement was obtained within 1 year of estimated seroconversion. Elite controllers had favorable time to development of AIDS (P=.048), a CD4 cell count of 350 cells/microL (P= .009), and more-stable CD4 cell trends, compared with viremic controllers. LTNPs defined by 10-year versus 7-year criteria had a longer survival time (P=.001), even after adjustment for differing periods of invulnerability (P= .042). Definitions of controllers and LTNPs describe distinct populations whose differing clinical outcomes improve with the stringency of criteria, underscoring the need for comparability between study populations.

  16. Clinical Hypnosis in the Treatment of Post-Menopausal Hot Flashes: A Randomized Controlled Trial

    PubMed Central

    Elkins, Gary R.; Fisher, William I.; Johnson, Aimee K.; Carpenter, Janet S.; Keith, Timothy Z.

    2012-01-01

    Objective The use of estrogen and progesterone to manage vasomotor symptoms (i.e., hot flashes, night sweats) has declined due to concerns over their risks and there is an increased interest in alternate, effective, and low-risk treatments. This study reports the results of a randomized, controlled trial of clinical hypnosis in treating vasomotor symptoms among post-menopausal women. Methods Randomized, single-blind, controlled, clinical trial involving 187 post-menopausal women reporting a minimum of seven hot flashes per day, or at least 50 hot flashes a week at baseline between December 2008 and April 2012. Eligible participants received five weekly sessions of either clinical hypnosis or structured-attention control. Primary outcomes were hot flash frequency (subjectively and physiologically recorded) and hot flash score assessed by daily diaries at weeks 2–6, and 12. Secondary outcomes included measures of hot flash related daily interference, sleep quality and treatment satisfaction. Results In a modified intent-to-treat analysis that included all randomized participants that provided data, reported subjective hot flash frequency from baseline to week 12 showed a mean reduction of 55.82 hot flashes for the clinical hypnosis intervention (74.16%), versus a 12.89 hot flash reduction (17.13%) for the control (p<.001, 95% CI, 36.15–49.67). Mean reduction in hot flash score was 18.83 (80.32%) for the clinical hypnosis intervention as compared to 3.53 (15.38%) for the control (p<.001, 95% CI, 12.60–17.54). At 12 week follow-up, the mean reduction in physiologically monitored hot flashes was 5.92 (56.86%) for clinical hypnosis and .88 (9.94%) for the control (p<.001, 95% CI, 2.00–5.46). Secondary outcomes were significantly improved compared to control at 12 week follow-up in hot flash related interference (p<.001, 95% CI, 2.74–4.02), sleep quality (p<.001, 95% CI, 3.65–5.84), and treatment satisfaction (p<.001, 95% CI, 7.79–8.59). Conclusion Compared

  17. [Clinical observation on the influence of earthquake crush injury on postoperative wound healing of extremity fractures].

    PubMed

    Chen, Fu-hong; Chen, Ze; Duan, Heng-qiong; Wan, Zhong-xian

    2008-10-01

    To observe the influence of earthquake crush injury on postoperative wound healing of extremity fractures. The study involved 85 patients with extremities fracture underwent internal fixation operation in 3 group, including 28 earthquake casualties with crush injuries in observation group, 27 earthquake casualties without crush injuries in control I group and 30 local patients during the same period in control II group. Urine routine, blood creatine kinase (CK) and wound conditions of patients in 3 groups were observed respectively. There was no significant difference in Urine routine and blood CK between 3 groups and was significant difference in wound conditions between observation group and each control group. Earthquake crush injuries can influence the postoperative wound healing of extremity fractures.

  18. A Controlled Trial of Teaching Clinical Biochemistry by the Keller Plan.

    ERIC Educational Resources Information Center

    Schwartz, Peter L.

    1980-01-01

    Thirty medical students at the University of Otago were randomly chosen to learn clinical biochemistry by the Keller Plan. The rest of the class acted as controls. The randomly selected Keller group scored significantly higher than the control group on a practice/review test and the final examination. (Author/MLW)

  19. Observer-based adaptive backstepping control for fractional order systems with input saturation.

    PubMed

    Sheng, Dian; Wei, Yiheng; Cheng, Songsong; Wang, Yong

    2017-07-03

    An observer-based fractional order anti-saturation adaptive backstepping control scheme is proposed for incommensurate fractional order systems with input saturation and partial measurable state in this paper. On the basis of stability analysis, a novel state observer is established first since the only information we could acquire is the system output. In order to compensate the saturation, a series of virtual signals are generated via the construction of fractional order auxiliary system. Afterwards, the controller design is carried out in accordance with the adaptive backstepping control method by introduction of the indirect Lyapunov method. To highlight the effectiveness of the proposed control scheme, simulation examples are demonstrated at last. Copyright © 2017 ISA. Published by Elsevier Ltd. All rights reserved.

  20. Osteoporosis therapies: evidence from health-care databases and observational population studies.

    PubMed

    Silverman, Stuart L

    2010-11-01

    Osteoporosis is a well-recognized disease with severe consequences if left untreated. Randomized controlled trials are the most rigorous method for determining the efficacy and safety of therapies. Nevertheless, randomized controlled trials underrepresent the real-world patient population and are costly in both time and money. Modern technology has enabled researchers to use information gathered from large health-care or medical-claims databases to assess the practical utilization of available therapies in appropriate patients. Observational database studies lack randomization but, if carefully designed and successfully completed, can provide valuable information that complements results obtained from randomized controlled trials and extends our knowledge to real-world clinical patients. Randomized controlled trials comparing fracture outcomes among osteoporosis therapies are difficult to perform. In this regard, large observational database studies could be useful in identifying clinically important differences among therapeutic options. Database studies can also provide important information with regard to osteoporosis prevalence, health economics, and compliance and persistence with treatment. This article describes the strengths and limitations of both randomized controlled trials and observational database studies, discusses considerations for observational study design, and reviews a wealth of information generated by database studies in the field of osteoporosis.

  1. Novel Observer Scheme of Fuzzy-MRAS Sensorless Speed Control of Induction Motor Drive

    NASA Astrophysics Data System (ADS)

    Chekroun, S.; Zerikat, M.; Mechernene, A.; Benharir, N.

    2017-01-01

    This paper presents a novel approach Fuzzy-MRAS conception for robust accurate tracking of induction motor drive operating in a high-performance drives environment. Of the different methods for sensorless control of induction motor drive the model reference adaptive system (MRAS) finds lot of attention due to its good performance. The analysis of the sensorless vector control system using MRAS is presented and the resistance parameters variations and speed observer using new Fuzzy Self-Tuning adaptive IP Controller is proposed. In fact, fuzzy logic is reminiscent of human thinking processes and natural language enabling decisions to be made based on vague information. The present approach helps to achieve a good dynamic response, disturbance rejection and low to plant parameter variations of the induction motor. In order to verify the performances of the proposed observer and control algorithms and to test behaviour of the controlled system, numerical simulation is achieved. Simulation results are presented and discussed to shown the validity and the performance of the proposed observer.

  2. Truth telling in medical practice: students' opinions versus their observations of attending physicians' clinical practice.

    PubMed

    Tang, Woung-Ru; Fang, Ji-Tseng; Fang, Chun-Kai; Fujimori, Maiko

    2013-07-01

    Truth telling or transmitting bad news is a problem that all doctors must frequently face. The purpose of this cross-sectional study was to investigate if medical students' opinions of truth telling differed from their observations of attending physicians' actual clinical practice. The subjects were 275 medical clerks/interns at a medical center in northern Taiwan. Data were collected on medical students' opinions of truth telling, their observations of physicians' clinical practice, students' level of satisfaction with truth telling practiced by attending physicians, and cancer patients' distress level when they were told the truth. Students' truth-telling awareness was significantly higher than the clinical truth-telling practice of attending physicians (p<0.001), and the means for these parameters had a moderate difference, especially in three aspects: method, emotional support, and providing additional information (p<0.001). Regardless of this difference, students were satisfied with the truth telling of attending physicians (mean ± SD=7.33 ± 1.74). However, our data also show that when cancer patients were informed of bad news, they all experienced medium to above average distress (5.93 ± 2.19). To develop the ability to tell the truth well, one must receive regular training in communication skills, including experienced attending physicians. This study found a significant difference between medical students' opinions on truth telling and attending physicians' actual clinical practice. More research is needed to objectively assess physicians' truth telling in clinical practice and to study the factors affecting the method of truth telling used by attending physicians in clinical practice. Copyright © 2012 John Wiley & Sons, Ltd.

  3. The Use of Propensity Scores and Observational Data to Estimate Randomized Controlled Trial Generalizability Bias

    PubMed Central

    Pressler, Taylor R.; Kaizar, Eloise E.

    2014-01-01

    While randomized controlled trials (RCT) are considered the “gold standard” for clinical studies, the use of exclusion criteria may impact the external validity of the results. It is unknown whether estimators of effect size are biased by excluding a portion of the target population from enrollment. We propose to use observational data to estimate the bias due to enrollment restrictions, which we term generalizability bias. In this paper we introduce a class of estimators for the generalizability bias and use simulation to study its properties in the presence of non-constant treatment effects. We find the surprising result that our estimators can be unbiased for the true generalizability bias even when all potentially confounding variables are not measured. In addition, our proposed doubly robust estimator performs well even for mis-specified models. PMID:23553373

  4. Observations of infection prevention and control practices in primary health care, Kenya

    PubMed Central

    Bedoya, Guadalupe; Dolinger, Amy; Rogo, Khama; Mwaura, Njeri; Wafula, Francis; Coarasa, Jorge; Goicoechea, Ana

    2017-01-01

    Abstract Objective To assess compliance with infection prevention and control practices in primary health care in Kenya. Methods We used an observational, patient-tracking tool to assess compliance with infection prevention and control practices by 1680 health-care workers during outpatient interactions with 14 328 patients at 935 health-care facilities in 2015. Compliance was assessed in five domains: hand hygiene; protective glove use; injections and blood sampling; disinfection of reusable equipment; and waste segregation. We calculated compliance by dividing the number of correct actions performed by the number of indications and evaluated associations between compliance and the health-care worker’s and facility’s characteristics. Findings Across 106 464 observed indications for an infection prevention and control practice, the mean compliance was 0.318 (95% confidence interval, CI: 0.315 to 0.321). The compliance ranged from 0.023 (95% CI: 0.021 to 0.024) for hand hygiene to 0.871 (95% CI: 0.866 to 0.876) for injection and blood sampling safety. Compliance was weakly associated with the facility’s characteristics (e.g. public or private, or level of specialization) and the health-care worker’s knowledge of, and training in, infection prevention and control practices. Conclusion The observational tool was effective for assessing compliance with infection prevention and control practices across multiple domains in primary health care in a low-income country. Compliance varied widely across infection prevention and control domains. The weak associations observed between compliance and the characteristics of health-care workers and facilities, such as knowledge and the availability of supplies, suggest that a broader focus on behavioural change is required. PMID:28670015

  5. The clinical and cost-effectiveness of brief advice for excessive alcohol consumption among people attending sexual health clinics: a randomised controlled trial

    PubMed Central

    Crawford, Mike J; Sanatinia, Rahil; Barrett, Barbara; Byford, Sarah; Dean, Madeleine; Green, John; Jones, Rachael; Leurent, Baptiste; Sweeting, Michael J; Touquet, Robin; Greene, Linda; Tyrer, Peter; Ward, Helen; Lingford-Hughes, Anne

    2015-01-01

    Objectives To examine the clinical and cost-effectiveness of brief advice for excessive alcohol consumption among people who attend sexual health clinics. Methods Two-arm, parallel group, assessor blind, pragmatic, randomised controlled trial. 802 people aged 19 years or over who attended one of three sexual health clinics and were drinking excessively were randomised to either brief advice or control treatment. Brief advice consisted of feedback on alcohol and health, written information and an offer of an appointment with an Alcohol Health Worker. Control participants received a leaflet on health and lifestyle. The primary outcome was mean weekly alcohol consumption during the previous 90 days measured 6 months after randomisation. The main secondary outcome was unprotected sex during this period. Results Among the 402 randomised to brief advice, 397 (99%) received it. The adjusted mean difference in alcohol consumption at 6 months was −2.33 units per week (95% CI −4.69 to 0.03, p=0.053) among those in the active compared to the control arm of the trial. Unprotected sex was reported by 154 (53%) of those who received brief advice, and 178 (59%) controls (adjusted OR=0.89, 95% CI 0.63 to 1.25, p=0.496). There were no significant differences in costs between study groups at 6 months. Conclusions Introduction of universal screening and brief advice for excessive alcohol use among people attending sexual health clinics does not result in clinically important reductions in alcohol consumption or provide a cost-effective use of resources. Trial registration number Current Controlled Trials ISRCTN 99963322. PMID:24936090

  6. Clinical coaching in primary care: Capable of improving control in patients with type 2 diabetes mellitus?

    PubMed

    González-Guajardo, Eduardo Enrique; Salinas-Martínez, Ana María; Botello-García, Antonio; Mathiew-Quiros, Álvaro

    2016-06-01

    Few clinical coaching studies are both endorsed by real cases and focused on reducing suboptimal diabetes control. We evaluated the effectiveness of coaching on improving type 2 diabetes goals after 3 years of implementation in primary care. A cross-sectional study with follow up was conducted during 2008-2011. Coaching consisted of guiding family doctors to improve their clinical abilities, and it was conducted by a medical doctor trained in skill building, experiential learning, and goal setting. Effectiveness was assessed by means of fasting plasma glucose and glycosylated hemoglobin outcomes. The main analysis consisted of 1×3 and 2×3 repeated measures ANOVAs. A significant coaching×time interaction was observed, indicating that the difference in glucose between primary care units with and without coaching increased over time (Wilks' lambda multivariate test, P<0.0001). Coaching increased 1.4 times (95%CI 1.3, 1.5) the possibility of reaching the fasting glucose goal after controlling for baseline values. There was also a significant improvement in glycosylated hemoglobin (Bonferroni-corrected p-value for pairwise comparisons, P<0.0001). A correctible and even preventable contributing component in diabetes care corresponds to physicians' performance. After 3 years of implementation, coaching was found to be worth the effort to improve type 2 diabetes control in primary care. Copyright © 2015 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

  7. Polymorphic robotic system controlled by an observing camera

    NASA Astrophysics Data System (ADS)

    Koçer, Bilge; Yüksel, Tugçe; Yümer, M. Ersin; Özen, C. Alper; Yaman, Ulas

    2010-02-01

    Polymorphic robotic systems, which are composed of many modular robots that act in coordination to achieve a goal defined on the system level, have been drawing attention of industrial and research communities since they bring additional flexibility in many applications. This paper introduces a new polymorphic robotic system, in which the detection and control of the modules are attained by a stationary observing camera. The modules do not have any sensory equipment for positioning or detecting each other. They are self-powered, geared with means of wireless communication and locking mechanisms, and are marked to enable the image processing algorithm detect the position and orientation of each of them in a two dimensional space. Since the system does not depend on the modules for positioning and commanding others, in a circumstance where one or more of the modules malfunction, the system will be able to continue operating with the rest of the modules. Moreover, to enhance the compatibility and robustness of the system under different illumination conditions, stationary reference markers are employed together with global positioning markers, and an adaptive filtering parameter decision methodology is enclosed. To the best of authors' knowledge, this is the first study to introduce a remote camera observer to control modules of a polymorphic robotic system.

  8. [From Nebuchadnezzar to the randomized controlled trial--milestones in the development of clinical research].

    PubMed

    Oberbaum, Menachem; Lysy, Joseph; Gropp, Cornelius

    2011-08-01

    The first clinical experiment is described in the bible: The prophet Daniel is reported being nourished during ten days by seeds and water only, in order to check if his physical state would deteriorate as a result of this minimal nutrition. In the 15th century, French surgeon Ambroise Parí experimented with a mixture of turpentine, egg protein and rose oil to treat combat wounds, which is thought to be the first clinical study to be reported. In the 19th century British scientist James Lind designed the first controlled prospective study with parallel groups, proving that ingesting citrus fruit prevents scurvy. A short time afterwards British scientist John Haygarth was the first to use a placebo drug in a clinical study. Important work on placebo was conducted by the American scientists Austin Flint and later by Henry K. Beecher, who showed that placebo itself has biological properties. The importance of comparative studies was first understood by French psychologist CLaude Bernard. He is considered the founder of the modern scientific method based on observation, analysis of data and examination of hypotheses. Bernard's work was based on the work of fellow Frenchman Pierre Charles Alexandre Louis, who is justly considered a founding father of modern epidemiology, and who was the first to use statistics in clinical experiments. Random distributions in clinical studies were reported even before this time, for instance in the work of the Flemish physician Johannes Baptista van Helmont. Danish Nobel prize winner Johannes Fibiger pioneered the use of selection bias in his work with diphtheria serum.

  9. New insight into the comparative power of quality-control rules that use control observations within a single analytical run.

    PubMed

    Parvin, C A

    1993-03-01

    The error detection characteristics of quality-control (QC) rules that use control observations within a single analytical run are investigated. Unlike the evaluation of QC rules that span multiple analytical runs, most of the fundamental results regarding the performance of QC rules applied within a single analytical run can be obtained from statistical theory, without the need for simulation studies. The case of two control observations per run is investigated for ease of graphical display, but the conclusions can be extended to more than two control observations per run. Results are summarized in a graphical format that offers many interesting insights into the relations among the various QC rules. The graphs provide heuristic support to the theoretical conclusions that no QC rule is best under all error conditions, but the multirule that combines the mean rule and a within-run standard deviation rule offers an attractive compromise.

  10. Dengue Fever in American Military Personnel in the Philippines: Clinical Observations on Hospitalized Patients during a 1984 Epidemic

    DTIC Science & Technology

    1989-03-01

    the mean maximum temperature was Hypotenson 15 (62.5) 102.0 + 1.3 F. A "saddle back" or dip- Rash (Non- Petechial ) 13 (54.2) hasic fever pattern was not...DENGUE FEVER IN AMERICAN MILITARY PERSONNEL IN THE PHILIPPINES: CLINICAL OBSERVATIONS ON HOSPITALIZED PATIENS DURING A 1984 EPIDEMIC C.G. Hayes, T.F...Accession Tr~I Jti ti DENGUE FEVER IN AMERICAN MILITARY PERSONNEL IN THE PHILIPPINES: CLINICAL OBSERVATIONS ON HOSPITALIZED PATIENTS DURING A 1984

  11. Pain control in orthodontics using a micropulse vibration device: A randomized clinical trial.

    PubMed

    Lobre, Wendy D; Callegari, Brent J; Gardner, Gary; Marsh, Curtis M; Bush, Anneke C; Dunn, William J

    2016-07-01

    To investigate the relationship between a micropulse vibration device and pain perception during orthodontic treatment. This study was a parallel group, randomized clinical trial. A total of 58 patients meeting eligibility criteria were assigned using block allocation to one of two groups: an experimental group using the vibration device or a control group (n  =  29 for each group). Patients used the device for 20 minutes daily. Patients rated pain intensity on a visual analog scale at appropriate intervals during the weeks after the separator or archwire appointment. Data were analyzed using repeated measures analysis of variance at α  =  .05. During the 4-month test period, significant differences between the micropulse vibration device group and the control group for overall pain (P  =  .002) and biting pain (P  =  .003) were identified. The authors observed that perceived pain was highest at the beginning of the month, following archwire adjustment. The micropulse vibration device significantly lowered the pain scores for overall pain and biting pain during the 4-month study period.

  12. Effectiveness and Persistence with Liraglutide Among Patients with Type 2 Diabetes in Routine Clinical Practice--EVIDENCE: A Prospective, 2-Year Follow-Up, Observational, Post-Marketing Study.

    PubMed

    Gautier, Jean-Francois; Martinez, Luc; Penfornis, Alfred; Eschwège, Eveline; Charpentier, Guillaume; Huret, Benoît; Madani, Suliya; Gourdy, Pierre

    2015-09-01

    The aim of this study was to investigate whether the efficacy of liraglutide observed in randomized controlled trials translates into therapeutic benefits in the French population during routine clinical practice. This observational, prospective, multicenter study included 3152 adults with type 2 diabetes who had recently started or were about to start liraglutide treatment. During 2 years of follow-up, an evaluation of the reasons for prescribing liraglutide, maintenance dose of liraglutide, changes in combined antidiabetic treatments, level of glycemic control, change in body weight and body mass index (BMI), patient satisfaction with diabetes treatment and safety of liraglutide were investigated. The primary study endpoint was the proportion of patients still receiving liraglutide and presenting with HbA1c <7.0% after 2 years of follow-up. At the end of the study, 29.5% of patients maintained liraglutide treatment and reached the HbA(1c) target. Mean (±SD) HbA(1c), fasting plasma glucose concentration, body weight and BMI were significantly reduced from baseline [8.46% (±1.46) to 7.44% (±1.20); 180 (±60) to 146 (±44) mg/dL; 95.2 (±20.0) to 91.1 (±19.6) kg; 34.0 (±7.2) to 32.5 (±6.9) kg/m(2); respectively, all P < 0.0001]. Patient treatment satisfaction increased, with the mean diabetes treatment satisfaction questionnaire status version score increasing from 22.17 (±7.64) to 28.55 (±5.79), P < 0.0001. The main adverse event type was gastrointestinal, with a frequency of 10.9%, and the percentage of patients suffering ≥1 hypoglycemic episode decreased from 6.9% to 4.4%. The results of the EVIDENCE study suggest that the effectiveness of liraglutide in real-world clinical practice is similar to that observed in randomized controlled trials. Novo Nordisk A/S. ClinicalTrials.gov identifier, NCT01226966.

  13. Standardized Observational Assessment of Attention Deficit Hyperactivity Disorder Combined and Predominantly Inattentive Subtypes. II. Classroom Observations.

    PubMed

    McConaughy, Stephanie H; Ivanova, Masha Y; Antshel, Kevin; Eiraldi, Ricardo B; Dumenci, Levent

    2009-07-01

    Trained classroom observers used the Direct Observation Form (DOF; McConaughy & Achenbach, 2009) to rate observations of 163 6- to 11-year-old children in their school classrooms. Participants were assigned to four groups based on a parent diagnostic interview and parent and teacher rating scales: Attention Deficit Hyperactivity Disorder (ADHD)-Combined type (n = 64); ADHD-Inattentive type (n = 22); clinically referred without ADHD (n = 51); and nonreferred control children (n = 26). The ADHD-Combined group scored significantly higher than the referred without ADHD group and controls on the DOF Intrusive and Oppositional syndromes, Attention Deficit Hyperactivity Problems scale, Hyperactivity-Impulsivity subscale, and Total Problems; and significantly lower on the DOF On-Task score. The ADHD-Inattentive group scored significantly higher than controls on the DOF Sluggish Cognitive Tempo and Attention Problems syndromes, Inattention subscale, and Total Problems; and significantly lower on the DOF On-Task score. Implications are discussed regarding the discriminative validity of standardized classroom observations for identifying children with ADHD and differentiating between the two ADHD subtypes.

  14. Standardized Observational Assessment of Attention Deficit Hyperactivity Disorder Combined and Predominantly Inattentive Subtypes. II. Classroom Observations

    PubMed Central

    McConaughy, Stephanie H.; Ivanova, Masha Y.; Antshel, Kevin; Eiraldi, Ricardo B.; Dumenci, Levent

    2010-01-01

    Trained classroom observers used the Direct Observation Form (DOF; McConaughy & Achenbach, 2009) to rate observations of 163 6- to 11-year-old children in their school classrooms. Participants were assigned to four groups based on a parent diagnostic interview and parent and teacher rating scales: Attention Deficit Hyperactivity Disorder (ADHD)—Combined type (n = 64); ADHD—Inattentive type (n = 22); clinically referred without ADHD (n = 51); and nonreferred control children (n = 26). The ADHD—Combined group scored significantly higher than the referred without ADHD group and controls on the DOF Intrusive and Oppositional syndromes, Attention Deficit Hyperactivity Problems scale, Hyperactivity-Impulsivity subscale, and Total Problems; and significantly lower on the DOF On-Task score. The ADHD—Inattentive group scored significantly higher than controls on the DOF Sluggish Cognitive Tempo and Attention Problems syndromes, Inattention subscale, and Total Problems; and significantly lower on the DOF On-Task score. Implications are discussed regarding the discriminative validity of standardized classroom observations for identifying children with ADHD and differentiating between the two ADHD subtypes. PMID:20802813

  15. [Clinical observation on fuzhong (supporting the middle-jiao) manipulation of tuina for infantile anorexia].

    PubMed

    Wang, Yuan-Yuan; Liu, Xiao-Ying

    2014-01-01

    To observe clinical therapeutic effect of fuzhong (supporting the middle-jiao) manipulation of tuina for infantile anorexia. Eighty-one children with anorexia were treated with fuzhong manipulation, including abdominal kneading, acupressure at Zhongwan (CV 12), Lanmen (Extra), Tianshu (ST 25), Zusanli (ST 36), Sanyinjiao (SP 6), spine pinching, warm moxibustion and warm scraping with supporting-yang cupping, three times a week, six times as a session. Onset time, therapeutic effect and TCM symptom scores before and after treatment were observed after two sessions and differences of therapeutic effect among different patterns were compared. Seventy-two children had the effect in one session while 41 children had the effect within half of a session. 38 cases were clinically cured, 15 cases were markedly effective, 23 cases were effective and 5 cases were failed. The total effective rate was 93.8%. Compared with before treatment, TCM symptom scores, including appetite, food intake, complexion and defecation, were all obviously improved after treatment (all P < 0.001). The clinical cured rate was 45.2% (19/42) in the pattern of dysfunction of spleen in transportation, 45.8% (11/24) in the pattern of qi deficiency of spleen and stomach, 50.0% (4/8) in the pattern of yin deficiency of spleen and stomach, 57.1% (4/7) in the pattern of liver sufficiency and spleen insufficiency, which had no obvious differences among different patterns (all P > 0.05). The fuzhong manipulation of tuina has quick onset time and satisfied clinical therapeutic effect, which could obviously improve symptoms and is fit for different patterns of infantile anorexia.

  16. Early experiences in evolving an enterprise-wide information model for laboratory and clinical observations.

    PubMed

    Chen, Elizabeth S; Zhou, Li; Kashyap, Vipul; Schaeffer, Molly; Dykes, Patricia C; Goldberg, Howard S

    2008-11-06

    As Electronic Healthcare Records become more prevalent, there is an increasing need to ensure unambiguous data capture, interpretation, and exchange within and across heterogeneous applications. To address this need, a common, uniform, and comprehensive approach for representing clinical information is essential. At Partners HealthCare System, we are investigating the development and implementation of enterprise-wide information models to specify the representation of clinical information to support semantic interoperability. This paper summarizes our early experiences in: (1) defining a process for information model development, (2) reviewing and comparing existing healthcare information models, (3) identifying requirements for representation of laboratory and clinical observations, and (4) exploring linkages to existing terminology and data standards. These initial findings provide insight to the various challenges ahead and guidance on next steps for adoption of information models at our organization.

  17. Assessing validity of observational intervention studies - the Benchmarking Controlled Trials.

    PubMed

    Malmivaara, Antti

    2016-09-01

    Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. To create and pilot test a checklist for appraising methodological validity of a BCT. The checklist was created by extracting the most essential elements from the comprehensive set of criteria in the previous paper on BCTs. Also checklists and scientific papers on observational studies and respective systematic reviews were utilized. Ten BCTs published in the Lancet and in the New England Journal of Medicine were used to assess feasibility of the created checklist. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies. However, the piloted checklist should be validated in further studies. Key messages Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. This paper presents a checklist for appraising methodological validity of BCTs and pilot-tests the checklist with ten BCTs published in leading medical journals. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies.

  18. A Clustering Based Approach for Observability and Controllability Analysis for Optimal Placement of PMU

    NASA Astrophysics Data System (ADS)

    Murthy, Ch; MIEEE; Mohanta, D. K.; SMIEE; Meher, Mahendra

    2017-08-01

    Continuous monitoring and control of the power system is essential for its healthy operation. This can be achieved by making the system observable as well as controllable. Many efforts have been made by several researchers to make the system observable by placing the Phasor Measurement Units (PMUs) at the optimal locations. But so far the idea of controllability with PMUs is not considered. This paper contributes how to check whether the system is controllable or not, if not then how make it controllable using a clustering approach. IEEE 14 bus system is considered to illustrate the concept of controllability.

  19. Effect of edge pruning on structural controllability and observability of complex networks

    PubMed Central

    Mengiste, Simachew Abebe; Aertsen, Ad; Kumar, Arvind

    2015-01-01

    Controllability and observability of complex systems are vital concepts in many fields of science. The network structure of the system plays a crucial role in determining its controllability and observability. Because most naturally occurring complex systems show dynamic changes in their network connectivity, it is important to understand how perturbations in the connectivity affect the controllability of the system. To this end, we studied the control structure of different types of artificial, social and biological neuronal networks (BNN) as their connections were progressively pruned using four different pruning strategies. We show that the BNNs are more similar to scale-free networks than to small-world networks, when comparing the robustness of their control structure to structural perturbations. We introduce a new graph descriptor, ‘the cardinality curve’, to quantify the robustness of the control structure of a network to progressive edge pruning. Knowing the susceptibility of control structures to different pruning methods could help design strategies to destroy the control structures of dangerous networks such as epidemic networks. On the other hand, it could help make useful networks more resistant to edge attacks. PMID:26674854

  20. Dementia Prevention: optimizing the use of observational data for personal, clinical, and public health decision-making.

    PubMed

    Dacks, Penny A; Andrieu, Sandrine; Blacker, Deborah; Carman, Aaron J; Green, Allan M; Grodstein, Francine; Henderson, Victor W; James, Bryan D; Lane, Rachel F; Lau, Joseph; Lin, Pei-Jung; Reeves, Barnaby C; Shah, Raj C; Vellas, Bruno; Yaffe, Kristine; Yurko-Mauro, Karin; Shineman, Diana W; Bennett, David A; Fillit, Howard M

    2014-02-01

    Worldwide, over 35 million people suffer from Alzheimer's disease and related dementias. This number is expected to triple over the next 40 years. How can we improve the evidence supporting strategies to reduce the rate of dementia in future generations? The risk of dementia is likely influenced by modifiable factors such as exercise, cognitive activity, and the clinical management of diabetes and hypertension. However, the quality of evidence is limited and it remains unclear whether specific interventions to reduce these modifiable risk factors can, in turn, reduce the risk of dementia. Although randomized controlled trials are the gold-standard for causality, the majority of evidence for long-term dementia prevention derives from, and will likely continue to derive from, observational studies. Although observational research has some unavoidable limitations, its utility for dementia prevention might be improved by, for example, better distinction between confirmatory and exploratory research, higher reporting standards, investment in effectiveness research enabled by increased data-pooling, and standardized exposure and outcome measures. Informed decision-making by the general public on low-risk health choices that could have broad potential benefits could be enabled by internet-based tools and decision-aids to communicate the evidence, its quality, and the estimated magnitude of effect.

  1. Wireless remote control clinical image workflow: utilizing a PDA for offsite distribution

    NASA Astrophysics Data System (ADS)

    Liu, Brent J.; Documet, Luis; Documet, Jorge; Huang, H. K.; Muldoon, Jean

    2004-04-01

    Last year we presented in RSNA an application to perform wireless remote control of PACS image distribution utilizing a handheld device such as a Personal Digital Assistant (PDA). This paper describes the clinical experiences including workflow scenarios of implementing the PDA application to route exams from the clinical PACS archive server to various locations for offsite distribution of clinical PACS exams. By utilizing this remote control application, radiologists can manage image workflow distribution with a single wireless handheld device without impacting their clinical workflow on diagnostic PACS workstations. A PDA application was designed and developed to perform DICOM Query and C-Move requests by a physician from a clinical PACS Archive to a CD-burning device for automatic burning of PACS data for the distribution to offsite. In addition, it was also used for convenient routing of historical PACS exams to the local web server, local workstations, and teleradiology systems. The application was evaluated by radiologists as well as other clinical staff who need to distribute PACS exams to offsite referring physician"s offices and offsite radiologists. An application for image workflow management utilizing wireless technology was implemented in a clinical environment and evaluated. A PDA application was successfully utilized to perform DICOM Query and C-Move requests from the clinical PACS archive to various offsite exam distribution devices. Clinical staff can utilize the PDA to manage image workflow and PACS exam distribution conveniently for offsite consultations by referring physicians and radiologists. This solution allows the radiologist to expand their effectiveness in health care delivery both within the radiology department as well as offisite by improving their clinical workflow.

  2. Magsat attitude dynamics and control: Some observations and explanations

    NASA Technical Reports Server (NTRS)

    Stengle, T. H.

    1980-01-01

    Before its reentry 7 months after launch, Magsat transmitted an abundance of valuable data for mapping the Earth's magnetic field. As an added benefit, a wealth of attitude data for study by spacecraft dynamicists was also collected. Because of its unique configuration, Magsat presented new control problems. With its aerodynamic trim boom, attitude control was given an added dimension. Minimization of attitude drift, which could be mapped in relative detail, became the goal. Momentum control, which was accomplished by pitching the spacecraft in order to balance aerodynamic and gravity gradient torques, was seldom difficult to achieve. Several interesting phenomena observed as part of this activity included occasional momentum wheel instability and a rough correlation between solar flux and the pitch angle required to maintain acceptable momentum. An overview is presented of the attitude behavior of Magsat and some of the control problems encountered. Plausible explanations for some of this behavior are offered. Some of the control philosophy used during the mission is examined and aerodynamic trimming operations are summarized.

  3. Design and implementation of a controlled clinical trial to evaluate the effectiveness and efficiency of routine opt-out rapid human immunodeficiency virus screening in the emergency department.

    PubMed

    Haukoos, Jason S; Hopkins, Emily; Byyny, Richard L; Conroy, Amy A; Silverman, Morgan; Eisert, Sheri; Thrun, Mark; Wilson, Michael; Boyett, Brian; Heffelfinger, James D

    2009-08-01

    In 2006, the Centers for Disease Control and Prevention (CDC) released revised recommendations for performing human immunodeficiency virus (HIV) testing in health care settings, including implementing routine rapid HIV screening, the use of an integrated opt-out consent, and limited prevention counseling. Emergency departments (EDs) have been a primary focus of these efforts. These revised CDC recommendations were primarily based on feasibility studies and have not been evaluated through the application of rigorous research methods. This article describes the design and implementation of a large prospective controlled clinical trial to evaluate the CDC's recommendations in an ED setting. From April 15, 2007, through April 15, 2009, a prospective quasi-experimental equivalent time-samples clinical trial was performed to compare the clinical effectiveness and efficiency of routine (nontargeted) opt-out rapid HIV screening (intervention) to physician-directed diagnostic rapid HIV testing (control) in a high-volume urban ED. In addition, three nested observational studies were performed to evaluate the cost-effectiveness and patient and staff acceptance of the two rapid HIV testing methods. This article describes the rationale, methodologies, and study design features of this program evaluation clinical trial. It also provides details regarding the integration of the principal clinical trial and its nested observational studies. Such ED-based trials are rare, but serve to provide valid comparisons between testing approaches. Investigators should consider similar methodology when performing future ED-based health services research.

  4. Observer-based H∞ resilient control for a class of switched LPV systems and its application

    NASA Astrophysics Data System (ADS)

    Yang, Dong; Zhao, Jun

    2016-11-01

    This paper deals with the issue of observer-based H∞ resilient control for a class of switched linear parameter-varying (LPV) systems by utilising a multiple parameter-dependent Lyapunov functions method. First, attention is focused upon the design of a resilient observer, an observer-based resilient controller and a parameter and estimate state-dependent switching signal, which can stabilise and achieve the disturbance attenuation for the given systems. Then, a solvability condition of the H∞ resilient control problem is given in terms of matrix inequality for the switched LPV systems. This condition allows the H∞ resilient control problem for each individual subsystem to be unsolvable. The observer, controller, and switching signal are explicitly computed by solving linear matrix inequalities (LMIs). Finally, the effectiveness of the proposed control scheme is illustrated by its application to a turbofan engine, which can hardly be handled by the existing approaches.

  5. The artificial satellite observation chronograph controlled by single chip microcomputer.

    NASA Astrophysics Data System (ADS)

    Pan, Guangrong; Tan, Jufan; Ding, Yuanjun

    1991-06-01

    The instrument specifications, hardware structure, software design, and other characteristics of the chronograph mounting on a theodolite used for artificial satellite observation are presented. The instrument is a real time control system with a single chip microcomputer.

  6. Toxoplasmosis: A history of clinical observations.

    PubMed

    Weiss, Louis M; Dubey, Jitender P

    2009-07-01

    It has been 100 years since Toxoplasma gondii was initially described in Tunis by Nicolle and Manceaux (1908) in the tissues of the gundi (Ctenodoactylus gundi) and in Brazil by Splendore (1908) in the tissues of a rabbit. Toxoplasma gondii is a ubiquitous, Apicomplexan parasite of warm-blooded animals that can cause several clinical syndromes including encephalitis, chorioretinitis, congenital infection and neonatal mortality. Fifteen years after the description of T. gondii by Nicolle and Manceaux a fatal case of toxoplasmosis in a child was reported by Janků. In 1939 Wolf, Cowen and Paige were the first to conclusively identify T. gondii as a cause of human disease. This review examines the clinical manifestations of infection with T. gondii and the history of the discovery of these manifestations.

  7. Toxoplasmosis: a history of clinical observations

    PubMed Central

    Weiss, Louis M.; Dubey, Jitender. P.

    2009-01-01

    It has been 100 years since Toxoplasma gondii was initially described in Tunis by Nicolle and Manceaux (1908) in the tissues of the gundi (Ctenodoactylus gundi) and in Brazil by Splendore (1908) in the tissues of a rabbit. Toxoplasma gondii is a ubiquitous, Apicomplexan parasite of warm-blooded animals that can cause several clinical syndromes including encephalitis, chorioretinitis, congenital infection and neonatal mortality. Fifteen years after the description of T. gondii by Nicolle and Manceaux a fatal case of toxoplasmosis in a child was reported by Janků. In 1939 Wolf, Cowen and Paige were the first to conclusively identify T. gondii as a cause of human disease. This review examines the clinical manifestations of infection with T. gondii and the history of the discovery of these manifestations. PMID:19217908

  8. Observer-based output feedback control of networked control systems with non-uniform sampling and time-varying delay

    NASA Astrophysics Data System (ADS)

    Meng, Su; Chen, Jie; Sun, Jian

    2017-10-01

    This paper investigates the problem of observer-based output feedback control for networked control systems with non-uniform sampling and time-varying transmission delay. The sampling intervals are assumed to vary within a given interval. The transmission delay belongs to a known interval. A discrete-time model is first established, which contains time-varying delay and norm-bounded uncertainties coming from non-uniform sampling intervals. It is then converted to an interconnection of two subsystems in which the forward channel is delay-free. The scaled small gain theorem is used to derive the stability condition for the closed-loop system. Moreover, the observer-based output feedback controller design method is proposed by utilising a modified cone complementary linearisation algorithm. Finally, numerical examples illustrate the validity and superiority of the proposed method.

  9. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial.

    PubMed

    Gomes, Evelim L F D; Carvalho, Celso R F; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

    2015-01-01

    The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma. A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function. No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p < 0.05). Although the mean energy expenditure at rest and during exercise training was similar for both groups, the maximum energy expenditure was higher in the VGG. The present findings strongly suggest that aerobic training promoted by an active video game had a positive impact on children with asthma in terms of clinical control, improvement in their exercise capacity and a reduction in pulmonary inflammation. Clinicaltrials.gov NCT01438294.

  10. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial

    PubMed Central

    Gomes, Evelim L. F. D.; Carvalho, Celso R. F.; Peixoto-Souza, Fabiana Sobral; Teixeira-Carvalho, Etiene Farah; Mendonça, Juliana Fernandes Barreto; Stirbulov, Roberto; Sampaio, Luciana Maria Malosá; Costa, Dirceu

    2015-01-01

    Objective The aim of the present study was to determine whether aerobic exercise involving an active video game system improved asthma control, airway inflammation and exercise capacity in children with moderate to severe asthma. Design A randomized, controlled, single-blinded clinical trial was carried out. Thirty-six children with moderate to severe asthma were randomly allocated to either a video game group (VGG; N = 20) or a treadmill group (TG; n = 16). Both groups completed an eight-week supervised program with two weekly 40-minute sessions. Pre-training and post-training evaluations involved the Asthma Control Questionnaire, exhaled nitric oxide levels (FeNO), maximum exercise testing (Bruce protocol) and lung function. Results No differences between the VGG and TG were found at the baseline. Improvements occurred in both groups with regard to asthma control and exercise capacity. Moreover, a significant reduction in FeNO was found in the VGG (p < 0.05). Although the mean energy expenditure at rest and during exercise training was similar for both groups, the maximum energy expenditure was higher in the VGG. Conclusion The present findings strongly suggest that aerobic training promoted by an active video game had a positive impact on children with asthma in terms of clinical control, improvementin their exercise capacity and a reductionin pulmonary inflammation. Trial Registration Clinicaltrials.gov NCT01438294 PMID:26301706

  11. Effect of a dentifrice containing Aloe vera on plaque and gingivitis control. A double-blind clinical study in humans.

    PubMed

    de Oliveira, Sílvia Morgana Araújo; Torres, Ticiana Carneiro; Pereira, Sérgio Luís da Silva; Mota, Olívia Morais de Lima; Carlos, Márlio Ximenes

    2008-01-01

    The effect of Aloe vera on the reduction of plaque and gingivitis was evaluated in a randomized, parallel and double-blind clinical trial. Subjects were randomly allocated to the test group (n=15) - dentifrice containing Aloe vera - or the control group (n=15) - fluoridated dentifrice. Plaque index (PI) and gingival bleeding index (GBI) were assessed at days 0 and 30. Subjects were asked to brush their teeth with the control or test dentifrice, three times a day, during a 30-day period. There was a significant reduction on plaque and gingivitis in both groups, but no statistically significant difference was observed among them (p>0.01). The dentifrice containing Aloe vera did not show any additional effect on plaque and gingivitis control compared to the fluoridated dentifrice.

  12. Impact of pharmaceutical care interventions on glycemic control and other health-related clinical outcomes in patients with type 2 diabetes: Randomized controlled trial.

    PubMed

    Wishah, Ruba A; Al-Khawaldeh, Omar A; Albsoul, Abla M

    2015-01-01

    The primary aim of this study was to evaluate the impact of pharmaceutical care interventions on glycemic control and other health-related clinical outcomes in patients with type 2 diabetes patients in Jordan. A randomized controlled clinical trial was conducted on 106 patients with uncontrolled type 2 diabetes seeking care in the diabetes clinics at Jordan University Hospital. Patients were randomly allocated into control and intervention group. The intervention group patients received pharmaceutical care interventions developed by the clinical pharmacist in collaboration with the physician while the control group patients received usual care without clinical pharmacist's input. Fasting blood glucose and HbA1c were measured at the baseline, at three months, and six months intervals for both intervention and control groups. After the six months follow-up, mean of HbA1c and FBS of the patients in the intervention group decreased significantly compared to the control group patients (P<0.05). Also, the results indicated that mean scores of patients' knowledge about medications, knowledge about diabetes and adherence to medications and diabetes self-care activities of the patients in the intervention group increased significantly compared to the control group (P<0.05). This study demonstrated an improvement in HbA1c, FBS, and lipid profile, in addition to self-reported medication adherence, diabetes knowledge, and diabetes self-care activities in patients with type 2 diabetes who received pharmaceutical care interventions. The results suggest the benefits of integrating clinical pharmacist services in multidisciplinary healthcare team and diabetes management in Jordan. Copyright © 2014 Diabetes India. Published by Elsevier Ltd. All rights reserved.

  13. Clinical observation of lymphocyte active immunotherapy in 380 patients with unexplained recurrent spontaneous abortion.

    PubMed

    Chen, Jian-Ling; Yang, Jian-Ming; Huang, Ya-Zhe; Li, Ying

    2016-11-01

    This study aims to investigate the clinical curative effect of lymphocyte active immunotherapy (LAI) on unexplained recurrent spontaneous abortion (RSA). A total of 749 RSA patients who received medical service in our hospital from October 2009 to June 2013 were enrolled into this study. These patients were randomly divided into two groups: LAI group (treatment group) and routine progesterone for maintenance tocolysis group (control group). A comparative analysis on the pregnancy outcomes in these two groups was conducted. Abortion rate was significantly lower in the LAI group than in the control group (P<0.05). Furthermore, pregnancy success rates were 89.7% and 32.2% in patients who received LAI and routine progesterone for maintenance tocolysis, respectively, and the difference was statistically significant (P<0.05). Our analysis suggested that LAI can treat RSA effectively and has an excellent clinical effect. Furthermore, the detection of blocking antibodies showed a positive prediction on pregnancy outcome. Copyright © 2016 Elsevier B.V. All rights reserved.

  14. Clinical photographic observation of plantar corns and callus associated with a nominal scale classification and inter- observer reliability study in a student population.

    PubMed

    Tollafield, David R

    2017-01-01

    The management of plantar corns and callus has a low cost-benefit with reduced prioritisation in healthcare. The distinction between types of keratin lesions that forms corns and callus has attracted limited interest. Observation is imperative to improving diagnostic predictions and a number of studies point to some confusion as to how best to achieve this. The use of photographic observation has been proposed to improve our understanding of intractable keratin lesions. Students from a podiatry school reviewed photographs where plantar keratin lesions were divided into four nominal groups; light callus (Grade 1), heavy defined callus (Grade 2), concentric keratin plugs (Grade 3) and callus with deeper density changes under the forefoot (Grade 4). A group of 'experts' assigned from qualified podiatrists validated the observer rated responses by the students. Cohen's weighted statistic (k) was used to measure inter-observer reliability. First year students (unskilled) performed less well when viewing photographs ( k  = 0.33) compared to third year students (semi-skilled, k  = 0.62). The experts performed better than students ( k  = 0.88) providing consistency with wound care models in other studies. Improved clinical annotation of clinical features, supported by classification of keratin- based lesions, combined with patient outcome tools, could improve the scientific rationale to prioritise patient care. Problems associated with photographic assessment involves trying to differentiate similar lesions without the benefit of direct palpation. Direct observation of callus with and without debridement requires further investigation alongside the model proposed in this paper.

  15. Contribution of family social support to the metabolic control of people with diabetes mellitus: A randomized controlled clinical trial.

    PubMed

    Gomes, Lilian Cristiane; Coelho, Anna Claudia Martins; Gomides, Danielle Dos Santos; Foss-Freitas, Maria Cristina; Foss, Milton César; Pace, Ana Emilia

    2017-08-01

    This randomized controlled clinical trial aimed to evaluate the contribution of family social support to the clinical/metabolic control of people with type 2 diabetes mellitus. Diabetes mellitus is a chronic disease that requires continuous care in order for individuals to reach glycemic control, the primordial goal of treatment. Family social support is essential to the development of care skills and their maintenance. However, there are few studies that investigate the contribution of family social support to diabetes control. The study was developed between June 2011 and May 2013, and included 164 people who were randomized using simple randomization. The intervention group differed from the control group in that it included a family caregiver, who was recognized by the patient as a source of social support. The educational interventions received by people with diabetes mellitus were used as the basis of the education provided through telephone calls to patients' family members and caregivers, and their purpose was to encourage dialogue between the patients and their relatives about the topics related to diabetes. Regarding the clinical impact, the results showed that there was a greater reduction in blood pressure and glycated hemoglobin in the intervention group than in the control group, showing a positive effect on the control of the disease. Families should be incorporated into the care of people with diabetes mellitus and especially in health care programs, in particular those that can promote different forms of social support to strengthen the bond between family members. Copyright © 2017 Elsevier Inc. All rights reserved.

  16. An observer-based compensator for distributed delays in integrated control systems

    NASA Technical Reports Server (NTRS)

    Luck, Rogelio; Ray, Asok

    1989-01-01

    This paper presents an algorithm for compensation of delays that are distributed within a control loop. The observer-based algorithm is especially suitable for compensating network-induced delays that are likely to occur in integrated control systems of the future generation aircraft. The robustness of the algorithm relative to uncertainties in the plant model have been examined.

  17. WeChat Public Account Use Improves Clinical Control of Cough-Variant Asthma: A Randomized Controlled Trial.

    PubMed

    Cao, Yuan; Lin, Shi-Hua; Zhu, Ding; Xu, Feng; Chen, Zhi-Hua; Shen, Hua-Hao; Li, Wen

    2018-03-14

    BACKGROUND WeChat is a convenient and popular social medium, and it seems to be an appropriate platform for education and management of patients. This study sought to identify usefulness in clinical control of cough-variant asthma (CVA). MATERIAL AND METHODS A randomized controlled trial was conducted among 80 CVA patients. After being assigned to either the traditional group (TG) or the WeChat group (WG), they received the same inhalation therapy, but patients in WG received additional education and instruction via our public account on the WeChat application. Questionnaires on asthma and chronic cough, data on pulmonary function, blood-related items, follow-up adherence, and Emergency Department (ED) visits were collected at the initial visit and at 3 months. RESULTS A total of 67 participants completed the trial for analysis. FEV1/predicted and FEV1/FVC were significantly increased in WG (p<0.001; p=0.012) after 3 months. PD20-FEV1 was increased in both groups compared with baseline, but more pronounced in WG (p=0.004). ACQ-7 scores were improved in both groups (p=0.024; p<0.001). Participants allocated to WG experienced a greater improvement in AQLQ and LCQ scores, and between-group differences were significant at 3 months (p=0.040; p=0.001). Furthermore, we observed decreases in blood eosinophil count and FeNO in WG (p=0.048; p=0.014), and WG presented better follow-up compliance (p=0.034). CONCLUSIONS Using WeChat as part of treatment and management of CVA can help patients learn about their disease and medications, as well as improve disease control and therapy outcomes.

  18. WeChat Public Account Use Improves Clinical Control of Cough-Variant Asthma: A Randomized Controlled Trial

    PubMed Central

    Cao, Yuan; Lin, Shi-Hua; Zhu, Ding; Xu, Feng; Chen, Zhi-Hua

    2018-01-01

    Background WeChat is a convenient and popular social medium, and it seems to be an appropriate platform for education and management of patients. This study sought to identify usefulness in clinical control of cough-variant asthma (CVA). Material/Methods A randomized controlled trial was conducted among 80 CVA patients. After being assigned to either the traditional group (TG) or the WeChat group (WG), they received the same inhalation therapy, but patients in WG received additional education and instruction via our public account on the WeChat application. Questionnaires on asthma and chronic cough, data on pulmonary function, blood-related items, follow-up adherence, and Emergency Department (ED) visits were collected at the initial visit and at 3 months. Results A total of 67 participants completed the trial for analysis. FEV1/predicted and FEV1/FVC were significantly increased in WG (p<0.001; p=0.012) after 3 months. PD20-FEV1 was increased in both groups compared with baseline, but more pronounced in WG (p=0.004). ACQ-7 scores were improved in both groups (p=0.024; p<0.001). Participants allocated to WG experienced a greater improvement in AQLQ and LCQ scores, and between-group differences were significant at 3 months (p=0.040; p=0.001). Furthermore, we observed decreases in blood eosinophil count and FeNO in WG (p=0.048; p=0.014), and WG presented better follow-up compliance (p=0.034). Conclusions Using WeChat as part of treatment and management of CVA can help patients learn about their disease and medications, as well as improve disease control and therapy outcomes. PMID:29536984

  19. Clinically controlled study on children's infectious mononucleosis treated by Chinese medicine.

    PubMed

    Yao, Yuan; Duan, Hong-mei; Yan, Hui-min; Zhen, Xiao-fang; Pan, Yu-chen; Yao, Yao; Chen, Li; Jing, Xue-fang; Chen, Hai-lun

    2009-10-01

    To evaluate the clinical efficacy and safety of Chinese drugs for the treatment of children's infectious mononucleosis (CIM). Sixty CIM patients were assigned into the treated group and the control group, patients in the treated group were administered with Chinese herbal decoction, and those in the control group were treated with intravenous dripping of ganciclovir 10 mg/kg per day, for a treatment course of 14 days. The total effective rate was 96.0% in the treated group and 97.1% in the control group, showing insignificant difference between groups. The efficacy in the treated group was superior to that in the control group on the fever clearance time (3.0+/-1.5 days vs 4.9+/-3.9 days ) and the disappearance time of cervical lymph node swelling (0.8+/-1.0 score vs 1.5+/-1.2 score), showing statistical significance (all P<0.05). T-cell subsets were markedly improved in both groups after treatment. Adverse reaction occurred in four cases of the control group. Using Chinese herbs for clearing heat, removing toxin, activating blood circulation, and dissolving stasis is effective and safe for the treatment of CIM. It can effectively improve the clinical symptoms and shows a certain effect on immune regulation.

  20. A Randomised Controlled Trial of a Brief Online Mindfulness-Based Intervention on Paranoia in a Non-Clinical Sample.

    PubMed

    Shore, Robert; Strauss, Clara; Cavanagh, Kate; Hayward, Mark; Ellett, Lyn

    2018-01-01

    Paranoia is common and distressing in the general population and can impact on health, emotional well-being and social functioning, such that effective interventions are needed. Brief online mindfulness-based interventions (MBIs) have been shown to reduce symptoms of anxiety and depression in non-clinical samples; however, at present, there is no research investigating whether they can reduce paranoia. The current study explored whether a brief online MBI increased levels of mindfulness and reduced levels of paranoia in a non-clinical population. The mediating effect of mindfulness on any changes in paranoia was also investigated. One hundred and ten participants were randomly allocated to either a 2-week online MBI including 10 min of daily guided mindfulness practice or to a waitlist control condition. Measures of mindfulness and paranoia were administered at baseline, post-intervention and 1-week follow-up. Participants in the MBI group displayed significantly greater reductions in paranoia compared to the waitlist control group. Mediation analysis demonstrated that change in mindfulness skills (specifically the observe, describe and non-react facets of the FFMQ) mediated the relationship between intervention type and change in levels of paranoia. This study provides evidence that a brief online MBI can significantly reduce levels of paranoia in a non-clinical population. Furthermore, increases in mindfulness skills from this brief online MBI can mediate reductions in non-clinical paranoia. The limitations of the study are discussed.

  1. An international observational study suggests that artificial intelligence for clinical decision support optimizes anemia management in hemodialysis patients.

    PubMed

    Barbieri, Carlo; Molina, Manuel; Ponce, Pedro; Tothova, Monika; Cattinelli, Isabella; Ion Titapiccolo, Jasmine; Mari, Flavio; Amato, Claudia; Leipold, Frank; Wehmeyer, Wolfgang; Stuard, Stefano; Stopper, Andrea; Canaud, Bernard

    2016-08-01

    Managing anemia in hemodialysis patients can be challenging because of competing therapeutic targets and individual variability. Because therapy recommendations provided by a decision support system can benefit both patients and doctors, we evaluated the impact of an artificial intelligence decision support system, the Anemia Control Model (ACM), on anemia outcomes. Based on patient profiles, the ACM was built to recommend suitable erythropoietic-stimulating agent doses. Our retrospective study consisted of a 12-month control phase (standard anemia care), followed by a 12-month observation phase (ACM-guided care) encompassing 752 patients undergoing hemodialysis therapy in 3 NephroCare clinics located in separate countries. The percentage of hemoglobin values on target, the median darbepoetin dose, and individual hemoglobin fluctuation (estimated from the intrapatient hemoglobin standard deviation) were deemed primary outcomes. In the observation phase, median darbepoetin consumption significantly decreased from 0.63 to 0.46 μg/kg/month, whereas on-target hemoglobin values significantly increased from 70.6% to 76.6%, reaching 83.2% when the ACM suggestions were implemented. Moreover, ACM introduction led to a significant decrease in hemoglobin fluctuation (intrapatient standard deviation decreased from 0.95 g/dl to 0.83 g/dl). Thus, ACM support helped improve anemia outcomes of hemodialysis patients, minimizing erythropoietic-stimulating agent use with the potential to reduce the cost of treatment. Copyright © 2016 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.

  2. 77 FR 72409 - Importer of Controlled Substances; Notice of Application; Fisher Clinical Services, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-05

    ... Application; Fisher Clinical Services, Inc. Pursuant to Title 21 Code of Federal Regulations 1301.34 (a), this is notice that on October 16, 2012, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown... import the listed controlled substance for analytical research and clinical trials. The import of the...

  3. 78 FR 5497 - Importer of Controlled Substances; Notice of Registration; Fisher Clinical Services, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-25

    ... Registration; Fisher Clinical Services, Inc. By Notice dated November 1, 2012, and published in the Federal Register on November 9, 2012, 77 FR 67396, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown... plans to import the listed controlled substance to conduct clinical trials. No comments or objections...

  4. Clinical benefits of oral nutritional supplementation for elderly hip fracture patients: a single blind randomised controlled trial.

    PubMed

    Myint, Ma Wai Wai; Wu, Jenny; Wong, Euann; Chan, Suk Ping; To, Tze Shing Jess; Chau, Mei Wa Rosanna; Ting, Kwai Hing; Fung, Pui Man; Au, Kit Sing Derrick

    2013-01-01

    malnutrition is an important risk factor for poor outcome in patients recovering after hip fracture surgery. This study aimed to investigate the clinical, nutritional and rehabilitation effects of an oral nutritional supplementation (ONS) in an inpatient rehabilitation setting. this was an observer-blinded randomised controlled trial of elderly post-surgical proximal femoral fracture patients. A ready-to-use oral liquid nutritional supplementation (18-24 g protein and 500 kcal per day) in addition to hospital diet was compared with hospital diet only. Both groups received usual rehabilitation therapy and oral calcium and vitamin D supplements. Outcomes were compared at discharge from rehabilitation and after 4 weeks of discharge. The primary outcome parameters were the serum albumin level, the body mass index (BMI), the functional independence measure (FIM) and the elderly mobility scale (EMS). Secondary outcome parameters were frequency of complications, inpatient length of stay, mortality and acute hospital use within 6 months after discharge. a total of 126 patients were recruited, 65 in the supplementation arm and 61 in the control arm. There was a significant difference in change in BMI with a decrease of 0.25 and 0.03 kg/m(2) in the ONS group and 0.72 and 0.49 kg/m(2) in the control group at hospital discharge and follow-up, respectively (P = 0.012). The length of stay in rehabilitation ward was shortened by 3.80 (SE = 1.81, P = 0.04) days favouring the ONS group. The total number of infection episodes was also reduced significantly. No difference was observed in the rate of change of the serum albumin level, the FIM and the EMS. clinical and nutritional benefits were seen in this trial but rehabilitation benefits could not be demonstrated.

  5. Model Predictive Flight Control System with Full State Observer using H∞ Method

    NASA Astrophysics Data System (ADS)

    Sanwale, Jitu; Singh, Dhan Jeet

    2018-03-01

    This paper presents the application of the model predictive approach to design a flight control system (FCS) for longitudinal dynamics of a fixed wing aircraft. Longitudinal dynamics is derived for a conventional aircraft. Open loop aircraft response analysis is carried out. Simulation studies are illustrated to prove the efficacy of the proposed model predictive controller using H ∞ state observer. The estimation criterion used in the {H}_{∞} observer design is to minimize the worst possible effects of the modelling errors and additive noise on the parameter estimation.

  6. Control of variable speed variable pitch wind turbine based on a disturbance observer

    NASA Astrophysics Data System (ADS)

    Ren, Haijun; Lei, Xin

    2017-11-01

    In this paper, a novel sliding mode controller based on disturbance observer (DOB) to optimize the efficiency of variable speed variable pitch (VSVP) wind turbine is developed and analyzed. Due to the highly nonlinearity of the VSVP system, the model is linearly processed to obtain the state space model of the system. Then, a conventional sliding mode controller is designed and a DOB is added to estimate wind speed. The proposed control strategy can successfully deal with the random nature of wind speed, the nonlinearity of VSVP system, the uncertainty of parameters and external disturbance. Via adding the observer to the sliding mode controller, it can greatly reduce the chattering produced by the sliding mode switching gain. The simulation results show that the proposed control system has the effectiveness and robustness.

  7. Observational Research Opportunities and Limitations

    PubMed Central

    Boyko, Edward J.

    2013-01-01

    Medical research continues to progress in its ability to identify treatments and characteristics associated with benefits and adverse outcomes. The principle engine for the evaluation of treatment efficacy is the randomized controlled trial (RCT). Due to the cost and other considerations, RCTs cannot address all clinically important decisions. Observational research often is used to address issues not addressed or not addressable by RCTs. This article provides an overview of the benefits and limitations of observational research to serve as a guide to the interpretation of this category of research designs in diabetes investigations. The potential for bias is higher in observational research but there are design and analysis features that can address these concerns although not completely eliminate them. Pharmacoepidemiologic research may provide important information regarding relative safety and effectiveness of diabetes pharmaceuticals. Such research must effectively address the important issue of confounding by indication in order to produce clinically meaningful results. Other methods such as instrumental variable analysis are being employed to enable stronger causal inference but these methods also require fulfillment of several key assumptions that may or may not be realistic. Nearly all clinical decisions involve probabilistic reasoning and confronting uncertainly, so a realistic goal for observational research may not be the high standard set by RCTs but instead the level of certainty needed to influence a diagnostic or treatment decision. PMID:24055326

  8. Observational research--opportunities and limitations.

    PubMed

    Boyko, Edward J

    2013-01-01

    Medical research continues to progress in its ability to identify treatments and characteristics associated with benefits and adverse outcomes. The principal engine for the evaluation of treatment efficacy is the randomized controlled trial (RCT). Due to the cost and other considerations, RCTs cannot address all clinically important decisions. Observational research often is used to address issues not addressed or not addressable by RCTs. This article provides an overview of the benefits and limitations of observational research to serve as a guide to the interpretation of this category of research designs in diabetes investigations. The potential for bias is higher in observational research but there are design and analysis features that can address these concerns although not completely eliminate them. Pharmacoepidemiologic research may provide important information regarding relative safety and effectiveness of diabetes pharmaceuticals. Such research must effectively address the important issue of confounding by indication in order to produce clinically meaningful results. Other methods such as instrumental variable analysis are being employed to enable stronger causal inference but these methods also require fulfillment of several key assumptions that may or may not be realistic. Nearly all clinical decisions involve probabilistic reasoning and confronting uncertainly, so a realistic goal for observational research may not be the high standard set by RCTs but instead the level of certainty needed to influence a diagnostic or treatment decision. © 2013.

  9. Research Methods in Healthcare Epidemiology and Antimicrobial Stewardship-Observational Studies.

    PubMed

    Snyder, Graham M; Young, Heather; Varman, Meera; Milstone, Aaron M; Harris, Anthony D; Munoz-Price, Silvia

    2016-10-01

    Observational studies compare outcomes among subjects with and without an exposure of interest, without intervention from study investigators. Observational studies can be designed as a prospective or retrospective cohort study or as a case-control study. In healthcare epidemiology, these observational studies often take advantage of existing healthcare databases, making them more cost-effective than clinical trials and allowing analyses of rare outcomes. This paper addresses the importance of selecting a well-defined study population, highlights key considerations for study design, and offers potential solutions including biostatistical tools that are applicable to observational study designs. Infect Control Hosp Epidemiol 2016;1-6.

  10. ASSOCIATION BETWEEN FRACTION OF EXHALED NITRIC OXIDE AND SPIROMETRY DATA AND CLINICAL CONTROL OF ASTHMA IN CHILDREN AND ADOLESCENTS

    PubMed Central

    Salviano, Luanda Dias da Silva; Taglia-Ferre, Karla Delevedove; Lisboa, Sandra; da Costa, Ana Carolina Carioca; Campos, Hisbello da Silva; March, Maria de Fátima Pombo

    2018-01-01

    ABSTRACT Objective: To evaluate the association between fraction of exhaled nitric oxide (FeNO) values and forced expiratory volume in the first second (FEV1) and the level of asthma control, as proposed by the Global Initiative for Asthma (GINA), in asthmatic children and adolescents attended at the National Institute of Women, Children and Adolescents Health Fernandes Figueira of Fundação Oswaldo Cruz (IFF/FIOCRUZ). Methods: This was a cross-sectional study, with a review of medical records of 90 asthmatics between 7 and 17 years old, who were followed up at the IFF/FIOCRUZ Asthma Outpatient Clinic and were referred to perform respiratory function tests (RFT)between March 2013 and September 2014. After classification according to GINA, patients performed complete spirometry and FeNO measurement. Subsequently, they were separated into two groups: regular and non-regular inhaled corticosteroid (ICS) use, regardless of the ventilatory pattern in spirometry. Results: The association between FEV1 values and the degree of asthma control according to GINA (p=0.001) was observed in all patients, regardless of ICS use, but there was no association between FEV1 and levels of FeNO. Conclusions: The correlation observed between GINA and FEV1 reinforces the importance of spirometry in the clinical follow-up of these patients. Although no association was found between the value of FeNO and the degree of asthma control and FEV1, FeNO may be an early method to detect airway inflammation, even before the symptoms and spirometric changes. PMID:29412429

  11. A concealed observational study of infection control and safe injection practices in Jordanian governmental hospitals.

    PubMed

    Al-Rawajfah, Omar M; Tubaishat, Ahmad

    2017-10-01

    The recognized international organizations on infection prevention recommend using an observational method as the gold standard procedure for assessing health care professional's compliance with standard infection control practices. However, observational studies are rarely used in Jordanian infection control studies. This study aimed to evaluate injection practices among nurses working in Jordanian governmental hospitals. A cross-sectional concealed observational design is used for this study. A convenience sampling technique was used to recruit a sample of nurses working in governmental hospitals in Jordan. Participants were unaware of the time and observer during the observation episode. A total of 384 nurses from 9 different hospitals participated in the study. A total of 835 injections events were observed, of which 73.9% were performed without handwashing, 64.5% without gloving, and 27.5% were followed by needle recapping. Handwashing rate was the lowest (18.9%) when injections were performed by beginner nurses. Subcutaneous injections were associated with the lowest rate (26.7%) of postinjection handwashing compared with other routes. This study demonstrates the need for focused and effective infection control educational programs in Jordanian hospitals. Future studies should consider exploring the whole infection control practices related to waste disposal and the roles of the infection control nurse in this process in Jordanian hospitals. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

  12. Tidal Control of Jet Eruptions Observed by Cassini ISS

    NASA Technical Reports Server (NTRS)

    Hurford, T. A.; Helfenstein, P.; Spitale, J. N.

    2012-01-01

    Observations by Cassini's Imaging Science Subsystem (ISS) of Enceladus' south polar region at high phase angles has revealed jets of material venting into space. Observations by Cassini's Composite Infrared Spectrometer (CIRS) have also shown that the south polar region is anomalously warm with hotspots associated with geological features called the Tiger Stripes. The Tiger Stripes are large rifts near the south pole of Enceladus, which are typically about 130 km in length, 2 km wide, with a trough 500 m deep, and are l1anked on each side by 100m tall ridges. Preliminary triangulation of jets as viewed at different times and with different viewing geometries in Cassini ISS images taken between 2005 and 2007 have constrained the locations of eight major eruptions of material and found all of them associated with the south polar fractures unofficially the 'Tiger Stripes', and found four of them coincident with the hotspots reported in 2006 by CIRS. While published ISS observations of jet activity suggest that individual eruption sites stay active on the timescale of years, any shorter temporal variability (on timescales of an orbital period, or 1.3 Earth days, for example) is more difficult to establish because of the spotty temporal coverage and the difficulty of visually isolating one jet from the forest of many seen in a typical image. Consequently, it is not known whether individual jets are continuously active, randomly active, or if they erupt on a predictable, periodic schedule. One mechanism that may control the timing of eruptions is diurnal tidal stress, which oscillates between compression/tension as well as right and left lateral shear at any given location throughout Enceladus' orbit and may allow the cracks to open and close regularly. We examine the stresses on the Tiger Stripe regions to see how well diurnal tidal stress caused by Enceladus' orbital eccentricity may possibly correlate with and thus control the observed eruptions. We then identify

  13. Assessing clinically meaningful treatment effects in controlled trials: chronic migraine as an example.

    PubMed

    Dodick, David W; Turkel, Catherine C; DeGryse, Ronald E; Diener, Hans-Christoph; Lipton, Richard B; Aurora, Sheena K; Nolan, Marissa E; Silberstein, Stephen D

    2015-02-01

    In addition to headache, persons with chronic migraine (CM) experience multiple symptoms, both ictal and interictal, that may contribute to their suffering. Translating clinical trial results into practice requires assessment of the results' clinical meaningfulness. When examining treatment benefit in this disabled patient population, multiple headache-symptom measures should be considered to fully reflect clinical relevance. Currently, only onabotulinumtoxinA is approved specifically for headache prophylaxis in adults with CM. Topiramate is the only other therapeutic agent with double-blind, placebo-controlled evidence in this population. Herein we evaluate the clinical meaningfulness of onabotulinumtoxinA and topiramate as headache prophylaxis in CM by comparing primary endpoints from the placebo-controlled, double-blind phase of the Phase 3 REsearch Evaluating Migraine Prophylaxis Therapy (PREEMPT) clinical program and the topiramate clinical trial (frequency of headache days [primary endpoint in PREEMPT; secondary in topiramate trial] and migraine/migrainous days [primary in topiramate trial, or "migraine/probable-migraine days"; secondary in PREEMPT]). Additionally, outcome measures such as responder rates, health-related quality of life, discontinuation rates, safety, and tolerability profiles are important clinical considerations. The clinical data indicate that statistically significant, clinically relevant treatment benefits exist for both onabotulinumtoxinA and topiramate. These data support these treatments as meaningful headache prophylaxis in adults with CM. CM is a chronic pain condition. We sought to determine the clinical relevance of recent trials in this disabled population. Clinical data indicate that statistically significant, clinically relevant treatment benefits exist for both onabotulinumtoxinA and topiramate, and support use of these treatments as meaningful headache prophylaxis in CM. Copyright © 2015 American Pain Society. Published

  14. Adaptive extended-state observer-based fault tolerant attitude control for spacecraft with reaction wheels

    NASA Astrophysics Data System (ADS)

    Ran, Dechao; Chen, Xiaoqian; de Ruiter, Anton; Xiao, Bing

    2018-04-01

    This study presents an adaptive second-order sliding control scheme to solve the attitude fault tolerant control problem of spacecraft subject to system uncertainties, external disturbances and reaction wheel faults. A novel fast terminal sliding mode is preliminarily designed to guarantee that finite-time convergence of the attitude errors can be achieved globally. Based on this novel sliding mode, an adaptive second-order observer is then designed to reconstruct the system uncertainties and the actuator faults. One feature of the proposed observer is that the design of the observer does not necessitate any priori information of the upper bounds of the system uncertainties and the actuator faults. In view of the reconstructed information supplied by the designed observer, a second-order sliding mode controller is developed to accomplish attitude maneuvers with great robustness and precise tracking accuracy. Theoretical stability analysis proves that the designed fault tolerant control scheme can achieve finite-time stability of the closed-loop system, even in the presence of reaction wheel faults and system uncertainties. Numerical simulations are also presented to demonstrate the effectiveness and superiority of the proposed control scheme over existing methodologies.

  15. Wavefront sensors for the active control of earth observation optical instruments

    NASA Astrophysics Data System (ADS)

    Velluet, Marie-Thérèse; Michau, Vincent; Rousset, Gérard

    2018-04-01

    This paper, "Wavefront sensors for the active control of earth observation optical instruments," was presented as part of International Conference on Space Optics—ICSO 1997, held in Toulouse, France.

  16. Validation of an image-based technique to assess the perceptual quality of clinical chest radiographs with an observer study

    NASA Astrophysics Data System (ADS)

    Lin, Yuan; Choudhury, Kingshuk R.; McAdams, H. Page; Foos, David H.; Samei, Ehsan

    2014-03-01

    We previously proposed a novel image-based quality assessment technique1 to assess the perceptual quality of clinical chest radiographs. In this paper, an observer study was designed and conducted to systematically validate this technique. Ten metrics were involved in the observer study, i.e., lung grey level, lung detail, lung noise, riblung contrast, rib sharpness, mediastinum detail, mediastinum noise, mediastinum alignment, subdiaphragm-lung contrast, and subdiaphragm area. For each metric, three tasks were successively presented to the observers. In each task, six ROI images were randomly presented in a row and observers were asked to rank the images only based on a designated quality and disregard the other qualities. A range slider on the top of the images was used for observers to indicate the acceptable range based on the corresponding perceptual attribute. Five boardcertificated radiologists from Duke participated in this observer study on a DICOM calibrated diagnostic display workstation and under low ambient lighting conditions. The observer data were analyzed in terms of the correlations between the observer ranking orders and the algorithmic ranking orders. Based on the collected acceptable ranges, quality consistency ranges were statistically derived. The observer study showed that, for each metric, the averaged ranking orders of the participated observers were strongly correlated with the algorithmic orders. For the lung grey level, the observer ranking orders completely accorded with the algorithmic ranking orders. The quality consistency ranges derived from this observer study were close to these derived from our previous study. The observer study indicates that the proposed image-based quality assessment technique provides a robust reflection of the perceptual image quality of the clinical chest radiographs. The derived quality consistency ranges can be used to automatically predict the acceptability of a clinical chest radiograph.

  17. Extra-facial melasma: clinical, histopathological, and immunohistochemical case-control study.

    PubMed

    Ritter, C G; Fiss, D V C; Borges da Costa, J A T; de Carvalho, R R; Bauermann, G; Cestari, T F

    2013-09-01

    Extra-facial melasma is a prevalent dermatosis in some populations with special characteristics in relation to its clinical aspects and probable etiopathogenic factors. Few studies have attempted to address this alteration of pigmentation, which has become a challenge in clinical Dermatology. To assess the clinical histopathological and immunohistochemical characteristics of extra-facial melasma, comparing affected, and unaffected sites. Case-control study with 45 patients in each group (melasma and disease-free volunteers), assessing their clinical characteristics. In 36 patients, biopsies were performed on the lesion and the normal perilesional skin. Specimens were stained with HE and Fontana-Masson, and melanocytes analysed by immunohistochemistry. Objective measurements were accomplished by a specifically designed image analysis software. The melasma group had a mean age ± SD of 56.67 ± 8 years, the majority of them were women (86.7%) and 82.1% of the female cases had reached menopause. There were no significant differences between groups in terms of presence of comorbidities, use of medications or hormone therapies. For extra-facial melasma patients, family history of this dermatose and of previous facial melasma was significantly higher than in the control group (P < 0.05). The HE staining showed increased rectification and basal hyperpigmentation, solar elastosis, and collagen degeneration in the pigmented area (P < 0.05). There was a significant increase in melanin density in melasma biopsies, but the immunohistochemical tests did not detect a difference between the groups in terms of number of melanocytes. Extra-facial melasma appears to be related to menopause, family history, and personal history of facial melasma, in the studied population. Histopathology revealed a pattern similar to what has been described for facial melasma, with signs of solar degeneration, and a similar number of melanocytes, when comparing patients, and controls, suggesting that

  18. Comparison of virtual patient simulation with mannequin-based simulation for improving clinical performances in assessing and managing clinical deterioration: randomized controlled trial.

    PubMed

    Liaw, Sok Ying; Chan, Sally Wai-Chi; Chen, Fun-Gee; Hooi, Shing Chuan; Siau, Chiang

    2014-09-17

    Virtual patient simulation has grown substantially in health care education. A virtual patient simulation was developed as a refresher training course to reinforce nursing clinical performance in assessing and managing deteriorating patients. The objective of this study was to describe the development of the virtual patient simulation and evaluate its efficacy, by comparing with a conventional mannequin-based simulation, for improving the nursing students' performances in assessing and managing patients with clinical deterioration. A randomized controlled study was conducted with 57 third-year nursing students who were recruited through email. After a baseline evaluation of all participants' clinical performance in a simulated environment, the experimental group received a 2-hour fully automated virtual patient simulation while the control group received 2-hour facilitator-led mannequin-based simulation training. All participants were then re-tested one day (first posttest) and 2.5 months (second posttest) after the intervention. The participants from the experimental group completed a survey to evaluate their learning experiences with the newly developed virtual patient simulation. Compared to their baseline scores, both experimental and control groups demonstrated significant improvements (P<.001) in first and second post-test scores. While the experimental group had significantly lower (P<.05) second post-test scores compared with the first post-test scores, no significant difference (P=.94) was found between these two scores for the control group. The scores between groups did not differ significantly over time (P=.17). The virtual patient simulation was rated positively. A virtual patient simulation for a refreshing training course on assessing and managing clinical deterioration was developed. Although the randomized controlled study did not show that the virtual patient simulation was superior to mannequin-based simulation, both simulations have demonstrated

  19. 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

  20. Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trial.

    PubMed

    Capeding, Maria Rosario; Tran, Ngoc Huu; Hadinegoro, Sri Rezeki S; Ismail, Hussain Imam H J Muhammad; Chotpitayasunondh, Tawee; Chua, Mary Noreen; Luong, Chan Quang; Rusmil, Kusnandi; Wirawan, Dewa Nyoman; Nallusamy, Revathy; Pitisuttithum, Punnee; Thisyakorn, Usa; Yoon, In-Kyu; van der Vliet, Diane; Langevin, Edith; Laot, Thelma; Hutagalung, Yanee; Frago, Carina; Boaz, Mark; Wartel, T Anh; Tornieporth, Nadia G; Saville, Melanie; Bouckenooghe, Alain

    2014-10-11

    An estimated 100 million people have symptomatic dengue infection every year. This is the first report of a phase 3 vaccine efficacy trial of a candidate dengue vaccine. We aimed to assess the efficacy of the CYD dengue vaccine against symptomatic, virologically confirmed dengue in children. We did an observer-masked, randomised controlled, multicentre, phase 3 trial in five countries in the Asia-Pacific region. Between June 3, and Dec 1, 2011, healthy children aged 2-14 years were randomly assigned (2:1), by computer-generated permuted blocks of six with an interactive voice or web response system, to receive three injections of a recombinant, live, attenuated, tetravalent dengue vaccine (CYD-TDV), or placebo, at months 0, 6, and 12. Randomisation was stratified by age and site. Participants were followed up until month 25. Trial staff responsible for the preparation and administration of injections were unmasked to group allocation, but were not included in the follow-up of the participants; allocation was concealed from the study sponsor, investigators, and parents and guardians. Our primary objective was to assess protective efficacy against symptomatic, virologically confirmed dengue, irrespective of disease severity or serotype, that took place more than 28 days after the third injection. The primary endpoint was for the lower bound of the 95% CI of vaccine efficacy to be greater than 25%. Analysis was by intention to treat and per procotol. This trial is registered with ClinicalTrials.gov, number NCT01373281. We randomly assigned 10,275 children to receive either vaccine (n=6851) or placebo (n=3424), of whom 6710 (98%) and 3350 (98%), respectively, were included in the primary analysis. 250 cases of virologically confirmed dengue took place more than 28 days after the third injection (117 [47%] in the vaccine group and 133 [53%] in the control group). The primary endpoint was achieved with 56·5% (95% CI 43·8-66·4) efficacy. We recorded 647 serious adverse

  1. Mucoceles of minor salivary glands in children. Own clinical observations.

    PubMed

    Lewandowski, Bogumił; Brodowski, Robert; Pakla, Paweł; Makara, Aleksander; Stopyra, Wojciech; Startek, Bartek

    Mucoceles are benign lesions associated with the pathology of the oral mucosa of minor salivary glands. Two types of cysts are distinguished depending on their pathogenesis. Most often they occur as a result of mechanical trauma and mucus extravasation into tissues or obstruction of the gland ducts. The aim of the study was to present our own experiences regarding mucoceles of minor salivary glands in the oral cavity taking into account how frequently the individual types of cysts occur in children. The research was carried out based on medical files from the years 2005-2015. These were: medical case records, operating books and the medical registry of patients treated at the Clinic of Maxillofacial Surgery, Frederic Chopin Clinical Regional Hospital in Rzeszow. In that period 64 children and teenagers, 28 girls and 36 boys were treated. What was considered was the age and gender of the patients, the reason for their appointment with a doctor, the location, size and histopathological type of the cysts, as well as the course and results of the diagnostic and therapeutic process. In the group analyzed, the reasons for referral to the Clinic were: in 25 patients accidental ascertainment of a non-symptomatic tumor in the oral cavity during examination by a dentist, pediatrician or laryngologist which had not caused any discomfort to the children; in 13 patients concern had been raised by a gradually increasing tumor; in 18 cases there was an increased tissue tension surrounding the tumor, while in 3 children red oedema was observed in the oral cavity (suspicion of abscess). The most frequent mucocele location was the lower lip (34 children). The most frequent size was 2.1-3 cm (28 children). The most frequent histological type was MEP. All the patients were treated at the Clinic in the one-day surgery mode, with good outcome. Mucocele ascertainment in children's oral cavity could be made accidentally in routine pediatric examination, therefore it is necessary to extend

  2. EFFECT OF A DENTIFRICE CONTAINING ALOE VERA ON PLAQUE AND GINGIVITIS CONTROL. A DOUBLE-BLIND CLINICAL STUDY IN HUMANS

    PubMed Central

    de Oliveira, Sílvia Morgana Araújo; Torres, Ticiana Carneiro; Pereira, Sérgio Luís da Silva; Mota, Olívia Morais de Lima; Carlos, Márlio Ximenes

    2008-01-01

    The effect of Aloe vera on the reduction of plaque and gingivitis was evaluated in a randomized, parallel and double-blind clinical trial. Subjects were randomly allocated to the test group (n=15) – dentifrice containing Aloe vera - or the control group (n=15) – fluoridated dentifrice. Plaque index (PI) and gingival bleeding index (GBI) were assessed at days 0 and 30. Subjects were asked to brush their teeth with the control or test dentifrice, three times a day, during a 30-day period. There was a significant reduction on plaque and gingivitis in both groups, but no statistically significant difference was observed among them (p>0.01). The dentifrice containing Aloe vera did not show any additional effect on plaque and gingivitis control compared to the fluoridated dentifrice. PMID:19089263

  3. Clinical Evaluation of the Use of a Multifunctional Remotely Controlled Insulin Pump

    PubMed Central

    Pinget, Michel; Lachgar, Karim; Parkin, Christopher G.; Grulet, Hervé; Guillon-Metz, Françoise; Weissmann, Joerg

    2014-01-01

    Current insulin pumps now feature advanced functions for calculating insulin dosages, delivering insulin and analyzing data, however, the perceived usefulness of these functions in clinical settings has not been well studied. We assessed the use and patient perceptions of an insulin delivery system (Accu-Chek® Combo, Roche Diagnostics, Mannheim, Germany) that combines an insulin pump and a handheld multifunctional blood glucose meter with integrated remote control functions. This prospective, observational, multicenter study enrolled 74 type 1 diabetes patients within 13 weeks after starting use of the pump system. At 4 to 24 weeks, investigators collected usage data from the latest 14-day period. Seventy-two patients completed the evaluation, aged 39 ± 15 years, diabetes duration 16 ± 13 years, HbA1c 8.3 ± 1.6%. At follow-up, 62 (86.1%) patients used the remote control for ≥50% of all boluses, 20 (27.8%) used the bolus advisor for ≥50% of all boluses, and 42 (58.3%) viewed at least 1 of the e-logbook reports. More than 95% of users appraised the functions as easy-to-use and useful; median scores from VAS (0 = useless to 100 = indispensable) ranged from 72 to 85. A high percentage of study patients used the system’s advanced features, especially the remote control feature for bolusing. Overall, patients assessed the functions as useful and easy to use. Results support the implementation of these smart capabilities in further insulin pump developments. PMID:25107708

  4. Clinical evaluation of the Jay Sensitivity Sensor Probe: a new microprocessor-controlled instrument to evaluate dentin hypersensitivity.

    PubMed

    Sowinski, Joseph A; Kakar, Ashish; Kakar, Kanupriya

    2013-05-01

    To compare the Jay Sensitivity Sensor Probe (Jay Probe), a new microprocessor-based, pre-calibrated instrument, with well accepted methods used to evaluate sensitivity, i.e. tactile response to the Yeaple Probe, air blast (Schiff scale), and patient responses by Visual Analog Score (VAS). Jay Probe assessments were accomplished using several approaches. With a cohort of 12 subjects, two clinical examiners compared the repeatability of the Jay and Yeaple Probes. A second evaluation of both probes was conducted during two independent parallel design clinical studies each enrolling 100 adults with dentin hypersensitivity (DH). In each study, subjects were evaluated for DH responses after twice daily oral hygiene with a negative control fluoride dentifrice or a positive control dentifrice formulated with ingredients proven to reduce sensitivity, i.e. potassium nitrate or 8.0% arginine with calcium carbonate. Tactile evaluations by the Jay and Yeaple Probes were conducted at baseline and recall visits over the 8-week duration of each study. Also evaluated at each visit were responses to air blast and to patient reported DH assessment by VAS. Low inter-examiner variability with no significant differences between replicate measurements (P > 0.05) was observed with the Jay Probe. Consistent with results from previous studies, subjects assigned dentifrices formulated with potassium nitrate or 8% arginine/calcium carbonate demonstrated improvements in Yeaple, air blast and VAS responses in comparison to those assigned the fluoride dentifrice (P < 0.05). Jay Probe responses correlated significantly with all other sensitivity measures (P < 0.05). Differences between these treatments were observed at all post-treatment evaluations using these methods.

  5. Use of historical control data for assessing treatment effects in clinical trials.

    PubMed

    Viele, Kert; Berry, Scott; Neuenschwander, Beat; Amzal, Billy; Chen, Fang; Enas, Nathan; Hobbs, Brian; Ibrahim, Joseph G; Kinnersley, Nelson; Lindborg, Stacy; Micallef, Sandrine; Roychoudhury, Satrajit; Thompson, Laura

    2014-01-01

    Clinical trials rarely, if ever, occur in a vacuum. Generally, large amounts of clinical data are available prior to the start of a study, particularly on the current study's control arm. There is obvious appeal in using (i.e., 'borrowing') this information. With historical data providing information on the control arm, more trial resources can be devoted to the novel treatment while retaining accurate estimates of the current control arm parameters. This can result in more accurate point estimates, increased power, and reduced type I error in clinical trials, provided the historical information is sufficiently similar to the current control data. If this assumption of similarity is not satisfied, however, one can acquire increased mean square error of point estimates due to bias and either reduced power or increased type I error depending on the direction of the bias. In this manuscript, we review several methods for historical borrowing, illustrating how key parameters in each method affect borrowing behavior, and then, we compare these methods on the basis of mean square error, power and type I error. We emphasize two main themes. First, we discuss the idea of 'dynamic' (versus 'static') borrowing. Second, we emphasize the decision process involved in determining whether or not to include historical borrowing in terms of the perceived likelihood that the current control arm is sufficiently similar to the historical data. Our goal is to provide a clear review of the key issues involved in historical borrowing and provide a comparison of several methods useful for practitioners. Copyright © 2013 John Wiley & Sons, Ltd.

  6. Use of historical control data for assessing treatment effects in clinical trials

    PubMed Central

    Viele, Kert; Berry, Scott; Neuenschwander, Beat; Amzal, Billy; Chen, Fang; Enas, Nathan; Hobbs, Brian; Ibrahim, Joseph G.; Kinnersley, Nelson; Lindborg, Stacy; Micallef, Sandrine; Roychoudhury, Satrajit; Thompson, Laura

    2014-01-01

    Clinical trials rarely, if ever, occur in a vacuum. Generally, large amounts of clinical data are available prior to the start of a study, particularly on the current study’s control arm. There is obvious appeal in using (i.e., ‘borrowing’) this information. With historical data providing information on the control arm, more trial resources can be devoted to the novel treatment while retaining accurate estimates of the current control arm parameters. This can result in more accurate point estimates, increased power, and reduced type I error in clinical trials, provided the historical information is sufficiently similar to the current control data. If this assumption of similarity is not satisfied, however, one can acquire increased mean square error of point estimates due to bias and either reduced power or increased type I error depending on the direction of the bias. In this manuscript, we review several methods for historical borrowing, illustrating how key parameters in each method affect borrowing behavior, and then, we compare these methods on the basis of mean square error, power and type I error. We emphasize two main themes. First, we discuss the idea of ‘dynamic’ (versus ‘static’) borrowing. Second, we emphasize the decision process involved in determining whether or not to include historical borrowing in terms of the perceived likelihood that the current control arm is sufficiently similar to the historical data. Our goal is to provide a clear review of the key issues involved in historical borrowing and provide a comparison of several methods useful for practitioners. PMID:23913901

  7. Advances in clinical NK cell studies: Donor selection, manufacturing and quality control

    PubMed Central

    Koehl, U.; Kalberer, C.; Spanholtz, J.; Lee, D. A.; Miller, J. S.; Cooley, S.; Lowdell, M.; Uharek, L.; Klingemann, H.; Curti, A.; Leung, W.; Alici, E.

    2016-01-01

    ABSTRACT Natural killer (NK) cells are increasingly used in clinical studies in order to treat patients with various malignancies. The following review summarizes platform lectures and 2013–2015 consortium meetings on manufacturing and clinical use of NK cells in Europe and United States. A broad overview of recent pre-clinical and clinical results in NK cell therapies is provided based on unstimulated, cytokine-activated, as well as genetically engineered NK cells using chimeric antigen receptors (CAR). Differences in donor selection, manufacturing and quality control of NK cells for cancer immunotherapies are described and basic recommendations are outlined for harmonization in future NK cell studies. PMID:27141397

  8. Sliding mode output feedback control based on tracking error observer with disturbance estimator.

    PubMed

    Xiao, Lingfei; Zhu, Yue

    2014-07-01

    For a class of systems who suffers from disturbances, an original output feedback sliding mode control method is presented based on a novel tracking error observer with disturbance estimator. The mathematical models of the systems are not required to be with high accuracy, and the disturbances can be vanishing or nonvanishing, while the bounds of disturbances are unknown. By constructing a differential sliding surface and employing reaching law approach, a sliding mode controller is obtained. On the basis of an extended disturbance estimator, a creative tracking error observer is produced. By using the observation of tracking error and the estimation of disturbance, the sliding mode controller is implementable. It is proved that the disturbance estimation error and tracking observation error are bounded, the sliding surface is reachable and the closed-loop system is robustly stable. The simulations on a servomotor positioning system and a five-degree-of-freedom active magnetic bearings system verify the effect of the proposed method. Copyright © 2014 ISA. Published by Elsevier Ltd. All rights reserved.

  9. [Glioblastoma metastases: a literature review and a description of six clinical observations].

    PubMed

    Goryaynov, S A; Potapov, A A; Ignatenko, M A; Zhukov, V Yu; Protskiy, S V; Zakharova, N A; Okhlopkov, V A; Shishkina, L V

    2015-01-01

    since the 1990s, the literature has described cases of glioblastoma metastases with the development of foci located at a distance from the primary tumor. However, the pathogenesis of this process remains unclear until the end. This focus is believed to result, on the one hand, from tumor metastasis from the primary site and, on the other hand, from multifocal growth. This article presents a literature review and a description of clinical observations of patients with glioblastoma metastases. The study included 6 patients (1 female and 5 males) with brain glioblastomas who received treatment at the Burdenko Neurosurgical Institute (5 patients) and the Department of Neurosurgery of the Research Center of Neurology (1 patient) in the period from 2010 to 2014. Neurophysiological control was used if the tumor was localized near the eloquent cortical areas and pathways; 4 of 6 patients were operated on using the methods of intraoperative fluorescence diagnosis (5-ALA agent--Alasens). Four patients had metastases within one hemisphere, two had metastases in the contralateral hemisphere in the period of 5 to 18 months after the first operation. The primary tumor site was located near the ventricular system in two patients. In one patient, the lateral ventricle was opened during the first operation. In another patient, the prepontine cistern was opened during the first operation. In two patients, the primary tumor site was located at a distance from the lateral ventricles, however, the tumor was located near them during recurrence. Based on metabolic navigation, fluorescence of the tumor was observed in the four patients during both the first and repeated operations. The close relationship between primary glioblastomas and metastases and the cerebrospinal fluid circulation pathways may confirm the fact of dissemination of tumor cells with cerebrospinal fluid flow. In our opinion, there should be an increased suspicion of the possibility for metastases of glioblastomas that

  10. Effects of Teriparatide in Patients with Osteoporosis in Clinical Practice: 42-Month Results During and After Discontinuation of Treatment from the European Extended Forsteo® Observational Study (ExFOS).

    PubMed

    Napoli, Nicola; Langdahl, Bente L; Ljunggren, Östen; Lespessailles, Eric; Kapetanos, George; Kocjan, Tomaz; Nikolic, Tatjana; Eiken, Pia; Petto, Helmut; Moll, Thomas; Lindh, Erik; Marin, Fernando

    2018-06-16

    This study aimed to describe clinical outcomes in patients prescribed teriparatide and followed up for 18 months after stopping the drug in real-life conditions. The Extended Forsteo® Observational Study analysed incident clinical fractures in 6-month intervals using logistic regression with repeated measures. Changes in back pain (visual analogue scale) and health-related quality of life (HRQoL; EQ-5D questionnaire) were analysed using mixed models for repeated measures. Patients were analysed if they had a post-baseline visit, regardless of whether and for how long they took teriparatide. Of 1531 patients analysed (90.7% female, mean age: 70.3 years), 76 (5.0%) never took teriparatide. Median treatment duration was 23.6 months. The adjusted odds of clinical fracture decreased by 47% in the > 12- to 18-month treatment period (p = 0.013) compared with the first 6-month period, with no statistically significant reduction in the > 18- to 24-month interval. The clinical fracture rate remained stable during the 18 months' post-teriparatide, when approximately 98% of patients took osteoporosis medication (51% bisphosphonates). Clinical vertebral fractures were reduced at every time period compared with the first 6 months. Adjusted mean back pain scores decreased and EQ-5D scores increased significantly at each post-baseline observation. In a real-life clinical setting, the risk of clinical fractures declined during 24 months of teriparatide treatment. This reduction was maintained 18 months after stopping teriparatide. In parallel, patients reported significant improvements in back pain and HRQoL. The results should be interpreted in the context of the non-controlled design of this observational study.

  11. Clinical observations and risk factors for tinnitus in a Sicilian cohort.

    PubMed

    Martines, Francesco; Sireci, Federico; Cannizzaro, Emanuele; Costanzo, Roberta; Martines, Enrico; Mucia, Mariana; Plescia, Fulvio; Salvago, Pietro

    2015-10-01

    The aims of this study were to determine the distribution of risk factors associated with tinnitus analysing their role in the development of tinnitus and the effects of their interaction; to evidence the importance of a suitable and adequate clinical and audiologic assessment to avoid those modifiable risk factors responsible for cochlear dysfunction and tinnitus onset. 46 subjects with tinnitus and 74 controls were studied according to: age, sex, Body Mass Index (BMI), neck circumference, tobacco smoking, feeling fatigue or headache, self reporting snoring, hypertension, diabetes, coronary heart disease, and/or hyperlipidemia, and laboratory finding as lipid profile and levels of reactive oxygen metabolites (d-ROM). Audiological assessment was performed by multi-frequency audiometry (PTA(0.5-16 kHz)) and transient-evoked otoacoustic emissions (TEOAE diagnostic). Univariate analysis was performed to examine the association between determinants and occurrence of tinnitus; Mantel-Haenszel test (G.or) was used to investigate the joint effect of determinants on tinnitus. Tinnitus was more frequent among males with age >50 years; BMI >30 kg/m(2), neck circumference >40 cm, headache, hypertension, hypercholesterolemia resulted significant risk factors for tinnitus (P < 0.0001). Tinnitus group had more comorbidity (P < 0.0001) and worse audiometric thresholds (60.87 Vs 21.62% hearing loss; P < 0.0001) with respect to control group. The interaction between hypertension-BMI ≥ 30 kg/m(2) (G.or = 8.45) and smoking-hypercholesterolemia (G.or = 5.08) increases the risk of tinnitus (P < 0.0001). Our results underline that several factors either individually or jointly contribute to tinnitus onset; a comprehensive knowledge about tinnitus risk factors and associated clinical conditions could contribute to minimizing this disorder.

  12. Changes in levels of biomarkers of exposure observed in a controlled study of smokers switched from conventional to reduced toxicant prototype cigarettes.

    PubMed

    Shepperd, Christopher J; Eldridge, Alison; Camacho, Oscar M; McAdam, Kevin; Proctor, Christopher J; Meyer, Ingo

    2013-06-01

    Reduced toxicant prototype (RTP) cigarettes with substantially reduced levels of tobacco smoke toxicants have been developed. Evaluation of these prototype cigarettes included measurement of biomarkers of exposure (BoE) to toxicants in smokers switched from conventional cigarettes to the RTPs. A 6-week single-blinded randomised controlled study with occasional clinical confinement was conducted ( ISRCTN7215735). All smoking subjects smoked a conventional cigarette for 2-weeks. Control groups continued to smoke the conventional cigarette while test groups switched to one of three RTP designs. Clinical confinement and additional assessments were performed for all smoking groups after 2 and 4-weeks. A non-smoker group provided background levels of BoE. On average, smokers switched to RTPs with reduced machine yields of toxicants had reduced levels of corresponding BoEs. For vapour phase toxicants such as acrolein and 1,3-butadiene reductions of ⩾70% were observed both in smoke chemistry and BoEs. Reductions in particulate phase toxicants such as tobacco-specific nitrosamines, aromatic amines and polyaromatic hydrocarbons depended upon the technologies used, but were in some cases ⩾80% although some increases in other particulate phase toxicants were observed. However, reductions in BoEs demonstrate that it is possible to produce prototype cigarettes that reduce exposure to toxicants in short-term use. Copyright © 2013 Elsevier Inc. All rights reserved.

  13. Approaching control for tethered space robot based on disturbance observer using super twisting law

    NASA Astrophysics Data System (ADS)

    Hu, Yongxin; Huang, Panfeng; Meng, Zhongjie; Wang, Dongke; Lu, Yingbo

    2018-05-01

    Approaching control is a key mission for the tethered space robot to perform the task of removing space debris. But the uncertainties of the TSR such as the change of model parameter have an important effect on the approaching mission. Considering the space tether and the attitude of the gripper, the dynamic model of the TSR is derived using Lagrange method. Then a disturbance observer is designed to estimate the uncertainty based on STW control method. Using the disturbance observer, a controller is designed, and the performance is compared with the dynamic inverse controller which turns out that the proposed controller performs better. Numerical simulation validates the feasibility of the proposed controller on the position and attitude tracking of the TSR.

  14. Clinical observations of a Cantonese cognitive-behavioral treatment program for Chinese immigrants.

    PubMed

    Shen, Edward K; Alden, Lynn E; Söchting, Ingrid; Tsang, Pheobe

    2006-01-01

    In this article, the authors describe our clinical observations about the process of delivering a Cantonese-language cognitive- behavioral therapy program to treat depression in Hong Kong immigrants to Vancouver, Canada. Our experiences indicated that standard referral and assessment procedures were not optimal for this population. Other factors that required consideration were how to convert Cantonese terms for dysphoric affect into English equivalents and how to implement cognitive modification strategies when dealing with culture-syntonic beliefs about social relationships. (PsycINFO Database Record (c) 2010 APA, all rights reserved).

  15. Use of Vitex agnus-castus in migrainous women with premenstrual syndrome: an open-label clinical observation.

    PubMed

    Ambrosini, Anna; Di Lorenzo, Cherubino; Coppola, Gianluca; Pierelli, Francesco

    2013-03-01

    Premenstrual syndrome (PMS) affects most women during their reproductive life. Headache is regarded as a typical symptom of PMS and, close to menses, migrainous women could experience their worst migraine attacks. Vitex agnus-castus (VAC) is a phytopharmaceutical compound, considered worldwide to be a valid tool to treat PMS. Aim of this study is to explore if headache is ameliorate in migrainous women treated with VAC for PMS by an open-label clinical observation. Migrainous women with PMS were enrolled in the study and advised to assume a treatment with VAC (40 mg/day) for PMS for a 3-month period. Effects both on PMS and headache were assessed. Out of 107 women, 100 completed the 3-month treatment for PMS. Out of them, 66 women reported a dramatic reduction of PMS symptoms, 26 a mild reduction, and 8 no effect. Concerning migraine, 42 % of patients experienced a reduction higher than 50 % in frequency of monthly attacks, and 57 % of patients experienced a reduction higher than 50 % in monthly days with headache. No patients reported remarkable side effects. Pending a placebo-controlled trial to confirm our results, we observed that the use of VAC in migrainous women affected by PMS resulted to be safe and well tolerated, and may positively influence the frequency and duration of migraine attacks.

  16. Observational study to analyze patterns of treatment of breakthrough dyspnea in cancer patients in clinical practice.

    PubMed

    Cabezón-Gutiérrez, Luis; Delgado-Mingorance, Ignacio; Nabal-Vicuña, María; Jiménez-López, Antonio Javier; Cabezón-Álvarez, Ana; Soler-López, Begoña

    2018-06-12

    Although breakthrough dyspnea is very frequent in cancer patients, there are no precise recommendations for treating it. The main objective of this study was to analyze what treatments are used in clinical practice for the management of breakthrough dyspnea in cancer patients in Spain and the secondary objectives were to describe the characteristics of cancer patients with breakthrough dyspnea and the attributes of the disorder. Cancer patients over 18 years of age, with breakthrough dyspnea and a Karnofsky performance score of ≥30, who were treated at departments of oncology in institutes across Spain were included in this cross-sectional observational study. The characteristics of breakthrough dyspnea, history of treatment, anthropometric variables, Mahler dyspnea index, Borg scale, Edmonton Symptoms Assessment Scale, and patient satisfaction with current breakthrough dyspnea treatment were assessed. The mean age of the 149 included patients was 66 years (95% confidence interval: 64.3 to 67.9), and 53 were females (35.6%). The mean breakthrough dyspnea intensity was 5.85 (95% confidence interval 5.48 to 6.22, Borg scale). A total of 55.1% of the first-choice treatments consisted of opioids, followed by oxygen (17.3%). A total of 119 patients (79.9%) received monotherapy for breakthrough dyspnea. Patients presenting with basal dyspnea received oxygen in a greater proportion of cases (21.1% vs 7.4%; p = 0.07). Patients with predictable dyspnea received a greater proportion of opioids (70.9% vs 44.4%; p = 0.01). Opioids constitute first-line therapy for breakthrough dyspnea in routine clinical practice, though the scientific evidence supporting their use is scarce. Further information derived from controlled clinical trials is needed regarding the comparative efficacy of the different treatments in order to justify their use.

  17. Recognizing and managing a deteriorating patient: a randomized controlled trial investigating the effectiveness of clinical simulation in improving clinical performance in undergraduate nursing students.

    PubMed

    Stayt, Louise Caroline; Merriman, Clair; Ricketts, Barry; Morton, Sean; Simpson, Trevor

    2015-11-01

    To report the results of a randomized controlled trial which explored the effectiveness of clinical simulation in improving the clinical performance of recognizing and managing an adult deteriorating patient in hospital. There is evidence that final year undergraduate nurses may lack knowledge, clinical skills and situation awareness required to manage a deteriorating patient competently. The effectiveness of clinical simulation as a strategy to teach the skills required to recognize and manage the early signs of deterioration needs to be evaluated. This study was a two centre phase II single, randomized, controlled trial with single blinded assessments. Data were collected in July 2013. Ninety-eight first year nursing students were randomized either into a control group, where they received a traditional lecture, or an intervention group where they received simulation. Participants completed a pre- and postintervention objective structured clinical examination. General Perceived Self Efficacy and Self-Reported Competency scores were measured before and after the intervention. Student satisfaction with teaching was also surveyed. The intervention group performed significantly better in the post-objective structured clinical examination. There was no significant difference in the postintervention General Perceived Self Efficacy and Self-Reported Competency scores between the control and intervention group. The intervention group was significantly more satisfied with their teaching method. Simulation-based education may be an effective educational strategy to teach nurses the skills to effectively recognize and manage a deteriorating patient. © 2015 John Wiley & Sons Ltd.

  18. The significance of clinical experience on learning outcome from resuscitation training-a randomised controlled study.

    PubMed

    Jensen, Morten Lind; Lippert, Freddy; Hesselfeldt, Rasmus; Rasmussen, Maria Birkvad; Mogensen, Simon Skibsted; Jensen, Michael Kammer; Frost, Torben; Ringsted, Charlotte

    2009-02-01

    The impact of clinical experience on learning outcome from a resuscitation course has not been systematically investigated. To determine whether half a year of clinical experience before participation in an Advanced Life Support (ALS) course increases the immediate learning outcome and retention of learning. This was a prospective single blinded randomised controlled study of the learning outcome from a standard ALS course on a volunteer sample of the entire cohort of newly graduated doctors from Copenhagen University. The outcome measurement was ALS-competence assessed using a validated composite test including assessment of skills and knowledge. The intervention was half a year of clinical work before an ALS course. The intervention group received the course after a half-year of clinical experience. The control group participated in an ALS course immediately following graduation. Invitation to participate was accepted by 154/240 (64%) graduates and 117/154 (76%) completed the study. There was no difference between the intervention and control groups with regard to the immediate learning outcome. The intervention group had significantly higher retention of learning compared to the control group, intervention group mean 82% (CI 80-83), control group mean 78% (CI 76-80), P=0.002. The magnitude of this difference was medium (effect size=0.57). Half a year of clinical experience, before participation in an ALS course had a small but statistically significant impact on the retention of learning, but not on the immediate learning outcome.

  19. Clinical observations on the treatment of prolapsing hemorrhoids with tissue selecting therapy

    PubMed Central

    Wang, Zhi-Gang; Zhang, Yong; Zeng, Xian-Dong; Zhang, Tie-Hui; Zhu, Qi-Dong; Liu, De-Long; Qiao, Yun-Yu; Mu, Nan; Yin, Zhi-Tao

    2015-01-01

    AIM: To compare the effects and postoperative complications between tissue selecting therapy stapler (TST) and Milligan-Morgan hemorrhoidectomy (M-M). METHODS: Four hundred and eighty patients with severe prolapsing hemorrhoids, who were admitted to the Shenyang Coloproctology Hospital between 2009 and 2012, were randomly divided into observation (n = 240) and control (n = 240) groups. Hemorrhoidectomies were performed with TST in the observation group and with the M-M technique in the control group. The therapeutic effects, operation security, and postoperative complications in the two groups were compared. The immediate and long-term complications were assessed according to corresponding criteria. Pain was assessed on a visual analogue scale. The efficacy was assessed by specialized criteria. The follow-up was conducted one year after the operation. RESULTS: The total effective rates of the observation and control groups were 99.5% (217/218) and 98.6% (218/221) respectively; the difference was not statistically significant (P = 0.322). Their were significant differences between observation and control groups in intraoperative blood loss (5.07 ± 1.14 vs 2.45 ± 0.57, P = 0.000), pain (12 h after the surgery: 5.08 ± 1.62 vs 7.19 ± 2.01, P = 0.000; at first dressing change: 2.64 ± 0.87 vs 4.34 ± 1.15, P = 0.000; first defecation: 3.91 ± 1.47 vs 5.63 ± 1.98, P = 0.001), urine retention (n = 22 vs n = 47, P = 0.001), anal pendant expansion after the surgery (2.35 ± 0.56 vs 5.16 ± 1.42, P = 0.000), operation time (18.3 ± 5.6 min vs 29.5 ± 8.2 min, P = 0.000), and the length of hospital stay (5.3 ± 0.6 d vs 11.4 ± 1.8 d, P = 0.000). Moreover TST showed significant reductions compared to M-M in the rates of long-term complications such as fecal incontinence (n = 3 vs n = 16, P = 0.003), difficult bowel movement (n = 1 vs n = 9, P = 0.011), intractable pain (n = 2 vs n = 12, P = 0.007), and anal discharge (n = 3 vs n = 23, P = 0.000). CONCLUSION: TST for

  20. Clinical observations on the treatment of prolapsing hemorrhoids with tissue selecting therapy.

    PubMed

    Wang, Zhi-Gang; Zhang, Yong; Zeng, Xian-Dong; Zhang, Tie-Hui; Zhu, Qi-Dong; Liu, De-Long; Qiao, Yun-Yu; Mu, Nan; Yin, Zhi-Tao

    2015-02-28

    To compare the effects and postoperative complications between tissue selecting therapy stapler (TST) and Milligan-Morgan hemorrhoidectomy (M-M). Four hundred and eighty patients with severe prolapsing hemorrhoids, who were admitted to the Shenyang Coloproctology Hospital between 2009 and 2012, were randomly divided into observation (n=240) and control (n=240) groups. Hemorrhoidectomies were performed with TST in the observation group and with the M-M technique in the control group. The therapeutic effects, operation security, and postoperative complications in the two groups were compared. The immediate and long-term complications were assessed according to corresponding criteria. Pain was assessed on a visual analogue scale. The efficacy was assessed by specialized criteria. The follow-up was conducted one year after the operation. The total effective rates of the observation and control groups were 99.5% (217/218) and 98.6% (218/221) respectively; the difference was not statistically significant (P=0.322). Their were significant differences between observation and control groups in intraoperative blood loss (5.07±1.14 vs 2.45±0.57, P=0.000), pain (12 h after the surgery: 5.08±1.62 vs 7.19±2.01, P=0.000; at first dressing change: 2.64±0.87 vs 4.34±1.15, P=0.000; first defecation: 3.91±1.47 vs 5.63±1.98, P=0.001), urine retention (n=22 vs n=47, P=0.001), anal pendant expansion after the surgery (2.35±0.56 vs 5.16±1.42, P=0.000), operation time (18.3±5.6 min vs 29.5±8.2 min, P=0.000), and the length of hospital stay (5.3±0.6 d vs 11.4±1.8 d, P=0.000). Moreover TST showed significant reductions compared to M-M in the rates of long-term complications such as fecal incontinence (n=3 vs n=16, P=0.003), difficult bowel movement (n=1 vs n=9, P=0.011), intractable pain (n=2 vs n=12, P=0.007), and anal discharge (n=3 vs n=23, P=0.000). TST for severe prolapsing hemorrhoids is a satisfactory technique for more rapid recovery, lower complication rates, and

  1. Treatment of adenoviral keratoconjunctivitis with a combination of povidone-iodine 1.0% and dexamethasone 0.1% drops: a clinical prospective controlled randomized study.

    PubMed

    Kovalyuk, Natalya; Kaiserman, Igor; Mimouni, Michael; Cohen, Ornit; Levartovsky, Shmuel; Sherbany, Hilda; Mandelboim, Michal

    2017-12-01

    To determine the efficacy of combination povidone-iodine (PVP-I) 1.0% eyedrops and dexamethasone 0.1% eyedrops in the treatment of adenoviral keratoconjunctivitis. In a prospective, randomized, controlled, double-blinded clinical trial patients with recent adenoviral keratoconjunctivitis (diagnosed clinically and confirmed by PCR), we randomly divided into three treatment groups: study group - received PVP-I 1.0% and dexamethasone 0.1%, control 1 group - received dexamethasone 0.1% and control 2 group - received lubricating eyedrops (hypromellose 0.3%). The treatment was administered four times a day in each group. All patients were examined and filled a questionnaire before treatment and on the 3rd, 5th and 7th days of treatment. We included in the study 78 eyes (26 in each group). Adenovirus type 8 was the most common pathogen (83% of cases). The fastest improvement in patients red eyes, discharge, superficial punctate keratitis and pseudomembranes was observed in the study group (p < 0.001). Those patients reached a near complete recovery in 5-7 days, which was also confirmed by reduction in Adenovirus titres by PCR. The slowest improvement was in the control 2 group. Subepithelial infiltrates (SEI) were observed in 44% of the control 1 group, 20% of the control 2 group and in 0% of the study group. The rate of reduction in Adenovirus titres was the slowest in the control 1 group. The combination of PVP-I 1.0% and dexamethasone 0.1% four times a day can reduce symptoms and expedite recovery in epidemic keratoconjunctivitis patients. © 2017 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  2. Acellular dermal matrix allograft. The results of controlled randomized clinical studies.

    PubMed

    Novaes, Arthur Belém; de Barros, Raquel Rezende Martins

    2008-10-01

    The aim of this presentation was to discuss the effectiveness of the acellular dermal matrix in root coverage therapy and in alveolar ridge augmentation, based on three controlled randomized clinical trials conducted by our research team (Novaes Jr et al., 2001; Barros et al., 2005; Luczyszyn et al., 2005). The first and second studies highlight the allograft's performance in the treatment of gingival recession. In both studies, clinical parameters were assessed prior to surgery and 6 or 12 months post-surgery. The first one compared the use of the acellular dermal matrix with the subepithelial connective tissue graft and showed 1.83 and 2.10 mm of recession reduction, respectively. Because no statistically significant differences between the groups were observed, it was concluded that the allograft can be used as a substitute for the autograft. In the second study, a new surgical approach was compared to a conventional surgical procedure described by Langer and Langer in 1985. A statistically significant greater recession reduction favoring the test procedure was achieved. The percentage of root coverage was 82.5% and 62.3% for test and control groups. Thus the new technique was considered more suitable for the treatment of gingival recessions with the allograft. Finally, the third study evaluated the allograft as a membrane, associated or not with a resorbable hydroxyapatite in bone regeneration to prevent ridge deformities. In one group the extraction sockets were covered only by the allograft and in the other, the alveoli were also filled with the resorbable hydroxyapatite. After six months, both treatments were able to preserve ridge thickness, considering the pre-operative values. In conclusion, no adverse healing events were noted with the use of allograft in site preservation procedures, and sites treated with the combination of allograft plus resorbable hydroxyapatite showed significantly greater ridge thickness preservation at six months when compared to

  3. Effect of Massage Therapy on Vital Signs and GCS Scores of ICU Patients: A Randomized Controlled Clinical Trial.

    PubMed

    Vahedian-Azimi, Amir; Ebadi, Abbas; Asghari Jafarabadi, Mohammad; Saadat, Soheil; Ahmadi, Fazlollah

    2014-08-01

    Unalleviated complications related to hospitalization, including stress, anxiety, and pain, can easily influence different structures, like the neural system, by enhancing the stimulation of sympathetic nervous pathways and causing unstable vital signs and deterioration in the level of consciousness. The purpose of this study was to determine the effects of massage therapy by family members on vital signs and Glasgow Coma Scale Score (GCS) of patients hospitalized in the Intensive Care Unit (ICU). This randomized controlled clinical trial was conducted at the ICU of the Shariati Hospital during 2012; 45 ICU patients and 45 family members in the experimental group and the same number of patients and family members in the control group were consecutively selected . The data collection instrument consisted of two parts. The first part included demographic data (age, marital status and Body Mass Index) and the second part included a checklist to record the patient's vital signs (systolic blood pressure (SBP), diastolic blood pressure (DBP), respiratory rate (RR), pulse rate (PR)) and GCS. All measurements were done at the same time in both groups before the intervention (full body massage therapy), and 1 hour, 2 hours, 3 hours, and 4 hours after intervention. The patients were provided with a 60-minute full body massage The massage protocol included static, surface tension, stretching, superficial lymph unload, transverse friction, and myofacial releasing techniques. Significant differences were observed between experimental and control groups in the SBP at 1 hour, SBP 2 hours, and SBP 3 hours, and also in GCS at 1 hour to GCS at 4 hours (P < 0.05). Multivariate analysis revealed a significant difference between experimental and control groups in SBP at all time points (P < 0.05). Massage via family members had several positive effects on the patients' clinical conditions, and therefore, it should be recognized as one of the most important clinical considerations in

  4. [Dynamic observation of clinical course in patients with subacute 1, 2-dichloroethane poisoning].

    PubMed

    Liu, Weiwei; Chen, Yuquan; Pan, Jing; Yang, Zhiqian; Liu, Yimin

    2015-03-01

    To observe the clinical characteristics and regular patterns of subacute 1, 2-dichloroethane poisoning patients for providing evidences to it's diagnosis, treatment and prognosis. 51 cases of subacute 1, 2-dichloroethane poisoning analyzed. They were divided into 3 groups according to their main clinical manifestation: group A mainly with intracranial hypertension (n = 25), group B with limbs tremor (n = 18), group C with mental and behavior disorder (n = 8). All cases' clinical symptoms, cranial computer tomography, cerebrospinal pressure (Group A) were observed, the durations of the onset, deterioration, improvement, recovery and whole course of the disease were compared between groups and in each group. In all of 51 cases, only the differences between the deterioration duration of cranial CT and symptom was significantly (t = 2.555, P<0.05), which indicate the deterioration of symptom was earlier than radiological change. The symptom deterioration of group C was the fastest than group A and group B (P<0.00). As to the change of symptom duration, group B's improvement, recovery and whole course was the longest comparing with group A and group C (P<0.05). As to the change of cranial CT duration, group B's recovery duration was the shortest and group A's recovery duration was the longest (P<0.01); group B's whole course was also the shortest and group A's whole course was the longest (P<0.05). The clinical course of symptoms, cranial computer tomography, cerebrospinal pressure (Group A) was compared in each group, in group A, the duration of improvement and whole course of the cranial CT and cerebrospinal pressure change was longer than that of the symptom change (P<0.01), this indicated that group A has longer asymptomatic intracranial hypertension and their cranial radiography recover slowly. In group B, their symptoms (3.94 ± 4.31 days) deteriorated is earlier than cranial CT changes (P<0.05), the recovery (92.39 ± 55.04 days) and whole course of symptom was

  5. The Individualized Quality Control Plan - Coming Soon to Clinical Microbiology Laboratories Everywhere!

    PubMed

    Anderson, Nancy

    2015-11-15

    As of January 1, 2016, microbiology laboratories can choose to adopt a new quality control option, the Individualized Quality Control Plan (IQCP), under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This voluntary approach increases flexibility for meeting regulatory requirements and provides laboratories the opportunity to customize QC for their testing in their unique environments and by their testing personnel. IQCP is an all-inclusive approach to quality based on risk management to address potential errors in the total testing process. It includes three main steps, (1) performing a risk assessment, (2) developing a QC plan, and (3) monitoring the plan through quality assessment. Resources are available from the Centers for Medicare & Medicaid Services, Centers for Disease Control and Prevention, American Society for Microbiology, Clinical and Laboratory Standards Institute, and accrediting organizations, such as the College of American Pathologists and Joint Commission, to assist microbiology laboratories implementing IQCP.

  6. Effect of intralesional platelet-rich plasma (PRP) treatment on clinical and ultrasonographic parameters in equine naturally occurring superficial digital flexor tendinopathies - a randomized prospective controlled clinical trial.

    PubMed

    Geburek, Florian; Gaus, Moritz; van Schie, Hans T M; Rohn, Karl; Stadler, Peter M

    2016-09-07

    Regenerative and anti-inflammatory effects on tendinopathies have been attributed to blood-derived biologicals. To date the evidence for the efficacy of autologous platelet-rich plasma (PRP) treatment of naturally occurring equine tendinopathies is limited. The purpose of this placebo-controlled clinical trial was to describe the effect of a single treatment of equine superficial digital flexor tendon (SDFT) disease with PRP on clinical and ultrasonographic parameters. Twenty horses with naturally occurring tendinopathies of forelimb SDFTs were randomly assigned to the PRP-treated group (n = 10) or control group (n = 10) after clinical and ultrasonographic examination. The SDFTs received an intralesional treatment with autologous PRP or were injected with saline, respectively (day 0). All horses participated in a standardized exercise programme and were re-examined clinically, with B-mode ultrasonography (5 times at regular intervals) and ultrasound tissue characterization (week 12 and 24 after treatment) until week 24. Long-term performance was estimated via telephone inquiry. Compared to day 0, lameness decreased significantly by week 8 after treatment with PRP and by week 12 in the control group. Ultrasonographically there was no difference in the summarized cross sectional area between the groups at any time point. Ultrasound tissue characterization showed that echo types representing disorganized matrix decreased significantly throughout the observation period in the PRP-treated group. Echo type II, representing discontinuous fascicles, not yet aligned into lines of stress was significantly higher 24 weeks after PRP treatment. Eighty percent of the PRP treated horses reached their previous or a higher level of performance after 12 months compared to 50 % in the CG. After 24 months these proportions were 60 % and 50 %, respectively. A single intralesional treatment with PRP up to 8 weeks after onset of clinical signs of tendinopathy contributes

  7. Global developmental delay in guanidionacetate methyltransferase deficiency: differences in formal testing and clinical observation.

    PubMed

    Verbruggen, Krijn T; Knijff, Wilma A; Soorani-Lunsing, Roelineke J; Sijens, Paul E; Verhoeven, Nanda M; Salomons, Gajja S; Goorhuis-Brouwer, Siena M; van Spronsen, Francjan J

    2007-09-01

    Guanidinoacetate N-methyltransferase (GAMT) deficiency is a defect in the biosynthesis of creatine (Cr). So far, reports have not focused on the description of developmental abilities in this disorder. Here, we present the result of formal testing of developmental abilities in a GAMT-deficient patient. Our patient, a 3-year-old boy with GAMT deficiency, presented clinically with a severe language production delay and nearly normal nonverbal development. Treatment with oral Cr supplementation led to partial restoration of the cerebral Cr concentration and a clinically remarkable acceleration of language production development. In contrast to clinical observation, formal testing showed a rather harmonic developmental delay before therapy and a general improvement, but no specific acceleration of language development after therapy. From our case, we conclude that in GAMT deficiency language delay is not always more prominent than delays in other developmental areas. The discrepancy between the clinical impression and formal testing underscores the importance of applying standardized tests in children with developmental delays. Screening for Cr deficiency by metabolite analysis of body fluids or proton magnetic resonance spectroscopy of the brain deficiency should be considered in any child with global developmental delay/mental retardation lacking clues for an alternative etiology.

  8. Clinical observations from nutrition services in college athletics.

    PubMed

    Quatromoni, Paula A

    2008-04-01

    College athletes are vulnerable to nutritional risks because of the rigorous demands of their sport, and because of the realities of college lifestyles. Athletes often adopt rigid training diets that predispose them to undernutrition, fatigue, and injury. Disordered eating, a common concern for college-aged women, affects a substantial number of female collegiate athletes, and is a growing concern for their male counterparts. Few resources exist to promote nutritional well-being among college athletes, particularly for individuals who suffer from eating pathology that is subclinical and often perceived as benign. This article presents evidence of the need for nutrition services for college athletes and describes nutritional risks that affect individuals across a variety of athletic teams. A multidisciplinary treatment model is depicted, featuring a nutrition practice at the core of a sports medicine wellness program in Division I college athletics. Observations from this practice document a substantial burden of subclinical eating disorders and elucidate characteristics of high-risk individuals. The Female Athlete Screening Tool is advocated as a useful tool for identifying eating pathology and triggering timely interventions. These insights from clinical practice identify opportunities and behavioral targets for intervention, and promote an effective model for health promotion in college athletics.

  9. Implementation of a Cardiogenic Shock Team and Clinical Outcomes (INOVA-SHOCK Registry): Observational and Retrospective Study.

    PubMed

    Tehrani, Behnam; Truesdell, Alexander; Singh, Ramesh; Murphy, Charles; Saulino, Patricia

    2018-06-28

    The development and implementation of a Cardiogenic Shock initiative focused on increased disease awareness, early multidisciplinary team activation, rapid initiation of mechanical circulatory support, and hemodynamic-guided management and improvement of outcomes in cardiogenic shock. The objectives of this study are (1) to collect retrospective clinical outcomes for acute decompensated heart failure cardiogenic shock and acute myocardial infarction cardiogenic shock, and compare current versus historical survival rates and clinical outcomes; (2) to evaluate Inova Heart and Vascular Institute site specific outcomes before and after initiation of the Cardiogenic Shock team on January 1, 2017; (3) to compare outcomes related to early implementation of mechanical circulatory support and hemodynamic-guided management versus historical controls; (4) to assess survival to discharge rate in patients receiving intervention from the designated shock team and (5) create a clinical archive of Cardiogenic Shock patient characteristics for future analysis and the support of translational research studies. This is an observational, retrospective, single center study. Retrospective and prospective data will be collected in patients treated at the Inova Heart and Vascular Institute with documented cardiogenic shock as a result of acute decompensated heart failure or acute myocardial infarction. This registry will include data from patients prior to and after the initiation of the multidisciplinary Cardiogenic Shock team on January 1, 2017. Clinical outcomes associated with early multidisciplinary team intervention will be analyzed. In the study group, all patients evaluated for documented cardiogenic shock (acute decompensated heart failure cardiogenic shock, acute myocardial infarction cardiogenic shock) treated at the Inova Heart and Vascular Institute by the Cardiogenic Shock team will be included. An additional historical Inova Heart and Vascular Institute control group will

  10. Clinical simulation training improves the clinical performance of Chinese medical students

    PubMed Central

    Zhang, Ming-ya; Cheng, Xin; Xu, An-ding; Luo, Liang-ping; Yang, Xuesong

    2015-01-01

    Background Modern medical education promotes medical students’ clinical operating capacity rather than the mastery of theoretical knowledge. To accomplish this objective, clinical skill training using various simulations was introduced into medical education to cultivate creativity and develop the practical ability of students. However, quantitative analysis of the efficiency of clinical skill training with simulations is lacking. Methods In the present study, we compared the mean scores of medical students (Jinan University) who graduated in 2013 and 2014 on 16 stations between traditional training (control) and simulative training groups. In addition, in a clinical skill competition, the objective structured clinical examination (OSCE) scores of participating medical students trained using traditional and simulative training were compared. The data were statistically analyzed and qualitatively described. Results The results revealed that simulative training could significantly enhance the graduate score of medical students compared with the control. The OSCE scores of participating medical students in the clinical skill competition, trained using simulations, were dramatically higher than those of students trained through traditional methods, and we also observed that the OSCE marks were significantly increased for the same participant after simulative training for the clinical skill competition. Conclusions Taken together, these data indicate that clinical skill training with a variety of simulations could substantially promote the clinical performance of medical students and optimize the resources used for medical education, although a precise analysis of each specialization is needed in the future. PMID:26478142

  11. One-year outcomes of repeated adjunctive photodynamic therapy during periodontal maintenance: a proof-of-principle randomized-controlled clinical trial.

    PubMed

    Lulic, Martina; Leiggener Görög, Isabelle; Salvi, Giovanni E; Ramseier, Christoph A; Mattheos, Nikolaos; Lang, Niklaus P

    2009-08-01

    Single photodynamic therapy (PDT) has been effective in initial periodontal therapy, but only improved bleeding on probing (BoP) in maintenance patients after a single use. Repeated PDT has not been addressed. To study the possible added benefits of repeated adjunctive PDT to conventional treatment of residual pockets in patients enrolled in periodontal maintenance. Ten maintenance patients with 70 residual pockets [probing pocket depth (PPD)>or=5 mm] were randomly assigned for treatment five times in 2 weeks (Days 0, 1, 2, 7, 14) with PDT (test) or non-activated laser (control) following debridement. The primary outcome variable was PPD, and the secondary variables were clinical attachment level (CAL) and BoP. These were assessed at 3, 6 and 12 months following the interventions. Greater PPD reductions were observed in the test (-0.67 +/- 0.34; p=0.01) compared with the control patients (-0.04 +/- 0.33; NS) after 6 months. Significant CAL gain (+0.52 +/- 0.31; p=0.01) was noted for the test, but not in the control (-0.27 +/- 0.52; NS) patients after 6 months. BoP percentages decreased significantly in test (97-64%, 67%, 77%), but not control patients after 3, 6 and 12 months. Repeated (five times) PDT adjunctive to debridement yielded improved clinical outcomes in residual pockets in maintenance patients. The effects were best documented after 6 months.

  12. Observation and control of blinking nitrogen-vacancy centres in discrete nanodiamonds.

    PubMed

    Bradac, C; Gaebel, T; Naidoo, N; Sellars, M J; Twamley, J; Brown, L J; Barnard, A S; Plakhotnik, T; Zvyagin, A V; Rabeau, J R

    2010-05-01

    Nitrogen-vacancy colour centres in diamond can undergo strong, spin-sensitive optical transitions under ambient conditions, which makes them attractive for applications in quantum optics, nanoscale magnetometry and biolabelling. Although nitrogen-vacancy centres have been observed in aggregated detonation nanodiamonds and milled nanodiamonds, they have not been observed in very small isolated nanodiamonds. Here, we report the first direct observation of nitrogen-vacancy centres in discrete 5-nm nanodiamonds at room temperature, including evidence for intermittency in the luminescence (blinking) from the nanodiamonds. We also show that it is possible to control this blinking by modifying the surface of the nanodiamonds.

  13. Birth Control in Clinical Trials: Industry Survey of Current Use Practices, Governance, and Monitoring.

    PubMed

    Stewart, J; Breslin, W J; Beyer, B K; Chadwick, K; De Schaepdrijver, L; Desai, M; Enright, B; Foster, W; Hui, J Y; Moffat, G J; Tornesi, B; Van Malderen, K; Wiesner, L; Chen, C L

    2016-03-01

    The Health and Environmental Sciences Institute (HESI) Developmental and Reproductive Toxicology Technical Committee sponsored a pharmaceutical industry survey on current industry practices for contraception use during clinical trials. The objectives of the survey were to improve our understanding of the current industry practices for contraception requirements in clinical trials, the governance processes set up to promote consistency and/or compliance with contraception requirements, and the effectiveness of current contraception practices in preventing pregnancies during clinical trials. Opportunities for improvements in current practices were also considered. The survey results from 12 pharmaceutical companies identified significant variability among companies with regard to contraception practices and governance during clinical trials. This variability was due primarily to differences in definitions, areas of scientific uncertainty or misunderstanding, and differences in company approaches to enrollment in clinical trials. The survey also revealed that few companies collected data in a manner that would allow a retrospective understanding of the reasons for failure of birth control during clinical trials. In this article, suggestions are made for topics where regulatory guidance or scientific publications could facilitate best practice. These include provisions for a pragmatic definition of women of childbearing potential, guidance on how animal data can influence the requirements for male and female birth control, evidence-based guidance on birth control and pregnancy testing regimes suitable for low- and high-risk situations, plus practical methods to ascertain the risk of drug-drug interactions with hormonal contraceptives.

  14. No additional cholesterol-lowering effect observed in the combined treatment of red yeast rice and Lactobacillus casei in hyperlipidemic patients: A double-blind randomized controlled clinical trial.

    PubMed

    Lee, Chien-Ying; Yu, Min-Chien; Perng, Wu-Tsun; Lin, Chun-Che; Lee, Ming-Yung; Chang, Ya-Lan; Lai, Ya-Yun; Lee, Yi-Ching; Kuan, Yu-Hsiang; Wei, James Cheng-Chung; Shih, Hung-Che

    2017-08-01

    To observe the effect of combining red yeast rice and Lactobacillus casei (L. casei) in lowering cholesterol in patients with primary hyperlipidemia, the later has also been shown to remove cholesterol in in vitro studies. A double-blind clinical trial was conducted to evaluate the cholesterol-lowering effect of the combination of red yeast rice and L. casei. Sixty patients with primary hyperlipidemia were recruited and randomized equally to either the treatment group (red yeast rice + L. casei) or the control group (red yeast rice + placebo). One red yeast rice capsule and two L. casei capsules were taken twice a day. The treatment lasted for 8 weeks, with an extended follow-up period of 4 weeks. The primary endpoint was a difference of serum low-density lipoprotein cholesterol (LDL-C) level at week 8. At week 8, the LDL-C serum level in both groups was lower than that at baseline, with a decrease of 33.85±26.66 mg/dL in the treatment group and 38.11±30.90 mg/dL in the control group; however, there was no statistical difference between the two groups (P>0.05). The total cholesterol was also lower than the baseline in both groups, yet without a statistical difference between the two groups. The only statistically signifificant difference between the two groups was the average diastolic pressure at week 12, which dropped by 2.67 mm Hg in the treatment group and increased by 4.43 mm Hg in the placebo group (P<0.05). The antihypertensive activity may be associated with L. casei. Red yeast rice can signifificantly reduce LDL-C, total cholesterol and triglyceride. The combination of red yeast rice and L. casei did not have an additional effect on lipid profifiles.

  15. A new fuzzy-disturbance observer-enhanced sliding controller for vibration control of a train-car suspension with magneto-rheological dampers

    NASA Astrophysics Data System (ADS)

    Nguyen, Sy Dzung; Choi, Seung-Bok; Nguyen, Quoc Hung

    2018-05-01

    Semi-active train-car suspensions are always impacted negatively by uncertainty and disturbance (UAD). In order to deal with this, we propose a novel optimal fuzzy disturbance observer-enhanced sliding mode controller (FDO-SMC) for magneto-rheological damper (MRD)-based semi-active train-car suspensions subjected to UAD whose variability rate may be high but bounded. The two main parts of the FDO-SMC are an adaptive sliding mode controller (ad-SMC) and an optimal fuzzy disturbance observer (op-FDO). As the first step, the initial structures of the sliding mode controller (SMC) and disturbance observer (DO) are built. Adaptive update laws for the SMC and DO are then set up synchronously via Lyapunov stability analysis. Subsequently, an optimal fuzzy system (op-FS) is designed to fully implement a parameter constraint mechanism so as to guarantee the system stability converging to the desired state even if the UAD variability rate increases in a given range. As a result, both the ad-SMC and op-FDO are formulated. It is shown from the comparative work with existing controllers that the proposed method provides the best vibration control capability with relatively low consumed power.

  16. Usefulness of a topical combination of dinotefuran and pyriproxyfen for long-term control of clinical signs of allergic dermatitis in privately-owned cats in Ile-de-France region.

    PubMed

    Crosaz, Odile; Bonati, Silvia; Briand, Amaury; Chapelle, Elodie; Cochet-Faivre, Noëlle; Ka, Diane; Darmon-Hadjaje, Céline; Varloud, Marie; Guillot, Jacques

    2017-08-23

    The present study assessed the activity of a combination of dinotefuran and pyriproxyfen (Vectra® Felis) for long-term control (3 months) of allergic dermatitis (AD) in privately-owned cats under common household conditions in Ile-de-France region. This was an open pre-treatment vs post-treatment study. Twenty-eight client-owned cats with clinical signs of AD were enrolled in the study. They received topical application of the combination of dinotefuran and pyriproxyfen on days 0, 28, 56 and 84. Two parameters (clinical signs and pruritus severity) were used to assess the animals' condition on days 0, 28 and 84. Fleas were counted if they were observed. Of the 28 cats initially enrolled, 26 were presented on day 28 and 20 for the final evaluation on day 84. A significant improvement in clinical signs and pruritus was observed in cats for which fleas and/or flea feces were detected on day 0. Globally, the post-treatment AD clinical scores on days 28 and 84 were different from that of the pre-treatment on day 0, with a reduction of 30% and 71%, respectively. For cats with fleas and/or flea feces, the reduction on days 28 and 84 was 33% and 85%, respectively. The improvement of clinical signs and pruritus was not significant in cats with no visible fleas and no flea feces at the beginning of the trial (n = 8). The present study indicated that the treatment with a combination of dinotefuran and pyriproxyfen should be considered as useful in controlling fleas on cats without additional environmental treatment and useful for long-term control of clinical signs and pruritus in allergic cats.

  17. Evaluating the Impact of Database Heterogeneity on Observational Study Results

    PubMed Central

    Madigan, David; Ryan, Patrick B.; Schuemie, Martijn; Stang, Paul E.; Overhage, J. Marc; Hartzema, Abraham G.; Suchard, Marc A.; DuMouchel, William; Berlin, Jesse A.

    2013-01-01

    Clinical studies that use observational databases to evaluate the effects of medical products have become commonplace. Such studies begin by selecting a particular database, a decision that published papers invariably report but do not discuss. Studies of the same issue in different databases, however, can and do generate different results, sometimes with strikingly different clinical implications. In this paper, we systematically study heterogeneity among databases, holding other study methods constant, by exploring relative risk estimates for 53 drug-outcome pairs and 2 widely used study designs (cohort studies and self-controlled case series) across 10 observational databases. When holding the study design constant, our analysis shows that estimated relative risks range from a statistically significant decreased risk to a statistically significant increased risk in 11 of 53 (21%) of drug-outcome pairs that use a cohort design and 19 of 53 (36%) of drug-outcome pairs that use a self-controlled case series design. This exceeds the proportion of pairs that were consistent across databases in both direction and statistical significance, which was 9 of 53 (17%) for cohort studies and 5 of 53 (9%) for self-controlled case series. Our findings show that clinical studies that use observational databases can be sensitive to the choice of database. More attention is needed to consider how the choice of data source may be affecting results. PMID:23648805

  18. Clinical learning experiences of nursing students using an innovative clinical partnership model: A non-randomized controlled trial.

    PubMed

    Chan, Aileen W K; Tang, Fiona W K; Choi, Kai Chow; Liu, Ting; Taylor-Piliae, Ruth E

    2018-06-05

    Clinical practicum is a major learning component for pre-registration nursing students. Various clinical practicum models have been used to facilitate students' clinical learning experiences, employing both university-based and hospital-based clinical teachers. Considering the strengths and limitations of these clinical practicum models, along with nursing workforce shortages, we developed and tested an innovative clinical partnership model (CPM) in Hong Kong. To evaluate an innovative CPM among nursing students actual and preferred clinical learning environment, compared with a conventional facilitation model (CFM). A non-randomized controlled trial examining students' clinical experiences, comparing the CPM (supervised by hospital clinical teacher) with the CFM (supervised by university clinical teacher). One university in Hong Kong. Pre-registration nursing students (N = 331), including bachelor of nursing (n = 246 year three-BN) and masters-entry nursing (n = 85 year one-MNSP). Students were assigned to either the CPM (n = 48 BN plus n = 85 MNSP students) or the CFM (n = 198 BN students) for their clinical practice experiences in an acute medical-surgical ward. Clinical teachers supervised between 6 and 8 students at a time, during these clinical practicums (duration = 4-6 weeks). At the end of the clinical practicum, students were invited to complete the Clinical Learning Environment Inventory (CLEI). Analysis of covariance was used to compare groups; adjusted for age, gender and prior work experience. A total of 259 students (mean age = 22 years, 76% female, 81% prior work experience) completed the CLEI (78% response rate). Students had higher scores on preferred versus actual experiences, in all domains of the CLEI. CPM student experiences indicated a higher preferred task orientation (p = 0.004), while CFM student experiences indicated a higher actual (p < 0.001) and preferred individualization (p = 0

  19. Temperature-Controlled Delivery of Radiofrequency Energy in Fecal Incontinence: A Randomized Sham-Controlled Clinical Trial.

    PubMed

    Visscher, Arjan P; Lam, Tze J; Meurs-Szojda, Maria M; Felt-Bersma, Richelle J F

    2017-08-01

    Controlled delivery of radiofrequency energy has been suggested as treatment for fecal incontinence. The aim of this study was to determine whether the clinical response to the radiofrequency energy procedure is superior to sham in patients with fecal incontinence. This was a randomized sham-controlled clinical trial from 2008 to 2015. This study was conducted in an outpatient clinic. Forty patients with fecal incontinence in whom maximal conservative management had failed were randomly assigned to receiving either radiofrequency energy or sham procedure. Fecal incontinence was measured using the Vaizey incontinence score (range, 0-24). The impact of fecal incontinence on quality of life was measured by using the fecal incontinence quality-of-life score (range, 1-4). Measurements were performed at baseline and at 6 months. Anorectal function was evaluated using anal manometry and anorectal endosonography at baseline and at 3 months. At baseline, Vaizey incontinence score was 16.8 (SD 2.9). At t = 6 months, the radiofrequency energy group improved by 2.5 points on the Vaizey incontinence score compared with the sham group (13.2 (SD 3.1), 15.6 (SD 3.3), p = 0.02). The fecal incontinence quality-of-life score at t = 6 months was not statistically different. Anorectal function did not show any alteration. Patients with severe fecal incontinence were included in the study, thus making it difficult to generalize the results. Both radiofrequency energy and sham procedure improved the fecal incontinence score, the radiofrequency energy procedure more than sham. Although statistically significant, the clinical impact for most of the patients was negligible. Therefore, the radiofrequency energy procedure should not be recommended for patients with fecal incontinence until patient-related factors associated with treatment success are known. See Video Abstract at http://links.lww.com/DCR/A373.

  20. Female Gynecologists and Their Birth Control Clinics: Eugenics in Practice in 1920s-1930s China.

    PubMed

    David, Mirela

    2018-01-01

    Yang Chao Buwei, the first Chinese translator of Margaret Sanger's What Every Girl Should Know, was the first female gynecologist to open up a birth control clinic in China. By the 1930s, other female gynecologists, like Guo Taihua, had internalized and combined national and eugenic concerns of race regeneration to focus on the control of women's reproduction. This symbiosis between racial regeneration and birth control is best seen in Yang Chongrui's integration of birth control into her national hygiene program. This article traces the efforts of pioneer gynecologists in giving contraceptive advice at their birth control clinics, which they framed as a humanitarian effort to ease the reproductive burden of working-class women. It also examines their connections with Sanger's international birth control movement, and their advocacy of contraception as practitioners, translators, and educators. The author argues that these Chinese female gynecologists not only borrowed, but adapted, Western scientific knowledge to Chinese social conditions through their writings and translations and in their clinical work.

  1. Adaptive disturbance compensation finite control set optimal control for PMSM systems based on sliding mode extended state observer

    NASA Astrophysics Data System (ADS)

    Wu, Yun-jie; Li, Guo-fei

    2018-01-01

    Based on sliding mode extended state observer (SMESO) technique, an adaptive disturbance compensation finite control set optimal control (FCS-OC) strategy is proposed for permanent magnet synchronous motor (PMSM) system driven by voltage source inverter (VSI). So as to improve robustness of finite control set optimal control strategy, a SMESO is proposed to estimate the output-effect disturbance. The estimated value is fed back to finite control set optimal controller for implementing disturbance compensation. It is indicated through theoretical analysis that the designed SMESO could converge in finite time. The simulation results illustrate that the proposed adaptive disturbance compensation FCS-OC possesses better dynamical response behavior in the presence of disturbance.

  2. Protocol for a randomised controlled trial for Reducing Arthritis Fatigue by clinical Teams (RAFT) using cognitive-behavioural approaches.

    PubMed

    Hewlett, S; Ambler, N; Almeida, C; Blair, P S; Choy, E; Dures, E; Hammond, A; Hollingworth, W; Kirwan, J; Plummer, Z; Rooke, C; Thorn, J; Tomkinson, K; Pollock, J

    2015-08-06

    Rheumatoid arthritis (RA) fatigue is distressing, leading to unmanageable physical and cognitive exhaustion impacting on health, leisure and work. Group cognitive-behavioural (CB) therapy delivered by a clinical psychologist demonstrated large improvements in fatigue impact. However, few rheumatology teams include a clinical psychologist, therefore, this study aims to examine whether conventional rheumatology teams can reproduce similar results, potentially widening intervention availability. This is a multicentre, randomised, controlled trial of a group CB intervention for RA fatigue self-management, delivered by local rheumatology clinical teams. 7 centres will each recruit 4 consecutive cohorts of 10-16 patients with RA (fatigue severity ≥ 6/10). After consenting, patients will have baseline assessments, then usual care (fatigue self-management booklet, discussed for 5-6 min), then be randomised into control (no action) or intervention arms. The intervention, Reducing Arthritis Fatigue by clinical Teams (RAFT) will be cofacilitated by two local rheumatology clinicians (eg, nurse/occupational therapist), who will have had brief training in CB approaches, a RAFT manual and materials, and delivered an observed practice course. Groups of 5-8 patients will attend 6 × 2 h sessions (weeks 1-6) and a 1 hr consolidation session (week 14) addressing different self-management topics and behaviours. The primary outcome is fatigue impact (26 weeks); secondary outcomes are fatigue severity, coping and multidimensional impact, quality of life, clinical and mood status (to week 104). Statistical and health economic analyses will follow a predetermined plan to establish whether the intervention is clinically and cost-effective. Effects of teaching CB skills to clinicians will be evaluated qualitatively. Approval was given by an NHS Research Ethics Committee, and participants will provide written informed consent. The copyrighted RAFT package will be freely available. Findings

  3. Protocol for a randomised controlled trial for Reducing Arthritis Fatigue by clinical Teams (RAFT) using cognitive–behavioural approaches

    PubMed Central

    Hewlett, S; Ambler, N; Almeida, C; Blair, P S; Choy, E; Dures, E; Hammond, A; Hollingworth, W; Kirwan, J; Plummer, Z; Rooke, C; Thorn, J; Tomkinson, K; Pollock, J

    2015-01-01

    Introduction Rheumatoid arthritis (RA) fatigue is distressing, leading to unmanageable physical and cognitive exhaustion impacting on health, leisure and work. Group cognitive–behavioural (CB) therapy delivered by a clinical psychologist demonstrated large improvements in fatigue impact. However, few rheumatology teams include a clinical psychologist, therefore, this study aims to examine whether conventional rheumatology teams can reproduce similar results, potentially widening intervention availability. Methods and analysis This is a multicentre, randomised, controlled trial of a group CB intervention for RA fatigue self-management, delivered by local rheumatology clinical teams. 7 centres will each recruit 4 consecutive cohorts of 10–16 patients with RA (fatigue severity ≥6/10). After consenting, patients will have baseline assessments, then usual care (fatigue self-management booklet, discussed for 5–6 min), then be randomised into control (no action) or intervention arms. The intervention, Reducing Arthritis Fatigue by clinical Teams (RAFT) will be cofacilitated by two local rheumatology clinicians (eg, nurse/occupational therapist), who will have had brief training in CB approaches, a RAFT manual and materials, and delivered an observed practice course. Groups of 5–8 patients will attend 6×2 h sessions (weeks 1–6) and a 1 hr consolidation session (week 14) addressing different self-management topics and behaviours. The primary outcome is fatigue impact (26 weeks); secondary outcomes are fatigue severity, coping and multidimensional impact, quality of life, clinical and mood status (to week 104). Statistical and health economic analyses will follow a predetermined plan to establish whether the intervention is clinically and cost-effective. Effects of teaching CB skills to clinicians will be evaluated qualitatively. Ethics and dissemination Approval was given by an NHS Research Ethics Committee, and participants will provide written

  4. Empathy in Boys with Gender Identity Disorder: A Comparison to Externalizing Clinical Control Boys and Community Control Boys and Girls

    ERIC Educational Resources Information Center

    Owen-Anderson, Allison F. H.; Jenkins, Jennifer M.; Bradley, Susan J.; Zucker, Kenneth J.

    2008-01-01

    Objective: The construct of empathy was examined in 20 boys with gender identity disorder (GID), 20 clinical control boys with externalizing disorders (ECC), 20 community control boys (NCB), and 20 community control girls (NCG). The mean age of the children was 6.86 years (range = 4-8 years). It was hypothesized that boys with GID would show…

  5. [Clinical observation on effect of shaogen decoction for the prevention and treatment of acute radiation esophagitis].

    PubMed

    Zhang, Jie; Zhang, Li; Wang, Jun

    2010-12-01

    To observe the effect of Shaogen Decoction (SGD) for the prevention and treatment of acute radiation esophagitis (ARE). Sixty patients with breast tumor receiving chemo/radiotherapy were assigned to two groups, the SGD group and the control group. The patients in the SGD group were administered with SGD, a Chinese preparation consisted of Radix Sophorae tonkinensis 10 g, Radix Paeoniae Alba 30 g, Radix Scrophulariae 15 g, Rhizoma Bletillae 15 g, Radix Notoginseng 3 g, etc., starting from the initial day of radiotherapy, 10 mL, thrice a day, while in case of 2nd or over 2nd grade ARE occurred, it was changed to 10 mL, every 2 h, medicated by keeping in mouth and slowly swallowed followed with 5-min forbiddance of food and water. The patients in the control group were treated, in case of 2nd or over 2nd grade ARE occurred, with antibiotic drugs (such as cefuroxime 4.5 g) and hormone (dexamethasone 5 mg) by intravenous infusion for 7 days. The incidence, happening time, and retaining time of ARE, therapeutic effect on it, as well as the proportion of patients for whom antibiotics and hormone were used in the two groups were observed. The incidence of 2nd or over 2nd grade ARE in the SGD group and the control group was 33.33% and 63.33%, respectively, that in the former was significantly lower (chi2 = 5.406, P<0.05). Different degrees of acute esophageal toxic response occurred in both groups, initially presenting at 19.8 +/- 7.4 days in the SGD group and at 20.2 +/- 9.6 days in the control group after radiotherapy, that was delayed in the former (t=2.130, P<0.05). Clinical symptom of ARE retained for 56.4 +/- 19.5 days and 58.2 +/- 15.0 days in the two groups, respectively, it was shorter in the SGD groups (t=2.441, P<0.05). Moreover, the proportion of patients for whom antibiotics and hormone were used in the SGD group was less. SGD acted, in coordinating with chemo-radiotherapy, to reduce the incidence, retard the happening and shorten the retaining time of 2nd or

  6. 77 FR 47109 - Manufacturer of Controlled Substances; Notice of Application; Clinical Supplies Management Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-07

    ... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Clinical Supplies Management Inc. Pursuant to Title 21 Code of Federal Regulations 1301.34(a), this is notice that on July 3, 2012, Clinical Supplies [[Page 47110

  7. Learning Clinical Skills during Bedside Teaching Encounters in General Practice: A Video-Observational Study with Insights from Activity Theory

    ERIC Educational Resources Information Center

    Ajjawi, Rola; Rees, Charlotte; Monrouxe, Lynn V.

    2015-01-01

    Purpose: This paper aims to explore how opportunities for learning clinical skills are negotiated within bedside teaching encounters (BTEs). Bedside teaching, within the medical workplace, is considered essential for helping students develop their clinical skills. Design/methodology/approach: An audio and/or video observational study examining…

  8. The effect of continuous passive motion and sling exercise training on clinical and functional outcomes following total knee arthroplasty: a randomized active-controlled clinical study.

    PubMed

    Mau-Moeller, Anett; Behrens, Martin; Finze, Susanne; Bruhn, Sven; Bader, Rainer; Mittelmeier, Wolfram

    2014-05-09

    The parallel-group randomized active-controlled clinical study was conducted to compare the effectiveness of two in-hospital range of motion (ROM) exercise programs following total knee arthroplasty (TKA). Continuous passive motion (CPM) is frequently used to increase ROM and improve postoperative recovery despite little conclusive scientific evidence. In contrast, a new active sling-based ROM therapy requires the activation of the knee joint muscles and dynamic joint stabilization. It was hypothesized that higher demands on muscle strength and muscle coordination during sling exercise training (ST) might be advantageous for early recovery following TKA. A total of 125 patients undergoing primary TKA were assessed for eligibility. Thirty-eight patients were randomly assigned to receive ST or CPM (control intervention) during hospital stay. Patients were assessed before TKA for baseline measurement (pretest), 1 day before discharge (posttest) and 3 months after TKA (follow-up). The passive knee flexion range of motion (pFL) was the primary outcome measure. Secondary outcome measures included active knee flexion range of motion, active and passive knee extension ROM, static postural control, physical activity, pain, length of hospital stay as well as clinical, functional and quality-of-life outcomes (SF-36, HSS and WOMAC scores). Data were analyzed according to the intention-to-treat principle. Differences between the groups were tested for significance by the unpaired Student's t test or an analysis of covariance (ANCOVA) adjusted for baseline, weight, sex, age, pain and physical activity. A between-group difference could be determined at posttest. The pFL was significantly higher by 6.0° (95% CI 0.9 to 11.2°; P = 0.022) in the ST group. No difference between groups in pFL was documented at follow-up. Furthermore, no significant differences could be observed for any secondary outcome measure at posttest and follow-up. ST seems to have a clinically relevant

  9. Distributed Adaptive Fuzzy Control for Nonlinear Multiagent Systems Via Sliding Mode Observers.

    PubMed

    Shen, Qikun; Shi, Peng; Shi, Yan

    2016-12-01

    In this paper, the problem of distributed adaptive fuzzy control is investigated for high-order uncertain nonlinear multiagent systems on directed graph with a fixed topology. It is assumed that only the outputs of each follower and its neighbors are available in the design of its distributed controllers. Equivalent output injection sliding mode observers are proposed for each follower to estimate the states of itself and its neighbors, and an observer-based distributed adaptive controller is designed for each follower to guarantee that it asymptotically synchronizes to a leader with tracking errors being semi-globally uniform ultimate bounded, in which fuzzy logic systems are utilized to approximate unknown functions. Based on algebraic graph theory and Lyapunov function approach, using Filippov-framework, the closed-loop system stability analysis is conducted. Finally, numerical simulations are provided to illustrate the effectiveness and potential of the developed design techniques.

  10. A pragmatic guide on how physicians can take over financial control of their clinical practice.

    PubMed

    Jacobs, Volker R; Fischer, Thorsten

    2012-01-01

    Control of clinical cost is becoming increasingly important in health care worldwide. Physicians should accept the limitation of resources and take responsibility to improve their clinical cost-reimbursement ratio. To achieve this, they will need basic education in clinic management to control and adjust costs and reimbursement, without impacting professional quality of care. Rational use of diagnostics and therapy should be implemented and frequently verified. Physicians are the only professionals that are able to integrate economics with health care. This is in the best interest of patients and will improve a physician's position, influence, and professional freedom levels within our hospitals.

  11. 77 FR 24985 - Importer of Controlled Substances; Notice of Application; Almac Clinical Services, Inc., (ACSI)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-26

    ... Application; Almac Clinical Services, Inc., (ACSI) Pursuant to 21 U.S.C. 958(i), the Attorney General shall... on March 5, 2012, Almac Clinical Services, Inc., (ACSI), 25 Fretz Road, Souderton, Pennsylvania 18964... the listed controlled substances in dosage form to conduct clinical trials. Any bulk manufacturer who...

  12. Disturbance observer based Takagi-Sugeno fuzzy control for an active seat suspension

    NASA Astrophysics Data System (ADS)

    Ning, Donghong; Sun, Shuaishuai; Zhang, Fei; Du, Haiping; Li, Weihua; Zhang, Bangji

    2017-09-01

    In this paper, a disturbance observer based Takagi-Sugeno (TS) fuzzy controller is proposed for an active seat suspension; both simulations and experiments have been performed verifying the performance enhancement and stability of the proposed controller. The controller incorporates closed-loop feedback control using the measured acceleration of the seat and deflection of the suspension; these two variables can be easily measured in practical applications, thus allowing the proposed controller to be robust and adaptable. A disturbance observer that can estimate the disturbance caused by friction, model simplification, and controller output error has also been used to compensate a H∞ state feedback controller. The TS fuzzy control method is applied to enhance the controller's performance by considering the variation of driver's weight during operation. The vibration of a heavy duty vehicle seat is largest in the frequency range between 2 Hz and 4 Hz, in the vertical direction; therefore, it is reasonable to focus on controlling low frequency vibration amplitudes and maintain the seat suspensions passivity at high frequency. Moreover, both the simulation and experimental results show that the active seat suspension with the proposed controller can effectively isolate unwanted vibration amplitudes below 4.5 Hz, when compared with a well-tuned passive seat suspension. The active controller has been further validated under bump and random road tests with both a 55 kg and a 70 kg loads. The bump road test demonstrated the controller has good transient response capabilities. The random road test result has been presented both in the time domain and the frequency domain. When with the above two loads, the controlled seat suspensions root-mean-square (RMS) accelerations were reduced by 45.5% and 49.5%, respectively, compared with a well-tuned passive seat suspension. The proposed active seat suspension controller has great potential and is very practical for application

  13. Using statistical process control to make data-based clinical decisions.

    PubMed

    Pfadt, A; Wheeler, D J

    1995-01-01

    Applied behavior analysis is based on an investigation of variability due to interrelationships among antecedents, behavior, and consequences. This permits testable hypotheses about the causes of behavior as well as for the course of treatment to be evaluated empirically. Such information provides corrective feedback for making data-based clinical decisions. This paper considers how a different approach to the analysis of variability based on the writings of Walter Shewart and W. Edwards Deming in the area of industrial quality control helps to achieve similar objectives. Statistical process control (SPC) was developed to implement a process of continual product improvement while achieving compliance with production standards and other requirements for promoting customer satisfaction. SPC involves the use of simple statistical tools, such as histograms and control charts, as well as problem-solving techniques, such as flow charts, cause-and-effect diagrams, and Pareto charts, to implement Deming's management philosophy. These data-analytic procedures can be incorporated into a human service organization to help to achieve its stated objectives in a manner that leads to continuous improvement in the functioning of the clients who are its customers. Examples are provided to illustrate how SPC procedures can be used to analyze behavioral data. Issues related to the application of these tools for making data-based clinical decisions and for creating an organizational climate that promotes their routine use in applied settings are also considered.

  14. Nonlinear disturbance observer based sliding mode control of a cable-driven rehabilitation robot.

    PubMed

    Niu, Jie; Yang, Qianqian; Chen, Guangtao; Song, Rong

    2017-07-01

    This paper introduces a cable-driven robot for upper-limb rehabilitation. Kinematic and dynamic of this rehabilitation robot is analyzed. A sliding mode controller combined with a nonlinear disturbance observer is proposed to control this robot in the presence of disturbances. Simulation is carried out to prove the effectiveness of the proposed control scheme, and the results of the proposed controller is compared with a PID controller and a traditional sliding mode controller. Results show that the proposed controller can effectively improve the tracking performance as compared with the other two controllers and cause lower chattering as compared with a traditional sliding mode controller.

  15. Relations of Anxiety Sensitivity, Control Beliefs, and Maternal Over-Control to Fears in Clinic-Referred Children with Specific Phobia

    PubMed Central

    Kane, Elisabeth J; Braunstein, Kara; Ollendick, Thomas H.; Muris, Peter

    2014-01-01

    The relations of fear to anxiety sensitivity, control beliefs, and maternal overprotection were examined in 126 7- to 13-year-old clinically referred children with specific phobias. Results indicated that anxiety sensitivity and control beliefs were significant predictors of children’s fear levels, accounting for approximately 48% of the total variance. Unexpectedly, age, gender, and maternal overprotection did not emerge as significant predictors of fear in the overall sample. In subsequent analyses, anxiety sensitivity was found to be a consistent, significant predictor for both girls and boys, for both younger and older children, and for children with and without an additional anxiety disorder diagnosis. Control beliefs were only a significant predictor for girls, younger children, and children with an additional anxiety diagnosis. Maternal overprotection was not a significant predictor for any group. Children with an additional anxiety disorder diagnosis had higher levels of fear, anxiety sensitivity, and maternal overprotection, as well as lower levels of control beliefs than the non-additional anxiety disorder subgroup. Future directions and clinical implications are explored. PMID:26273182

  16. Relations of Anxiety Sensitivity, Control Beliefs, and Maternal Over-Control to Fears in Clinic-Referred Children with Specific Phobia.

    PubMed

    Kane, Elisabeth J; Braunstein, Kara; Ollendick, Thomas H; Muris, Peter

    2015-07-01

    The relations of fear to anxiety sensitivity, control beliefs, and maternal overprotection were examined in 126 7- to 13-year-old clinically referred children with specific phobias. Results indicated that anxiety sensitivity and control beliefs were significant predictors of children's fear levels, accounting for approximately 48% of the total variance. Unexpectedly, age, gender, and maternal overprotection did not emerge as significant predictors of fear in the overall sample. In subsequent analyses, anxiety sensitivity was found to be a consistent, significant predictor for both girls and boys, for both younger and older children, and for children with and without an additional anxiety disorder diagnosis. Control beliefs were only a significant predictor for girls, younger children, and children with an additional anxiety diagnosis. Maternal overprotection was not a significant predictor for any group. Children with an additional anxiety disorder diagnosis had higher levels of fear, anxiety sensitivity, and maternal overprotection, as well as lower levels of control beliefs than the non-additional anxiety disorder subgroup. Future directions and clinical implications are explored.

  17. A randomized, controlled clinical trial of intravenous lipid emulsion as an adjunctive treatment for permethrin toxicosis in cats.

    PubMed

    Peacock, Rachel E; Hosgood, Giselle; Swindells, Katrin L; Smart, Lisa

    2015-01-01

    To assess for any clinical benefit of intravenous lipid emulsion (ILE) for permethrin toxicosis in cats by comparing the progression of clinical signs of cats before and after treatment with ILE to cats treated with a saline control. To accomplish this objective, a clinical staging system for cats with permethrin toxicosis was developed and validated. Prospective, multicenter, randomized, controlled clinical trial. University veterinary teaching hospital and 12 private veterinary emergency hospitals. Thirty-four client-owned cats with permethrin toxicosis. A clinical staging system was designed based on abnormalities found on physical examination of cats with permethrin toxicosis. The clinical staging system had 6 stages, ranging from Stage A for cats with no abnormalities to Stage F for cats with grand mal seizures. The system was validated for intraviewer and interviewer variability. Cats in the clinical trial were randomized to receive 15 mL/kg of either intravenous 0.9% saline (control) or 20% ILE over 60 minutes. For each cat, a clinical stage was recorded at set time points before and after the randomized treatment was administered. The distribution of clinical stage stratified over time was compared across treatment groups. The clinical staging system showed excellent repeatability (P = 1.0) and reliability (P = 1.0). In the clinical trial, there was a significant difference in the distribution of clinical stages over time (P < 0.001) and from presentation stage to Stage B (P = 0.006), with ILE-treated cats (n = 20) having lower clinical stages earlier than control cats (n = 14). There was no significant difference in signalment, body weight, or supportive treatment between the groups. The clinical staging system was repeatable and reliable. Clinical stages of permethrin toxicosis in ILE-treated cats improved earlier compared to control cats, suggesting ILE may be a useful adjunctive therapy in the treatment of permethrin toxicosis in cats. © Veterinary

  18. Clinical Signs and Blood Test Results Among Humans Infected With Zoonotic Simian Foamy Virus: A Case-Control Study.

    PubMed

    Buseyne, Florence; Betsem, Edouard; Montange, Thomas; Njouom, Richard; Bilounga Ndongo, Chanceline; Hermine, Olivier; Gessain, Antoine

    2018-06-05

    A spillover of simian foamy virus (SFV) to humans, following bites from infected nonhuman primates (NHPs), is ongoing in exposed populations. These retroviruses establish persistent infections of unknown physiological consequences to the human host. We performed a case-control study to compare 24 Cameroonian hunters infected with gorilla SFV and 24 controls matched for age and ethnicity. A complete physical examination and blood test were performed for all participants. Logistic regression and Wilcoxon signed rank tests were used to compare cases and controls. The cases had significantly lower levels of hemoglobin than the controls (median, 12.7 vs 14.4 g/dL; P = .01). Basophil levels were also significantly lower in cases than controls, with no differences for other leukocyte subsets. Cases had significantly higher urea, creatinine, protein, creatinine phosphokinase, and lactate dehydrogenase levels and lower bilirubin levels than controls. Cases and controls had similar frequencies of general, cutaneous, gastrointestinal, neurological, and cardiorespiratory signs. The first case-control study of apparently healthy SFV-infected Cameroonian hunters showed the presence of hematological abnormalities. A thorough clinical and laboratory workup is now needed to establish the medical relevance of these observations because more than half of cases had mild or moderate anemia. NCT03225794.

  19. Repurposing historical control clinical trial data to provide safety context.

    PubMed

    Bhuyan, Prakash; Desai, Jigar; Louis, Matthew St; Carlsson, Martin; Bowen, Edward; Danielson, Mark; Cantor, Michael N

    2016-02-01

    Billions of dollars spent, millions of subject-hours of clinical trial experience and an abundance of archived study-level data, yet why are historical data underutilized? We propose that historical data can be aggregated to provide safety, background incidence rate and context to improve the evaluation of new medicinal products. Here, we describe the development and application of the eControls database, which is derived from the control arms of studies of licensed products, and discuss the challenges and potential solutions to the proper application of historical data to help interpret product safety. Copyright © 2015 Elsevier Ltd. All rights reserved.

  20. Impact of bariatric surgery on clinical depression. Interrupted time series study with matched controls.

    PubMed

    Booth, Helen; Khan, Omar; Prevost, A Toby; Reddy, Marcus; Charlton, Judith; Gulliford, Martin C

    2015-03-15

    Obesity is associated with depression. This study aimed to evaluate whether clinical depression is reduced after bariatric surgery (BS). Obese adults who received BS procedures from 2002 to 2014 were sampled from the UK Clinical Practice Research Datalink. An interrupted time series design, with matched controls, was conducted from three years before, to a maximum of seven years after surgery. Controls were matched for body mass index (BMI), age, gender and year of procedure. Clinical depression was defined as a medical diagnosis recorded in year, or an antidepressant prescribed in year to a participant ever diagnosed with depression. Adjusted odds ratios (AOR) were estimated. There were 3045 participants (mean age 45.9; mean BMI 44.0kg/m(2)) who received BS, including laparoscopic gastric banding in 1297 (43%), gastric bypass in 1265 (42%), sleeve gastrectomy in 477 (16%) and six undefined. Before surgery, 36% of BS participants, and 21% of controls, had clinical depression; between-group AOR, 2.02, 95%CI 1.75-2.33, P<0.001. In the second post-operative year 32% had depression; AOR, compared to time without surgery, 0.83 (0.76-0.90, P<0.001). By the seventh year, the prevalence of depression increased to 37%; AOR 0.99 (0.76-1.29, P=0.959). Despite matching there were differences in depression between BS and control patients, representing the highly selective nature of BS. Depression is frequent among individuals selected to undergo bariatric surgery. Bariatric surgery may be associated with a modest reduction in clinical depression over the initial post-operative years but this is not maintained. Copyright © 2014 The Authors. Published by Elsevier B.V. All rights reserved.

  1. Calculation of controllability and observability matrices for special case of continuous-time multi-order fractional systems.

    PubMed

    Hassanzadeh, Iman; Tabatabaei, Mohammad

    2017-03-28

    In this paper, controllability and observability matrices for pseudo upper or lower triangular multi-order fractional systems are derived. It is demonstrated that these systems are controllable and observable if and only if their controllability and observability matrices are full rank. In other words, the rank of these matrices should be equal to the inner dimension of their corresponding state space realizations. To reduce the computational complexities, these matrices are converted to simplified matrices with smaller dimensions. Numerical examples are provided to show the usefulness of the mentioned matrices for controllability and observability analysis of this case of multi-order fractional systems. These examples clarify that the duality concept is not necessarily true for these special systems. Copyright © 2017 ISA. Published by Elsevier Ltd. All rights reserved.

  2. 78 FR 59064 - Importer of Controlled Substances; Notice of Application; Fisher Clinical Services, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-25

    ... DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; Fisher Clinical Services, Inc. Pursuant to Title 21 Code of Federal Regulations (CFR) 1301.34 (a), this is notice that on June 21, 2013, Fisher Clinical Services, Inc., 7554 Schantz Road, Allentown...

  3. High co-occurrence of anorectal chlamydia with urogenital chlamydia in women visiting an STI clinic revealed by routine universal testing in an observational study; a recommendation towards a better anorectal chlamydia control in women.

    PubMed

    van Liere, Geneviève A F S; Hoebe, Christian J P A; Wolffs, Petra F G; Dukers-Muijrers, Nicole H T M

    2014-05-19

    Symptom- and sexual history-based testing i.e., testing on indication, for anorectal sexually transmitted infections (STIs) in women is common. Yet, it is unknown whether this strategy is effective. Moreover, little is known about alternative transmission routes i.e. by fingers/toys. This study assesses anorectal STI prevalence and infections missed by current testing practice, thereby informing the optimal control strategy for anorectal STIs in women. Women (n = 663) attending our STI-clinic between May 2012-July 2013 were offered routine testing for anorectal and urogenital Chlamydia trachomatis and Neisseria gonorrhoeae. Data were collected on demographics, sexual behaviour and symptoms. Women were assigned to one of the categories: indication (reported anal sex/symptoms), fingers/toys (only reported use of fingers/toys), or without indication. Of women, 92% (n = 654) participated. There were 203 reports (31.0%) of anal sex and/or symptoms (indication), 48 reports (7.3%) of only using fingers/toys (fingers/toys), and 403 reports (61.6%) of no anal symptoms, no anal sex and no anal use of fingers/toys (without indication). The overall prevalence was 11.2% (73/654) for urogenital chlamydia and 8.4% (55/654) for anorectal chlamydia. Gonorrhoea infections were not observed. Prevalence of anorectal chlamydia was 7.9% (16/203) for women with indication and 8.6% (39/451) for all other women (P = 0.74). Two-thirds (39/55) of anorectal infections were diagnosed in women without indication. Isolated anorectal chlamydia was rare (n = 3): of all women with an anorectal infection, 94.5% (52/55) also had co-occurrence of urogenital chlamydia. Of all women with urogenital chlamydia, 71.2% (52/73) also had anorectal chlamydia. Current selective testing on indication of symptoms and sexual history is not an appropriate control strategy for anorectal chlamydia in women visiting an STI clinic. Routine universal anorectal testing is feasible and may be a possible

  4. High co-occurrence of anorectal chlamydia with urogenital chlamydia in women visiting an STI clinic revealed by routine universal testing in an observational study; a recommendation towards a better anorectal chlamydia control in women

    PubMed Central

    2014-01-01

    Background Symptom- and sexual history-based testing i.e., testing on indication, for anorectal sexually transmitted infections (STIs) in women is common. Yet, it is unknown whether this strategy is effective. Moreover, little is known about alternative transmission routes i.e. by fingers/toys. This study assesses anorectal STI prevalence and infections missed by current testing practice, thereby informing the optimal control strategy for anorectal STIs in women. Methods Women (n = 663) attending our STI-clinic between May 2012-July 2013 were offered routine testing for anorectal and urogenital Chlamydia trachomatis and Neisseria gonorrhoeae. Data were collected on demographics, sexual behaviour and symptoms. Women were assigned to one of the categories: indication (reported anal sex/symptoms), fingers/toys (only reported use of fingers/toys), or without indication. Results Of women, 92% (n = 654) participated. There were 203 reports (31.0%) of anal sex and/or symptoms (indication), 48 reports (7.3%) of only using fingers/toys (fingers/toys), and 403 reports (61.6%) of no anal symptoms, no anal sex and no anal use of fingers/toys (without indication). The overall prevalence was 11.2% (73/654) for urogenital chlamydia and 8.4% (55/654) for anorectal chlamydia. Gonorrhoea infections were not observed. Prevalence of anorectal chlamydia was 7.9% (16/203) for women with indication and 8.6% (39/451) for all other women (P = 0.74). Two-thirds (39/55) of anorectal infections were diagnosed in women without indication. Isolated anorectal chlamydia was rare (n = 3): of all women with an anorectal infection, 94.5% (52/55) also had co-occurrence of urogenital chlamydia. Of all women with urogenital chlamydia, 71.2% (52/73) also had anorectal chlamydia. Conclusions Current selective testing on indication of symptoms and sexual history is not an appropriate control strategy for anorectal chlamydia in women visiting an STI clinic. Routine universal anorectal

  5. Green tea (Camellia sinensis) for patients with knee osteoarthritis: A randomized open-label active-controlled clinical trial.

    PubMed

    Hashempur, Mohammad Hashem; Sadrneshin, Sara; Mosavat, Seyed Hamdollah; Ashraf, Alireza

    2018-02-01

    Green tea is known as a dietary supplement and a novel functional food worldwide. Since there are increasing preclinical evidence about efficacy of green tea for treating osteoarthritis, this study has aimed at assessing its efficacy and safety for patients with knee osteoarthritis. This is a randomized open-label active-controlled clinical trial. As many as fifty adults with osteoarthritis of knee were randomly allocated to receive the green tea extract (in dosage form of tablet) plus diclofenac tablet as "intervention group"; or: diclofenac tablet alone as "control group" for a period of four weeks. Patients were assessed at the beginning of intervention, and then 4 weeks later, in terms of pain score via visual analogue scale (VAS), and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire's total score in addition to its 3 sub-scores. Furthermore, they were asked about any adverse effects during intervention period. Mean differences of VAS pain, total WOMAC, and WOMAC physical function scores in green tea group showed a significant reduction, compared with the control group (P = 0.038, P = 0.006, and P = 0.004, respectively). However, No significant differences between the two groups were observed, regarding mean differences of WOMAC pain and stiffness scores of the enrolled patients (P = 0.163, and P = 0.150, respectively). Additionally, only 1 patient reported gastric upset [in control group]. It seems that green tea extract might well be considered as an adjunctive treatment both for control of pain and for the betterment of knee joint physical function in adults with osteoarthritis. However, further studies of longer duration and larger sample size are needed. Copyright © 2016 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  6. Assessing validity of observational intervention studies – the Benchmarking Controlled Trials

    PubMed Central

    Malmivaara, Antti

    2016-01-01

    Abstract Background: Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations. Aims: To create and pilot test a checklist for appraising methodological validity of a BCT. Methods: The checklist was created by extracting the most essential elements from the comprehensive set of criteria in the previous paper on BCTs. Also checklists and scientific papers on observational studies and respective systematic reviews were utilized. Ten BCTs published in the Lancet and in the New England Journal of Medicine were used to assess feasibility of the created checklist. Results: The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies. Conclusions: The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies. However, the piloted checklist should be validated in further studies.Key messagesBenchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations.This paper presents a checklist for appraising methodological validity of BCTs and pilot-tests the checklist with ten BCTs published in leading medical journals. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies.The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies. PMID:27238631

  7. [Clinical application of moving cupping therapy based on skin reaction observation and syndrome differentiation].

    PubMed

    Deng, Xiao-Lan; Chen, Bo; Chen, Ze-Lin

    2014-12-01

    The diagnostic evidence on clinical diseases and theoretic basis of moving cupping therapy were ex- plored in the paper. By the observation of the local reaction, such as skin appearance and color, the affected location, duration of sickness and nature of disease were judged. Different moving cupping methods were selected for different disorders. It was discovered that the property of syndromes should be recognized by the palpation on skin and muscle in the moving cupping therapy so that the pathogenesis and treating principle could be carefully determined. The moving cupping therapy is the important component of body surface therapy. Skin reaction observation and syndrome differentiation is the essential guidance of the moving cupping therapy.

  8. Full-order Luenberger observer based on fuzzy-logic control for sensorless field-oriented control of a single-sided linear induction motor.

    PubMed

    Holakooie, Mohammad Hosein; Ojaghi, Mansour; Taheri, Asghar

    2016-01-01

    This paper investigates sensorless indirect field oriented control (IFOC) of SLIM with full-order Luenberger observer. The dynamic equations of SLIM are first elaborated to draw full-order Luenberger observer with some simplifying assumption. The observer gain matrix is derived from conventional procedure so that observer poles are proportional to SLIM poles to ensure the stability of system for wide range of linear speed. The operation of observer is significantly impressed by adaptive scheme. A fuzzy logic control (FLC) is proposed as adaptive scheme to estimate linear speed using speed tuning signal. The parameters of FLC are tuned using an off-line method through chaotic optimization algorithm (COA). The performance of the proposed observer is verified by both numerical simulation and real-time hardware-in-the-loop (HIL) implementation. Moreover, a detailed comparative study among proposed and other speed observers is obtained under different operation conditions. Copyright © 2015 ISA. Published by Elsevier Ltd. All rights reserved.

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

    PubMed

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

    2014-08-01

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

  10. [Clinical observation on treatment of oligospermia and asthenospermia with Liuwu Shengjing Decoction].

    PubMed

    Guo, Jun; Song, Chun-sheng; Geng, Qiang

    2007-11-01

    To investigate the clinical efficacy and safety of Liuwu Shengjing Decoction (LWD) in treating oligospermia and asthenospermia. One hundred and fourteen patients were randomized into two groups, the treated group administrated with self-formulated LWD, and the control group administrated with Wuzi Yanzong Pill (WYP). All were treated for 3 months. Patients' semen was analyzed before and after treatment, and the therapeutic efficacy was evaluated. The total effective rate was 94.8% in the treated group, with a partner pregnant rate of 8.6% (5/58), while in the control group, they were 85.7% and 5.4% (3/56) respectively. The efficacy in the treated group was better (P = 0.03). Patients' sperm count and viability of sperm were improved in both groups (P < 0.05 or P < 0.01), but the improvement in the treated group was superior (P < 0.05). LWD could effectively improve the condition of male infertility with oligospermia and asthenospermia.

  11. Assuring Quality Control of Clinical Education in Multiple Clinical Affiliates.

    ERIC Educational Resources Information Center

    Davis, Judith A.

    A plan was developed to assure equivalency of clinical education among the medical laboratory technician (MLT) programs affiliated with Sandhills Community College. The plan was designed by faculty to monitor the quality of clinical courses offered by the clinical affiliates. The major strategies were to develop competencies, slide/tape modules, a…

  12. Knowledge, compliance with good clinical practices and barriers to effective control of postoperative pain among nurses from hospitals with and without a "Hospital without Pain" certificate.

    PubMed

    Tomaszek, Lucyna; Dębska, Grażyna

    2018-04-01

    (i) To compare knowledge and compliance with good clinical practices regarding control of postoperative pain among nurses employed at hospitals with and without a "Hospital without Pain" certificate, (ii) to identify the determinants of nurses' knowledge and (iii) to define barriers to effective control of postoperative pain. Only a slight improvement in postoperative pain control has been observed recently, if any. Implementation of good clinical practices in the control of postoperative pain requires involvement of nurses. A cross-sectional study. The study included 257 nurses from hospitals with a "Hospital without Pain" certificate and 243 nurses from noncertified hospitals, with mean job seniority of 17.6 ± 9.6 years. All respondents answered 26 questions regarding postoperative pain control-related issues. Based on the answers, overall scores were calculated for (i) nurses' knowledge, (ii) compliance with good clinical practices and (iii) barriers to effective control of postoperative pain. Nurses from the certified hospitals presented with significantly higher levels of knowledge and compliance with good clinical practices and identified significantly more barriers to effective control of postoperative pain. Apart from certification of a hospital, better knowledge of postoperative pain control was determined by higher education, participation in postgraduate training programmes and other relevant courses, self-education from medical journals, employment at paediatric ward or intensive care unit. The most commonly reported barriers to effective control of pain included too low doses of painkillers prescribed by physicians and inability to modify the protocol of pain treatment by the nurse. Control of postoperative pain can be improved by enrolling nurses in various forms of continuous training and by providing them with greater autonomy in administering painkillers to surgical patients. Better quality of care offered to patients with postoperative pain

  13. 78 FR 54913 - Importer of Controlled Substances; Notice of Application; Clinical Supplies Management, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-06

    ... DEPARTMENT OF JUSTICE Drug Enforcement Administration Importer of Controlled Substances; Notice of Application; Clinical Supplies Management, Inc. Pursuant to Title 21 Code of Federal Regulations 1301.34 (a), this is notice that on July 22, 2013, Clinical Supplies Management, Inc., 342 42nd Street South, Fargo...

  14. Internal hydraulic control in the Little Belt, Denmark - observations of flow configurations and water mass formation

    NASA Astrophysics Data System (ADS)

    Holtegaard Nielsen, Morten; Vang, Torben; Chresten Lund-Hansen, Lars

    2017-12-01

    Internal hydraulic control, which occurs when stratified water masses are forced through an abrupt constriction, plays an enormous role in nature on both large and regional scales with respect to dynamics, circulation, and water mass formation. Despite a growing literature on this subject surprisingly few direct observations have been made that conclusively show the existence of and the circumstances related to internal hydraulic control in nature. In this study we present observations from the Little Belt, Denmark, one of three narrow straits connecting the Baltic Sea and the North Sea. The observations (comprised primarily of along-strait, detailed transects of salinity and temperature; continuous observations of flow velocity, salinity, and temperature at a permanent station; and numerous vertical profiles of salinity, temperature, fluorescence, and flow velocity in various locations) show that internal hydraulic control is a frequently occurring phenomenon in the Little Belt. The observations, which are limited to south-going flows of approximately two-layered water masses, show that internal hydraulic control may take either of two configurations, i.e. the lower or the upper layer being the active, accelerating one. This is connected to the depth of the pycnocline on the upstream side and the topography, which is both deepening and contracting toward the narrow part of the Little Belt. The existence of two possible flow configurations is known from theoretical and laboratory studies, but we believe that this has never been observed in nature and reported before. The water masses formed by the intense mixing, which is tightly connected with the presence of control, may be found far downstream of the point of control. The observations show that these particular water masses are associated with chlorophyll concentrations that are considerably higher than in adjacent water masses, showing that control has a considerable influence on the primary production and

  15. ICARUS study: prevalence and clinical features of impulse control disorders in Parkinson's disease.

    PubMed

    Antonini, Angelo; Barone, Paolo; Bonuccelli, Ubaldo; Annoni, Karin; Asgharnejad, Mahnaz; Stanzione, Paolo

    2017-04-01

    Impulse control disorders/other compulsive behaviours ('ICD behaviours') occur in Parkinson's disease (PD), but prospective studies are scarce, and prevalence and clinical characteristics of patients are insufficiently defined. To assess the presence of ICD behaviours over a 2-year period, and evaluate patients' clinical characteristics. A prospective, non-interventional, multicentre study (ICARUS (Impulse Control disorders And the association of neuRopsychiatric symptoms, cognition and qUality of life in ParkinSon disease); SP0990) in treated Italian PD outpatients. Study visits: baseline, year 1, year 2. Surrogate primary variable: presence of ICD behaviours and five ICD subtypes assessed by modified Minnesota Impulsive Disorder Interview (mMIDI). 1069/1095 (97.6%) patients comprised the Full Analysis Set. Point prevalence of ICD behaviours (mMIDI; primary analysis) was stable across visits: 28.6% (306/1069) at baseline, 29.3% (292/995) at year 1, 26.5% (245/925) at year 2. The most prevalent subtype was compulsive eating, followed by punding, compulsive sexual behaviour, gambling and buying disorder. Patients who were ICD positive at baseline were more likely to be male, younger, younger at PD onset, have longer disease duration, more severe non-motor symptoms (including mood and sexual function), depressive symptoms, sleep impairment and poorer PD-related quality of life. However, they did not differ from the ICD-negative patients in their severity of PD functional disability, motor performance and cognitive function. Prevalence of ICD behaviours was relatively stable across the 2-year observational period. ICD-positive patients had more severe depression, poorer sleep quality and reduced quality of life. © 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.

  16. Observer design for compensation of network-induced delays in integrated communication and control systems

    NASA Technical Reports Server (NTRS)

    Luck, R.; Ray, A.

    1988-01-01

    A method for compensating the effects of network-induced delays in integrated communication and control systems (ICCS) is proposed, and a finite-dimensional time-invariant ICCS model is developed. The problem of analyzing systems with time-varying and stochastic delays is circumvented by the application of a deterministic observer. For the case of controller-to-actuator delays, the observed design must rely on an extended model which represents the delays as additional states.

  17. Observational therapeutics: Scope, challenges, and organization.

    PubMed

    Vaidya, Rama

    2011-10-01

    The importance of Observational Therapeutics in the progress of medicine has been neglected in the current era of the hierarchal position imparted to Randomized Controlled Trials (RCTs) for new drug discovery and practice of evidence-based medicine. There is a need to reflect on the reason for many new drugs being withdrawn during post marketing surveillance. There are several examples in literature where drug-discovery has originated initially from keen clinical and / or laboratory observations. The roots of these discoveries have often been from observations made by practitioners of traditional medicine including Ayurveda. The present article draws attention to the scope and challenges for observational therapeutics. There is an urgent need for the meticulous planning for a systematic organization of developing observational therapeutics, with a full understanding of its strengths and limitations.

  18. Clinical characteristics and pregnancy outcomes of Syrian refugees: a case-control study in a tertiary care hospital in Istanbul, Turkey.

    PubMed

    Erenel, Hakan; Aydogan Mathyk, Begum; Sal, Veysel; Ayhan, Isil; Karatas, Suat; Koc Bebek, Arzu

    2017-01-01

    We aimed to compare the clinical characteristics and pregnancy outcomes in women who are Syrian refugees and Turkish women who are non-refugees at a maternity center in Istanbul, Turkey. A total of 600 singleton pregnancies who delivered at Sisli Hamidiye Etfal Training and Research Hospital were included in the study. Demographic data, obstetrical history, clinical findings, obstetrical and neonatal outcomes were compared between 300 Syrian refugees and 300 control patients. The Syrian refugee patients were significantly younger than Turkish patients. The percentage of adolescents aged 12-19 years were significantly higher in the Syrian patients (14.3 vs. 5.3 %, p < 0,001). 41.3 % of the refugee patients had no antenatal care. However, this ratio was only 7.7 % for the control group (p < 0.001). Preterm birth rates showed no difference between the groups, however, postterm birth rates were significantly higher in the control group. Low Birthweight (<2500 gr), oligohydramnios, stillbirth and fetal anomaly rates were not different between the two groups. In comparison to non-refugee control patients, refugee women in our study had poor antenatal care but no adverse perinatal outcomes were observed. Further larger multicenter studies may provide more convincing data about obstetric outcomes in the Syrian refugee population as well as adolescent pregnancies in this population.

  19. Franklin, Lavoisier, and Mesmer: origin of the controlled clinical trial.

    PubMed

    Herr, Harry W

    2005-01-01

    In 1784, a Royal Commission headed by Benjamin Franklin and Antoine Lavoisier designed a series of ingenious experiments to debunk France's greatest medical rogue, Anton Mesmer, and his bizarre healing of illnesses based on his bogus theory of animal magnetism. Using intentional subject ignorance and sham interventions to investigate mesmerism, Franklin's commission provided a model for the controlled clinical trial.

  20. Ear Acupuncture Therapy for Masticatory Myofascial and Temporomandibular Pain: A Controlled Clinical Trial.

    PubMed

    Ferreira, Luciano Ambrosio; Grossmann, Eduardo; Januzzi, Eduardo; Gonçalves, Rafael Tardin Rosa Ferraz; Mares, Fernando Antonio Guedes; de Paula, Marcos Vinicius Queiroz; Carvalho, Antonio Carlos Pires

    2015-01-01

    Ear acupuncture works by reducing painful sensations with analgesic effect through microsystem therapy and has been demonstrated to be as effective as conventional therapies in the control of facial pain. This clinical trial aimed to evaluate the adjuvant action of auricular acupuncture through an observation of the evolution of temporomandibular and masticatory myofascial symptoms in two groups defined by the therapies elected: auricular acupuncture associated with occlusal splint (study) and the use of the occlusal splint plate alone (control). We have selected 20 patients, who were randomly allocated into two groups of ten individuals. Symptoms were evaluated in five different moments, every seven days. We analyzed the orofacial muscle and joint palpation in order to measure the intensity of the experienced pain. Both groups showed a statistically significant decrease in muscle and joint symptoms (p < 0.05). However, comparisons between the groups showed an expressive and significant reduction of symptomatology in the study group (p < 0.05) already on the first week of therapy. According to the results, to the methodological criteria developed and statistical analysis applied, the conclusion is that auricular acupuncture therapy has synergistic action on conventional occlusal splint treatment. It was demonstrated to be effective in the reduction of symptoms in the short term.

  1. Ear Acupuncture Therapy for Masticatory Myofascial and Temporomandibular Pain: A Controlled Clinical Trial

    PubMed Central

    Ferreira, Luciano Ambrosio; Grossmann, Eduardo; Januzzi, Eduardo; Gonçalves, Rafael Tardin Rosa Ferraz; Mares, Fernando Antonio Guedes; de Paula, Marcos Vinicius Queiroz; Carvalho, Antonio Carlos Pires

    2015-01-01

    Ear acupuncture works by reducing painful sensations with analgesic effect through microsystem therapy and has been demonstrated to be as effective as conventional therapies in the control of facial pain. This clinical trial aimed to evaluate the adjuvant action of auricular acupuncture through an observation of the evolution of temporomandibular and masticatory myofascial symptoms in two groups defined by the therapies elected: auricular acupuncture associated with occlusal splint (study) and the use of the occlusal splint plate alone (control). We have selected 20 patients, who were randomly allocated into two groups of ten individuals. Symptoms were evaluated in five different moments, every seven days. We analyzed the orofacial muscle and joint palpation in order to measure the intensity of the experienced pain. Both groups showed a statistically significant decrease in muscle and joint symptoms (p < 0.05). However, comparisons between the groups showed an expressive and significant reduction of symptomatology in the study group (p < 0.05) already on the first week of therapy. According to the results, to the methodological criteria developed and statistical analysis applied, the conclusion is that auricular acupuncture therapy has synergistic action on conventional occlusal splint treatment. It was demonstrated to be effective in the reduction of symptoms in the short term. PMID:26351510

  2. [Clinical efficacy of special effect san xiao decoction on type 2 diabetes mellitus].

    PubMed

    Li, Zhi-Qiang; Chang, Hong-Juan; Sang, Wen-Feng

    2013-01-01

    To investigate the clinical efficacies of the special effect San Xiao decoction on type 2 diabetes mellitus and its impact on inflammatory factors. 116 patients with type 2 diabetes mellitus were randomly divided into control group and observation group from Aug. 2010 to Aug. 2012, and each group had 58 cases. Both of the two groups were given the conventional basic treatment and 0.5 g/time, oral, 2 times/d of metformin. The observation group was received 1 dose/d of special effect San Xiao decoction on the basis of the basic treatment, and the treatment course was 12 weeks. The fasting blood glucose (FBG), 2h postprandial blood glucose (PBG), glycosylated hemoglobin (HbA1c), tumor necrosis factor-alpha (TNF-alpha), interleukin-6 ( IL-6) and c-reactive protein (CRP) were observed after the treatment. The FBG, PBG, HbA1c and insulin sensitive index (ISI) of the observation group were better than those of the control group (P < 0.05 or P < 0.01); BMI and body weight of the observation group were lower than those of the control group (P < 0.05); The blood sugar control effect of the observation group was better than that of the control group (P < 0.05); The hypoglycemia incidence of the observation group was lower than that of the control group (P < 0.01); TNF-alpha, IL-6 and CRP of the observation group were lower than those of the control group (P < 0.01). The clinical efficacy of the special effect San Xiao decoction on type 2 diabetes mellitus is significant, it has the role of alleviating inflammatory response for diabetes and it also has less adverse reactions, which is worth to be applied in clinical.

  3. The role of clinical toxicologists and poison control centers in public health.

    PubMed

    Sutter, Mark E; Bronstein, Alvin C; Heard, Stuart E; Barthold, Claudia L; Lando, James; Lewis, Lauren S; Schier, Joshua G

    2010-06-01

    Poison control centers and clinical toxicologists serve many roles within public health; however, the degree to which these entities collaborate is unknown. The objective of this survey was to identify successful collaborations of public health agencies with clinical toxicologists and poison control centers. Four areas including outbreak identification, syndromic surveillance, terrorism preparedness, and daily public health responsibilities amenable to poison control center resources were assessed. An online survey was sent to the directors of poison control centers, state epidemiologists, and the most senior public health official in each state and selected major metropolitan areas. This survey focused on three areas: service, structure within the local or state public health system, and remuneration. Questions regarding remuneration and poison control center location within the public health structure were asked to assess if these were critical factors of successful collaborations. Senior state and local public health officials were excluded because of a low response rate. The survey was completed in October 2007. A total of 111 respondents, 61 poison control centers and 50 state epidemiologists, were eligible for the survey. Sixty-nine (62%) of the 111 respondents, completed and returned the survey. Thirty-three (54%) of the 61 poison control centers responded, and 36 of the 50 state epidemiologists (72%) responded. The most frequent collaborations were terrorism preparedness and epidemic illness reporting. Additional collaborations also exist. Important collaborations exist outside of remuneration or poison control centers being a formal part of the public health structure. Poison control centers have expanded their efforts to include outbreak identification, syndromic surveillance, terrorism preparedness, and daily public health responsibilities amenable to poison control center resources. Collaboration in these areas and others should be expanded. Published

  4. Accuracy of electronic implant torque controllers following time in clinical service.

    PubMed

    Mitrani, R; Nicholls, J I; Phillips, K M; Ma, T

    2001-01-01

    Tightening of the screws in implant-supported restorations has been reported to be problematic, in that if the applied torque is too low, screw loosening occurs. If the torque is too high, then screw fracture can take place. Thus, accuracy of the torque driver is of the utmost importance. This study evaluated 4 new electronic torque drivers (controls) and 10 test electronic torque drivers, which had been in clinical service for a minimum of 5 years. Torque values of the test drivers were measured and were compared with the control values using a 1-way analysis of variance. Torque delivery accuracy was measured using a technique that simulated the clinical situation. In vivo, the torque driver turns the screw until the selected tightening torque is reached. In this laboratory experiment, an implant, along with an attached abutment and abutment gold screw, was held firmly in a Tohnichi torque gauge. Calibration accuracy for the Tohnichi is +/- 3% of the scale value. During torque measurement, the gold screw turned a minimum of 180 degrees before contact was made between the screw and abutment. Three torque values (10, 20, and 32 N-cm) were evaluated, at both high- and low-speed settings. The recorded torque measurements indicated that the 10 test electronic torque drivers maintained a torque delivery accuracy equivalent to the 4 new (unused) units. Judging from the torque output values obtained from the 10 test units, the clinical use of the electronic torque driver suggests that accuracy did not change significantly over the 5-year period of clinical service.

  5. 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.

  6. 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

  7. The role and potential contribution of clinical research nurses to clinical trials.

    PubMed

    Spilsbury, Karen; Petherick, Emily; Cullum, Nicky; Nelson, Andrea; Nixon, Jane; Mason, Su

    2008-02-01

    This study explores the scope and potential contribution of the Clinical Research Nurse (CRN) role to clinical trials of a nursing-specific topic. Over the past two decades, there have been increases in the numbers of nurses working as CRNs because of the increasing global demand for clinical trials. CRNs can influence the quality of clinical trials but the scope and contribution of the role to clinical trials is not known. Qualitative focus group study. A focus group interview was carried out with CRNs (n = 9) employed on a large, multi-centre (six NHS Trusts) randomized controlled trial of pressure area care. The focus group interview was recorded, alongside field notes of participant interactions and behaviours, and transcribed verbatim. Data were analysed for thematic content and process. CRNs described their transition to a clinical research role. They reported a lack of confidence, role conflict as researcher and nurse, the challenges of gaining cooperation of clinical nursing staff to comply with trial protocols and difficulties maintaining their own motivation. CRNs provided their perceptions and observations of pressure area care and prevention. They identified areas of inadequate treatment, management and care, influenced by organizational and clinical aspects of care delivery. The study reveals challenges associated with training and management of CRNs. CRNs are usually associated with trial recruitment and data collection. This study highlights the additional contributions of CRNs for the study of topics specific to nursing as the result of their unique placement in the research centres as informal 'participant observers.' Such observations enhance understanding of the contexts being studied. These findings are relevant to the design and conduct of research studies of nursing care and practice and present ways for investigators to optimize the skills and knowledge of nurses working as CRNs.

  8. The clinical spectrum of Erdheim-Chester disease: an observational cohort study

    PubMed Central

    O’Brien, Kevin J.; Xi, Liqiang; Malayeri, Ashkan A.; Gardner, Pamela J.; Alvarado Enriquez, Jhonell R.; Shah, Nikeith; Gochuico, Bernadette R.; Raffeld, Mark; Gahl, William A.

    2017-01-01

    Erdheim-Chester disease (ECD) is a rare, potentially fatal multiorgan myeloid neoplasm occurring mainly in adults. The diagnosis is established by clinical, radiologic, and histologic findings; ECD tumors contain foamy macrophages that are CD68+, CD163+, CD1a−, and frequently S100−. The purpose of this report is to describe the clinical and molecular variability of ECD. Between 2011 and 2015, 60 consecutive ECD patients (45 males, 15 females) were prospectively evaluated at the National Institutes of Health Clinical Center. Comprehensive imaging and laboratory studies were performed, and tissues were examined for BRAF V600E and MAPK pathway mutations. Mean age at first manifestations of ECD was 46 years; a diagnosis was established, on average, 4.2 years after initial presentation. Bone was the most common tissue affected, with osteosclerosis in 95% of patients. Other manifestations observed in one-third to two-thirds of patients included cardiac mass and periaortic involvement, diabetes insipidus, retro-orbital infiltration, retroperitoneal, lung, central nervous system, skin, and xanthelasma, affecting patients in variable ways. Methods of detection included imaging studies of various modalities. Mutation in BRAF V600E was detected in 51% of 57 biopsy specimens. One patient had an ARAF D228V mutation, and 1 patient had an activating ALK fusion. Treatments included interferon α, imatinib, anakinra, cladribine, vemurafenib, and dabrafenib with trametinib; 11 patients received no therapy. The diagnosis of ECD is elusive because of the rarity and varied presentations of the disorder. Identification of BRAF and other MAPK pathway mutations in biopsy specimens improves ECD diagnosis, allows for development of targeted treatments, and demonstrates that ECD is a neoplastic disorder. This study was registered at www.clinicaltrials.gov as #NCT01417520. PMID:28553668

  9. Significance of clinical observations and biochemical alterations in buffalo calves with dietary abomasal impaction.

    PubMed

    El-Ashker, Maged R; Salama, Mohamed F; El-Boshy, Mohamed E; Abo El-Fadle, Eman A

    2018-01-02

    The present study aimed to throw light on the clinical characteristics of abomasal impaction in buffalo calves and its associated biochemical alterations. For this reason, a total of 20 male buffalo calves (Bubalus bubalis) with abomasal impaction were studied. The investigated calves were at 6 to 12 months of age and were belonged to three private farms in Dakahlia Governorate besides sporadic cases admitted to the Veterinary Teaching Hospital, Faculty of Veterinary Medicine, Mansoura University, Egypt. Ten apparently healthy buffalo calves were also included as controls. According to the clinical outcome, the diseased calves were categorized into survivors (n = 11) and non-survivors (n = 9). Blood samples were collected from all animals to estimate blood gases besides a panel of selected biochemical parameters. The definitive diagnosis of dietary abomasal impaction was achieved by either left flank exploratory laparotomy or by necropsy. Both survivors and non-survivors demonstrated common clinical findings including distension of ventro-lateral aspect of the right abdomen, and varying degrees of dehydration. The great majority of survivors (81%) and 100% of non-survivors were anorexic and had rumen stasis as well as hard texture upon ballottement of the left flank. Approximately 45% of non-survivors had frothy salivation, expiratory grunting and were being tender when strong percussion was applied on the right flank. Diseased calves had metabolic alkalosis, while plasma potassium and chloride were significantly lower in non-survivors than those of survivors (P < 0.05). Serum malondialdehyde, superoxide dismutase and uric acid were significantly higher in diseased buffalo than controls and in non-survivors than survivors (P < 0.05). Serum total protein, albumin, creatinine, urea, aspartate aminotransferase, gamma-glutamyl transferase, and total bilirubin levels were also higher in non-survivors than those of survivors (P < 0.05). Buffalo

  10. The role of observational investigations in comparative effectiveness research.

    PubMed

    Marko, Nicholas F; Weil, Robert J

    2010-12-01

    Comparative effectiveness research (CER) seeks to inform clinical decisions between alternate treatment strategies using data that reflects real patient populations and real-world clinical scenarios for the purpose of improving patient outcomes. There are multiple clinical situations where the unique characteristics of observational investigations can inform medical decision-making within the CER paradigm. Accordingly, it is critical for clinicians to appreciate the strengths and limitations of observational research, particularly as they apply to CER. This review focuses on the role of observational research in CER. We discuss the concept of evidence hierarchies as they relate to observational research and CER, review the scope and nature of observational research, present the rationale for its inclusion in CER investigations, discuss potential sources of bias in observational investigations as well as strategies used to compensate for these biases, and discuss a framework to implement observational research in CER. The CER paradigm recognizes the limitations of hierarchical models of evidence and favors application of a strength-of-evidence model. In this model, observational research fills gaps in randomized clinical trial data and is particularly valuable to investigate effectiveness, harms, prognosis, and infrequent outcomes as well as in circumstances where randomization is not possible and in studies of many surgical populations. Observational investigations must be designed with careful consideration of potential sources of bias and must incorporate strategies to control such bias prospectively, and their results must be reported in a uniform and transparent fashion. When these conditions can be achieved, observational research represents a valuable and critical component of modern CER. © 2010, International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

  11. Extended observer based on adaptive second order sliding mode control for a fixed wing UAV.

    PubMed

    Castañeda, Herman; Salas-Peña, Oscar S; León-Morales, Jesús de

    2017-01-01

    This paper addresses the design of attitude and airspeed controllers for a fixed wing unmanned aerial vehicle. An adaptive second order sliding mode control is proposed for improving performance under different operating conditions and is robust in presence of external disturbances. Moreover, this control does not require the knowledge of disturbance bounds and avoids overestimation of the control gains. Furthermore, in order to implement this controller, an extended observer is designed to estimate unmeasurable states as well as external disturbances. Additionally, sufficient conditions are given to guarantee the closed-loop stability of the observer based control. Finally, using a full 6 degree of freedom model, simulation results are obtained where the performance of the proposed method is compared against active disturbance rejection based on sliding mode control. Copyright © 2016 ISA. Published by Elsevier Ltd. All rights reserved.

  12. Theory of Mind in Schizophrenia: Associations With Clinical and Cognitive Insight Controlling for Levels of Psychopathology.

    PubMed

    Popolo, Raffaele; Dimaggio, Giancarlo; Luther, Lauren; Vinci, Giancarlo; Salvatore, Giampaolo; Lysaker, Paul H

    2016-03-01

    Poor insight in schizophrenia is a risk factor for both poor outcomes and treatment adherence. Accordingly, interest in identifying causes of poor insight has increased. This study explored whether theory of mind (ToM) impairments are linked to poor clinical and cognitive insight independent of psychopathology. Participants with schizophrenia (n = 37) and control subjects (n = 40) completed assessments of ToM with the Hinting Task and the Brüne Picture Sequencing Task, clinical insight and psychopathology with the Positive and Negative Syndrome Scale, and cognitive insight with the Beck Cognitive Insight Scale. Results indicated that the schizophrenia group had greater impairments in ToM relative to control subjects. In the schizophrenia group, the Hinting Task performance was related to both cognitive and clinical insight, with only the relationship with cognitive insight persisting after controlling for psychopathology. Picture Sequencing Task performance was related to cognitive insight only. Future research directions and clinical implications are discussed.

  13. Time to publication for publicly funded clinical trials in Australia: an observational study.

    PubMed

    Strand, Linn Beate; Clarke, Philip; Graves, Nicholas; Barnett, Adrian G

    2017-03-22

    To examine the length of time between receiving funding and publishing the protocol and main paper for randomised controlled trials. An observational study using survival analysis. Publicly funded health and medical research in Australia. Randomised controlled trials funded by the National Health and Medical Research Council of Australia between 2008 and 2010. Time from funding to the protocol paper and main results paper. Multiple variable survival models examining whether study characteristics predicted publication times. We found 77 studies with a total funding of $A59 million. The median time to publication of the protocol paper was 6.4 years after funding (95% CI 4.1 to 8.1). The proportion with a published protocol paper 8 years after funding was 0.61 (95% CI 0.48 to 0.74). The median time to publication of the main results paper was 7.1 years after funding (95% CI 6.3 to 7.6). The proportion with a published main results paper 8 years after funding was 0.72 (95% CI 0.56 to 0.87). The HRs for how study characteristics might influence timing were generally close to one with narrow CIs, the notable exception was that a longer study length lengthened the time to the main paper (HR=0.62 per extra study year, 95% CI 0.43 to 0.89). Despite the widespread registration of clinical trials, there remain serious concerns of trial results not being published or being published with a long delay. We have found that these same concerns apply to protocol papers, which should be publishable soon after funding. Funding agencies could set a target of publishing the protocol paper within 18 months of funding. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  14. Dulce Wireless Tijuana: A Randomized Control Trial Evaluating the Impact of Project Dulce and Short-Term Mobile Technology on Glycemic Control in a Family Medicine Clinic in Northern Mexico.

    PubMed

    Anzaldo-Campos, María Cecilia; Contreras, Sonia; Vargas-Ojeda, Adriana; Menchaca-Díaz, Rufino; Fortmann, Addie; Philis-Tsimikas, Athena

    2016-04-01

    The global epidemic of diabetes calls for innovative interventions. This study evaluated the effectiveness of the Project Dulce model, with and without wireless technology, on glycemic control and other clinical and self-reported outcomes in patients with poorly controlled type 2 diabetes in Mexico. Adults with type 2 diabetes and a glycated hemoglobin A1c (HbA1c) level of ≥8% were recruited from Family Medical Unit #27 of the Instituto Mexicano del Seguro Social (IMSS) in Tijuana, México, and randomly assigned to one of three groups: Project Dulce-only (PD); Project Dulce technology-enhanced with mobile tools (PD-TE); or IMSS standard of care/control group (CG). Clinical and self-reported outcomes were assessed at baseline, Month 4, and Month 10. Time-by-group interactions and within-group changes were analyzed. HbA1c reductions from baseline to Month 10 were significantly greater in PD-TE (-3.0% [-33 mmol/mol]) and PD (-2.6% [-28.7 mmol/mol]) compared with CG (-1.3% [-14.2 mmol/mol]) (P = 0.009 and 0.001, respectively). PD-TE and PD also exhibited significant improvement in diabetes knowledge when compared with CG (P < 0.05 for both). No statistically significant differences were detected between PD and PD-TE on these indicators (P = 0.54 and 0.86, respectively). Several within-group improvements were observed on other clinical and self-report indicators but did not vary significantly across groups. Project Dulce with and without wireless technology substantially improved glycemic control and diabetes knowledge in high-risk patients with type 2 diabetes in a Mexican family medical unit, suggesting that integrating peer-led education, nurse coordination, and 3G wireless technology is an effective approach for improving diabetes outcomes in high-risk populations.

  15. Value-based HR practices, i-deals and clinical error control with CSR as a moderator.

    PubMed

    Luu, Tuan; Rowley, Chris; Siengthai, Sununta; Thanh Thao, Vo

    2017-05-08

    Purpose Notwithstanding the rising magnitude of system factors in patient safety improvement, "human factors" such as idiosyncratic deals (i-deals) which also contribute to the adjustment of system deficiencies should not be neglected. The purpose of this paper is to investigate the role of value-based HR practices in catalyzing i-deals, which then influence clinical error control. The research further examines the moderating role of corporate social responsibility (CSR) on the effect of value-based HR practices on i-deals. Design/methodology/approach The data were collected from middle-level clinicians from hospitals in the Vietnam context. Findings The research results confirmed the effect chain from value-based HR practices through i-deals to clinical error control with CSR as a moderator. Originality/value The HRM literature is expanded through enlisting i-deals and clinical error control as the outcomes of HR practices.

  16. Recommendations for conducting controlled clinical studies of dental restorative materials.

    PubMed

    Hickel, R; Roulet, J-F; Bayne, S; Heintze, S D; Mjör, I A; Peters, M; Rousson, V; Randall, R; Schmalz, G; Tyas, M; Vanherle, G

    2007-03-01

    About 35 years ago, Ryge provided a practical approach to evaluation of clinical performance of restorative materials. This systematic approach was soon universally accepted. While that methodology has served us well, a large number of scientific methodologies and more detailed questions have arisen that require more rigor. Current restorative materials have vastly improved clinical performance and any changes over time are not easily detected by the limited sensitivity of the Ryge criteria in short term clinical investigations. However, the clinical evaluation of restorations not only involves the restorative material per se but also different operative techniques. For instance, a composite resin may show good longevity data when applied in conventional cavities but not in modified operative approaches. Insensitivity, combined with the continually evolving and non-standard investigator modifications of the categories, scales, and reporting methods, has created a body of literature that is extremely difficult to meaningfully interpret. In many cases, the insensitivity of the original Ryge methods is misinterpreted as good clinical performance. While there are many good features of the original system, it is now time to move to a more contemporary one. The current review approaches this challenge in two ways: (1) a proposal for a modern clinical testing protocol for controlled clinical trials, and (2) an in-depth discussion of relevant clinical evaluation parameters, providing 84 references that are primarily related to issues or problems for clinical research trials. Together, these two parts offer a standard for the clinical testing of restorative materials/procedures and provide significant guidance for research teams in the design and conduct of contemporary clinical trials. Part 1 of the review considers the recruitment of subjects, restorations per subject, clinical events, validity versus bias, legal and regulatory aspects, rationales for clinical trial

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

    PubMed

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

    2009-10-01

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

  18. Do Contemporary Randomized Controlled Trials Meet ESMO Thresholds for Meaningful Clinical Benefit?

    PubMed

    Del Paggio, J C; Azariah, B; Sullivan, R; Hopman, W M; James, F V; Roshni, S; Tannock, I F; Booth, C M

    2017-01-01

    The European Society for Medical Oncology (ESMO) recently released a magnitude of clinical benefit scale (ESMO-MCBS) for systemic therapies for solid cancers. Here, we evaluate contemporary randomized controlled trials (RCTs) against the proposed ESMO thresholds for meaningful clinical benefit. RCTs evaluating systemic therapy for breast cancer, nonsmall cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic cancer published 2011-2015 were reviewed. Data were abstracted regarding trial characteristics and outcomes, and these were applied to the ESMO-MCBS. We also determined whether RCTs were designed to detect an effect that would meet clinical benefit as defined by the ESMO-MCBS. About 277 eligible RCTs were included (40% breast, 31% NSCLC, 22% CRC, 6% pancreas). Median sample size was 532 and 83% were funded by industry. Among all 277 RCTs, the experimental therapy was statistically superior to the control arm in 138 (50%) trials: results of only 31% (43/138) of these trials met the ESMO-MCBS clinical benefit threshold. RCTs with curative intent were more likely to meet clinically meaningful thresholds than those with palliative intent [61% (19/31) versus 22% (24/107), P < 0.001]. Among the 226 RCTs for which the ESMO-MCBS could be applied, 31% (70/226) were designed to detect an effect size that could meet ESMO-MCBS thresholds. Less than one-third of contemporary RCTs with statistically significant results meet ESMO thresholds for meaningful clinical benefit, and this represents only 15% of all published trials. Investigators, funding agencies, regulatory agencies, and industry should adopt more stringent thresholds for meaningful benefit in the design of future RCTs. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  19. A Nonlinear Spacecraft Attitude Controller and Observer with an Unknown Constant Gyro Bias and Gyro Noise

    NASA Technical Reports Server (NTRS)

    Deutschmann, Julie; Sanner, Robert M.

    2001-01-01

    A nonlinear control scheme for attitude control of a spacecraft is combined with a nonlinear gyro bias observer for the case of constant gyro bias, in the presence of gyro noise. The observer bias estimates converge exponentially to a mean square bound determined by the standard deviation of the gyro noise. The resulting coupled, closed loop dynamics are proven to be globally stable, with asymptotic tracking which is also mean square bounded. A simulation of the proposed observer-controller design is given for a rigid spacecraft tracking a specified, time-varying attitude sequence to illustrate the theoretical claims.

  20. Aloe vera gel and cesarean wound healing; a randomized controlled clinical trial.

    PubMed

    Molazem, Zahra; Mohseni, Fatemeh; Younesi, Masoumeh; Keshavarzi, Sareh

    2014-08-31

    Failure in complete healing of the wound is one of the probable complications of cesarean. The present study aimed to determine the effectiveness of dressing with aloe vera gel in healing of cesarean wound. This prospective randomized double-blind clinical trial was conducted on 90 women who had undergone cesarean operation in Amir-al-Momenin hospital (Gerash, Iran). The participants were randomly divided into two groups each containing 45 patients. In one group, the wound was dressed with aloe vera gel, while simple dressing was used in the control group. Wound healing was assessed 24 hours and 8 days after the cesarean operation using REEDA scale. The data were analyzed through Chi-square and t-test. The participants' mean age was 27.56±4.20 in the aloe vera group and 26.62±4.88 in the control group, but the difference was not statistically significant. However, a significant difference was found between the two groups concerning body mass index, heart rate, and systolic blood pressure (P<0.05). Also, a significant difference was observed between the two groups with respect to the wound healing score 24 hours after the operation (P=0.003). After 8 days, however, the difference in the wound healing score was not significant (P=0.283). Overall, 45 participants in the aloe vera group and 35 ones in the control group had obtained a zero score 24 hours after the operation. These measures were respectively obtained as 42 and 41eight days after the operation. According to the findings of this study, the women are recommended to be informed regarding the positive effects of dressing with aloe vera gel.

  1. Effect of Massage Therapy on Vital Signs and GCS Scores of ICU Patients: A Randomized Controlled Clinical Trial

    PubMed Central

    Vahedian-Azimi, Amir; Ebadi, Abbas; Asghari Jafarabadi, Mohammad; Saadat, Soheil; Ahmadi, Fazlollah

    2014-01-01

    Background: Unalleviated complications related to hospitalization, including stress, anxiety, and pain, can easily influence different structures, like the neural system, by enhancing the stimulation of sympathetic nervous pathways and causing unstable vital signs and deterioration in the level of consciousness. Objectives: The purpose of this study was to determine the effects of massage therapy by family members on vital signs and Glasgow Coma Scale Score (GCS) of patients hospitalized in the Intensive Care Unit (ICU). Patients and Methods: This randomized controlled clinical trial was conducted at the ICU of the Shariati Hospital during 2012; 45 ICU patients and 45 family members in the experimental group and the same number of patients and family members in the control group were consecutively selected . The data collection instrument consisted of two parts. The first part included demographic data (age, marital status and Body Mass Index) and the second part included a checklist to record the patient’s vital signs (systolic blood pressure (SBP), diastolic blood pressure (DBP), respiratory rate (RR), pulse rate (PR)) and GCS. All measurements were done at the same time in both groups before the intervention (full body massage therapy), and 1 hour, 2 hours, 3 hours, and 4 hours after intervention. The patients were provided with a 60-minute full body massage The massage protocol included static, surface tension, stretching, superficial lymph unload, transverse friction, and myofacial releasing techniques. Results: Significant differences were observed between experimental and control groups in the SBP at 1 hour, SBP 2 hours, and SBP 3 hours, and also in GCS at 1 hour to GCS at 4 hours (P < 0.05). Multivariate analysis revealed a significant difference between experimental and control groups in SBP at all time points (P < 0.05). Conclusions: Massage via family members had several positive effects on the patients’ clinical conditions, and therefore, it should

  2. Clinical Efficacy of Low Molecular Heparin on Unexplained Recurrent Spontaneous Abortion.

    PubMed

    Xu, Guang-Li; Hu, Xiao-Fang; Han, Yong-Mei; Wei, Ai-Wu

    2018-06-01

    To study the clinical effect of low molecular heparin on unexplained recurrent spontaneous abortion (URSA). A total of 120 URSA patients were collected in our hospital from October 2015 to September 2017. They were divided into two groups: control group (n = 60) and observation group (n = 60). The patients in the control group were administered with progesterone and human chorionic gonadotropin, and the observation group with low molecular heparin. Pregnancy outcomes, incidence of complications in pregnancy and adverse drug reactions were compared in the two groups. The pregnancy success rate of patients in the observation group (90.00%) is higher than that in the control group (68.33%) (p < 0.05). The incidence of complications in pregnancy in the observation group (90.00%) is lower than those in the control group (68.33%) (p < 0.05). The incidence of adverse drug reactions between the patients in the observation group (20.00%) and those in the control group (23.33%) showed no significant difference (p > 0.05). Low molecular heparin treatment can improve pregnancy success rate and reduce the incidence of complications in the URSA patients. Low molecular heparin is characterized by safety and reliability and has potential for application in clinic.

  3. Regression-based statistical mediation and moderation analysis in clinical research: Observations, recommendations, and implementation.

    PubMed

    Hayes, Andrew F; Rockwood, Nicholas J

    2017-11-01

    There have been numerous treatments in the clinical research literature about various design, analysis, and interpretation considerations when testing hypotheses about mechanisms and contingencies of effects, popularly known as mediation and moderation analysis. In this paper we address the practice of mediation and moderation analysis using linear regression in the pages of Behaviour Research and Therapy and offer some observations and recommendations, debunk some popular myths, describe some new advances, and provide an example of mediation, moderation, and their integration as conditional process analysis using the PROCESS macro for SPSS and SAS. Our goal is to nudge clinical researchers away from historically significant but increasingly old school approaches toward modifications, revisions, and extensions that characterize more modern thinking about the analysis of the mechanisms and contingencies of effects. Copyright © 2016 Elsevier Ltd. All rights reserved.

  4. Development of Automatic Controller of Brain Temperature Based on the Conditions of Clinical Use

    NASA Astrophysics Data System (ADS)

    Utsuki, Tomohiko; Wakamatsu, Hidetoshi

    A new automatic controller of brain temperature was developed based on the inevitable conditions of its clinical use from the viewpoint of various kinds of feasibility, in particular, electric power consumption of less than 1,500W in ICU. The adaptive algorithm was employed to cope with individual time-varying characteristic change of patients. The controller under water-surface cooling hypothermia requires much power for the frequent regulation of the water temperature of cooling blankets. Thus, in this study, the power consumption of the controller was checked by several kinds of examinations involving the control simulation of brain temperature using a mannequin with thermal characteristics similar to that of adult patients. The required accuracy of therapeutic brain hypothermia, i.e. control deviation within ±0.1C was experimentally confirmed using “root mean square of the control error”, despite the present controller consumes less energy comparing with the one in the case of our conventional controller, where it can still keeps remaining power margin more than 300W even in the full operation. Thereby, the clinically required water temperature was also confirmed within the limit of power supply, thus its practical application is highly expected with less physical burden of medical staff inclusive of more usability and more medical cost performance.

  5. Evaluation of different ranges of LH:FSH ratios in polycystic ovarian syndrome (PCOS) - Clinical based case control study.

    PubMed

    Malini, N A; Roy George, K

    2018-05-01

    Polycystic ovary syndrome (PCOS) is a highly prevalent endocrine and metabolic disorder among reproductive aged women, leading to infertility. One of the common clinical manifestations in PCOS is that there is a difference in the range of LH production in different case of PCOS and accordingly variability in LH:FSH ratio was observed. The aim of the present study was to evaluate different ranges of LH:FSH ratios in PCOS. In this cross sectional study, a consecutive series of 745 women (aged 28.11 ± 0.2) who were subjected to infertility treatment at specialist infertility clinics in central Travancore region were considered. About 50 healthy females (aged 27.58 ± 0.4) with regular menstrual cycles were regarded as control. The data were collected from hospital records using subject's written informed consent. PCOS patients were observed to have different ranges of LH:FSH ratios from < 1 range to 4.6-5.5 and subjects were classified into 7 PCO subgroups on the basis of their LH:FSH ratios. In whole PCO group, body weight, LH, FSH, LH:FSH ratio, insulin, HbA1c, estradiol, testosterone and TSH were significantly (P < .05) increased whereas progesterone and SHBG levels were significantly (P < .05) decreased in comparison to control. In various PCO subgroups as LH levels and LH:FSH ratios were increased, levels of insulin, testosterone and AMH were increased and SHBG levels were decreased accordingly. This finding suggested a dependence of insulin, LH and testosterone in initiating the hormonal imbalances in PCOS. Copyright © 2018 Elsevier Inc. All rights reserved.

  6. Control strategies and noncompliance in abusive mother-child dyads: an observational study.

    PubMed

    Oldershaw, L; Walters, G C; Hall, D K

    1986-06-01

    The present observational study of child abuse has isolated parental control strategies and child response as a promising area of investigation. The social interaction of 10 abusive and 10 matched control mothers and their preschool children was videotaped in a simulated home environment involving both structured and unstructured activities. A coding scheme was developed to record interactional behavior in each dyad. Particular emphasis was placed on the analysis of mother command/child compliance sequences. Compared to controls, abusive mothers employed more commands, and more power-assertive and less positively oriented control strategies. They were also more intrusive, more inconsistent in their use of parenting techniques, displayed more flattened affect throughout their control interactions, and were less flexible in their attempts to gain compliance from the child. In turn, children of abusive mothers demonstrated far more noncompliant behavior than their control counterparts.

  7. Controlled outcome studies of child clinical hypnosis.

    PubMed

    Adinolfi, Barbara; Gava, Nicoletta

    2013-09-01

    Background Hypnosis is defined as "as an interaction in which the hypnotist uses suggested scenarios ("suggestions") to encourage a person's focus of attention to shift towards inner experiences". Aim of the work The focus of this review is to summarize the findings of controlled outcome studies investigating the potential of clinical hypnosis in pediatric populations. We will examine the following themes: anesthesia, acute and chronic pain, chemotherapy-related distress, along with other specific medical issues. Results Hypnosis is an effective method to reduce pain and anxiety before, during and after the administration of anesthetics, during local dental treatments, invasive medical procedures and in burn children. Hypnosis can be successfully used to manage recurrent headaches, abdominal pain, irritable bowel syndrome and chemotherapy-related distress. Hypnosis has an important role in managing symptoms and improving the quality of life of children suffering from asthma and cystic fibrosis and in facilitating the treatment of insomnia in school-age children. Finally, hypnosis can be effectively used for the treatment of some habitual disorders such as nocturnal enuresis and dermatologic conditions, including atopic dermatitis and chronic eczema Conclusions Clinical hypnosis seems to be a useful, cheap and side-effects free tool to manage fear, pain and several kinds of stressful experiences in pediatric populations. Children who receive self-hypnosis trainings achieve significantly greater improvements in their physical health, quality of life, and self-esteem.

  8. Highly Sensitive Assay for Detection of Enterovirus in Clinical Specimens by Reverse Transcription-PCR with an Armored RNA Internal Control

    PubMed Central

    Beld, Marcel; Minnaar, René; Weel, Jan; Sol, Cees; Damen, Marjolein; van der Avoort, Harry; Wertheim-van Dillen, Pauline; Breda, Alex van; Boom, René

    2004-01-01

    The objective of the present study was the development of a diagnostic reverse transcription (RT)-PCR for the specific detection of enterovirus (EV) RNA in clinical specimens controlled by an internal control (IC) RNA. The IC RNA contains the same primer binding sites as EV RNA but has a different probe region. The IC RNA was packaged into an MS2 phage core particle (armored) and was added to the clinical sample to allow monitoring of both extraction efficiency and RT-PCR efficiency. Serial dilutions of the IC RNA were made, and the detection limit of the RT-PCR was tested in a background of EV RNA-negative cerebrospinal fluid. The sensitivity and specificity of the RT-PCR assay were tested by using all 64 known EV serotypes, several non-EV serotypes, and two Quality Control for Molecular Diagnostics (QCMD) Program EV proficiency panels from 2001 and 2002. In total, 322 clinical specimens were tested by RT-PCR, and to establish the clinical utility of the RT-PCR, a comparison of the results of viral culture and RT-PCR was done with 87 clinical specimens. The lower limit of sensitivity was reached at about 150 copies of IC RNA/ml. All 64 EV serotypes were positive, while all non-EV serotypes were negative. All culture-positive samples of the 2001 QCMD proficiency panel (according to the 50% tissue culture infective doses per milliliter) were positive by RT-PCR. Invalid results, i.e., negativity for both EV RNA and IC RNA, due to inhibition of RT-PCR were observed for 33.3% of the members of the 2002 QCMD proficiency panel and 3.1% of the clinical specimens. Inhibition of RT-PCR could be relieved by the addition of 400 ng of bovine α-casein per μl to both the RT reaction mixture and the PCR mixture. With this optimized protocol, the results for all samples of the 2002 QCMD proficiency panel and all clinical specimens except one fecal sample (0.3%) were valid. Evaluation of the clinical samples demonstrated that EV infection could be detected in 12 of 87 samples (13

  9. Disturbance observer based model predictive control for accurate atmospheric entry of spacecraft

    NASA Astrophysics Data System (ADS)

    Wu, Chao; Yang, Jun; Li, Shihua; Li, Qi; Guo, Lei

    2018-05-01

    Facing the complex aerodynamic environment of Mars atmosphere, a composite atmospheric entry trajectory tracking strategy is investigated in this paper. External disturbances, initial states uncertainties and aerodynamic parameters uncertainties are the main problems. The composite strategy is designed to solve these problems and improve the accuracy of Mars atmospheric entry. This strategy includes a model predictive control for optimized trajectory tracking performance, as well as a disturbance observer based feedforward compensation for external disturbances and uncertainties attenuation. 500-run Monte Carlo simulations show that the proposed composite control scheme achieves more precise Mars atmospheric entry (3.8 km parachute deployment point distribution error) than the baseline control scheme (8.4 km) and integral control scheme (5.8 km).

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

    PubMed

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

    2015-07-01

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

  11. Effectiveness of Vildagliptin in Clinical Practice: Pooled Analysis of Three Korean Observational Studies (the VICTORY Study).

    PubMed

    Suh, Sunghwan; Song, Sun Ok; Kim, Jae Hyeon; Cho, Hyungjin; Lee, Woo Je; Lee, Byung-Wan

    2017-01-01

    The present observational study aimed to evaluate the clinical effectiveness of vildagliptin with metformin in Korean patients with type 2 diabetes mellitus (T2DM). Data were pooled from the vildagliptin postmarketing survey (PMS), the vildagliptin/metformin fixed drug combination (DC) PMS, and a retrospective observational study of vildagliptin/metformin (fixed DC or free DC). The effectiveness endpoint was the proportion of patients who achieved a glycemic target (HbA1c) of ≤7.0% at 24 weeks. In total, 4303 patients were included in the analysis; of these, 2087 patients were eligible. The mean patient age was 56.99 ± 11.25 years. Overall, 58.94% patients achieved an HbA1c target of ≤7.0% at 24 weeks. The glycemic target achievement rate was significantly greater in patients with baseline HbA1c < 7.5% versus ≥7.5% (84.64% versus 43.97%), receiving care at the hospital versus clinic (67.95% versus 52.33%), and receiving vildagliptin/metformin fixed DC versus free DC (70.69% versus 55.42%). Multivariate logistic regression analysis indicated that disease duration ( P < 0.0001), baseline HbA1c ( P < 0.0001), and DC type ( P = 0.0103) had significant effects on drug effectiveness. Vildagliptin plus metformin appeared as an effective treatment option for patients with T2DM in clinical practice settings in Korea.

  12. Medication safety research by observational study design.

    PubMed

    Lao, Kim S J; Chui, Celine S L; Man, Kenneth K C; Lau, Wallis C Y; Chan, Esther W; Wong, Ian C K

    2016-06-01

    Observational studies have been recognised to be essential for investigating the safety profile of medications. Numerous observational studies have been conducted on the platform of large population databases, which provide adequate sample size and follow-up length to detect infrequent and/or delayed clinical outcomes. Cohort and case-control are well-accepted traditional methodologies for hypothesis testing, while within-individual study designs are developing and evolving, addressing previous known methodological limitations to reduce confounding and bias. Respective examples of observational studies of different study designs using medical databases are shown. Methodology characteristics, study assumptions, strengths and weaknesses of each method are discussed in this review.

  13. Leveraging Disturbance Observer Based Torque Control for Improved Impedance Rendering with Series Elastic Actuators

    NASA Technical Reports Server (NTRS)

    Mehling, Joshua S.; Holley, James; O'Malley, Marcia K.

    2015-01-01

    The fidelity with which series elastic actuators (SEAs) render desired impedances is important. Numerous approaches to SEA impedance control have been developed under the premise that high-precision actuator torque control is a prerequisite. Indeed, the design of an inner torque compensator has a significant impact on actuator impedance rendering. The disturbance observer (DOB) based torque control implemented in NASA's Valkyrie robot is considered here and a mathematical model of this torque control, cascaded with an outer impedance compensator, is constructed. While previous work has examined the impact a disturbance observer has on torque control performance, little has been done regarding DOBs and impedance rendering accuracy. Both simulation and a series of experiments are used to demonstrate the significant improvements possible in an SEA's ability to render desired dynamic behaviors when utilizing a DOB. Actuator transparency at low impedances is improved, closed loop hysteresis is reduced, and the actuator's dynamic response to both commands and interaction torques more faithfully matches that of the desired model. All of this is achieved by leveraging DOB based control rather than increasing compensator gains, thus making improved SEA impedance control easier to achieve in practice.

  14. Sliding mode based trajectory linearization control for hypersonic reentry vehicle via extended disturbance observer.

    PubMed

    Xingling, Shao; Honglun, Wang

    2014-11-01

    This paper proposes a novel hybrid control framework by combing observer-based sliding mode control (SMC) with trajectory linearization control (TLC) for hypersonic reentry vehicle (HRV) attitude tracking problem. First, fewer control consumption is achieved using nonlinear tracking differentiator (TD) in the attitude loop. Second, a novel SMC that employs extended disturbance observer (EDO) to counteract the effect of uncertainties using a new sliding surface which includes the estimation error is integrated to address the tracking error stabilization issues in the attitude and angular rate loop, respectively. In addition, new results associated with EDO are examined in terms of dynamic response and noise-tolerant performance, as well as estimation accuracy. The key feature of the proposed compound control approach is that chattering free tracking performance with high accuracy can be ensured for HRV in the presence of multiple uncertainties under control constraints. Based on finite time convergence stability theory, the stability of the resulting closed-loop system is well established. Also, comparisons and extensive simulation results are presented to demonstrate the effectiveness of the control strategy. Copyright © 2014 ISA. Published by Elsevier Ltd. All rights reserved.

  15. Increasing the clinical efficacy of NK and antibody-mediated cancer immunotherapy: potential predictors of successful clinical outcome based on observations in high-risk neuroblastoma.

    PubMed

    Koehn, Tony A; Trimble, Lori L; Alderson, Kory L; Erbe, Amy K; McDowell, Kimberly A; Grzywacz, Bartosz; Hank, Jacquelyn A; Sondel, Paul M

    2012-01-01

    Disease recurrence is frequent in high-risk neuroblastoma (NBL) patients even after multi-modality aggressive treatment [a combination of chemotherapy, surgical resection, local radiation therapy, autologous stem cell transplantation, and cis-retinoic acid (CRA)]. Recent clinical studies have explored the use of monoclonal antibodies (mAbs) that bind to disialoganglioside (GD(2)), highly expressed in NBL, as a means to enable immune effector cells to destroy NBL cells via antibody-dependent cell-mediated cytotoxicity (ADCC). Preclinical data indicate that ADCC can be more effective when appropriate effector cells are activated by cytokines. Clinical studies have pursued this by administering anti-GD(2) mAb in combination with ADCC-enhancing cytokines (IL2 and GM-CSF), a regimen that has demonstrated improved cancer-free survival. More recently, early clinical studies have used a fusion protein that consists of the anti-GD(2) mAb directly linked to IL2, and anti-tumor responses were seen in the Phase II setting. Analyses of genes that code for receptors that influence ADCC activity and natural killer (NK) cell function [Fc receptor (FcR), killer immunoglublin-like receptor (KIR), and KIR-ligand (KIR-L)] suggest patients with anti-tumor activity are more likely to have certain genotype profiles. Further analyses will need to be conducted to determine whether these genotypes can be used as predictive markers for favorable therapeutic outcome. In this review, we discuss factors that affect response to mAb-based tumor therapies such as hu14.18-IL2. Many of our observations have been made in the context of NBL; however, we will also include some observations made with mAbs targeting other tumor types that are consistent with results in NBL. Therefore, we hypothesize that the NBL observations discussed here may also be relevant to mAb therapy for other cancers, in which ADCC is known to play a role.

  16. Full-order observer for direct torque control of induction motor based on constant V/F control technique.

    PubMed

    Pimkumwong, Narongrit; Wang, Ming-Shyan

    2018-02-01

    This paper presents another control method for the three-phase induction motor that is direct torque control based on constant voltage per frequency control technique. This method uses the magnitude of stator flux and torque errors to generate the stator voltage and phase angle references for controlling the induction motor by using constant voltage per frequency control method. Instead of hysteresis comparators and optimum switching table, the PI controllers and space vector modulation technique are used to reduce torque and stator-flux ripples and achieve constant switching frequency. Moreover, the coordinate transformations are not required. To implement this control method, a full-order observer is used to estimate stator flux and overcome the problems from drift and saturation in using pure integrator. The feedback gains are designed by simple manner to improve the convergence of stator flux estimation, especially in low speed range. Furthermore, the necessary conditions to maintain the stability for feedback gain design are introduced. The simulation and experimental results show accurate and stable operation of the introduced estimator and good dynamic response of the proposed control method. Copyright © 2017 ISA. Published by Elsevier Ltd. All rights reserved.

  17. Family-based therapy for dementia caregivers: clinical observations

    PubMed Central

    MITRANI, V. B.; CZAJA, S. J.

    2008-01-01

    Family caregiving for dementia patients is a major social and clinical problem. Family caregivers face major stressful emotional, social and economic burdens, and the negative consequences associated with caregiving are well documented. Given the projected increase in the number of people with dementia, there is a need to identify approaches that will help families manage the challenges of caregiving. Social support from friends and family members has consistently been found to mediate caregiver outcomes, yet many caregivers face problems with isolation and estrangement from family members. In this regard, family-based therapy is a promising intervention for increasing social support for caregivers, and enhancing their quality of life and ability to provide care.This paper will discuss how family-based therapy can be applied as an intervention for family caregivers of dementia patients.The clinical implications of specific interactional patterns will be presented via case examples from an ongoing clinical trial with white American and Cuban American caregivers of dementia patients.The intent is to demonstrate how identification of interactional patterns is a valuable tool for implementing family-based interventions. PMID:18548132

  18. Utilization of Positive and Negative Controls to Examine Comorbid Associations in Observational Database Studies.

    PubMed

    Desai, Jigar R; Hyde, Craig L; Kabadi, Shaum; St Louis, Matthew; Bonato, Vinicius; Katrina Loomis, A; Galaznik, Aaron; Berger, Marc L

    2017-03-01

    Opportunities to leverage observational data for precision medicine research are hampered by underlying sources of bias and paucity of methods to handle resulting uncertainty. We outline an approach to account for bias in identifying comorbid associations between 2 rare genetic disorders and type 2 diabetes (T2D) by applying a positive and negative control disease paradigm. Association between 10 common and 2 rare genetic disorders [Hereditary Fructose Intolerance (HFI) and α-1 antitrypsin deficiency] and T2D was compared with the association between T2D and 7 negative control diseases with no established relationship with T2D in 4 observational databases. Negative controls were used to estimate how much bias and variance existed in datasets when no effect should be observed. Unadjusted association for common and rare genetic disorders and T2D was positive and variable in magnitude and distribution in all 4 databases. However, association between negative controls and T2D was 200% greater than expected indicating the magnitude and confidence intervals for comorbid associations are sensitive to systematic bias. A meta-analysis using this method demonstrated a significant association between HFI and T2D but not for α-1 antitrypsin deficiency. For observational studies, when covariate data are limited or ambiguous, positive and negative controls provide a method to account for the broadest level of systematic bias, heterogeneity, and uncertainty. This provides greater confidence in assessing associations between diseases and comorbidities. Using this approach we were able to demonstrate an association between HFI and T2D. Leveraging real-world databases is a promising approach to identify and corroborate potential targets for precision medicine therapies.

  19. Palliative care team visits. Qualitative study through participant observation.

    PubMed

    Alfaya Góngora, Maria Del Mar; Bueno Pernias, Maria José; Hueso Montoro, César; Guardia Mancilla, Plácido; Montoya Juárez, Rafael; García Caro, Maria Paz

    2016-03-30

    To describe the clinical encounters that occur when a palliative care team provides patient care and the features that influence these encounters and indicate whether they are favorable or unfavorable depending on the expectations and feelings of the various participants. A qualitative case study conducted via participant observation. A total of 12 observations of the meetings of palliative care teams with patients and families in different settings (home, hospital and consultation room) were performed. The visits were follow-up or first visits, either scheduled or on demand. Content analysis of the observation was performed. The analysis showed the normal follow-up activity of the palliative care unit that was focused on controlling symptoms, sharing information and providing advice on therapeutic regimens and care. The environment appeared to condition the patients' expressions and the type of patient relationship. Favorable clinical encounter conditions included kindness and gratitude. Unfavorable conditions were deterioration caused by approaching death, unrealistic family objectives and limited resources. Home visits from basic palliative care teams play an important role in patient and family well-being. The visits seem to focus on controlling symptoms and are conditioned by available resources.

  20. Palliative care team visits. Qualitative study through participant observation

    PubMed Central

    Bueno Pernias, Maria José; Hueso Montoro, César; Guardia Mancilla, Plácido; Montoya Juárez, Rafael; García Caro, Maria Paz

    2016-01-01

    Objectives: To describe the clinical encounters that occur when a palliative care team provides patient care and the features that influence these encounters and indicate whether they are favorable or unfavorable depending on the expectations and feelings of the various participants. Methods: A qualitative case study conducted via participant observation. A total of 12 observations of the meetings of palliative care teams with patients and families in different settings (home, hospital and consultation room) were performed. The visits were follow-up or first visits, either scheduled or on demand. Content analysis of the observation was performed. Results: The analysis showed the normal follow-up activity of the palliative care unit that was focused on controlling symptoms, sharing information and providing advice on therapeutic regimens and care. The environment appeared to condition the patients' expressions and the type of patient relationship. Favorable clinical encounter conditions included kindness and gratitude. Unfavorable conditions were deterioration caused by approaching death, unrealistic family objectives and limited resources. Conclusion: Home visits from basic palliative care teams play an important role in patient and family well-being. The visits seem to focus on controlling symptoms and are conditioned by available resources. PMID:27226663

  1. Cognitive control level of action for analyzing verbal reports in educative clinical simulation situations.

    PubMed

    Morineau, Thierry; Meineri, Sebastien; Chapelain, Pascal

    2017-03-01

    Several methods and theoretical frameworks have been proposed for efficient debriefing after clinical simulation sessions. In these studies, however, the cognitive processes underlying the debriefing stage are not directly addressed. Cognitive control constitutes a conceptual link between behavior and reflection on behavior to apprehend debriefing cognitively. Our goal was to analyze cognitive control from verbal reports using the Skill-Rule-Knowledge model. This model considers different cognitive control levels from skill-based to rule-based and knowledge-based control. An experiment was conducted with teams of nursing students who were confronted with emergency scenarios during high-fidelity simulation sessions. Participants' descriptions of their actions were asked in the course of the simulation scenarios or during the debriefing stage. 52 nursing students working in 26 pairs participated in this study. Participants were divided into two groups: an "in situ" group in which they had to describe their actions at different moments of a deteriorating patient scenario, and a "debriefing" group, in which, at the same moments, they had to describe their actions displayed on a video recording. In addition to a cognitive analysis, the teams' clinical performance was measured. The cognitive control level in the debriefing group was generally higher than in the in situ group. Good team performance was associated with a high level of cognitive control after a patient's significant state deterioration. These findings are in conformity with the "Skill-Rule-Knowledge" model. The debriefing stage allows a deeper reflection on action compared with the in situ condition. If an abnormal event occurs as an adverse event, then participants' mental processes tend to migrate towards knowledge-based control. This migration particularly concerns students with the best clinical performance. Thus, this cognitive framework can help to strengthen the analysis of verbal reports. Copyright

  2. [Multicenter randomized controlled clinical study on levornidazole and sodium chloride injection in the treatment of pelvic anaerobic infections].

    PubMed

    Ma, Ling; Zhang, Yuan-Zhen; Zheng, Yi-Lin; Wang, Ze-Hua; Xu, You-di; Kong, Li-Na

    2010-10-01

    to evaluate clinical efficacy and safety of levornidazole in the treatment of pelvic anaerobic infections. a multicenter randomized controlled clinical study was conducted to evaluate clinical efficacy and safety of levornidazole. One hundred and fourty-three patients with pelvic anaerobic bacteria infection were classified into 70 cases treated by levornidazole in study group and 73 cases treated by Ornidazole in control group. Those patients in two groups were both administered at a dose of 0.5 g twice daily for 5 - 7 days. The rate of clinical efficacy, bacteria clearance and adverse effect were recorded and compared between two groups. at the endpoint, the rate of clinical efficacy were 80% (56/70) in study group and 81% (59/73) in control group, which did not reach significant difference (P > 0.05). The rate of bacteria clearance were 97% (36/37) in study group and 92% (22/24) in control group, which also did not reach significant difference (P > 0.05). The rate of adverse reaction of 3% (20/70) in study group was significantly lower than 22% (16/73) in control group (P < 0.05). it is effective and safe to treat pelvic anaerobic infections with levornidazole and sodium chloride injection.

  3. Assessment of Clinical Effect of Perioperative Comprehensive Nursing Intervention Pattern in 23G Minimally Invasive Vitreous Surgery.

    PubMed

    Shen, Jie; Li, Su-Yan; Wang, Jian-Yu; Chen, Jing; Wang, Wen

    2016-01-01

    We observed the clinical effects of comprehensive nursing intervention pattern in 23G minimally invasive vitreous surgery according to the comprehensive nursing intervention table developed by our hospital, which would supply a basis for its clinical application. In this prospective study, we followed 120 patients undergoing 23G minimally invasive vitreous surgery from Xuzhou First People's Hospital from February 2013 to February 2015 and divided them into control and observation groups by a random number table (60 patients in each group). A regular nursing pattern was adopted for the control group, and a comprehensive nursing intervention pattern was adopted for the observation group. After that, a comparative analysis was made to identify the differences between the clinical effects of the two groups. Scores of cognition ratio, patient compliance and comfort level of patients in the observation group were higher than those of the control group were, and there was significant difference between the groups (P< 0.05). Complication incidence of the observation group is significantly lower than that of the control group (P<0.05). The comprehensive nursing intervention pattern developed by our hospital can improve clinical effects notably, which is of application value .We recommend it to be applied in eye diseases.

  4. Sliding mode control for Mars entry based on extended state observer

    NASA Astrophysics Data System (ADS)

    Lu, Kunfeng; Xia, Yuanqing; Shen, Ganghui; Yu, Chunmei; Zhou, Liuyu; Zhang, Lijun

    2017-11-01

    This paper addresses high-precision Mars entry guidance and control approach via sliding mode control (SMC) and Extended State Observer (ESO). First, differential flatness (DF) approach is applied to the dynamic equations of the entry vehicle to represent the state variables more conveniently. Then, the presented SMC law can guarantee the property of finite-time convergence of tracking error, which requires no information on high uncertainties that are estimated by ESO, and the rigorous proof of tracking error convergence is given. Finally, Monte Carlo simulation results are presented to demonstrate the effectiveness of the suggested approach.

  5. Benchmarking Controlled Trial--a novel concept covering all observational effectiveness studies.

    PubMed

    Malmivaara, Antti

    2015-06-01

    The Benchmarking Controlled Trial (BCT) is a novel concept which covers all observational studies aiming to assess effectiveness. BCTs provide evidence of the comparative effectiveness between health service providers, and of effectiveness due to particular features of the health and social care systems. BCTs complement randomized controlled trials (RCTs) as the sources of evidence on effectiveness. This paper presents a definition of the BCT; compares the position of BCTs in assessing effectiveness with that of RCTs; presents a checklist for assessing methodological validity of a BCT; and pilot-tests the checklist with BCTs published recently in the leading medical journals.

  6. Benchmarking Controlled Trial—a novel concept covering all observational effectiveness studies

    PubMed Central

    Malmivaara, Antti

    2015-01-01

    Abstract The Benchmarking Controlled Trial (BCT) is a novel concept which covers all observational studies aiming to assess effectiveness. BCTs provide evidence of the comparative effectiveness between health service providers, and of effectiveness due to particular features of the health and social care systems. BCTs complement randomized controlled trials (RCTs) as the sources of evidence on effectiveness. This paper presents a definition of the BCT; compares the position of BCTs in assessing effectiveness with that of RCTs; presents a checklist for assessing methodological validity of a BCT; and pilot-tests the checklist with BCTs published recently in the leading medical journals. PMID:25965700

  7. Linear Extended State Observer-Based Motion Synchronization Control for Hybrid Actuation System of More Electric Aircraft.

    PubMed

    Wang, Xingjian; Liao, Rui; Shi, Cun; Wang, Shaoping

    2017-10-25

    Moving towards the more electric aircraft (MEA), a hybrid actuator configuration provides an opportunity to introduce electromechanical actuator (EMA) into primary flight control. In the hybrid actuation system (HAS), an electro-hydraulic servo actuator (EHSA) and an EMA operate on the same control surface. In order to solve force fighting problem in HAS, this paper proposes a novel linear extended state observer (LESO)-based motion synchronization control method. To cope with the problem of unavailability of the state signals required by the motion synchronization controller, LESO is designed for EHSA and EMA to observe the state variables. Based on the observed states of LESO, motion synchronization controllers could enable EHSA and EMA to simultaneously track the desired motion trajectories. Additionally, nonlinearities, uncertainties and unknown disturbances as well as the coupling term between EHSA and EMA can be estimated and compensated by using the extended state of the proposed LESO. Finally, comparative simulation results indicate that the proposed LESO-based motion synchronization controller could reduce significant force fighting between EHSA and EMA.

  8. Linear Extended State Observer-Based Motion Synchronization Control for Hybrid Actuation System of More Electric Aircraft

    PubMed Central

    Liao, Rui; Shi, Cun; Wang, Shaoping

    2017-01-01

    Moving towards the more electric aircraft (MEA), a hybrid actuator configuration provides an opportunity to introduce electromechanical actuator (EMA) into primary flight control. In the hybrid actuation system (HAS), an electro-hydraulic servo actuator (EHSA) and an EMA operate on the same control surface. In order to solve force fighting problem in HAS, this paper proposes a novel linear extended state observer (LESO)-based motion synchronization control method. To cope with the problem of unavailability of the state signals required by the motion synchronization controller, LESO is designed for EHSA and EMA to observe the state variables. Based on the observed states of LESO, motion synchronization controllers could enable EHSA and EMA to simultaneously track the desired motion trajectories. Additionally, nonlinearities, uncertainties and unknown disturbances as well as the coupling term between EHSA and EMA can be estimated and compensated by using the extended state of the proposed LESO. Finally, comparative simulation results indicate that the proposed LESO-based motion synchronization controller could reduce significant force fighting between EHSA and EMA. PMID:29068392

  9. Clinical management issues vary by specialty in the Victorian Audit of Surgical Mortality: a retrospective observational study

    PubMed Central

    Vinluan, Jessele; Retegan, Claudia; Chen, Andrew; Beiles, Charles Barry

    2014-01-01

    Objective Clinical management issues are contributory factors to mortality. The aim of this study was to use data from the Victorian Audit of Surgical Mortality (VASM), an educational peer-review process for surgeons, to discover differences in the incidence of these issues between surgical specialties in order to focus attention to areas of care that might be improved. Design This study used retrospectively analysed observational data from VASM. Clinical management issues between eight specialties were assessed using χ2 analysis. Data sources VASM data were reported by participating public and private health services, the Coroner and self-reporting surgeons across Victoria. Results A total of 2946 specific clinical issues as deficiencies of care were reported. 15% of cases had significant issues of care. The most common clinical management issue was the delay in delivery of treatment. Other clinical issues included the quality of communication and documentation, preoperative and postoperative care, adverse events and protocol issues. There were significant differences in issues between specialties. Conclusions The clinical management issues presented across surgical specialties were similar; however, five issues of clinical care differed significantly in frequency across surgical specialties. The three main issues varying among specialties were complications after operation, communication and postoperative care. Addressing these clinical management issues via the peer-review process may impact positively on patient care. PMID:24980043

  10. Placebo Devices as Effective Control Methods in Acupuncture Clinical Trials: A Systematic Review

    PubMed Central

    Zhang, Claire Shuiqing; Tan, Hsiewe Ying; Zhang, George Shengxi; Zhang, Anthony Lin; Xue, Charlie Changli; Xie, Yi Min

    2015-01-01

    While the use of acupuncture has been recognised by the World Health Organisation, its efficacy for many of the common clinical conditions is still undergoing validation through randomised controlled trials (RCTs). A credible placebo control for such RCTs to enable meaningful evaluation of its efficacy is to be established. While several non-penetrating acupuncture placebo devices, namely the Streitberger, the Park and the Takakura Devices, have been developed and used in RCTs, their suitability as inert placebo controls needs to be rigorously determined. This article systematically reviews these devices as placebo interventions. Electronic searches were conducted on four English and two Chinese databases from their inceptions to July 2014; hand searches of relevant references were also conducted. RCTs, in English or Chinese language, comparing acupuncture with one of the aforementioned devices as the control intervention on human participants with any clinical condition and evaluating clinically related outcomes were included. Thirty-six studies were included for qualitative analysis while 14 were in the meta-analysis. The meta-analysis does not support the notion of either the Streitberger or the Park Device being inert control interventions while none of the studies involving the Takakura Device was included in the meta-analysis. Sixteen studies reported the occurrence of adverse events, with no significant difference between verum and placebo acupuncture. Author-reported blinding credibility showed that participant blinding was successful in most cases; however, when blinding index was calculated, only one study, which utilised the Park Device, seemed to have an ideal blinding scenario. Although the blinding index could not be calculated for the Takakura Device, it was the only device reported to enable practitioner blinding. There are limitations with each of the placebo devices and more rigorous studies are needed to further evaluate their effects and

  11. Design of clinical trials involving multiple hypothesis tests with a common control.

    PubMed

    Schou, I Manjula; Marschner, Ian C

    2017-07-01

    Randomized clinical trials comparing several treatments to a common control are often reported in the medical literature. For example, multiple experimental treatments may be compared with placebo, or in combination therapy trials, a combination therapy may be compared with each of its constituent monotherapies. Such trials are typically designed using a balanced approach in which equal numbers of individuals are randomized to each arm, however, this can result in an inefficient use of resources. We provide a unified framework and new theoretical results for optimal design of such single-control multiple-comparator studies. We consider variance optimal designs based on D-, A-, and E-optimality criteria, using a general model that allows for heteroscedasticity and a range of effect measures that include both continuous and binary outcomes. We demonstrate the sensitivity of these designs to the type of optimality criterion by showing that the optimal allocation ratios are systematically ordered according to the optimality criterion. Given this sensitivity to the optimality criterion, we argue that power optimality is a more suitable approach when designing clinical trials where testing is the objective. Weighted variance optimal designs are also discussed, which, like power optimal designs, allow the treatment difference to play a major role in determining allocation ratios. We illustrate our methods using two real clinical trial examples taken from the medical literature. Some recommendations on the use of optimal designs in single-control multiple-comparator trials are also provided. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  12. Religion, Spirituality, and Medicine: Psychiatrists’ and Other Physicians’ Differing Observations, Interpretations, and Clinical Approaches

    PubMed Central

    Curlin, Farr A.; Lawrence, Ryan E.; Odell, Shaun; Chin, Marshall H.; Lantos, John D.; Koenig, Harold G.; Meador, Keith G.

    2010-01-01

    Objective This study compared the ways in which psychiatrists and nonpsychiatrists interpret the relationship between religion/spirituality and health and address religion/spirituality issues in the clinical encounter. Method The authors mailed a survey to a stratified random sample of 2,000 practicing U.S. physicians, with an oversampling of psychiatrists. The authors asked the physicians about their beliefs and observations regarding the relationship between religion/spirituality and patient health and about the ways in which they address religion/spirituality in the clinical setting. Results A total of 1,144 physicians completed the survey. Psychiatrists generally endorse positive influences of religion/spirituality on health, but they are more likely than other physicians to note that religion/spirituality sometimes causes negative emotions that lead to increased patient suffering (82% versus 44%). Compared to other physicians, psychiatrists are more likely to encounter religion/spirituality issues in clinical settings (92% versus 74% report their patients sometimes or often mention religion/spirituality issues), and they are more open to addressing religion/spirituality issues with patients (93% versus 53% say that it is usually or always appropriate to inquire about religion/spirituality). Conclusions This study suggests that the vast majority of psychiatrists appreciate the importance of religion and/or spirituality at least at a functional level. Compared to other physicians, psychiatrists also appear to be more comfortable, and have more experience, addressing religion/spirituality concerns in the clinical setting. PMID:18056237

  13. The clinical features of angular cheilitis occurring during orthodontic treatment: a multi-centre observational study.

    PubMed

    Cross, David; Eide, May L; Kotinas, Anastasios

    2010-06-01

    To report the prevalence and clinical features of angular cheilitis occurring in patients undergoing orthodontic treatment. Cross-sectional, observational study. Three centres were involved; Glasgow Dental Hospital and two specialist orthodontic practices, one in Scotland and one in Greece. Six hundred and sixty consecutive patients undergoing orthodontic treatment were examined over a 9 month period. The presence and absence of angular cheilitis was recorded. A six-point clinical scale was used to describe the clinical features of angular cheilitis when present. Chi-squared tests were used to investigate the association between the presence of angular cheilitis and oral hygiene level/appliance type. Eleven per cent of orthodontic patients in this Western European population, showed signs of angular cheilitis. No correlation was found between the presence of angular cheilitis and gender. Good oral hygiene was associated with a reduced prevalence (P<0.01). Angular cheilitis is a multifactorial condition that can occur in a small percentage of patients during orthodontic treatment. Good oral hygiene may be associated with a reduced risk. A new clinical grade of angular cheilitis is suggested that may help future research. Further studies are required to investigate the microbiological features associated with angular cheilitis occurring in orthodontic patients, as well as associations with medical conditions, such as asthma.

  14. Correlation of Predicted and Observed Optical Properties of Multilayer Thermal Control Coatings

    NASA Technical Reports Server (NTRS)

    Jaworske, Donald A.

    1998-01-01

    Thermal control coatings on spacecraft will be increasingly important, as spacecraft grow smaller and more compact. New thermal control coatings will be needed to meet the demanding requirements of next generation spacecraft. Computer programs are now available to design optical coatings and one such program was used to design several thermal control coatings consisting of alternating layers of WO3 and SiO2. The coatings were subsequently manufactured with electron beam evaporation and characterized with both optical and thermal techniques. Optical data were collected in both the visible region of the spectrum and the infrared. Predictions of solar absorptance and infrared emittance were successfully correlated to the observed thermal control properties. Functional performance of the coatings was verified in a bench top thermal vacuum chamber.

  15. Use of a Differential Observing Response to Expand Restricted Stimulus Control

    ERIC Educational Resources Information Center

    Walpole, Carrie Wallace; Roscoe, Eileen M.; Dube, William V.

    2007-01-01

    This study extends previous work on the use of differential observing responses (DOR) to remediate atypically restricted stimulus control. A participant with autism had high matching-to-sample accuracy scores with printed words that had no letters in common (e.g., "cat," "lid," "bug") but poor accuracy with words that had two letters in common…

  16. Development and Clinical Assessment of a Comprehensive Product for Pigmentation Control in Multiple Ethnic Populations.

    PubMed

    Makino, Elizabeth T; Kadoya, Kuniko; Sigler, Monya L; Hino, Peter D; Mehta, Rahul C

    2016-12-01

    Pigmentary changes in people of different ethnic origins are controlled by slight variations in key biological pathways leading to different outcomes from the same treatment. It is important to develop and test products for desired outcomes in varying ethnic populations. To develop a comprehensive product (LYT2) that affects all major biological pathways controlling pigmentation and test for clinical efficacy and safety in different ethnic populations. A thorough analysis of biological pathways was used to identify ingredient combinations for LYT2 that provided optimal melanin reduction in a 3-D skin model. Expression of four key genes for melanogenesis, TYR, TYRP-1, DCT, and MITF was analyzed by qPCR. Clinical study was conducted to compare the efficacy and tolerability of LYT2 against 4% hydroquinone (HQ). Average melanin suppression by LYT2 in 7 independent experiments was 45%. All four key genes show significant down- regulation of expression. LYT2 provided statistically significant reductions in mean overall hyperpigmentation grades as early as week 2 compared to baseline, with continued significant improvements through week 12 in all ethnic groups tested. We have successfully combined management of 6 categories of pathways related to melanogenesis: melanocyte activation, melanosome development, melanin production, melanin distribution, keratinocyte turnover, and barrier function to create a comprehensive HQ-free product. The outcome clearly shows greater pigmentation control with LYT2 compared to other HQ-free products in skin tissue models and earlier control in clinical studies compared to 4% HQ. Clinical study shows pigmentation control benefits of LYT2 in people of Caucasian, Hispanic, and African ethnic origins. J Drugs Dermatol. 2016;15(12):1562-1570.

  17. Controllability and observability analysis for vertex domination centrality in directed networks

    NASA Astrophysics Data System (ADS)

    Wang, Bingbo; Gao, Lin; Gao, Yong; Deng, Yue; Wang, Yu

    2014-06-01

    Topological centrality is a significant measure for characterising the relative importance of a node in a complex network. For directed networks that model dynamic processes, however, it is of more practical importance to quantify a vertex's ability to dominate (control or observe) the state of other vertices. In this paper, based on the determination of controllable and observable subspaces under the global minimum-cost condition, we introduce a novel direction-specific index, domination centrality, to assess the intervention capabilities of vertices in a directed network. Statistical studies demonstrate that the domination centrality is, to a great extent, encoded by the underlying network's degree distribution and that most network positions through which one can intervene in a system are vertices with high domination centrality rather than network hubs. To analyse the interaction and functional dependence between vertices when they are used to dominate a network, we define the domination similarity and detect significant functional modules in glossary and metabolic networks through clustering analysis. The experimental results provide strong evidence that our indices are effective and practical in accurately depicting the structure of directed networks.

  18. Observational studies: a valuable source for data on the true value of RA therapies.

    PubMed

    van Vollenhoven, Ronald F; Severens, Johan L

    2011-03-01

    The validity of observational studies is sometimes questioned because of the limitations of non-randomly assigned controls, various biases such as channeling bias, confounding by indication, and other pitfalls. Yet, (post-marketing) observational data can provide important information regarding not only drug safety but also the effectiveness and appropriate use of agents in the real world, outside of clinical trials. Observational studies also provide data regarding the wider value of these agents in terms of, for example, reducing the need for surgical procedures, reducing absenteeism and increasing productivity. Importantly, data from some observational registry studies have subsequently been confirmed by clinical trials, supporting the overall validity of the registry-based approach. Observational studies also allow measures such as health assessment questionnaire scores, disease activity scores, and glucocorticoid use over time to be monitored for longer periods. Furthermore, observational data in real, less strictly selected patients without the constraints of formal study populations may produce findings not observed in clinical trials but that warrant further investigation in a controlled trial environment. For example, recent data from the Stockholm tumor necrosis factor follow-up registry in Sweden showed increases in the time people worked after initiation of biologics that, surprisingly, continued into the fourth and fifth years of treatment--a finding not observed with standardized outcomes. Observational studies are truly an underappreciated and valuable source of data on the real value of anti-rheumatic therapies, and these data are essential for making sound decisions regarding coverage and reimbursement.

  19. Oral pregabalin for postoperative pain relief after third molar extraction: a randomized controlled clinical trial.

    PubMed

    Olmedo-Gaya, Maria Victoria; Manzano-Moreno, Francisco J; Galvez-Mateos, Rafael; González-Rodriguez, Maria Paloma; Talero-Sevilla, Cristina; Vallecillo-Capilla, Manuel

    2016-09-01

    The aim of this randomized controlled clinical trial was to evaluate the efficacy and safety of pregabalin administered pre- and postoperatively in patients with pain and swelling due to the surgical removal of impacted lower third molars. The final study sample comprised 60 volunteers (23 males and 37 females). Group 1 (n = 30) received 75 mg oral pregabalin 1 h before surgery and 1 h after surgery. Group 2 (n = 30) served as a control group and received no pregabalin. Both groups were administered with 650 mg paracetamol every 8 h for 2 days. Postoperative pain intensity and swelling were measured using a visual analog scale (VAS); pain relief experienced was reported using a four-point verbal rating scale (VRS); the rescue medication requirement, adverse effects, and global impression of the medication were also recorded. No significant difference in pain intensity (VAS) was observed between the groups. However, fewer rescue medication tablets were needed by pregabalin-treated patients than by controls (p = 0.021). The frequency and intensity of adverse effects were significantly higher in pregabalin-treated patients (p < 0.001), although no serious adverse events occurred. No significant difference in the degree of swelling was observed in any measurement except that from mandibular angle to lip junction, which showed lesser inflammation in the pregabalin group at 24 h post-surgery (p = 0.011). The global opinion on the medication received was more positive in the pregabalin group (p = 0.042). The administration of pregabalin reduces the requirement for rescue medication after third molar surgery and results in a more constant pain level, with fewer peaks of pain intensity. These findings suggest that pregabalin may be useful to control acute postoperative pain. Adverse effects are known to be reduced at the low pregabalin dose used in our study.

  20. Clinical inertia in poorly controlled elderly hypertensive patients: a cross-sectional study in Spanish physicians to ascertain reasons for not intensifying treatment.

    PubMed

    Gil-Guillén, Vicente; Orozco-Beltrán, Domingo; Carratalá-Munuera, Concepción; Márquez-Contreras, Emilio; Durazo-Arvizu, Ramón; Cooper, Richard; Pertusa-Martínez, Salvador; Pita-Fernandez, Salvador; González-Segura, Diego; Martin-de-Pablo, José Luis; Pallarés, Vicente; Fernández, Antonio; Redón, Josep

    2013-06-01

    Clinical inertia, the failure of physicians to initiate or intensify therapy when indicated, is a major problem in the management of hypertension and may be more prevalent in elderly patients. Overcoming clinical inertia requires understanding its causes and evaluating certain factors, particularly those related to physicians. The objective of our study was to determine the rate of clinical inertia and the physician-reported reasons for it. An observational, cross-sectional, multi-center study was carried out in a primary care setting. We included 512 physicians, with a consecutive sampling of 1,499 hypertensive patients with clinical inertia. Clinical inertia was defined when physicians did not modify treatment despite knowing that the therapeutic target had not been reached. Clinical inertia was considered to be justified (JCI) when physicians provided an explanation for not intensifying treatment and as not justified (nJCI) when no reasons were given. JCI was observed in 30.1 % (95 % CI 27.8-32.4) of patients (n = 451) and nJCI in 69.9 % (95 % CI 67.6-72.2) (n = 1,058). JCI was associated with higher blood pressure (BP) values (both systolic and diastolic) and diabetes (p = 0.012) than nJCI. nJCI was associated with patients having an isolated increase of systolic or diastolic or high borderline BP values or cardiovascular disease. Physicians provided reasons for not intensifying treatment in poorly controlled patients in only 30 % of instances. Main reasons for not intensifying treatment were borderline BP values, co-morbidity, suspected white coat effect, or perceived difficulty achieving target. nJCI was associated with high borderline BP values and cardiovascular disease.

  1. Flexible Modes Control Using Sliding Mode Observers: Application to Ares I

    NASA Technical Reports Server (NTRS)

    Shtessel, Yuri B.; Hall, Charles E.; Baev, Simon; Orr, Jeb S.

    2010-01-01

    The launch vehicle dynamics affected by bending and sloshing modes are considered. Attitude measurement data that are corrupted by flexible modes could yield instability of the vehicle dynamics. Flexible body and sloshing modes are reconstructed by sliding mode observers. The resultant estimates are used to remove the undesirable dynamics from the measurements, and the direct effects of sloshing and bending modes on the launch vehicle are compensated by means of a controller that is designed without taking the bending and sloshing modes into account. A linearized mathematical model of Ares I launch vehicle was derived based on FRACTAL, a linear model developed by NASA/MSFC. The compensated vehicle dynamics with a simple PID controller were studied for the launch vehicle model that included two bending modes, two slosh modes and actuator dynamics. A simulation study demonstrated stable and accurate performance of the flight control system with the augmented simple PID controller without the use of traditional linear bending filters.

  2. Implementing self sustained quality control procedures in a clinical laboratory.

    PubMed

    Khatri, Roshan; K C, Sanjay; Shrestha, Prabodh; Sinha, J N

    2013-01-01

    Quality control is an essential component in every clinical laboratory which maintains the excellence of laboratory standards, supplementing to proper disease diagnosis, patient care and resulting in overall strengthening of health care system. Numerous quality control schemes are available, with combinations of procedures, most of which are tedious, time consuming and can be "too technical" whereas commercially available quality control materials can be expensive especially for laboratories in developing nations like Nepal. Here, we present a procedure performed at our centre with self prepared control serum and use of simple statistical tools for quality assurance. The pooled serum was prepared as per guidelines for preparation of stabilized liquid quality control serum from human sera. Internal Quality Assessment was performed on this sample, on a daily basis which included measurement of 12 routine biochemical parameters. The results were plotted on Levey-Jennings charts and analysed with quality control rules, for a period of one month. The mean levels of biochemical analytes in self prepared control serum were within normal physiological range. This serum was evaluated every day along with patients' samples. The results obtained were plotted on control charts and analysed using common quality control rules to identify possible systematic and random errors. Immediate mitigation measures were taken and the dispatch of erroneous reports was avoided. In this study we try to highlight on a simple internal quality control procedure which can be performed by laboratories, with minimum technology, expenditure, and expertise and improve reliability and validity of the test reports.

  3. The effect of learner's control of self-observation strategies on learning of front crawl.

    PubMed

    Marques, Priscila Garcia; Corrêa, Umberto Cesar

    2016-02-01

    This study investigated the effect of learner's control of self-observation strategies on motor skill learning. For this purpose, beginner and intermediate learner swimmers practised the front crawl. Seventy college students took part in this experiment. They comprised 40 novice learners, both male (n=19) and female (n=21), with an average age of 20.7 years (±0.44), and 30 intermediate learners, both male (n=17) and female (n=13), with an average age of 21.1 years (±0.86). The design involved a pretest (one day), four acquisition sessions (four days), and a retention test (one day). They were divided into three groups: (1) choice, which could choose to watch a video with their best or overall performance during practise; (2) yoked, which were paired to those of the choice group; and (3) control (did not watch any video). The measures included the performance of front crawl and self-efficacy. The results showed that: (1) beginners who chose a type of observation strategy had superior motor skill learning; (2) for intermediate learners, self-observation promoted better motor learning, regardless of the control of choices; (3) self-observation improved self-efficacy beliefs. Copyright © 2016 Elsevier B.V. All rights reserved.

  4. Learner-Controlled Self-Observation is Advantageous for Motor Skill Acquisition

    PubMed Central

    Ste-Marie, Diane M.; Vertes, Kelly A.; Law, Barbi; Rymal, Amanda M.

    2013-01-01

    There were two main objectives of this research. First, we wanted to examine whether video feedback of the self (self-observation) was more effective for motor skill learning when the choice to view the video was provided to the learner (learner-controlled, LC) as opposed to an experimenter-controlled (EC) delivery. Secondly, we explored whether there were differences in the self-regulatory processes of self-efficacy and intrinsic motivation, as well as perceived choice between the LC and EC conditions. Two groups (LC and EC) of children (M age of 11.2 years; SD = 1.89) attempted to learn a progression of trampoline skills during a 2-day acquisition phase in which video self-observation was available. The second acquisition day was followed by a no self-observation retention test 1 day later. It was hypothesized that, during retention, the LC group would be more self-efficacious about their ability to progress through the trampoline skills, show greater intrinsic motivation and perceived choice, and go further in skill progression than the EC group. Analysis of the acquisition data showed the LC group had greater increases in self-efficacy as compared to the EC group. Results of the retention test showed that the participants in the LC group obtained higher scores on the intrinsic motivation and perceived choice measures and had higher skill progression scores as compared to the EC group. Regression analysis showed that group assignment and self-efficacy were significant predictors of the physical performance benefits noted in retention. These findings are discussed within Zimmerman’s (2004) self-regulation of learning model. PMID:23355826

  5. Observation and Control of Hamiltonian Chaos in Wave-particle Interaction

    NASA Astrophysics Data System (ADS)

    Doveil, F.; Elskens, Y.; Ruzzon, A.

    2010-11-01

    Wave-particle interactions are central in plasma physics. The paradigm beam-plasma system can be advantageously replaced by a traveling wave tube (TWT) to allow their study in a much less noisy environment. This led to detailed analysis of the self-consistent interaction between unstable waves and an either cold or warm electron beam. More recently a test cold beam has been used to observe its interaction with externally excited wave(s). This allowed observing the main features of Hamiltonian chaos and testing a new method to efficiently channel chaotic transport in phase space. To simulate accurately and efficiently the particle dynamics in the TWT and other 1D particle-wave systems, a new symplectic, symmetric, second order numerical algorithm is developed, using particle position as the independent variable, with a fixed spatial step. This contribution reviews : presentation of the TWT and its connection to plasma physics, resonant interaction of a charged particle in electrostatic waves, observation of particle trapping and transition to chaos, test of control of chaos, and description of the simulation algorithm. The velocity distribution function of the electron beam is recorded with a trochoidal energy analyzer at the output of the TWT. An arbitrary waveform generator is used to launch a prescribed spectrum of waves along the 4m long helix of the TWT. The nonlinear synchronization of particles by a single wave, responsible for Landau damping, is observed. We explore the resonant velocity domain associated with a single wave as well as the transition to large scale chaos when the resonant domains of two waves and their secondary resonances overlap. This transition exhibits a devil's staircase behavior when increasing the excitation level in agreement with numerical simulation. A new strategy for control of chaos by building barriers of transport in phase space as well as its robustness is successfully tested. The underlying concepts extend far beyond the

  6. Klebsiella pneumoniae liver abscess in diabetic patients: association of glycemic control with the clinical characteristics

    PubMed Central

    2013-01-01

    Background Klebsiella pneumoniae liver abscess (KPLA) has been reported with increasing frequency in East Asian countries in the past 3 decades, especially in Taiwan and Korea. Diabetes is a well-known risk factor for KPLA and highly associated with septic metastatic complications from KPLA. We investigated the association of glycemic control in diabetic patients with the clinical characteristics of KPLA in Taiwan. Methods Adult diabetic patients with KPLA were identified retrospectively in a medical center from January 2007 to January 2012. Clinical characteristics were compared among patients with different levels of current hemoglobin A1c (HbA1c). Risk factors for metastatic infection from KPLA were analyzed. Results Patients with uncontrolled glycemia (HbA1c ≥ 7%) were significantly younger than those with controlled glycemia (HbA1c < 7%). Patients with uncontrolled glycemia had the trend to have a higher rate of gas-forming liver abscess, cryptogenic liver abscess, and metastatic infection than those with controlled glycemia. Cryptogenic liver abscess and metastatic infection were more common in the poor glycemic control group (HbA1c value >; 10%) after adjustment with age. HbA1c level and abscess < 5 cm were independent risk factors for metastatic complications from KPLA. Conclusions Glycemic control in diabetic patients played an essential role in the clinical characteristics of KPLA, especially in metastatic complications from KPLA. PMID:23363608

  7. Robustness of reduced-order observer-based controllers in transitional 2D Blasius boundary layers

    NASA Astrophysics Data System (ADS)

    Belson, Brandt; Semeraro, Onofrio; Rowley, Clarence; Pralits, Jan; Henningson, Dan

    2011-11-01

    In this work, we seek to delay transition in the Blasius boundary layer. We trip the flow with an upstream disturbance and dampen the growth of the resulting structures downstream. The observer-based controllers use a single sensor and a single localized body force near the wall. To formulate the controllers, we first find a reduced-order model of the system via the Eigensystem Realization Algorithm (ERA), then find the H2 optimal controller for this reduced-order system. We find the resulting controllers are effective only when the sensor is upstream of the actuator (in a feedforward configuration), but as is expected, are sensitive to model uncertainty. When the sensor is downstream of the actuator (in a feedback configuration), the reduced-order observer-based controllers are not robust and ineffective on the full system. In order to investigate the robustness properties of the system, an iterative technique called the adjoint of the direct adjoint (ADA) is employed to find a full-dimensional H2 optimal controller. This avoids the reduced-order modelling step and serves as a reference point. ADA is promising for investigating the lack of robustness previously mentioned.

  8. Observer perspective imagery with stuttering.

    PubMed

    Lowe, Robyn; Menzies, Ross; Packman, Ann; O'Brian, Sue; Onslow, Mark

    2015-01-01

    Adults who stutter are at risk of developing a range of psychological conditions. Social anxiety disorder is the most common anxiety disorder associated with stuttering. Observer perspective imagery is one cognitive process involved in the maintenance of some anxiety disorders. This involves viewing images as if looking at the self from the perspective of another. In contrast, the field perspective involves looking out from the self at the surrounding environment. The purpose of this study was to assess the presence of observer perspective imagery with stuttering. The authors administered the Hackmann, Surawy and Clark (1998) semi-structured interview to 30 adults who stutter and 30 controls. Group images and impressions were compared for frequency, perspective recalled and emotional valence. The stuttering group was significantly more likely than controls to recall images and impressions from an observer rather than a field perspective for anxious situations. It is possible the present results could reflect the same attentional processing bias that occurs with anxiety disorders in the non-stuttering population. These preliminary results provide an explanation for the persistence of conditions such as social anxiety disorder with stuttering. Clinical implications are discussed.

  9. Promoting positive condom use experiences among young black MSM: a randomized controlled trial of a brief, clinic-based intervention.

    PubMed

    Crosby, Richard A; Mena, Leandro; Smith, Rachel Vickers

    2018-06-01

    The aim of this study is to determine, among young Black men who have sex with men (YBMSM), the 12-month efficacy of a single-session, clinic-based intervention promoting condom use to enhance sexual pleasure (purpose 1) and the use of condoms from the start-to-finish of anal sex (purpose 2). A pre-test, post-test randomized controlled trial was conducted, using a 12-month period of follow-up observation, in STI clinics. Data from 394 YBMSM completing baseline and 12-month follow-up assessments were analyzed. The experimental condition comprised a one-to-one, interactive program (Focus on the Future) designed for tailored delivery. Regarding study purpose 1, in an age-adjusted linear regression model for 277 HIV-uninfected men, there was a significant effect of the intervention (Beta=0.13, P =0.036) relative to more favorable sexual experiences when using condoms. Regarding study purpose 2, in an adjusted logistic regression model, for HIV-uninfected men, there was a significant effect of the intervention (AOR=0.54, P =0.048) relative to using condoms from start-to-finish of anal sex. Significant effects for HIV-infected men were not observed. A small, but non-significant, effect was observed relative to men's self-report of always using condoms. This single-session program may be a valuable counseling tool for use in conjunction with pre-exposure prophylaxis-related care for HIV-uninfected YBMSM.

  10. Fuzzy observer-based control for maximum power-point tracking of a photovoltaic system

    NASA Astrophysics Data System (ADS)

    Allouche, M.; Dahech, K.; Chaabane, M.; Mehdi, D.

    2018-04-01

    This paper presents a novel fuzzy control design method for maximum power-point tracking (MPPT) via a Takagi and Sugeno (TS) fuzzy model-based approach. A knowledge-dynamic model of the PV system is first developed leading to a TS representation by a simple convex polytopic transformation. Then, based on this exact fuzzy representation, a H∞ observer-based fuzzy controller is proposed to achieve MPPT even when we consider varying climatic conditions. A specified TS reference model is designed to generate the optimum trajectory which must be tracked to ensure maximum power operation. The controller and observer gains are obtained in a one-step procedure by solving a set of linear matrix inequalities (LMIs). The proposed method has been compared with some classical MPPT techniques taking into account convergence speed and tracking accuracy. Finally, various simulation and experimental tests have been carried out to illustrate the effectiveness of the proposed TS fuzzy MPPT strategy.

  11. Clinical predictors of rectal lymphogranuloma venereum infection: results from a multicentre case–control study in the UK

    PubMed Central

    Pallawela, S N S; Sullivan, A K; Macdonald, N; French, P; White, J; Dean, G; Smith, A; Winter, A J; Mandalia, S; Alexander, S; Ison, C; Ward, H

    2014-01-01

    Objective Since 2003, over 2000 cases of lymphogranuloma venereum (LGV) have been diagnosed in the UK in men who have sex with men (MSM). Most cases present with proctitis, but there are limited data on how to differentiate clinically between LGV and other pathology. We analysed the clinical presentations of rectal LGV in MSM to identify clinical characteristics predictive of LGV proctitis and produced a clinical prediction model. Design A prospective multicentre case–control study was conducted at six UK hospitals from 2008 to 2010. Cases of rectal LGV were compared with controls with rectal symptoms but without LGV. Methods Data from 98 LGV cases and 81 controls were collected from patients and clinicians using computer-assisted self-interviews and clinical report forms. Univariate and multivariate logistic regression was used to compare symptoms and signs. Clinical prediction models for LGV were compared using receiver operating curves. Results Tenesmus, constipation, anal discharge and weight loss were significantly more common in cases than controls. In multivariate analysis, tenesmus and constipation alone were suggestive of LGV (OR 2.98, 95% CI 0.99 to 8.98 and 2.87, 95% CI 1.01 to 8.15, respectively) and that tenesmus alone or in combination with constipation was a significant predictor of LGV (OR 6.97, 95% CI 2.71 to 17.92). The best clinical prediction was having one or more of tenesmus, constipation and exudate on proctoscopy, with a sensitivity of 77% and specificity of 65%. Conclusions This study indicates that tenesmus alone or in combination with constipation makes a diagnosis of LGV in MSM presenting with rectal symptoms more likely. PMID:24687130

  12. Aloe Vera Gel and Cesarean Wound Healing; A Randomized Controlled Clinical Trial

    PubMed Central

    Molazem, Zahra; Mohseni, Fatemeh; Younesi, Masoumeh; Keshavarzi, Sareh

    2015-01-01

    Background: Failure in complete healing of the wound is one of the probable complications of cesarean. The present study aimed to determine the effectiveness of dressing with aloe vera gel in healing of cesarean wound. Methods: This prospective randomized double-blind clinical trial was conducted on 90 women who had undergone cesarean operation in Amir-al-Momenin hospital (Gerash, Iran). The participants were randomly divided into two groups each containing 45 patients. In one group, the wound was dressed with aloe vera gel, while simple dressing was used in the control group. Wound healing was assessed 24 hours and 8 days after the cesarean operation using REEDA scale. The data were analyzed through Chi-square and t-test. Results: The participants’ mean age was 27.56±4.20 in the aloe vera group and 26.62±4.88 in the control group, but the difference was not statistically significant. However, a significant difference was found between the two groups concerning body mass index, heart rate, and systolic blood pressure (P<0.05). Also, a significant difference was observed between the two groups with respect to the wound healing score 24 hours after the operation (P=0.003). After 8 days, however, the difference in the wound healing score was not significant (P=0.283). Overall, 45 participants in the aloe vera group and 35 ones in the control group had obtained a zero score 24 hours after the operation. These measures were respectively obtained as 42 and 41eight days after the operation. Conclusion: According to the findings of this study, the women are recommended to be informed regarding the positive effects of dressing with aloe vera gel. PMID:25560349

  13. Clinical characteristics and patient-reported outcomes in patients with inadequately controlled rheumatoid arthritis despite ongoing treatment.

    PubMed

    Taylor, Peter C; Alten, Rieke; Gomez-Reino, Juan J; Caporali, Roberto; Bertin, Philippe; Sullivan, Emma; Wood, Robert; Piercy, James; Vasilescu, Radu; Spurden, Dean; Alvir, Jose; Tarallo, Miriam

    2018-01-01

    Despite the wide array of treatments available for rheumatoid arthritis (RA), some patients continue to report unmet clinical needs. We investigated the extent of inadequate disease control in patients with RA. Data were drawn from the Adelphi 2014 RA Disease-Specific Program in France, Germany, Italy, Spain and the UK. Rheumatologists provided patient demographics, comorbidities, satisfaction with RA control and other clinical details. Patients reported their level of satisfaction and completed the EuroQoL 5-Dimensions Health Questionnaire and Work Productivity and Activity Impairment Questionnaire. Patients had been on their current therapy ≥3 months and had 28-joint disease activity scores (DAS28) reported. Adequately controlled (DAS28 ≤3.2) and inadequately controlled (DAS28 >3.2) patient cohorts were compared using univariate tests. Of 1147 patients, 74% were women, the mean age was 52 years and the mean time since RA diagnosis was 7 years. Twenty-seven percent of patients had inadequately controlled RA, whereas 73% had adequately controlled RA. Inadequately controlled patients were more affected clinically versus adequately controlled patients; 69% vs 13% had moderate/severe RA, the current level of pain was 4.6 vs 2.3, and 67% vs 41% experienced flares, respectively (all p<0.0001). Inadequately controlled patients had higher rates of depression (16% vs 5%; p<0.0001), worse health state, greater work and activity impairment, and lower satisfaction rates among the patients and their physicians than the adequately controlled cohort. RA was insufficiently controlled in over a quarter of patients despite their current therapy and this had a negative impact on the patients.

  14. ELECTRON MICROSCOPIC OBSERVATION OF SPECIMENS UNDER CONTROLLED GAS PRESSURE

    PubMed Central

    Heide, Hans Gunther

    1962-01-01

    A technique for encasing specimens in a thin gas layer during their observation in the Siemens Elmiskop I is described. All gases can be employed at pressures up to one atmosphere. Destruction of specimens can occur in the beam; all organic specimens are particularly liable to decompose. The conditions under which this can be avoided are given. A useful application of the technique allows one to prevent specimens from drying out, as they normally do in vacuum. A further application uses the controlled removal of carbon for thinning organic layers and for selective etching of organic materials. PMID:13905967

  15. Effectiveness of Vildagliptin in Clinical Practice: Pooled Analysis of Three Korean Observational Studies (the VICTORY Study)

    PubMed Central

    Suh, Sunghwan; Song, Sun Ok; Kim, Jae Hyeon; Cho, Hyungjin

    2017-01-01

    The present observational study aimed to evaluate the clinical effectiveness of vildagliptin with metformin in Korean patients with type 2 diabetes mellitus (T2DM). Data were pooled from the vildagliptin postmarketing survey (PMS), the vildagliptin/metformin fixed drug combination (DC) PMS, and a retrospective observational study of vildagliptin/metformin (fixed DC or free DC). The effectiveness endpoint was the proportion of patients who achieved a glycemic target (HbA1c) of ≤7.0% at 24 weeks. In total, 4303 patients were included in the analysis; of these, 2087 patients were eligible. The mean patient age was 56.99 ± 11.25 years. Overall, 58.94% patients achieved an HbA1c target of ≤7.0% at 24 weeks. The glycemic target achievement rate was significantly greater in patients with baseline HbA1c < 7.5% versus ≥7.5% (84.64% versus 43.97%), receiving care at the hospital versus clinic (67.95% versus 52.33%), and receiving vildagliptin/metformin fixed DC versus free DC (70.69% versus 55.42%). Multivariate logistic regression analysis indicated that disease duration (P < 0.0001), baseline HbA1c (P < 0.0001), and DC type (P = 0.0103) had significant effects on drug effectiveness. Vildagliptin plus metformin appeared as an effective treatment option for patients with T2DM in clinical practice settings in Korea. PMID:29057274

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

    PubMed

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

    2018-05-01

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

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

    PubMed Central

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

    2018-01-01

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

  18. [Effects of blood glucose control on glucose variability and clinical outcomes in patients with severe acute pancreatitis in intensive care unit].

    PubMed

    Wu, Jing; Sun, Qiuhong; Yang, Hua

    2015-05-19

    To explore the effects of blood glucose control on glucose variability and clinical outcomes in patients with severe acute pancreatitis in intensive care unit (ICU). A total of 72 ICU patients with severe acute pancreatitis were recruited and divided randomly into observation and control groups (n = 36 each). Both groups were treated conventionally. And the observation group achieved stable blood glucose at 6.1-8.3 mmol/L with intensive glucose control. The length of ICU and hospital stays, ICU mortality rate, transit operative rate, concurrent infection rate, admission blood glucose, glycosylated hemoglobin, mean insulin dose, mean blood glucose, blood glucose value standard deviation (GLUSD), glycemic liability index (GLUGLI) and mean amplitude of glycemic excursion (GLUMAGE) of two groups were compared. At the same time, the relationship between blood glucose variability, ICU mortality rate and its predictive value were analyzed by correlation analysis and receiver operating characteristic curve (ROC). The lengths of ICU and hospital stays of observation group were all significantly less than those of the control group [(11.7 ± 9.9) vs (15.9 ± 8.02) days, (21.8 ± 10.8) vs (28.2 ± 12.7) days, P < 0.05]. In observation group, the rates of pulmonary infection (27.78%) and hematogenous infection (5.56%) were all significantly lower than those of control group (72.22%, 38.89%, P < 0.05). The values of mean blood glucose value and GLUSD of observation group were significantly lower than those of control group [(7.4 ± 1.1) vs (9.6 ± 1.2), (1.8 ± 1.0) vs (2.5 ± 1.3) mmol/L]. The differences were statistically significant (P < 0.05). While the dose of insulin [(70.2 ± 47.6) vs (34.4 ± 38.6) U/d] was significantly higher than that of control group (P < 0.05). Bivariate correlation analysis showed that ICU mortality rate was positively correlated with GLUGLI (r = 0.368, P < 0.05). ROC curve analysis showed that, AUC of GLUGLI was 0.748 and 95% CI 0.551-0.965 (P

  19. Er:YAG laser in the treatment of periodontal sites with recurring chronic inflammation: a 12-month randomized, controlled clinical trial.

    PubMed

    Krohn-Dale, Ivar; Bøe, Olav E; Enersen, Morten; Leknes, Knut N

    2012-08-01

    The objective of this randomized, controlled clinical trial was to compare the clinical and microbiological effects of pocket debridement using erbium-doped: yttrium, aluminium and garnet (Er:YAG) laser with conventional debridement in maintenance patients. Fifteen patients, all smokers, having at least four teeth with residual probing depth (PD) ≥ 5 mm were recruited. Two pockets in two jaw quadrants were randomly assigned to subgingival debridement using an Er:YAG laser (test) or ultrasonic scaler/curette (control) at 3-month intervals. Relative attachment level (RAL), PD, bleeding on probing and dental plaque were recorded at baseline and at 6 and 12 months. Microbiological subgingival samples were taken at the same time points and analysed using a checkerboard DNA-DNA hybridization technique. A significant decrease in PD took place in both treatments from baseline to 12 months (p < 0.01). In the control, the mean initial PD decreased from 5.4 to 4.0 mm at 12 months. For the test, a similar decrease occurred. No significant between-treatment differences were shown at any time point. The mean RAL showed no overall significant inter- or intra-treatment differences (p > 0.05). No significant between-treatment differences were observed in subgingival microbiological composition or total pathogens. The results failed to support that an Er:YAG laser may be superior to conventional debridement in the treatment of smokers with recurring chronic inflammation. This appears to be the first time that repeated Er-YAG laser instrumentation has been compared with mechanical instrumentation of periodontal sites with recurring chronic inflammation over a clinically relevant time period. © 2012 John Wiley & Sons A/S.

  20. [Learning in clinical simulation: observational study on satisfaction perceived by students of nursing].

    PubMed

    Rubbi, Ivan; Ferri, Paola; Andreina, Giulia; Cremonini, Valeria

    2016-01-01

    Simulation in the context of the educational workshop is becoming an important learning method, as it allows to play realistic clinical-care situations. These vocational training activities promote the development of cognitive, affective and psychomotor skills in a pedagogical context safe and risk-free, but need to be accounted for using by valid and reliable instruments. To inspect the level of satisfaction of the students of a Degree in Nursing in northern Italy about static and high-fidelity exercises with simulators and clinical cases. A prospective observational study has been conducted involving a non-probabili- stic sample of 51 third-year students throughout the academic year 2013/14. The data collection instrument consists of three questionnaires Student Satisfaction and Self-confidence in Learning Scale, Educational Practices Questionnaire, Simulation Design Scale and 3 questions on overall satisfaction. Statistical analysis was performed with SPSS 20.0 and Office 2003 Excel. The response rate of 89.5% is obtained. The Cronbach Alfa showed a good internal reliability (α = .982). The students were generally satisfied with the activities carried out in the teaching laboratory, showing more enthusiasm for the simulation with static mannequins (71%) and with high-fidelity simulators (60%), activities for which they have experienced a significant involvement and active learning. The teaching with clinical cases scored a lesser degree of satisfaction (38%) and for this method it was found the largest number of elements of weakness.

  1. Parenting clinically anxious versus healthy control children aged 4-12 years.

    PubMed

    van der Sluis, C M; van Steensel, F J A; Bögels, S M

    2015-05-01

    This study investigated whether parenting behaviors differed between parents of 68 clinically anxious children and 106 healthy control children aged 4-12 years. The effects of parent gender, child gender and child age on parenting were explored. Mothers and fathers completed a questionnaire to assess parenting behaviors in for children hypothetically anxious situations. Results showed that parents of clinically anxious children reported more anxiety-enhancing parenting (reinforcement of dependency and punishment) as well as more positive parenting (positive reinforcement). For the clinical sample, fathers reported using more modeling/reassurance than mothers, and parents reported using more force with their 4-7-year-olds than with their 8-12-year-olds. No interaction effects were found for child gender with child anxiety status on parenting. Results indicate that for intervention, it is important to measure parenting behaviors, and to take into account father and mother differences and the age of the child. Copyright © 2015 Elsevier Ltd. All rights reserved.

  2. Design of a multi-arm randomized clinical trial with no control arm.

    PubMed

    Magaret, Amalia; Angus, Derek C; Adhikari, Neill K J; Banura, Patrick; Kissoon, Niranjan; Lawler, James V; Jacob, Shevin T

    2016-01-01

    Clinical trial designs that include multiple treatments are currently limited to those that perform pairwise comparisons of each investigational treatment to a single control. However, there are settings, such as the recent Ebola outbreak, in which no treatment has been demonstrated to be effective; and therefore, no standard of care exists which would serve as an appropriate control. For illustrative purposes, we focused on the care of patients presenting in austere settings with critically ill 'sepsis-like' syndromes. Our approach involves a novel algorithm for comparing mortality among arms without requiring a single fixed control. The algorithm allows poorly-performing arms to be dropped during interim analyses. Consequently, the study may be completed earlier than planned. We used simulation to determine operating characteristics for the trial and to estimate the required sample size. We present a potential study design targeting a minimal effect size of a 23% relative reduction in mortality between any pair of arms. Using estimated power and spurious significance rates from the simulated scenarios, we show that such a trial would require 2550 participants. Over a range of scenarios, our study has 80 to 99% power to select the optimal treatment. Using a fixed control design, if the control arm is least efficacious, 640 subjects would be enrolled into the least efficacious arm, while our algorithm would enroll between 170 and 430. This simulation method can be easily extended to other settings or other binary outcomes. Early dropping of arms is efficient and ethical when conducting clinical trials with multiple arms. Copyright © 2015 Elsevier Inc. All rights reserved.

  3. Medical Devices; Immunology and Microbiology Devices; Classification of the Assayed Quality Control Material for Clinical Microbiology Assays. Final order.

    PubMed

    2017-07-27

    The Food and Drug Administration (FDA, Agency, or we) is classifying the assayed quality control material for clinical microbiology assays into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the assayed quality control material for clinical microbiology assays' classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.

  4. Clinical Outcomes of Fixed Versus As-Needed Use of Artificial Tears in Dry Eye Disease: A 6-Week, Observer-Masked Phase 4 Clinical Trial.

    PubMed

    Asbell, Penny; Vingrys, Algis J; Tan, Jacqueline; Ogundele, Abayomi; Downie, Laura E; Jerkins, Gary; Shettle, Lee

    2018-05-01

    To evaluate the clinical effects of using fixed (four times daily [QID]) versus as-needed (PRN) dosing of an artificial tear product (polyethylene glycol/propylene glycol [PEG/PG]; Systane Ultra) in individuals with dry eye disease. In this prospective, multicenter, observer-masked, active-control, parallel-group trial, participants were randomized (1:2 allocation) to receive 1 drop of PEG/PG QID (n = 34) or PRN (n = 63) for 28 days. The primary endpoint was change from baseline in the total ocular surface staining (TOSS) score (according to the Oxford scale) at day 28. At day 28, the change from baseline in least squares mean (LSM) TOSS scores for QID and PRN groups were -1.19 and -0.94, respectively (treatment difference [TD]: -0.26; 95% confidence interval [CI]: -∞ to 0.21; P = 0.184); superiority of QID versus PRN dosing was not established, as the upper limit of one-sided 95% CI for TD was not <0 (prespecified limit). At day 28, for QID and PRN groups, the LSM change from baseline in Impact of Dry Eye on Everyday Life (IDEEL) scores was symptom-bother, -7.0 and -2.94 (TD: -4.06, P = 0.037); treatment effectiveness, 2.43 and 0.16 (TD: 2.28, P = 0.278); and treatment-related inconvenience, -11.56 and -2.77 (TD: -8.8, P = 0.996), respectively. Incidence of adverse events was low (≤3.2%) in both the groups; no serious adverse events were reported. QID dosing of PEG/PG was not superior to PRN dosing in terms of ocular staining. The IDEEL symptom-bother score favored QID dosing, suggesting that regular use of artificial tears may provide better symptomatic relief than PRN use. (ClinicalTrials.gov number, NCT02446015.).

  5. Definition of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage as an outcome event in clinical trials and observational studies: proposal of a multidisciplinary research group.

    PubMed

    Vergouwen, Mervyn D I; Vermeulen, Marinus; van Gijn, Jan; Rinkel, Gabriel J E; Wijdicks, Eelco F; Muizelaar, J Paul; Mendelow, A David; Juvela, Seppo; Yonas, Howard; Terbrugge, Karel G; Macdonald, R Loch; Diringer, Michael N; Broderick, Joseph P; Dreier, Jens P; Roos, Yvo B W E M

    2010-10-01

    In clinical trials and observational studies there is considerable inconsistency in the use of definitions to describe delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage. A major cause for this inconsistency is the combining of radiographic evidence of vasospasm with clinical features of cerebral ischemia, although multiple factors may contribute to DCI. The second issue is the variability and overlap of terms used to describe each phenomenon. This makes comparisons among studies difficult. An international ad hoc panel of experts involved in subarachnoid hemorrhage research developed and proposed a definition of DCI to be used as an outcome measure in clinical trials and observational studies. We used a consensus-building approach. It is proposed that in observational studies and clinical trials aiming to investigate strategies to prevent DCI, the 2 main outcome measures should be: (1) cerebral infarction identified on CT or MRI or proven at autopsy, after exclusion of procedure-related infarctions; and (2) functional outcome. Secondary outcome measure should be clinical deterioration caused by DCI, after exclusion of other potential causes of clinical deterioration. Vasospasm on angiography or transcranial Doppler can also be used as an outcome measure to investigate proof of concept but should be interpreted in conjunction with DCI or functional outcome. The proposed measures reflect the most relevant morphological and clinical features of DCI without regard to pathogenesis to be used as an outcome measure in clinical trials and observational studies.

  6. Admission interview scores are associated with clinical performance in an undergraduate physiotherapy course: an observational study.

    PubMed

    Edgar, Susan; Mercer, Annette; Hamer, Peter

    2014-12-01

    The purpose of this study was to determine if there is an association between admission interview score and subsequent academic and clinical performance, in a four-year undergraduate physiotherapy course. Retrospective observational study. 141 physiotherapy students enrolled in two entry year groups. Individual student performance in all course units, practical examinations, clinical placements as well as year level and overall Grade Point Average. Predictor variables included admission interview scores, admission academic scores and demographic data (gender, age and entry level). Interview score demonstrated a significant association with performance in three of six clinical placements through the course. This association was stronger than for any other admission criterion although effect sizes were small to moderate. Further, it was the only admission score to have a significant association with overall Clinical Grade Point Average for the two year groups analysed (r=0.322). By contrast, academic scores on entry showed significant associations with all year level Grade Point Averages except Year 4, the clinical year. This is the first study to review the predictive validity of an admission interview for entry into a physiotherapy course in Australia. The results show that performance in this admission interview is associated with overall performance in clinical placements through the course, while academic admission scoring is not. These findings suggest that there is a role for both academic and non-academic selection processes for entry into physiotherapy. Copyright © 2014 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  7. ? observer-based decentralised fuzzy control design for nonlinear interconnected systems: an application to vehicle dynamics

    NASA Astrophysics Data System (ADS)

    Latrach, Chedia; Kchaou, Mourad; Guéguen, Hervé

    2017-05-01

    In this study, a decentralised output learning control strategy for a class of nonlinear interconnected systems is studied. Based on Takagi-Sugeno fuzzy (TS) model to approximate the considered interconnected nonlinear systems, a decentralised observer-based control scheme is designed to override the external disturbances such that the ? performance is achieved. The appealing attributes of this approach include: (1) the closed-loop system exhibits a robustness against nonlinear interconnections and external disturbance, (2) by one-step procedure, the gain matrices of observer and controller are obtained on a single step. In simulation results, the controller design is evaluated on the steering stability of a car where the nonlinear model describes the side slip, roll and yaw motions of the automotive vehicle equipped with four-wheel-steering and active suspension.

  8. Prenatal Pregnancy Complications and Psychiatric Symptoms: Children with ASD versus Clinic Controls

    ERIC Educational Resources Information Center

    Tudor, Megan E.; DeVincent, Carla J.; Gadow, Kenneth D.

    2012-01-01

    The current study examined the association between prenatal pregnancy complications (PPC) and childhood psychiatric symptoms in children with an autism spectrum disorder (ASD) and non-ASD children who were referred to a psychiatric clinic (Controls). Parents completed a "DSM-IV"-referenced rating scale and developmental history questionnaire.…

  9. Dermatologic care in the homeless and underserved populations: observations from the Venice Family Clinic.

    PubMed

    Grossberg, Anna L; Carranza, Dafnis; Lamp, Karen; Chiu, Melvin W; Lee, Catherine; Craft, Noah

    2012-01-01

    Dermatologic care in the homeless and impoverished urban underserved populations is rarely described despite the wide prevalence of skin concerns in this population. Because the homeless population may be subject to increased sun exposure compared to the nonhomeless population, they also may be at increased risk for skin cancer. We sought to describe the spectrum of dermatologic diseases seen in a free clinic in Venice, California--the Venice Family Clinic (VFC)--as well as the differences in diagnoses between the homeless and nonhomeless patients seen at this clinic. A retrospective chart review was performed of dermatology patients (N = 82) seen at VFC throughout the 2006 calendar year. The homeless population (n = 22) was found to have more diagnoses of malignant/premalignant growths (25% [16/64] of all homeless diagnoses) compared to their nonhomeless (n = 60) counterparts (6.1% [8/132] of all nonhomeless diagnoses; P < .0001). This difference was sustained when ethnicity was controlled, with 29.6% [16/54] of diagnoses in the homeless white group consisting of malignant/ premalignant growths compared to 8.9% [4/45] of diagnoses in the nonhomeless white cohort (P < .005). Homeless patients may have a higher incidence of skin cancers and precancerous skin lesions due to increased sun exposure and/or limited access to dermatologic care.

  10. Patient Engagement in Randomized Controlled Tai Chi Clinical Trials among the Chronically Ill.

    PubMed

    Jiang, Dongsheng; Kong, Weihong; Jiang, Joanna J

    2017-01-01

    Physicians encounter various symptom-based complaints each day. While physicians strive to support patients with chronic illnesses, evidence indicates that patients who are actively involved in their health care have better health outcomes and sometimes lowers costs. This article is to analyze how patient engagement is described when complex interventions such as Tai Chi were delivered in Randomized Controlled clinical Trials (RCTs). It reviews the dynamic patient- physician relationship in chronic illness management and to illustrate the patient engagement process, using Tai Chi as an example intervention. RCTs are considered the gold standard in clinical research. This study is a qualitative analysis of RCTs using Tai Chi as an intervention. A systematic literature search was performed to identify quality randomized controlled clinical trials that investigated the effects of Tai Chi. Selected clinical trials were classified according to research design, intervention style, patient engagement, and outcomes. Patient engagement was classified based on levels of patient participation, compliance, and selfmanagement. The chronic health conditions included in this paper are Parkinson's disease, polyneuropathy, hypertension, stroke, chronic insomnia, chronic heart failure, fibromyalgia, osteoarthritis, central obesity, depression, deconditioning in the elderly, or being pre-clinically disabled. We found that patient engagement, as a concept, was not well defined in literature. It covers a wide range of related terms, such as patient involvement, participation, shared decision- making, patient activation, adherence, compliance, and self-management. Tai Chi, as a very complex practice system, is to balance all aspects of a patient's life; however, the level of patient engagement is difficult to describe using conventional clinical trial design. To accurately illustrate the effect of a complex intervention, novel research design must explore ways to measure patient

  11. Robust partial integrated guidance and control for missiles via extended state observer.

    PubMed

    Wang, Qing; Ran, Maopeng; Dong, Chaoyang

    2016-11-01

    A novel extended state observer (ESO) based control is proposed for a class of nonlinear systems subject to multiple uncertainties, and then applied to partial integrated guidance and control (PIGC) design for a missile. The proposed control strategy incorporates both an ESO and an adaptive sliding mode control law. The multiple uncertainties are treated as an extended state of the plant, and then estimate them using the ESO and compensate for them in the control action, in real time. Based on the output of the ESO, the resulting adaptive sliding mode control law is inherently continuous and differentiable. Strict proof is given to show that the estimation error of the ESO can be arbitrarily small in a finite time. In addition, the adaptive sliding mode control law can achieve finite time convergence to a neighborhood of the origin, and the accurate expression of the convergent region is given. Finally, simulations are conducted on the planar missile-target engagement geometry. The effectiveness of the proposed control strategy in enhanced interception performance and improved robustness against multiple uncertainties are demonstrated. Copyright © 2016 ISA. Published by Elsevier Ltd. All rights reserved.

  12. Reporting of interventions and "standard of care" control arms in pediatric clinical trials: a quantitative analysis.

    PubMed

    Yu, Ashley M; Balasubramanaiam, Bannuya; Offringa, Martin; Kelly, Lauren E

    2018-06-13

    In pediatric medicine, the usual treatment received by children ("standard of care") varies across centers. Evaluations of new treatments often compare to the existing "standard of care" to determine if a treatment is more effective, has a better safety profile, or costs less. The objective of our study was to evaluate intervention and "standard of care" control arms reported in published pediatric clinical trials. Pediatric clinical trials, published in 2014, reporting the use of a "standard of care" control arm were included. Duplicate assessment of reporting completeness was done using the 12-item TIDieR (Template for Intervention Description and Replication) checklist for both the "standard of care" control arms and intervention arms within the same published study. Following screening, 214 pediatric trials in diverse therapeutic areas were included. Several different terms were used to describe "standard of care." There was a significant difference between the mean reported TIDieR checklist items of "standard of care" control arms (5.81 (SD 2.13) and intervention arms (8.45 (SD 1.39, p < 0.0001). Reporting of intervention and "standard of care" control arms in pediatric clinical trials should be improved as current "standard of care" reporting deficiencies limit reproducibility of research and may ultimately contribute to research waste.

  13. Effective Information Extraction Framework for Heterogeneous Clinical Reports Using Online Machine Learning and Controlled Vocabularies

    PubMed Central

    Zheng, Shuai; Ghasemzadeh, Nima; Hayek, Salim S; Quyyumi, Arshed A

    2017-01-01

    Background Extracting structured data from narrated medical reports is challenged by the complexity of heterogeneous structures and vocabularies and often requires significant manual effort. Traditional machine-based approaches lack the capability to take user feedbacks for improving the extraction algorithm in real time. Objective Our goal was to provide a generic information extraction framework that can support diverse clinical reports and enables a dynamic interaction between a human and a machine that produces highly accurate results. Methods A clinical information extraction system IDEAL-X has been built on top of online machine learning. It processes one document at a time, and user interactions are recorded as feedbacks to update the learning model in real time. The updated model is used to predict values for extraction in subsequent documents. Once prediction accuracy reaches a user-acceptable threshold, the remaining documents may be batch processed. A customizable controlled vocabulary may be used to support extraction. Results Three datasets were used for experiments based on report styles: 100 cardiac catheterization procedure reports, 100 coronary angiographic reports, and 100 integrated reports—each combines history and physical report, discharge summary, outpatient clinic notes, outpatient clinic letter, and inpatient discharge medication report. Data extraction was performed by 3 methods: online machine learning, controlled vocabularies, and a combination of these. The system delivers results with F1 scores greater than 95%. Conclusions IDEAL-X adopts a unique online machine learning–based approach combined with controlled vocabularies to support data extraction for clinical reports. The system can quickly learn and improve, thus it is highly adaptable. PMID:28487265

  14. Clinical observation of biomimetic mineralized collagen artificial bone putty for bone reconstruction of calcaneus fracture

    PubMed Central

    Pan, Yong-Xiong; Yang, Guang-Gang; Li, Zhong-Wan; Shi, Zhong-Min; Sun, Zhan-Dong

    2018-01-01

    Abstract This study investigated clinical outcomes of biomimetic mineralized collagen artificial bone putty for bone reconstruction in the treatment of calcaneus fracture. Sixty cases of calcaneal fractures surgically treated with open reduction and internal fixation in our hospital from June 2014–2015 were chosen and randomly divided into two groups, including 30 cases treated with biomimetic mineralized collagen artificial bone putty as treatment group, and 30 cases treated with autogenous ilia as control group. The average follow-up time was 17.2 ± 3.0 months. The results showed that the surgery duration and postoperative drainage volume of treatment group were significantly lower than control group; there were no statistically significant differences in the fracture healing time, American Orthopaedic Foot and Ankle Society scores at 3 and 12 months after surgery, Böhler’s angle, Gissane’s angle and height of calcaneus between the two groups. There were no significant differences in wound complication and reject reaction between the two groups, while significant difference in donor site complication. As a conclusion, the implantation of biomimetic mineralized collagen artificial bone putty in the open reduction of calcaneal fracture resulted in reliable effect and less complications, which is suitable for clinical applications in the treatment of bone defect in calcaneal fractures. PMID:29644087

  15. A problem of optimal control and observation for distributed homogeneous multi-agent system

    NASA Astrophysics Data System (ADS)

    Kruglikov, Sergey V.

    2017-12-01

    The paper considers the implementation of a algorithm for controlling a distributed complex of several mobile multi-robots. The concept of a unified information space of the controlling system is applied. The presented information and mathematical models of participants and obstacles, as real agents, and goals and scenarios, as virtual agents, create the base forming the algorithmic and software background for computer decision support system. The controlling scheme assumes the indirect management of the robotic team on the basis of optimal control and observation problem predicting intellectual behavior in a dynamic, hostile environment. A basic content problem is a compound cargo transportation by a group of participants in the case of a distributed control scheme in the terrain with multiple obstacles.

  16. [Primary quality control in Israel Air Force clinics].

    PubMed

    Gilutz, H; Shamis, A; Ben-Amitay, D; Burger, A; Caine, Y G

    1994-05-15

    The practice of primary medicine within a military framework differs from that in the civilian environment in: accessibility, its consumers, obligations of the providers, involvement of the funder (the commanders), and ability to define and enforce professional guide lines. These differences influence the scope of medical service, as well as affect the methods and results of quality control. A system of quality control evaluation and feedback of military primary care in 16 Israel Air Force clinics was carried out by a team of experienced physicians using peer group review and according to a specially prepared protocol. Emphasis was placed on medical record assessment using obligatory markers of adequate medical evaluation and treatment. Identification of the population at risk, further medical training, and medical administration with a direct effect on the quality of medical treatment were also evaluated. 2 quality control surveys with feedback were carried out 6 months apart. The overall mean score was 81.66 +/- 7.16% at the first evaluation, increasing to 88.60 +/- 7.46% at the second (p < 0.01). The greatest improvements were in follow-up of population at risk (increasing from 68.4% to 86.4%, p < 0.025), training of medical teams, (from 75.7% to 87.5%, p < 0.05) and patient case management (from 79.4% to 85.1%, N.S.). Categories in which there was no improvement were medical records, recovery of old medical files and patient education. The categories in which there was improvement had a common denominator: "recognition of importance" and "provision of patterns" by headquarters. The quality control system was designed for routine use, and not as a research project.(ABSTRACT TRUNCATED AT 250 WORDS)

  17. Myopia Control with Bifocal Contact Lenses: A Randomized Clinical Trial.

    PubMed

    Aller, Thomas A; Liu, Maria; Wildsoet, Christine F

    2016-04-01

    Most studies have reported only minimal reductions in myopia progression with bifocal or progressive multifocal spectacles, although somewhat larger, although mostly still clinically insignificant, effects have been reported in children with nearpoint esophoria and/or accommodative dysfunctions. The CONTROL study was a 1-year, prospective, randomized, clinical trial of bifocal contact lenses for control of myopia in children with eso fixation disparities at near. Eighty-six myopic subjects, aged 8 to 18 years, were enrolled in the study after passing the screening examination. Of these, 79 completed lens assignment and 78 completed the study. The mean refractive error of these 79 subjects was -2.69 ± 1.40D (SD), and all had progressed by -0.50D or more since their last examination. All subjects also had eso fixation disparity at near. Subjects were randomly assigned to wear either Vistakon Acuvue 2 (single-vision soft contact lenses [SVSCLs]) or Vistakon Acuvue Bifocal (bifocal soft contact lenses [BFSCLs]). Bifocal adds were selected to neutralize the associated phoria. Treatment outcomes included cycloplegic autorefraction and axial length, assessed in terms of changes after 6 and 12 months of treatment from pretreatment baseline values. The BFSCLs significantly slowed myopia progression, with statistically significant differences between the treatment groups after 6 months. After 12 months of treatment, the SVSCL group had progressed by -0.79 ± 0.43D compared with -0.22 ± 0.34D for the BFSCL group (cycloplegic objective spherical equivalent, average of two eyes). Corresponding axial length changes were 0.24 ± 0.17 mm and 0.05 ± 0.14 mm, respectively. All of these differences were found to be statistically significant (unpaired t-tests, p < 0.001). The distance center bifocal contact lenses tested in this study achieved greater control over myopia progression and axial elongation (>70%) compared with most published results with multifocal spectacles. Further

  18. Antiobesity Effect of Caraway Extract on Overweight and Obese Women: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial

    PubMed Central

    Radzi, Che Wan Jasimah Bt wan Mohamed; Hajifaraji, Majid; Haerian, Batoul Sadat; Mosaddegh, Mohammad Hossein; Cordell, Geoffrey A.

    2013-01-01

    Caraway (Carum carvi L.), a potent medicinal plant, is traditionally used for treating obesity. This study investigates the weight-lowering effects of caraway extract (CE) on physically active, overweight and obese women through a randomized, triple-blind, placebo-controlled clinical trial. Seventy overweight and obese, healthy, aerobic-trained, adult females were randomly assigned to two groups (n = 35 per group). Participants received either 30 mL/day of CE or placebo without changing their diet or physical activity. Subjects were examined at baseline and after 90 days for changes in body composition, anthropometric indices, and clinical and paraclinical variables. The treatment group, compared with placebo, showed a significant reduction of weight, body mass index, body fat percentage, and waist-to-hip ratio. No changes were observed in lipid profile, urine-specific gravity, and blood pressure of subjects. The results suggest that a dietary CE with no restriction in food intake, when combined with exercise, is of value in the management of obesity in women wishing to lower their weight, BMI, body fat percentage, and body size, with no clinical side effects. In conclusion, results of this study suggest a possible phytotherapeutic approach for caraway extract in the management of obesity. This trial is registered with NCT01833377. PMID:24319489

  19. Dulce Wireless Tijuana: A Randomized Control Trial Evaluating the Impact of Project Dulce and Short-Term Mobile Technology on Glycemic Control in a Family Medicine Clinic in Northern Mexico

    PubMed Central

    Contreras, Sonia; Vargas-Ojeda, Adriana; Menchaca-Díaz, Rufino; Fortmann, Addie; Philis-Tsimikas, Athena

    2016-01-01

    Abstract Background: The global epidemic of diabetes calls for innovative interventions. This study evaluated the effectiveness of the Project Dulce model, with and without wireless technology, on glycemic control and other clinical and self-reported outcomes in patients with poorly controlled type 2 diabetes in Mexico. Subjects and Methods: Adults with type 2 diabetes and a glycated hemoglobin A1c (HbA1c) level of ≥8% were recruited from Family Medical Unit #27 of the Instituto Mexicano del Seguro Social (IMSS) in Tijuana, México, and randomly assigned to one of three groups: Project Dulce–only (PD); Project Dulce technology-enhanced with mobile tools (PD-TE); or IMSS standard of care/control group (CG). Clinical and self-reported outcomes were assessed at baseline, Month 4, and Month 10. Time-by-group interactions and within-group changes were analyzed. Results: HbA1c reductions from baseline to Month 10 were significantly greater in PD-TE (−3.0% [−33 mmol/mol]) and PD (−2.6% [−28.7 mmol/mol]) compared with CG (−1.3% [−14.2 mmol/mol]) (P = 0.009 and 0.001, respectively). PD-TE and PD also exhibited significant improvement in diabetes knowledge when compared with CG (P < 0.05 for both). No statistically significant differences were detected between PD and PD-TE on these indicators (P = 0.54 and 0.86, respectively). Several within-group improvements were observed on other clinical and self-report indicators but did not vary significantly across groups. Conclusions: Project Dulce with and without wireless technology substantially improved glycemic control and diabetes knowledge in high-risk patients with type 2 diabetes in a Mexican family medical unit, suggesting that integrating peer-led education, nurse coordination, and 3G wireless technology is an effective approach for improving diabetes outcomes in high-risk populations. PMID:26914371

  20. Design of the Women's Health Initiative clinical trial and observational study. The Women's Health Initiative Study Group.

    PubMed

    1998-02-01

    The Women's Health Initiative (WHI) is a large and complex clinical investigation of strategies for the prevention and control of some of the most common causes of morbidity and mortality among postmenopausal women, including cancer, cardiovascular disease, and osteoporotic fractures. The WHI was initiated in 1992, with a planned completion date of 2007. Postmenopausal women ranging in age from 50 to 79 are enrolled at one of 40 WHI clinical centers nationwide into either a clinical trial (CT) that will include about 64,500 women or an observational study (OS) that will include about 100,000 women. The CT is designed to allow randomized controlled evaluation of three distinct interventions: a low-fat eating pattern, hypothesized to prevent breast cancer and colorectal cancer and, secondarily, coronary heart disease; hormone replacement therapy, hypothesized to reduce the risk of coronary heart disease and other cardiovascular diseases and, secondarily, to reduce the risk of hip and other fractures, with increased breast cancer risk as a possible adverse outcome; and calcium and vitamin D supplementation, hypothesized to prevent hip fractures and, secondarily, other fractures and colorectal cancer. Overall benefit-versus-risk assessment is a central focus in each of the three CT components. Women are screened for participation in one or both of the components--dietary modification (DM) or hormone replacement therapy (HRT)--of the CT, which will randomize 48,000 and 27,500 women, respectively. Women who prove to be ineligible for, or who are unwilling to enroll in, these CT components are invited to enroll in the OS. At their 1-year anniversary of randomization, CT women are invited to be further randomized into the calcium and vitamin D (CaD) trial component, which is projected to include 45,000 women. The average follow-up for women in either CT or OS is approximately 9 years. Concerted efforts are made to enroll women of racial and ethnic minority groups, with a