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Sample records for meaningful clinical benefit

  1. "Meaningful use" of EHR in dental school clinics: how to benefit from the U.S. HITECH Act's financial and quality improvement incentives.

    Science.gov (United States)

    Kalenderian, Elsbeth; Walji, Muhammad; Ramoni, Rachel B

    2013-04-01

    Through the 2009 HITECH (Health Information Technology for Economic and Clinical Health) Act, the U.S. government committed $27 billion to incentivize the adoption and "meaningful use" of certified electronic health records (EHRs) by providers, including dentists. Given their patient profiles, dental school clinics are in a position to benefit from this time-delimited commitment to support the adoption and use of certified EHR technology under the Medicaid-based incentive. The benefits are not merely financial: rather, the meaningful use objectives and clinical quality measures can drive quality improvement initiatives within dental practices and help develop a community of medical and dental professionals focused on quality. This article describes how dentists can qualify as eligible providers and the set of activities that must be undertaken and attested to in order to obtain this incentive. Two case studies describe the approaches that can be used to meet the Medicaid threshold necessary to be eligible for the incentive. Dentists can and have successfully applied for meaningful use incentive payments. Given the diverse set of patients who are treated at dental schools, these dental practices are among those most likely to benefit from the incentive programs.

  2. Thymoma calcification: Is it clinically meaningful?

    Directory of Open Access Journals (Sweden)

    Alkaied Homam

    2011-08-01

    Full Text Available Abstract Among anterior mediastinal lesions, thymoma is the most common. Thymomas are tumors of thymic epithelial cell origin that are distinguished by inconsistent histological and biologic behavior. Chest imaging studies typically show a round or lobulated tumor in the anterior mediastinum. Calcifications in thymomas are classically punctuate or amorphous, positioned within the lesion. Chest computed tomography (CT features suggesting higher risk thymoma consist of tumor heterogeneity, vascular involvement, lobulation, pulmonary nodules, lymphadenopathy, and pleural manifestations. Imaging findings have an imperfect ability to predict stage and prognosis for thymoma patients. Our objective is to highlight the clinical implications of thymoma calcifications on the diagnosis, clinical manifestation and prognosis. A pubmed and google search was performed using the following words: thymoma calcification, calcified thymus, mediastinal calcification, anterior mediastinal calcification, and calcified thymoma. After reviewing 370 articles, 32 eligible articles describing thymoma calcifications were found and included in this review. Although the presence of thymus calcifications was more common in patients with invasive thymomas, they were present in significant portion of non-invasive thymomas. The presence of calcifications was not a significant factor in differentiating between benign and malignant thymoma. As a result, the type, location, size or other characteristics of thymus gland calcifications were not relevant features in clinical and radiologic diagnosis of thymoma. The histopathological diagnosis is still the only possible way to confirm the neoplastic nature of thymoma. All types of thymomas should be evaluated and managed independently of the presence of calcifications.

  3. Health information technology: integration of clinical workflow into meaningful use of electronic health records.

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    Bowens, Felicia M; Frye, Patricia A; Jones, Warren A

    2010-10-01

    This article examines the role that clinical workflow plays in successful implementation and meaningful use of electronic health record (EHR) technology in ambulatory care. The benefits and barriers of implementing EHRs in ambulatory care settings are discussed. The researchers conclude that widespread adoption and meaningful use of EHR technology rely on the successful integration of health information technology (HIT) into clinical workflow. Without successful integration of HIT into clinical workflow, clinicians in today's ambulatory care settings will continue to resist adoption and implementation of EHR technology.

  4. Early- versus Late-Onset Dysthymia: A Meaningful Clinical Distinction?

    OpenAIRE

    Sansone, Randy A.; Sansone, Lori A.

    2009-01-01

    In the current Diagnostic and Statistical Manual of Mental Disorders, dysthymic disorder is categorized as either early-onset or late-onset, based upon the emergence of symptoms before or after the age of 21, respectively. Does this diagnostic distinction have any meaningful clinical implications? In this edition of The Interface, we present empirical studies that have, within a single study, compared individuals with early-versus late-onset dysthymia. In this review, we found that, compared ...

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

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    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

  6. Association between clinically meaningful behavior problems and overweight in children.

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    Lumeng, Julie C; Gannon, Kate; Cabral, Howard J; Frank, Deborah A; Zuckerman, Barry

    2003-11-01

    To determine whether there is a relationship between clinically meaningful behavior problems and concurrent and future overweight in 8- to 11-year-old children. 1998 National Longitudinal Survey of Youth interview data for 8- to 11-year-old children and their mothers were analyzed. A Behavior Problems Index score >90th percentile was considered clinically meaningful. Child overweight was defined as a body mass index (BMI) >or=95th percentile for age and sex. Multiple logistic regression was used to control for potential confounders (selected a priori): child's sex, race, use of behavior-modifying medication, history of academic retention, and hours of television per day; maternal obesity, smoking status, marital status, education, and depressive symptoms; family poverty status; and Home Observation for Measurement of the Environment-Short Form (HOME-SF) cognitive stimulation score. In an attempt to elucidate temporal sequence, a second analysis was conducted with a subsample of normal-weight children who became overweight between 1996 and 1998 while controlling for BMI z score in 1996. The sample included 755 mother-child pairs. Of the potential confounding variables, race, maternal obesity, academic grade retention, maternal education, poverty status, and HOME-SF cognitive stimulation score acted as joint confounders, altering the relationship between behavior problems and overweight in the multiple logistic regression model. With these covariates in the final model, behavior problems were independently associated with concurrent child overweight (adjusted odds ratio: 2.95; 95% confidence interval: 1.34-6.49). The relationship was strengthened in the subsample of previously normal-weight children, with race, maternal obesity, HOME-SF cognitive stimulation score, and 1996 BMI z score acting as confounders (adjusted odds ratio: 5.23; 95% confidence interval: 1.37-19.9). Clinically meaningful behavior problems in 8- to 11-year-old children were independently

  7. Reaping the benefits of meaningful work: The mediating versus moderating role of work engagement.

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    Johnson, Matthew J; Jiang, Lixin

    2017-08-01

    This study examined whether meaningful work may improve one's quality of life outside of the workplace (i.e., work-to-life enrichment). More importantly, we proposed and tested competing hypotheses regarding the role of work engagement in the relationship between meaningful work and work-to-life enrichment. Specifically, we investigated whether work engagement served as a mediator of this relationship, as suggested by the job demands-resources model, or instead a moderator, as suggested by conservation of resources theory. Two-wave survey data were collected from 194 respondents recruited via Amazon Mechanical Turk. Analyses showed that meaningful work was positively related to work-to-life enrichment over time (i.e., 3 months later). Additionally, work engagement mediated but did not moderate the relationship between meaningful work at Time 1 and work-to-life enrichment at Time 2. We suggest that organizations foster a sense of meaningfulness in employees to facilitate engagement and in turn enrich employees' lives beyond the workplace. Therefore, not only organizations, but individuals as well may reap the benefits of meaningful work. Copyright © 2016 John Wiley & Sons, Ltd.

  8. Is the diagnostic threshold for bulimia nervosa clinically meaningful?

    Science.gov (United States)

    Chapa, Danielle A N; Bohrer, Brittany K; Forbush, Kelsie T

    2018-01-01

    The DSM-5 differentiates full- and sub-threshold bulimia nervosa (BN) according to average weekly frequencies of binge eating and inappropriate compensatory behaviors. This study was the first to evaluate the modified frequency criterion for BN published in the DSM-5. The purpose of this study was to test whether community-recruited adults (N=125; 83.2% women) with current full-threshold (n=77) or sub-threshold BN (n=48) differed in comorbid psychopathology and eating disorder (ED) illness duration, symptom severity, and clinical impairment. Participants completed the Clinical Impairment Assessment and participated in semi-structured clinical interviews of ED- and non-ED psychopathology. Differences between the sub- and full-threshold BN groups were assessed using MANOVA and Chi-square analyses. ED illness duration, age-of-onset, body mass index (BMI), alcohol and drug misuse, and the presence of current and lifetime mood or anxiety disorders did not differ between participants with sub- and full-threshold BN. Participants with full-threshold BN had higher levels of clinical impairment and weight concern than those with sub-threshold BN. However, minimal clinically important difference analyses suggested that statistically significant differences between participants with sub- and full-threshold BN on clinical impairment and weight concern were not clinically significant. In conclusion, sub-threshold BN did not differ from full-threshold BN in clinically meaningful ways. Future studies are needed to identify an improved frequency criterion for BN that better distinguishes individuals in ways that will more validly inform prognosis and effective treatment planning for BN. Copyright © 2017 Elsevier Ltd. All rights reserved.

  9. Imaging studies and biomarkers to detect clinically meaningful vesicoureteral reflux

    Directory of Open Access Journals (Sweden)

    Michaella Maloney Prasad

    2017-06-01

    Full Text Available The work-up of a febrile urinary tract infection is generally performed to detect vesicoureteral reflux (VUR and its possible complications. The imaging modalities most commonly used for this purpose are renal-bladder ultrasound, voiding cystourethrogram and dimercapto-succinic acid scan. These studies each contribute valuable information, but carry individual benefits and limitations that may impact their efficacy. Biochemical markers are not commonly used in pediatric urology to diagnose or differentiate high-risk disease, but this is the emerging frontier, which will hopefully change our approach to VUR in the future. As it becomes more apparent that there is tremendous clinical variation within grades of VUR, the need to distinguish clinically significant from insignificant disease grows. The unfortunate truth about VUR is that recommendations for treatment may be inconsistent. Nuances in clinical decision-making will always exist, but opinions for medical versus surgical intervention should be more standardized, based on risk of injury to the kidney.

  10. Predicting loss of employment over three years in multiple sclerosis: clinically meaningful cognitive decline.

    Science.gov (United States)

    Morrow, Sarah A; Drake, Allison; Zivadinov, Robert; Munschauer, Frederick; Weinstock-Guttman, Bianca; Benedict, Ralph H B

    2010-10-01

    Cognitive dysfunction is common in multiple sclerosis (MS), yet the magnitude of change on objective neuropsychological (NP) tests that is clinically meaningful is unclear. We endeavored to determine NP markers of the transition from employment to work disability in MS, as indicated by degree of decline on individual tests. Participants were 97 employed MS patients followed over 41.3 ± 17.6 months with a NP battery covering six domains of cognitive function. Deterioration at follow-up was designated as documented and paid disability benefits (conservative definition) or a reduction in hours/work responsibilities (liberal definition). Using the conservative definition, 28.9% reported deteriorated employment status and for the liberal definition, 45.4%. The Symbol Digit Modalities Test (SDMT) and California Verbal Learning Test, Total Learning (CVLT2-TL) measures distinguished employed and disabled patients at follow-up. Controlling for demographic and MS characteristics, the odds ratio of a deterioration based on a change of 2.0 on the CVLT2-TL was 3.7 (95% CI 1.2-11.4 and SDMT by 4.0 was 4.2 (95% CI 1.2-14.8), accounting for 86.7% of the area under the ROC curve. We conclude that decline on NP testing over time is predictive of deterioration in vocational status, establishing a magnitude of decline on NP tests that is clinically meaningful.

  11. Are estimates of meaningful decline in mobility performance consistent among clinically important subgroups? (Health ABC Study).

    NARCIS (Netherlands)

    Perera, S.; Studenski, S.; Newman, A.; Simonsick, E.; Harris, T.; Schwartz, A.; Visser, M.

    2014-01-01

    Background: Meaningful change criteria help determine if function has improved or declined, but their magnitudes may vary across clinically relevant subgroups. We estimate meaningful decline in four common measures of physical performance in subgroups of older adults based on initial performance,

  12. Clinically Meaningful Use of Blood Tumor Markers in Oncology.

    Science.gov (United States)

    Holdenrieder, Stefan; Pagliaro, Lance; Morgenstern, David; Dayyani, Farshid

    2016-01-01

    Before the introduction of modern imaging techniques and the recent developments in molecular diagnosis, tumor markers (TMs) were among the few available diagnostic tools for the management of cancer patients. Easily obtained from serum or plasma samples, TMs are minimally invasive and convenient, and the associated costs are low. Single TMs were traditionally used but these have come under scrutiny due to their low sensitivity and specificity when used, for example, in a screening setting. However, recent research has shown superior performance using a combination of multiple TMs as a panel for assessment, or as part of validated algorithms that also incorporate other clinical factors. In addition, newer TMs have been discovered that have an increased sensitivity and specificity profile for defined malignancies. The aim of this review is to provide a concise overview of the appropriate uses of both traditional and newer TMs and their roles in diagnosis, prognosis, and the monitoring of patients in current clinical practice. We also look at the future direction of TMs and their integration with other diagnostic modalities and other emerging serum based biomarkers, such as circulating nucleic acids, to ultimately advance diagnostic performance and improve patient management.

  13. Clinically Meaningful Use of Blood Tumor Markers in Oncology

    Directory of Open Access Journals (Sweden)

    Stefan Holdenrieder

    2016-01-01

    Full Text Available Before the introduction of modern imaging techniques and the recent developments in molecular diagnosis, tumor markers (TMs were among the few available diagnostic tools for the management of cancer patients. Easily obtained from serum or plasma samples, TMs are minimally invasive and convenient, and the associated costs are low. Single TMs were traditionally used but these have come under scrutiny due to their low sensitivity and specificity when used, for example, in a screening setting. However, recent research has shown superior performance using a combination of multiple TMs as a panel for assessment, or as part of validated algorithms that also incorporate other clinical factors. In addition, newer TMs have been discovered that have an increased sensitivity and specificity profile for defined malignancies. The aim of this review is to provide a concise overview of the appropriate uses of both traditional and newer TMs and their roles in diagnosis, prognosis, and the monitoring of patients in current clinical practice. We also look at the future direction of TMs and their integration with other diagnostic modalities and other emerging serum based biomarkers, such as circulating nucleic acids, to ultimately advance diagnostic performance and improve patient management.

  14. The role of socio-technical principles in leveraging meaningful benefits from IT investments.

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    Doherty, Neil F

    2014-03-01

    In recent years there has been a great deal of academic and practitioner interest in the role of 'benefits realisation management' [BRM] approaches, as a means of proactively leveraging value from IT investments. This growing body of work owes a very considerable, but as yet unacknowledged, debt to the work of Ken Eason, and other early socio-technical theorists. Consequently, the aim of this paper is to demonstrate, using the literature, how many of the principles, practices and techniques of BRM have evolved either directly or indirectly from socio-technical approaches to systems design. In so doing, this article makes a further important contribution to the literature by explicitly identifying the underlying principles and key practices of benefits realisation management. Copyright © 2012 Elsevier Ltd and The Ergonomics Society. All rights reserved.

  15. The ADAS-cog and clinically meaningful change in the VISTA clinical trial of galantamine for Alzheimer's disease.

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    Rockwood, Kenneth; Fay, Sherri; Gorman, Mary

    2010-02-01

    A minimum 4-point change at 6 months on the Alzheimer's disease assessment scale-cognitive subscale (ADAS-cog) is deemed clinically important, but this cut-point has been little studied in relation to clinical meaningfulness. In an investigator-initiated, clinical trial of galantamine, we investigated the extent to which a 4-point change classifies goal attainment by individual patients. Secondary analysis of the video imaging synthesis of treating Alzheimer's disease (VISTA) study: a 4-month, multi-centre, parallel-group, double-blind, placebo-controlled, trial of galantamine in 130 mild-moderate Alzheimer's disease patients (4-month open-label follow-up). ADAS-cog responses at 6 months were compared with outcomes on three clinical measures: clinician's interview based impression of change-plus caregiver input (CIBIC+), patient/carer-goal attainment scaling (PGAS) and clinician-GAS (CGAS). Thirty-seven of 99 patients improved by > or = 4 points on the ADAS-cog at 6 months, and 16/99 showed > or = 4-point worsening. ADAS-cog change scores correlated notionally to modestly with changes on the CGAS (r = -0.31), the PGAS (r = -0.29) and the CIBIC+ (r = 0.31). As a group, patients with ADAS-cog improvement were significantly more likely to improve on the clinical measures; those who worsened showed non-significant clinical decline. Individually, about half were misclassified in relation to each clinical measure; often when the ADAS-Cog detected 'no change', clinically meaningful effects could be detected. Even so, no ADAS-Cog cut-point optimally classified patients' clinical responses. A 4-point ADAS-cog change at 6 months is clinically meaningful for groups. Substantial individual misclassification between the ADAS-cog and clinical measures suggests no inherent meaning to a 4-point ADAS-cog change for a given patient.

  16. A patent extension proposal to end the underrepresentation of women in clinical trials and secure meaningful drug guidance for women.

    Science.gov (United States)

    Hathaway, Cynthia

    2012-01-01

    Historically, women have been systematically excluded from or underrepresented in human clinical trials of new drugs. Due to fundamental physiological differences between women and men with regard to how drugs work in the human body, testing of drugs in men alone can both deny women the full benefit of a drug and cause them to suffer from increased adverse side effects. Attempts to reform drug development law and agency practices to resolve this problem have met with only partial success. Proposed herein is a patent term extension and for studies in women, modeled upon the pediatric patent term extension, but with several key differences intended to reduce the cost to the public and fund auxiliary programs to address off-patent medicines as well. Such an extension would incentivize this research and provide meaningful guidance to women and their physicians.

  17. Identifying clinically meaningful symptom response cut-off values on the SANS in predominant negative symptoms.

    Science.gov (United States)

    Levine, Stephen Z; Leucht, Stefan

    2013-04-01

    The treatment and measurement of negative symptoms are currently at issue in schizophrenia, but the clinical meaning of symptom severity and change is unclear. To offer a clinically meaningful interpretation of severity and change scores on the Scale for the Assessment of Negative Symptoms (SANS). Patients were intention-to-treat participants (n=383) in two double-blind randomized placebo-controlled clinical trials that compared amisulpride with placebo for the treatment of predominant negative symptoms. Equipercentile linking was used to examine extrapolation from (a) CGI-S to SANS severity ratings, and (b) CGI-I to SANS percentage change (n=383). Linking was conducted at baseline, 8-14 days, 28-30 days, and 56-60 days of the trials. Across visits, CGI-S ratings of 'not ill' linked to SANS scores of 0-13, and ranged to 'extreme' ratings that linked to SANS scores of 102-105. The relationship between the CGI-S and the SANS severity scores assumed a linear trend (1=0-13, 2=15-56, 3=37-61, 4=49-66, 5=63-75, 6=79-89, 7=102-105). Similarly the relationship between CGI-I ratings and SANS percentage change followed a linear trend. For instance, CGI-I ratings of 'very much improved' were linked to SANS percent changes of -90 to -67, 'much improved' to -50 to -42, and 'minimally improved' to -21 to -13. The current results uniquely contribute to the debate surrounding negative symptoms by providing clinical meaning to SANS severity and change scores and so offer direction regarding clinically meaningful response cut-off scores to guide treatment targets of predominant negative symptoms. Copyright © 2013 Elsevier B.V. All rights reserved.

  18. A business case for HIT adoption: effects of "meaningful use" EHR financial incentives on clinic revenue.

    Science.gov (United States)

    Behkami, Nima A; Dorr, David A; Morrice, Stuart

    2010-01-01

    The goal of this study is to describe a framework that allows decision makers to efficiently evaluate factors that affect Electronic Health Record (EHR) adoption and test suitable interventions; specifically financial incentives. The United States healthcare delivery system is experiencing a transformation to improve population health. There is strong agreement that "meaningful use" of Health Information Technology (HIT) is a major enabler in this effort. However it's also understood that the high cost of implementing an EHR is an obstacle for adoption. To help understand these complexities we developed a simulation model designed to capture the dynamic nature of policy interventions that affect the adoption of EHR. We found that "Effective" use of HIT approaches break-even-point and larger clinic revenue many times faster that "average" or "poor" use of HIT. This study uses a systems perspective to the evaluate EHR adoption process through the "meaningful use" redesign as proposed in the American Reinvestment and Recovery Act 2009 in the United States healthcare industry by utilizing the System Dynamics methodology and Scenario Analysis.

  19. Assessing Abnormal Uterine Bleeding: Are Physicians Taking a Meaningful Clinical History?

    Science.gov (United States)

    Lam, Christina; Anderson, Britta; Lopes, Vrishali; Schulkin, Jay; Matteson, Kristen

    2017-07-01

    Women with abnormal uterine bleeding (AUB) report significant reductions in quality of life (QOL), which can be attributed in many cases to the fear of embarrassing episodes of bleeding. We performed this study to determine whether or not during clinical encounters physicians addressed the impact of AUB on patient-reported QOL. Between October 2008 and May 2009, we conducted a cross-sectional study of members of the American College of Obstetricians and Gynecologists. Surveys were distributed using a mixed method (web- and mail-based) and included questions about physician characteristics and types of questions used when obtaining a clinical history from a patient with AUB. We calculated the proportion of physicians who endorsed asking each type of clinical question with 95% confidence intervals (CIs). Four hundred seventeen questionnaires were returned (52%). Ninety-nine percent (95% CI 98.4%-99.9%) reported always asking a bleeding heaviness question, 87.2% (95% CI 83.2%-90.5%) reported always asking a QOL question, and 17.5% (95% CI 13.6%-21.9%) reported always asking a mood associated with bleeding question. Seventy-eight percent specifically asked patients about bleeding through their clothes, and 55% asked about changing social plans because of bleeding. Only 18% endorsed that asking about QOL was most essential for the evaluation of women with AUB. No physician characteristics such as years since completing residency, geography, or gender were associated with how commonly providers reported asking questions regarding impact of bleeding on QOL. Physicians may not be optimizing patient-provider interactions during menstrual history taking with patients with AUB by failing to assess impact of AUB on QOL in a way that is meaningful to patients.

  20. The importance of culturally meaningful activity for health benefits among older Korean immigrant living in the United States

    Directory of Open Access Journals (Sweden)

    Junhyoung Kim

    2015-06-01

    Full Text Available Research indicates that participation in culturally meaningful activity is beneficial for immigrants’ health and well-being, yet older Korean immigrants struggle with accepting new cultural perspectives, which can negatively affect their health and well-being. Using in-depth interviews, this study was designed to capture the value of culturally meaningful activities for health among older Korean immigrants. Three themes were identified: (a improved psychological well-being, (b enhanced positive emotions and feelings, and (c social connections developed with others. The findings suggest that by engaging in various culturally meaningful activities, older Korean immigrants gain a sense of social, cultural, and psychological significance in life. This study also provided evidence that older Korean immigrants maintain and develop their cultural identity through culturally meaningful activities.

  1. The importance of culturally meaningful activity for health benefits among older Korean immigrant living in the United States.

    Science.gov (United States)

    Kim, Junhyoung; Kim, May; Han, Areum; Chin, Seungtae

    2015-01-01

    Research indicates that participation in culturally meaningful activity is beneficial for immigrants' health and well-being, yet older Korean immigrants struggle with accepting new cultural perspectives, which can negatively affect their health and well-being. Using in-depth interviews, this study was designed to capture the value of culturally meaningful activities for health among older Korean immigrants. Three themes were identified: (a) improved psychological well-being, (b) enhanced positive emotions and feelings, and (c) social connections developed with others. The findings suggest that by engaging in various culturally meaningful activities, older Korean immigrants gain a sense of social, cultural, and psychological significance in life. This study also provided evidence that older Korean immigrants maintain and develop their cultural identity through culturally meaningful activities.

  2. A clinically meaningful fetal hemoglobin threshold for children with sickle cell anemia during hydroxyurea therapy.

    Science.gov (United States)

    Estepp, Jeremie H; Smeltzer, Matthew P; Kang, Guolian; Li, Chen; Wang, Winfred C; Abrams, Christina; Aygun, Banu; Ware, Russell E; Nottage, Kerri; Hankins, Jane S

    2017-12-01

    Hydroxyurea has proven clinical benefits and is recommended to be offered to all children with sickle cell anemia (SCA), but the optimal dosing regimen remains controversial. Induction of red blood cell fetal hemoglobin (HbF) by hydroxyurea appears to be dose-dependent. However, it is unknown whether maximizing HbF% improves clinical outcomes. HUSTLE (NCT00305175) is a prospective observational study with a primary goal of describing the long-term clinical effects of hydroxyurea escalated to maximal tolerated dose (MTD) in children with SCA. In 230 children, providing 610 patient-years of follow up, the mean attained HbF% at MTD was >20% for up to 4 years of follow-up. When HbF% values were ≤20%, children had twice the odds of hospitalization for any reason (P 20% was associated with fewer hospitalizations without significant toxicity. These data support the use of hydroxyurea in children, and suggest that the preferred dosing strategy is one that targets a HbF endpoint >20%. © 2017 Wiley Periodicals, Inc.

  3. A patient and public involvement (PPI) toolkit for meaningful and flexible involvement in clinical trials - a work in progress.

    Science.gov (United States)

    Bagley, Heather J; Short, Hannah; Harman, Nicola L; Hickey, Helen R; Gamble, Carrol L; Woolfall, Kerry; Young, Bridget; Williamson, Paula R

    2016-01-01

    Funders of research are increasingly requiring researchers to involve patients and the public in their research. Patient and public involvement (PPI) in research can potentially help researchers make sure that the design of their research is relevant, that it is participant friendly and ethically sound. Using and sharing PPI resources can benefit those involved in undertaking PPI, but existing PPI resources are not used consistently and this can lead to duplication of effort. This paper describes how we are developing a toolkit to support clinical trials teams in a clinical trials unit. The toolkit will provide a key 'off the shelf' resource to support trial teams with limited resources, in undertaking PPI. Key activities in further developing and maintaining the toolkit are to: ● listen to the views and experience of both research teams and patient and public contributors who use the tools; ● modify the tools based on our experience of using them; ● identify the need for future tools; ● update the toolkit based on any newly identified resources that come to light; ● raise awareness of the toolkit and ● work in collaboration with others to either develop or test out PPI resources in order to reduce duplication of work in PPI. Background Patient and public involvement (PPI) in research is increasingly a funder requirement due to the potential benefits in the design of relevant, participant friendly, ethically sound research. The use and sharing of resources can benefit PPI, but available resources are not consistently used leading to duplication of effort. This paper describes a developing toolkit to support clinical trials teams to undertake effective and meaningful PPI. Methods The first phase in developing the toolkit was to describe which PPI activities should be considered in the pathway of a clinical trial and at what stage these activities should take place. This pathway was informed through review of the type and timing of PPI activities within

  4. Initial validation of a proxy indicator of functioning as a potential tool for establishing a clinically meaningful cocaine use outcome.

    Science.gov (United States)

    Kiluk, Brian D; Babuscio, Theresa A; Nich, Charla; Carroll, Kathleen M

    2017-10-01

    Establishing a non-abstinence cocaine use outcome as clinically meaningful has been elusive, in part due to the lack of association between cocaine use outcomes and meaningful indicators of long-term functioning. Using data pooled across 7 clinical trials evaluating treatments for cocaine (N=718), a dichotomous indicator of functioning was created to represent a meaningful outcome ('problem-free functioning' - PFF), defined as the absence of problems across non-substance-related domains on the Addiction Severity Index. Its validity was evaluated at multiple time points (baseline, end-of-treatment, terminal follow-up) and used to explore associations with cocaine use. The percentage of participants meeting PFF criteria increased over time (baseline=18%; end-of-treatment=32%; terminal follow-up=37%). At each time point, ANOVAs indicated those who met PFF criteria reported significantly less distress on the Brief Symptom Inventory and less perceived stress on the Perceived Stress Scale. Generalized linear models indicated categorical indices of self-reported cocaine use at the end of treatment were predictive of the probability of meeting PFF criteria during follow-up (β=-0.01, pcocaine use in the final month of treatment was associated with PFF during follow-up, with strongest associations between PFF and abstinence or 'occasional' use. Copyright © 2017 Elsevier B.V. All rights reserved.

  5. The OnyCOE-t™ questionnaire: responsiveness and clinical meaningfulness of a patient-reported outcomes questionnaire for toenail onychomycosis

    Directory of Open Access Journals (Sweden)

    Kianifard Farid

    2006-08-01

    Full Text Available Abstract Background This research was conducted to confirm the validity and reliability and to assess the responsiveness and clinical meaningfulness of the OnyCOE-t™, a questionnaire specifically designed to measure patient-reported outcomes (PRO associated with toenail onychomycosis. Methods 504 patients with toenail onychomycosis randomized to receive 12 weeks of terbinafine 250 mg/day with or without target toenail debridement in the IRON-CLAD® trial completed the OnyCOE-t™ at baseline, weeks 6, 12, 24, and 48. The OnyCOE-t™ is composed of 6 multi-item scales and 1 single-item scale. These include a 7-item Toenail Symptom assessment, which comprises both Symptom Frequency and Symptom Bothersomeness scales; an 8-item Appearance Problems scale; a 7-item Physical Activities Problems scale; a 1-item Overall Problem scale; a 7-item Stigma scale; and a 3-item Treatment Satisfaction scale. In total, 33 toenail onychomycosis-specific items are included in the OnyCOE-t™. Clinical data, in particular the percent clearing of mycotic involvement in the target toenail, and OnyCOE-t™ responses were used to evaluate the questionnaire's reliability, validity, responsiveness, and the minimally clinical important difference (MCID. Results The OnyCOE-t™ was shown to be reliable and valid. Construct validity and known groups validity were acceptable. Internal consistency reliability of multi-item scales was demonstrated by Cronbach's alpha > .84. Responsiveness was good, with the Treatment Satisfaction, Symptom Frequency, Overall Problem, and Appearance Problem scales demonstrating the most responsiveness (Guyatt's statistic of 1.72, 1.31, 1.13, and 1.11, respectively. MCID was evaluated for three different clinical measures, and indicated that approximately an 8.5-point change (on a 0 to 100 scale was clinically meaningful based on a 25% improvement in target nail clearing. Conclusion The OnyCOE-t™ questionnaire is a unique, toenail-specific PRO

  6. Potential benefits and risks of clinical xenotransplantation

    Directory of Open Access Journals (Sweden)

    Cooper DKC

    2012-07-01

    Full Text Available David KC Cooper,1 David Ayares21Thomas E Starzl Transplantation Institute, University of Pittsburgh Medical Center, Pittsburgh, PA, USA; 2Revivicor, Blacksburg, VA, USAAbstract: The transplantation of organs and cells from pigs into humans could overcome the critical and continuing problem of the lack of availability of deceased human organs and cells for clinical transplantation. Developments in the genetic engineering of pigs have enabled considerable progress to be made in the experimental laboratory in overcoming the immune barriers to successful xenotransplantation. With regard to pig organ xenotransplantation, antibody- and cell-mediated rejection have largely been overcome, and the current major barrier is the development of coagulation dysregulation. This is believed to be due to a combination of immune activation of the vascular endothelial cells of the graft and molecular incompatibilities between the pig and primate coagulation–anticoagulation systems. Pigs with new genetic modifications specifically directed to this problem are now becoming available. With regard to less complex tissues, such as islets (for the treatment of diabetes, neuronal cells (for the treatment of Parkinson's disease, and corneas, the remaining barriers are less problematic, and graft survival in nonhuman primate models extends for >1 year in all three cases. In planning the initial clinical trials, consideration will be concentrated on the risk–benefit ratio, based to a large extent on the results of preclinical studies in nonhuman primates. If the benefit to the patient is anticipated to be high, eg, insulin-independent control of glycemia, and the potential risks low, eg, minimal risk of transfer of a porcine infectious agent, then a clinical trial would be justified.Keywords: infection, pigs, genetically-engineered, xenotransplantation, islets, xenotransplantation, organs

  7. Inter-observer reliability assessments in time motion studies: the foundation for meaningful clinical workflow analysis.

    Science.gov (United States)

    Lopetegui, Marcelo A; Bai, Shasha; Yen, Po-Yin; Lai, Albert; Embi, Peter; Payne, Philip R O

    2013-01-01

    Understanding clinical workflow is critical for researchers and healthcare decision makers. Current workflow studies tend to oversimplify and underrepresent the complexity of clinical workflow. Continuous observation time motion studies (TMS) could enhance clinical workflow studies by providing rich quantitative data required for in-depth workflow analyses. However, methodological inconsistencies have been reported in continuous observation TMS, potentially reducing the validity of TMS' data and limiting their contribution to the general state of knowledge. We believe that a cornerstone in standardizing TMS is to ensure the reliability of the human observers. In this manuscript we review the approaches for inter-observer reliability assessment (IORA) in a representative sample of TMS focusing on clinical workflow. We found that IORA is an uncommon practice, inconsistently reported, and often uses methods that provide partial and overestimated measures of agreement. Since a comprehensive approach to IORA is yet to be proposed and validated, we provide initial recommendations for IORA reporting in continuous observation TMS.

  8. A clinically meaningful training effect in walking speed using functional electrical stimulation for motor-incomplete spinal cord injury.

    Science.gov (United States)

    Street, Tamsyn; Singleton, Christine

    2018-05-01

    The study aimed to investigate the presence of a training effect for rehabilitation of walking function in motor-incomplete spinal cord injury (SCI) through daily use of functional electrical stimulation (FES). A specialist FES outpatient centre. Thirty-five participants (mean age 53, SD 15, range 18-80; mean years since diagnosis 9, range 5 months - 39 years) with drop foot and motor-incomplete SCI (T12 or higher, ASIA Impairment Scale C and D) able to ambulate 10 metres with the use of a walking stick or frame. FES of the peroneal nerve, glutei and hamstrings as clinically indicated over six months in the community. The data was analysed for a training effect (difference between unassisted ten metre walking speed at baseline and after six months) and orthotic effects (difference between walking speed with and without FES) initially on day one and after six months. The data was further analysed for a minimum clinically important difference (MCID) (>0.06 m/s). A clinically meaningful, significant change was observed for initial orthotic effect (0.13m/s, CI: 0.04-0.17, P = 0.013), total orthotic effect (0.11m/s, CI: 0.04-0.18, P = 0.017) and training effect (0.09m/s, CI: 0.02-0.16, P = 0.025). The results suggest that daily independent use of FES may produce clinically meaningful changes in walking speed which are significant for motor-incomplete SCI. Further research exploring the mechanism for the presence of a training effect may be beneficial in targeting therapies for future rehabilitation.

  9. Radiographic Progression-Free Survival as a Clinically Meaningful End Point in Metastatic Castration-Resistant Prostate Cancer: The PREVAIL Randomized Clinical Trial.

    Science.gov (United States)

    Rathkopf, Dana E; Beer, Tomasz M; Loriot, Yohann; Higano, Celestia S; Armstrong, Andrew J; Sternberg, Cora N; de Bono, Johann S; Tombal, Bertrand; Parli, Teresa; Bhattacharya, Suman; Phung, De; Krivoshik, Andrew; Scher, Howard I; Morris, Michael J

    2018-05-01

    Drug development for metastatic castration-resistant prostate cancer has been limited by a lack of clinically relevant trial end points short of overall survival (OS). Radiographic progression-free survival (rPFS) as defined by the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) is a candidate end point that represents a clinically meaningful benefit to patients. To demonstrate the robustness of the PCWG2 definition and to examine the relationship between rPFS and OS. PREVAIL was a phase 3, randomized, double-blind, placebo-controlled multinational study that enrolled 1717 chemotherapy-naive men with metastatic castration-resistant prostate cancer from September 2010 through September 2012. The data were analyzed in November 2016. Patients were randomized 1:1 to enzalutamide 160 mg or placebo until confirmed radiographic disease progression or a skeletal-related event and initiation of either cytotoxic chemotherapy or an investigational agent for prostate cancer treatment. Sensitivity analyses (SAs) of investigator-assessed rPFS were performed using the final rPFS data cutoff (May 6, 2012; 439 events; SA1) and the interim OS data cutoff (September 16, 2013; 540 events; SA2). Additional SAs using investigator-assessed rPFS from the final rPFS data cutoff assessed the impact of skeletal-related events (SA3), clinical progression (SA4), a confirmatory scan for soft-tissue disease progression (SA5), and all deaths regardless of time after study drug discontinuation (SA6). Correlations between investigator-assessed rPFS (SA2) and OS were calculated using Spearman ρ and Kendall τ via Clayton copula. In the 1717 men (mean age, 72.0 [range, 43.0-93.0] years in enzalutamide arm and 71.0 [range, 42.0-93.0] years in placebo arm), enzalutamide significantly reduced risk of radiographic progression or death in all SAs, with hazard ratios of 0.22 (SA1; 95% CI, 0.18-0.27), 0.31 (SA2; 95% CI, 0.27-0.35), 0.21 (SA3; 95% CI, 0.18-0.26), 0.21 (SA4; 95% CI, 0.17-0.26), 0

  10. Towards meaningful medication-related clinical decision support: recommendations for an initial implementation.

    Science.gov (United States)

    Phansalkar, S; Wright, A; Kuperman, G J; Vaida, A J; Bobb, A M; Jenders, R A; Payne, T H; Halamka, J; Bloomrosen, M; Bates, D W

    2011-01-01

    Clinical decision support (CDS) can improve safety, quality, and cost-effectiveness of patient care, especially when implemented in computerized provider order entry (CPOE) applications. Medication-related decision support logic forms a large component of the CDS logic in any CPOE system. However, organizations wishing to implement CDS must either purchase the computable clinical content or develop it themselves. Content provided by vendors does not always meet local expectations. Most organizations lack the resources to customize the clinical content and the expertise to implement it effectively. In this paper, we describe the recommendations of a national expert panel on two basic medication-related CDS areas, specifically, drug-drug interaction (DDI) checking and duplicate therapy checking. The goals of this study were to define a starter set of medication-related alerts that healthcare organizations can implement in their clinical information systems. We also draw on the experiences of diverse institutions to highlight the realities of implementing medication decision support. These findings represent the experiences of institutions with a long history in the domain of medication decision support, and the hope is that this guidance may improve the feasibility and efficiency CDS adoption across healthcare settings.

  11. Towards sophisticated learning from EHRs: increasing prediction specificity and accuracy using clinically meaningful risk criteria.

    Science.gov (United States)

    Vasiljeva, Ieva; Arandjelovic, Ognjen

    2016-08-01

    Computer based analysis of Electronic Health Records (EHRs) has the potential to provide major novel insights of benefit both to specific individuals in the context of personalized medicine, as well as on the level of population-wide health care and policy. The present paper introduces a novel algorithm that uses machine learning for the discovery of longitudinal patterns in the diagnoses of diseases. Two key technical novelties are introduced: one in the form of a novel learning paradigm which enables greater learning specificity, and another in the form of a risk driven identification of confounding diagnoses. We present a series of experiments which demonstrate the effectiveness of the proposed techniques, and which reveal novel insights regarding the most promising future research directions.

  12. Distinguishing between statistical significance and practical/clinical meaningfulness using statistical inference.

    Science.gov (United States)

    Wilkinson, Michael

    2014-03-01

    Decisions about support for predictions of theories in light of data are made using statistical inference. The dominant approach in sport and exercise science is the Neyman-Pearson (N-P) significance-testing approach. When applied correctly it provides a reliable procedure for making dichotomous decisions for accepting or rejecting zero-effect null hypotheses with known and controlled long-run error rates. Type I and type II error rates must be specified in advance and the latter controlled by conducting an a priori sample size calculation. The N-P approach does not provide the probability of hypotheses or indicate the strength of support for hypotheses in light of data, yet many scientists believe it does. Outcomes of analyses allow conclusions only about the existence of non-zero effects, and provide no information about the likely size of true effects or their practical/clinical value. Bayesian inference can show how much support data provide for different hypotheses, and how personal convictions should be altered in light of data, but the approach is complicated by formulating probability distributions about prior subjective estimates of population effects. A pragmatic solution is magnitude-based inference, which allows scientists to estimate the true magnitude of population effects and how likely they are to exceed an effect magnitude of practical/clinical importance, thereby integrating elements of subjective Bayesian-style thinking. While this approach is gaining acceptance, progress might be hastened if scientists appreciate the shortcomings of traditional N-P null hypothesis significance testing.

  13. Evaluating clinically meaningful change on the ITP-PAQ: preliminary estimates of minimal important differences.

    Science.gov (United States)

    Mathias, Susan D; Gao, Sue K; Rutstein, Mark; Snyder, Claire F; Wu, Albert W; Cella, David

    2009-02-01

    Interpretation of data from health-related quality of life (HRQoL) questionnaires can be enhanced with the availability of minimally important difference (MID) estimates. This information will aid clinicians in interpreting HRQoL differences within patients over time and between treatment groups. The Immune Thrombocytopenic Purpura (ITP)-Patient Assessment Questionnaire (PAQ) is the only comprehensive HRQoL questionnaire available for adults with ITP. Forty centers from within the US and Europe enrolled ITP patients into one of two multicenter, randomized, placebo-controlled, double-blind, 6-month, phase III clinical trials of romiplostim. Patients enrolled in these studies self-administered the ITP-PAQ and two items assessing global change (anchors) at baseline and weeks 4, 12, and 24. Using data from the ITP-PAQ and these two anchors, an anchor-based estimate was computed and combined with the standard error of measurement and standard deviation to compute a distribution-based estimate in order to provide an MID range for each of the 11 scales of the ITP-PAQ. A total of 125 patients participated in these clinical trials and provided data for use in these analyses. Combining results from anchor- and distribution-based approaches, MID values were computed for 9 of the 11 scales. MIDs ranged from 8 to 12 points for Symptoms, Bother, Psychological, Overall QOL, Social Activity, Menstrual Symptoms, and Fertility, while the range was 10 to 15 points for the Fatigue and Activity scales of the ITP-PAQ. These estimates, while slightly higher than other published MID estimates, were consistent with moderate effect sizes. These MID estimates will serve as a useful tool to researchers and clinicians using the ITP-PAQ, providing guidance for interpretation of baseline scores as well as changes in ITP-PAQ scores over time. Additional work should be done to finalize these initial estimates using more appropriate anchors that correlate more highly with the ITP-PAQ scales.

  14. Detecting a clinically meaningful change in tic severity in Tourette syndrome: a comparison of three methods.

    Science.gov (United States)

    Jeon, Sangchoon; Walkup, John T; Woods, Douglas W; Peterson, Alan; Piacentini, John; Wilhelm, Sabine; Katsovich, Lily; McGuire, Joseph F; Dziura, James; Scahill, Lawrence

    2013-11-01

    To compare three statistical strategies for classifying positive treatment response based on a dimensional measure (Yale Global Tic Severity Scale [YGTSS]) and a categorical measure (Clinical Global Impression-Improvement [CGI-I] scale). Subjects (N=232; 69.4% male; ages 9-69years) with Tourette syndrome or chronic tic disorder participated in one of two 10-week, randomized controlled trials comparing behavioral treatment to supportive therapy. The YGTSS and CGI-I were rated by clinicians blind to treatment assignment. We examined the percent reduction in the YGTSS-Total Tic Score (TTS) against Much Improved or Very Much Improved on the CGI-I, computed a signal detection analysis (SDA) and built a mixture model to classify dimensional response based on the change in the YGTSS-TTS. A 25% decrease on the YGTSS-TTS predicted positive response on the CGI-I during the trial. The SDA showed that a 25% reduction in the YGTSS-TTS provided optimal sensitivity (87%) and specificity (84%) for predicting positive response. Using a mixture model without consideration of the CGI-I, the dimensional response was defined by 23% (or greater) reduction on the YGTSS-TTS. The odds ratio (OR) of positive response (OR=5.68, 95% CI=[2.99, 10.78]) on the CGI-I for behavioral intervention was greater than the dimensional response (OR=2.86, 95% CI=[1.65, 4.99]). A 25% reduction on the YGTSS-TTS is highly predictive of positive response by all three analytic methods. For trained raters, however, tic severity alone does not drive the classification of positive response. Clinicaltrials.gov identifiers: NCT00218777; NCT00231985. © 2013.

  15. Evaluation of Short-Term Changes in Serum Creatinine Level as a Meaningful End Point in Randomized Clinical Trials.

    Science.gov (United States)

    Coca, Steven G; Zabetian, Azadeh; Ferket, Bart S; Zhou, Jing; Testani, Jeffrey M; Garg, Amit X; Parikh, Chirag R

    2016-08-01

    Observational studies have shown that acute change in kidney function (specifically, AKI) is a strong risk factor for poor outcomes. Thus, the outcome of acute change in serum creatinine level, regardless of underlying biology or etiology, is frequently used in clinical trials as both efficacy and safety end points. We performed a meta-analysis of clinical trials to quantify the relationship between positive or negative short-term effects of interventions on change in serum creatinine level and more meaningful clinical outcomes. After a thorough literature search, we included 14 randomized trials of interventions that altered risk for an acute increase in serum creatinine level and had reported between-group differences in CKD and/or mortality rate ≥3 months after randomization. Seven trials assessed interventions that, compared with placebo, increased risk of acute elevation in serum creatinine level (pooled relative risk, 1.52; 95% confidence interval, 1.22 to 1.89), and seven trials assessed interventions that, compared with placebo, reduced risk of acute elevation in serum creatinine level (pooled relative risk, 0.57; 95% confidence interval, 0.44 to 0.74). However, pooled risks for CKD and mortality associated with interventions did not differ from those with placebo in either group. In conclusion, several interventions that affect risk of acute, mild to moderate, often temporary elevation in serum creatinine level in placebo-controlled randomized trials showed no appreciable effect on CKD or mortality months later, raising questions about the value of using small to moderate changes in serum creatinine level as end points in clinical trials. Copyright © 2016 by the American Society of Nephrology.

  16. Corpus callosum atrophy as a marker of clinically meaningful cognitive decline in secondary progressive multiple sclerosis. Impact on employment status.

    Science.gov (United States)

    Papathanasiou, Athanasios; Messinis, Lambros; Zampakis, Petros; Papathanasopoulos, Panagiotis

    2017-09-01

    Cognitive impairment in Multiple Sclerosis (MS) is more frequent and pronounced in secondary progressive MS (SPMS). Cognitive decline is an important predictor of employment status in patients with MS. Magnetic Resonance Imaging (MRI) markers have been used to associate tissue damage with cognitive dysfunction. The aim of the study was to designate the MRI marker that predicts cognitive decline in SPMS and explore its effect on employment status. 30 SPMS patients and 30 healthy participants underwent neuropsychological assessment using the Trail Making Test (TMT) parts A and B, semantic and phonological verbal fluency task and a computerized cognitive screening battery (Central Nervous System Vital Signs). Employment status was obtained as a quality of life measure. Brain MRI was performed in all participants. We measured total lesion volume, third ventricle width, thalamic and corpus callosum atrophy. The frequency of cognitive decline for our SPMS patients was 80%. SPMS patients differed significantly from controls in all neuropsychological measures. Corpus callosum area was correlated with cognitive flexibility, processing speed, composite memory, executive functions, psychomotor speed, reaction time and phonological verbal fluency task. Processing speed and composite memory were the most sensitive markers for predicting employment status. Corpus callosum area was the most sensitive MRI marker for memory and processing speed. Corpus callosum atrophy predicts a clinically meaningful cognitive decline, affecting employment status in our SPMS patients. Copyright © 2017 Elsevier Ltd. All rights reserved.

  17. Clinically meaningful differences in pain, disability and quality of life for chronic nonspecific neck pain - a reanalysis of 4 randomized controlled trials of cupping therapy.

    Science.gov (United States)

    Lauche, Romy; Langhorst, Jost; Dobos, Gustav J; Cramer, Holger

    2013-08-01

    The assessment of clinically meaningful differences in patients' self-reported outcomes has become increasingly important when interpreting the results of clinical studies. Although these assessments have become quite common there are hardly any data for nonspecific neck pain, especially in the context of complementary and alternative medicine. The aim of this analysis is the determination of minimal clinically important differences (MCID) and substantial clinical benefits (SCB) in patients with chronic nonspecific neck pain after cupping treatment. The data set comprised a total of 200 patients with chronic nonspecific neck pain participating in clinical trials on cupping therapy. The MCID and SCB for pain intensity (VAS), neck disability index (NDI) and the subscale bodily pain (SF-36-BP) as well as physical component summary (SF-36-PCS) of the SF-36 were determined using receiver operating characteristic (ROC) curve analysis with an adapted assessment of change in health status (SF-36), i.e. a 5-point Likert scale ranging from "much better" to "much worse", as anchor. MCID derived from the ROC was the score to distinguish "somewhat better" from "about the same", and the SCB was the score to distinguish "much better" from "somewhat better". The calculated MCIDs were: -8mm (-21%) for VAS, -3 points (-10.2%) for NDI, +10 points (+20.5%) for SF-36-BP and +2.6 points (+7.7%) for SF-36-PCS. The SCBs were: -26.5mm (-66.8%) for VAS, -8.4 points (-29%) for NDI, +15.5 points (+43.1%) for SF-36-BP and +5.1 points (+12.9%) for SF-36-PCS. Accuracy of the estimations was good for MCID in general and for SCB regarding VAS and NDI. The results support the assumption that patients' perceptions of treatment benefits measured by VAS in these trials might be comparable to others in conventional therapies. For NDI and SF-36-PCS the estimated differences were smaller than in previous reports indicating that context factors such as patient characteristics and specific treatment

  18. Clinical Evidence of Exercise Benefits for Stroke.

    Science.gov (United States)

    Han, Peipei; Zhang, Wen; Kang, Li; Ma, Yixuan; Fu, Liyuan; Jia, Liye; Yu, Hairui; Chen, Xiaoyu; Hou, Lin; Wang, Lu; Yu, Xing; Kohzuki, Masahiro; Guo, Qi

    2017-01-01

    Even though stroke is the third, not the first, most common cause of disability-adjusted life years in developed countries, it is one of the most expensive to treat. Part of the expense is due to secondary problems in the post-stroke period including: cognition, memory, attention span, pain, sensation loss, psychological issues, and problems with mobility and balance. Research has identified that exercise has both positive physical and psychosocial effects for post-stroke patients. Therefore, this scientific statement provides an overview on exercise rehabilitation for post-stroke patients.We will use systematic literature reviews, clinical and epidemiology reports, published morbidity and mortality studies, clinical and public health guidelines, patient files, and authoritative statements to support this overview.Evidence clearly supports the use of various kinds of exercise training (e.g., aerobic, strength, flexibility, neuromuscular, and traditional Chinese exercise) for stroke survivors. Aerobic exercise, the main form of cardiac rehabilitation, may play an important role in improving aerobic fitness, cardiovascular fitness, cognitive abilities, walking speed and endurance, balance, quality of life, mobility, and other health outcomes among stroke patients. Strength exercise, included in national stroke guidelines and recommended for general health promotion for stroke survivors, can lead to improvements in functionality, psychosocial aspects, and quality of life for post-stroke patients. Flexibility exercises can relieve muscle spasticity problems, improve motor function, range of motion, and prevent contractures. Stretching exercises can also prevent joint contractures, muscle shortening, decrease spasticity, reduce joint stiffness and improve a post-stroke patient's overall function. Neuromuscular exercises can improve activities of daily living (ADL) through coordination and balance activities. Traditional Chinese exercises are used to improve walking and

  19. Clinical benefit and preservation of flavonols in dark chocolate manufacturing.

    Science.gov (United States)

    McShea, Andrew; Ramiro-Puig, Emma; Munro, Sandra B; Casadesus, Gemma; Castell, Margarida; Smith, Mark A

    2008-11-01

    The consumption of high-cacao-content chocolate has been associated with positive health benefits ascribed to flavanol [corrected] antioxidants derived from the ground, fermented cocoa seeds of Theobroma cacao. However, flavanols [corrected] impart a bitter, astringent flavor to foodstuffs, frequently masked in chocolates and confections by aggressive processing and adulteration with other flavors. Recent reports have implied that not all varieties of dark chocolate are created equally, and significant caveats exist regarding its potential health benefits. It is perhaps not surprising that extensive processing, dilution, and the addition of flavor modifiers may improve the palatability of chocolate, but could have negative nutritional and clinical benefits. This article examines the chemical composition of chocolate and the clinical data associated with the consumption of flavonoid-rich cocoa. We review the steps in chocolate manufacturing that directly affect the antioxidant levels in chocolate products, and the caveats associated with claims of health benefits from the consumption of dark chocolate.

  20. Benefits and Burdens of Participation in a Longitudinal Clinical Trial

    Science.gov (United States)

    Lazovski, Jaime; Losso, Marcelo; Krohmal, Benjamin; Emanuel, Ezekiel J.; Grady, Christine; Wendler, David

    2010-01-01

    systematic data on the impact that longitudinal clinical trials have on patient participants are needed to ensure that all the risks and potential benefits of participating in clinical research are properly evaluated and disclosed. Recognizing the lack of systematic data on this topic, we surveyed 582 individuals from Argentina, Brazil, and Thailand who were participating in the ESPRIT study, a Phase III randomized trial of interleukin-2 in HIV disease. Respondents were asked about the benefits and burdens of participating in ESPRIT using a self-administered survey. We found that 91% of respondents in the IL-2 treatment arm and 79% in the no IL-2 control arm reported medical benefits from their participation. In addition, 68% in the IL-2 treatment arm and 60% of the no IL-2 controls reported non-medical benefits. Thirteen percent of the IL-2 respondents and 5% of the non-IL2 respondents reported problems with their jobs due to study participation. Given that respondents, including those in the control arm, reported medical and non-medical benefits and burdens from their research participation, investigators and review committees should be aware of and respond to the potential for research participants to experience benefits and burdens that are unrelated to the intervention being tested. PMID:19754238

  1. Clinical meaningfulness of Alzheimer's Disease Assessment Scale-Cognitive subscale change in relation to goal attainment in patients on cholinesterase inhibitors.

    Science.gov (United States)

    Rockwood, Kenneth; Howlett, Susan E; Hoffman, Deborah; Schindler, Rachel; Mitnitski, Arnold

    2017-10-01

    The clinical meaningfulness of Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog) subscale change is disputed. We compared 2- to 4-point ADAS-Cog changes with changes in Goal Attainment Scaling (GAS) and everyday function across initial ADAS-Cog scores and treatment responses. This exploratory analysis evaluated mild-moderate Alzheimer's disease patients treated with donepezil (12 months) or galantamine (8 months). Clinical meaningfulness was defined as concomitant ADAS-Cog and GAS changes of ±3 points and/or functional improvement. Patients with ≥3-point ADAS-Cog improvement significantly improved on GAS but not on standard tests of everyday function. ADAS-Cog "no change" (≤±3 points) was seen with mean GAS improvement. Initial ADAS-Cog improvement made endpoint improvement (ADAS-Cog 3 points and GAS 1 point) more likely (odds ratio = 6.9; 95% confidence interval = 2.5-19.5). In contrast, initial deterioration made endpoint improvement unlikely (0.33; 0.14-0.64). ADAS-Cog improvement and no change were each associated with GAS improvement. Initial ADAS-Cog worsening was unlikely to result in later improvement. ISRCTN26167328. Copyright © 2017. Published by Elsevier Inc.

  2. Aligning institutional priorities: engaging house staff in a quality improvement and safety initiative to fulfill Clinical Learning Environment Review objectives and electronic medical record Meaningful Use requirements.

    Science.gov (United States)

    Flanagan, Meghan R; Foster, Carolyn C; Schleyer, Anneliese; Peterson, Gene N; Mandell, Samuel P; Rudd, Kristina E; Joyner, Byron D; Payne, Thomas H

    2016-02-01

    House staff quality improvement projects are often not aligned with training institution priorities. House staff are the primary users of inpatient problem lists in academic medical centers, and list maintenance has significant patient safety and financial implications. Improvement of the problem list is an important objective for hospitals with electronic health records under the Meaningful Use program. House staff surveys were used to create an electronic problem list manager (PLM) tool enabling efficient problem list updating. Number of new problems added and house staff perceptions of the problem list were compared before and after PLM intervention. The PLM was used by 654 house staff after release. Surveys demonstrated increased problem list updating (P = .002; response rate 47%). Mean new problems added per day increased from 64 pre-PLM to 125 post-PLM (P house staff in institutional quality and safety initiatives with tangible institutional benefits. Copyright © 2016 Elsevier Inc. All rights reserved.

  3. A Survey of the Non-clinical Benefits of EBVM

    Directory of Open Access Journals (Sweden)

    Sarah Hauser

    2017-08-01

    Full Text Available Objective: This study aims to add non-clinical benefits to the virtues for adopting Evidence-based Veterinary Medicine (EBVM. The objective is to quantify the commercial benefits of EBVM through an online survey of veterinary professionals, giving clear indications of the key areas of non-clinical benefits of EBVM. Further, the study aims to outline barriers to the wider implementation of EBVM and find preferred ways of overcoming those barriers.Background: A PICO-based literature review (Hauser and Jackson, 2016 found that while there are some papers suggesting a link between the practice of EBVM and better non-clinical benefits such as client satisfaction, a single study, focusing on the non-clinical benefits of EBVM, had yet to be conducted. This study builds on the findings of an exploratory study (Jackson and Hauser, 2017 outlining key areas of non-clinical benefits of EBVM: increased client satisfaction and retention, improved reputation, confidence, as well as employee engagement.Evidentiary value: This online survey of veterinary professionals (n=407 provides evidence for practitioners, universities and other veterinary staff regarding the non-clinical benefits of EBVM, the barriers to a wider adoption of the practice and ways of overcoming those barriers.Methods: The online survey of veterinary professionals was conducted during September – October 2016 and contained 23 questions. Survey participation was voluntary and the data used for analysis were de-identified.Results: The survey responses of 407 veterinary professionals provide quantitative evidence of how EBVM is put into practice, how EBVM is perceived to impact client behaviour and employee engagement, what the barriers are to practising EBVM and how these could be overcome. Key findings are that veterinary professionals are more likely to practise EBVM if they have been taught how to do so at vet school. EBVM is a way to provide value to and build trust with clients. Survey

  4. Targeting small airways in asthma: Improvement in clinical benefit?

    DEFF Research Database (Denmark)

    Ulrik, Charlotte Suppli; Lange, Peter

    2010-01-01

    Background and Aim:  Disease control is not achieved in a substantial proportion of patients with asthma. Recent advances in aerosol formulations and delivery devices may offer more effective therapy. This review will focus on the importance and potential clinical benefit of targeting the lung...... half the daily dose with no increased risk of systemic effects. Clinical studies of adults with asthma have shown a greater effect of ultrafine ICS, compared with non-ultrafine ICS, on quality of life, small airway patency, and markers of pulmonary and systemic inflammation, but no difference...... with regard to conventional clinical indices of lung function and asthma control. Conclusions:  Asthma patients treated with ultrafine ICS, compared with non-ultrafine ICS, have at least similar chance of achieving asthma control at a lower daily dose. Further clinical studies are needed to explore whether...

  5. Targeting small airways in asthma: Improvement in clinical benefit?

    DEFF Research Database (Denmark)

    Ulrik, Charlotte Suppli; Lange, Peter

    2010-01-01

    Background and Aim: Disease control is not achieved in a substantial proportion of patients with asthma. Recent advances in aerosol formulations and delivery devices may offer more effective therapy. This review will focus on the importance and potential clinical benefit of targeting the lung...... half the daily dose with no increased risk of systemic effects. Clinical studies of adults with asthma have shown a greater effect of ultrafine ICS, compared with non-ultrafine ICS, on quality of life, small airway patency, and markers of pulmonary and systemic inflammation, but no difference...... with regard to conventional clinical indices of lung function and asthma control. Conclusions: Asthma patients treated with ultrafine ICS, compared with non-ultrafine ICS, have at least similar chance of achieving asthma control at a lower daily dose. Further clinical studies are needed to explore whether...

  6. Evidence based exercise - clinical benefits of high intensity interval training.

    Science.gov (United States)

    Shiraev, Tim; Barclay, Gabriella

    2012-12-01

    Aerobic exercise has a marked impact on cardiovascular disease risk. Benefits include improved serum lipid profiles, blood pressure and inflammatory markers as well as reduced risk of stroke, acute coronary syndrome and overall cardiovascular mortality. Most exercise programs prescribed for fat reduction involve continuous, moderate aerobic exercise, as per Australian Heart Foundation clinical guidelines. This article describes the benefits of exercise for patients with cardiovascular and metabolic disease and details the numerous benefits of high intensity interval training (HIIT) in particular. Aerobic exercise has numerous benefits for high-risk populations and such benefits, especially weight loss, are amplified with HIIT. High intensity interval training involves repeatedly exercising at a high intensity for 30 seconds to several minutes, separated by 1-5 minutes of recovery (either no or low intensity exercise). HIT is associated with increased patient compliance and improved cardiovascular and metabolic outcomes and is suitable for implementation in both healthy and 'at risk' populations. Importantly, as some types of exercise are contraindicated in certain patient populations and HIIT is a complex concept for those unfamiliar to exercise, some patients may require specific assessment or instruction before commencing a HIIT program.

  7. Effect of comorbid tics on a clinically meaningful response to 8-week open-label trial of fluoxetine in obsessive compulsive disorder.

    Science.gov (United States)

    Husted, David S; Shapira, Nathan A; Murphy, Tanya K; Mann, Giselle D; Ward, Herbert E; Goodman, Wayne K

    2007-01-01

    Currently, there are limited published data evaluating the effects of tics on serotonin reuptake inhibitor (SRI) monotherapy responses in treating obsessive-compulsive disorder (OCD). One retrospective case-controlled analysis of OCD patients treated with SRI monotherapy showed lesser improvement in OCD symptoms in patients with tics than those without. However, more recently there were preliminary reports of OCD subjects treated with SRI monotherapy which did not demonstrate poorer response in subjects with tics or Tourette's Syndrome (TS). The specific aim of this study was to investigate whether the presence of comorbid chronic tics affected "clinically meaningful improvement" [McDougle, C.J., Goodman, W.K., Leckman, J.F., Barr, L.C., Heninger, G.R., Price, L.H., 1993. The efficacy of fluvoxamine in obsessive-compulsive disorder: effects of comorbid chronic tic disorder. Journal of Clinical Psychopharmacology 13, 354-358] of OCD in an 8-week open-label trial of fluoxetine monotherapy. Seventy-four adult subjects (13 patients with comorbid chronic tics and 61 patients without tics) with a primary DSM-IV OCD diagnosis were treated with up to 40mg fluoxetine for 8 weeks and had at least one post-baseline evaluation. The results indicate that there was a significant response by time in both fluoxetine-with-tic subjects and fluoxetine-without-tic subjects. Additionally, there were 3 (23.0%) OCD subjects with tics who had clinically meaningful improvement versus 16 (26.2%) OCD subjects without tics that demonstrated similar levels of improvement. These findings indicate that OCD patients with or without chronic tic disorders did not have a differential response to an 8-week open-label trial of fluoxetine. Limitations include the relatively low number of tic subjects and the open-label nature of the study. Additional data are needed on how comorbid tics may affect SRI treatment response in OCD.

  8. Electronic clinical safety reporting system: a benefits evaluation.

    Science.gov (United States)

    Elliott, Pamela; Martin, Desmond; Neville, Doreen

    2014-06-11

    Eastern Health, a large health care organization in Newfoundland and Labrador (NL), started a staged implementation of an electronic occurrence reporting system (used interchangeably with "clinical safety reporting system") in 2008, completing Phase One in 2009. The electronic clinical safety reporting system (CSRS) was designed to replace a paper-based system. The CSRS involves reporting on occurrences such as falls, safety/security issues, medication errors, treatment and procedural mishaps, medical equipment malfunctions, and close calls. The electronic system was purchased from a vendor in the United Kingdom that had implemented the system in the United Kingdom and other places, such as British Columbia. The main objective of the new system was to improve the reporting process with the goal of improving clinical safety. The project was funded jointly by Eastern Health and Canada Health Infoway. The objectives of the evaluation were to: (1) assess the CSRS on achieving its stated objectives (particularly, the benefits realized and lessons learned), and (2) identify contributions, if any, that can be made to the emerging field of electronic clinical safety reporting. The evaluation involved mixed methods, including extensive stakeholder participation, pre/post comparative study design, and triangulation of data where possible. The data were collected from several sources, such as project documentation, occurrence reporting records, stakeholder workshops, surveys, focus groups, and key informant interviews. The findings provided evidence that frontline staff and managers support the CSRS, identifying both benefits and areas for improvement. Many benefits were realized, such as increases in the number of occurrences reported, in occurrences reported within 48 hours, in occurrences reported by staff other than registered nurses, in close calls reported, and improved timelines for notification. There was also user satisfaction with the tool regarding ease of use

  9. The clinical meaningfulness of ADAS-Cog changes in Alzheimer's disease patients treated with donepezil in an open-label trial.

    Science.gov (United States)

    Rockwood, Kenneth; Fay, Sherri; Gorman, Mary; Carver, Daniel; Graham, Janice E

    2007-08-30

    In 6-month anti-dementia drug trials, a 4-point change in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) is held to be clinically important. We examined how this change compared with measures of clinical meaningfulness. This is a secondary analysis of a 12 month open-label study of 100 patients (71 women) diagnosed with mild to moderate AD treated with 5-10 mg of donepezil daily. We studied the observed case, 6-month change from baseline on the ADAS-Cog, the Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-Plus), patient-Goal Attainment Scaling (PGAS) and clinician-GAS (CGAS). At 6 months, donepezil-treated patients (n = 95) were more likely to show no change (+/- 3 points) on the ADAS-Cog (56%) than to improve (20%) or decline (24%) by 4-points. ADAS-Cog change scores were little correlated with other measures: from -0.09 for PGAS to 0.27 for the CIBIC-Plus. While patients who improved on the ADAS-Cog were less likely to decline on the clinical measures (26%), 43% of patients who declined on the ADAS-Cog improved on at least two of the clinical measures. The ADAS-Cog did not capture all clinically important effects. In general, ADAS-Cog improvement indicates clinical improvement, whereas many people with ADAS-Cog decline do not show clinical decline. The open-label design of this study does not allow us to know whether this is a treatment effect, which requires further investigation.

  10. Avoidance of androgen deprivation therapy in radiorecurrent prostate cancer as a clinically meaningful endpoint for salvage cryoablation.

    Science.gov (United States)

    Ginsburg, Kevin B; Elshafei, Ahmed; Yu, Changhong; Jones, J Stephen; Cher, Michael L

    2017-10-01

    To investigate the ability of salvage cryoablation of the prostate (SCAP) to delay the need for androgen deprivation therapy (ADT) in local recurrence after radiation therapy to the prostate using the Cryo-On-Line Database (COLD) registry. The COLD registry is comprised of a combination of retrospectively and prospectively collected data on patients undergoing primary and SCAP. Patients with local recurrence after radiation therapy were identified. Kaplan-Meier analysis was used to calculate ADT-free survival. We identified 898 patients that have undergone SCAP in the COLD registry. Overall, the calculated 5-year ADT-free survival probability was 0.713. When stratified by D'Amico risk group, 264 high-risk patients (71.9%), 234 intermediate-risk (86.7%),and 228 low-risk (87.7%) were free of ADT post-SCAP. This correlates with a 5-year ADT-free survival of 60.7, 73.9, and 82.4%, respectively. Patients with post-SCAP PSA nadir of <0.2 ng/mL had a 5 year ADT-free survival of 87.1% compared to 48.7% with a PSA nadir ≥0.2 ng/mL. Pre-operative ADT use or full versus partial gland SCAP did not have an effect on ADT use post-operatively. In 118 (55.4%) of patients with post-operative biochemical recurrence, ADT was not used. For patients with local recurrence after radiation, SCAP is an option that provides a high chance of avoiding or delaying ADT. The potential to delay ADT and its associated side effects should be a part of counseling sessions with the patient when discussing treatment options for locally recurrent prostate cancer after radiation. Avoidance of ADT is more clinically relevant than PSA elevation. © 2017 Wiley Periodicals, Inc.

  11. [3D imaging benefits in clinical pratice of orthodontics].

    Science.gov (United States)

    Frèrejouand, Emmanuel

    2016-12-01

    3D imaging possibilities raised up in the last few years in the orthodontic field. In 2016, it can be used for diagnosis improvement and treatment planning by using digital set up combined to CBCT. It is relevant for orthodontic mechanic updating by creating visible or invisible customised appliances. It forms the basis of numerous scientific researches. The author explains the progress 3D imaging brings to diagnosis and clinics but also highlights the requirements it creates. The daily use of these processes in orthodontic clinical practices needs to be regulated regarding the benefit/risk ratio and the patient satisfaction. The command of the digital work flow created by these technics requires habits modifications from the orthodontist and his staff. © EDP Sciences, SFODF, 2016.

  12. Roflumilast: clinical benefit in patients suffering from COPD

    DEFF Research Database (Denmark)

    Ulrik, Charlotte Suppli; Calverley, Peter Michael Anthony

    2010-01-01

    BACKGROUND AND AIMS: Chronic obstructive pulmonary disease (COPD) is associated with substantial morbidity and mortality and is characterised by persistent airway inflammation, which leads to impaired airway function, quality of life and intermittent exacerbations. In spite of recent advances...... in the treatment of COPD, new treatment options for COPD are clearly necessary. The oral phosphodiesterase-4 (PDE4) inhibitor roflumilast represents a new class of drugs that has shown efficacy and acceptable tolerability in preclinical and short-term clinical studies in patients with COPD. METHODS AND RESULTS......) , and a reduction in frequency and severity of COPD exacerbations, as well as a positive effect on several patient-reported outcomes. The clinical benefit of roflumilast appears to be greatest in patients with more symptomatic and severe disease who experience exacerbations. The most common adverse effects...

  13. Roflumilast: clinical benefit in patients suffering from COPD

    DEFF Research Database (Denmark)

    Ulrik, Charlotte Suppli; Calverley, Peter Michael Anthony

    2010-01-01

    BACKGROUND AND AIMS:  Chronic obstructive pulmonary disease (COPD) is associated with substantial morbidity and mortality and is characterised by persistent airway inflammation, which leads to impaired airway function, quality of life and intermittent exacerbations. In spite of recent advances...... in the treatment of COPD, new treatment options for COPD are clearly necessary. The oral phosphodiesterase-4 (PDE4) inhibitor roflumilast represents a new class of drugs that has shown efficacy and acceptable tolerability in preclinical and short-term clinical studies in patients with COPD. METHODS AND RESULTS......) , and a reduction in frequency and severity of COPD exacerbations, as well as a positive effect on several patient-reported outcomes. The clinical benefit of roflumilast appears to be greatest in patients with more symptomatic and severe disease who experience exacerbations. The most common adverse effects...

  14. Clinical benefit of antiangiogenic therapy in advanced and metastatic chondrosarcoma.

    Science.gov (United States)

    Jones, Robin L; Katz, Daniela; Loggers, Elizabeth T; Davidson, Darin; Rodler, Eve T; Pollack, Seth M

    2017-08-29

    Chondrosarcoma is the most common bone sarcoma in adults. Conventional chondrosarcoma, the commonest histological subtype, is largely resistant to anthracycline-based chemotherapy. There have been anecdotal reports of durable clinical benefit with antiangiogenic agents in this disease. A retrospective search of patients treated at three sarcoma referral centers was performed to identify patients with advanced chondrosarcoma treated with antiangiogenic agents. The aim of this study was to evaluate the efficacy and safety of antiangiogenic agents in advanced chondrosarcoma. Ten patients were identified; seven with conventional, one each with clear cell, extraskeletal mesenchymal chondrosarcoma and extraskeletal myxoid chondrosarcoma. The median progression-free survival for patients with conventional and clear cell sarcoma was 22.6 months. Median overall survival has not been met. Antiangiogenic therapy was well tolerated in this series of patients. Our retrospective data suggest that antiangiogenic therapy can provide prolonged clinical benefit in advanced chondrosarcoma patients. Further prospective trials are required to precisely define the role of this class of agent in advanced chondrosarcoma.

  15. Clinically meaningful scores on pain catastrophizing before and after multidisciplinary rehabilitation: a prospective study of individuals with subacute pain after whiplash injury.

    Science.gov (United States)

    Scott, Whitney; Wideman, Timothy H; Sullivan, Michael J L

    2014-03-01

    Pain catastrophizing has emerged as a significant risk factor for problematic recovery after musculoskeletal injury. As such, there has been an increased focus on interventions that target patients' levels of catastrophizing. However, it is not presently clear how clinicians might best interpret scores on catastrophizing before and after treatment. Thus, the purpose of this study was to provide preliminary guidelines for the clinical interpretation of scores on pain catastrophizing among individuals with subacute pain after musculoskeletal injury. A sample of 166 occupationally disabled individuals with subacute pain due to a whiplash injury participated in this study. Participants completed a 7-week standardized multidisciplinary rehabilitation program aimed at fostering functional recovery. Participants completed the Pain Catastrophizing Scale (PCS) upon program commencement and completion. One year later, participants indicated their pain severity and involvement in employment activities. Separate receiver operating characteristic curve analyses were conducted to determine absolute pretreatment and posttreatment and percent change scores on the PCS that were best associated with clinically important levels of pain and employment status at the follow-up. An absolute pretreatment PCS score of 24 best identified patients according to follow-up clinical outcomes. Posttreatment PCS scores of 14 and 15 best identified patients with high follow-up pain intensity ratings and those who did not return to work, respectively. PCS reductions of approximately 38% to 44% were best associated with return to work and low pain intensity ratings at follow-up. The results indicate scores on catastrophizing before and after treatment that are clinically meaningful. These results may serve as preliminary guidelines to assess the clinical significance of interventions targeting pain catastrophizing in patients with subacute pain after musculoskeletal injury.

  16. The use of a responder analysis to identify clinically meaningful differences in chronic urticaria patients following placebo- controlled treatment with rupatadine 10 and 20 mg.

    Science.gov (United States)

    Giménez-Arnau, A; Izquierdo, I; Maurer, M

    2009-09-01

    According to the EAACI/GA(2)LEN/EDF guidelines for urticaria management, modern non-sedating H1-antihistamines are the first-line symptomatic treatment for chronic urticaria. Two previous randomized clinical trials demonstrated rupatadine efficacy and safety in chronic urticaria treatment. However, a responder analysis to identify clinically meaningful differences in patients with chronic urticaria has not yet been performed. This analysis includes the pooled data from two randomized, double-blind, placebo-controlled, multicentre studies in which chronic urticaria patients were treated with rupatadine at different doses. Responder rates were defined as the percentage of patients after 4 weeks of treatment who exhibited a reduction of symptoms by at least 50% or 75% as compared to baseline. The variables analysed were as follows: Mean Pruritus Score (MPS), Mean Number of Wheals (MNW), and Mean Urticaria Activity Score (UAS). A total of 538 patients were included. This responder analysis, using different response levels, shows that the efficacy of rupatadine 10 mg and 20 mg is significantly better as compared to placebo in the treatment of chronic urticaria patients. Notably, treatment with rupatadine 20 mg daily resulted in a higher percentage of patients with response of 75% symptom reduction or better than rupatadine 10 mg. Our results support the use of higher than standard doses of non sedating antihistamines in chronic urticaria. We strongly recommend performing and reporting responder analyses for established and new drugs used by patients with chronic urticaria.

  17. Can emergency medicine research benefit from adaptive design clinical trials?

    Science.gov (United States)

    Flight, Laura; Julious, Steven A; Goodacre, Steve

    2017-04-01

    Adaptive design clinical trials use preplanned interim analyses to determine whether studies should be stopped or modified before recruitment is complete. Emergency medicine trials are well suited to these designs as many have a short time to primary outcome relative to the length of recruitment. We hypothesised that the majority of published emergency medicine trials have the potential to use a simple adaptive trial design. We reviewed clinical trials published in three emergency medicine journals between January 2003 and December 2013. We determined the proportion that used an adaptive design as well as the proportion that could have used a simple adaptive design based on the time to primary outcome and length of recruitment. Only 19 of 188 trials included in the review were considered to have used an adaptive trial design. A total of 154/165 trials that were fixed in design had the potential to use an adaptive design. Currently, there seems to be limited uptake in the use of adaptive trial designs in emergency medicine despite their potential benefits to save time and resources. Failing to take advantage of adaptive designs could be costly to patients and research. It is recommended that where practical and logistical considerations allow, adaptive designs should be used for all emergency medicine clinical trials. 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/.

  18. Biochemical Benefits, Diagnosis, and Clinical Risks Evaluation of Kratom

    Directory of Open Access Journals (Sweden)

    Dimy Fluyau

    2017-04-01

    Full Text Available BackgroundKratom (Mitragyna speciosa is a tropical tree with a long history of traditional use in parts of Africa and Southeast Asia. Kratom is also known as Thom, Thang, and Biak. Its leaves and the teas brewed from them have long been used by people in that region to manage pain and opioid withdrawal and to stave off fatigue. Kratom is actually consumed throughout the world for its stimulant effects and as an opioid substitute (in form of tea, chewed, smoked, or ingested in capsules. Some case reports have associated kratom exposure with psychosis, seizures, intrahepatic cholestasis, other medical conditions, and deaths. The clinical manifestations of kratom effects are not well defined and the clinical studies are limited. Data research suggest that both stimulant and sedative dose-dependent effects do exist, in addition to antinociceptive, antidepressant activity, anxiolytic-like effects, and anorectic effects, but a growing concern for the drug’s effects and safety of use has resulted in national and international attention primarily due to an increase in hospital visits and deaths in several countries that are believed to have been caused by extracts of the plant. There is a dearth of double blind controlled studies. In this study, we aim to use existing literature to clarify both benefits and risks of kratom as well as its diagnosis evaluation as kratom misuse is an emerging trend in the Western world.MethodsLiterature review using databases such as Embase, Medline, PubMed, Cochrane Library, and Mendeley from 2007 to 2017 were evaluated by all authors to analyze current state on benefits, risks, and diagnosis evaluation of kratom (M. speciosa.ResultsData analysis suggested that kratom possesses some benefits such as stimulant and sedative effects as wells as antinociceptive effects. It seems to inhibit pro-inflammatory mediator release and vascular permeability and can enhance immunity. In addition, it may be an antidepressant and

  19. Antibiotics in aggressive periodontitis, is there a clinical benefit?

    Science.gov (United States)

    Rajendra, Anjana; Spivakovsky, Silvia

    2016-12-01

    Data sourcesMedline, Embase and CENTRAL databases were searched up to December 2014. Unpublished data were sought by searching a database listing unpublished studies OpenGray [http://www.opengrey.eu/], formerly OpenSIGLE.Study selectionRandomised clinical trials assessing treatment of patients with AgP comparing scaling and root planing (SRP) alone with SRP plus a single antibiotic or a combination of drugs with a minimum of three months follow-up were considered. Studies specifically designed to evaluate smokers or subjects with diabetes mellitus and HIV/AIDS were not included.Data extraction and synthesisTwo researchers independently screened titles, abstracts and full texts of the search results. The studies, which fulfilled inclusion criteria, underwent validity assessment and data extraction using a specifically designed form. The quality of included studies was assessed using the Cochranes collaboration tool for risk of bias. Only two of the 11 included trials were considered at a low risk of bias. The data extracted from ten studies was analysed by pair-wise meta-analyses and the data extracted from five studies was included in Bayesian network meta-analyses pooled estimates. The six studies evaluated in the pairwise meta-analyses were excluded in the pooled estimates because four studies included patients with advanced disease only and one study did not present average data for pocket depth (PD) and clinical attachment level (CAL) and another one for using a different mechanical treatment.ResultsFourteen studies reporting 11 randomised clinical trials with a total of 388 patients were included in the review. Nine of 11 studies reported a statistically significant greater gain in full mouth mean clinical attachment (CA) and reduction in probing depth (PD) when a systemic antibiotic was used. From those studies the calculated mean difference for CA gained was 1.08 mm (p benefits in CA gain and PD reduction when SRP was associated with systemic antibiotics

  20. The challenge of a meaningful job

    DEFF Research Database (Denmark)

    Jepsen, Ingrid

    and the feeling of doing high quality care generate job satisfaction. The obligation and pressure to perform well and the disadvantages on the midwives’ private lives is counterbalanced by the feeling of doing a meaningful and important job. Working in caseload midwifery creates a feeling of working in a self....... The methodology was inspired by ethnography, and applied methods were field observations followed by interviews. Participants: Thirteen out of eighteen midwives working in caseloads were observed during one or two days in the antenatal clinic and interviewed at a later occasion. Findings: The recognition......-governing model within the public hospital, without losing the technological benefits of a modern birth unit. For pregnant women with a challenging personality or attitude towards others, Caseload midwifery may provide an extra opportunity to feel recognized and respected. Key conclusions: Caseload midwifery...

  1. Clinical benefit response of concurrent chemoradiotherapy with protracted 5-fluorouracil infusion in patients with locally advanced pancreatic cancer

    International Nuclear Information System (INIS)

    Okusaka, Takuji; Okada, Shuichi; Ishii, Hiroshi

    1998-01-01

    Pancreatic cancer is a highly virulent disease with a poor prognosis. Although objective tumor response to chemotherapy and/or radiotherapy is low, some patients show an improvement in their symptoms after treatments, without obvious tumor regression. We assessed the clinical benefit of concurrent chemoradiotherapy with protracted 5-fluorouracil infusion in patients with locally advanced pancreatic cancer. Sixteen patients were enrolled in this study. The clinical benefit response to the chemoradiotherapy was evaluated by 2 indicators, including pain (intensity of pain and consumption of morphine) and performance status. A patient was defined to be a clinical benefit responder if 1 of these 2 variables was positive, and the other variable was positive or stable. Seven patients (44%) responded. Six patients (38%) were classified as stable, and 3 (19%) as nonresponders. The survival period in responders was significantly longer than that in nonresponders and stable patients. Concurrent external-beam radiation therapy, with protracted 5-fluorouracil infusion, may be a meaningful treatment for locally advanced pancreatic cancer. (author)

  2. Clinical imaging guidelines part 2: Risks, benefits, barriers, and solutions.

    Science.gov (United States)

    Malone, James; del Rosario-Perez, Maria; Van Bladel, Lodewijk; Jung, Seung Eun; Holmberg, Ola; Bettmann, Michael A

    2015-02-01

    A recent international meeting was convened by two United Nations bodies to focus on international collaboration on clinical appropriateness/referral guidelines for use in medical imaging. This paper, the second of 4 from this technical meeting, addresses barriers to the successful development/deployment of clinical imaging guidelines and means of overcoming them. It reflects the discussions of the attendees, and the issues identified are treated under 7 headings: ■ Practical Strategy for Development and Deployment of Guidelines; ■ Governance Arrangements and Concerns with Deployment of Guidelines; ■ Finance, Sustainability, Reimbursement, and Related Issues; ■ Identifying Benefits and Radiation Risks from Radiological Examinations; ■ Information Given to Patients and the Public, and Consent Issues; ■ Special Concerns Related to Pregnancy; and ■ The Research Agenda. Examples of topics identified include the observation that guideline development is a global task and there is no case for continuing it as the project of the few professional organizations that have been brave enough to make the long-term commitment required. Advocacy for guidelines should include the expectations that they will facilitate: (1) better health care delivery; (2) lower cost of that delivery; with (3) reduced radiation dose and associated health risks. Radiation protection issues should not be isolated; rather, they should be integrated with the overall health care picture. The type of dose/radiation risk information to be provided with guidelines should include the uncertainty involved and advice on application of the precautionary principle with patients. This principle may be taken as an extension of the well-established medical principle of "first do no harm." Copyright © 2015. Published by Elsevier Inc.

  3. Meaningful and Purposeful Practice

    Science.gov (United States)

    Clementi, Donna

    2014-01-01

    This article describes a graphic, designed by Clementi and Terrill, the authors of "Keys to Planning for Learning" (2013), visually representing the components that contribute to meaningful and purposeful practice in learning a world language, practice that leads to greater proficiency. The entire graphic is centered around the letter…

  4. Clinical Benefit of Allogeneic Melanoma Cell Lysate-Pulsed Autologous Dendritic Cell Vaccine in MAGE-Positive Colorectal Cancer Patients

    DEFF Research Database (Denmark)

    Toh, Han Chong; Wang, Who-Whong; Chia, Whay Kuang

    2009-01-01

    PURPOSE: We evaluated the clinical benefit of an allogeneic melanoma cell lysate (MCL)-pulsed autologous dendritic cell (DC) vaccine in advanced colorectal cancer patients expressing at least one of six MAGE-A antigens overexpressed by the cell line source of the lysate. EXPERIMENTAL DESIGN: DCs...... were cultured from peripheral blood mononuclear cells (PBMC), pulsed with the allogeneic MCL, and matured using cytokines that achieved high CD83- and CCR7-expressing DCs. Each patient received up to 10 intradermal vaccinations (3-5 x 10(6) cells per dose) at biweekly intervals. RESULTS: Twenty......-free for >27 and >37 months, respectively. This result is particularly meaningful as all patients had progressive disease before treatment. Overall, DC vaccination was associated with a serial decline in regulatory T cells. Using an antibody array, we characterized plasma protein profiles in responding...

  5. Challenges in Measuring Benefit of Clinical Research Training Programs--the ASH Clinical Research Training Institute Example.

    Science.gov (United States)

    Sung, Lillian; Crowther, Mark; Byrd, John; Gitlin, Scott D; Basso, Joe; Burns, Linda

    2015-12-01

    The American Society of Hematology developed the Clinical Research Training Institute (CRTI) to address the lack of training in patient-oriented research among hematologists. As the program continues, we need to consider metrics for measuring the benefits of such a training program. This article addresses the benefits of clinical research training programs. The fundamental and key components are education and mentorship. However, there are several other benefits including promotion of collaboration, job and advancement opportunities, and promotion of work-life balance. The benefits of clinical research training programs need to be measured so that funders and society can judge if they are worth the investment in time and resources. Identification of elements that are important to program benefit is essential to measuring the benefit of the program as well as program planning. Future work should focus on the constructs which contribute to benefits of clinical research training programs such as CRTI.

  6. The journey of primary care practices to meaningful use: a Colorado Beacon Consortium study.

    Science.gov (United States)

    Fernald, Douglas H; Wearner, Robyn; Dickinson, W Perry

    2013-01-01

    The Health Information Technology for Economic and Clinical Health Act of 2009 provides for incentive payments through Medicare and Medicaid for clinicians who implement electronic health records (EHRs) and use this technology meaningfully to improve patient care. There are few comprehensive descriptions of how primary care practices achieve the meaningful use of clinical data, including the formal stage 1 meaningful use requirements. Evaluation of the Colorado Beacon Consortium project included iterative qualitative analysis of practice narratives, provider and staff interviews, and separate focus groups with quality improvement (QI) advisors and staff from the regional health information exchange (HIE). Most practices described significant realignment of practice priorities and aims, which often required substantial education and training of physicians and staff. Re-engineering office processes, data collection protocols, EHRs, staff roles, and practice culture comprised the primary effort and commitment to attest to stage 1 meaningful use and subsequent meaningful use of clinical data. While realizing important benefits, practices bore a significant burden in learning the true capabilities of their EHRs with little effective support from vendors. Attestation was an important initial milestone in the process, but practices faced substantial ongoing work to use their data meaningfully for patient care and QI. Key resources were instrumental to these practices: local technical EHR expertise; collaborative learning mechanisms; and regular contact and support from QI advisors. Meeting the stage 1 requirements for incentives under Medicare and Medicaid meaningful use criteria is the first waypoint in a longer journey by primary care practices to the meaningful use of electronic data to continuously improve the care and health of their patients. The intensive re-engineering effort for stage 1 yielded practice changes consistent with larger practice aims and goals

  7. Cost and economic benefit of clinical decision support systems for cardiovascular disease prevention: a community guide systematic review.

    Science.gov (United States)

    Jacob, Verughese; Thota, Anilkrishna B; Chattopadhyay, Sajal K; Njie, Gibril J; Proia, Krista K; Hopkins, David P; Ross, Murray N; Pronk, Nicolaas P; Clymer, John M

    2017-05-01

    This review evaluates costs and benefits associated with acquiring, implementing, and operating clinical decision support systems (CDSSs) to prevent cardiovascular disease (CVD). Methods developed for the Community Guide were used to review CDSS literature covering the period from January 1976 to October 2015. Twenty-one studies were identified for inclusion. It was difficult to draw a meaningful estimate for the cost of acquiring and operating CDSSs to prevent CVD from the available studies ( n  = 12) due to considerable heterogeneity. Several studies ( n  = 11) indicated that health care costs were averted by using CDSSs but many were partial assessments that did not consider all components of health care. Four cost-benefit studies reached conflicting conclusions about the net benefit of CDSSs based on incomplete assessments of costs and benefits. Three cost-utility studies indicated inconsistent conclusions regarding cost-effectiveness based on a conservative $50,000 threshold. Intervention costs were not negligible, but specific estimates were not derived because of the heterogeneity of implementation and reporting metrics. Expected economic benefits from averted health care cost could not be determined with confidence because many studies did not fully account for all components of health care. We were unable to conclude whether CDSSs for CVD prevention is either cost-beneficial or cost-effective. Several evidence gaps are identified, most prominently a lack of information about major drivers of cost and benefit, a lack of standard metrics for the cost of CDSSs, and not allowing for useful life of a CDSS that generally extends beyond one accounting period. Published by Oxford University Press on behalf of the American Medical Informatics Association 2017. This work is written by US Government employees and is in the public domain in the US.

  8. Generating Evidence for Clinical Benefit of PET/CT in Diagnosing Cancer Patients

    DEFF Research Database (Denmark)

    Vach, Werner; Høilund-Carlsen, Poul Flemming; Gerke, Oke

    2011-01-01

    For diagnostic methods such as PET/CT, not only diagnostic accuracy but also clinical benefit must be demonstrated. However, there is a lack of consensus about how to approach this task. Here we consider 6 clinical scenarios to review some basic approaches to demonstrating the clinical benefit...... of PET/CT in cancer patients: replacement of an invasive procedure, improved accuracy of initial diagnosis, improved accuracy of staging for curative versus palliative treatment, improved accuracy of staging for radiation versus chemotherapy, response evaluation, and acceleration of clinical decisions....... We also develop some guidelines for the evaluation of clinical benefit. First, it should be clarified whether there is a direct benefit of the use of PET/CT or an indirect benefit because of improved diagnostic accuracy. If there is an indirect benefit, then decision modeling should be used initially...

  9. Monitoring worksite clinic performance using a cost-benefit tool.

    Science.gov (United States)

    Tao, Xuguang; Chenoweth, David; Alfriend, Amy S; Baron, David M; Kirkland, Tracie W; Scherb, Jill; Bernacki, Edward J

    2009-10-01

    The purpose of this study was to explore the usefulness of continuously assessing the return on investment (ROI) of worksite medical clinics as a means of evaluating clinic performance. Visit data from January 1, 2007, to December 31, 2008, were collected from all the on-site clinics operated for the Pepsi Bottling Group. An average system-wide ROI was calculated from the time of each clinic's opening and throughout the study period. A multivariate linear regression model was used to determine the association of average ROI with penetration/utilization rate and plant size. A total of 26 on-site clinics were actively running as of December 2008. The average ROI at the time of start up was 0.4, which increased to 1.2 at approximately 4 months and 1.6 at the end of the first year of operation. Overall, it seems that the cost of operating a clinic becomes equal to the cost of similar care purchased in the community (ROI = 1) at approximately 3 months after a clinic's opening and flattens out at the end of the first year. The magnitude of the ROI was closely related to the number of visits (a function of the penetration/utilization rate) and the size of the plant population served. Serial monitoring of ROIs is a useful metric in assessing on-site clinic performance and quantifying the effect of new initiatives aimed at increasing a clinic's cost effectiveness.

  10. Life is pretty meaningful.

    Science.gov (United States)

    Heintzelman, Samantha J; King, Laura A

    2014-09-01

    The human experience of meaning in life is widely viewed as a cornerstone of well-being and a central human motivation. Self-reports of meaning in life relate to a host of important functional outcomes. Psychologists have portrayed meaning in life as simultaneously chronically lacking in human life as well as playing an important role in survival. Examining the growing literature on meaning in life, we address the question "How meaningful is life, in general?" We review possible answers from various psychological sources, some of which anticipate that meaning in life should be low and others that it should be high. Summaries of epidemiological data and research using two self-report measures of meaning in life suggest that life is pretty meaningful. Diverse samples rate themselves significantly above the midpoint on self-reports of meaning in life. We suggest that if meaning in life plays a role in adaptation, it must be commonplace, as our analysis suggests. (c) 2014 APA, all rights reserved.

  11. ESMO-Magnitude of Clinical Benefit Scale version 1.1

    NARCIS (Netherlands)

    Cherny, N. I.; Dafni, U.; Bogaerts, J.; Latino, N. J.; Pentheroudakis, G.; Douillard, J. -Y.; Tabernero, J.; Zielinski, C.; Piccart, M. J.; de Vries, E. G. E.

    2017-01-01

    Background: The ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS) version 1.0 (v1.0) was published in May 2015 and was the first version of a validated and reproducible tool to assess the magnitude of clinical benefit from new cancer therapies. The ESMO-MCBS was designed to be a dynamic tool with

  12. Model for investigating the benefits of clinical supervision in psychiatric nursing

    DEFF Research Database (Denmark)

    Gonge, Henrik; Buus, Niels

    2011-01-01

    with the effectiveness of clinical supervision, as measured by the Manchester Clinical Supervision Scale (MCSS). Furthermore, MCSS scores were associated with benefits, such as increased job satisfaction, vitality, rational coping and less stress, emotional exhaustion, and depersonalization. Multivariate analyses......The objective of this study was to test a model for analysing the possible benefits of clinical supervision. The model suggested a pathway from participation to effectiveness to benefits of clinical supervision, and included possible influences of individual and workplace factors. The study sample...

  13. Costs and benefits of nursing clinical education for hospital institutions

    Directory of Open Access Journals (Sweden)

    Olivério Ribeiro

    2014-11-01

    Conclusion: The inferences show that the presence of students in Clinical Teachings in the hospitals leads to a positive balance of 21.57 € per day and service, with a positive reinforcement associated to the resulting citizens satisfaction facing student rendered cares.

  14. Benefits of a Clinical Planning and Coordination Module

    DEFF Research Database (Denmark)

    Jensen, Sanne; Vingtoft, Søren; Nøhr, Christian

    2013-01-01

    Digital Clinical Practice Guidelines are commonly used in Danish health care. Planning and decision support are particularly important to patients with chronic diseases, who often are in contact with General Practitioners, Community Nurses and hospitals. In the Capital Region of Denmark...

  15. Benefits of a clinical pharmacokinetic service in optimising ...

    African Journals Online (AJOL)

    before the termination of the study (test period). Patients kept a seizure diary throughout the study. The MichaelisMenten model was used to calculate doses and predict steady-state serum concentrations. Setting. ine epilepsy clinics. Subjects. One hundred and ninety-five (113 black and 82 coloured) compliant people with ...

  16. Benefits of Outsourcing Strategy and IT Technology in Clinical Trials.

    Science.gov (United States)

    Stamenovic, Milorad; Dobraca, Amra

    2017-09-01

    Aim of this paper is to describe some of models of outsourcing (numerous and response to different types of risks and increment of quality is based on individual problem and situation). Defining whether to outsource or not and whether to build or buy new information technology (IT) is question for contract research organization (CRO) and Pharma companies dealing with clinical trials, so the aim of this paper is to show business model that could make process of decision making less time consuming, less segmented and more efficient. This paper has a descriptive character, and represents a review of the literature that deals with the described issues. Outsourcing should enable optimal capacity flexibility (technology that is outsourced should be done only optimally not entirely). The goal with CRO partners is to establish equivalent levels of global quality, as extensions of other research and development activities (by unification of standards of performance of alliance partners with best standards of industry). IT is gaining greater significance at each stage of clinical study and represent an inevitable element of the quality of a clinical study (for the purpose of monitoring of clinical site activities, data collection and management, medical monitoring, statistical programming, statistical analysis, clinical study reporting). CROs are able to maximize work within the CRO global development, to support the notion of a fully integrated outsourced company; facilitate the use of similar business processes and norms, reusing established CRO standards and improve CRO operational decision making within outsourced studies by providing consistent and current information across outsourced and in-house activities.

  17. Benefits of Outsourcing Strategy and IT Technology in Clinical Trials

    Science.gov (United States)

    Stamenovic, Milorad; Dobraca, Amra

    2017-01-01

    Introduction: Aim of this paper is to describe some of models of outsourcing (numerous and response to different types of risks and increment of quality is based on individual problem and situation). Defining whether to outsource or not and whether to build or buy new information technology (IT) is question for contract research organization (CRO) and Pharma companies dealing with clinical trials, so the aim of this paper is to show business model that could make process of decision making less time consuming, less segmented and more efficient. Material and methods: This paper has a descriptive character, and represents a review of the literature that deals with the described issues. Results: Outsourcing should enable optimal capacity flexibility (technology that is outsourced should be done only optimally not entirely). The goal with CRO partners is to establish equivalent levels of global quality, as extensions of other research and development activities (by unification of standards of performance of alliance partners with best standards of industry). IT is gaining greater significance at each stage of clinical study and represent an inevitable element of the quality of a clinical study (for the purpose of monitoring of clinical site activities, data collection and management, medical monitoring, statistical programming, statistical analysis, clinical study reporting). Conclusion: CROs are able to maximize work within the CRO global development, to support the notion of a fully integrated outsourced company; facilitate the use of similar business processes and norms, reusing established CRO standards and improve CRO operational decision making within outsourced studies by providing consistent and current information across outsourced and in-house activities. PMID:29114116

  18. Absorbable stent: focus on clinical applications and benefits.

    Science.gov (United States)

    Gonzalo, Nieves; Macaya, Carlos

    2012-01-01

    Coronary stents have improved very significantly the immediate and long-term results of percutaneous coronary interventions. However, once the vessel has healed, the scaffolding function of the stent is no longer needed, and the presence of a permanent metallic prosthesis poses important disadvantages. This has led to the idea of creating new devices that are able to provide mechanical support for a determined period and then disappear from the vessel, allowing its natural healing and avoiding the risks associated with having a permanent metallic cage, such as stent thrombosis. Absorbable stents currently appear as one of the most promising fields in interventional cardiology. The present article will review the available clinical evidence regarding these devices at present and their future perspectives.

  19. The Risks and Benefits of Cannabis in the Dermatology Clinic.

    Science.gov (United States)

    Dhadwal, Gurbir; Kirchhof, Mark G

    Cannabis ( Cannabis sativa/indica), also known as marijuana, has been used for medicinal and recreational purposes for millennia. There has been a recent trend to legalize the use of cannabis, as illustrated by the recent legalization votes in numerous states in the United States and legislation in Canada to allow recreational cannabis use. With this increasing consumption of cannabis, dermatologists will see increased pressure to prescribe cannabis and will see the side effects of cannabis use with greater frequency. There are several approved medical indications for cannabis use, including psoriasis, lupus, nail-patella syndrome, and severe pain. In addition, very preliminary studies have suggested cannabis and its derivatives might have use in acne, dermatitis, pruritus, wound healing, and skin cancer. Further well-controlled studies are required to explore these potential uses. Conversely, the side effects of cannabis use are relatively well documented, and dermatologists should be aware of these presentations. Side effects of cannabis use include cannabis allergy manifesting as urticaria and pruritus, cannabis arteritis presenting with necrosis and ulcers, and oral cancers from cannabis smoke. In this review, we summarize some of the studies and reports regarding the medicinal uses of cannabis in the dermatology clinic and some of the side effects that might present more often to dermatologists as the use of cannabis increases.

  20. Absorbable stent: focus on clinical applications and benefits

    Directory of Open Access Journals (Sweden)

    Gonzalo N

    2012-02-01

    Full Text Available Nieves Gonzalo, Carlos MacayaInterventional Cardiology, Cardiovascular Institute. Hospital Clinico San Carlos, Instituto de Investigación Sanitaria del Hospital Clinico San Carlos, Madrid, SpainAbstract: Coronary stents have improved very significantly the immediate and long-term results of percutaneous coronary interventions. However, once the vessel has healed, the scaffolding function of the stent is no longer needed, and the presence of a permanent metallic prosthesis poses important disadvantages. This has led to the idea of creating new devices that are able to provide mechanical support for a determined period and then disappear from the vessel, allowing its natural healing and avoiding the risks associated with having a permanent metallic cage, such as stent thrombosis. Absorbable stents currently appear as one of the most promising fields in interventional cardiology. The present article will review the available clinical evidence regarding these devices at present and their future perspectives.Keywords: absorbable stent, bioresorbable stent, absorb, percutaneous coronary intervention

  1. Overview of digital breast tomosynthesis: Clinical cases, benefits and disadvantages.

    Science.gov (United States)

    Nguyen, T; Levy, G; Poncelet, E; Le Thanh, T; Prolongeau, J F; Phalippou, J; Massoni, F; Laurent, N

    2015-09-01

    In France, the national breast cancer-screening program is based on mammography combined with clinical breast examination, and sometimes breast ultrasound for patients with high breast density. Digital breast tomosynthesis is a currently assessed 3D imaging technique in which angular projections of the stationary compressed breast are acquired automatically. When combined with mammography, clinicians can review both conventional (2D) as well as three-dimensional (3D) data. The purpose of this article is to review recent reports on this new breast imaging technique and complements this information with our personal experience. The main advantages of tomosynthesis are that it facilitates the detection and characterization of breast lesions, as well as the diagnosis of occult lesions in dense breasts. However, to do this, patients are exposed to higher levels of radiation than with 2D mammography. In France, the indications for tomosynthesis and its use in breast cancer-screening (individual and organized) are yet to be defined, as is its role in the diagnosis and staging of breast cancer (multiple lesions). Further studies assessing in particular the combined reconstruction of the 2D view using 3D tomosynthesis data acquired during a single breast compression event, and therefore reducing patient exposure to radiation, are expected to provide valuable insight. Copyright © 2015 Éditions françaises de radiologie. Published by Elsevier Masson SAS. All rights reserved.

  2. How to estimate the health benefits of additional research and changing clinical practice

    OpenAIRE

    Claxton, Karl; Griffin, Susan; Koffijberg, Hendrik; McKenna, Claire

    2015-01-01

    A simple extension of standard meta-analysis can provide quantitative estimates of the potential health benefits of further research and of implementing the findings of existing research, which can help inform research prioritisation and efforts to change clinical practice

  3. How to estimate the health benefits of additional research and changing clinical practice

    OpenAIRE

    Claxton, Karl; Griffin, Susan; Koffijberg, Hendrik; McKenna, Claire

    2015-01-01

    A simple extension of standard metaanalysis can provide quantitative estimates of the potential health benefits of further research and of implementing the findings of existing research, which can help inform research prioritisation and efforts to change clinical practice

  4. Individualized cardiovascular disease prevention in clinical practice : Estimation of benefit and cost

    NARCIS (Netherlands)

    Slob, MC

    2017-01-01

    For treatment decisions in clinical practice, group-level treatment effects need to be translated into benefit for an individual patient. In both the primary and secondary cardiovascular prevention setting (Chapter 2), patients differ widely in the risk for cardiovascular events, and the benefit

  5. An Exploratory Study Investigating the Non-Clinical Benefits of Evidence-Based Veterinary Medicine

    Directory of Open Access Journals (Sweden)

    Elizabeth Jackson

    2017-05-01

    Full Text Available Objective: As little prior research exists about the non-clinical benefits of evidence-based veterinary medicine (EBVM, this exploratory study was conducted to identify non-clinical benefits of EBVM to veterinary practices, as well as highlighting the barriers to further implementation, and ways to overcome them.Background: A PICO-based literature review (Hauser and Jackson, 2016 was conducted to establish current knowledge about the non-clinical benefits of EBVM. It found that while there are some papers suggesting a link between the practice of EBVM and better non-clinical benefits such as client satisfaction and client retention, a single study, focusing on the non-clinical benefits of EBVM, had yet to be conducted.Evidentiary value: This exploratory study provides a solid basis for the further development of a confirmatory study of the themes identified in the interviews. The impact on practice from our findings is significant as it details the key areas where the use of EBVM can yield commercial benefits from the perspective of a group of EBVM experts via interview. It is entirely possible that international veterinary environments which mirror that of the UK will find this research beneficial.Methods: Due to the paucity of data about the non-clinical benefits of EBVM, an exploratory, qualitative approach was taken to this research in order to build a platform for further confirmatory, quantitative investigation (Zikmund, 2003. In February and March 2016 interviews with 16 RCVS Knowledge Group chairs[1] were conducted. The interview guide contained broad, open-ended questions to explore existing tacit knowledge about the non-commercial benefits of EBVM. The interviews were audio recorded and transcribed verbatim and subsequently analysed using NVivo 11 software.Results: This qualitative enquiry showed that the key areas where the use of EBVM can yield non-clinical benefits are through increased client satisfaction and retention, improved

  6. Beyond meaningful use: getting meaningful value from IT.

    Science.gov (United States)

    Fortin, Jason; Zywiak, Walt

    2010-02-01

    The HITECH provisions of ARRA include financial incentives for providers to demonstrate meaningful use of certified EHR technology. However, to maximize the value of IT under new payment models, provider organizations will need to go beyond meaningful use criteria in three key areas: Delivering high-quality care. Ensuring coordinated care. Integrating financial systems.

  7. Clinically Relevant Physical Benefits of Exercise Interventions in Breast Cancer Survivors.

    Science.gov (United States)

    Kirkham, Amy A; Bland, Kelcey A; Sayyari, Sarah; Campbell, Kristin L; Davis, Margot K

    2016-02-01

    Evidence is currently limited for the effect of exercise on breast cancer clinical outcomes. However, several of the reported physical benefits of exercise, including peak oxygen consumption, functional capacity, muscle strength and lean mass, cardiovascular risk factors, and bone health, have established associations with disability, cardiovascular disease risk, morbidity, and mortality. This review will summarize the clinically relevant physical benefits of exercise interventions in breast cancer survivors and discuss recommendations for achieving these benefits. It will also describe potential differences in intervention delivery that may impact outcomes and, lastly, describe current physical activity guidelines for cancer survivors.

  8. Is There a Clinically Meaningful Change in the Blood Pressure of Osteoarthritis Patients with Comorbid Hypertension During the Course of Balneotherapy?

    Science.gov (United States)

    Hayta, Emrullah; Yılmaz, Mehmet Birhan; Yayıkçı, İlker; Özer, Zafer; Şahin, Özlem

    2015-01-01

    Background: Balneotherapy (BT) is a treatment modality that uses the physical and chemical effects of water, including thermomineral, acratothermal, and acratopegal waters. It has many effects on cardiovascular system. Aim: The aim of the study is to investigate the effects of 3-week BT on blood pressure of osteoarthritis (OA) patients with no hypertension (HT), and controlled or uncontrolled HT. Materials and Methods: The OA patients (n = 270) were divided into three groups: No HT, controlled HT, and uncontrolled HT. All the groups received BT in the facilities of our university hospital at the same time every day (10:00-11:30 AM) for 10 min per day, 5 days per week, for a total duration of 15 days in a 3-week period. Systolic and diastolic blood pressures and pulse rates were measured before and after BT on daily basis. Results: Overall, (1) the pulse rates of study groups measured after BT were significantly increased compared to before BT; (2) the systolic blood pressures of study groups measured before and after BT were found as comparable; and (3) the diastolic blood pressures of no HT and controlled HT groups measured before and after BT were not statistically significant (P > 0.05); however, in the uncontrolled HT group, the diastolic blood pressure showed a decreasing trend after BT (P < 0.05). Conclusions: In patients with OA, BT can be safely used without resulting in any meaningful changes in systolic and diastolic blood pressures in patients with normal and controlled HT but a decrease in diastolic blood pressure of patients with uncontrolled HT. This may be an advantage in OA patients having HT as comorbid disease. PMID:26713300

  9. The Effect of Clinical Simulation with Debriefing for Meaningful Learning in Courses of Nursing Theory and Practicum on Student Knowledge and Perception of Instruction

    Science.gov (United States)

    Shea, Kathleen

    2015-01-01

    Nursing students are expected to apply knowledge from lectures and laboratories to the clinical setting. One major challenge of nursing educators is facilitating the transfer of knowledge to the clinical-practice setting. Simulation-based education provides students with an experiential-learning activity within the context of a simulated clinical…

  10. Mutational and putative neoantigen load predict clinical benefit of adoptive T cell therapy in melanoma

    DEFF Research Database (Denmark)

    Lauss, Martin; Donia, Marco; Harbst, Katja

    2017-01-01

    Adoptive T-cell therapy (ACT) is a highly intensive immunotherapy regime that has yielded remarkable response rates and many durable responses in clinical trials in melanoma; however, 50-60% of the patients have no clinical benefit. Here, we searched for predictive biomarkers to ACT in melanoma. ...

  11. Helping others increases meaningful work: Evidence from three experiments.

    Science.gov (United States)

    Allan, Blake A; Duffy, Ryan D; Collisson, Brian

    2018-03-01

    The aim of the current research was to examine whether manipulating task significance increased the meaningfulness of work among students (Study 1), an online sample of working adults (Study 2), and public university employees (Study 3). In Study 1, students completed a typing task for the benefit of themselves, a charity, or someone they knew would directly benefit from their work. People who worked to benefit someone else, rather than themselves, reported greater task meaningfulness. In Study 2, a representative, online sample of employees reflected on a time when they worked to benefit themselves or someone else at work. Results revealed that people who reflected on working to benefit someone else, rather than themselves, reported greater work meaningfulness. In Study 3, public university employees participated in a community intervention by working as they normally would, finding new ways to help people each day, or finding several new ways to help others on a single day. People who helped others many times in a single day experienced greater gains in work meaningfulness over time. Across 3 experimental studies, we found that people who perceived their work as helping others experienced more meaningfulness in their work. This highlights the potential mechanisms practitioners, employers, and other parties can use to increase the meaningfulness of work, which has implications for workers' well-being and productivity. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

  12. Model for investigating the benefits of clinical supervision in psychiatric nursing: a survey study.

    Science.gov (United States)

    Gonge, Henrik; Buus, Niels

    2011-04-01

    The objective of this study was to test a model for analysing the possible benefits of clinical supervision. The model suggested a pathway from participation to effectiveness to benefits of clinical supervision, and included possible influences of individual and workplace factors. The study sample was 136 nursing staff members in permanent employment on nine general psychiatric wards and at four community mental health centres at a Danish psychiatric university hospital. Data were collected by means of a set of questionnaires. Participation in clinical supervision was associated with the effectiveness of clinical supervision, as measured by the Manchester Clinical Supervision Scale (MCSS). Furthermore, MCSS scores were associated with benefits, such as increased job satisfaction, vitality, rational coping and less stress, emotional exhaustion, and depersonalization. Multivariate analyses indicated that certain individual and workplace factors were related to subscales of the MCSS, as well as some of the benefits. The study supported the suggested model, but methodological limitations apply. © 2011 The Authors. International Journal of Mental Health Nursing © 2011 Australian College of Mental Health Nurses Inc.

  13. Effect of amifostine on patient assessed clinical benefit in irradiated head and neck cancer

    International Nuclear Information System (INIS)

    Wasserman, Todd; Mackowiak, John I.; Brizel, David M.; Oster, Wolfgang; Zhang, Jianliang; Peeples, Patricia J.; Sauer, Rolf

    2000-01-01

    Purpose: To determine if head and neck (H/N) cancer patients receiving daily amifostine during radiation therapy (RT) experienced clinical benefit (improvement in their ability to carry out normal functions with reduced discomfort) compared to nonamifostine treated patients. Methods and Materials: This was an open-label, multi-institutional randomized trial in 303 H/N cancer patients treated with RT +amifostine. Clinical benefit was measured using an 8-item validated Patient Benefit Questionnaire (PBQ) during and up to 11 months after RT. Results: 301 patients completed one or more PBQ assessments. Amifostine patients had significantly better PBQ scores (p < 0.05) than controls. The improvement in PBQ scores was most significant during chronic xerostomia. Conclusions: Amifostine use results in improved Patient Benefit Questionnaire (PBQ) scores, which is indicative of improved oral toxicity related outcomes and improved clinical benefit. Less oral toxicity should lead to preservation of late dental and oral health, and improvements in activities such as diet, nutrition, and sleep

  14. Decision theory and the evaluation of risks and benefits of clinical trials.

    Science.gov (United States)

    Bernabe, Rosemarie D C; van Thiel, Ghislaine J M W; Raaijmakers, Jan A M; van Delden, Johannes J M

    2012-12-01

    Research ethics committees (RECs) are tasked to assess the risks and the benefits of a clinical trial. In previous studies, it was shown that RECs find this task difficult, if not impossible, to do. The current approaches to benefit-risk assessment (i.e. Component Analysis and the Net Risk Test) confound the various risk-benefit tasks, and as such, make balancing impossible. In this article, we show that decision theory, specifically through the expected utility theory and multiattribute utility theory, enable for an explicit and ethically weighted risk-benefit evaluation. This makes a balanced ethical justification possible, and thus a more rationally defensible decision making. Copyright © 2012 Elsevier Ltd. All rights reserved.

  15. Net Clinical Benefit of Antithrombotic Therapy in Patients With Atrial Fibrillation and Chronic Kidney Disease

    DEFF Research Database (Denmark)

    Bonde, A. N.; Lip, G. Y. H.; Kamper, A. L.

    2014-01-01

    (Congestive heart failure; Hypertension; Age >= 75 years; Diabetes mellitus; previous Stroke, transient ischemic attack, or thromboembolism; Vascular disease; Age 65 to 74 years; Sex category) strata and the net clinical benefit of warfarin in patients with AF and CKD in a nationwide cohort. METHODS...

  16. Human Genome Editing in the Clinic: New Challenges in Regulatory Benefit-Risk Assessment.

    Science.gov (United States)

    Abou-El-Enein, Mohamed; Cathomen, Toni; Ivics, Zoltán; June, Carl H; Renner, Matthias; Schneider, Christian K; Bauer, Gerhard

    2017-10-05

    As genome editing rapidly progresses toward the realization of its clinical promise, assessing the suitability of current tools and processes used for its benefit-risk assessment is critical. Although current regulations may initially provide an adequate regulatory framework, improvements are recommended to overcome several existing technology-based safety and efficacy issues. Copyright © 2017 Elsevier Inc. All rights reserved.

  17. A counterfactual p-value approach for benefit-risk assessment in clinical trials.

    Science.gov (United States)

    Zeng, Donglin; Chen, Ming-Hui; Ibrahim, Joseph G; Wei, Rachel; Ding, Beiying; Ke, Chunlei; Jiang, Qi

    2015-01-01

    Clinical trials generally allow various efficacy and safety outcomes to be collected for health interventions. Benefit-risk assessment is an important issue when evaluating a new drug. Currently, there is a lack of standardized and validated benefit-risk assessment approaches in drug development due to various challenges. To quantify benefits and risks, we propose a counterfactual p-value (CP) approach. Our approach considers a spectrum of weights for weighting benefit-risk values and computes the extreme probabilities of observing the weighted benefit-risk value in one treatment group as if patients were treated in the other treatment group. The proposed approach is applicable to single benefit and single risk outcome as well as multiple benefit and risk outcomes assessment. In addition, the prior information in the weight schemes relevant to the importance of outcomes can be incorporated in the approach. The proposed CPs plot is intuitive with a visualized weight pattern. The average area under CP and preferred probability over time are used for overall treatment comparison and a bootstrap approach is applied for statistical inference. We assess the proposed approach using simulated data with multiple efficacy and safety endpoints and compare its performance with a stochastic multi-criteria acceptability analysis approach.

  18. The discrepancy between social isolation and loneliness as a clinically meaningful metric: findings from the Irish and English longitudinal studies of ageing (TILDA and ELSA).

    Science.gov (United States)

    McHugh, J E; Kenny, R A; Lawlor, B A; Steptoe, A; Kee, F

    2017-06-01

    Scant evidence is available on the discordance between loneliness and social isolation among older adults. We aimed to investigate this discordance and any health implications that it may have. Using nationally representative datasets from ageing cohorts in Ireland (TILDA) and England (ELSA), we created a metric of discordance between loneliness and social isolation, to which we refer as Social Asymmetry. This metric was the categorised difference between standardised scores on a scale of loneliness and a scale of social isolation, giving categories of: Concordantly Lonely and Isolated, Discordant: Robust to Loneliness, or Discordant: Susceptible to Loneliness. We used regression and multilevel modelling to identify potential relationships between Social Asymmetry and cognitive outcomes. Social Asymmetry predicted cognitive outcomes cross-sectionally and at a two-year follow-up, such that Discordant: Robust to Loneliness individuals were superior performers, but we failed to find evidence for Social Asymmetry as a predictor of cognitive trajectory over time. We present a new metric and preliminary evidence of a relationship with clinical outcomes. Further research validating this metric in different populations, and evaluating its relationship with other outcomes, is warranted. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  19. Use of online clinical videos for clinical skills training for medical students: benefits and challenges.

    Science.gov (United States)

    Jang, Hye Won; Kim, Kyong-Jee

    2014-03-21

    Multimedia learning has been shown effective in clinical skills training. Yet, use of technology presents both opportunities and challenges to learners. The present study investigated student use and perceptions of online clinical videos for learning clinical skills and in preparing for OSCE (Objective Structured Clinical Examination). This study aims to inform us how to make more effective us of these resources. A mixed-methods study was conducted for this study. A 30-items questionnaire was administered to investigate student use and perceptions of OSCE videos. Year 3 and 4 students from 34 Korean medical schools who had access to OSCE videos participated in the online survey. Additionally, a semi-structured interview of a group of Year 3 medical students was conducted for an in-depth understanding of student experience with OSCE videos. 411 students from 31 medical schools returned the questionnaires; a majority of them found OSCE videos effective for their learning of clinical skills and in preparing for OSCE. The number of OSCE videos that the students viewed was moderately associated with their self-efficacy and preparedness for OSCE (p mobile devices; they agreed more with the statement that it was convenient to access the video clips than their peers who accessed the videos using computers (p students reported lack of integration into the curriculum and lack of interaction as barriers to more effective use of OSCE videos. The present study confirms the overall positive impact of OSCE videos on student learning of clinical skills. Having faculty integrate these learning resources into their teaching, integrating interactive tools into this e-learning environment to foster interactions, and using mobile devices for convenient access are recommended to help students make more effective use of these resources.

  20. Benefits and challenges of international clinical education from a US-based physiotherapist faculty perspective.

    Science.gov (United States)

    Pechak, Celia; Black, Jill D

    2013-12-01

    The influence of internationalization on physiotherapist education in at least North American-based programmes has become more apparent. Faculty and students have been involved in various international activities. One category of activities includes international clinical education (ICE), where students earn clinical education credit for their learning activities at international sites. Although this educational strategy appears to be increasingly used in at least the United States and Canada, the related literature is limited in scope. The purpose of this portion of the present study was to investigate the benefits and challenges of ICE for US-based students, US-based physiotherapy programmes and international partners from the perspective of US-based faculty sending students for clinical education internationally. Content analysis was used for this qualitative study. Fifteen US-based faculty members who had experience in sending physiotherapist students for ICE were recruited. The primary researcher conducted semi-structured phone interviews, averaging approximately 60 minutes in length. The primary and secondary researchers completed data analysis using NVivo 8 software (QSR International Inc., Cambridge, MA). Benefits of ICE to the students included exposure to alternate health systems, broadening of student perspectives and clinical competence. Challenges consisted of funding and possible language barrier. Increased visibility, expanded global perspective and faculty collaborations were benefits to the programme. Ensuring a quality learning experience was the greatest programme challenge. Benefits to the international site included education and faculty collaborations/exchanges; challenges were language, student clinical preparation and unfamiliarity with the student evaluation tool. Because the sample was limited to 15 US-based faculty members, the results may not be relevant to all programmes inside or outside of the United States. Additionally, the study

  1. Psychological context of work meaningfulness

    Directory of Open Access Journals (Sweden)

    Karel Paulík

    2014-12-01

    Full Text Available There is a significant shift of approach to the management of organizations and workers in recent decades. This shift in management philosophy is characterized by converting from traditional, conventional (rather bureaucratic management models to rather humanistic/existential oriented models. This transition comes partly from the understanding that human resources are the most promising and effective way for organization development, partly from a shift in the understanding of the role of organizations in society. The key point of these approaches has become a "meaning" or "meaningfulness" in relation to the work and organization. The importance of work meaningfulness is not only in its potential to increase the competitiveness of organizations, but especially in its major (mostly positive impacts on the employee himself and his work (and by that the organization and its performance. Work meaningfulness is strongly connected to the work engagement, which represents the active personal participation in the work process, manifested by vigor, active cooperation, willingness to contribute to the company's success and dedication to work. Work engagement seems to be next important factor affecting work attitudes and achievements of employees. The paper gives an overview of various approaches to work meaningfulness and work engagement, on the basis of which authors propose new model of work meaningfulness with overlap to work engagement. The work meaningfulness is not seen as one-dimensional variable, but consists of complex of interacting factors and processes that define an individual perceived meaning and importance of the work. Meaningful work is influenced by three areas. The first is the organizational culture. This is defined as a specific pattern of values, norms, beliefs, attitudes and assumptions that are often not clearly expressed, but affect the way individuals behave in an organization and how things are done. The second area is the work

  2. Meaningful radiation worker training for temporary craftsmen

    International Nuclear Information System (INIS)

    Williams, S.L.

    1976-01-01

    The carefully organized Radiation Worker Training Program presented to permanently assigned personnel at a power reactor facility too often falls by the wayside when temporary craftsmen are brought in for an outage. Even though these temporary workers will frequently be assigned to outage jobs with high radiation and/or contamination exposures, their Radiation Worker Training is often squeezed into an already busy schedule, thus reducing its effectiveness. As an aid for evaluating the effectiveness of an existing Radiation Worker Training Program for temporary craftsmen or for setting up a new program, the following guides are presented and discussed in this paper: the training environment; the interest and meaningfulness of the presentation; the method or methods used for presentation of the training information; the use of demonstrations; trainee participation; and, measuring the amount and type of information retained by a trainee. Meaningful Radiation Worker Training for temporary craftsmen can pay big dividends. Craftsmen can be expected to make fewer mistakes, thus reducing radiation exposure and lessening the chance for the spread of contamination. The craftsmen will also benefit by being able to work longer and utility management will benefit by having lower outage costs

  3. Analysis of the clinical benefit of 5-fluorouracil and radiation treatment in locally advanced pancreatic cancer

    International Nuclear Information System (INIS)

    Fisher, Barbara J.; Perera, Francisco E.; Kocha, Walter; Tomiak, Anna; Taylor, Marianne; Vincent, Mark; Bauman, Glenn S.

    1999-01-01

    Purpose: To assess the palliative benefit of 5-fluorouracil (5-FU) and radiotherapy in patients with surgically unresectable localized pancreatic cancer. Methods and Materials: Twenty-five patients with locally advanced surgically unresectable symptomatic pancreatic cancer received 5-FU chemotherapy and local radiation therapy. They were retrospectively reviewed in regard to their clinical benefit response (a composite of measurement of pain assessment, weight, and Karnofsky performance status [KPS]), as well as radiological response, time to progression, and overall survival. Results: Median survival for the 25 patients was 9 months and median progression-free survival was 6 months. Thirty-two percent of patients survived in excess of 1 year. Analgesic requirements increased >50% in 2 patients and KPS deteriorated in 10 patients. Of the 13 remaining patients, 2 sustained a >7% weight loss and 2 gained weight post-treatment. Six patients improved in one parameter of analgesic consumption, weight loss or KPS without deteriorating in any others. Thus, the clinical benefit response index for 5-FU-radiation was 6/25 (24%). In terms of tumor response, 8 patients (44%) demonstrated a reduction in tumor volume post-treatment, 4 of whom (22%) experienced a >50% reduction. Four additional patients had radiologically stable disease. Conclusion: In this retrospective analysis, the clinical benefit response index for 5-FU-radiation was 24%, a value similar to the 23.8% reported for single agent gemcitabine. The median survival of 7 months was also similar to the 5.65 months reported for gemcitabine. The radiological partial response rate of 22% and the 1-year survival of 32% were higher for 5-FU-radiation than the reported values for gemcitabine. A randomized trial would be necessary to compare 5-FU-radiation to gemcitabine directly; however, from this review it did not appear that the overall palliative benefit of 5-FU-radiation was inferior to gemcitabine

  4. When Veterinarians Support Canine Therapy: Bidirectional Benefits for Clinics and Therapy Programs

    Directory of Open Access Journals (Sweden)

    John-Tyler Binfet

    2018-01-01

    Full Text Available This paper proposes a mutually beneficial model of collaboration between veterinarians and canine therapy programs. Veterinarians and the clinics for whom they work routinely establish collaborations with multiple and varied stakeholders. This might include a laboratory for processing samples and the corresponding courier company needed to deliver samples to the lab or a partnership with a local dog rescue organization for whom discounted rates are offered. One community partnership that stands to benefit both the clinic and the community agency, is for veterinarians to work in tandem with a local canine-assisted therapy program. The benefits to such an alliance are multifold and address aspects of veterinary medicine including client recruitment, community education, and access to a network of devoted dog enthusiasts.

  5. Cooperative study of clinical benefits from use of the fully portable blood irradiator

    International Nuclear Information System (INIS)

    Hungate, F.P.

    1994-10-01

    This report looks at the clinical benefits from use of a fully portable blood irradiator, techniques developed by Pacific Northwest Laboratory. Significant accomplishments included the following: blood irradiators were successfully fabricated by PNL; irradiators were activated at the University of Missouri and quality tested at PNL; A-V shunts for irradiators were successfully fabricated in the PNL plastics shop; all activities necessary for experimental work on animals using the blood irradiators were completed

  6. Cooperative study of clinical benefits from use of the fully portable blood irradiator

    Energy Technology Data Exchange (ETDEWEB)

    Hungate, F.P.

    1994-10-01

    This report looks at the clinical benefits from use of a fully portable blood irradiator, techniques developed by Pacific Northwest Laboratory. Significant accomplishments included the following: blood irradiators were successfully fabricated by PNL; irradiators were activated at the University of Missouri and quality tested at PNL; A-V shunts for irradiators were successfully fabricated in the PNL plastics shop; all activities necessary for experimental work on animals using the blood irradiators were completed.

  7. Benefits and harms in clinical trials of duloxetine for treatment of major depressive disorder

    DEFF Research Database (Denmark)

    Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn

    2014-01-01

    , with respect to benefits and major harms. DESIGN: Data on primary efficacy analysis and major harms extracted from each data source and compared. SETTING: Nine randomised placebo controlled trials of duloxetine (total 2878 patients) submitted to the European Medicines Agency (EMA) for marketing approval.......gov and the manufacturer's online clinical trial registry were searched for trial results. RESULTS: Clinical study reports fully described the primary efficacy analysis and major harms (deaths (including suicides), suicide attempts, serious adverse events, and discontinuations because of adverse events). There were minor......, respectively. We also found publication bias in relation to beneficial effects. CONCLUSION: Clinical study reports contained extensive data on major harms that were unavailable in journal articles and in trial registry reports. There were inconsistencies between protocols and clinical study reports and within...

  8. The m-Health revolution: Exploring perceived benefits of WhatsApp use in clinical practice.

    Science.gov (United States)

    Ganasegeran, Kurubaran; Renganathan, Pukunan; Rashid, Abdul; Al-Dubai, Sami Abdo Radman

    2017-01-01

    The dawn of m-Health facilitates new horizons of professional communication through WhatsApp, allowing health professionals to interact fast and efficiently for effective patient management. This preliminary study aimed to investigate perceived benefits, if any, of WhatsApp use across general medical and emergency teams during clinical practice in Malaysia. A cross-sectional study was conducted in a universal sample of 307 health professionals comprising of nurses, medical assistants, medical residents, medical officers and physicians across medical and casualty departments in a Malaysian public hospital. The self-administered questionnaire consisted of items on socio-demographics, WhatsApp usage characteristics and the type of communication events during clinical practice. The majority of respondents (68.4%) perceived WhatsApp as beneficial during clinical practice. In multivariate analysis, perceived benefits was significantly higher amongst the clinical management group (aOR=2.6, 95% CI 1.5-4.6, p=0.001), those using WhatsApp for >12months (aOR=1.7, 95% CI 1.0-3.0, p=0.047), those receiving response ≤15min to a new communication (aOR=1.9, 95% CI 1.1-3.2, p=0.017), and frequent information giving events (aOR=2.4, 95% CI 1.2-4.8, p=0.016). Perceived benefits of WhatsApp use in clinical practice was significantly associated with usage characteristics and type of communication events. This study lays the foundation for quality improvement innovations in patient management delivered through m-Health technology. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  9. Estimating the clinical benefits of vaccinating boys and girls against HPV-related diseases in Europe

    International Nuclear Information System (INIS)

    Marty, Rémi; Roze, Stéphane; Bresse, Xavier; Largeron, Nathalie; Smith-Palmer, Jayne

    2013-01-01

    HPV is related to a number of cancer types, causing a considerable burden in both genders in Europe. Female vaccination programs can substantially reduce the incidence of HPV-related diseases in women and, to some extent, men through herd immunity. The objective was to estimate the incremental benefit of vaccinating boys and girls using the quadrivalent HPV vaccine in Europe versus girls-only vaccination. Incremental benefits in terms of reduction in the incidence of HPV 6, 11, 16 and 18-related diseases (including cervical, vaginal, vulvar, anal, penile, and head and neck carcinomas and genital warts) were assessed. The analysis was performed using a model constructed in Microsoft®Excel, based on a previously-published dynamic transmission model of HPV vaccination and published European epidemiological data on incidence of HPV-related diseases. The incremental benefits of vaccinating 12-year old girls and boys versus girls-only vaccination was assessed (70% vaccine coverage were assumed for both). Sensitivity analyses around vaccine coverage and duration of protection were performed. Compared with screening alone, girls-only vaccination led to 84% reduction in HPV 16/18-related carcinomas in females and a 61% reduction in males. Vaccination of girls and boys led to a 90% reduction in HPV 16/18-related carcinomas in females and 86% reduction in males versus screening alone. Relative to a girls-only program, vaccination of girls and boys led to a reduction in female and male HPV-related carcinomas of 40% and 65%, respectively and a reduction in the incidence of HPV 6/11-related genital warts of 58% for females and 71% for males versus girls-only vaccination. In Europe, the vaccination of 12-year old boys and girls against HPV 6, 11, 16 and 18 would be associated with substantial additional clinical benefits in terms of reduced incidence of HPV-related genital warts and carcinomas versus girls-only vaccination. The incremental benefits of adding boys vaccination are

  10. A Case of Appendiceal Adenocarcinoma with Clinical Benefit from FOLFOX and Bevacizumab

    Directory of Open Access Journals (Sweden)

    Erin D. Powell

    2009-07-01

    Full Text Available A 44-year-old woman presented with lower abdominal pain and bilateral ovarian masses on ultrasound. Exploratory laparotomy revealed extensive peritoneal and intra-abdominal disease and an abnormal appendix. Bilateral salpingo-oophorectomy, infracolic omentectomy, ileocolic resection and primary anastomosis were performed. Final pathology revealed a primary appendiceal adenocarcinoma, poorly differentiated, of signet ring cell type. CT scan postoperatively revealed gross residual disease. The patient was treated with FOLFOX chemotherapy combined with bevacizumab. Repeat CT scan showed a decrease in residual disease and the patient clinically improved. After her treatment has been continued for 13 months, she remains clinically well and her CT scan shows sustained disease stability. Disseminated appendiceal carcinoma is generally considered to be refractory to 5-FU-based chemotherapy and, to our knowledge, this is the first reported case of a patient with appendiceal adenocarcinoma demonstrating clinical benefit and sustained stability of disease with combination chemotherapy plus bevacizumab.

  11. Clinical Benefits of Memantine Treatment for Alzheimer's Disease in the Okayama Memantine Study II (OMS II).

    Science.gov (United States)

    Matsuzono, Kosuke; Yamashita, Toru; Ohta, Yasuyuki; Hishikawa, Nozomi; Koike, Makoto; Sato, Kota; Kono, Syoichiro; Deguchi, Kentaro; Nakano, Yumiko; Abe, Koji

    2015-01-01

    The clinical benefits of memantine, depending on the baseline cognitive and affective conditions in real world dementia clinics, have not been completely examined. We performed the "Okayama Memantine Study II (OMS II)" to retrospectively evaluate the clinical effects of memantine monotherapy (n = 38) in Alzheimer's disease (AD) patients using seven batteries to assess dementia at the baseline, at 3, 6, and 12 months. Additionally, we divided 163 AD patients treated with memantine into two subgroups depending on the baseline cognitive score of the Mini-Mental State Examination (MMSE): the MMSE OMS II showed that memantine monotherapy improved BPSD until 12 months. The higher baseline cognitive subgroup (MMSE ≥15) and the worse baseline BPSD subgroup were expected to show better effects with memantine.

  12. Analyzing the blood-brain barrier: the benefits of medical imaging in research and clinical practice.

    Science.gov (United States)

    Chassidim, Yoash; Vazana, Udi; Prager, Ofer; Veksler, Ronel; Bar-Klein, Guy; Schoknecht, Karl; Fassler, Michael; Lublinsky, Svetlana; Shelef, Ilan

    2015-02-01

    A dysfunctional BBB is a common feature in a variety of brain disorders, a fact stressing the need for diagnostic tools designed to assess brain vessels' permeability in space and time. Biological research has benefited over the years various means to analyze BBB integrity. The use of biomarkers for improper BBB functionality is abundant. Systemic administration of BBB impermeable tracers can both visualize brain regions characterized by BBB impairment, as well as lead to its quantification. Additionally, locating molecular, physiological content in regions from which it is restricted under normal BBB functionality undoubtedly indicates brain pathology-related BBB disruption. However, in-depth research into the BBB's phenotype demands higher analytical complexity than functional vs. pathological BBB; criteria which biomarker based BBB permeability analyses do not meet. The involvement of accurate and engineering sciences in recent brain research, has led to improvements in the field, in the form of more accurate, sensitive imaging-based methods. Improvements in the spatiotemporal resolution of many imaging modalities and in image processing techniques, make up for the inadequacies of biomarker based analyses. In pre-clinical research, imaging approaches involving invasive procedures, enable microscopic evaluation of BBB integrity, and benefit high levels of sensitivity and accuracy. However, invasive techniques may alter normal physiological function, thus generating a modality-based impact on vessel's permeability, which needs to be corrected for. Non-invasive approaches do not affect proper functionality of the inspected system, but lack in spatiotemporal resolution. Nevertheless, the benefit of medical imaging, even in pre-clinical phases, outweighs its disadvantages. The innovations in pre-clinical imaging and the development of novel processing techniques, have led to their implementation in clinical use as well. Specialized analyses of vessels' permeability

  13. Post graduate clinical placements: evaluating benefits and challenges with a mixed methods cross sectional design.

    Science.gov (United States)

    Yiend, Jenny; Tracy, Derek K; Sreenan, Brian; Cardi, Valentina; Foulkes, Tina; Koutsantoni, Katerina; Kravariti, Eugenia; Tchanturia, Kate; Willmott, Lucy; Shergill, Sukhi; Reedy, Gabriel

    2016-02-16

    Systematic evaluations of clinical placements are rare, especially when offered alongside academic postgraduate courses. An evidence-based approach is important to allow pedagogically-driven provision, rather than that solely governed by opinion or market demand. Our evaluation assessed a voluntary clinical placement scheme allied to a mental health course. Data were collected over academic years 2010/11- 2013/14, from participating students (n = 20 to 58) and clinician supervisors (n = 10-12), using a mixed-methods cross-sectional design. Quantitative evaluation captured information on uptake, dropout, resource use, attitudes and experience, using standardized (the Placement Evaluation Questionnaire; the Scale To Assess the Therapeutic Relationship - Clinical version and the University of Toronto Placement Supervisor Evaluation) and bespoke questionnaires and audit data. Qualitative evaluation comprised two focus groups (5 clinicians, 5 students), to investigate attitudes, experience, perceived benefits, disadvantages and desired future developments. Data were analysed using framework analysis to identify a priori and emergent themes. High uptake (around 70 placements per annum), low dropout (2-3 students per annum; 5 %) and positive focus group comments suggested placements successfully provided added value and catered sufficiently to student demand. Students' responses confirmed that placements met expectations and the perception of benefit remained after completion with 70 % (n = 14) reporting an overall positive experience, 75 % (n = 15) reporting a pleasant learning experience, 60 % (n = 12) feeling that their clinical skills were enhanced and 85 % (n = 17) believing that it would benefit other students. Placements contributed the equivalent of seven full time unskilled posts per annum to local health care services. While qualitative data revealed perceived 'mutual benefit' for both students and clinicians, this was qualified by

  14. Opioid growth factor improves clinical benefit and survival in patients with advanced pancreatic cancer

    Directory of Open Access Journals (Sweden)

    Jill P Smith

    2010-03-01

    Full Text Available Jill P Smith1, Sandra I Bingaman1, David T Mauger2, Harold H Harvey1, Laurence M Demers3, Ian S Zagon41Departments of Medicine, 2Public Health Sciences, 3Pathology, and 4Neurosciences and Anatomy, Pennsylvania State University, College of Medicine, Hershey Medical Center, Hershey, PA, USABackground: Advanced pancreatic cancer carries the poorest prognosis of all gastrointestinal malignancies. Once the tumor has spread beyond the margins of the pancreas, chemotherapy is the major treatment modality offered to patients; however, chemotherapy does not significantly improve survival.Objective: Opioid growth factor (OGF; [Met5]-enkephalin is a natural peptide that has been shown to inhibit growth of pancreatic cancer in cell culture and in nude mice. The purpose of this study was to evaluate the effects of OGF biotherapy on subjects with advanced pancreatic cancer who failed chemotherapy.Methods: In a prospective phase II open-labeled clinical trial, 24 subjects who failed standard chemotherapy for advanced pancreatic cancer were treated weekly with OGF 250 μg/kg intravenously. Outcomes measured included clinical benefit, tumor response by radiographic imaging, quality of life, and survival.Results: Clinical benefit response was experienced by 53% of OGF-treated patients compared to historical controls of 23.8% and 4.8% for gemcitabine and 5-fluorouracil (5-FU, respectively. Of the subjects surviving more than eight weeks, 62% showed either a decrease or stabilization in tumor size by computed tomography. The median survival time for OGF-treated patients was three times that of untreated patients (65.5 versus 21 days, p < 0.001. No adverse effects on hematologic or chemistry parameters were noted, and quality of life surveys suggested improvement with OGF. Limitations: Measurements other than survival were not allowed in control patients, and clinical benefit comparisons were made to historical controls.Conclusion: OGF biotherapy improves the

  15. Delivering maximum clinical benefit at an affordable price: engaging stakeholders in cancer care.

    Science.gov (United States)

    Kelly, Ronan J; Smith, Thomas J

    2014-03-01

    Cancer costs continue to increase alarmingly despite much debate about how they can be reduced. The oncology community needs to take greater responsibility for our own practice patterns, especially when using expensive tests and treatments with marginal value: we cannot continue to accept novel therapeutics with very small benefits for exorbitant prices. Patients, payers, and pharmaceutical communities should be constructively engaged to communicate medically and economically possible goals, and eventually, to reduce use and costs. Diagnostic tests and treatments should have to show true value to be added to existing protocols. In this article, we discuss three key drivers of costs: end-of-life care patterns, medical imaging, and drugs. We propose health-care models that have the potential to decrease costs and discuss solutions to maintain clinical benefit at an affordable price. Copyright © 2014 Elsevier Ltd. All rights reserved.

  16. Increasing clinical relevance in oral radiology: Benefits and challenges when implementing digital assessment.

    Science.gov (United States)

    de Lange, T; Møystad, A; Torgersen, G R

    2018-02-13

    The aims of the study were to investigate benefits and challenges in implementing a digital examination and study the clinical relevance of the digital examination in relation to clinical training and practice. The study was based on semi-structured focus-group interviews from two distinct student populations (2016 and 2017) in a bachelor programme in dental hygiene. In addition, conversational data from a plenary discussion from the whole second student population (2017) were collected and analysed. The data were approached on basis of content analysis. A benefit experienced in the digital examination was the ease in typing and editing answers on the computer. This suggests an increased effectiveness in computer-based compared to analogue examinations. An additional advantage was the experienced relevance of the examination related to the clinic. This finding refers not only to the digital presentations of images, but also to the entire setting in the clinic and dental practice. The limitations reported by the students were non-optimal viewing conditions for presenting radiographic images and difficulties in obtaining an overview of the assignments compared to paper-based examinations due to the linear digital examination format. The last finding on lacking overview revealed an influence on student performances which should be taken seriously in designing digital examinations. In conclusion, the digital layout increases efficiency and clinical relevance of examinations to a certain extent. Obstacles were found in limitations related to image presentation and lack of overview of the examination. The latter challenge raises questions related to developing suitable assessment software. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  17. Perceived Benefits of Pre-Clinical Simulation-based Training on Clinical Learning Outcomes among Omani Undergraduate Nursing Students

    Directory of Open Access Journals (Sweden)

    Girija Madhavanprabhakaran

    2015-01-01

    Full Text Available Objectives: This study aimed to explore the benefits perceived by Omani undergraduate maternity nursing students regarding the effect of pre-clinical simulation-based training (PSBT on clinical learning outcomes. Methods: This non-experimental quantitative survey was conducted between August and December 2012 among third-year baccalaureate nursing students at Sultan Qaboos University in Muscat, Oman. Voluntary participants were exposed to faculty-guided PSBT sessions using low- and medium-fidelity manikins, standardised scenarios and skill checklists on antenatal, intranatal, postnatal and newborn care and assessment. Participants answered a purposely designed self-administered questionnaire on the benefits of PSBT in enhancing learning outcomes. Items were categorised into six subscales: knowledge, skills, patient safety, academic safety, confidence and satisfaction. Scores were rated on a four-point Likert scale. Results: Of the 57 participants, the majority (95.2% agreed that PSBT enhanced their knowledge. Most students (94.3% felt that their patient safety practices improved and 86.5% rated PSBT as beneficial for enhancing skill competencies. All male students and 97% of the female students agreed that PSBT enhanced their confidence in the safe holding of newborns. Moreover, 93% of participants were satisfied with PSBT. Conclusion: Omani undergraduate nursing students perceived that PSBT enhanced their knowledge, skills, patient safety practices and confidence levels in providing maternity care. These findings support the use of simulation training as a strategy to facilitate clinical learning outcomes in future nursing courses in Oman, although further research is needed to explore the objective impact of PSBT on learning outcomes.

  18. Sustainable Benefits of a Community Hospital-Based Paediatric Asthma Clinic.

    Science.gov (United States)

    Kuzik, Brian A; Chen, Chee P; Hansen, Miriam J; Montgomery, Paula L

    2017-01-01

    In 2011, we reported that our paediatric asthma clinic (PAC) appeared to significantly reduce the burden of paediatric asthma in our community. Supported by these results, the PAC underwent a gradual threefold expansion while maintaining the same model of care. We now report on the outcome of that expansion and demonstrate that our PAC continues to significantly reduce the burden of paediatric asthma in our community. As previously, newly enrolled PAC patients continue to show a 12-month reduction in asthma-related emergency department (ED) visits and admissions exceeding 60% and 80%, respectively. This consistent short-term benefit, coupled with clinic expansion, has contributed to a significant improvement in our rate of paediatric asthma-related ED visits or hospitalizations when compared to other Ontario hospitals.

  19. POSTSURGICAL RECURRENT CUSHING DISEASE: CLINICAL BENEFIT OF EARLY INTERVENTION IN PATIENTS WITH NORMAL URINARY FREE CORTISOL.

    Science.gov (United States)

    Carroll, Ty B; Javorsky, Bradley R; Findling, James W

    2016-10-01

    To assess the performance of biochemical markers in the detection of recurrent Cushing disease (CD), as well as the potential benefit of early intervention in recurrent CD patients with elevated late-night salivary cortisol (LNSC) and normal urinary free cortisol (UFC). The design was a single-center, retrospective chart review. Patients treated by the authors from 2008-2013 were included. Recurrence was defined by postsurgical remission of CD with subsequent abnormal LNSC, UFC, or dexamethasone suppression test (DST). We identified 15 patients with postsurgical recurrent CD after initial remission; all but one underwent testing with LNSC, DST, and UFC. Although 12 of 15 patients had normal UFC at time of recurrence, DST was abnormal in 11 of 15, and all 14 patients with LNSC results had ≥1 elevated measurement. Nine patients (7 with normal UFC) showed radiologic evidence of a pituitary tumor at time of recurrence. Among the 14 patients with available follow-up data, 12 have demonstrated significant improvement since receiving treatment. Five patients underwent repeat pituitary surgery and 4 achieved clinical and biochemical remission. Eight patients received mifepristone or cabergoline, and 6 showed clinical and/or biochemical improvement. Three patients (2 with prior mifepristone) underwent bilateral adrenalectomy and 2 demonstrated significant clinical improvements. LNSC is more sensitive than UFC or DST for detection of CD recurrence. Prompt intervention when LNSC is elevated, despite normal UFC, may yield significant clinical benefit for many patients with CD. Early treatment for patients with recurrent CD should be prospectively evaluated, utilizing LNSC elevation as an early biochemical marker. ACTH = adrenocorticotropic hormone CD = Cushing disease CS = Cushing syndrome CV = coefficient of variation DST = dexamethasone suppression test IPSS = inferior petrosal sinus sampling LNSC = late-night salivary cortisol QoL = quality of life TSS = transsphenoidal

  20. Clinical benefit from ipilimumab therapy in melanoma patients may be associated with serum CTLA4 levels

    Directory of Open Access Journals (Sweden)

    Anna M. Leung

    2014-05-01

    Full Text Available Stage IV metastatic melanoma patients historically have a poor prognosis with 5-10% 5-year survival. Ipilimumab, a monoclonal antibody against cytotoxic T-lymphocyte antigen 4 (CTLA4, is one of the first treatments to provide beneficial durable responses in advanced melanoma. However, less than 25% of those treated benefit, treatment is expensive, and side effects can be fatal. Since soluble (s CTLA4 may mediate inhibitory effects previously ascribed to the membrane-bound isoform (mCTLA4, we hypothesized patients benefiting from ipilimumab have higher serum levels of sCTLA4. We found that higher sCTLA4 levels correlated both with response and improved survival in patients treated with ipilimumab in a small patient cohort (patients with (n=9 and without (n=5 clinical benefit. sCTLA4 levels were statistically higher in ipilimumab-treated patients with response to ipilimumab. In contrast, sCTLA4 levels did not correlate with survival in patients who did not receive ipilimumab (n=11. These preliminary observations provide a previously unrecognized link between serum sCTLA-4 levels and response to ipilimumab as well as to improved survival in ipilimumab-treated melanoma patients and a potential mechanism by which ipilimumab functions.

  1. Korean Cancer Patients' Awareness of Clinical Trials, Perceptions on the Benefit and Willingness to Participate.

    Science.gov (United States)

    Lim, Yoojoo; Lim, Jee Min; Jeong, Won Jae; Lee, Kyung-Hun; Keam, Bhumsuk; Kim, Tae-Yong; Kim, Tae Min; Han, Sae-Won; Oh, Do Youn; Kim, Dong-Wan; Kim, Tae-You; Heo, Dae Seog; Bang, Yung-Jue; Im, Seock-Ah

    2017-10-01

    The purpose of this study was to assess current levels of awareness of clinical trials (CTs), perceptions regarding their benefits and willingness to participate to CTs among Korean cancer patients. From December 2012 to August 2015, we distributed questionnaires to cancer patients receiving systemic anti-cancer therapy at Seoul National University Hospital, Seoul, Korea. A total of 397 out of 520 requested patients (76.3%) responded to the survey. Among the 397 patients, 62.5% were female and the median age was 52 years. Overall, 97.4% (387/397) answered that they have at least heard of CTs. When asked about their level of awareness, 23.8% (92/387) answered that they could more than roughly explain about CTs. The average visual analogue scale score of CT benefit in all patients was 6.43 (standard deviation, 2.20). Patients who were only familiar with the term without detailed knowledge of the contents had the least expectation of benefit from CTs (p=0.015). When asked about their willingness to participate in CTs, 56.7% (225/397) answered positively. Patients with higher levels of awareness of CTs showed higher willingness to participate (p awareness regarding CTs was positively related to the positive perception and willingness to participate. Although the general awareness of CTs was high, a relatively large proportion of patients did not have accurate knowledge; therefore, proper and accurate patient education is necessary.

  2. Korean Cancer Patients’ Awareness of Clinical Trials, Perceptions on the Benefit and Willingness to Participate

    Science.gov (United States)

    Lim, Yoojoo; Lim, Jee Min; Jeong, Won Jae; Lee, Kyung-Hun; Keam, Bhumsuk; Kim, Tae-Yong; Kim, Tae Min; Han, Sae-Won; Oh, Do Youn; Kim, Dong-Wan; Kim, Tae-You; Heo, Dae Seog; Bang, Yung-Jue; Im, Seock-Ah

    2017-01-01

    Purpose The purpose of this study was to assess current levels of awareness of clinical trials (CTs), perceptions regarding their benefits and willingness to participate to CTs among Korean cancer patients. Materials and Methods From December 2012 to August 2015, we distributed questionnaires to cancer patients receiving systemic anti-cancer therapy at Seoul National University Hospital, Seoul, Korea. Results A total of 397 out of 520 requested patients (76.3%) responded to the survey. Among the 397 patients, 62.5% were female and the median age was 52 years. Overall, 97.4% (387/397) answered that they have at least heard of CTs. When asked about their level of awareness, 23.8% (92/387) answered that they could more than roughly explain about CTs. The average visual analogue scale score of CT benefit in all patients was 6.43 (standard deviation, 2.20). Patients who were only familiar with the term without detailed knowledge of the contents had the least expectation of benefit from CTs (p=0.015). When asked about their willingness to participate in CTs, 56.7% (225/397) answered positively. Patients with higher levels of awareness of CTs showed higher willingness to participate (p awareness regarding CTs was positively related to the positive perception and willingness to participate. Although the general awareness of CTs was high, a relatively large proportion of patients did not have accurate knowledge; therefore, proper and accurate patient education is necessary. PMID:28392549

  3. Benefits, pitfalls and risks of phytotherapy in clinical practice in otorhinolaryngology.

    Science.gov (United States)

    Laccourreye, O; Werner, A; Laccourreye, L; Bonfils, P

    2017-04-01

    To elucidate the benefits, pitfalls and risks of phytotherapy in the clinical practice of otorhinolaryngology. The PubMed and Cochrane databases were searched using the following keywords: phytotherapy, phytomedicine, herbs, otology, rhinology, laryngology, otitis, rhinitis, laryngitis and otorhinolaryngology. Seventy-two articles (18 prospective randomized studies, 4 Cochrane analyses, 4 meta-analysis and 15 reviews of the literature) devoted to clinical studies were analyzed. Articles devoted to in vitro or animal studies, biochemical analyses or case reports (including fewer than 10 patients) and articles dealing with honey, aromatherapy or minerals were excluded. Per os ginkgo biloba has no indications in tinnitus, presbycusis or anosmia following viral rhinitis. Traditional Asian medicine has no proven benefit in sudden deafness or laryngeal papillomatosis. Per os mistletoe extracts associated to conventional treatment for head and neck squamous cell carcinoma does not increase 5-year survival. Extracts of various herbs, notably echinacea, eucalyptus, petasites hybridus, pelargonium sidoides, rosemary, spirulina and thyme, show superiority over placebo for rhinosinusitis and allergic rhinitis, as does gingko biloba for selected vertigo. There have been encouraging preliminary results for intratumoral injection of mistletoe in head and neck carcinoma and acupoint herbal patching for allergic rhinitis. Herb intake should be screened for in case of certain unexplained symptoms such as epistaxis, headache or dizziness, or signs suggesting allergy. Phytotherapy should be interrupted ahead of surgery and/or chemotherapy. Scientific proof of the benefit of phytotherapy in otorhinolaryngology remains to be established but, given its widespread use and the reported data, knowledge of this form of treatment needs to be developed. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  4. Humidification during laparoscopic surgery: overview of the clinical benefits of using humidified gas during laparoscopic surgery.

    Science.gov (United States)

    Binda, Maria Mercedes

    2015-11-01

    The peritoneum is the serous membrane that covers the abdominal cavity and most of the intra-abdominal organs. It is a very delicate layer highly susceptible to damage and it is not designed to cope with variable conditions such as the dry and cold carbon dioxide (CO2) during laparoscopic surgery. The aim of this review was to evaluate the effects caused by insufflating dry and cold gas into the abdominal cavity after laparoscopic surgery. A literature search using the Pubmed was carried out. Articles identified focused on the key issues of laparoscopy, peritoneum, morphology, pneumoperitoneum, humidity, body temperature, pain, recovery time, post-operative adhesions and lens fogging. Insufflating dry and cold CO2 into the abdomen causes peritoneal damage, post-operative pain, hypothermia and post-operative adhesions. Using humidified and warm gas prevents pain after surgery. With regard to hypothermia due to desiccation, it can be fully prevented using humidified and warm gas. Results relating to the patient recovery are still controversial. The use of humidified and warm insufflation gas offers a significant clinical benefit to the patient, creating a more physiologic peritoneal environment and reducing the post-operative pain and hypothermia. In animal models, although humidified and warm gas reduces post-operative adhesions, humidified gas at 32 °C reduced them even more. It is clear that humidified gas should be used during laparoscopic surgery; however, a question remains unanswered: to achieve even greater clinical benefit to the patient, at what temperature should the humidified gas be when insufflated into the abdomen? More clinical trials should be performed to resolve this query.

  5. Building Bridges Through Meaningful Occupation

    Directory of Open Access Journals (Sweden)

    Jennifer Fortuna

    2017-07-01

    Full Text Available Mary Block, MS, OTR/L, an occupational therapist and artist based in Illinois, provided the cover art for the Summer 2017 issue of The Open Journal of Occupational Therapy (OJOT. Generations is a sculpture made from concrete that measures 240 x100 in. (6.096 x 2.54 m. The piece was commissioned by Mary’s home town, the Village of Deerfield, IL. Mary always knew she wanted to be an artist. When competing paradigms altered Mary’s career path, the field of occupational therapy helped her to shape a new worldview. In uncertain times, meaningful occupation empowered Mary to start over again where she originally began

  6. Do benefits accrue from longer rotations for students in Rural Clinical Schools?

    Science.gov (United States)

    Denz-Penhey, Harriet; Shannon, Susan; Murdoch, Campbell J; Newbury, Jonathon W

    2005-01-01

    The Australian Government has provided funding for Rural Clinical Schools (RCS) to provide substantial rural clinical experience to medical students. The strategy aims to acculturate students into rural living with the intended long-term outcome of increasing the availability and viability of rural health services. When evaluators from two of the Rural Clinical Schools discussed findings and insights relating to rural rotations from their in-depth evaluation studies of their respective schools they found a range of similarities. This article is a collaboration that articulates parallel findings from evaluations over 2 years, using three different approaches to students' placements across the two RCS: (1) students based long term in one centre (with only a few days away at a time); (2) students based long term in one centre with short-term rotations of 3-6 weeks away from home base; and (3) week rotations without a home base. The two RCS, as part of their initial establishment, put comprehensive internal evaluation processes in place, including the employment of dedicated evaluators extant from the teaching and assessment of the rural medical curriculum. Data were collected and analysed according to standard education evaluation procedures. Home-base preference: most students preferred having a home base in one centre and having as little time as possible away from that centre, while recognising that sometimes the requirement to go and learn elsewhere was useful. The reasons for this were three-fold: academic, clinical and social. Academic benefits: students enjoyed the excellence of teaching and learning opportunities in their rural sites and did not want their discipline of learning interrupted by what they perceived as unnecessary change. Students with a home base used their learning opportunities qualitatively differently from those students who had 6 week rotations. Their learning became self-directed and students sought opportunities to extend and consolidate

  7. A systematic review on clinical benefits of continuous administration of beta-lactam antibiotics.

    Science.gov (United States)

    Roberts, Jason A; Webb, Steven; Paterson, David; Ho, Kwok M; Lipman, Jeffrey

    2009-06-01

    The clinical benefits of extended infusion or continuous infusion of beta-lactam antibiotics remain controversial. We systematically reviewed the literature to determine whether any clinical benefits exist for administration of beta-lactam antibiotics by extended or continuous infusion. PubMed (January 1950 to November 2007), EMBASE (1966 to November 2007), and the Cochrane Controlled Trial Register were searched (updated November 2007). Randomized controlled trials (RCTs) were meta-analyzed, and observational studies were described by two unblinded reviewers. A total of 846 patients from eligible prospective randomized controlled studies were included in the meta-analysis. Two observational studies were deemed appropriate for description. A meta-analysis of prospective RCTs was undertaken using Review Manager. Among a total of 59 potentially relevant studies, 14 RCTs involving a total of 846 patients from nine countries were deemed appropriate for meta-analysis. The use of continuous infusion of a beta-lactam antibiotic was not associated with an improvement in clinical cure (n = 755 patients; odds ratio: 1.04, 95% confidence interval: 0.74-1.46, p = 0.83, I = 0%) or mortality (n = 541 patients; odds ratio: 1.00, 95% confidence interval: 0.48-2.06, p = 1.00, I = 14.8%). All RCTs except one used a higher antibiotic dose in the bolus administration group. Two observational studies, not pooled because they did not meet the a priori criteria for meta-analysis, showed that beta-lactam administration by extended or continuous infusion was associated with an improvement in clinical cure. The difference in the results between the meta-analysis results and the observational studies could be explained by the bias created by a higher dose of antibiotic in the bolus group in the RCTs and because many of the RCTs only recruited patients with a low acuity of illness. The limited data available suggest that continuous infusion of beta-lactam antibiotics leads to the same

  8. Chyawanprash: A review of therapeutic benefits as in authoritative texts and documented clinical literature.

    Science.gov (United States)

    Narayana, D B Anantha; Durg, Sharanbasappa; Manohar, P Ram; Mahapatra, Anita; Aramya, A R

    2017-02-02

    Chyawanprash (CP), a traditional immune booster recipe, has a long history of ethnic origin, development, household preparation and usage. There are even mythological stories about the origin of this recipe including its nomenclature. In the last six decades, CP, because of entrepreneurial actions of some research Vaidyas (traditional doctors) has grown to industrial production and marketing in packed forms to a large number of consumers/patients like any food or health care product. Currently, CP has acquired a large accepted user base in India and in a few countries out-side India. Authoritative texts, recognized by the Drugs and Cosmetics Act of India, describe CP as an immunity enhancer and strength giver meant for improving lung functions in diseases with compromised immunity. This review focuses on published clinical efficacy and safety studies of CP for correlation with health benefits as documented in the authoritative texts, and also briefs on its recipes and processes. Authoritative texts were searched for recipes, processes, and other technical details of CP. Labels of marketing CP products (Indian) were studied for the health claims. Electronic search for studies of CP on efficacy and safety data were performed in PubMed/MEDLINE and DHARA (Digital Helpline for Ayurveda Research Articles), and Ayurvedic books were also searched for clinical studies. The documented clinical studies from electronic databases and Ayurvedic books evidenced that individuals who consume CP regularly for a definite period of time showed improvement in overall health status and immunity. However, most of the clinical studies in this review are of smaller sample size and short duration. Further, limitation to access and review significant data on traditional products like CP in electronic databases was noted. Randomized controlled trials of high quality with larger sample size and longer follow-up are needed to have significant evidence on the clinical use of CP as immunity

  9. Review of nanomaterials in dentistry: interactions with the oral microenvironment, clinical applications, hazards, and benefits.

    Science.gov (United States)

    Besinis, Alexandros; De Peralta, Tracy; Tredwin, Christopher J; Handy, Richard D

    2015-03-24

    Interest in the use of engineered nanomaterials (ENMs) as either nanomedicines or dental materials/devices in clinical dentistry is growing. This review aims to detail the ultrafine structure, chemical composition, and reactivity of dental tissues in the context of interactions with ENMs, including the saliva, pellicle layer, and oral biofilm; then describes the applications of ENMs in dentistry in context with beneficial clinical outcomes versus potential risks. The flow rate and quality of saliva are likely to influence the behavior of ENMs in the oral cavity, but how the protein corona formed on the ENMs will alter bioavailability, or interact with the structure and proteins of the pellicle layer, as well as microbes in the biofilm, remains unclear. The tooth enamel is a dense crystalline structure that is likely to act as a barrier to ENM penetration, but underlying dentinal tubules are not. Consequently, ENMs may be used to strengthen dentine or regenerate pulp tissue. ENMs have dental applications as antibacterials for infection control, as nanofillers to improve the mechanical and bioactive properties of restoration materials, and as novel coatings on dental implants. Dentifrices and some related personal care products are already available for oral health applications. Overall, the clinical benefits generally outweigh the hazards of using ENMs in the oral cavity, and the latter should not prevent the responsible innovation of nanotechnology in dentistry. However, the clinical safety regulations for dental materials have not been specifically updated for ENMs, and some guidance on occupational health for practitioners is also needed. Knowledge gaps for future research include the formation of protein corona in the oral cavity, ENM diffusion through clinically relevant biofilms, and mechanistic investigations on how ENMs strengthen the tooth structure.

  10. Standardizing Clinically Meaningful Outcome Measures Beyond HbA1c for Type 1 Diabetes: A Consensus Report of the American Association of Clinical Endocrinologists, the American Association of Diabetes Educators, the American Diabetes Association, the Endocrine Society, JDRF International, The Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine Society, and the T1D Exchange.

    Science.gov (United States)

    Agiostratidou, Gina; Anhalt, Henry; Ball, Dana; Blonde, Lawrence; Gourgari, Evgenia; Harriman, Karen N; Kowalski, Aaron J; Madden, Paul; McAuliffe-Fogarty, Alicia H; McElwee-Malloy, Molly; Peters, Anne; Raman, Sripriya; Reifschneider, Kent; Rubin, Karen; Weinzimer, Stuart A

    2017-12-01

    To identify and define clinically meaningful type 1 diabetes outcomes beyond hemoglobin A 1c (HbA 1c ) based upon a review of the evidence, consensus from clinical experts, and input from researchers, people with type 1 diabetes, and industry. Priority outcomes include hypoglycemia, hyperglycemia, time in range, diabetic ketoacidosis (DKA), and patient-reported outcomes (PROs). While priority outcomes for type 1 and type 2 diabetes may overlap, type 1 diabetes was the focus of this work. A Steering Committee-comprising representatives from the American Association of Clinical Endocrinologists, the American Association of Diabetes Educators, the American Diabetes Association, the Endocrine Society, JDRF International, The Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine Society, and the T1D Exchange-was the decision-making body for the Type 1 Diabetes Outcomes Program. Their work was informed by input from researchers, industry, and people with diabetes through Advisory Committees representing each stakeholder group. Stakeholder surveys were used to identify priority outcomes. The outcomes prioritized in the surveys were hypoglycemia, hyperglycemia, time in range, DKA, and PROs. To develop consensus on the definitions of these outcomes, the Steering Committee relied on published evidence, their clinical expertise, and feedback from the Advisory Committees. The Steering Committee developed definitions for hypoglycemia, hyperglycemia, time in range, and DKA in type 1 diabetes. The definitions reflect their assessment of the outcome's short- and long-term clinical impact on people with type 1 diabetes. Knowledge gaps to be addressed by future research were identified. The Steering Committee discussed PROs and concluded that further type 1 diabetes-specific development is needed. The Steering Committee recommends use of the defined clinically meaningful outcomes beyond HbA 1c in the research, development, and evaluation of type 1 diabetes

  11. Clinical Benefit of Valvular Surgery in Patients with Chronic Kidney Disease.

    Science.gov (United States)

    Chen, Yan; Au, Wing-Kuk; Chan, Daniel; Sit, Ko-Yung; Zhen, Zhe; Ho, Kar-Lai; Wong, Debbie; Ho, Lai-Ming; Yap, Desmond; Lam, Yui-Ming; Lau, Chu-Pak; Tse, Hung-Fat; Chan, Tak-Mao; Yiu, Kai-Hang

    2018-06-20

    Concomitant chronic kidney disease (CKD) is common in patients with significant valvular heart disease (VHD). This study sought to evaluate the clinical benefit of valvular surgery in patients with concomitant CKD.We evaluated 349 patients with significant VHD who were referred for surgery. Patients were divided into those with CKD stage ≥ 3 (CKD patients; n = 88) and those with CKD stage 1 or 2 (no CKD patients; n = 261). 63 patients did not receive surgery, of which 20 patients had CKD and 43 had no CKD. Mortality and change in eGFR were assessed after a median follow-up of 21 months.In the whole study population, 25% of the patients had CKD and these patients had higher mortality than those with no CKD. The annual mortality rates of patients with CKD who did and did not undergo surgery were 7.9% and 28.0%, respectively. In patients with no CKD, the annual mortality rates of those who did and did not undergo surgery were 1.8% and 2.3%, respectively. Importantly, surgery was associated with significant survival benefit in patients with CKD (log-rank test, P < 0.01), but was neutral in patients with no CKD. Multivariable analysis confirmed the survival benefit of valvular surgery in all patients, which was most significant in patients with CKD. Furthermore, eGFR was preserved in patients who underwent valvular surgery but declined significantly in those who did not.CKD is common in patients with significant VHD and, if left untreated surgically, these patients exhibit a high mortality.

  12. RELATIONAL NEEDS OF THE THERAPIST: COUNTERTRANSFERENCE, CLINICAL WORK AND SUPERVISION. BENEFITS AND DISRUPTIONS IN PSYCHOTHERAPY

    Directory of Open Access Journals (Sweden)

    Lindsay Stewart

    2010-02-01

    Full Text Available Relational needs are the emotional needs which underlie our social connectedness and help sustain and nurture our attachments to others. In doing psychotherapy, therapists must be attuned not only to the needs of the client, but also to their own relational needs. Through self awareness and knowledge of healthy and appropriate boundaries, therapists can ensure the best interest of the client is kept foremost. In this article, the influence of the therapist’s own relational needs in the psychotherapy process is examined in terms of the possible benefits and disruptions to the client’s emotional growth. This is discussed in the context of the Integrative Psychotherapy model based on the core concepts of inquiry, involvement and attunement. Clinical supervision is seen as an important part of working through counter-transference.

  13. Advance MRI for pediatric brain tumors with emphasis on clinical benefits

    Energy Technology Data Exchange (ETDEWEB)

    Goo, Hyun Woo; Ra, Young Shin [Asan Medical Center, University of Ulsan College of Medicine, Seoul(Korea, Republic of)

    2017-01-15

    Conventional anatomic brain MRI is often limited in evaluating pediatric brain tumors, the most common solid tumors and a leading cause of death in children. Advanced brain MRI techniques have great potential to improve diagnostic performance in children with brain tumors and overcome diagnostic pitfalls resulting from diverse tumor pathologies as well as nonspecific or overlapped imaging findings. Advanced MRI techniques used for evaluating pediatric brain tumors include diffusion-weighted imaging, diffusion tensor imaging, functional MRI, perfusion imaging, spectroscopy, susceptibility-weighted imaging, and chemical exchange saturation transfer imaging. Because pediatric brain tumors differ from adult counterparts in various aspects, MRI protocols should be designed to achieve maximal clinical benefits in pediatric brain tumors. In this study, we review advanced MRI techniques and interpretation algorithms for pediatric brain tumors.

  14. Escitalopram—translating molecular properties into clinical benefit: reviewing the evidence in major depression

    Science.gov (United States)

    Leonard, Brian; Taylor, David

    2010-01-01

    The majority of currently marketed drugs contain a mixture of enantiomers; however, recent evidence suggests that individual enantiomers can have pharmacological properties that differ importantly from enantiomer mixtures. Escitalopram, the S-enantiomer of citalopram, displays markedly different pharmacological activity to the R-enantiomer. This review aims to evaluate whether these differences confer any significant clinical advantage for escitalopram over either citalopram or other frequently used antidepressants. Searches were conducted using PubMed and EMBASE (up to January 2009). Abstracts of the retrieved studies were reviewed independently by both authors for inclusion. Only those studies relating to depression or major depressive disorder were included. The search identified over 250 citations, of which 21 studies and 18 pooled or meta-analyses studies were deemed suitable for inclusion. These studies reveal that escitalopram has some efficacy advantage over citalopram and paroxetine, but no consistent advantage over other selective serotonin reuptake inhibitors. Escitalopram has at least comparable efficacy to available serotonin-norepinephrine reuptake inhibitors, venlafaxine XR and duloxetine, and may offer some tolerability advantages over these agents. This review suggests that the mechanistic advantages of escitalopram over citalopram translate into clinical efficacy advantages. Escitalopram may have a favourable benefit-risk ratio compared with citalopram and possibly with several other antidepressant agents. PMID:20147575

  15. Benefits of whole body vibration training in patients hospitalised for COPD exacerbations - a randomized clinical trial.

    Science.gov (United States)

    Greulich, Timm; Nell, Christoph; Koepke, Janine; Fechtel, Juliane; Franke, Maja; Schmeck, Bernd; Haid, Daniel; Apelt, Sandra; Filipovic, Silke; Kenn, Klaus; Janciauskiene, Sabina; Vogelmeier, Claus; Koczulla, Andreas Rembert

    2014-04-11

    Patients with stable COPD show improvements in exercise capacity and muscular function after the application of whole body vibration. We aimed to evaluate whether this modality added to conventional physiotherapy in exacerbated hospitalised COPD patients would be safe and would improve exercise capacity and quality of life. 49 hospitalised exacerbated COPD patients were randomized (1:1) to undergo physiotherapy alone or physiotherapy with the addition of whole body vibration. The primary endpoint was the between-group difference of the 6-minute walking test (day of discharge - day of admission). Secondary assessments included chair rising test, quality of life, and serum marker analysis. Whole body vibration did not cause procedure-related adverse events. Compared to physiotherapy alone, it led to significantly stronger improvements in 6-minute walking test (95.55 ± 76.29 m vs. 6.13 ± 81.65 m; p = 0.007) and St. Georges Respiratory Questionnaire (-6.43 ± 14.25 vs. 5.59 ± 19.15, p = 0.049). Whole body vibration increased the expression of the transcription factor peroxisome proliferator receptor gamma coactivator-1-α and serum levels of irisin, while it decreased serum interleukin-8. Whole body vibration during hospitalised exacerbations did not cause procedure-related adverse events and induced clinically significant benefits regarding exercise capacity and health-related quality of life that were associated with increased serum levels of irisin, a marker of muscle activity. German Clinical Trials Register DRKS00005979. Registered 17 March 2014.

  16. Benefits of plasma rich in growth factors (PRGF) in skin photodamage: clinical response and histological assessment.

    Science.gov (United States)

    Díaz-Ley, B; Cuevast, J; Alonso-Castro, L; Calvo, M I; Ríos-Buceta, L; Orive, G; Anitua, E; Jaén, P

    2015-01-01

    Skin ageing is characterized by small and fine wrinkles, roughness, laxity, and pigmentation as a result of epidermal thinning, collagen degradation, dermal atrophy, and fewer fibroblasts. Plasma rich in growth factors (PRGF) is an autologous plasma preparation enriched in proteins obtained from patient's own blood aimed at accelerating tissue repair and regeneration. To evaluate the benefits of PRGF in skin photodamage, 10 healthy volunteers were treated with three consecutive intradermal injections of PRGF in the facial area. Clinical outcomes and histological analysis were performed. A statistically significant increase in the epidermis and papillary dermis thickness was seen after PRGF treatment (p PRGF treatment, a reduction of the average area fraction of solar elastosis was observed in patients with clinical and histological signs of skin photodamage (p PRGF use was 0.75 (9/12) for the group of patients with signs of skin photodamage. Intradermal PRGF infiltration appears to be an effective treatment for the photodamaged skin. © 2015 Wiley Periodicals, Inc.

  17. FOXM1 coming of age: Time for translation into clinical benefits?

    Directory of Open Access Journals (Sweden)

    Muy-Teck eTeh

    2012-10-01

    Full Text Available A decade since the first evidence implicating the cell cycle transcription factor FOXM1 in human tumourigenesis, a slew of subsequent studies revealed an oncogenic role of FOXM1 in the majority of human cancers including oral, nasopharynx, oropharynx, oesophagus, breast, ovary, prostate, lung, liver, pancreas, kidney, colon, brain, cervix, thyroid, bladder, uterus, testis, stomach, skin and blood. Its aberrant upregulation in almost all different cancer types suggests a fundamental role for FOXM1 in tumourigenesis. Its dose-dependent expression pattern correlated well with tumour progression starting from cancer predisposition and initiation, early premalignancy and progression, to metastatic invasion. In addition, emerging studies have demonstrated a causal link between FOXM1 and chemotherapeutic drug resistance. Despite the well-established multifaceted roles for FOXM1 in all stages of oncogenesis, its translation into clinical benefit is yet to materialise. In this contribution, I reviewed and discussed how our current knowledge on the oncogenic mechanisms of FOXM1 could be exploited for clinical use as biomarker for risk prediction, early cancer screening, molecular diagnostics/prognostics and/or companion diagnostics for pers

  18. Escitalopram--translating molecular properties into clinical benefit: reviewing the evidence in major depression.

    LENUS (Irish Health Repository)

    Leonard, Brian

    2010-08-01

    The majority of currently marketed drugs contain a mixture of enantiomers; however, recent evidence suggests that individual enantiomers can have pharmacological properties that differ importantly from enantiomer mixtures. Escitalopram, the S-enantiomer of citalopram, displays markedly different pharmacological activity to the R-enantiomer. This review aims to evaluate whether these differences confer any significant clinical advantage for escitalopram over either citalopram or other frequently used antidepressants. Searches were conducted using PubMed and EMBASE (up to January 2009). Abstracts of the retrieved studies were reviewed independently by both authors for inclusion. Only those studies relating to depression or major depressive disorder were included. The search identified over 250 citations, of which 21 studies and 18 pooled or meta-analyses studies were deemed suitable for inclusion. These studies reveal that escitalopram has some efficacy advantage over citalopram and paroxetine, but no consistent advantage over other selective serotonin reuptake inhibitors. Escitalopram has at least comparable efficacy to available serotonin-norepinephrine reuptake inhibitors, venlafaxine XR and duloxetine, and may offer some tolerability advantages over these agents. This review suggests that the mechanistic advantages of escitalopram over citalopram translate into clinical efficacy advantages. Escitalopram may have a favourable benefit-risk ratio compared with citalopram and possibly with several other antidepressant agents.

  19. Pellagra-like condition is xeroderma pigmentosum/Cockayne syndrome complex and niacin confers clinical benefit.

    Science.gov (United States)

    Hijazi, H; Salih, M A; Hamad, M H A; Hassan, H H; Salih, S B M; Mohamed, K A; Mukhtar, M M; Karrar, Z A; Ansari, S; Ibrahim, N; Alkuraya, F S

    2015-01-01

    An extremely rare pellagra-like condition has been described, which was partially responsive to niacin and associated with a multisystem involvement. The condition was proposed to represent a novel autosomal recessive entity but the underlying mutation remained unknown for almost three decades. The objective of this study was to identify the causal mutation in the pellagra-like condition and investigate the mechanism by which niacin confers clinical benefit. Autozygosity mapping and exome sequencing were used to identify the causal mutation, and comet assay on patient fibroblasts before and after niacin treatment to assess its effect on DNA damage. We identified a single disease locus that harbors a novel mutation in ERCC5, thus confirming that the condition is in fact xeroderma pigmentosum/Cockayne syndrome (XP/CS) complex. Importantly, we also show that the previously described dermatological response to niacin is consistent with a dramatic protective effect against ultraviolet-induced DNA damage in patient fibroblasts conferred by niacin treatment. Our findings show the power of exome sequencing in reassigning previously described novel clinical entities, and suggest a mechanism for the dermatological response to niacin in patients with XP/CS complex. This raises interesting possibilities about the potential therapeutic use of niacin in XP. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  20. Dupilumab therapy provides clinically meaningful improvement in patient-reported outcomes (PROs): A phase IIb, randomized, placebo-controlled, clinical trial in adult patients with moderate to severe atopic dermatitis (AD).

    Science.gov (United States)

    Simpson, Eric L; Gadkari, Abhijit; Worm, Margitta; Soong, Weily; Blauvelt, Andrew; Eckert, Laurent; Wu, Richard; Ardeleanu, Marius; Graham, Neil M H; Pirozzi, Gianluca; Sutherland, E Rand; Mastey, Vera

    2016-09-01

    Moderate to severe atopic dermatitis (AD) is associated with substantial patient burden despite current therapies. We sought to evaluate dupilumab treatment on patient-reported outcomes in adults with moderate to severe AD. Adults (N = 380) with moderate to severe AD inadequately controlled by topical medications were randomized to 16 weeks of double-blind, subcutaneous treatment with dupilumab 100 mg every 4 weeks, 200 mg every 2 weeks, 300 mg every 2 weeks, 300 mg once weekly, or placebo. Patient-reported outcomes included pruritus numeric rating scale; patient-reported sleep item on Scoring AD scale; Patient-Oriented Eczema Measure; Hospital Anxiety and Depression Scale; Dermatology Life Quality Index; and 5-dimension 3-level EuroQol. Dupilumab reduced peak itch at 16 weeks relative to placebo by 1.1 to 3.2 points on numeric rating scale (P health-related quality of life on Dermatology Life Quality Index and 5-dimension 3-level EuroQol (P mental health, and health-related quality of life; the two 300-mg dose regimens resulted in greatest benefits. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  1. Clinical benefit and cost effectiveness of total knee arthroplasty in the older patient

    Directory of Open Access Journals (Sweden)

    Krummenauer F

    2009-02-01

    Full Text Available Abstract Purpose Total knee arthroplasty (TKA is an effective, but also cost-intensive health care procedure for the elderly. Furthermore, bearing demographic changes in Western Europe in mind, TKA-associated financial investment for health care insurers will increase notably and thereby catalyze discussions on ressource allocation to Orthopedic surgery. To derive a quantitative rationale for such discussions within Western Europe's health care systems, a prospective assessment of both the benefit of TKA from a patient's perspective as well as its cost effectiveness from a health care insurer's perspective was implemented. Methods A prospective cost effectiveness trial recruited a total of 65 patients (60% females, who underwent TKA in 2006; median age of patients was 66 years (interquartile range 61 - 74 years. Before and three months after surgery patients were interviewed by means of the EuroQol-5D and the WOMAC questionnaires to assess their individual benefit due to TKA and the subsequent inpatient rehabilitation. Both questionnaires' benefit estimates were transformed into the number of gained quality adjusted life years [QALYs]. Total direct cost estimates for the overall care were based on German DRG and rehabilitation cost rates [€]. The primary clinical endpoint of the investigation was the individual number of QALYs gained by TKA based on the WOMAC interview; the primary health economic endpoint was the marginal cost effectiveness ratio (MCER relating the costs to the associated gain in quality of life [€/QALY]. Results Total direct costs for the overall procedure were estimed 9549 € in median. The WOMAC based interview revealed an overall gain of 4.59 QALYs (interquartile range 2.39 - 6.21 QALYs, resulting in marginal costs of 1795 €/QALY (1488 - 3288 €/QALY. The corresponding EuroQol based estimates were 2.93 QALYs (1.75 - 5.59 QALYs and 3063 €/QALY (1613 - 5291 €/QALY. Logistic regression modelling identified the

  2. Two approaches to incorporate clinical data uncertainty into multiple criteria decision analysis for benefit-risk assessment of medicinal products.

    Science.gov (United States)

    Wen, Shihua; Zhang, Lanju; Yang, Bo

    2014-07-01

    The Problem formulation, Objectives, Alternatives, Consequences, Trade-offs, Uncertainties, Risk attitude, and Linked decisions (PrOACT-URL) framework and multiple criteria decision analysis (MCDA) have been recommended by the European Medicines Agency for structured benefit-risk assessment of medicinal products undergoing regulatory review. The objective of this article was to provide solutions to incorporate the uncertainty from clinical data into the MCDA model when evaluating the overall benefit-risk profiles among different treatment options. Two statistical approaches, the δ-method approach and the Monte-Carlo approach, were proposed to construct the confidence interval of the overall benefit-risk score from the MCDA model as well as other probabilistic measures for comparing the benefit-risk profiles between treatment options. Both approaches can incorporate the correlation structure between clinical parameters (criteria) in the MCDA model and are straightforward to implement. The two proposed approaches were applied to a case study to evaluate the benefit-risk profile of an add-on therapy for rheumatoid arthritis (drug X) relative to placebo. It demonstrated a straightforward way to quantify the impact of the uncertainty from clinical data to the benefit-risk assessment and enabled statistical inference on evaluating the overall benefit-risk profiles among different treatment options. The δ-method approach provides a closed form to quantify the variability of the overall benefit-risk score in the MCDA model, whereas the Monte-Carlo approach is more computationally intensive but can yield its true sampling distribution for statistical inference. The obtained confidence intervals and other probabilistic measures from the two approaches enhance the benefit-risk decision making of medicinal products. Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  3. Cost-benefit analysis of childhood asthma management through school-based clinic programs.

    Science.gov (United States)

    Tai, Teresa; Bame, Sherry I

    2011-04-01

    Asthma is a leading chronic illness among American children. School-based health clinics (SBHCs) reduced expensive ER visits and hospitalizations through better healthcare access and monitoring in select case studies. The purpose of this study was to examine the cost-benefit of SBHC programs in managing childhood asthma nationwide for reduction in medical costs of ER, hospital and outpatient physician care and savings in opportunity social costs of lowing absenteeism and work loss and of future earnings due to premature deaths. Eight public data sources were used to compare costs of delivering primary and preventive care for childhood asthma in the US via SBHC programs, including direct medical and indirect opportunity costs for children and their parents. The costs of nurse staffing for a nationwide SBHC program were estimated at $4.55 billion compared to the estimated medical savings of $1.69 billion, including ER, hospital, and outpatient care. In contrast, estimated total savings for opportunity costs of work loss and premature death were $23.13 billion. Medical savings alone would not offset the expense of implementing a SBHC program for prevention and monitoring childhood asthma. However, even modest estimates of reducing opportunity costs of parents' work loss would be far greater than the expense of this program. Although SBHC programs would not be expected to affect the increasing prevalence of childhood asthma, these programs would be designed to reduce the severity of asthma condition with ongoing monitoring, disease prevention and patient compliance.

  4. Clinical Benefit of Second-Line Palliative Chemotherapy in Advanced Soft-Tissue Sarcoma

    Directory of Open Access Journals (Sweden)

    Anna Minchom

    2010-01-01

    Full Text Available Background. This paper aimed to assess the utility of second-line chemotherapy in patients with advanced soft-tissue sarcoma. Materials and Methods. A retrospective search of a prospectively maintained database identified patients treated between 1991 and 2005. Patients with gastrointestinal stromal tumours, small round cell tumours, and Ewing's sarcoma were excluded. Response was assessed using WHO and RECIST. Patients who achieved stable disease for 6 months or more were classified as having disease control. Results. Three hundred and seventy-nine patients received second-line chemotherapy. Eighty-six (22.7% achieved disease control. Median duration of response was 11 months (95% CI: 9–13. On multivariate analysis, pathological subtype, absence of lung metastases, and the use of combination chemotherapy were independent predictors of disease control. Twenty-eight (16.1% patients who failed to respond to first-line therapy achieved disease control. Eight (2.1% patients had sufficient downstaging to enable complete surgical resection. Progression-free survival was 23% at 6 months. Median overall survival was 8 months (95% CI: 7–10 months. On multivariate analysis, synovial histology and absence of lung metastases were associated with improved survival. Conclusion. Second-line chemotherapy can provide clinical benefit in over 20% of soft-tissue sarcoma patients.

  5. Net clinical benefit of new oral anticoagulants (dabigatran, rivaroxaban, apixaban) versus no treatment in a 'real world' atrial fibrillation population

    DEFF Research Database (Denmark)

    Banerjee, A; Lane, D A; Torp-Pedersen, C

    2012-01-01

    The concept of net clinical benefit has been used to quantify the balance between risk of ischaemic stroke (IS) and risk of intracranial haemorrhage (ICH) with the use oral anticoagulant therapy (OAC) in the setting of non-valvular atrial fibrillation (AF), and has shown that patients at highest ...... in AF. Using 'real world' data, our modelling analysis has shown that when the risk of bleeding and stroke are both high, all three new drugs appear to have a greater net clinical benefit compared to warfarin....

  6. Does perioperative high-dose prednisolone have clinical benefits for generalized myasthenia gravis?

    Science.gov (United States)

    Sekine, Yasuo; Kawaguchi, Naoki; Hamada, Chikuma; Sekiguchi, Hiromi; Yasufuku, Kazuhiro; Iyoda, Akira; Shibuya, Kiyoshi; Fujisawa, Takehiko

    2006-06-01

    The purpose of this study was to clarify the clinical benefits of perioperative administration of high-dose prednisolone (PSL) combined with extended thymectomy on the long-term outcomes of 116 consecutive patients with generalized myasthenia gravis (MG). A retrospective review was conducted on 116 patients diagnosed with generalized MG who received alternate-day oral administration of high-dose PSL (100 mg/alternate days) and had undergone transsternal extended thymectomy. Incidences of postoperative myasthenic crisis, adverse effects of steroid, long-term outcomes, such as complete stable remission (CSR), pharmacologic remission (PR) or improvement (Imp), and disease recurrence after CSR were evaluated. Six patients (5.2%) experienced post-thymectomy myasthenic crisis. Crude cumulative CSR and PR + CSR rates were 44.8 and 62.7%, respectively. Life table analysis showed that 41.8, 52.8 and 63.4% of the patients were in CSR at 3, 5 and 10 years, respectively. Multivariate analysis revealed that age and pretreatment classification according to the Myasthenia Gravis Foundation of America (MGFA) criteria tended to be independent predictors of CSR. There were 6.9% with compressive vertebral fracture, 13.8% with cataract, and 5.2% with steroid-induced diabetes. Life table analysis revealed that recurrence rates after CSR were 36.8 and 46.0% at 3 and 5 years, respectively. Patients with thymoma had a significantly higher rate of recurrence than those without thymoma (p = 0.001). Alternate-day administration of high-dose prednisolone reduced the risk of post-thymectomy myasthenic crisis. Presence of thymoma was a risk factor for MG recurrence after CSR.

  7. Proven and potential clinical benefits of washing red blood cells before transfusion: current perspectives

    Directory of Open Access Journals (Sweden)

    Schmidt AE

    2016-08-01

    Full Text Available Amy E Schmidt, Majed A Refaai, Scott A Kirkley, Neil Blumberg Department of Pathology and Laboratory Medicine, University of Rochester Medical Center, Rochester, NY, USA Abstract: Red blood cells (RBCs are washed for a variety of reasons such as to remove excess potassium, cytokines, and other allergen proteins from the supernatant and/or to mitigate the effects of the storage lesion. The storage lesion is a product of RBC aging and include leakage of potassium and chloride from the RBCs, depletion of 2,3-diphosphoglycerate and adenosine triphosphate, loss of phospholipids and cholesterol, exposure of phosphatidylserine, elaboration of lipid mediators, loss of glutathione, autoxidation of hemoglobin to methemoglobin contributing to decreased blood flow viscosity and adherence to endothelial cells, increased microparticle formation, and disruption of NO-mediated vasodilation. A storage lesion is thought to be caused in part by oxidative stress, which is characterized by functional and structural changes to the RBCs. The effects of the RBC storage lesion on patient morbidity and mortality have been studied intensively with mixed results. Here, we will summarize the potential benefits of RBC washing. Notably, all patient-based studies on washed RBCs are single-center, small randomized studies or observational data, which await replication and tests of generalizability. Some of the most promising preliminary data suggest that washed transfusions of red cells and platelets reduce mortality in low risk, younger patients with acute myeloid leukemia, mitigate lung injury, and substantially reduce mortality in cardiac surgery. Larger randomized trials to replicate or refute these findings are urgently needed and, most importantly, have the potential to strikingly improve clinical outcomes following transfusion. Keywords: washed blood, transfusion, immunomodulation, red blood cell

  8. Vacuum-assisted wound closure in vascular surgery - clinical and cost benefits in a developing country

    Directory of Open Access Journals (Sweden)

    Končar Igor

    2016-01-01

    Full Text Available Background/Aim. Surgical and chronic wounds in vascular patients might contribute to limb loss and death. Vacuum-assisted closure (VAC - Kinetic Concepts, Inc. (KCI, has been increasingly used in Western Europe and the USA clinical practice for 15 years. Advantages of this method are faster wound healing, wound approximation, lower wound related treatment costs and improved quality of life during treatment. Evidence related to the usage of VAC therapy in vascular patients and cost effectiveness of VAC therapy in a developing country are lacking. The aim of this study was to explore results of VAC therapy in vascular surgery comparing to conventional methods and to test cost effects in a developing country like Serbia. Methods. All patients with wound infection or dehiscence operated at the tertiary vascular university clinic in the period from January 2011 - January 2012, were treated with VAC therapy. The primary endpoint was wound closure, while secondary endpoints were hospital stay, the number of weekly dressings, costs of wound care, working time of medical personnel. The patients were divided into groups according to the wound type and location: wound with exposed synthetic vascular implant (25%, laparotomy (13%, foot amputation (29%, major limb amputation (21%, fasciotomy (13%. The results of primary and secondary endpoint were compared with the results of conventional treatment during the previous year. Results. There was one death (1/42, 2.38% and one limb loss (1/12, 2.38% in the VAC group, and 8 deaths (8/38, 21.05% and 5 (5/38, 13.15% limb losses in the patients treated with conventional therapy. In the VAC group there was one groin bleeding (1/12, 2.38%, one groin reinfection (1/12, 2.38% and one resistance to therapy with a consequent limb loss. Costs of hospital stay (p < 0.001 and nursing time (p < 0.001 were reduced with VAC therapy in the group with exposed graft. Conclusion. VAC therapy is the effective method for care of

  9. Which elderly patients with severe aortic stenosis benefit from surgical treatment? An aid to clinical decision making

    NARCIS (Netherlands)

    Bouma, Berto J.; van den Brink, Renee B.; Zwinderman, K.; Cheriex, Emile C.; Hamer, Hans H.; Lie, Kong I.; Tijssen, Jan G.

    2004-01-01

    Background and aim of the study: Clinical decision-making in an individual elderly patient with severe aortic stenosis (AS) is difficult. The prognosis is influenced by increased age and various cardiac morbidity and comorbidity, and the benefit of surgery is uncertain because the prognosis with

  10. Home intravenous antibiotic therapy in children with cystic fibrosis: clinical outcome, quality of life and economic benefit

    OpenAIRE

    Chrysochoou, EA; Hatziagorou, E; Kirvassilis, F; Tsanakas, J

    2016-01-01

    Background: Pediatric home care has improved therapeutic options for children with chronic disease. Home intravenous (IV) antibiotic treatment against Pseudomonas aeruginosa (PsA) in cystic fibrosis (CF) patients has offered increased flexibility to these patients and family life. A prospective clinical study was conducted to compare safety, efficacy, and cost benefits of home versus hospital IV antibiotic treatment among CF children and adolescents.

  11. Audio-Visual and Meaningful Semantic Context Enhancements in Older and Younger Adults.

    Directory of Open Access Journals (Sweden)

    Kirsten E Smayda

    Full Text Available Speech perception is critical to everyday life. Oftentimes noise can degrade a speech signal; however, because of the cues available to the listener, such as visual and semantic cues, noise rarely prevents conversations from continuing. The interaction of visual and semantic cues in aiding speech perception has been studied in young adults, but the extent to which these two cues interact for older adults has not been studied. To investigate the effect of visual and semantic cues on speech perception in older and younger adults, we recruited forty-five young adults (ages 18-35 and thirty-three older adults (ages 60-90 to participate in a speech perception task. Participants were presented with semantically meaningful and anomalous sentences in audio-only and audio-visual conditions. We hypothesized that young adults would outperform older adults across SNRs, modalities, and semantic contexts. In addition, we hypothesized that both young and older adults would receive a greater benefit from a semantically meaningful context in the audio-visual relative to audio-only modality. We predicted that young adults would receive greater visual benefit in semantically meaningful contexts relative to anomalous contexts. However, we predicted that older adults could receive a greater visual benefit in either semantically meaningful or anomalous contexts. Results suggested that in the most supportive context, that is, semantically meaningful sentences presented in the audiovisual modality, older adults performed similarly to young adults. In addition, both groups received the same amount of visual and meaningful benefit. Lastly, across groups, a semantically meaningful context provided more benefit in the audio-visual modality relative to the audio-only modality, and the presence of visual cues provided more benefit in semantically meaningful contexts relative to anomalous contexts. These results suggest that older adults can perceive speech as well as younger

  12. Reflections on Meaningfulness and its Social Relevance

    Directory of Open Access Journals (Sweden)

    Nicole Note

    2010-06-01

    Full Text Available Philosophers who write about the meaning of life are few nowadays. Thesubject has lost its attractiveness. Perceived from a viewpoint of logical positivism or language philosophy, the whole issue of meaningfulness seems rather pointless. It is often considered to be related to metaphysics, making it less suitable for philosophical inquiry. The topic of meaningfulness seems too intangible. Indeed, the few philosophers that have embarked on examining meaningfulness have proven to be well aware of the challenges this poses. At times they acknowledge that the more they concentrate on the subject, the more it seems to fall apart into unintelligible pieces about whichnothing of philosophical value can be said.

  13. A meaningful workplace: Framework, space and context ...

    African Journals Online (AJOL)

    A meaningful workplace: Framework, space and context. ... PL Steenkamp, JS Basson ... The organisation experiences a loss of productivity, quality, innovation, et cetera ... This is what this article is about: to conceptualise the workplace as ...

  14. Making Social Studies Meaningful to Elementary Students.

    Science.gov (United States)

    Klein, Susan

    1982-01-01

    Describes a unit on Ancient Greece designed to make social studies meaningful to fourth and fifth graders. Individual projects and group activities helped students learn about ancient Greek culture. (AM)

  15. Meaningful work, work engagement and organisational commitment

    Directory of Open Access Journals (Sweden)

    Madelyn Geldenhuys

    2014-03-01

    Research purpose: The aim of the study was to investigate the relationships amongst psychological meaningfulness, work engagement and organisational commitment and to test for a possible mediation effect of work engagement on the relationship between psychological meaningfulness and organisational commitment. Motivation for the study: Managers have to rethink ways of improving productivity and performance at work, due to the diverse, and in some instances escalating, needs of employees (e.g. financial support to uphold their interest in and enjoyment of working. Research approach, design and method: A quantitative approach was employed to gather the data for the study, utilising a cross-sectional survey design. The sample (n = 415 consisted of working employees from various companies and positions in Gauteng, South Africa. Main findings: The results confirmed a positive relationship between psychological meaningfulness, work engagement and organisational commitment. Further, psychological meaningfulness predicts work engagement, whilst psychological meaningfulness and work engagement predict organisational commitment. Practical/managerial implications: Employers identifying their employees’ commitment patterns and mapping out strategies for enhancing those that are relevant to organisational goals will yield positive work outcomes (e.g. employees who are creative, seek growth or challenges for themselves. Contribution/value-add: This study contributes to the literature through highlighting the impact that meaningful work has on sustaining employee commitment to the organisation.

  16. Operating Room Delays: Meaningful Use in Electronic Health Record.

    Science.gov (United States)

    Van Winkle, Rachelle A; Champagne, Mary T; Gilman-Mays, Meri; Aucoin, Julia

    2016-06-01

    Perioperative areas are the most costly to operate and account for more than 40% of expenses. The high costs prompted one organization to analyze surgical delays through a retrospective review of their new electronic health record. Electronic health records have made it easier to access and aggregate clinical data; 2123 operating room cases were analyzed. Implementing a new electronic health record system is complex; inaccurate data and poor implementation can introduce new problems. Validating the electronic health record development processes determines the ease of use and the user interface, specifically related to user compliance with the intent of the electronic health record development. The revalidation process after implementation determines if the intent of the design was fulfilled and data can be meaningfully used. In this organization, the data fields completed through automation provided quantifiable, meaningful data. However, data fields completed by staff that required subjective decision making resulted in incomplete data nearly 24% of the time. The ease of use was further complicated by 490 permutations (combinations of delay types and reasons) that were built into the electronic health record. Operating room delay themes emerged notwithstanding the significant complexity of the electronic health record build; however, improved accuracy could improve meaningful data collection and a more accurate root cause analysis of operating room delays. Accurate and meaningful use of data affords a more reliable approach in quality, safety, and cost-effective initiatives.

  17. "They put you on your toes": Physical Therapists' Perceived Benefits from and Barriers to Supervising Students in the Clinical Setting.

    Science.gov (United States)

    Davies, Robyn; Hanna, Elizabeth; Cott, Cheryl

    2011-01-01

    To identify the perceived benefits of and barriers to clinical supervision of physical therapy (PT) students. In this qualitative descriptive study, three focus groups and six key-informant interviews were conducted with clinical physical therapists or administrators working in acute care, orthopaedic rehabilitation, or complex continuing care. Data were coded and analyzed for common ideas using a constant comparison approach. Perceived barriers to supervising students tended to be extrinsic: time and space constraints, challenging or difficult students, and decreased autonomy or flexibility for the clinical physical therapists. Benefits tended to be intrinsic: teaching provided personal gratification by promoting reflective practice and exposing clinical educators to current knowledge. The culture of different health care institutions was an important factor in therapists' perceptions of student supervision. Despite different disciplines and models of supervision, there is considerable synchronicity in the issues reported by physical therapists and other disciplines. Embedding the value of clinical teaching in the institution, along with strong communication links among academic partners, institutions, and potential clinical faculty, may mitigate barriers and increase the commitment and satisfaction of teaching staff.

  18. A harmonized and efficient clinical research environment would benefit patients and enhance European competitiveness. Commentary.

    Science.gov (United States)

    Amato, Antonino; Aringhieri, Eugenio; Boccia, Stefania; Buccella, Filippo; Gorini, Barbara; Gramaglia, Donatella; Masetti, Riccardo; Rossi, Paolo; Pelicci, Pier Giuseppe

    2017-01-01

    The forthcoming implementation of the European Clinical Trial Regulation (Regulation (EU) No. 536/2014), which is expected to facilitate the conduct of clinical trials across the European Union, will require National Authorities to create the best conditions for the implementation of the new Regulation through national guidelines, so that sponsors may reconsider Europe as a prime location for planning clinical trials. During a meeting titled "Innovation in Clinical Research", an expert panel discussed potential local advances fostering competitiveness of European clinical research with representatives of the pharmaceutical industry, patient organisations and Italian regulatory agency in view of the forthcoming implementation of (EU) No. 536/2014 on clinical trials of medicinal products. In this article we summarise the findings of the meeting, describe features characterising clinical research patterns and offer some suggestions on the possible involvement of all stakeholders in order to foster research innovation and allow the timely access to novel medicines for patients.

  19. Work engagement and meaningful work across generational cohorts

    Directory of Open Access Journals (Sweden)

    Crystal Hoole

    2015-08-01

    Full Text Available Orientation: Engaging employees and providing employees with a sense of meaning at work is not a one-size-fits-all approach. Although research has shown that differences between work engagement and meaningful work amongst generational cohorts exist, results are still inconclusive. With age becoming increasingly more important as a diversity factor, a better understanding of the dynamics between work engagement and meaningful work across different generational cohorts is necessary to design the right strategy for each organisation’s unique parameters. Research purpose: The aim of this study was to determine whether there is a relationship between work engagement and meaningful work and whether there are significant variances between the levels of work engagement and meaningful work between different generational cohorts. Motivation for study: Work engagement has consistently been highlighted by researchers and human resources experts as a recommended solution to provide companies with the upper hand when it comes to creating a competitive edge. Yet, levels of work engagement are far from ideal, requiring intensified efforts to identify solutions towards raising overall engagement levels. In recent years, much of the focus in terms of generating engagement has been aimed in the direction of financial rewards and other benefits; some organisational experts are of the opinion that a shift is occurring towards meaningful work instead of monetary rewards as the driver of engagement. The changing nature of the work landscape also suggests that generational cohorts experience work engagement and meaningful work differently. Understanding these complexities is mandatory in creating solutions towards improving levels of engagement and meaningful work. Research approach, design and method: A cross-sectional quantitative research approach has been followed. The Utrecht Work Engagement Scale (UWES and Psychological Meaningful Scale (PMS were administered

  20. Development of free statistical software enabling researchers to calculate confidence levels, clinical significance curves and risk-benefit contours

    International Nuclear Information System (INIS)

    Shakespeare, T.P.; Mukherjee, R.K.; Gebski, V.J.

    2003-01-01

    Confidence levels, clinical significance curves, and risk-benefit contours are tools improving analysis of clinical studies and minimizing misinterpretation of published results, however no software has been available for their calculation. The objective was to develop software to help clinicians utilize these tools. Excel 2000 spreadsheets were designed using only built-in functions, without macros. The workbook was protected and encrypted so that users can modify only input cells. The workbook has 4 spreadsheets for use in studies comparing two patient groups. Sheet 1 comprises instructions and graphic examples for use. Sheet 2 allows the user to input the main study results (e.g. survival rates) into a 2-by-2 table. Confidence intervals (95%), p-value and the confidence level for Treatment A being better than Treatment B are automatically generated. An additional input cell allows the user to determine the confidence associated with a specified level of benefit. For example if the user wishes to know the confidence that Treatment A is at least 10% better than B, 10% is entered. Sheet 2 automatically displays clinical significance curves, graphically illustrating confidence levels for all possible benefits of one treatment over the other. Sheet 3 allows input of toxicity data, and calculates the confidence that one treatment is more toxic than the other. It also determines the confidence that the relative toxicity of the most effective arm does not exceed user-defined tolerability. Sheet 4 automatically calculates risk-benefit contours, displaying the confidence associated with a specified scenario of minimum benefit and maximum risk of one treatment arm over the other. The spreadsheet is freely downloadable at www.ontumor.com/professional/statistics.htm A simple, self-explanatory, freely available spreadsheet calculator was developed using Excel 2000. The incorporated decision-making tools can be used for data analysis and improve the reporting of results of any

  1. The communication of the radiation risk from CT in relation to its clinical benefit in the era of personalized medicine. Pt. 2. Benefits versus risk of CT

    Energy Technology Data Exchange (ETDEWEB)

    Westra, Sjirk J. [Massachusetts General Hospital, Division of Pediatric Radiology, Boston, MA (United States)

    2014-10-15

    In order to personalize the communication of the CT risk, we need to describe the risk in the context of the clinical benefit of CT, which will generally be much higher, provided a CT scan has a well-established clinical indication. However as pediatric radiologists we should be careful not to overstate the benefit of CT, being aware that medico-legal pressures and the realities of health care economics have led to overutilization of the technology. And even though we should not use previously accumulated radiation dose to a child as an argument against conducting a clinically indicated scan (the ''sunk-cost'' bias), we should consider patients' radiation history in the diagnostic decision process. As a contribution to future public health, it makes more sense to look for non-radiating alternatives to CT in the much larger group of basically healthy children who are receiving occasional scans for widely prevalent conditions such as appendicitis and trauma than to attempt lowering CT use in the smaller group of patients with chronic conditions with a limited life expectancy. When communicating the CT risk with individual patients and their parents, we should acknowledge and address their concerns within the framework of informed decision-making. When appropriate, we may express the individual radiation risk, based on estimates of summated absorbed organ dose, as an order of magnitude rather than as an absolute number, and compare this with the much larger natural cancer incidence over a child's lifetime, and with other risks in medicine and daily life. We should anticipate that many patients cannot make informed decisions on their own in this complex matter, and we should offer our guidance while maintaining respect for patient autonomy. Proper documentation of the informed decision process is important for future reference. In concert with our referring physicians, pediatric radiologists are well-equipped to tackle the complexities

  2. The communication of the radiation risk from CT in relation to its clinical benefit in the era of personalized medicine. Pt. 2. Benefits versus risk of CT

    International Nuclear Information System (INIS)

    Westra, Sjirk J.

    2014-01-01

    In order to personalize the communication of the CT risk, we need to describe the risk in the context of the clinical benefit of CT, which will generally be much higher, provided a CT scan has a well-established clinical indication. However as pediatric radiologists we should be careful not to overstate the benefit of CT, being aware that medico-legal pressures and the realities of health care economics have led to overutilization of the technology. And even though we should not use previously accumulated radiation dose to a child as an argument against conducting a clinically indicated scan (the ''sunk-cost'' bias), we should consider patients' radiation history in the diagnostic decision process. As a contribution to future public health, it makes more sense to look for non-radiating alternatives to CT in the much larger group of basically healthy children who are receiving occasional scans for widely prevalent conditions such as appendicitis and trauma than to attempt lowering CT use in the smaller group of patients with chronic conditions with a limited life expectancy. When communicating the CT risk with individual patients and their parents, we should acknowledge and address their concerns within the framework of informed decision-making. When appropriate, we may express the individual radiation risk, based on estimates of summated absorbed organ dose, as an order of magnitude rather than as an absolute number, and compare this with the much larger natural cancer incidence over a child's lifetime, and with other risks in medicine and daily life. We should anticipate that many patients cannot make informed decisions on their own in this complex matter, and we should offer our guidance while maintaining respect for patient autonomy. Proper documentation of the informed decision process is important for future reference. In concert with our referring physicians, pediatric radiologists are well-equipped to tackle the complexities associated with the communication

  3. Benefits and harms in clinical trials of duloxetine for treatment of major depressive disorder

    DEFF Research Database (Denmark)

    Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn

    2014-01-01

    , respectively. We also found publication bias in relation to beneficial effects. CONCLUSION: Clinical study reports contained extensive data on major harms that were unavailable in journal articles and in trial registry reports. There were inconsistencies between protocols and clinical study reports and within.......gov and the manufacturer's online clinical trial registry were searched for trial results. RESULTS: Clinical study reports fully described the primary efficacy analysis and major harms (deaths (including suicides), suicide attempts, serious adverse events, and discontinuations because of adverse events). There were minor...... clinical study reports. Clinical study reports should be used as the data source for systematic reviews of drugs, but they should first be checked against protocols and within themselves for accuracy and consistency....

  4. Prostate cancer mortality in screen and clinically detected prostate cancer : Estimating the screening benefit

    NARCIS (Netherlands)

    van Leeuwen, Pim J.; Connolly, David; Gavin, Anna; Roobol, Monique J.; Black, Amanda; Bangma, Chris H.; Schroder, Fritz H.

    Background: To estimate the benefits of prostate-specific antigen (PSA) screening on prostate cancer (Pca) metastasis and Pca-specific mortality, we compared two populations with a well-defined difference in intensity of screening. Methods: Between 1997 and 1999, a total of 11,970 men, aged 55-74

  5. Quantification of human motion: gait analysis-benefits and limitations to its application to clinical problems.

    Science.gov (United States)

    Simon, Sheldon R

    2004-12-01

    The technology supporting the analysis of human motion has advanced dramatically. Past decades of locomotion research have provided us with significant knowledge about the accuracy of tests performed, the understanding of the process of human locomotion, and how clinical testing can be used to evaluate medical disorders and affect their treatment. Gait analysis is now recognized as clinically useful and financially reimbursable for some medical conditions. Yet, the routine clinical use of gait analysis has seen very limited growth. The issue of its clinical value is related to many factors, including the applicability of existing technology to addressing clinical problems; the limited use of such tests to address a wide variety of medical disorders; the manner in which gait laboratories are organized, tests are performed, and reports generated; and the clinical understanding and expectations of laboratory results. Clinical use is most hampered by the length of time and costs required for performing a study and interpreting it. A "gait" report is lengthy, its data are not well understood, and it includes a clinical interpretation, all of which do not occur with other clinical tests. Current biotechnology research is seeking to address these problems by creating techniques to capture data rapidly, accurately, and efficiently, and to interpret such data by an assortment of modeling, statistical, wave interpretation, and artificial intelligence methodologies. The success of such efforts rests on both our technical abilities and communication between engineers and clinicians.

  6. [Benefits of using rapid HIV testing at the PMU-FLON walk-in clinic in Lausanne].

    Science.gov (United States)

    Gilgien, W; Aubert, J; Bischoff, T; Herzig, L; Perdrix, J

    2012-05-16

    Lab tests are frequently used in primary care to guide patient care. This is particularly the case when a severe disorder, or one that will affect patients' initial care, needs to be excluded rapidly. At the PMU-FLON walk-in clinic the use of HIV testing as recommended by the Swiss Office of Public Health was hampered by the delay in obtaining test results. This led us to introduce rapid HIV testing which provides results within 30 minutes. Following the first 250 tests the authors discuss the results as well as the benefits of rapid HIV testing in an urban walk-in clinic.

  7. Clinical Benefit of Pazopanib in a Patient with Metastatic Chondrosarcoma: A Case Report and Review of the Literature

    Directory of Open Access Journals (Sweden)

    Onoufrios Tsavaris

    2018-03-01

    Full Text Available Chondrosarcoma is a rare malignancy characterized by the production of cartilage matrix, displaying heterogeneous histopathology and clinical behavior. Due to lack of effective treatment for advanced disease, the clinical management of metastatic chondrosarcoma is exceptionally challenging. Chondrosarcomas harbor molecular abnormalities, such as overexpression of platelet-derived growth factor receptor (PDGFR-alpha and PDGFR-beta, which are required for cancer development, progression, and metastasis. Pazopanib is a potent and selective multitargeted tyrosine kinase inhibitor, which co-inhibits stem cell growth factor receptor (c-KIT, fibroblast growth factor receptor (FGFR, PDGFR, and vascular endothelial growth factor receptor (VEGFR and has demonstrated clinical activity in patients with advanced previously treated soft tissue sarcoma. Herein, we describe the unique case of a patient with metastatic chondrosarcoma who derived clinical benefit from pazopanib after first-line chemotherapy failure.

  8. Effect of amitriptyline vs. physiotherapy in management of fibromyalgia syndrome: What predicts a clinical benefit?

    Directory of Open Access Journals (Sweden)

    Joshi M

    2009-01-01

    Full Text Available Context : Fibromyalgia is a chronic disabling condition, and physicians treat it using a number of different treatment modalities. It is not known if one or more of such modalities are better than the others. We compared the efficacy of physiotherapy and amitriptyline in disability reduction in patients of fibromyalgia syndrome in a rural tertiary care hospital in Central India. Design : Open-label alternate patient treatment allocation. Materials and Methods : A six-month follow-up was done to assess the benefit of amitriptyline and physiotherapy for disability reduction in patients with fibromyalgia syndrome. Primary outcome measure was improvement in fibromyalgia impact questionnaire (FIQ score. Statistical Analysis Used : Predictors of benefit were determined using multivariate logistic regression. Results : A total of 175 outpatients were assigned to either amitriptyline (n=87 or structured physiotherapy (n=88 treatments. There was a significant but similar (P=0.82 improvement in disability in both groups. High FIQ score at baseline and low socioeconomic status scores were significant predictors of benefit. Conclusions : Therapy with amitriptyline or physiotherapy is equally effective in improving outcome in patients of fibromyalgia over a period of six months.

  9. Are students ready for meaningful use?

    Directory of Open Access Journals (Sweden)

    Gary S. Ferenchick

    2013-11-01

    Full Text Available Background: The meaningful use (MU of electronic medical records (EMRs is being implemented in three stages. Key objectives of stage one include electronic analysis of data entered into structured fields, using decision-support tools (e.g., checking drug–drug interactions [DDI] and electronic information exchange. Objective: The authors assessed the performance of medical students on 10 stage-one MU tasks and measured the correlation between students’ MU performance and subsequent end-of-clerkship professionalism assessments and their grades on an end-of-year objective structured clinical examination. Participants: Two-hundred and twenty-two third-year medical students on the internal medicine (IM clerkship. Design/main measures: From July 2010 to February 2012, all students viewed 15 online tutorials covering MU competencies. The authors measured student MU documentation and performance in the chart of a virtual patient using a fully functional training EMR. Specific MU measurements included, adding: a new problem, a new medication, an advanced directive, smoking status, the results of screening tests; and performing a DDI (in which a major interaction was probable, and communicating a plan for this interaction. Key results: A total of 130 MU errors were identified. Sixty-eight (30.6% students had at least one error, and 30 (13.5% had more than one (range 2–6. Of the 130 errors, 90 (69.2% were errors in structured data entry. Errors occurred in medication dosing and instructions (18%, DDI identification (12%, documenting smoking status (15%, and colonoscopy results (23%. Students with MU errors demonstrated poorer performance on end-of-clerkship professionalism assessments (r=−0.112, p=0.048 and lower observed structured clinical examination (OSCE history-taking skills (r=−0.165, p=0.008 and communication scores (r=− 0.173, p=0.006. Conclusions: MU errors among medical students are common and correlate with subsequent poor

  10. Meaningful Interaction in a Local Context

    DEFF Research Database (Denmark)

    Holck, Ulla

    2006-01-01

    This keynote is based on a Ph.D. thesis on development of socially meaningful interaction in music therapy with children with very poor communication skills (Holck 2002). The aim was to identify some of the conditions, whereby actions can be understood as meaningful - that is, whereby the child......’ Samspil i Musikterapi [Eng.: ’Commusical’ Interplay in Music Therapy. Qualitative Video Analyses of Musical and Gestural Interactions with Children with Severe Functional Limitations, including Children with Autism]. Unpubl. PhD thesis, Aalborg Universitet. Holck, U. (2004) Interaction Themes in Music...

  11. Weighing the evidence: risks and benefits of participatory documentary in corporatized clinics.

    Science.gov (United States)

    Hansen, Helena

    2013-12-01

    This paper describes the effects of one U.S.-based public psychiatry clinic's shift to a centralized, corporate style of management, in response to pressures to cut expenditures by focusing on "evidence based" treatments. Participant observation research conducted between 2008 and 2012 for a larger study involving 127 interviews with policy makers, clinic managers, clinical practitioners and patients revealed that the shift heralded the decline of arts based therapies in the clinic, and of the social networks that had developed around them. It also inspired a participatory video self-documentary project among art group members, to portray the importance of arts-based therapies and garner public support for such therapies. Group members found a way to take action in the face of unilateral decision making, but experienced subsequent restrictions on clinic activities and discharge of core members from the clinic. The paper ends with a discussion of biopolitics, central legibility through corporate standardization, and the potential and risks of participatory documentaries to resist these trends. Copyright © 2013. Published by Elsevier Ltd.

  12. Sweeping the floor or putting a man on the moon : How to define and measure meaningful work

    NARCIS (Netherlands)

    Both-Nwabuwe, Jitske M.C.; Dijkstra, Maria T.M.; Beersma, Bianca

    2017-01-01

    Meaningful work is integral to well-being and a flourishing life. The construct of "meaningful work" is, however, consistently affected by conceptual ambiguity. Although there is substantial support for arguments to maintain the status of conceptual ambiguity, we make a case for the benefits of

  13. Benefits of a transfer clinic in adolescent and young adult kidney transplant patients.

    Science.gov (United States)

    McQuillan, Rory F; Toulany, Alene; Kaufman, Miriam; Schiff, Jeffrey R

    2015-01-01

    Adolescent and young adult kidney transplant recipients have worse graft outcomes than older and younger age groups. Difficulties in the process of transition, defined as the purposeful, planned movement of adolescents with chronic health conditions from child to adult-centered health care systems, may contribute to this. Improving the process of transition may improve adherence post-transfer to adult care services. The purpose of this study is to investigate whether a kidney transplant transfer clinic for adolescent and young adult kidney transplant recipients transitioning from pediatric to adult care improves adherence post-transfer. We developed a joint kidney transplant transfer clinic between a pediatric kidney transplant program, adult kidney transplant program, and adolescent medicine at two academic health centers. The transfer clinic facilitated communication between the adult and pediatric transplant teams, a face-to-face meeting of the patient with the adult team, and a meeting with the adolescent medicine physician. We compared the outcomes of 16 kidney transplant recipients transferred before the clinic was established with 16 patients who attended the clinic. The primary outcome was a composite measure of non-adherence. Non-adherence was defined as either self-reported medication non-adherence or displaying two of the following three characteristics: non-attendance at clinic, non-attendance for blood work appointments, or undetectable calcineurin inhibitor levels within 1 year post-transfer. The two groups were similar at baseline, with non-adherence identified in 43.75 % of patients. Non-adherent behavior in the year post-transfer, which included missing clinic visits, missing regular blood tests, and undetectable calcineurin inhibitor levels, was significantly lower in the cohort which attended the transfer clinic (18.8 versus 62.5 %, p = 0.03). The median change in estimated glomerular filtration rate (eGFR) in the year following transfer

  14. Benefits of a Transfer Clinic in Adolescent and Young Adult Kidney Transplant Patients

    Directory of Open Access Journals (Sweden)

    Rory F. McQuillan

    2015-12-01

    Full Text Available Background: Adolescent and young adult kidney transplant recipients have worse graft outcomes than older and younger age groups. Difficulties in the process of transition, defined as the purposeful, planned movement of adolescents with chronic health conditions from child to adult-centered health care systems, may contribute to this. Improving the process of transition may improve adherence post-transfer to adult care services. Objective: The purpose of this study is to investigate whether a kidney transplant transfer clinic for adolescent and young adult kidney transplant recipients transitioning from pediatric to adult care improves adherence post-transfer. Methods: We developed a joint kidney transplant transfer clinic between a pediatric kidney transplant program, adult kidney transplant program, and adolescent medicine at two academic health centers. The transfer clinic facilitated communication between the adult and pediatric transplant teams, a face-to-face meeting of the patient with the adult team, and a meeting with the adolescent medicine physician. We compared the outcomes of 16 kidney transplant recipients transferred before the clinic was established with 16 patients who attended the clinic. The primary outcome was a composite measure of non-adherence. Non-adherence was defined as either self-reported medication non-adherence or displaying two of the following three characteristics: non-attendance at clinic, non-attendance for blood work appointments, or undetectable calcineurin inhibitor levels within 1 year post-transfer. Results: The two groups were similar at baseline, with non-adherence identified in 43.75 % of patients. Non-adherent behavior in the year post-transfer, which included missing clinic visits, missing regular blood tests, and undetectable calcineurin inhibitor levels, was significantly lower in the cohort which attended the transfer clinic (18.8 versus 62.5 %, p = 0.03. The median change in estimated glomerular

  15. Students' Meaningful Learning Orientation and Their Meaningful Understandings of Meiosis and Genetics.

    Science.gov (United States)

    Cavallo, Ann Liberatore

    This 1-week study explored the extent to which high school students (n=140) acquired meaningful understanding of selected biological topics (meiosis and the Punnett square method) and the relationship between these topics. This study: (1) examined "mental modeling" as a technique for measuring students' meaningful understanding of the…

  16. Does carbetocin for prevention of postpartum haemorrhage at caesarean section provide clinical or financial benefit compared with oxytocin?

    Science.gov (United States)

    Higgins, L; Mechery, J; Tomlinson, A J

    2011-11-01

    Postpartum haemorrhage is a major cause of maternal morbidity and mortality worldwide. A recent Cochrane review of carbetocin (long-acting oxytocin analogue) concluded that its use decreased additional uterotonic requirements, however, no included studies compared its use against intravenous bolus oxytocin. The majority of studies of carbetocin have considered its use in vaginal delivery; no studies have examined the economic implications of its use. This study describes a clinical and financial evaluation undertaken at a United Kingdom District General Hospital surrounding the introduction of carbetocin for prophylaxis against postpartum haemorrhage at caesarean deliveries. A range of clinical outcomes were observed including frequency of postpartum haemorrhage, estimated blood loss, transfusion requirements, change in haemoglobin or haemodynamics, use of additional uterotonics and perioperative recovery. Finally, a composite financial analysis was performed. No clinically significant benefit was found, however associated costs increased by £18.52/patient.

  17. Considering benefits and harms of duloxetine for treatment of stress urinary incontinence: a meta-analysis of clinical study reports

    DEFF Research Database (Denmark)

    Maund, Emma; Guski, Louise Schow; Gøtzsche, Peter C.

    2017-01-01

    BACKGROUND: The European Medicines Agency makes clinical study reports publicly available and publishes reasons for not approving applications for marketing authorization. Duloxetine has been approved in Europe for the treatment of stress urinary incontinence in women. The reported adverse effects...... of duloxetine include mental health problems and suicidality. We obtained clinical study reports from the European Medicines Agency concerning use of this drug for stress urinary incontinence. METHODS: We performed a meta-analysis of 4 randomized placebo-controlled trials of duloxetine (involving a total...... of 1913 patients) submitted to the European Medicines Agency for marketing approval for the indication of stress urinary incontinence in women. We used data from the clinical study reports (totalling 6870 pages and including individual patient data) to assess benefits (including frequency of incontinence...

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

    Science.gov (United States)

    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

  19. Benefits of Exercise on the Executive Functions in People with Parkinson Disease: A Controlled Clinical Trial.

    Science.gov (United States)

    de Oliveira, Renata Terra; Felippe, Lilian Assunção; Bucken Gobbi, Lilian Teresa; Barbieri, Fabio Augusto; Christofoletti, Gustavo

    2017-05-01

    We have made a 3-arm trial (group vs. individual exercise vs. no treatment) to test the effects of a 6-month exercise program upon the executive functions in participants with Parkinson disease. Twenty-four subjects were randomly allocated in 3 groups and undertook individualized exercises (G1, n = 8), group exercises (G2, n = 8), or monitoring (G3, n = 8). Executive functions were evaluated by means of the Wisconsin card sorting test and the Raven colored matrices, both assessed at the beginning of the program and after 6 months. The statistical analyses consisted of the application of repeated measurement tests, with a significant level of 5%. The findings showed similar behavior of groups in terms of the Wisconsin card sorting test (P = 0.792), reporting no benefit of the program on such instrument. Differently, Raven colored matrices evidenced a significant benefit provided by the intervention (P = 0.032). Compared with the control group, individuals from G1 had a substantial improvement on executive functions (P = 0.031) and from G2 had a trend of significance (P = 0.072). Findings of this study show that 6 months of exercise improved some aspects of executive functions when compared with control peers. Individual therapy seems to have a more prominent improvement than group therapy.

  20. Protestant ethic: Contributing towards a meaningful workplace ...

    African Journals Online (AJOL)

    The article also indicates that the Protestant ethic can indeed contribute towards a meaningful experience whilst performing work-related tasks in workspace. The Protestant work ethic is more than a cultural norm that places a positive moral value on doing a good job. Based on a belief that work has intrinsic value for its own ...

  1. Remedial principles and meaningful engagement in education ...

    African Journals Online (AJOL)

    This article evaluates the meaningful engagement doctrine in the education rights jurisprudence of the Constitutional Court in the light of a set of normative principles developed by Susan Sturm for evaluating participatory public law remedies. It commences by identifying four principles for evaluating participatory remedies ...

  2. Meaningful Learning in the Cooperative Classroom

    Science.gov (United States)

    Sharan, Yael

    2015-01-01

    Meaningful learning is based on more than what teachers transmit; it promotes the construction of knowledge out of learners' experience, feelings and exchanges with other learners. This educational view is based on the constructivist approach to learning and the co-operative learning approach. Researchers and practitioners in various…

  3. Meaningful Use of School Health Data

    Science.gov (United States)

    Johnson, Kathleen Hoy; Bergren, Martha Dewey

    2011-01-01

    Meaningful use (MU) of Electronic Health Records (EHRs) is an important development in the safety and security of health care delivery in the United States. Advancement in the use of EHRs occurred with the passage of the American Recovery and Reinvestment Act of 2009, which provides incentives for providers to support adoption and use of EHRs.…

  4. Wonderful Life : Exploring Wonder in Meaningful Moments

    NARCIS (Netherlands)

    van de Goor, Marie Jacqueline; Sools, Anna Maria; Westerhof, Gerben Johan; Bohlmeijer, Ernst Thomas

    In this article, we bring the study of meaning together with the emerging field of study focusing on the emotions of wonder: wonder, enchantment, awe, and being moved. It is in meaningful moments that these two meet, and in our empirical study, we used the emotions of wonder as a lens to investigate

  5. Assessing Assessment: In Pursuit of Meaningful Learning

    Science.gov (United States)

    Rootman-le Grange, Ilse; Blackie, Margaret A. L.

    2018-01-01

    The challenge of supporting the development of meaningful learning is prevalent in chemistry education research. One of the core activities used in the learning process is assessments. The aim of this paper is to illustrate how the semantics dimension of Legitimation Code Theory can be a helpful tool to critique the quality of assessments and…

  6. Fishing for meaningful units in connected speech

    DEFF Research Database (Denmark)

    Henrichsen, Peter Juel; Christiansen, Thomas Ulrich

    2009-01-01

    In many branches of spoken language analysis including ASR, the set of smallest meaningful units of speech is taken to coincide with the set of phones or phonemes. However, fishing for phones is difficult, error-prone, and computationally expensive. We present an experiment, based on machine...

  7. The benefits of a Neurogenetics clinic in an adult Academic Teaching Hospital.

    Science.gov (United States)

    Olszewska, Diana A; McVeigh, Terri; Fallon, Emer M; Pastores, Gregory M; Lynch, Tim

    2018-03-09

    Genetics is the backbone of Neurology, where a number of disorders have a genetic aetiology and are complex, requiring a dedicated Neurogenetics clinic. Genetics in the Republic of Ireland is under-resourced, with the lowest number of consultants per million of population in Europe. In November 2014, we established the monthly adult Neurogenetics clinic in Ireland, staffed by 2 consultants and 2 registrars from each speciality. We see patients with complex rare neurological conditions that may potentially have an underlying genetic basis, in the presence or absence of a family history. We performed a retrospective cohort analysis, reviewing symptoms and work-up data. Twenty-seven patients attended a pilot clinic over 12 months. Conditions encountered included Parkin-related PD, leucodystrophy, ataxia, fronto-temporal lobar degeneration, spinocerebellar ataxia type 6 (SCA6) and ataxia-telangiectasia. Identification of pathogenic mutations directed screening, treatment and facilitated onward genetic counselling (n = 10, 33%). A number of novel mutations were identified in MAPT gene ("missing tau mutation" McCarthy et al., Brain, 2015), SLCA1 gene and GRN (progranulin). Phenotypic features not previously reported were seen; e.g. writer's cramp in SCA6; paroxysmal myoclonus in the glucose transporter protein type 1 (GLUT1) deficiency. Breast cancer screening for ATM mutations carriers and referral to international experts in two undiagnosed patients were arranged. The establishment of a Neurogenetics clinic has addressed a gap in service and allowed identification of rare and atypical diagnoses.

  8. Benefits of a clinical planning and coordination module: a simulation study

    DEFF Research Database (Denmark)

    Jensen, Sanne; Vingtoft, Søren; Nøhr, Christian

    2013-01-01

    igital Clinical Practice Guidelines are commonly used in Danish health care. Planning and decision support are particularly important to patients with chronic diseases, who often are in contact with General Practitioners, Community Nurses and hospitals. In the Capital Region of Denmark...

  9. Electronically implemented clinical indicators based on a data warehouse in a tertiary hospital: its clinical benefit and effectiveness.

    Science.gov (United States)

    Yoo, Sooyoung; Kim, Seok; Lee, Kee-Hyuck; Jeong, Chang Wook; Youn, Sang Woong; Park, Kyoung Un; Moon, So Young; Hwang, Hee

    2014-07-01

    Assessing and monitoring care and service using clinical indicators (CIs) can allow the measurement of and lead to improvements in the quality of care. However, the management and maintenance of CI data has been shown to be difficult because the data are usually collected and provided manually. In this study, for the purpose of efficient managing quality indicators, a data warehouse (DW)-based CI monitoring system was developed. The clinical effectiveness and efficiency of a DW-based CI monitoring was investigated through several case studies of the system's operation at a tertiary hospital. This study analyzed the CIs that have been developed over the past 8 years at a 1340-bed tertiary general university hospital in South Korea to improve and monitor the quality of care and patient safety. The hospital was opened as a fully digital hospital in 2003, and the CIs were computerized in 2005 by implementing a DW-based CI monitoring system. We classified the computerized CIs and evaluated the monitoring results for several representative CIs, such as the optimal prescribing of preventive antibiotics, the average length of stay, the mortality rate, and the rehospitalization rate. During the development of the system in 2005, 12 of 19 CIs were computerized, and this number gradually increased until 299 of 335 CIs were computerized by 2012. In addition, among the CIs built computationally through the CI task force team, focal CIs subject to monitoring were selected annually, and the results of this monitoring were shared with all of the staff or the related department and its staff. By providing some examples of our CI monitoring results, we showed the feasibility of improving the quality of care, and maintaining the optimum level of patient care with less labor. The results of this study provide evidence regarding the clinical effectiveness and efficiency as well as the systems operation experience of a DW-based CI monitoring system. These findings may aid medical

  10. Review of endoscopic radiofrequency in biliopancreatic tumours with emphasis on clinical benefits, controversies and safety

    Science.gov (United States)

    Alvarez-Sánchez, María-Victoria; Napoléon, Bertrand

    2016-01-01

    Most pancreatic cancers and extrahepatic cholangiocarcinomas are unresectable at the time of diagnosis, and even in case of a resectable cancer, for elderly or patients with coexistent comorbidities, surgery is not an option. Current treatment alternatives in these scenarios are very limited. Biliary stenting with self-expanding metal stents (SEMS) is the mainstay palliative treatment of biliary obstruction due to unresectable pancreatic cancer or cholangiocarcinoma. Nevertheless, more than 50% of SEMS become occluded after 6 mo due to tumour over- and ingrowth, leading to hospital readmissions and reinterventions that significantly impair quality of life. Regimes of chemotherapy or chemoradiotherapy also provide minimal survival benefits. Therefore, novel therapies are eagerly awaited. Radiofrequency (RF) energy causes coagulative necrosis leading to local destruction of the accessed malignant tissue and has an established role in the treatment of malignancies in several solid organs, especially liver cancers. However, pancreatic and extrahepatic biliary cancers are not easily accessed by a percutaneous route, making the procedure dangerous. Over the past five years, the development of dedicated devices compatible with endoscopic instruments has offered a minimally invasive option for RF energy delivery in biliopancreatic cancers. Emerging experience with endoscopic RF ablation (RFA) in this setting has been reported in the literature, but little is known about its feasibility, efficacy and safety. A literature review makes it clear that RFA in biliopancreatic tumours is feasible with high rates of technical success and acceptable safety profile. Although available data suggest a benefit of survival with RFA, there is not enough evidence to draw a firm conclusion about its efficacy. For this reason, prospective randomized trials comparing RFA with standard palliative treatments with quality-of-life and survival endpoints are required. Anecdotal reports have also

  11. Clinical benefit of gluten-free diet in screen-detected older celiac disease patients

    Directory of Open Access Journals (Sweden)

    Vilppula Anitta

    2011-12-01

    Full Text Available Abstract Background The utility of serologic screening for celiac disease is still debatable. Evidence suggests that the disorder remains undetected even in the older population. It remains obscure whether screening makes good or harm in subjects with long-standing gluten ingestion. We evaluated whether older subjects benefit from active detection and subsequent gluten free dietary treatment of celiac disease. Methods Thirty-five biopsy-proven patients aged over 50 years had been detected by serologic mass screening. We examined the disease history, dietary compliance, symptoms, quality of life and bone mineral density at baseline and 1-2 years after the commencement of a gluten-free diet. Symptoms were evaluated by gastrointestinal symptom rating scale and quality of life by psychological general well-being questionnaires. Small bowel biopsy, serology, laboratory parameters assessing malabsorption, and bone mineral density were investigated. Results Dietary compliance was good. The patients had initially low mean serum ferritin values indicating subclinical iron deficiency, which was restored by a gluten-free diet. Vitamin B12, vitamin D and erythrocyte folic acid levels increased significantly on diet. Celiac patients had a history of low-energy fractures more often than the background population, and the diet had a beneficial effect on bone mineral density. Alleviation in gastrointestinal symptoms was observed, even though the patients reported no or only subtle symptoms at diagnosis. Quality of life remained unchanged. Of all the cases, two thirds would have been diagnosed even without screening if the family history, fractures or concomitant autoimmune diseases had been taken carefully into account. Conclusions Screen-detected patients benefited from a gluten-free diet. We encourage a high index of suspicion and active case-finding in celiac disease as an alternative to mass screening in older patients.

  12. [Who benefits from the night clinic? - Value of a part-time treatment facility].

    Science.gov (United States)

    Stutz, Constanze; Kawohl, Wolfram; Platz, Christoph; Warnke, Ingeborg; Jäger, Matthias

    2017-12-01

    The night clinic which is part of the psychiatric department of the University of Zurich is a part-time treatment option with psychiatric treatment and support in the evening. This study aimed to characterize the patients and detect different functions of the treatment setting. Data of 253 patients covering a six-year period from 2008 up to 2013 were retrospectively assessed using descriptive methods. Subgroups according to the situation before admission and after discharge were compared. Patients admitted from home differed considerably from those who were transferred from a psychiatric ward concerning sociodemographic and clinical factors. They were more frequently single, unemployed, received disability funds and suffered from a psychotic disorder. They were also more likely to be discharged in a supported housing condition. The night clinic serves as an alternative to full inpatient treatment for individuals who have work as well as a rehabilitative option for homeless patients with severe mental illness. It contributes to a reduction of avoidance of inpatients stays for those groups of patients.

  13. Benefits, Barriers, and Motivators to Training Dietetic Interns in Clinical Settings: A Comparison between Preceptors and Nonpreceptors.

    Science.gov (United States)

    AbuSabha, Rayane; Muller, Colette; MacLasco, Jacqueline; George, Mary; Houghton, Erica; Helm, Alison

    2018-03-01

    The shortage of supervised practice sites in dietetics is associated with fewer numbers of preceptors available to supervise interns, especially in the clinical setting. To identify clinical dietitians' perceived benefits and challenges of training dietetic interns and to determine key motivators that would entice nonpreceptors to volunteer for the role. Registered dietitian nutritionists working in clinical settings completed a semi-structured, audiotaped interview followed by a brief questionnaire. Clinical dietitians working in hospitals, long-term care facilities, and outpatient clinics (n=100) participated: 54 preceptors and 46 nonpreceptors. Qualitative analysis was conducted using an iterative process to identify and code common themes. T tests were used to compare mean differences between the opinions of preceptors and nonpreceptors. Preceptors had approximately 5 more years of experience (mean=14.27±12.09 years) than nonpreceptors (mean=8.83±9.72 years) (Pmotivator for taking on interns. Incentive programs should be developed to entice nonpreceptors to take on interns. These programs should include extensive training on the preceptor role and how to alleviate the burden of time spent supervising interns and should provide a significant number of CPEUs to make the added workload worthwhile. Copyright © 2018 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

  14. Clinical and economic benefit of general practitioner integration to a symptomatic breast service.

    Science.gov (United States)

    Beecher, S M; Donlan, C; O'Leary, D P; Kerin, M J; McLaughlin, R

    2016-11-01

    Integration of general practitioners (GPs) into a tertiary care team is a model used internationally to assist with provision of patient care. Symptomatic breast clinics have seen significant increases in attendances and consequential staffing issues. We wished to analyze the integration of GPs into a tertiary breast care team and establish whether their inclusion is a cost-effective approach. A prospectively maintained database was used to identify 1614 new and 1453 review patients seen in the clinic between September and December 2013. The triple assessment clinical, radiological, and biopsy scores of patients assessed by GPs were compared to those assessed by registrars and to the overall number of patients seen. A cost analysis was performed based on the hourly rates of GPs and registrars. 1614 new patients seen over the 4-month period. GPs reviewed a mean of 153.6 new patients and registrars reviewed a mean of 97.8. Registrars reviewed patients who were allocated higher 'S' scores, with 46 % of patients allocated an S4 and 21 % of patients allocated an S5 score. GPs reviewed a mean of 115.6 return patients and registrars reviewed a mean of 110.1 return patients. The weekly cost of employing 3 GPs for 15 h was €835. This compares favorably to the cost of employing a full-time registrar. This study demonstrates that GPs can play a substantial role in the provision of a symptomatic breast service. In addition, the incorporation of GPs in this setting can prove cost-effective.

  15. [Clinical benefit of HCV core antigen assay in patients receiving interferon and ribavirin combination therapy].

    Science.gov (United States)

    Higashimoto, Makiko; Takahashi, Masahiko; Jokyu, Ritsuko; Saito, Hidetsugu

    2006-02-01

    A highly sensitive second generation HCV core antigen assay has recently been developed. We compared viral disappearance and kinetics data between commercially available core antigen assays, Lumipulse Ortho HCV Ag, and a quantitative HCV RNA PCR assay, Cobas Amplicor HCV Monitor Test, Version 2 to estimate the predictive benefit of sustained viral response (SVR) and non-SVR in 59 patients treated with interferon and ribavirin combination therapy. We found a good correlation between HCV core Ag and HCV RNA level regardless of genotype. Although the sensitivity of the core antigen assay was lower than PCR, the dynamic range was broader than that of the PCR assay, so that we did not need to dilute the samples in 59 patients. We detected serial decline of core Ag levels in 24 hrs, 7 days and 14 days after interferon combination therapy. The decline of core antigen levels was significant in SVR patients compared to non-SVR as well as in genotype 2a, 2b patients compared to 1b. Core antigen-negative on day 1 could predict all 10 SVR patients (PPV = 100%), whereas RNA-negative could predict 22 SVR out of 25 on day 14 (PPV = 88.0%). None of the patients who had detectable serum core antigen on day 14 became SVR(NPV = 100%), although NPV was 91.2% on RNA negativity. An easy, simple, low cost new HCV core antigen detecting system seems to be useful for assessing and monitoring IFN treatment for HCV.

  16. Net benefits: assessing the effectiveness of clinical networks in Australia through qualitative methods

    Directory of Open Access Journals (Sweden)

    Cunningham Frances C

    2012-11-01

    Full Text Available Abstract Background In the 21st century, government and industry are supplementing hierarchical, bureaucratic forms of organization with network forms, compatible with principles of devolved governance and decentralization of services. Clinical networks are employed as a key health policy approach to engage clinicians in improving patient care in Australia. With significant investment in such networks in Australia and internationally, it is important to assess their effectiveness and sustainability as implementation mechanisms. Methods In two purposively selected, musculoskeletal clinical networks, members and stakeholders were interviewed to ascertain their perceptions regarding key factors relating to network effectiveness and sustainability. We adopted a three-level approach to evaluating network effectiveness: at the community, network, and member levels, across the network lifecycle. Results Both networks studied are advisory networks displaying characteristics of the ‘enclave’ type of non-hierarchical network. They are hybrids of the mandated and natural network forms. In the short term, at member level, both networks were striving to create connectivity and collaboration of members. Over the short to medium term, at network level, both networks applied multi-disciplinary engagement in successfully developing models of care as key outputs, and disseminating information to stakeholders. In the long term, at both community and network levels, stakeholders would measure effectiveness by the broader statewide influence of the network in changing and improving practice. At community level, in the long term, stakeholders acknowledged both networks had raised the profile, and provided a ‘voice’ for musculoskeletal conditions, evidencing some progress with implementation of the network mission while pursuing additional implementation strategies. Conclusions This research sheds light on stakeholders’ perceptions of assessing clinical

  17. Net benefits: assessing the effectiveness of clinical networks in Australia through qualitative methods.

    Science.gov (United States)

    Cunningham, Frances C; Ranmuthugala, Geetha; Westbrook, Johanna I; Braithwaite, Jeffrey

    2012-11-02

    In the 21st century, government and industry are supplementing hierarchical, bureaucratic forms of organization with network forms, compatible with principles of devolved governance and decentralization of services. Clinical networks are employed as a key health policy approach to engage clinicians in improving patient care in Australia. With significant investment in such networks in Australia and internationally, it is important to assess their effectiveness and sustainability as implementation mechanisms. In two purposively selected, musculoskeletal clinical networks, members and stakeholders were interviewed to ascertain their perceptions regarding key factors relating to network effectiveness and sustainability. We adopted a three-level approach to evaluating network effectiveness: at the community, network, and member levels, across the network lifecycle. Both networks studied are advisory networks displaying characteristics of the 'enclave' type of non-hierarchical network. They are hybrids of the mandated and natural network forms. In the short term, at member level, both networks were striving to create connectivity and collaboration of members. Over the short to medium term, at network level, both networks applied multi-disciplinary engagement in successfully developing models of care as key outputs, and disseminating information to stakeholders. In the long term, at both community and network levels, stakeholders would measure effectiveness by the broader statewide influence of the network in changing and improving practice. At community level, in the long term, stakeholders acknowledged both networks had raised the profile, and provided a 'voice' for musculoskeletal conditions, evidencing some progress with implementation of the network mission while pursuing additional implementation strategies. This research sheds light on stakeholders' perceptions of assessing clinical network effectiveness at community, network, and member levels during the network

  18. Main technical aspects and clinical benefits of respiratory Gating for radiotherapy of lung neoplasm

    International Nuclear Information System (INIS)

    Benites, Rafaela Freitas Oliveira

    2016-01-01

    The concern with the irradiation of lung tumors is that many of them can move along the breathing, which can cause problems in defining accurately the target and increases the irradiation of normal tissues. The objectives are to present the 4D CT principles, image acquisition, reconstruction and application in planning of the radiotherapy. It justifies the quick implantation, improvements in acquisition and images, the possibility in quantify the tumor movement, verifying strategies and delivery treatment. It's concluded that the toxicity risk is reduced with the respiratory gating, and the results suggests that the closed RT will be of clinical relevance. (author)

  19. A Novel Glycinate-based Body Wash: Clinical Investigation Into Ultra-mildness, Effective Conditioning, and Improved Consumer Benefits.

    Science.gov (United States)

    Regan, Jamie; Mollica, Leonel-Maximo; Ananthapadmanabhan, K P

    2013-06-01

    To assess the properties of a novel body wash containing the mild surfactant glycinate. Biochemical and clinical assays. Research laboratories and clinical sites in the United States and Canada. Women 18 to 65 years of age (cleansing efficacy); male and female subjects 26 to 63 years of age with mild or moderate dryness and erythema (leg-controlled application test); subjects 5 to 65 years of age with mild-to-moderate eczema (eczema compatibility); and women 18 to 64 years of age (home use). Assessments across studies included colorimetric dye exclusion to assess skin damage potential (corneosurfametry), efficacy of cosmetic product removal from skin, change from baseline in visual dryness, change from baseline in Eczema Area and Severity Index, and self-perceived eczema attributes and self-reported product preference. The glycinate-based cleanser demonstrated mildness to skin components when evaluated in a corneosurfametry assay. Short-term use under exaggerated wash conditions in subjects with dryness scores benefits.

  20. Depression and Anxiety During Pregnancy: Evaluating the Literature in Support of Clinical Risk-Benefit Decision-Making.

    Science.gov (United States)

    Dalke, Katharine Baratz; Wenzel, Amy; Kim, Deborah R

    2016-06-01

    Depression and anxiety during pregnancy are common, and patients and providers are faced with complex decisions regarding various treatment modalities. A structured discussion of the risks and benefits of options with the patient and her support team is recommended to facilitate the decision-making process. This clinically focused review, with emphasis on the last 3 years of published study data, evaluates the major risk categories of medication treatments, namely pregnancy loss, physical malformations, growth impairment, behavioral teratogenicity, and neonatal toxicity. Nonpharmacological treatment options, including neuromodulation and psychotherapy, are also briefly reviewed. Specific recommendations, drawn from the literature and the authors' clinical experience, are also offered to help guide the clinician in decision-making.

  1. Clinician-Reported Outcome Assessments of Treatment Benefit: Report of the ISPOR Clinical Outcome Assessment Emerging Good Practices Task Force.

    Science.gov (United States)

    Powers, John H; Patrick, Donald L; Walton, Marc K; Marquis, Patrick; Cano, Stefan; Hobart, Jeremy; Isaac, Maria; Vamvakas, Spiros; Slagle, Ashley; Molsen, Elizabeth; Burke, Laurie B

    2017-01-01

    A clinician-reported outcome (ClinRO) assessment is a type of clinical outcome assessment (COA). ClinRO assessments, like all COAs (patient-reported, observer-reported, or performance outcome assessments), are used to 1) measure patients' health status and 2) define end points that can be interpreted as treatment benefits of medical interventions on how patients feel, function, or survive in clinical trials. Like other COAs, ClinRO assessments can be influenced by human choices, judgment, or motivation. A ClinRO assessment is conducted and reported by a trained health care professional and requires specialized professional training to evaluate the patient's health status. This is the second of two reports by the ISPOR Clinical Outcomes Assessment-Emerging Good Practices for Outcomes Research Task Force. The first report provided an overview of COAs including definitions important for an understanding of COA measurement practices. This report focuses specifically on issues related to ClinRO assessments. In this report, we define three types of ClinRO assessments (readings, ratings, and clinician global assessments) and describe emerging good measurement practices in their development and evaluation. The good measurement practices include 1) defining the context of use; 2) identifying the concept of interest measured; 3) defining the intended treatment benefit on how patients feel, function, or survive reflected by the ClinRO assessment and evaluating the relationship between that intended treatment benefit and the concept of interest; 4) documenting content validity; 5) evaluating other measurement properties once content validity is established (including intra- and inter-rater reliability); 6) defining study objectives and end point(s) objectives, and defining study end points and placing study end points within the hierarchy of end points; 7) establishing interpretability in trial results; and 8) evaluating operational considerations for the implementation of

  2. Clinical benefit of ertapenem compared to flomoxef for the treatment of cefotaxime-resistant Enterobacteriaceae bacteremia.

    Science.gov (United States)

    Lee, Chen-Hsiang; Chen, I-Ling; Li, Chia-Chin; Chien, Chun-Chih

    2018-01-01

    Cefotaxime-resistant Enterobacteriaceae (CE) infections are intractable, with limited treatment options. Though carbapenems are frequently prescribed for CE infections, the emergence of carbapenem-resistant Enterobacteriaceae is of huge concern. Flomoxef is effective against CE in vitro, and some clinical data on its demonstrated effectiveness against CE bloodstream infections (BSIs) exists. We conducted a retrospective study on adults with BSI caused by flomoxef-susceptible CE to investigate the efficacy of flomoxef compared with that of ertapenem. The outcome was evaluated with propensity score-based matching and logistic regression analysis. Demographic and clinical characteristics of patients treated with flomoxef (n = 58) or ertapenem (n = 188) were compared. In the multivariate analysis, severe sepsis (adjusted odds ratio [AOR] = 3.84; 95% confidence interval [CI], 1.16-12.78; p = 0.03), high BSI mortality score (AOR = 5.59; 95% CI, 2.37-13.21; p flomoxef-treated patients were matched to 116 ertapenem-treated patients. There were no intergroup differences in BSI severity, comorbidity, or BSI sources. The 28-day mortality rates (20.7% vs 13.8%, p = 0.28) did not differ significantly. However, hospitalization length was shorter in the ertapenem group (10.2 ± 8.5 vs. 14.6 ± 9.4 days, p < 0.01). Although similar outcomes were observed between the groups, ertapenem therapy was associated with a shorter hospitalization time in adults after CE BSI.

  3. SGLT2 inhibitors with cardiovascular benefits: Transforming clinical care in Type 2 diabetes mellitus.

    Science.gov (United States)

    d'Emden, Michael; Amerena, John; Deed, Gary; Pollock, Carol; Cooper, Mark E

    2018-02-01

    Cardiovascular risk reduction in individuals with Type 2 diabetes mellitus (T2DM) is a key part of clinical management. Sodium-glucose co-transporter (SGLT2) inhibitors improve glycaemic control, reduce body weight and decrease blood pressure. In addition, the SGLT2 inhibitors empagliflozin and canagliflozin reduced the risk of composite cardiovascular events in high-risk individuals with T2DM in the EMPA-REG OUTCOME trial and the CANVAS Program, respectively. Empagliflozin also reduced cardiovascular deaths and improved renal outcomes. This class of agents should be considered in people with established cardiovascular disease, usually in combination with other glucose lowering medications, when satisfactory glycaemic control has not been achieved. The dose of insulin or sulfonylureas may need to be lowered when used with SGLT2 inhibitors, to reduce the risk of hypoglycaemia. Genitourinary infections can occur with SGLT2 inhibitors in a small proportion of people. In people with osteoporosis or prior amputation, it may be prudent to use empagliflozin rather than canagliflozin, based on the increased risk for bone fractures and amputations observed with canagliflozin in the CANVAS Program. SGLT2 inhibitors have the potential to transform the clinical care of persons with T2DM by not only improving glycaemic control but also reducing blood pressure, body weight and diabetes-related end-organ complications. Copyright © 2017 Elsevier B.V. All rights reserved.

  4. Patient-perceived satisfactory improvement (PPSI): interpreting meaningful change in pain from the patient's perspective

    NARCIS (Netherlands)

    ten Klooster, Peter M.; Drossaers-Bakker, K.W.; Taal, Erik; van de Laar, Mart A F J

    2006-01-01

    The assessment of clinically meaningful changes in patient-reported pain has become increasingly important when interpreting results of clinical studies. However, proposed response criteria, such as the minimal clinically important difference, do not correspond with the growing need for information

  5. Herpes Simplex Encephalitis: Lack of Clinical Benefit of Long-term Valacyclovir Therapy.

    Science.gov (United States)

    Gnann, John W; Sköldenberg, Birgit; Hart, John; Aurelius, Elisabeth; Schliamser, Silvia; Studahl, Marie; Eriksson, Britt-Marie; Hanley, Daniel; Aoki, Fred; Jackson, Alan C; Griffiths, Paul; Miedzinski, Lil; Hanfelt-Goade, Diane; Hinthorn, Daniel; Ahlm, Clas; Aksamit, Allen; Cruz-Flores, Salvador; Dale, Ilet; Cloud, Gretchen; Jester, Penelope; Whitley, Richard J

    2015-09-01

    Despite the proven efficacy of acyclovir (ACV) therapy, herpes simplex encephalitis (HSE) continues to cause substantial morbidity and mortality. Among patients with HSE treated with ACV, the mortality rate is approximately 14%-19%. Among survivors, 45%-60% have neuropsychological sequelae at 1 year. Thus, improving therapeutic approaches to HSE remains a high priority. Following completion of a standard course of intravenous ACV, 87 adult patients with HSE (confirmed by positive polymerase chain reaction [PCR] for herpes simplex virus DNA in cerebrospinal fluid) were randomized to receive either valacyclovir (VACV) 2 g thrice daily (n = 40) or placebo tablets (n = 47) for 90 days (12 tablets of study medication daily). The primary endpoint was survival with no or mild neuropsychological impairment at 12 months, as measured by the Mattis Dementia Rating Scale (MDRS). Logistic regression was utilized to assess factors related to the primary endpoint. The demographic characteristics of the 2 randomization groups were statistically similar with no significant differences in age, sex, or race. At 12 months, there was no significant difference in the MDRS scoring for VACV-treated vs placebo recipients, with 85.7% and 90.2%, respectively, of patients demonstrating no or mild neuropsychological impairment (P = .72). No significant study-related adverse events were encountered in either treatment group. Following standard treatment with intravenous ACV for PCR-confirmed HSE, an additional 3-month course of oral VACV therapy did not provide added benefit as measured by neuropsychological testing 12 months later in a population of relatively high-functioning survivors. NCT00031486. © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  6. Clinical benefits of tight glycaemic control: focus on the intensive care unit.

    Science.gov (United States)

    Mesotten, Dieter; Van den Berghe, Greet

    2009-12-01

    While stress hyperglycaemia has traditionally been regarded as an adaptive, beneficial response, it is clear that hyperglycaemia and hypoglycaemia are associated with increased risk of death in critically ill intensive care unit (ICU) patients. Recent studies on blood-glucose control failed to fully clarify whether this association is causal. Early proof-of-concept single-centre randomised controlled studies found that maintaining normoglycaemia by intensive insulin therapy, as compared with tolerating hyperglycaemia as an adaptive response, improved patient outcome. However, recent large multicentre studies VISEP, GLUCONTROL and NICE-SUGAR) could not confirm this survival benefit. Methodological disparity in the execution of the complex intervention of tight glycaemic control may have contributed significantly to the contradicting results. First, different target ranges for blood glucose were used in the control group of the GLUCONTROL and 'Normoglycemia in intensive care evaluation and survival using glucose algorithm' regulation' (NICE-SUGAR) studies. Second, problems to steer blood-glucose levels within target range in the intervention group resulted in a significant overlap of the treatment groups. Third, allowing inaccurate blood-glucose measurement devices, in combination with different blood sampling sites and types of infusion pumps, may have led to unnoticed swings in blood-glucose levels. Fourth, the level of expertise of the intensive care nurses with the therapy may have been variable due to low number of study patients per centre. Finally, the studies on tight blood-glucose control were done with vastly different nutritional and end-of-life strategies. The currently available studies do not allow to confidently recommend one optimal target for glucose in heterogeneous ICU patient groups and settings. Provided that adequate devices for blood-glucose measurement and insulin administration are available, together with an extensive experience of the

  7. Clinical benefit from pharmacological elevation of high-density lipoprotein cholesterol: meta-regression analysis.

    Science.gov (United States)

    Hourcade-Potelleret, F; Laporte, S; Lehnert, V; Delmar, P; Benghozi, Renée; Torriani, U; Koch, R; Mismetti, P

    2015-06-01

    Epidemiological evidence that the risk of coronary heart disease is inversely associated with the level of high-density lipoprotein cholesterol (HDL-C) has motivated several phase III programmes with cholesteryl ester transfer protein (CETP) inhibitors. To assess alternative methods to predict clinical response of CETP inhibitors. Meta-regression analysis on raising HDL-C drugs (statins, fibrates, niacin) in randomised controlled trials. 51 trials in secondary prevention with a total of 167,311 patients for a follow-up >1 year where HDL-C was measured at baseline and during treatment. The meta-regression analysis showed no significant association between change in HDL-C (treatment vs comparator) and log risk ratio (RR) of clinical endpoint (non-fatal myocardial infarction or cardiac death). CETP inhibitors data are consistent with this finding (RR: 1.03; P5-P95: 0.99-1.21). A prespecified sensitivity analysis by drug class suggested that the strength of relationship might differ between pharmacological groups. A significant association for both statins (p<0.02, log RR=-0.169-0.0499*HDL-C change, R(2)=0.21) and niacin (p=0.02, log RR=1.07-0.185*HDL-C change, R(2)=0.61) but not fibrates (p=0.18, log RR=-0.367+0.077*HDL-C change, R(2)=0.40) was shown. However, the association was no longer detectable after adjustment for low-density lipoprotein cholesterol for statins or exclusion of open trials for niacin. Meta-regression suggested that CETP inhibitors might not influence coronary risk. The relation between change in HDL-C level and clinical endpoint may be drug dependent, which limits the use of HDL-C as a surrogate marker of coronary events. Other markers of HDL function may be more relevant. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  8. Colchicine in Pericardial Disease: from the Underlying Biology and Clinical Benefits to the Drug-Drug Interactions in Cardiovascular Medicine.

    Science.gov (United States)

    Schenone, Aldo L; Menon, Venu

    2018-06-14

    This is an in-depth review on the mechanism of action, clinical utility, and drug-drug interactions of colchicine in the management of pericardial disease. Recent evidence about therapeutic targets on pericarditis has demonstrated that NALP3 inflammasome blockade is the cornerstone in the clinical benefits of colchicine. Such benefits extend from acute and recurrent pericarditis to transient constriction and post-pericardiotomy syndrome. Despite the increased utilization of colchicine in cardiovascular medicine, safety concerns remains unsolved regarding the long-term use of colchicine in the cardiac patient. Moreover, recent evidence has demonstrated that numerous cardiovascular medications, ranging from antihypertensive medication to antiarrhythmics, are known to interact with the CYP3A4 and/or P-gp system increasing the toxicity potential of colchicine. The use of adjunctive colchicine in the management of inflammatory pericardial diseases is standard of care in current practice. It is advised that a careful medication reconciliation with emphasis on pharmacokinetic is completed before prescribing colchicine in order to avoid harmful interaction by finding an alternative regimen or adjusting colchicine dosing.

  9. PET with coincidence gamma cameras - clinical benefit from the radiooncologists' point of view

    International Nuclear Information System (INIS)

    Richter, E.; Feyerabend, T.; Stallmann, C.; Lauer, I.; Baehre, M.

    2001-01-01

    Positron emission tomography with FDG (FDG-PET) is a new technique, which displays the cellular metabolic activity. Since tumors exhibit an increased metabolic activity when compared to normal tissue, this imaging modality has a particularly high importance. FDG-PET is not only useful for localizing and staging of malignant tumors, but also to evaluate therapy response. In this context, PET is superior to morphologically orientated modalities, because therapeutically induced changes in glucose metabolism precede morphologic alterations. Numerous studies indicate, that PET will play an important role in radiooncology concerning therapy planning and monitoring the effects of therapy during and after treatment. Further clinical studies are necessary to evaluate the information provided by FDG-PET more precisely. Coincidence gamma cameras with adequate imaging characteristics will gain enhanced importance to meet these increasing demands. (orig.) [de

  10. Estimated clinical benefit of protecting neurogenesis in the developing brain during radiation therapy for pediatric medulloblastoma

    DEFF Research Database (Denmark)

    Blomstrand, M.; Berthelsen, Anne Kiil; Munck af Rosenschöld, Per Martin

    2012-01-01

    to the whole-brain irradiation that is part of standard management. Neurogenesis is very sensitive to radiation, and limiting the radiation dose to the hippocampus and the subventricular zone (SVZ) may preserve neurocognitive function. Radiotherapy plans were created using 4 techniques: standard opposing...... fields, intensity-modulated radiotherapy (IMRT), intensity-modulated arc therapy (IMAT), and intensity-modulated proton therapy (IMPT). Mean dose to the hippocampus and SVZ (mean for both sites) could be limited to 88.3% (range, 83.6%-91.0%), 77.1% (range, 71.5%-81.3%), and 42.3% (range, 26......-modulated proton therapy, thus making this an attractive option to be tested in a prospective clinical trial....

  11. Clinical outcomes and benefits for staging of surgical lymph node mapping after esophagectomy.

    Science.gov (United States)

    Lagarde, S M; Phillips, A W; Navidi, M; Disep, B; Griffin, S M

    2017-12-01

    Dissection of lymph nodes (LN) immediately after esophagectomy is utilized by some surgeons to aid determination of LN stations involved in esophageal cancer. Some suggest that this increases LN yield and gives information regarding the pattern of lymphatic spread, others feel that this may compromise a circumferential resection margin (CRM) assessment. The aim of this study is to evaluate the effect of ex vivo dissection on the assessment of the CRM and the pattern of lymph node dissemination in patients with adenocarcinoma of the esophagus and gastroesophageal junction (GEJ) undergoing radical surgery after neoadjuvant chemotherapy and their prognostic impact. Data from consecutive patients with potentially curable adenocarcinoma of the distal esophagus and GEJ who received neoadjuvant treatment followed by surgery were analyzed. Clinical and pathological findings were reviewed and LN burden and location correlated with clinical outcome. Pathology specimens were dissected into individual LN groups 'ex-vivo' by the surgeon. A total of 301 patients were included: 295 had a radical proximal and distal resection margin however in 62(20.6%) CRM could not be assessed. A median of 33(10-77) nodes were recovered. A 117(38.9%) patients were ypN0 while 184(61.1%) were LN positive (ypN1-N3). LN stations close to the tumor were most frequently involved. Twenty-seven (14.7%) patients had only thoracic stations involved, 48(26.1%) only abdominal stations and 109 (59.2%) had both. Median survival for yN0 patients was 171 months compared to 24 months for those LN positive (PCRM assessment in up to 20% of cases. It also provides valuable information regarding the pattern of nodal spread. © The Authors 2017. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  12. Clinical and economic benefits of fidaxomicin compared to vancomycin for Clostridium difficile infection.

    Science.gov (United States)

    Gallagher, Jason C; Reilly, Joseph P; Navalkele, Bhagyashri; Downham, Gemma; Haynes, Kevin; Trivedi, Manish

    2015-11-01

    We studied the clinical and economic impact of a protocol encouraging the use of fidaxomicin as a first-line drug for treatment of Clostridium difficile infection (CDI) in patients hospitalized during a 2-year period. This study evaluated patients who received oral vancomycin or fidaxomicin for the treatment of CDI during a 2-year period. All included patients were eligible for administration of fidaxomicin via a protocol that encouraged its use for selected patients. The primary clinical endpoint was 90-day readmission with a diagnosis of CDI. Hospital charges and insurance reimbursements for readmissions were calculated along with the cost of CDI therapy to estimate the financial impact of the choice of therapy. Recurrences were seen in 10/49 (20.4%) fidaxomicin patients and 19/46 (41.3%) vancomycin patients (P = 0.027). In a multivariate analysis that included determinations of severity of CDI, serum creatinine increases, and concomitant antibiotic use, only fidaxomicin was significantly associated with decreased recurrence (adjusted odds ratio [aOR], 0.33; 95% confidence interval [CI], 0.12 to 0.93). The total lengths of stay of readmitted patients were 183 days for vancomycin and 87 days for fidaxomicin, with costs of $454,800 and $196,200, respectively. Readmissions for CDI were reimbursed on the basis of the severity of CDI, totaling $151,136 for vancomycin and $107,176 for fidaxomicin. Fidaxomicin drug costs totaled $62,112, and vancomycin drug costs were $6,646. We calculated that the hospital lost an average of $3,286 per fidaxomicin-treated patient and $6,333 per vancomycin-treated patient, thus saving $3,047 per patient with fidaxomicin. Fidaxomicin use for CDI treatment prevented readmission and decreased hospital costs compared to use of oral vancomycin. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

  13. How a modified approach to dental coding can benefit personal and professional development with improved clinical outcomes.

    Science.gov (United States)

    Lam, Raymond; Kruger, Estie; Tennant, Marc

    2014-12-01

    One disadvantage of the remarkable achievements in dentistry is that treatment options have never been more varied or confusing. This has made the concept of Evidenced Based Dentistry more applicable to modern dental practice. Despite merit in the concept whereby clinical decisions are guided by scientific evidence, there are problems with establishing a scientific base. This is no more challenging than in modern dentistry where the gap between rapidly developing products/procedures and its evidence base are widening. Furthermore, the burden of oral disease continues to remain high at the population level. These problems have prompted new approaches to enhancing research. The aim of this paper is to outline how a modified approach to dental coding may benefit clinical and population level research. Using publically assessable data obtained from the Australian Chronic Disease Dental Scheme and item codes contained within the Australian Schedule of Dental Services and Glossary, a suggested approach to dental informatics is illustrated. A selection of item codes have been selected and expanded with the addition of suffixes. These suffixes provided circumstantial information that will assist in assessing clinical outcomes such as success rates and prognosis. The use of item codes in administering the CDDS yielded a large database of item codes. These codes are amenable to dental informatics which has been shown to enhance research at both the clinical and population level. This is a cost effective method to supplement existing research methods. Copyright © 2014 Elsevier Inc. All rights reserved.

  14. Can Repeat Injection Provide Clinical Benefit in Patients with Lumbosacral Diseases When First Epidural Injection Results Only in Partial Response?

    Science.gov (United States)

    Lee, Jung Hwan; Lee, Sang-Ho

    2016-02-01

    Epidural steroid injection (ESI) is known to be an effective treatment for lower back or radicular pain due to herniated intervertebral disc (HIVD) and spinal stenosis (SS). Although repeat ESI has generally been indicated to provide more pain relief in partial responders after a single ESI, there has been little evidence supporting the usefulness of repeat injections in cumulative clinical pain reduction. The purpose of this study was to determine whether repeat ESI at a prescribed interval of 2 to 3 weeks after the first injection would provide greater clinical benefit in patients with partial pain reduction than that provided by intermittent injection performed only when pain was aggravated. An Institutional Review Board (IRB)-approved retrospective chart review. Spine hospital. Two hundred and four patients who had underwent transforaminal ESI (TFESI) for treatment of lower back and radicular pain due to HIVD or SS and could be followed-up for one year were enrolled. We divided the patients into 2 groups. Group A (N = 108) comprised partial responders (NRS = 3 after first injection) who underwent repeat injection at a prescribed interval of 2 to 3 weeks after the first injection. Group B (N = 96) comprised partial responders who did not receive a repeat injection at the prescribed interval, but received repeat injections only for aggravation of pain. Various clinical data including total number of injections during one year, duration of NRS group A, or after first injection in group B (time to reinjection), were assessed. These data were compared between groups A and B in terms of total population, HIVD, and SS. In the whole population, the mean time to reinjection was 6.09 ± 3.02 months in group A and 3.69 ± 2.07 months in group B. The NRS groups A and B, respectively. In HIVD patients, the mean time to reinjection was 5.82 ± 3.23 months in group A and 3.84 ± 2.34 months in group B, and NRS groups A and B, respectively. In SS patients, the mean time to

  15. Clinical benefits of incorporating doxycycline into a canine heartworm treatment protocol

    Directory of Open Access Journals (Sweden)

    C. Thomas Nelson

    2017-11-01

    Full Text Available Abstract Background The objective of heartworm treatment is to improve the clinical condition of the patient and to eliminate pre-cardiac, juvenile, and adult worm stages with minimal complications. Pulmonary thromboembolisms are an inevitable consequence of worm death and can result in severe pulmonary reactions and even death of the patient. To minimize these reactions, various treatment protocols involving melarsomine, the only adulticidal drug approved by the US Food and Drug Administrations (FDA, in conjunction with macrocyclic lactone heartworm preventives and glucocorticosteroids have been advocated. The discovery of the bacterial endosymbiont Wolbachia in Dirofilaria immitis has led to several experimental studies examining the effects of administering doxycycline to reduce or eliminate Wolbachia organism. These studies have shown a decrease in gross and microscopic pathology of pulmonary parenchyma in experimental heartworm infections pretreated with doxycycline before melarsomine administration. Methods Electronic medical records from a large veterinary practice in northeast Alabama were searched to identify dogs treated for heartworms with melarsomine from January 2005 through December 2012. The search was refined further to select for dogs that met the following criteria: 1 received two or three doses of ivermectin heartworm preventive prior to melarsomine injections, 2 received one injection of melarsomine followed by two injections 4 to 8 weeks later, and 3 were treated with prednisone following melarsomine injections. The dogs were then divided into those that also were treated with doxycycline 10 mg/kg BID for 4 weeks (Group A, n = 47 and those that did not receive doxycycline (Group B, n = 47. The medical notes of all 94 cases were then reviewed for comments concerning coughing, dyspnea, or hemoptysis in the history, physical exam template, or from telephone conversations with clients the week following each visit. Any

  16. Clinical benefits of incorporating doxycycline into a canine heartworm treatment protocol.

    Science.gov (United States)

    Nelson, C Thomas; Myrick, Elizabeth S; Nelson, Thomas A

    2017-11-09

    The objective of heartworm treatment is to improve the clinical condition of the patient and to eliminate pre-cardiac, juvenile, and adult worm stages with minimal complications. Pulmonary thromboembolisms are an inevitable consequence of worm death and can result in severe pulmonary reactions and even death of the patient. To minimize these reactions, various treatment protocols involving melarsomine, the only adulticidal drug approved by the US Food and Drug Administrations (FDA), in conjunction with macrocyclic lactone heartworm preventives and glucocorticosteroids have been advocated. The discovery of the bacterial endosymbiont Wolbachia in Dirofilaria immitis has led to several experimental studies examining the effects of administering doxycycline to reduce or eliminate Wolbachia organism. These studies have shown a decrease in gross and microscopic pathology of pulmonary parenchyma in experimental heartworm infections pretreated with doxycycline before melarsomine administration. Electronic medical records from a large veterinary practice in northeast Alabama were searched to identify dogs treated for heartworms with melarsomine from January 2005 through December 2012. The search was refined further to select for dogs that met the following criteria: 1) received two or three doses of ivermectin heartworm preventive prior to melarsomine injections, 2) received one injection of melarsomine followed by two injections 4 to 8 weeks later, and 3) were treated with prednisone following melarsomine injections. The dogs were then divided into those that also were treated with doxycycline 10 mg/kg BID for 4 weeks (Group A, n = 47) and those that did not receive doxycycline (Group B, n = 47). The medical notes of all 94 cases were then reviewed for comments concerning coughing, dyspnea, or hemoptysis in the history, physical exam template, or from telephone conversations with clients the week following each visit. Any dog that died within one year of treatment

  17. Clinical benefit of ertapenem compared to flomoxef for the treatment of cefotaxime-resistant Enterobacteriaceae bacteremia

    Directory of Open Access Journals (Sweden)

    Lee C

    2018-02-01

    Full Text Available Chen-Hsiang Lee,1,2 I-Ling Chen,3 Chia-Chin Li,4 Chun-Chih Chien4 1Department of Internal Medicine, Division of Infectious Diseases, Kaohsiung Chang Gung Memorial, Hospital, 2Chang Gung University, College of Medicine, 3Department of Pharmacy, 4Department of Laboratory Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan Objectives: Cefotaxime-resistant Enterobacteriaceae (CE infections are intractable, with limited treatment options. Though carbapenems are frequently prescribed for CE infections, the emergence of carbapenem-resistant Enterobacteriaceae is of huge concern. Flomoxef is effective against CE in vitro, and some clinical data on its demonstrated effectiveness against CE bloodstream infections (BSIs exists.Patients and methods: We conducted a retrospective study on adults with BSI caused by flomoxef-susceptible CE to investigate the efficacy of flomoxef compared with that of ertapenem. The outcome was evaluated with propensity score-based matching and logistic regression analysis.Results: Demographic and clinical characteristics of patients treated with flomoxef (n = 58 or ertapenem (n = 188 were compared. In the multivariate analysis, severe sepsis (adjusted odds ratio [AOR] = 3.84; 95% confidence interval [CI], 1.16–12.78; p = 0.03, high BSI mortality score (AOR = 5.59; 95% CI, 2.37–13.21; p < 0.01, ultimately or rapidly fatal comorbidity (AOR = 10.60; 95% CI, 3.43–32.75; p < 0.01, and pneumonia (AOR = 10.11; 95% CI, 3.43–29.81; p < 0.01 were independently associated with 28-day mortality. Using propensity scores, 58 flomoxef-treated patients were matched to 116 ertapenem-treated patients. There were no intergroup differences in BSI severity, comorbidity, or BSI sources. The 28-day mortality rates (20.7% vs 13.8%, p = 0.28 did not differ significantly. However, hospitalization length was shorter in the ertapenem group (10.2 ± 8.5 vs. 14.6 ± 9.4 days, p < 0.01.Conclusion: Although similar outcomes were

  18. Comparison of clinical benefits and outcome in patients with programmable and nonprogrammable implantable cardioverter defibrillators.

    Science.gov (United States)

    Mehta, D; Saksena, S; Krol, R B; Makhija, V

    1992-09-01

    Technological advances in implantable cardioverter defibrillators (ICDs) have provided a variety of programmable parameters and antitachycardia therapies whose utility and impact on clinical outcome is presently unknown. ICDs have capabilities for cardioversion defibrillation alone (first generation ICDs), or in conjunction with demand ventricular pacing (second generation ICDs), or with demand pacing and antitachycardia pacing (third generation ICDs). We examined the pattern of antitachycardia therapy use and long-term survival in 110 patients with sustained ventricular tachycardia (VT) or ventricular fibrillation (VF). Group I included 62 patients with nonprogrammable first generation ICDs that delivered committed shock therapy after ventricular tachyarrhythmia detection based on electrogram rate and/or morphology was satisfied. Group II included 48 patients with multiprogrammable ICDs (including second and third generation ICDs) that had programmable tachyarrhythmia detection based on rate and tachycardia confirmation prior to delivery of electrical treatment with either programmable shocks and/or, as in the third generation ICDs, antitachycardia pacing. Incidence and patterns of antitachycardia therapy use and long-term survival were compared in the two groups. The incidence of appropriate shocks in patients who completed 1 year of follow-up was significantly greater in group I (30 of 43 patients = 70% vs 11 of 26 patients = 42%; P less than 0.05). In the total follow-up period, a significantly larger proportion of group I patients as compared to group II patients used the shock therapies (46 of 62 patients = 74% vs 25 of 48 patients = 52%; P less than 0.01), with the majority doing so within the first year of implantation (96% and 92%, respectively). Although the frequency of antitachycardia therapy activation was similar, the number of shocks delivered per patient was lower in group II, particularly in the initial 3 months of follow-up (P = 0.06). No clinical

  19. Clinical benefits, costs, and cost-effectiveness of neonatal intensive care in Mexico.

    Directory of Open Access Journals (Sweden)

    Jochen Profit

    2010-12-01

    Full Text Available Neonatal intensive care improves survival, but is associated with high costs and disability amongst survivors. Recent health reform in Mexico launched a new subsidized insurance program, necessitating informed choices on the different interventions that might be covered by the program, including neonatal intensive care. The purpose of this study was to estimate the clinical outcomes, costs, and cost-effectiveness of neonatal intensive care in Mexico.A cost-effectiveness analysis was conducted using a decision analytic model of health and economic outcomes following preterm birth. Model parameters governing health outcomes were estimated from Mexican vital registration and hospital discharge databases, supplemented with meta-analyses and systematic reviews from the published literature. Costs were estimated on the basis of data provided by the Ministry of Health in Mexico and World Health Organization price lists, supplemented with published studies from other countries as needed. The model estimated changes in clinical outcomes, life expectancy, disability-free life expectancy, lifetime costs, disability-adjusted life years (DALYs, and incremental cost-effectiveness ratios (ICERs for neonatal intensive care compared to no intensive care. Uncertainty around the results was characterized using one-way sensitivity analyses and a multivariate probabilistic sensitivity analysis. In the base-case analysis, neonatal intensive care for infants born at 24-26, 27-29, and 30-33 weeks gestational age prolonged life expectancy by 28, 43, and 34 years and averted 9, 15, and 12 DALYs, at incremental costs per infant of US$11,400, US$9,500, and US$3,000, respectively, compared to an alternative of no intensive care. The ICERs of neonatal intensive care at 24-26, 27-29, and 30-33 weeks were US$1,200, US$650, and US$240, per DALY averted, respectively. The findings were robust to variation in parameter values over wide ranges in sensitivity analyses

  20. Clinical benefits of drug-eluting stent implantation in septuagenarians with coronary artery disease

    International Nuclear Information System (INIS)

    Fang Yuehua; Shen Weifeng; Zhang Ruiyan; Zhang Jiansheng; Hu Jian; Zhang Xian; Zheng Aifang

    2005-01-01

    Objective: This study evaluated the safety and long-term outcomes of drug-eluting stents in septuagenarians with coronary artery disease. Methods: Two hundred and thirty-nine consecutive patients with coronary artery disease underwent drug-eluting stenting, including 88 patients aged ≥70 years (group A) and 151 aged <70 years (group B). Baseline clinical characteristics, procedural success rate, occurrence of cardiac events during follow-up were recorded and compared between the two groups. Results: Procedural success rate and complications were similar for the two groups. During follow-up, group A had higher recurrence rate of chest pain than group B (23.9% vs. 7.3%, P<0.001), and occurrence of cardiac events was higher in group A than in group B (5.7% vs. 2.7%, P<0.296). There was no significant difference in the frequency of restenosis between the two groups. Conclusions: Drug-eluting stent implantation for septuagenarians with coronary artery disease is safe but may have more recurrence of angina than younger ones during long-term follow-up. (authors)

  1. Hypnosis in the Perioperative Management of Breast Cancer Surgery: Clinical Benefits and Potential Implications

    Science.gov (United States)

    Roelants, Fabienne; Pospiech, Audrey; Momeni, Mona; Watremez, Christine

    2016-01-01

    The aim of this review is to summarize data published on the use of perioperative hypnosis in patients undergoing breast cancer surgery (BCS). Indeed, the majority of BCS patients experience stress, anxiety, nausea, vomiting, and pain. Correct management of the perioperative period and surgical removal of the primary tumor are clearly essential but can affect patients on different levels and hence have a negative impact on oncological outcomes. This review examines the effect of clinical hypnosis performed during the perioperative period. Thanks to its specific properties and techniques allowing it to be used as complementary treatment preoperatively, hypnosis has an impact most notably on distress and postoperative pain. During surgery, hypnosis may be applied to limit immunosuppression, while, in the postoperative period, it can reduce pain, anxiety, and fatigue and improve wound healing. Moreover, hypnosis is inexpensive, an important consideration given current financial concerns in healthcare. Of course, large randomized prospective studies are now needed to confirm the observed advantages of hypnosis in the field of oncology. PMID:27635132

  2. What are the potential benefits of clinical beta-cell imaging in diabetes mellitus?

    Science.gov (United States)

    Göke, Burkhard

    2010-05-01

    Previously, studies of the endocrine pancreatic beta-cell were mainly performed ex vivo by morphological means. This data supported the analysis of pathophysiological changes in the pancreatic islet during insults such as diabetes mellitus. Metabolic testing of the pancreatic islet by assaying hormone parameters such als plasma insulin or C-peptide combined with more or less sophisticated calculations allowed conclusions about states of insulin resistance or secretory failure. It also allowed certain correlations of endocrine function with beta-cell mass. Today, with firmer pathophysiological concepts about beta-cell failure, modern protocols of islet transplantation, and drugs on the market coming with promises of preservation or even expansion of beta-cell mass in diabetes mellitus it has become very attractive to search for tools measuring beta-cell mass, if possible even repeatingly in the same organism in vivo. From a clinical point of view, the potential of pancreatic beta-cell mass imaging technologies is looked upon with high expectations. Methodologically, the decisive question is whether it is likely that future beta-cell imaging will provide significant advantages over the metabolic methods already in hand. With new in vivo tools, studies of beta-cell mass and function may offer even new approaches stratifying patients to anti-diabetic therapies.

  3. [Medical short stay unit for geriatric patients in the emergency department: clinical and healthcare benefits].

    Science.gov (United States)

    Pareja, Teresa; Hornillos, Mercedes; Rodríguez, Miriam; Martínez, Javier; Madrigal, María; Mauleón, Coro; Alvarez, Bárbara

    2009-01-01

    To evaluate the impact of comprehensive geriatric assessment and management of high-risk elders in a medical short stay unit located in the emergency department of a general hospital. We performed a descriptive, prospective study of patients admitted to the medical short stay unit for geriatric patients of the emergency department in 2006. A total of 749 patients were evaluated, with a mean (standard deviation) stay in the unit of 37 (16) h. The mean age was 86 (7) years; 57% were women, and 50% had moderate-severe physical impairment and dementia. Thirty-five percent lived in a nursing home. The most frequent reason for admission was exacerbation of chronic cardiopulmonary disease. Multiple geriatric syndromes were identified. The most frequent were immobility, pressure sores and behavioral disorders related to dementia. Seventy percent of the patients were discharged to home after being stabilized and were followed-up by the geriatric clinic and day hospital (39%), the home care medical team (11%), or the nursing home or primary care physician (20%). During the month after discharge, 17% were readmitted and 7.7% died, especially patients with more advanced age or functional impairment. After the unit was opened, admissions to the acute geriatric unit fell by 18.2%. Medical short stay units for geriatric patients in emergency departments may be useful for geriatric assessment and treatment of exacerbations of chronic diseases. These units can help to reduce the number of admissions and optimize the care provided in other ambulatory and domiciliary geriatric settings.

  4. Correlation between vitiligo occurrence and clinical benefit in advanced melanoma patients treated with nivolumab: A multi-institutional retrospective study.

    Science.gov (United States)

    Nakamura, Yasuhiro; Tanaka, Ryota; Asami, Yuri; Teramoto, Yukiko; Imamura, Taichi; Sato, Sayuri; Maruyama, Hiroshi; Fujisawa, Yasuhiro; Matsuya, Taisuke; Fujimoto, Manabu; Yamamoto, Akifumi

    2017-02-01

    Vitiligo is occasionally seen in melanoma patients. Although several studies indicate a correlation between vitiligo occurrence and clinical response in melanoma patients receiving immunotherapy, most studies have included heterogeneous patient and treatment settings. The aim of this study is to investigate the correlation between the occurrence of vitiligo and clinical benefit of nivolumab treatment in advanced melanoma patients. We retrospectively reviewed unresectable stage III or IV melanoma patients treated with nivolumab. Of 35 melanoma patients treated with nivolumab, 25.7% (9/35) developed vitiligo during treatment. The time from the start of nivolumab treatment to occurrence of vitiligo ranged 2-9 months (mean, 5.2). Of nine patients who developed vitiligo, two (22.2%) had a complete response to nivolumab and two (22.2%) had a partial response. The objective response rate was significantly higher in patients with vitiligo than in patients without vitiligo (4/9 [44.4%] vs 2/26 [7.7%]; P = 0.027). The mean time to vitiligo occurrence in patients achieving an objective response was significantly less than that in patients who showed no response (3.1 vs 6.8 months, P = 0.004). Vitiligo occurrence was significantly associated with prolonged progression-free and overall survival (hazard ratio, 0.24 and 0.16; 95% confidence interval, 0.11-0.55 and 0.03-0.79; P = 0.005, and 0.047, respectively). At the 20-week landmark analysis, however, vitiligo was not associated with a statistically significant overall survival benefit (P = 0.28). The occurrence of vitiligo during nivolumab treatment may be correlated with favorable clinical outcome. © 2016 Japanese Dermatological Association.

  5. Clinical benefits of new immobilization system for hypofractionated radiotherapy of intrahepatic hepatocellular carcinoma by helical tomotherapy

    Energy Technology Data Exchange (ETDEWEB)

    Hu, Yong; Zhou, Yong-Kang; Chen, Yi-Xing; Shi, Shi-Ming; Zeng, Zhao-Chong, E-mail: zeng.zhaochong@zs-hospital.sh.cn

    2017-04-01

    Objective: A comprehensive clinical evaluation was conducted, assessing the Body Pro-Lok immobilization and positioning system to facilitate hypofractionated radiotherapy of intrahepatic hepatocellular carcinoma (HCC), using helical tomotherapy to improve treatment precision. Methods: Clinical applications of the Body Pro-Lok system were investigated (as above) in terms of interfractional and intrafractional setup errors and compressive abdominal breath control. To assess interfractional setup errors, a total of 42 patients who were given 5 to 20 fractions of helical tomotherapy for intrahepatic HCC were analyzed. Overall, 15 patients were immobilized using simple vacuum cushion (group A), and the Body Pro-Lok system was used in 27 patients (group B), performing megavoltage computed tomography (MVCT) scans 196 times and 435 times, respectively. Pretreatment MVCT scans were registered to the planning kilovoltage computed tomography (KVCT) for error determination, and group comparisons were made. To establish intrafractional setup errors, 17 patients with intrahepatic HCC were selected at random for immobilization by Body Pro-Lok system, undergoing MVCT scans after helical tomotherapy every week. A total of 46 MVCT re-scans were analyzed for this purpose. In researching breath control, 12 patients, randomly selected, were immobilized by Body Pro-Lok system and subjected to 2-phase 4-dimensional CT (4DCT) scans, with compressive abdominal control or in freely breathing states, respectively. Respiratory-induced liver motion was then compared. Results: Mean interfractional setup errors were as follows: (1) group A: X, 2.97 ± 2.47 mm; Y, 4.85 ± 4.04 mm; and Z, 3.77 ± 3.21 mm; pitch, 0.66 ± 0.62°; roll, 1.09 ± 1.06°; and yaw, 0.85 ± 0.82°; and (2) group B: X, 2.23 ± 1.79 mm; Y, 4.10 ± 3.36 mm; and Z, 1.67 ± 1.91 mm; pitch, 0.45 ± 0.38°; roll, 0.77 ± 0.63°; and yaw, 0.52 ± 0.49°. Between-group differences were statistically significant in 6 directions (p

  6. Clinical benefits of new immobilization system for hypofractionated radiotherapy of intrahepatic hepatocellular carcinoma by helical tomotherapy

    International Nuclear Information System (INIS)

    Hu, Yong; Zhou, Yong-Kang; Chen, Yi-Xing; Shi, Shi-Ming; Zeng, Zhao-Chong

    2017-01-01

    Objective: A comprehensive clinical evaluation was conducted, assessing the Body Pro-Lok immobilization and positioning system to facilitate hypofractionated radiotherapy of intrahepatic hepatocellular carcinoma (HCC), using helical tomotherapy to improve treatment precision. Methods: Clinical applications of the Body Pro-Lok system were investigated (as above) in terms of interfractional and intrafractional setup errors and compressive abdominal breath control. To assess interfractional setup errors, a total of 42 patients who were given 5 to 20 fractions of helical tomotherapy for intrahepatic HCC were analyzed. Overall, 15 patients were immobilized using simple vacuum cushion (group A), and the Body Pro-Lok system was used in 27 patients (group B), performing megavoltage computed tomography (MVCT) scans 196 times and 435 times, respectively. Pretreatment MVCT scans were registered to the planning kilovoltage computed tomography (KVCT) for error determination, and group comparisons were made. To establish intrafractional setup errors, 17 patients with intrahepatic HCC were selected at random for immobilization by Body Pro-Lok system, undergoing MVCT scans after helical tomotherapy every week. A total of 46 MVCT re-scans were analyzed for this purpose. In researching breath control, 12 patients, randomly selected, were immobilized by Body Pro-Lok system and subjected to 2-phase 4-dimensional CT (4DCT) scans, with compressive abdominal control or in freely breathing states, respectively. Respiratory-induced liver motion was then compared. Results: Mean interfractional setup errors were as follows: (1) group A: X, 2.97 ± 2.47 mm; Y, 4.85 ± 4.04 mm; and Z, 3.77 ± 3.21 mm; pitch, 0.66 ± 0.62°; roll, 1.09 ± 1.06°; and yaw, 0.85 ± 0.82°; and (2) group B: X, 2.23 ± 1.79 mm; Y, 4.10 ± 3.36 mm; and Z, 1.67 ± 1.91 mm; pitch, 0.45 ± 0.38°; roll, 0.77 ± 0.63°; and yaw, 0.52 ± 0.49°. Between-group differences were statistically significant in 6 directions (p

  7. Clinical outcomes and immune benefits of anti-epileptic drug therapy in HIV/AIDS

    Directory of Open Access Journals (Sweden)

    Krentz Hartmut B

    2010-06-01

    Full Text Available Abstract Background Anti-epileptic drugs (AEDs are frequently prescribed to persons with HIV/AIDS receiving combination antiretroviral therapy (cART although the extent of AED use and their interactions with cART are uncertain. Herein, AED usage, associated toxicities and immune consequences were investigated. Methods HIV replication was analysed in proliferating human T cells during AED exposure. Patients receiving AEDs in a geographically-based HIV care program were assessed using clinical and laboratory variables in addition to assessing AED indication, type, and cumulative exposures. Results Valproate suppressed proliferation in vitro of both HIV-infected and uninfected T cells (p 0.05 but AED exposures did not affect HIV production in vitro. Among 1345 HIV/AIDS persons in active care between 2001 and 2007, 169 individuals were exposed to AEDs for the following indications: peripheral neuropathy/neuropathic pain (60%, seizure/epilepsy (24%, mood disorder (13% and movement disorder (2%. The most frequently prescribed AEDs were calcium channel blockers (gabapentin/pregabalin, followed by sodium channel blockers (phenytoin, carbamazepine, lamotrigine and valproate. In a nested cohort of 55 AED-treated patients receiving cART and aviremic, chronic exposure to sodium and calcium channel blocking AEDs was associated with increased CD4+ T cell levels (p 0.05 with no change in CD8+ T cell levels over 12 months from the beginning of AED therapy. Conclusions AEDs were prescribed for multiple indications without major adverse effects in this population but immune status in patients receiving sodium or calcium channel blocking drugs was improved.

  8. PACS: Do clinical users benefit from it as a training adjunct?

    Directory of Open Access Journals (Sweden)

    J van Heerden

    2011-05-01

    Full Text Available Background. Over the past four years, Steve Biko Academic Hospital has been in the process of implementing and refining the use of a picture archiving and communications system (PACS. As part of a post-implementation refining process, it is necessary to evaluate user-perceptions in order to improve on good system qualities and correct flaws. Aim. The aim of this study was to assess whether medical clinicians perceived PACS as a positive adjunct to training and teaching opportunities – specifically those opportunities related to radiological image viewing and interpretation as part of patient case discussions. Method. Standardised questionnaires with ‘free text’ and ‘option selection’ questions were distributed to clinicians who, as part of their training, rotated at Steve Biko Academic Hospital (where a PACS is in place as well as other teaching hospitals without a PACS. Between February 2009 and May 2009, approximately 400 questionnaires were distributed. As a result of constant academic rotations, leave schedules of medical staff and posts vacated, questionnaires could not be distributed to the entire target population that was estimated to be in the region of 550 medical clinicians (comprising senior medical students, interns, medical officers, registrars and consultants. Of the 400 questionnaires distributed, 189 completed questionnaires were returned. Completion of the questionnaires was voluntary and anonymous. Results and conclusion. Although a PACS relates specifically to the archiving and retrieval of radiological images and reports, it became clear from the feedback received from medical clinicians (who are ward-based, theatre-based or clinic-based users of a digital system that many other factors, such as lack of adequate hardware and sub-optimal personal IT proficiency, contributed to some of the negative PACS-related perceptions and ‘lost teaching opportunities’ reported. Negative comments specifically related to PACS

  9. End user programming with personally meaningful objects

    CSIR Research Space (South Africa)

    Smith, Andrew C

    2016-09-01

    Full Text Available (Kimchi et al., 2003). Perceptual organisation is a neuro-cognitive process that dictates how we perceive objects in physical space and how we interpret some objects as being distinct from others and yet other objects as part of a whole (Helm, 2014... called the designer-cum-user. Using this approach, the user creates a personally meaningful artefact that represents the target product. Although not confirmed, we anticipate that this approach reduces the initial cognitive load on the user when he uses...

  10. Contractualist reasoning, HIV cure clinical trials, and the moral (ir)relevance of the risk/benefit ratio.

    Science.gov (United States)

    Kumar, Rahul

    2017-02-01

    Institutional review boards (IRB) normally require of a morally defensible clinical trial that any trial participant will benefit from the inquiry, or at least not be exposed to a significant risk of having their prospects worsened by participating. Stage 1 HIV cure trials tend not to meet this requirement. Does that show them to be morally indefensible? Utilitarian thinking about this question supports a negative answer. But one might reasonably expect a Kantian moral theory to support the conclusion that exposing trial participants to a significant risk of their prospects being worsened by their participation to be morally indefensible, on grounds that this would be a clear case of using a person as a mere means. In this paper, I argue, drawing on Kantian contractualist thinking, that requiring the risk/benefit ratio for participants be positive if a trial is to be morally defensible does not in fact gain any support from Kantian thinking about morality. 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/.

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

    Science.gov (United States)

    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.

  12. Negative argininosuccinate synthetase expression in melanoma tumours may predict clinical benefit from arginine-depleting therapy with pegylated arginine deiminase

    Science.gov (United States)

    Feun, L G; Marini, A; Walker, G; Elgart, G; Moffat, F; Rodgers, S E; Wu, C J; You, M; Wangpaichitr, M; Kuo, M T; Sisson, W; Jungbluth, A A; Bomalaski, J; Savaraj, N

    2012-01-01

    Background: Arginine-depleting therapy with pegylated arginine deiminase (ADI-PEG20) was reported to have activity in advanced melanoma in early phase I–II trial, and clinical trials are currently underway in other cancers. However, the optimal patient population who benefit from this treatment is unknown. Methods: Advanced melanoma patients with accessible tumours had biopsy performed before the start of treatment with ADI-PEG20 and at the time of progression or relapse when amenable to determine whether argininosuccinate synthetase (ASS) expression in tumour was predictive of response to ADI-PEG20. Results: Twenty-seven of thirty-eight patients treated had melanoma tumours assessable for ASS staining before treatment. Clinical benefit rate (CBR) and longer time to progression were associated with negative expression of tumour ASS. Only 1 of 10 patients with ASS-positive tumours (ASS+) had stable disease, whereas 4 of 17 (24%) had partial response and 5 had stable disease, when ASS expression was negative (ASS−), giving CBR rates of 52.9 vs 10%, P=0.041. Two responding patients with negative ASS expression before therapy had rebiopsy after tumour progression and the ASS expression became positive. The survival of ASS− patients receiving at least four doses at 320 IU m−2 was significantly better than the ASS+ group at 26.5 vs 8.5 months, P=0.024. Conclusion: ADI-PEG20 is safe and the drug is only efficacious in melanoma patients whose tumour has negative ASS expression. Argininosuccinate synthetase tumour positivity is associated with drug resistance and tumour progression. PMID:22472884

  13. Head and neck cancers: clinical benefits of three-dimensional conformal radiotherapy and of intensity-modulated radiotherapy

    International Nuclear Information System (INIS)

    Giraud, P.; Jaulerry, C.; Brunin, F.; Zefkili, S.; Helfre, S.; Chauvet, I.; Rosenwald, J.C.; Cosset, J.M.

    2002-01-01

    The conformal radiotherapy approach, three-dimensional conformal radiotherapy (3DCRT) or intensity-modulated radiotherapy (IMRT), is based on modern imaging modalities, efficient 3-D treatment planning systems, sophisticated immobilization systems and rigorous quality assurance and treatment verification. The central objective of conformal radiotherapy is to ensure a high dose distribution tailored to the limits of the target volume while reducing exposure of normal tissues. These techniques would then allow further tumor dose escalation. Head-and-neck tumors are some of the most attractive localizations to test conformal radiotherapy. They combine ballistic difficulties due to particularly complex shapes (nasopharynx, ethmoid) and problems due to the number and low tolerance of neighbouring organs like parotids, eyes, brainstem and spinal cord. The therapeutic irradiation of head-and-neck tumors thus remains a challenge for the radiation oncologist. Conformal radiotherapy does have a significant potential for improving local control and reducing toxicity when compared to standard radiotherapy. However, in the absence of prospective randomized trials, it is somewhat difficult at present to evaluate the real benefits drawn from 3DCRT and IMRT. The published clinical reports on the use of conformal radiotherapy are essentially dealing with dosimetric comparisons on relatively small numbers of patients. Recently, a few publications have emphasized the clinical experience several precursor teams with a suitable follow-up. This paper describes the current state-of-the-art of 3DCRT and IMRT in order to evaluate the impact of these techniques on head-and-neck cancers irradiation. (authors)

  14. A systematic review on recurrent respiratory papillomatosis: clinical effect and duration of benefit of different treatment modalities

    Directory of Open Access Journals (Sweden)

    Elina Kiverniti

    2011-12-01

    Full Text Available The aim of this study is to compare different modalities used for the treatment of recurrent respiratory papillomatosis (RRP in adults and children in terms of their clinical effect and the duration of benefit. Systematic review of papers was written in the English language and published between 1977 and 2007. Outcomes are number of patients with a clinical response and length of time the response lasted for. We found 28 useful studies. There were 1,045 subjects, 416 children and 339 adults who underwent different treatments for RRP between 1976 and 2007. The methods used consisted of cidofovir, interferon, surgical excision, indole-3-carbinol, acyclovir, mumps vaccine, and photodynamic therapy. 62.5% of patients had a complete response on cidofovir (11 studies, 45.14% on interferon (8 studies, 33.33% on I3C (2 studies, 44.36% after surgery (5 studies, 77.55% after the mumps vaccine (1 study, 100% on acyclovir (1 study, and 9.09% after photodynamic therapy (1 study. The effect of different modalities lasted between 9 and 27 months. In conclusion, it is impossible to reach any reliable conclusions as to which method is the most durable and effective. There is a great need for randomised control multicentre trials on the treatment of RRP, so that reliable results can be produced.

  15. The Retention of Meaningful Understanding of Meiosis and Genetics.

    Science.gov (United States)

    Cavallo, Ann Liberatore

    This study investigated the retention of meaningful understanding of the biological topics of meiosis, the Punnett square method and the relations between these two topics. This study also explored the predictive influence of students' general tendency to learn meaningfully or by rote (meaningful learning orientation), prior knowledge of meiosis,…

  16. The Benefits of Including Clinical Factors in Rectal Normal Tissue Complication Probability Modeling After Radiotherapy for Prostate Cancer

    International Nuclear Information System (INIS)

    Defraene, Gilles; Van den Bergh, Laura; Al-Mamgani, Abrahim; Haustermans, Karin; Heemsbergen, Wilma; Van den Heuvel, Frank; Lebesque, Joos V.

    2012-01-01

    Purpose: To study the impact of clinical predisposing factors on rectal normal tissue complication probability modeling using the updated results of the Dutch prostate dose-escalation trial. Methods and Materials: Toxicity data of 512 patients (conformally treated to 68 Gy [n = 284] and 78 Gy [n = 228]) with complete follow-up at 3 years after radiotherapy were studied. Scored end points were rectal bleeding, high stool frequency, and fecal incontinence. Two traditional dose-based models (Lyman-Kutcher-Burman (LKB) and Relative Seriality (RS) and a logistic model were fitted using a maximum likelihood approach. Furthermore, these model fits were improved by including the most significant clinical factors. The area under the receiver operating characteristic curve (AUC) was used to compare the discriminating ability of all fits. Results: Including clinical factors significantly increased the predictive power of the models for all end points. In the optimal LKB, RS, and logistic models for rectal bleeding and fecal incontinence, the first significant (p = 0.011–0.013) clinical factor was “previous abdominal surgery.” As second significant (p = 0.012–0.016) factor, “cardiac history” was included in all three rectal bleeding fits, whereas including “diabetes” was significant (p = 0.039–0.048) in fecal incontinence modeling but only in the LKB and logistic models. High stool frequency fits only benefitted significantly (p = 0.003–0.006) from the inclusion of the baseline toxicity score. For all models rectal bleeding fits had the highest AUC (0.77) where it was 0.63 and 0.68 for high stool frequency and fecal incontinence, respectively. LKB and logistic model fits resulted in similar values for the volume parameter. The steepness parameter was somewhat higher in the logistic model, also resulting in a slightly lower D 50 . Anal wall DVHs were used for fecal incontinence, whereas anorectal wall dose best described the other two endpoints. Conclusions

  17. The Benefits of Including Clinical Factors in Rectal Normal Tissue Complication Probability Modeling After Radiotherapy for Prostate Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Defraene, Gilles, E-mail: gilles.defraene@uzleuven.be [Radiation Oncology Department, University Hospitals Leuven, Leuven (Belgium); Van den Bergh, Laura [Radiation Oncology Department, University Hospitals Leuven, Leuven (Belgium); Al-Mamgani, Abrahim [Department of Radiation Oncology, Erasmus Medical Center - Daniel den Hoed Cancer Center, Rotterdam (Netherlands); Haustermans, Karin [Radiation Oncology Department, University Hospitals Leuven, Leuven (Belgium); Heemsbergen, Wilma [Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam (Netherlands); Van den Heuvel, Frank [Radiation Oncology Department, University Hospitals Leuven, Leuven (Belgium); Lebesque, Joos V. [Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam (Netherlands)

    2012-03-01

    Purpose: To study the impact of clinical predisposing factors on rectal normal tissue complication probability modeling using the updated results of the Dutch prostate dose-escalation trial. Methods and Materials: Toxicity data of 512 patients (conformally treated to 68 Gy [n = 284] and 78 Gy [n = 228]) with complete follow-up at 3 years after radiotherapy were studied. Scored end points were rectal bleeding, high stool frequency, and fecal incontinence. Two traditional dose-based models (Lyman-Kutcher-Burman (LKB) and Relative Seriality (RS) and a logistic model were fitted using a maximum likelihood approach. Furthermore, these model fits were improved by including the most significant clinical factors. The area under the receiver operating characteristic curve (AUC) was used to compare the discriminating ability of all fits. Results: Including clinical factors significantly increased the predictive power of the models for all end points. In the optimal LKB, RS, and logistic models for rectal bleeding and fecal incontinence, the first significant (p = 0.011-0.013) clinical factor was 'previous abdominal surgery.' As second significant (p = 0.012-0.016) factor, 'cardiac history' was included in all three rectal bleeding fits, whereas including 'diabetes' was significant (p = 0.039-0.048) in fecal incontinence modeling but only in the LKB and logistic models. High stool frequency fits only benefitted significantly (p = 0.003-0.006) from the inclusion of the baseline toxicity score. For all models rectal bleeding fits had the highest AUC (0.77) where it was 0.63 and 0.68 for high stool frequency and fecal incontinence, respectively. LKB and logistic model fits resulted in similar values for the volume parameter. The steepness parameter was somewhat higher in the logistic model, also resulting in a slightly lower D{sub 50}. Anal wall DVHs were used for fecal incontinence, whereas anorectal wall dose best described the other two endpoints

  18. Myasthenia Gravis Impairment Index: Responsiveness, meaningful change, and relative efficiency.

    Science.gov (United States)

    Barnett, Carolina; Bril, Vera; Kapral, Moira; Kulkarni, Abhaya V; Davis, Aileen M

    2017-12-05

    To study responsiveness and meaningful change of the Myasthenia Gravis Impairment Index (MGII) and its relative efficiency compared to other measures. We enrolled 95 patients receiving prednisone, IV immunoglobulin (IVIg), or plasma exchange (PLEX) and 54 controls. Patients were assessed with the MGII and other measures-including the Quantitative Myasthenia Gravis Score, Myasthenia Gravis Composite, and Myasthenia Gravis Activities of Daily Living-at baseline and 3-4 weeks after treatment. Statistical markers of responsiveness included between-groups and within-group differences, and we estimated the relative efficiency of the MGII compared to other measures. Patient-meaningful change was assessed with an anchor-based method, using the patient's impression of change. We determined the minimal detectable change (MDC) and the minimal important difference (MID) at the group and individual level. Treated patients had a higher change in MGII scores than controls (analysis of covariance p 1 favoring the MGII. The MGII demonstrated responsiveness to prednisone, IVIg, and PLEX in patients with myasthenia. There is a differential response in ocular and generalized symptoms to type of therapy. The MGII has higher relative efficiency than comparison measures and is viable for use in clinical trials. Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

  19. Clinically Meaningful Use of Blood Tumor Markers in Oncology

    OpenAIRE

    Holdenrieder, Stefan; Pagliaro, Lance; Morgenstern, David; Dayyani, Farshid

    2016-01-01

    Before the introduction of modern imaging techniques and the recent developments in molecular diagnosis, tumor markers (TMs) were among the few available diagnostic tools for the management of cancer patients. Easily obtained from serum or plasma samples, TMs are minimally invasive and convenient, and the associated costs are low. Single TMs were traditionally used but these have come under scrutiny due to their low sensitivity and specificity when used, for example, in a screening setting. H...

  20. Towards a mathematical theory of meaningful communication

    Science.gov (United States)

    Corominas-Murtra, Bernat; Fortuny, Jordi; Solé, Ricard V.

    2014-04-01

    Meaning has been left outside most theoretical approaches to information in biology. Functional responses based on an appropriate interpretation of signals have been replaced by a probabilistic description of correlations between emitted and received symbols. This assumption leads to potential paradoxes, such as the presence of a maximum information associated to a channel that creates completely wrong interpretations of the signals. Game-theoretic models of language evolution and other studies considering embodied communicating agents show that the correct (meaningful) match resulting from agent-agent exchanges is always achieved and natural systems obviously solve the problem correctly. Inspired by the concept of duality of the communicative sign stated by the swiss linguist Ferdinand de Saussure, here we present a complete description of the minimal system necessary to measure the amount of information that is consistently decoded. Several consequences of our developments are investigated, such as the uselessness of a certain amount of information properly transmitted for communication among autonomous agents.

  1. Creating Visual Design and Meaningful Audience Experiences

    DEFF Research Database (Denmark)

    Steijn, Arthur; Ion Wille, Jakob

    2014-01-01

    The main purpose of the EU Interreg funded Classical Composition Music and Experience Design project, was to rethink audience experiences and develop knowledge of applied technologies connected to classical music and live concerts. The project and its main objectives was motivated by at least thee...... conditions. The most important being 1) the development in new technology creating new expectations in audiences attending cultural events, including classical concerts, 2) resent decline in audiences attending classical music and 3) a will to strengthen relations between cultural institutions, creative...... businesses and educational institutions in the Øresund region (including the city and surroundings of Malmø and Copenhagen). Therefore the project Classical Composition Music and Experience Design focused on developing new and meaningful audience experiences where live classical music meets new digital...

  2. Meaningful Academic Work as Praxis in Emergence

    Directory of Open Access Journals (Sweden)

    Keijo Räsänen

    2008-01-01

    Full Text Available The managerial form of university governance has changed the conditions of academic work in many countries. While some academics consider this a welcome development, others experience it as a threat to their autonomy and to the meaningfulness of their work. This essay suggests a stance in response to the current conditions that should serve especially the latter group of academics. The claim is that by approaching academic work as a potential praxis in emergence, it is possible to appreciate local, autonomous activity in renewing academic work. Even if such efforts remain difficult, dispersed in space, discontinuous in time, and incomplete, they may provide a sense of direction and keep up hope. The conception of praxis is a way of articulating the mission of such efforts; simultaneously, it is also a way of defining an epistemic object for research on academic work.

  3. Challenges in the Clinical Application of the American Society of Clinical Oncology Value Framework: A Medicare Cost-Benefit Analysis in Chronic Lymphocytic Leukemia.

    Science.gov (United States)

    Seymour, Erlene K; Schiffer, Charles A; de Souza, Jonas A

    2017-12-01

    The ASCO Value Framework calculates the value of cancer therapies. Given costly novel therapeutics for chronic lymphocytic leukemia, we used the framework to compare net health benefit (NHB) and cost within Medicare of all regimens listed in the National Comprehensive Cancer Network (NCCN) guidelines. The current NCCN guidelines for chronic lymphocytic leukemia were reviewed. All referenced studies were screened, and only randomized controlled prospective trials were included. The revised ASCO Value Framework was used to calculate NHB. Medicare drug pricing was used to calculate the cost of therapies. Forty-nine studies were screened. The following observations were made: only 10 studies (20%) could be evaluated; when comparing regimens studied against the same control arm, ranking NHB scores were comparable to their preference in guidelines; NHB scores varied depending on which variables were used, and there were no clinically validated thresholds for low or high values; treatment-related deaths were not weighted in the toxicity scores; and six of the 10 studies used less potent control arms, ranked as the least-preferred NCCN-recommended regimens. The ASCO Value Framework is an important initial step to quantify value of therapies. Essential limitations include the lack of clinically relevant validated thresholds for NHB scores and lack of incorporation of grade 5 toxicities/treatment-related mortality into its methodology. To optimize its application for clinical practice, we urge investigators/sponsors to incorporate and report the required variables to calculate the NHB of regimens and encourage trials with stronger comparator arms to properly quantify the relative value of therapies.

  4. 21 CFR 50.53 - Clinical investigations involving greater than minimal risk and no prospect of direct benefit to...

    Science.gov (United States)

    2010-04-01

    ... minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable... minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable... intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or...

  5. Sweeping the Floor or Putting a Man on the Moon: How to Define and Measure Meaningful Work.

    Science.gov (United States)

    Both-Nwabuwe, Jitske M C; Dijkstra, Maria T M; Beersma, Bianca

    2017-01-01

    Meaningful work is integral to well-being and a flourishing life. The construct of "meaningful work" is, however, consistently affected by conceptual ambiguity. Although there is substantial support for arguments to maintain the status of conceptual ambiguity, we make a case for the benefits of having consensus on a definition and scale of meaningful work in the context of paid work. The objective of this article, therefore, was twofold. Firstly, we wanted to develop a more integrative definition of meaningful work. Secondly, we wanted to establish a corresponding operationalization. We reviewed the literature on the existing definitions of meaningful work and the scales designed to measure it. We found 14 definitions of meaningful work. Based on these definitions, we identified four categories of definitions, which led us to propose an integrative and comprehensive definition of meaningful work. We identified two validated scales that were partly aligned with the proposed definition. Based on our review, we conclude that scholars in this field should coalesce rather than diverge their efforts to conceptualize and measure meaningful work.

  6. Pleiotropic benefit of monomeric and oligomeric flavanols on vascular health--a randomized controlled clinical pilot study.

    Directory of Open Access Journals (Sweden)

    Antje R Weseler

    integrative multi-biomarker approach unveiled the pleiotropic vascular health benefit of an 8 weeks supplementation with 200 mg/d MOF in humans. TRIAL REGISTRATION: ClinicalTrials.gov NCT00742287.

  7. The Near-Term Viability and Benefits of eLabels for Patients, Clinical Sites, and Sponsors.

    Science.gov (United States)

    Smith-Gick, Jodi; Barnes, Nicola; Barone, Rocco; Bedford, Jeff; James, Jason R; Reisner, Stacy Frankovitz; Stephenson, Michael

    2018-01-01

    Current clinical trial labels are designed primarily to meet regulatory requirements. These labels have low patient and site utility, few are opened, and they have limited space and small fonts. As our world transitions from paper to electronic, an opportunity exists to provide patients with information about their investigational clinical trial product in a way that is more easily accessible, meets Health Authority requirements, and provides valuable additional information for the patient and caregiver. A TransCelerate initiative was launched to understand the current regulatory and technology landscape for the potential use an electronic label (eLabel) for investigational medicinal products (IMPs). Concepts and an example proof of concept were developed intended to show the "art of the possible" for a foundational eLabel and a "universal printed label." In addition, possible patient-centric enhancements were captured in the eLabel proof of concept. These concepts were shared with Health Authorities as well as patient and site advisory groups to gather feedback and subsequently enhance the concepts. Feedback indicated that the concept of an eLabel provides value and concepts should continue to be pursued. While the Health Authorities engaged with did not express issues with the use of an eLabel per se, the reduction in the content on the paper label is not possible in some geographic locations due to existing regulations. There is nothing that prevents transmitting the label electronically in conjunction with current conventional labeling. While there are still some regulatory barriers that need to be addressed for reducing what is on the paper label, advancement toward a more patient-centric approach benefits stakeholders and will enable a fully connected patient-centric experience. The industry must start now to build the foundation.

  8. Addition of meloxicam to the treatment of bovine clinical mastitis results in a net economic benefit to the dairy farmer.

    Science.gov (United States)

    van Soest, Felix J S; Abbeloos, Elke; McDougall, Scott; Hogeveen, Henk

    2018-04-01

    Recently, it has been shown that the addition of meloxicam to standard antimicrobial therapy for clinical mastitis (CM) improves the conception rate of dairy cows contracting CM in the first 120 d in milk. The objective of our study was to assess whether this improved reproduction through additional treatment with meloxicam would result in a positive net economic benefit for the farmer. We developed a stochastic bio-economic simulation model, in which a dairy cow with CM in the first 120 d in milk was simulated. Two scenarios were simulated in which CM cases were treated with meloxicam in conjunction with antimicrobial therapy or with antimicrobial therapy alone. The scenarios differed for conception rates (31% with meloxicam or 21% without meloxicam) and for the cost of CM treatment. Sensitivity analyses were undertaken for the biological and economic components of the model to assess the effects of a wide range of inputs on inferences about the cost effectiveness of meloxicam treatment. Model results showed an average net economic benefit of €42 per CM case per year in favor of the meloxicam scenario. Cows in the no-meloxicam treatment scenario had higher returns on milk production, lower costs upon calving, and reduced costs of treatment. However, these did not outweigh the savings associated with lower feed intake, reduced number of inseminations, and the reduced culling rate. The net economic benefit favoring meloxicam therapy was a consequence of the better reproductive performance in the meloxicam scenario in which cows had a shorter calving to conception interval (132 vs. 143 d), a shorter intercalving interval (405 vs. 416 d), and fewer inseminations per conception (2.9 vs. 3.7) compared with cows in the no-meloxicam treatment scenario. This resulted in a shorter lactation, hence a lower lactational milk production (8,441 vs. 8,517 kg per lactation) with lower feeding costs in the meloxicam group. A lower culling rate (12 vs. 25%) resulted in lower

  9. Benefit and outcome of using temozolomide-based chemoradiotherapy followed by temozolomide alone for glioblastoma in clinical practice.

    Science.gov (United States)

    Salma, Svetlana; Djan, Igor; Bjelan, Mladen; Vulekovic, Petar; Novakovic, Mico; Vidovic, Vladimir; Lucic, Milos

    2017-01-01

    Temozolomide (TEM), an oral alkylating agent, has shown promising activity in the last 10 years in the treatment of glioblastoma multiforme (GBM). Our goal was to show the benefit of concomitant therapy involving 3D conformal radiotherapy and temozolomide in clinical practice. This was a retrospective/prospective study and included a total of 113 patients with GBM diagnosis. Forty- seven patients received postoperative radiotherapy and 66 received concomitant temozolomide plus 3D conformal radiotherapy. The mean overall survival of patients who received postoperative radiotherapy alone was 9.93±6.475 months, compared to statistically longer overall survival in the group of patients who received radiotherapy plus temozolomide (13.89±8.049 months) (p=0.006). The latter group was divided into two subgroups, one consisting of patients who received 6 complete cycles of temozolomide, and a second with patients who received incomplete treatment. Statistically significant longer overall survival was registered in the first subgroup compared to the second (p=0.006). The concomitant usage of temozolomide and radiotherapy was beneficial, and statistically significant difference among groups and subgroups was observed regarding overall survival.

  10. Clinical benefit, complication patterns and cost effectiveness of laser in situ keratomileusis (LASIK) in moderate myopia: results of independent meta analyses on clinical outcome and postoperative complication profiles.

    Science.gov (United States)

    Lamparter, J; Dick, H B; Krummenauer, Frank

    2005-09-12

    Laser in situ keratomileusis (LASIK) means a patient investment of 2426 Euro per eye, which usually cannot be funded by European health care insurers. In the context of recent resource allocation discussions, however, the cost effectiveness of LASIK could become an important indication of allocation decisions. Therefore an evidence based estimation of its incremental cost effectiveness was intended. Three independent meta analyses were implemented to estimate the refractive gain (dpt) due to conventional LASIK procedures as well as the predictability of the latter (%) (fraction of eyes achieving a postoperative refraction with maximum deviation of +/- 0.5 dpt from the target refraction). Study reports of 1995 - 2004 (English or German language) were screened for appropriate key words. Meta effects in refractive gain and predictability were estimated by means and standard deviations of reported effect measures. Cost data were estimated by German DRG rates and individual clinical pathway calculations; cost effectiveness was then computed in terms of the incremental cost effectiveness ratio (ICER) for both clinical benefit endpoints. A sensitivity analysis comprised cost variations of +/- 10 % and utility variations alongside the meta effects' 95% confidence intervals. Total direct costs from the patients' perspective were estimated at 2426 Euro per eye, associated with a refractive meta benefit of 5.93 dpt (95% meta confidence interval 5.32 - 6.54 dpt) and a meta predictability of 67% (43% - 91%). In terms of incremental costs, the unilateral LASIK implied a patient investion of 409 Euro (sensitivity range 351 - 473 Euro) per gained refractive unit or 36 Euro (27 - 56 Euro) per gained percentage point in predictability. When LASIK associated complication patterns were considered, the total direct costs amounted up to 3075 Euro, resulting in incremental costs of 519 Euro / dpt (sensitivity range 445 - 600 Euro / dpt) or 46 Euro / % (34 - 72 Euro / %). Most frequently

  11. A randomized clinical trial of high-dosage coenzyme Q10 in early Parkinson disease: no evidence of benefit.

    Science.gov (United States)

    Beal, M Flint; Oakes, David; Shoulson, Ira; Henchcliffe, Claire; Galpern, Wendy R; Haas, Richard; Juncos, Jorge L; Nutt, John G; Voss, Tiffini Smith; Ravina, Bernard; Shults, Clifford M; Helles, Karen; Snively, Victoria; Lew, Mark F; Griebner, Brian; Watts, Arthur; Gao, Shan; Pourcher, Emmanuelle; Bond, Louisette; Kompoliti, Katie; Agarwal, Pinky; Sia, Cherissa; Jog, Mandar; Cole, Linda; Sultana, Munira; Kurlan, Roger; Richard, Irene; Deeley, Cheryl; Waters, Cheryl H; Figueroa, Angel; Arkun, Ani; Brodsky, Matthew; Ondo, William G; Hunter, Christine B; Jimenez-Shahed, Joohi; Palao, Alicia; Miyasaki, Janis M; So, Julie; Tetrud, James; Reys, Liza; Smith, Katharine; Singer, Carlos; Blenke, Anita; Russell, David S; Cotto, Candace; Friedman, Joseph H; Lannon, Margaret; Zhang, Lin; Drasby, Edward; Kumar, Rajeev; Subramanian, Thyagarajan; Ford, Donna Stuppy; Grimes, David A; Cote, Diane; Conway, Jennifer; Siderowf, Andrew D; Evatt, Marian Leslie; Sommerfeld, Barbara; Lieberman, Abraham N; Okun, Michael S; Rodriguez, Ramon L; Merritt, Stacy; Swartz, Camille Louise; Martin, W R Wayne; King, Pamela; Stover, Natividad; Guthrie, Stephanie; Watts, Ray L; Ahmed, Anwar; Fernandez, Hubert H; Winters, Adrienna; Mari, Zoltan; Dawson, Ted M; Dunlop, Becky; Feigin, Andrew S; Shannon, Barbara; Nirenberg, Melissa Jill; Ogg, Mattson; Ellias, Samuel A; Thomas, Cathi-Ann; Frei, Karen; Bodis-Wollner, Ivan; Glazman, Sofya; Mayer, Thomas; Hauser, Robert A; Pahwa, Rajesh; Langhammer, April; Ranawaya, Ranjit; Derwent, Lorelei; Sethi, Kapil D; Farrow, Buff; Prakash, Rajan; Litvan, Irene; Robinson, Annette; Sahay, Alok; Gartner, Maureen; Hinson, Vanessa K; Markind, Samuel; Pelikan, Melisa; Perlmutter, Joel S; Hartlein, Johanna; Molho, Eric; Evans, Sharon; Adler, Charles H; Duffy, Amy; Lind, Marlene; Elmer, Lawrence; Davis, Kathy; Spears, Julia; Wilson, Stephanie; Leehey, Maureen A; Hermanowicz, Neal; Niswonger, Shari; Shill, Holly A; Obradov, Sanja; Rajput, Alex; Cowper, Marilyn; Lessig, Stephanie; Song, David; Fontaine, Deborah; Zadikoff, Cindy; Williams, Karen; Blindauer, Karen A; Bergholte, Jo; Propsom, Clara Schindler; Stacy, Mark A; Field, Joanne; Mihaila, Dragos; Chilton, Mark; Uc, Ergun Y; Sieren, Jeri; Simon, David K; Kraics, Lauren; Silver, Althea; Boyd, James T; Hamill, Robert W; Ingvoldstad, Christopher; Young, Jennifer; Thomas, Karen; Kostyk, Sandra K; Wojcieszek, Joanne; Pfeiffer, Ronald F; Panisset, Michel; Beland, Monica; Reich, Stephen G; Cines, Michelle; Zappala, Nancy; Rivest, Jean; Zweig, Richard; Lumina, L Pepper; Hilliard, Colette Lynn; Grill, Stephen; Kellermann, Marye; Tuite, Paul; Rolandelli, Susan; Kang, Un Jung; Young, Joan; Rao, Jayaraman; Cook, Maureen M; Severt, Lawrence; Boyar, Karyn

    2014-05-01

    Coenzyme Q10 (CoQ10), an antioxidant that supports mitochondrial function, has been shown in preclinical Parkinson disease (PD) models to reduce the loss of dopamine neurons, and was safe and well tolerated in early-phase human studies. A previous phase II study suggested possible clinical benefit. To examine whether CoQ10 could slow disease progression in early PD. A phase III randomized, placebo-controlled, double-blind clinical trial at 67 North American sites consisting of participants 30 years of age or older who received a diagnosis of PD within 5 years and who had the following inclusion criteria: the presence of a rest tremor, bradykinesia, and rigidity; a modified Hoehn and Yahr stage of 2.5 or less; and no anticipated need for dopaminergic therapy within 3 months. Exclusion criteria included the use of any PD medication within 60 days, the use of any symptomatic PD medication for more than 90 days, atypical or drug-induced parkinsonism, a Unified Parkinson's Disease Rating Scale (UPDRS) rest tremor score of 3 or greater for any limb, a Mini-Mental State Examination score of 25 or less, a history of stroke, the use of certain supplements, and substantial recent exposure to CoQ10. Of 696 participants screened, 78 were found to be ineligible, and 18 declined participation. The remaining 600 participants were randomly assigned to receive placebo, 1200 mg/d of CoQ10, or 2400 mg/d of CoQ10; all participants received 1200 IU/d of vitamin E. Participants were observed for 16 months or until a disability requiring dopaminergic treatment. The prospectively defined primary outcome measure was the change in total UPDRS score (Parts I-III) from baseline to final visit. The study was powered to detect a 3-point difference between an active treatment and placebo. The baseline characteristics of the participants were well balanced, the mean age was 62.5 years, 66% of participants were male, and the mean baseline total UPDRS score was 22.7. A total of 267 participants

  12. Brain natriuretic peptide precursor (NT-pro-BNP) levels predict for clinical benefit to sunitinib treatment in patients with metastatic renal cell carcinoma

    International Nuclear Information System (INIS)

    Papazisis, Konstantinos T; Kortsaris, Alexandros H; Kontovinis, Lukas F; Papandreou, Christos N; Kouvatseas, George; Lafaras, Christos; Antonakis, Evangelos; Christopoulou, Maria; Andreadis, Charalambos; Mouratidou, Despoina

    2010-01-01

    Sunitinib is an oral, multitargeted tyrosine kinase inhibitor that has been approved for the treatment of metastatic renal cell carcinoma. Although the majority of sunitinib-treated patients receive a clinical benefit, almost a third of the patients will not respond. Currently there is no available marker that can predict for response in these patients. We estimated the plasma levels of NT-pro-BNP (the N-terminal precursor of brain natriuretic peptide) in 36 patients that were treated with sunitinib for metastatic clear-cell renal carcinoma. From the 36 patients, 9 had progressive disease and 27 obtained a clinical benefit (objective response or disease stabilization). Increases in plasma NT-pro-BNP were strongly correlated to clinical outcome. Patients with disease progression increased plasma BNP at statistically significant higher levels than patients that obtained a clinical benefit, and this was evident from the first 15 days of treatment (a three-fold increase in patients with progressive disease compared to stable NT-pro-BNP levels in patients with clinical benefit, p < 0.0001). Median progression-free survival was 12.0 months in patients with less than 1.5 fold increases (n = 22) and 3.9 months in patients with more than 1.5 fold increases in plasma NT-pro-BNP (n = 13) (log-rank test, p = 0.001). This is the first time that a potential 'surrogate marker' has been reported with such a clear correlation to clinical benefit at an early time of treatment. Due to the relative small number of accessed patients, this observation needs to be further addressed on larger cohorts. More analyses, including multivariate analyses are needed before such an observation can be used in clinical practice

  13. Economic Cost of Ovine Johne’s Disease in Clinically Affected New Zealand Flocks and Benefit-Cost of Vaccination

    Science.gov (United States)

    Gautam, Milan; Anderson, Peter; Ridler, Anne; Wilson, Peter; Heuer, Cord

    2018-01-01

    The aims of this study were to estimate the on-fam economic cost of ovine Johne’s disease (OJD) based on collected incidence and mortality data, and the benefit-cost of OJD vaccination in typical OJD affected flocks in New Zealand after having vaccinated for a number of years. Owners of 20 sheep breeding and finishing farms known to be clinically affected by ovine Johne’s disease in New Zealand participated in the study and were monitored for up to two years. Farms were categorized as fine-wool (Merino, Half-Bred, Corriedale, n = 15), and other breeds (Romney, composite breeds, n = 5). Ovine JD was confirmed by gross- and histo-pathology in 358 ewes culled due to chronic progressive wasting. An additional 228 ewes with low body condition score (BCS), but not targeted for culling, were tested with ELISA to estimate the proportion of OJD in ewes in the lower 5% BCS of the flock. Calculations were done separately for fine-wool and other breeds. Based on the data, mortality due to OJD, its associated cost and the benefit-cost of vaccination were evaluated for a hypothetical farm with 2000 ewes by stochastic simulation. Total ewe mortality was similar in fine-wool and other breeds, but the estimated mortality due to OJD was 2.7 times as high in fine-wool (median 1.8%, interquartile range IQR 1.2–2.7%) than other breeds (median 0.69%, IQR 0.3–1.2%), but with large variation between farms. ELISA results demonstrated fine-wool sheep had a higher seroprevalence than other breeds (39%, 95% CI 18–61% vs. 9%, 95% CI 0–22%). Stochastic modelling indicated that the average annual cost of mortality due to OJD in a flock of 2000 ewes was NZD 13,100 (IQR 8900–18,600) in fine-wool and NZD 4300 (IQR 2200–7600) in other breeds. Vaccinating replacement lambs against OJD may be cost-effective in most flocks when the pre-vaccination annual ewe mortality due to OJD is >1%. To make the best-informed decision about vaccination it is therefore essential for farmers to

  14. Determining clinical benefits of drug-eluting coronary stents according to the population risk profile: a meta-regression from 31 randomized trials.

    Science.gov (United States)

    Moreno, Raul; Martin-Reyes, Roberto; Jimenez-Valero, Santiago; Sanchez-Recalde, Angel; Galeote, Guillermo; Calvo, Luis; Plaza, Ignacio; Lopez-Sendon, Jose-Luis

    2011-04-01

    The use of drug-eluting stents (DES) in unfavourable patients has been associated with higher rates of clinical complications and stent thrombosis, and because of that concerns about the use of DES in high-risk settings have been raised. This study sought to demonstrate that the clinical benefit of DES increases as the risk profile of the patients increases. A meta-regression analysis from 31 randomized trials that compared DES and bare-metal stents, including overall 12,035 patients, was performed. The relationship between the clinical benefit of using DES (number of patients to treat [NNT] to prevent one episode of target lesion revascularization [TLR]), and the risk profile of the population (rate of TLR in patients allocated to bare-metal stents) in each trial was evaluated. The clinical benefit of DES increased as the risk profile of each study population increased: NNT for TLR=31.1-1.2 (TLR for bare-metal stents); prisk profile of each study population, since the effect of DES in mortality, myocardial infarction, and stent thrombosis, was not adversely affected by the risk profile of each study population (95% confidence interval for β value 0.09 to 0.11, -0.12 to 0.19, and -0.03 to-0.15 for mortality, myocardial infarction, and stent thrombosis, respectively). The clinical benefit of DES increases as the risk profile of the patients increases, without affecting safety. Copyright © 2009 Elsevier Ireland Ltd. All rights reserved.

  15. A review of content-based image retrieval systems in medical applications-clinical benefits and future directions.

    Science.gov (United States)

    Müller, Henning; Michoux, Nicolas; Bandon, David; Geissbuhler, Antoine

    2004-02-01

    content-based access methods into picture archiving and communication systems (PACS) have been created. This article gives an overview of available literature in the field of content-based access to medical image data and on the technologies used in the field. Section 1 gives an introduction into generic content-based image retrieval and the technologies used. Section 2 explains the propositions for the use of image retrieval in medical practice and the various approaches. Example systems and application areas are described. Section 3 describes the techniques used in the implemented systems, their datasets and evaluations. Section 4 identifies possible clinical benefits of image retrieval systems in clinical practice as well as in research and education. New research directions are being defined that can prove to be useful. This article also identifies explanations to some of the outlined problems in the field as it looks like many propositions for systems are made from the medical domain and research prototypes are developed in computer science departments using medical datasets. Still, there are very few systems that seem to be used in clinical practice. It needs to be stated as well that the goal is not, in general, to replace text-based retrieval methods as they exist at the moment but to complement them with visual search tools.

  16. Motivational reading on education, meaningful reading realisation

    Directory of Open Access Journals (Sweden)

    Adriana Qafa

    2017-07-01

    Full Text Available In this study I will present some ideas on today’s educational practice for motivation, the realization of the meaningful reading. There is a special place for the methodical ranking of the reading process, starting in school. Main requests of this reading, consist of the deep meaning of the subject, exploration of the idea, and other elements of the subject, implementation of the technique’s rules of the expressive reading, such as breathing, voice, diction, intonation, spelling, stoppages, logical emphasizes, emotional expressions, temper, timber, gesticulations, and mimic. There is also highlighted the fact that the used method comes from the pupils’ results and depends on the capability and level of the teacher, from the programming’s scale, the tools that are put into disposition, the age and the level of the pupils, and from the environment that the teacher creates during courses. At the end there are some practical guidelines for the realization of the expressive reading in the literature subject.

  17. Meaningful Learning Moments on a Family Medicine Clerkship: When Students Are Patient Centered.

    Science.gov (United States)

    Huang, William Y; Rogers, John C; Nelson, Elizabeth A; Wright, Crystal C; Teal, Cayla R

    2016-04-01

    Reflection after patient encounters is an important aspect of clinical learning. After our medical school instituted a reflection paper assignment for all clerkships, we wanted to learn about the types of encounters that students found meaningful on a family medicine clerkship and how they impacted students' learning. Family and Community Medicine Clerkship students completed a reflection paper after the clerkship, based on guidelines that were used for all clerkship reflection papers at our medical school. Two reviewers independently organized student responses into themes and then jointly prioritized common themes and negotiated any initial differences into other themes. A total of 272 reflection papers describing an actual learning moment in patient care were submitted during the study period of January 2011--December 2012. In describing actions performed, students most frequently wrote about aspects of patient-centered care such as listening to the patient, carefully assessing the patient's condition, or giving a detailed explanation to the patient. In describing effects of those actions, students wrote about what they learned about the patient-physician interaction, the trust that patients demonstrated in them, the approval they gained from their preceptors, and the benefits they saw from their actions. An important contribution of a family medicine clerkship is the opportunity for students to further their skills in patient-centered care and realize the outcomes of providing that type of care.

  18. Community Partnerships: Pathways to Meaningful Mathematics

    Science.gov (United States)

    Bush, Sarah B.; Karp, Karen S.; Lentz, Tova; Nadler, Jennifer

    2013-01-01

    This article showcases the benefits of the alliance the authors have established during the past two years with the Barnes Foundation to add more mathematics activities to their repertoire and to integrate more art into their mathematics lessons. Recently, they decided to focus on activities at the K-grade 2 level that could be used as an on-site…

  19. Is there a clinical benefit with a smooth compensator design compared with a plunged compensator design for passive scattered protons?

    Energy Technology Data Exchange (ETDEWEB)

    Tabibian, Art A., E-mail: art.tabibian@gmail.com [University of Texas School of Allied Health-Medical Dosimetry, Houston, TX (United States); Powers, Adam; Dolormente, Keith; Oommen, Sneha; Tiwari, Akhil [University of Texas School of Allied Health-Medical Dosimetry, Houston, TX (United States); Palmer, Matt [MD Anderson Department of Radiation Oncology, Houston, TX (United States); Zhu, Xiaorong R.; Li, Heng; Sahoo, Narayan; Wisdom, Paul [MD Anderson Department of Radiation Physics, Houston, TX (United States); Velasco, Kyle [Radiation Oncology Resources, Goshen, IN (United States); Erhart, Kevin; Stanley, Henry [Decimal, Inc, Sanford, FL (United States); Nguyen, Bao-Ngoc T. [MD Anderson Department of Radiation Oncology, Houston, TX (United States)

    2015-04-01

    In proton therapy, passive scattered proton plans use compensators to conform the dose to the distal surface of the planning volume. These devices are custom made from acrylic or wax for each treatment field using either a plunge-drilled or smooth-milled compensator design. The purpose of this study was to investigate if there is a clinical benefit of generating passive scattered proton radiation treatment plans with the smooth compensator design. We generated 4 plans with different techniques using the smooth compensators. We chose 5 sites and 5 patients for each site for the range of dosimetric effects to show adequate sample. The plans were compared and evaluated using multicriteria (MCA) plan quality metrics for plan assessment and comparison using the Quality Reports [EMR] technology by Canis Lupus LLC. The average absolute difference for dosimetric metrics from the plunged-depth plan ranged from −4.7 to +3.0 and the average absolute performance results ranged from −6.6% to +3%. The manually edited smooth compensator plan yielded the best dosimetric metric, +3.0, and performance, + 3.0% compared to the plunged-depth plan. It was also superior to the other smooth compensator plans. Our results indicate that there are multiple approaches to achieve plans with smooth compensators similar to the plunged-depth plans. The smooth compensators with manual compensator edits yielded equal or better target coverage and normal tissue (NT) doses compared with the other smooth compensator techniques. Further studies are under investigation to evaluate the robustness of the smooth compensator design.

  20. Benefits of a clinical data warehouse with data mining tools to collect data for a radiotherapy trial.

    Science.gov (United States)

    Roelofs, Erik; Persoon, Lucas; Nijsten, Sebastiaan; Wiessler, Wolfgang; Dekker, André; Lambin, Philippe

    2013-07-01

    Collecting trial data in a medical environment is at present mostly performed manually and therefore time-consuming, prone to errors and often incomplete with the complex data considered. Faster and more accurate methods are needed to improve the data quality and to shorten data collection times where information is often scattered over multiple data sources. The purpose of this study is to investigate the possible benefit of modern data warehouse technology in the radiation oncology field. In this study, a Computer Aided Theragnostics (CAT) data warehouse combined with automated tools for feature extraction was benchmarked against the regular manual data-collection processes. Two sets of clinical parameters were compiled for non-small cell lung cancer (NSCLC) and rectal cancer, using 27 patients per disease. Data collection times and inconsistencies were compared between the manual and the automated extraction method. The average time per case to collect the NSCLC data manually was 10.4 ± 2.1 min and 4.3 ± 1.1 min when using the automated method (pdata collected for NSCLC and 5.3% for rectal cancer, there was a discrepancy between the manual and automated method. Aggregating multiple data sources in a data warehouse combined with tools for extraction of relevant parameters is beneficial for data collection times and offers the ability to improve data quality. The initial investments in digitizing the data are expected to be compensated due to the flexibility of the data analysis. Furthermore, successive investigations can easily select trial candidates and extract new parameters from the existing databases. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  1. Review of existing experimental approaches for the clinical evaluation of the benefits of plant food supplements on cardiovascular function.

    Science.gov (United States)

    Meoni, Paolo; Restani, Patrizia; Mancama, Dalu T

    2013-06-01

    We conducted a survey of the National Centre for Biotechnology Information (NCBI) PubMed database to identify methods most commonly used for the evaluation of the effect of plant food supplements on the cardiovascular system and their relevance to the regulatory status of these products. Particularly, our search strategy was aimed at the selection of studies concerning the clinical evaluation of the beneficial effects of the most commonly studied plant food supplements acting on the cardiovascular system. Following the screening of 3839 papers for inclusion criteria, 48 published reports were retained for this review. Most studies included in this review used a double blind controlled design, and evaluated the effect of plant food supplements on individuals affected by a disease of the cardiovascular system. The majority of the studies were found to be of low methodological quality on the Jadad scale, mainly because of inadequate reporting of adverse events and of patient withdrawals. In comparison, measures used for the evaluation of benefits included mostly cardiovascular risk factors as recommended in international guidelines and in accordance with principles laid down for the evaluation of health claims in food. The risk factors most frequently evaluated belonged to the category of "lipid function and levels", "heart function" and "blood pressure". For the absolute majority of the studies, the study period did not exceed one month. This review highlights critical factors to be considered in the design of studies evaluating the health effects of plant food supplements on the cardiovascular system. Between others, the inclusion of healthy individuals, better reporting and description of the characteristics of the product used could improve the quality and relevance of these studies.

  2. Clinical update on benefit versus risks of oral paracetamol alone or with codeine: still a good option?

    Science.gov (United States)

    Kress, Hans Georg; Untersteiner, Gerald

    2017-02-01

    After decades of worldwide use of paracetamol/acetaminophen as a popular and apparently safe prescription and over-the-counter medicine, the future role of this poorly understood analgesic has been seriously questioned by recent concerns about prenatal, cardiovascular (CV) and hepatic safety, and also about its analgesic efficacy. At the same time the usefulness of codeine in combination products has come under debate. Based on a PubMed database literature search on the terms efficacy, safety, paracetamol, acetaminophen, codeine and their combinations up to and including June 2016, this clinical update reviews the current evidence of the benefit and risks of oral paracetamol alone and with codeine for mild-to-moderate pain in adults, and compares the respective efficacy and safety profiles with those of nonsteroidal anti-inflammatory drugs (NSAIDs). Whereas there is a clear strong association of NSAID use and gastrointestinal (GI) and CV morbidity and mortality, evidence for paracetamol with and without codeine supports the recommended use even in most vulnerable individuals, such as the elderly, pregnant women, alcoholics, and compromised GI and CV patients. The controversies and widespread misconceptions about the complex hepatic metabolism and potential hepatotoxicity have been corrected by recent reviews, and paracetamol remains the first-line nonopioid analgesic in patients with liver diseases if notes of caution are applied. Due to its safety and tolerability profile paracetamol remained a first-line treatment in many international guidelines. Alone and with codeine it is a safe and effective option in adults, whilst NSAIDs are obviously less safe as alternatives, given the risk of potentially fatal GI and CV adverse effects.

  3. Intravitreal bevacizumab has initial clinical benefit lasting eight weeks in eyes with neovascular age-related macular degeneration

    Directory of Open Access Journals (Sweden)

    P William Conrad

    2008-06-01

    Full Text Available P William Conrad, David N Zacks, Mark W JohnsonDepartment of Ophthalmology and Visual Sciences, Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan, USAPurpose: To determine whether the effect of a single initial intravitreal injection of bevacizumab for neovascular age-related macular degeneration (AMD persists for 8 weeks.Methods: We reviewed the records of 25 consecutive patients with neovascular AMD treated with intravitreal bevacizumab. Patients were included (n = 15 if follow up data were available from 4 and 8 week visits after a single initial injection. Additionally, optical coherence tomography (OCT images were graded qualitatively in a masked fashion by a single reader.Results: Baseline mean visual acuity was 20/200, improving to 20/125 at 4 weeks (p = 0.0153 and 20/100 at 8 weeks (p = 0.0027. Mean central retinal thickness was 316 ± 107 µm at baseline and decreased to 223 ± 70 µm and 206 ± 45 µm at 4 and 8 weeks post-injection, respectively (p = 0.0003 and 0.0005. By masked OCT grading, macular fluid was resolved in 10/15 (66.7% and 11/15 (73.3% eyes at 4 and 8 weeks, respectively, and 3/15 (20% eyes had continued reduction in residual macular fluid between 4 and 8 weeks.Conclusions: A single initial bevacizumab injection has persistent clinical benefit lasting 8 weeks in most eyes with neovascular AMD. Results of prospective randomized studies are needed before changes in treatment regimens can be recommended.Keywords: age-related macular degeneration, bevacizumab, choroidal neovascular membrane, optical coherence tomography

  4. Benefits of a clinical data warehouse with data mining tools to collect data for a radiotherapy trial

    International Nuclear Information System (INIS)

    Roelofs, Erik; Persoon, Lucas; Nijsten, Sebastiaan; Wiessler, Wolfgang; Dekker, André; Lambin, Philippe

    2013-01-01

    Introduction: Collecting trial data in a medical environment is at present mostly performed manually and therefore time-consuming, prone to errors and often incomplete with the complex data considered. Faster and more accurate methods are needed to improve the data quality and to shorten data collection times where information is often scattered over multiple data sources. The purpose of this study is to investigate the possible benefit of modern data warehouse technology in the radiation oncology field. Material and methods: In this study, a Computer Aided Theragnostics (CAT) data warehouse combined with automated tools for feature extraction was benchmarked against the regular manual data-collection processes. Two sets of clinical parameters were compiled for non-small cell lung cancer (NSCLC) and rectal cancer, using 27 patients per disease. Data collection times and inconsistencies were compared between the manual and the automated extraction method. Results: The average time per case to collect the NSCLC data manually was 10.4 ± 2.1 min and 4.3 ± 1.1 min when using the automated method (p < 0.001). For rectal cancer, these times were 13.5 ± 4.1 and 6.8 ± 2.4 min, respectively (p < 0.001). In 3.2% of the data collected for NSCLC and 5.3% for rectal cancer, there was a discrepancy between the manual and automated method. Conclusions: Aggregating multiple data sources in a data warehouse combined with tools for extraction of relevant parameters is beneficial for data collection times and offers the ability to improve data quality. The initial investments in digitizing the data are expected to be compensated due to the flexibility of the data analysis. Furthermore, successive investigations can easily select trial candidates and extract new parameters from the existing databases

  5. SU-F-T-92: Clinical Benefit for Breast and Chest Wall Setup in Using a Breast Board

    Energy Technology Data Exchange (ETDEWEB)

    Li, S; Miyamoto, C; Serratore, D; Liang, Q; Dziemianowicz, E [Temple University Hospital, Philadelphia, PA (United States)

    2016-06-15

    Purpose: To validate benefit of using a breast board (BB) by analyzing the geometry and dosimetry changes of the regions of interest (ROIs) between CT scans with and without BB. Methods: Seven patients, two chest walls (CW) and five breasts, use BB at CT simulation and no BB at diagnostic CT were included. By using deformable image registration software (Velocity AI), diagnostic CT and planning CT were rigidly co-registered according to the thoracic cage at the target. The heart and the target were then deformedly matched and the contours of the planned ROIs were transferred to the diagnostic CT. Which were brought back to the planning CT data set though the initial rigid co-registration in order to keep the deformed ROIs redefined in the diagnostic CT. Anatomic shifts and volume changes of a ROI beyond the rigid translation were recorded and dosimetry changes to ROIs were compared with recalculated DVHs. Results: Patient setup without the BB had small but systematic heart shifts superiorly by ∼5 mm. Torso rotations in two cases moved the heart in opposite directions by ∼10 mm. The breast target volume, shape, and locations were significantly changed with arm extension over the head but not in cases with the arm extended laterally. Breast setup without BB could increase the mean dose to the heart and the maximal dose to the anterior ventricle wall by 1.1 and 6.7 Gy, respectively. Conclusion: A method for evaluation of breast setup technique is introduced and applied for patients. Results of systematic heart displacement without using the BB and the potential increase of heart doses encourage us to further investigate the current trend of not using a BB for easy setup and CT scans. Using a BB would likely increase patient sag during prolonged IMRT and real-time patient position monitoring is clinically desired.

  6. A framework to assess the value of application of formal criteria to check clinical relevance in RCTs as part of a benefit assessment strategy.

    Science.gov (United States)

    Vach, Werner; Gladstone, Beryl Primrose

    2016-01-01

    Recently, the topic of assessing clinical relevance on top of statistical significance in the analysis of randomized control trials (RCTs) has got increasing attention, in particular as part of benefit assessments. Several formal criteria to serve this purpose have been published. In this paper, we present a framework to assess the value of the application of such criteria. We propose to quantify the need for the assessment of clinical relevance by the actual risk of having accepted a benefit for a treatment with an irrelevant effect in a successful RCT. We then study how this risk can be controlled by two popular criteria based on comparing the effect estimate or the lower bound of the confidence interval with a given threshold. We further propose to quantify the impact of using formal criteria by considering the expected costs when specifying error-specific costs for each of the three possible types of errors: A benefit may be accepted for a treatment, which is actually inferior, or which is not inferior, but only implies an irrelevant improvement, or a benefit may be rejected for a treatment implying a relevant improvement. This way we can demonstrate that the impact depends on parameters which are typically not explicitly defined in the frame of benefit assessments. Depending on the values of these parameters, formal checks of clinical relevance may imply better decisions on average, but they may also imply more harm than good on average. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  7. Clinical benefits and oncologic equivalence of self-expandable metallic stent insertion for right-sided malignant colonic obstruction.

    Science.gov (United States)

    Ji, Woong Bae; Kwak, Jung Myun; Kang, Dong Woo; Kwak, Han Deok; Um, Jun Won; Lee, Sun-Il; Min, Byung-Wook; Sung, Nak Song; Kim, Jin; Kim, Seon Hahn

    2017-01-01

    The efficacy of stenting for right-sided malignant colonic obstruction is unknown. This study aimed to evaluate the safety, feasibility, and clinical benefits of self-expandable metallic stent insertion for right-sided malignant colonic obstruction. Clinical data from patients who underwent right hemicolectomy for right colon cancer from January 2006 to July 2014 at three Korea University hospitals were retrospectively reviewed. A total of 39 patients who developed malignant obstruction in the right-sided colon were identified, and their data were analyzed. Stent insertion was attempted in 16 patients, and initial technical success was achieved in 14 patients (87.5 %). No stent-related immediate complications were reported. Complete relief from obstruction was achieved in all 14 patients. Twenty-five patients, including two patients who failed stenting, underwent emergency surgery. In the stent group, 93 % (13/14) of patients underwent elective laparoscopic surgery, and only one surgery was converted to an open procedure. All patients in the emergency group underwent emergency surgery within 24 h of admission. In the emergency group, only 12 % (3/25) of patients underwent laparoscopic surgery, with one surgery converted to an open procedure. All patients in both groups underwent either laparoscopy-assisted or open right/extended right hemicolectomy with primary anastomoses as the first operation. The operative times, retrieved lymph nodes, and pathologic stage did not differ between the two groups. Postoperative hospital stay (9.4 ± 3.4 days in the stent group vs. 12.4 ± 5.9 in the emergency group, p = 0.089) and time to resume oral food intake (3.2 ± 2.1 days in the stent group vs. 5.7 ± 3.4 in the emergency group, p = 0.019) were shorter in the stent group. And there were no significant differences in disease-free survival and overall survival between the two groups. Stent insertion appears to be safe and feasible in patients with right

  8. Estimating the clinical and economic benefit associated with incremental improvements in sustained virologic response in chronic hepatitis C.

    Science.gov (United States)

    McEwan, Phil; Ward, Thomas; Bennett, Hayley; Kalsekar, Anupama; Webster, Samantha; Brenner, Michael; Yuan, Yong

    2015-01-01

    Hepatitis C virus (HCV) infection is one of the principle causes of chronic liver disease. Successful treatment significantly decreases the risk of hepatic morbidity and mortality. Current standard of care achieves sustained virologic response (SVR) rates of 40-80%; however, the HCV therapy landscape is rapidly evolving. The objective of this study was to quantify the clinical and economic benefit associated with increasing levels of SVR. A published Markov model (MONARCH) that simulates the natural history of hepatitis C over a lifetime horizon was used. Discounted and non-discounted life-years (LYs), quality-adjusted life-years (QALYs) and cost of complication management were estimated for various plausible SVR rates. To demonstrate the robustness of projections obtained, the model was validated to ten UK-specific HCV studies. QALY estimates ranged from 18.0 years for those treated successfully in fibrosis stage F0 to 7.5 years (discounted) for patients in fibrosis stage F4 who remain untreated. Predicted QALY gains per 10% improvement in SVR ranged from 0.23 (F0) to 0.64 (F4) and 0.58 (F0) to 1.35 (F4) in 40 year old patients (discounted and non-discounted results respectively). In those aged 40, projected discounted HCV-related costs are minimised with successful treatment in F0/F1 (at approximately £ 300), increasing to £ 49,300 in F4 patients who remain untreated. Validation of the model to published UK cost-effectiveness studies produce R2 goodness of fit statistics of 0.988, 0.978 and of 0.973 for total costs, QALYs and incremental cost effectiveness ratios, respectively. Projecting the long-term clinical and economic consequences associated with chronic hepatitis C is a necessary requirement for the evaluation of new treatments. The principle analysis demonstrates the significant impact on expected costs, LYs and QALYs associated with increasing SVR. A validation analysis demonstrated the robustness of the results reported.

  9. Vacuum-assisted wound closure in vascular surgery--clinical and cost benefits in a developing country.

    Science.gov (United States)

    Koncar, Igor; Cvetković, Slobodan; Dragas, Marko; Pejkić, Sinisa; Lazović, Goran; Banzić, Igor; Zuvela, Marinko; Marković, Miroslav; Davidović, Lazar

    2016-01-01

    BACKGROUND/AIM. Surgical and chronic wounds in vascular patients might contribute to limb loss and death. Vacuum-assisted closure (VAC)--Kinetic Concepts, Inc. (KCI), has been increasingly used in Western Europe and the U.S.A. clinical practice for 15 years. Advantages of this method are faster wound healing, wound approximation, lower wound related treatment costs and improved quality of life during treatment. Evidence related to the usage of VAC therapy in vascular patients and cost effectiveness of VAC therapy in a developing country are lacking. The aim of this study was to explore results of VAC therapy in vascular surgery comparing to conventional methods and to test cost effects in a developing country like Serbia. All patients with wound infection or dehiscence operated at the tertiary vascular university clinic in the period from January 2011-January 2012, were treated with VAC therapy. The primary endpoint was wound closure, while secondary endpoints were hospital stay, the number of weekly dressings, costs of wound care, working time of medical personnel. The patients were divided into groups according to the wound type and location: wound with exposed synthetic vascular implant (25%), laparotomy (13%), foot amputation (29%), major limb amputation (21%), fasciotomy (13%). The results of primary and secondary endpoint were compared with the results of conventional treatment during the previous year. There was one death (1/42, 2.38%) and one limb loss (1/12, 2.38%) in the VAC group, and 8 deaths (8/38, 21.05%) and 5 (5/38, 13.15%) limb losses in the patients treated with conventional therapy. In the VAC group there was one groin bleeding (1/12, 2.38%), one groin reinfection (1/12, 2.38%) and one resistance to therapy with a consequent limb loss. Costs of hospital stay (p VAC therapy in the group with exposed graft. VAC therapy is the effective method for care of complicated wounds in vascular surgery. Patients with infection of wound with the exposed

  10. Ambulatory and Non-Ambulatory Benefits of Lower Limb Exoskeleton Use, with and without FES, in Clinical and Community Settings

    Science.gov (United States)

    2017-10-01

    research investigates the extent to which regular walking in an exoskeleton will provide mobility, health , and recovery benefits to individuals with spinal...15. SUBJECT TERMS spinal cord injury, paraplegia, exoskeleton, physical medicine and rehabilitation, rehabilitation research, legged mobility...regular walking in an exoskeleton will provide mobility, health , and recovery benefits to individuals with spinal cord injury. The research is comprised

  11. A meaningful MESS (Medical Education Scholarship Support

    Directory of Open Access Journals (Sweden)

    Shari A. Whicker

    2016-07-01

    Full Text Available Background: Graduate medical education faculty bear the responsibility of demonstrating active research and scholarship; however, faculty who choose education-focused careers may face unique obstacles related to the lack of promotion tracks, funding, career options, and research opportunities. Our objective was to address education research and scholarship barriers by providing a collaborative peer-mentoring environment and improve the production of research and scholarly outputs. Methods: We describe a Medical Education Scholarship Support (MESS group created in 2013. MESS is an interprofessional, multidisciplinary peer-mentoring education research community that now spans multiple institutions. This group meets monthly to address education research and scholarship challenges. Through this process, we develop new knowledge, research, and scholarly products, in addition to meaningful collaborations. Results: MESS originated with eight founding members, all of whom still actively participate. MESS has proven to be a sustainable unfunded local community of practice, encouraging faculty to pursue health professions education (HPE careers and fostering scholarship. We have met our original objectives that involved maintaining 100% participant retention; developing increased knowledge in at least seven content areas; and contributing to the development of 13 peer-reviewed publications, eight professional presentations, one Masters of Education project, and one educational curriculum. Discussion: The number of individuals engaged in HPE research continues to rise. The MESS model could be adapted for use at other institutions, thereby reducing barriers HPE researchers face, providing an effective framework for trainees interested in education-focused careers, and having a broader impact on the education research landscape.

  12. The Meaningful Roles Intervention: An Evolutionary Approach to Reducing Bullying and Increasing Prosocial Behavior.

    Science.gov (United States)

    Ellis, Bruce J; Volk, Anthony A; Gonzalez, Jose-Michael; Embry, Dennis D

    2016-12-01

    Bullying is a problem that affects adolescents worldwide. Efforts to prevent bullying have been moderately successful at best, or iatrogenic at worst. We offer an explanation for this limited success by employing an evolutionary-psychological perspective to analyze antibullying interventions. We argue that bullying is a goal-directed behavior that is sensitive to benefits as well as costs, and that interventions must address these benefits. This perspective led us to develop a novel antibullying intervention, Meaningful Roles, which offers bullies prosocial alternatives-meaningful roles and responsibilities implemented through a school jobs program and reinforced through peer-to-peer praise notes-that effectively meet the same status goals as bullying behavior. We describe this new intervention and how its theoretical evolutionary roots may be applicable to other intervention programs. © 2015 The Authors. Journal of Research on Adolescence © 2015 Society for Research on Adolescence.

  13. Qualitative Insights from a Canadian Multiinstitutional Research Study: In Search of Meaningful E-learning

    OpenAIRE

    Lorraine M. Carter; Vince Salyers; Sue Myers; Carol Hipfner; Caroline Hoffart; Christa MacLean; Kathy White; Theresa Matus; Vivian Forssman; Penelope Barrett

    2014-01-01

    This paper reports the qualitative findings of a mixed methods research study conducted at three Canadian post-secondary institutions. Called the Meaningful E-learning or MEL project, the study was an exploration of the teaching and learning experiences of faculty and students as well as their perceptions of the benefits and challenges of e-learning. Importantly, e-learning was conceptualized as the integration of pedagogy, instructional technology, and the Internet into teaching ...

  14. [Quantifying the additional clinical benefit of new medicines: little - considerable - significant - 6 remarks from a biometrician's point of view].

    Science.gov (United States)

    Vach, Werner

    2014-11-01

    According to the German Pharmaceutical Market Reorganisation Act [Arzneimittelmarktneuordnungsgesetz (AMNOG)] of 22.12.2010, the benefit assessment of a new drug should include an evaluation of the "degree of additional benefit". A corresponding regulation of the German Ministry of Health states that the quantification of the degree of additional benefit should be made in the terms "major additional benefit", "considerable additional benefit" and "little additional benefit". In September 2011 the IQWiG undertook and explained in appendix A of the dossier evaluation of Ticagrelor an "operationalisation of the extent of additional benefit according to AM-NutzenV". Therein a distinction was made between the target categories "survival time (mortality)", "serious (or, respectively, severe) symptoms", "quality of life", and "not serious (or, respectively, not severe) symptoms". In the operationalisation of the IQWiG, the categorisation of the additional benefit with regard to mortality was addressed by definition of threshold values for the upper limit of the 95% confidence interval for the relative risk (RR). The statutory regulations and the operationalisation of the IQWiG will have direct long-term effects on the provision of medical care since they have a say as to which drugs are to be available at which prices. By introduction of terms such as "major additional benefit", "considerable additional benefit" or "desired effects" and linking them to statistical parameters and algorithms, they also open a series of further fundamental questions as to if and how we should handle these terms in the future and what consequences are inherent to the use of statistical criteria in their "definition". In the present article 6 of the questions that arise in this context are discussed: Can a "considerable additional benefit" be defined with statistical methods? Can a classification of the additional benefit on the basis of an estimated RR be reliable? What are the fundamental

  15. The Omaha system and meaningful use: applications for practice, education, and research.

    Science.gov (United States)

    Martin, Karen S; Monsen, Karen A; Bowles, Kathryn H

    2011-01-01

    Meaningful use has become ubiquitous in the vocabulary of health information technology. It suggests that better healthcare does not result from the adoption of technology and electronic health records, but by increasing interoperability and informing clinical decisions at the point of care. Although the initial application of meaningful use was limited to eligible professionals and hospitals, it incorporates complex processes and workflow that involve all nurses, other healthcare practitioners, and settings. The healthcare community will become more integrated, and interdisciplinary practitioners will provide enhanced patient-centered care if electronic health records adopt the priorities of meaningful use. Standardized terminologies are a necessary component of such electronic health records. The Omaha System is an exemplar of a standardized terminology that enables meaningful use of clinical data to support and improve patient-centered clinical practice, education, and research. It is user-friendly, generates data that can be shared with patients and their families, and enables healthcare providers to analyze and exchange patient-centered coded data. Use of the Omaha System is increasing steadily in diverse practice, education, and research settings nationally and internationally.

  16. Senior Benefits

    Science.gov (United States)

    Information Medicaid Public Health Centers Temporary "Cash" Assistance Senior Benefits Program GovDelivery Skip Navigation Links Health and Social Services > Public Assistance > Senior Benefits Page Content Senior Benefits Senior Benefits Logo Senior Benefits Fact Sheet - June, 2016 Reduction Information

  17. Job enrichment: creating meaningful career development opportunities for nurses.

    Science.gov (United States)

    Duffield, Christine; Baldwin, Richard; Roche, Michael; Wise, Sarah

    2014-09-01

    This paper presents an evaluation of a career development policy in South Australia which increased the number of senior staff nurse positions and provided senior registered nurses with time away from clinical duties to undertake agreed projects. We use Kanter's model of structural power and commitment theory to understand the dimensions of this policy. Development strategies for experienced staff who wish to remain at the bedside are needed, especially in smaller health services with limited opportunities for horizontal or vertical mobility. Face-to-face semistructured interviews were conducted with 54 senior staff nurses who participated in the career structure arrangements. The policy enhanced the structure of opportunity in three ways: by increasing the number of senior staff nurse positions, the ladder steps were improved; undertaking strategic projects developed new skills; and the job enrichment approach facilitated time out from the immediate pressures of ward work and challenged nurses in a different way. Through job enrichment, South Australia has found a novel way of providing meaningful career development opportunities for experienced nurses. Methods of job enrichment need to be considered as part of career development policy, especially where movement between clinical facilities is limited and staff wish to remain at the bedside. © 2013 John Wiley & Sons Ltd.

  18. Meaningfulness of Service and Marital Satisfaction in Army Couples

    Science.gov (United States)

    Bergmann, Jeffrey S.; Renshaw, Keith D.; Allen, Elizabeth S.; Markman, Howard J.; Stanley, Scott M.

    2015-01-01

    The vast numbers of military service members who have been deployed since 2001 highlights the need to better understand relationships of military couples. A unique consideration in military couples is the concept of meaningfulness of service, or the value service members and their partners place on military service in spite of the sacrifices it requires. In a sample of 606 Army couples, we used path analysis to examine how male service members’ and female spouses’ perceived meaningfulness of service added to the prediction of marital satisfaction in both members of the couple, when accounting for service members’ PTSD symptoms. Spouses’ perceived meaningfulness of service was linked with higher marital satisfaction in spouses, regardless of service member’s perceived meaningfulness of service. Service members’ perceived meaningfulness of service was also associated with increased marital satisfaction in service members, but only when their spouses also perceived higher meaningfulness. There were no significant interactions between service members’ PTSD and either partner’s perceived meaningfulness. Implications for enhanced attention to spousal perceptions of meaningfulness of service are discussed. PMID:25046347

  19. Intrinsic Value and a Meaningful Life | Audi | Philosophical Papers

    African Journals Online (AJOL)

    I distinguish various ways in which human life may be thought to be meaningful and present an account of what might be called existential meaningfulness. The account is neutral with respect to both theism and naturalism, but each is addressed in several places and the paper's main points are harmonious with certain ...

  20. Meaningfulness of service and marital satisfaction in Army couples.

    Science.gov (United States)

    Bergmann, Jeffrey S; Renshaw, Keith D; Allen, Elizabeth S; Markman, Howard J; Stanley, Scott M

    2014-10-01

    The vast numbers of military service members who have been deployed since 2001 highlights the need to better understand relationships of military couples. A unique consideration in military couples is the concept of meaningfulness of service, or the value service members and their partners place on military service in spite of the sacrifices it requires. In a sample of 606 Army couples, the authors used path analysis to examine how male service members' and female spouses' perceived meaningfulness of service added to the prediction of marital satisfaction in both members of the couple, when accounting for service members' PTSD symptoms. Spouses' perceived meaningfulness of service was linked with higher marital satisfaction in spouses, regardless of service member's perceived meaningfulness of service. Service members' perceived meaningfulness of service was also associated with increased marital satisfaction in service members, but only when their spouses also perceived higher meaningfulness. There were no significant interactions between service members' PTSD and either partner's perceived meaningfulness. Implications for enhanced attention to spousal perceptions of meaningfulness of service are discussed. (PsycINFO Database Record (c) 2014 APA, all rights reserved).

  1. Meaningful Use of Health Information Technology by Rural Hospitals

    Science.gov (United States)

    McCullough, Jeffrey; Casey, Michelle; Moscovice, Ira; Burlew, Michele

    2011-01-01

    Purpose: This study examines the current status of meaningful use of health information technology (IT) in Critical Access Hospitals (CAHs), other rural, and urban US hospitals, and it discusses the potential role of Medicare payment incentives and disincentives in encouraging CAHs and other rural hospitals to achieve meaningful use. Methods: Data…

  2. Characteristics of meaningful chemistry education - The case of water quality

    NARCIS (Netherlands)

    Westbroek, Hanna Barbara

    2005-01-01

    This thesis addresses the question of how to involve students in meaningful chemistry education by a proper implementation of three characteristics of meaningful: a context, a need-to-know approach and attention for student input. The characteristics were adopted as solution strategies for

  3. Relationship between meaningful work and job performance in nurses.

    Science.gov (United States)

    Tong, Ling

    2018-04-01

    The present study was designed to determine the relationship between meaningful work and job performance, and the impact of meaningful work on nursing care quality. Meaningful work has been suggested as a significant factor affecting job performance, but the relationship has never been studied in nurses in China. A descriptive correlational study was designed to assess the level of meaningful work, tasks, and contextual performance as well as their relationships. We used a stratified random-sampling approach to enrol nurses from hospitals. Multivariate regression analysis was applied to determine the relationship between meaningful work and their demographic data. There were significant, positive relationships between meaningful work and task performance and contextual performance. Education level, work unit, and employment type influenced meaningful work. The work motivation score of the nurses was lower than that of the other 2 dimensions, and a negative work motivation score negatively influenced job performance. Improving meaningful work and providing more support and assistance could improve nurse performance, thereby improving the quality of nursing care. © 2018 John Wiley & Sons Australia, Ltd.

  4. Self-Determination and Meaningful Work: Exploring Socioeconomic Constraints

    Directory of Open Access Journals (Sweden)

    Blake A Allan

    2016-02-01

    Full Text Available This study examined a model of meaningful work among a diverse sample of working adults. From the perspectives of Self-Determination Theory and the Psychology of Working Framework, we tested a structural model with social class and work volition predicting SDT motivation variables, which in turn predicted meaningful work. Partially supporting hypotheses, work volition was positively related to internal regulation and negatively related to amotivation, whereas social class was positively related to external regulation and amotivation. In turn, internal regulation was positively related to meaningful work, whereas external regulation and amotivation were negatively related to meaningful work. Indirect effects from work volition to meaningful work via internal regulation and amotivation were significant, and indirect effects from social class to meaningful work via external regulation and amotivaiton were significant. This study highlights the important relations between SDT motivation variables and meaningful work, especially the large positive relation between internal regulation and meaningful work. However, results also reveal that work volition and social class may play critical roles in predicting internal regulation, external regulation, and amotivation.

  5. Self-Determination and Meaningful Work: Exploring Socioeconomic Constraints.

    Science.gov (United States)

    Allan, Blake A; Autin, Kelsey L; Duffy, Ryan D

    2016-01-01

    This study examined a model of meaningful work among a diverse sample of working adults. From the perspectives of Self-Determination Theory and the Psychology of Working Framework, we tested a structural model with social class and work volition predicting SDT motivation variables, which in turn predicted meaningful work. Partially supporting hypotheses, work volition was positively related to internal regulation and negatively related to amotivation, whereas social class was positively related to external regulation and amotivation. In turn, internal regulation was positively related to meaningful work, whereas external regulation and amotivation were negatively related to meaningful work. Indirect effects from work volition to meaningful work via internal regulation and amotivation were significant, and indirect effects from social class to meaningful work via external regulation and amotivation were significant. This study highlights the important relations between SDT motivation variables and meaningful work, especially the large positive relation between internal regulation and meaningful work. However, results also reveal that work volition and social class may play critical roles in predicting internal regulation, external regulation, and amotivation.

  6. Meaningful work and secondary school teachers' intention to leave ...

    African Journals Online (AJOL)

    The following measuring instruments were used: Work-role Fit Scale, Job Enrichment Scale, Co-worker and Supervisor Relationships Scales, Psychological Meaningfulness Scale and Turnover Intention Scale. Work-role fit and job enrichment both had direct positive effect on experiences of psychological meaningfulness at ...

  7. Between order and chaos: The quest for meaningful information

    NARCIS (Netherlands)

    Adriaans, P.

    2009-01-01

    The notion of meaningful information seems to be associated with the sweet spot between order and chaos. This form of meaningfulness of information, which is primarily what science is interested in, is not captured by both Shannon information and Kolmogorov complexity. In this paper I develop a

  8. Meaningful spatial and temporal sequences of activities in dwelling

    NARCIS (Netherlands)

    Hematalikeikha, M.A.; Coolen, H.C.C.H.; Pourdeihimi, S.

    2014-01-01

    Human activities based on human needs are affected by affordances and meanings that occur in the dwelling. Activities over time and space have meaningful sequences. The meaningfulness of activities in the cultural framework is conditioned by its special temporality and spatiality. Also, temporal or

  9. Meaningful work and secondary school teachers' intention to leave

    Directory of Open Access Journals (Sweden)

    M. Janik

    2015-05-01

    Full Text Available The study investigates the relations between secondary school teachers' work-role fit, job enrichment, supervisor relationships, co-worker relationships, psychological meaningfulness of work and intention to leave. A cross-sectional survey was used. The participants were 502 secondary school teachers in Namibia. The following measuring instruments were used: Work-role Fit Scale, Job Enrichment Scale, Co-worker and Supervisor Relationships Scales, Psychological Meaningfulness Scale and Turnover Intention Scale. Work-role fit and job enrichment both had direct positive effect on experiences of psychological meaningfulness at work, while poor work-role fit and low psychological meaningfulness both had a direct effect on teachers' intentions to leave. An analysis of the indirect effects showed that poor work-role fit and poor job enrichment affected intention to leave due to the concomitant experience of low psychological meaningfulness. These findings have implications for the retention of teachers in secondary schools.

  10. ON THE DERIVATIVE OF SMOOTH MEANINGFUL FUNCTIONS

    Directory of Open Access Journals (Sweden)

    Sanjo Zlobec

    2011-02-01

    Full Text Available The derivative of a function f in n variables at a point x* is one of the most important tools in mathematical modelling. If this object exists, it is represented by the row n-tuple f(x* = [∂f/∂xi(x*] called the gradient of f at x*, abbreviated: “the gradient”. The evaluation of f(x* is usually done in two stages, first by calculating the n partials and then their values at x = x*. In this talk we give an alternative approach. We show that one can characterize the gradient without differentiation! The idea is to fix an arbitrary row n-tuple G and answer the following question: What is a necessary and sufficient condition such that G is the gradient of a given f at a given x*? The answer is given after adjusting the quadratic envelope property introduced in [3]. We work with smooth, i.e., continuously differentiable, functions with a Lipschitz derivative on a compact convex set with a non-empty interior. Working with this class of functions is not a serious restriction. In fact, loosely speaking, “almost all” smooth meaningful functions used in modelling of real life situations are expected to have a bounded “acceleration” hence they belong to this class. In particular, the class contains all twice differentiable functions [1]. An important property of the functions from this class is that every f can be represented as the difference of some convex function and a convex quadratic function. This decomposition was used in [3] to characterize the zero derivative points. There we obtained reformulations and augmentations of some well known classic results on optimality such as Fermats extreme value theorem (known from high school and the Lagrange multiplier theorem from calculus [2, 3]. In this talk we extend the results on zero derivative points to characterize the relation G = f(x*, where G is an arbitrary n-tuple. Some special cases: If G = O, we recover the results on zero derivative points. For functions of a single

  11. “They put you on your toes”: Physical Therapists' Perceived Benefits from and Barriers to Supervising Students in the Clinical Setting

    Science.gov (United States)

    Hanna, Elizabeth; Cott, Cheryl

    2011-01-01

    ABSTRACT Purpose: To identify the perceived benefits of and barriers to clinical supervision of physical therapy (PT) students. Method: In this qualitative descriptive study, three focus groups and six key-informant interviews were conducted with clinical physical therapists or administrators working in acute care, orthopaedic rehabilitation, or complex continuing care. Data were coded and analyzed for common ideas using a constant comparison approach. Results: Perceived barriers to supervising students tended to be extrinsic: time and space constraints, challenging or difficult students, and decreased autonomy or flexibility for the clinical physical therapists. Benefits tended to be intrinsic: teaching provided personal gratification by promoting reflective practice and exposing clinical educators to current knowledge. The culture of different health care institutions was an important factor in therapists' perceptions of student supervision. Conclusions: Despite different disciplines and models of supervision, there is considerable synchronicity in the issues reported by physical therapists and other disciplines. Embedding the value of clinical teaching in the institution, along with strong communication links among academic partners, institutions, and potential clinical faculty, may mitigate barriers and increase the commitment and satisfaction of teaching staff. PMID:22379263

  12. Community-based medical education: is success a result of meaningful personal learning experiences?

    Science.gov (United States)

    Kelly, Len; Walters, Lucie; Rosenthal, David

    2014-01-01

    Community-based medical education (CBME) is the delivery of medical education in a specific social context. Learners become a part of social and medical communities where their learning occurs. Longitudinal integrated clerkships (LICs) are year-long community-based placements where the curriculum and clinical experience is typically delivered by primary care physicians. These programs have proven to be robust learning environments, where learners develop strong communication skills and excellent clinical reasoning. To date, no learning model has been offered to describe CBME. The characteristics of CBME are explored by the authors who suggest that the social and professional context provided in small communities enhances medical education. The authors postulate that meaningfulness is engendered by the authentic context, which develops over time. These relationships with preceptors, patients and the community provide meaningfulness, which in turn enhances learning. The authors develop a novel learning model. They propose that the context-rich environment of CBME allows for meaningful relationships and experiences for students and that such meaningfulness enhances learning.

  13. "Meaningful use" of electronic health records and its relevance to laboratories and pathologists

    Directory of Open Access Journals (Sweden)

    Walter H Henricks

    2011-01-01

    Full Text Available Electronic health records (EHRs have emerged as a major topic in health care and are central to the federal government′s strategy for transforming healthcare delivery in the United States. Recent federal actions that aim to promote the use of EHRs promise to have significant implications for laboratories and for pathology practices. Under the HITECH (Health Information Technology Economic and Clinical Health Act, an EHR incentive program has been established through which individual physicians and hospitals can qualify to receive incentive payments if they achieve "meaningful use" of "certified" EHR technology. The rule also establishes payment penalties in future years for eligible providers who have not met the requirements for meaningful use of EHRs. Meaningful use must be achieved using EHR technology that has been certified in accordance with functional and technical criteria that are set forth a regulation that parallels the meaningful use criteria in the incentive program. These actions and regulations are important to laboratories and pathologists for a number of reasons. Several of the criteria and requirements in the meaningful use rules and EHR certification criteria relate directly or indirectly to laboratory testing and laboratory information management, and future stage requirements are expected to impact the laboratory as well. Furthermore, as EHR uptake expands, there will be greater expectations for electronic interchange of laboratory information and laboratory information system (LIS-EHR interfaces. Laboratories will need to be aware of the technical, operational, and business challenges that they may face as expectations for LIS-EHR increase. This paper reviews the important recent federal efforts aimed at accelerating EHR use, including the incentive program for EHR meaningful use, provider eligibility, and EHR certification criteria, from a perspective of their relevance for laboratories and pathology practices.

  14. The Fanconi Anemia BRCA Pathway as a Predictor of Benefit from Bevacizumab in a Large Phase 3 Clinical Trial in Ovarian Cancer

    Science.gov (United States)

    2014-12-01

    1 AWARD NUMBER: W81XWH-13-1-0421 TITLE: The Fanconi Anemia BRCA Pathway as a Predictor of Benefit from Bevacizumab in a Large Phase III Clinical...DATES COVERED 30Sep2013 - 29Sep2015 4. TITLE AND SUBTITLE 5a. CONTRACT NUMBER W81XWH-13-1-0421 The Fanconi Anemia BRCA Pathway as a Predictor of...another upfront clinical trial GOG262. We found that germline or somatic mutations in the BRCA- Fanconi anemia pathway was significantly associated with

  15. Cardiovascular Magnetic Resonance Imaging-Incremental Value in a Series of 361 Patients Demonstrating Cost Savings and Clinical Benefits: An Outcome-Based Study.

    Science.gov (United States)

    Hegde, Vinayak A; Biederman, Robert Ww; Mikolich, J Ronald

    2017-01-01

    This study was designed to assess the clinical impact and cost-benefit of cardiovascular magnetic resonance imaging (CMR). In the face of current health care cost concerns, cardiac imaging modalities have come under focused review. Data related to CMR clinical impact and cost-benefit are lacking. Retrospective review of 361 consecutive patients (pts) who underwent CMR exams was conducted. Indications for CMR were tabulated for appropriateness criteria. Components of the CMR exam were identified along with evidence of clinical impact. The cost of each CMR exam was ascertained along with cost savings attributable to the CMR exam for calculation of an incremental cost-effectiveness ratio. A total of 354 of 361 pts (98%) had diagnostic quality studies. Of the 361 pts, 350 (97%) had at least 1 published Appropriateness Criterion for CMR. A significant clinical impact attributable to CMR exam results was observed in 256 of 361 pts (71%). The CMR exam resulted in a new diagnosis in 69 of 361 (27%) pts. Cardiovascular magnetic resonance imaging results avoided invasive procedures in 38 (11%) pts and prevented additional diagnostic testing in 26 (7%) pts. Comparison of health care savings using CMR as opposed to current standards of care showed a net cost savings of $833 037, ie, per patient cost savings of $2308. Cardiovascular magnetic resonance imaging provides diagnostic image quality in >98% of cases. Cardiovascular magnetic resonance imaging findings have documentable clinical impact on patient management in 71% of pts undergoing the exam, in a cost beneficial manner.

  16. Antecedents and outcomes of meaningful work among school teachers

    Directory of Open Access Journals (Sweden)

    Elmari Fouché

    2017-03-01

    Research purpose: The aim of this study was to investigate antecedents and outcomes of meaningful work among school teachers. Motivation for the study: Meaningful work underpins people’s motivation and affects their well-being and job satisfaction. Furthermore, it is a significant pathway to healthy and authentic organisations. However, a research gap exists regarding the effects of different antecedents and outcomes of meaningful work. Research approach, design and method: A cross-sectional survey was used with a convenience sample of 513 teachers. The Work-Life Questionnaire, Revised Job Diagnostic Survey, Co-worker Relations Scale, Work and Meaning Inventory, Personal Resources Scale, Work Engagement Scale, Turnover Intention Scale and a measure of self-rated performance were administered. Main findings: A calling orientation, job design and co-worker relations were associated with meaningful work. A low calling orientation and poor co-worker relationships predicted burnout. A calling orientation, a well-designed job, good co-worker relationships and meaningful work predicted work engagement. Job design was moderately associated with self-ratings of performance. The absence of a calling orientation predicted teachers’ intention to leave the organisation. Practical/managerial implications: Educational managers should consider implementing interventions to affect teachers’ calling orientation (through job crafting, perceptions of the nature of their jobs (by allowing autonomy and co-worker relations (through teambuilding to promote perceptions of meaningful work. Promoting perceptions of meaningful work might contribute to lower burnout, higher work engagement, better self-ratings of performance and retention of teachers. Contribution/value-add: This study contributes to scientific knowledge regarding the effects of three antecedents, namely a calling orientation, job design and co-worker relationships on meaningful work. It also contributed to knowledge

  17. Redefining meaningful age groups in the context of disease.

    Science.gov (United States)

    Geifman, Nophar; Cohen, Raphael; Rubin, Eitan

    2013-12-01

    Age is an important factor when considering phenotypic changes in health and disease. Currently, the use of age information in medicine is somewhat simplistic, with ages commonly being grouped into a small number of crude ranges reflecting the major stages of development and aging, such as childhood or adolescence. Here, we investigate the possibility of redefining age groups using the recently developed Age-Phenome Knowledge-base (APK) that holds over 35,000 literature-derived entries describing relationships between age and phenotype. Clustering of APK data suggests 13 new, partially overlapping, age groups. The diseases that define these groups suggest that the proposed divisions are biologically meaningful. We further show that the number of different age ranges that should be considered depends on the type of disease being evaluated. This finding was further strengthened by similar results obtained from clinical blood measurement data. The grouping of diseases that share a similar pattern of disease-related reports directly mirrors, in some cases, medical knowledge of disease-age relationships. In other cases, our results may be used to generate new and reasonable hypotheses regarding links between diseases.

  18. Qualitative Insights from a Canadian Multi-Institutional Research Study: In Search of Meaningful E-Learning

    Science.gov (United States)

    Carter, Lorraine M.; Salyers, Vince; Myers, Sue; Hipfner, Carol; Hoffart, Caroline; MacLean, Christa; White, Kathy; Matus, Theresa; Forssman, Vivian; Barrett, Penelope

    2014-01-01

    This paper reports the qualitative findings of a mixed methods research study conducted at three Canadian post-secondary institutions. Called the Meaningful E-learning or MEL project, the study was an exploration of the teaching and learning experiences of faculty and students as well as their perceptions of the benefits and challenges of…

  19. Are there long-term benefits in following stable heart failure patients in a heart failure clinic?

    DEFF Research Database (Denmark)

    Leetmaa, Tina; Villadsen, Henrik; Mikkelsen, Kirsten

    2008-01-01

    Objectives and Design. This study describes the long-term outcome of 163 patients with stable mild to moderate heart failure (NYHA II-III), who already were enrolled in a heart failure clinic and now were randomized to continued follow-up in the heart failure (HF) clinic or else to usual care (UC...

  20. Cost-benefit assessment of using electronic health records data for clinical research versus current practices: Contribution of the Electronic Health Records for Clinical Research (EHR4CR) European Project.

    Science.gov (United States)

    Beresniak, Ariel; Schmidt, Andreas; Proeve, Johann; Bolanos, Elena; Patel, Neelam; Ammour, Nadir; Sundgren, Mats; Ericson, Mats; Karakoyun, Töresin; Coorevits, Pascal; Kalra, Dipak; De Moor, Georges; Dupont, Danielle

    2016-01-01

    The widespread adoption of electronic health records (EHR) provides a new opportunity to improve the efficiency of clinical research. The European EHR4CR (Electronic Health Records for Clinical Research) 4-year project has developed an innovative technological platform to enable the re-use of EHR data for clinical research. The objective of this cost-benefit assessment (CBA) is to assess the value of EHR4CR solutions compared to current practices, from the perspective of sponsors of clinical trials. A CBA model was developed using an advanced modeling approach. The costs of performing three clinical research scenarios (S) applied to a hypothetical Phase II or III oncology clinical trial workflow (reference case) were estimated under current and EHR4CR conditions, namely protocol feasibility assessment (S1), patient identification for recruitment (S2), and clinical study execution (S3). The potential benefits were calculated considering that the estimated reduction in actual person-time and costs for performing EHR4CR S1, S2, and S3 would accelerate time to market (TTM). Probabilistic sensitivity analyses using Monte Carlo simulations were conducted to manage uncertainty. Should the estimated efficiency gains achieved with the EHR4CR platform translate into faster TTM, the expected benefits for the global pharmaceutical oncology sector were estimated at €161.5m (S1), €45.7m (S2), €204.5m (S1+S2), €1906m (S3), and up to €2121.8m (S1+S2+S3) when the scenarios were used sequentially. The results suggest that optimizing clinical trial design and execution with the EHR4CR platform would generate substantial added value for pharmaceutical industry, as main sponsors of clinical trials in Europe, and beyond. Copyright © 2015 Elsevier Inc. All rights reserved.

  1. Enhancing the Meaningfulness of Work for Astronauts on Long Duration Space Exploration Missions.

    Science.gov (United States)

    Britt, Thomas W; Sytine, Anton; Brady, Ashley; Wilkes, Russ; Pittman, Rebecca; Jennings, Kristen; Goguen, Kandice

    2017-08-01

    Numerous authors have identified the stressors likely to be encountered on long duration space exploration missions (e.g., to Mars), including the possibility of significant crises, separation from family, boredom/monotony, and interpersonal conflict. Although many authors have noted that meaningful work may be beneficial for astronauts on these missions, none have detailed the sources of meaningful work for astronauts and how these sources may differ between astronauts. The present article identifies how engagement in meaningful work during long duration missions may mitigate the adverse effects of demands and increase the potential for benefits resulting from the missions. Semistructured interviews were conducted with nine NASA personnel, including astronauts, flight directors, and flight surgeons. Questions addressed sources of meaning for astronauts, characteristics of tasks that enhance vs. detract from meaning, and recommendations for enhancing meaning. Personnel mentioned contributing to humanity and the next generation, contributing to the mission, and exploration as the most meaningful aspects of their work. Characteristics of tasks that enhanced meaning included using a variety of skills, feeling personal control over their schedule, autonomy in the execution of tasks, and understanding the importance of the experiments conducted on the mission. Top recommendations to sustain meaning were insuring social needs were met through such activities as the strategic use of social media, giving astronauts autonomy as well as structure, and conducting training during transit. Implications are addressed for tailoring meaning-based interventions for astronauts participating on long duration missions and assessing the effectiveness of these interventions.Britt TW, Sytine A, Brady A, Wilkes R, Pittman R, Jennings K, Goguen K. Enhancing the meaningfulness of work for astronauts on long duration space exploration missions. Aerosp Med Hum Perform. 2017; 88(8):779-783.

  2. Durable Clinical Benefit in Metastatic Renal Cell Carcinoma Patients Who Discontinue PD-1/PD-L1 Therapy for Immune-Related Adverse Events.

    Science.gov (United States)

    Martini, Dylan J; Hamieh, Lana; McKay, Rana R; Harshman, Lauren C; Brandao, Raphael; Norton, Craig K; Steinharter, John A; Krajewski, Katherine M; Gao, Xin; Schutz, Fabio A; McGregor, Bradley; Bossé, Dominick; Lalani, Aly-Khan A; De Velasco, Guillermo; Michaelson, M Dror; McDermott, David F; Choueiri, Toni K

    2018-04-01

    The current standard of care for treatment of metastatic renal cell carcinoma (mRCC) patients is PD-1/PD-L1 inhibitors until progression or toxicity. Here, we characterize the clinical outcomes for 19 mRCC patients who experienced an initial clinical response (any degree of tumor shrinkage), but after immune-related adverse events (irAE) discontinued all systemic therapy. Clinical baseline characteristics, outcomes, and survival data were collected. The primary endpoint was time to progression from the date of treatment cessation (TTP). Most patients had clear cell histology and received anti-PD-1/PD-L1 therapy as second-line or later treatment. Median time on PD-1/PD-L1 therapy was 5.5 months (range, 0.7-46.5) and median TTP was 18.4 months (95% CI, 4.7-54.3) per Kaplan-Meier estimation. The irAEs included arthropathies, ophthalmopathies, myositis, pneumonitis, and diarrhea. We demonstrate that 68.4% of patients ( n = 13) experienced durable clinical benefit off treatment (TTP of at least 6 months), with 36% ( n = 7) of patients remaining off subsequent treatment for over a year after their last dose of anti-PD-1/PD-L1. Three patients with tumor growth found in a follow-up visit, underwent subsequent surgical intervention, and remain off systemic treatment. Nine patients (47.4%) have ongoing irAEs. Our results show that patients who benefitted clinically from anti-PD-1/PD-L1 therapy can experience sustained beneficial responses, not needing further therapies after the initial discontinuation of treatment due to irAEs. Investigation of biomarkers indicating sustained benefit to checkpoint blockers are needed. Cancer Immunol Res; 6(4); 402-8. ©2018 AACR . ©2018 American Association for Cancer Research.

  3. Employee use and perceived benefit of a complementary and alternative medicine wellness clinic at a major military hospital: evaluation of a pilot program.

    Science.gov (United States)

    Duncan, Alaine D; Liechty, Janet M; Miller, Cathy; Chinoy, Gail; Ricciardi, Richard

    2011-09-01

    The objectives of this study were to examine the feasibility of a weekly on-site complementary and alternative medicine (CAM) wellness clinic for staff at a military hospital, and to describe employees' perceptions of program effectiveness. The study setting was the Restore & Renew(®) Wellness Clinic at a United States Department of Defense hospital. The subjects were hospital nurses, physicians, clinicians, support staff, and administrators. The walk-in wellness clinic was open 8:00 am-2:00 pm 1 day a week. Participants selected one or more modalities each visit: ear acupuncture, clinical acupressure, and Zero Balancing.(®) A self-report survey was done after each clinic visit to evaluate clinic features and perceived impact on stress-related symptoms, compassion for patients, sleep, and workplace or personal relationships. Surveys completed after first-time and repeat visits (n=2,756 surveys) indicated that most participants agreed or strongly agreed they felt more relaxed after sessions (97.9%), less stress (94.5%), more energy (84.3%), and less pain (78.8%). Ninety-seven percent (97%) would recommend it to a co-worker. Among surveys completed after five or more visits, more than half (59%-85%) strongly agreed experiencing increased compassion with patients, better sleep, improved mood, and more ease in relations with co-workers. Perceived benefits were sustained and enhanced by number of visits. The most frequently reported health habit changes were related to exercise, stress reduction, diet/nutrition, and weight loss. This evaluation suggests that a hospital-based wellness clinic based on CAM principles and modalities is feasible, well-utilized, and perceived by most participants to have positive health benefits related to stress reduction at work, improved mood and sleep, and lifestyle.

  4. No benefit of intraoperative whole blood sequestration and autotransfusion during coronary artery bypass grafting : results of a randomized clinical trial

    NARCIS (Netherlands)

    Ramnath, A N; Naber, H R; de Boer, A; Leusink, J A

    OBJECTIVES: In a randomized clinical trial of patients undergoing elective coronary artery bypass grafting, we evaluated the effect of intraoperative whole blood sequestration and autotransfusion on postoperative blood loss and the use of allogeneic blood products. METHODS: Male patients were

  5. Clinical benefit of drugs targeting mitochondrial function as an adjunct to reperfusion in ST-segment elevation myocardial infarction

    DEFF Research Database (Denmark)

    Campo, Gianluca; Pavasini, Rita; Morciano, Giampaolo

    2017-01-01

    AIMS: To perform a systematic review and meta-analysis of randomized clinical trials (RCT) comparing the effectiveness of drugs targeting mitochondrial function vs. placebo in patients with ST-segment elevation myocardial infarction (STEMI) undergoing mechanical coronary reperfusion. METHODS...

  6. Callings, work role fit, psychological meaningfulness and work ...

    African Journals Online (AJOL)

    meaningful work experiences, which also impact individuals' work .... group 25 to 29 years. .... significant chi-squared difference tests, after these path deletions, indicated that .... Counseling Psychology, 59:479-485. doi: 10.1037/a0028949.

  7. Poignancy: Mixed Emotional Experience in the Face of Meaningful Endings

    Science.gov (United States)

    Ersner-Hershfield, Hal; Mikels, Joseph A.; Sullivan, Sarah J.; Carstensen, Laura L.

    2009-01-01

    The experience of mixed emotions increases with age. Socioemotional selectivity theory suggests that mixed emotions are associated with shifting time horizons. Theoretically, perceived constraints on future time increase appreciation for life, which, in turn, elicits positive emotions such as happiness. Yet, the very same temporal constraints heighten awareness that these positive experiences come to an end, thus yielding mixed emotional states. In 2 studies, the authors examined the link between the awareness of anticipated endings and mixed emotional experience. In Study 1, participants repeatedly imagined being in a meaningful location. Participants in the experimental condition imagined being in the meaningful location for the final time. Only participants who imagined “last times” at meaningful locations experienced more mixed emotions. In Study 2, college seniors reported their emotions on graduation day. Mixed emotions were higher when participants were reminded of the ending that they were experiencing. Findings suggest that poignancy is an emotional experience associated with meaningful endings. PMID:18179325

  8. Readiness for Meaningful Use of Health Information Tech...

    Data.gov (United States)

    U.S. Department of Health & Human Services — According to findings reported in Readiness for Meaningful Use of Health Information Technology and Patient Centered Medical Home Recognition Survey Results,...

  9. The clinical benefits of antiretroviral therapy in severely immunocompromised HIV-1-infected patients with and without complete viral suppression

    DEFF Research Database (Denmark)

    Mocroft, Amanda; Bannister, Wendy P; Kirk, Ole

    2012-01-01

    The aim of this study was to determine whether there is a protective effect of combination antiretroviral therapy (cART) on the development of clinical events in patients with ongoing severe immunosuppression.......The aim of this study was to determine whether there is a protective effect of combination antiretroviral therapy (cART) on the development of clinical events in patients with ongoing severe immunosuppression....

  10. Meaningful work and secondary school teachers' intention to leave

    OpenAIRE

    Janik, M.; Rothmann, S.

    2015-01-01

    The study investigates the relations between secondary school teachers' work-role fit, job enrichment, supervisor relationships, co-worker relationships, psychological meaningfulness of work and intention to leave. A cross-sectional survey was used. The participants were 502 secondary school teachers in Namibia. The following measuring instruments were used: Work-role Fit Scale, Job Enrichment Scale, Co-worker and Supervisor Relationships Scales, Psychological Meaningfulness Scale and Turnove...

  11. Design democratization with communities: Drawing toward locally meaningful design

    DEFF Research Database (Denmark)

    Winschiers-Goagoses, Naska; Winschiers-Theophilus, Heike; Rodil, Kasper

    2012-01-01

    The authors present community drawing as meaningful representations to inform locally valid technology design. They investigate recognition within and across cultural borders, thereby exposing variances of localities. The study contributes to the still scarce body of empirical work on culturally...... meaningful development of visual representations and recognition, as part of a longitudinal research project in which we co-design a 3D visualization for a specific Namibian pilot site....

  12. PROMOTING MEANINGFUL LEARNING THROUGH CREATE-SHARE-COLLABORATE

    OpenAIRE

    Sailin, Siti Nazuar; Mahmor, Noor Aida

    2017-01-01

    Students in this 21st century are required to acquire these 4C skills: Critical thinking, Communication, Collaboration and Creativity. These skills can be integrated in the teaching and learning through innovative teaching that promotes active and meaningful learning. One way of integrating these skills is through collaborative knowledge creation and sharing. This paper providesan example of meaningful teaching and learning activities designed within the Create-Share-Collaborate instructional...

  13. Self-Determination and Meaningful Work: Exploring Socioeconomic Constraints

    OpenAIRE

    Allan, Blake A.; Autin, Kelsey L.; Duffy, Ryan D.

    2016-01-01

    This study examined a model of meaningful work among a diverse sample of working adults. From the perspectives of Self-Determination Theory and the Psychology of Working Framework, we tested a structural model with social class and work volition predicting SDT motivation variables, which in turn predicted meaningful work. Partially supporting hypotheses, work volition was positively related to internal regulation and negatively related to amotivation, whereas social class was positively relat...

  14. The effect of occupational meaningfulness on occupational commitment

    Directory of Open Access Journals (Sweden)

    Itai Ivtzan

    2014-11-01

    Full Text Available Existing research lacks a scholarly consensus on how to define and validly measure ‘meaningful work’ (e.g., Rosso, Dekas & Wrzesniewski, 2010. The following correlational study highlights the value of investigating meaningfulness in the context of occupational commitment. The study hypothesizes that occupational commitment is positively correlated with occupational meaningfulness, where meaningfulness is defined as the extent to which people’s occupations contribute to personal meaning in life. One-hundred and fifty-six full-time office based UK workers completed an online questionnaire including 18 questions measuring levels of occupational commitment (Meyer, Allen & Smith, 1993, in addition to six novel items measuring occupational meaningfulness. The results supported the hypothesis and also showed that the affective sub-type of occupational commitment had the highest correlation with occupational meaningfulness. Such results exhibit the importance of finding meaning at work, as well as the relevance of this to one’s level of commitment to his or her job. This paper argues that individuals should consider OM before choosing to take a specific role, whereas organizations ought to consider the OM of their potential candidates before recruiting them into a role. Possible directions for future research directions are also discussed.

  15. Meaningful work and mental health: job satisfaction as a moderator.

    Science.gov (United States)

    Allan, Blake A; Dexter, Chelsea; Kinsey, Rebecca; Parker, Shelby

    2018-02-01

    Depression, anxiety and stress are common problems for modern workers. Although having meaningful work, or work that is significant, facilitates personal growth, and contributes to the greater good, has been linked to better mental health, people's work might also need to be satisfying or enjoyable to improve outcomes. The purpose of the present study was to examine meaningful work's relation to mental health (i.e. depression, anxiety and stress) and investigate job satisfaction as a moderator of this relation. The study hypotheses were tested with a large, diverse sample recruited from an online source. Partially supporting hypotheses, when controlling for job satisfaction, meaningful work negatively correlated with depression but did not have a significant relation with anxiety and stress. Similarly, job satisfaction negatively predicted depression and stress. Furthermore, the relations between meaningful work and both anxiety and stress were moderated by job satisfaction. Specifically, only people perceiving their work as meaningful and satisfying reported less anxiety and stress. Although continued research is needed, employers and employees may have to target both the meaningfulness and job satisfaction to address the issues of stress and anxiety among working adults.

  16. Integrating Positive and Clinical Psychology: Viewing Human Functioning as Continua from Positive to Negative Can Benefit Clinical Assessment, Interventions and Understandings of Resilience

    OpenAIRE

    Johnson, J; Wood, AM

    2017-01-01

    In this review we argue in favour of further integration between the disciplines of positive and clinical psychology. We argue that most of the constructs studied by both positive and clinical psychology exist on continua ranging from positive to negative (e.g., gratitude to ingratitude, anxiety to calmness) and so it is meaningless to speak of one or other field studying the “positive” or the “negative”. However, we highlight historical and cultural factors which have led positive and clinic...

  17. Using perceptual mapping methods to understand gender differences in perceived barriers and benefits of clinical research participation in urban minority HIV+ patients.

    Science.gov (United States)

    Bass, Sarah Bauerle; Wolak, Caitlin; Greener, Judith; Tedaldi, Ellen; Nanavati, Aasit; Ruppert, Katey; Gordon, Thomas F

    2016-01-01

    Minority participation in HIV clinical trials research is critical to understanding the impact of medications or behavioral interventions, but little is known about gender differences in perceptions of participation. We surveyed 50 minority HIV+ patients from an urban clinic to assess perceived risks/benefits of clinical trial research participation and used innovative marketing methods to analyze results. Perceptual mapping and vector message-modeling, a method that creates 3-D models representing how groups conceptualize elements, were used to assess how male and female participants could be motivated to participate. Results showed men farther away from participation and more concerned with HIV disclosure and experimentation than women. Men expressed distrust of the medical system, doubted HIV's origin, and knew less about research implementation. Women were closer to participation in both behavior and medical trials and perceived medication issues as more significant, including fear of losing medication stability, medications not working, being in the placebo group, and experiencing side effects. Vector modeling shows that messages would need to focus on different aspects of clinical research for men and women and that interventions aimed at minority HIV+ patients to encourage clinical trial participation would need to be targeted to their unique perceptions. Understanding gender perceptions of HIV clinical research has significant implications for targeting messages to increase minority participation.

  18. The Benefits of Multidisciplinary Learning in Clinical Practice for Law, Finance, and Social Work Students: An Australian Experience

    Science.gov (United States)

    Hyams, Ross; Brown, Grace; Foster, Richard

    2013-01-01

    In July 2010, the faculties of Law, Business and Economics, and Medicine at Monash University, Australia commenced placing law, finance, and social work students in a multidisciplinary clinic at a community legal service operated by the University. Students from the three disciplines began seeing legal service clients at the same time as a team.…

  19. Addition of meloxicam to the treatment of bovine clinical mastitis results in a net economic benefit to the dairy farmer

    NARCIS (Netherlands)

    Soest, van Felix J.S.; Abbeloos, Elke; McDougall, Scott; Hogeveen, Henk

    2018-01-01

    Recently, it has been shown that the addition of meloxicam to standard antimicrobial therapy for clinical mastitis (CM) improves the conception rate of dairy cows contracting CM in the first 120 d in milk. The objective of our study was to assess whether this improved reproduction through additional

  20. Clinical benefit of steroid use in patients undergoing cardiopulmonary bypass: a meta-analysis of randomized trials

    DEFF Research Database (Denmark)

    Whitlock, R.P.; Chan, S.; Devereaux, P.J.

    2008-01-01

    We sought to establish the efficacy and safety of prophylactic steroids in adult patients undergoing cardiopulmonary bypass (CPB). We performed a meta-analysis of randomized trials reporting the effects of prophylactic steroids on clinical outcomes after CPB. Outcomes examined were mortality...

  1. A randomised trial of differentiated prednisolone treatment in active rheumatoid arthritis. Clinical benefits and skeletal side effects

    DEFF Research Database (Denmark)

    Hansen, M; Podenphant, J; Florescu, A

    1999-01-01

    OBJECTIVES: To study benefits and skeletal side effects of carefully monitored prednisolone treatment in patients with active rheumatoid arthritis. METHODS: One hundred and two patients with active rheumatoid arthritis were randomly allocated to treatment with disease modifying anti......-inflammatory drug (DMARD) alone or DMARD and prednisolone in a one year follow up study. Prednisolone was given in a dose regimen adapted to the disease activity of the individual patient. The mean dose was 6 mg and the mean cumulated dose was 2160 mg. Patients were followed up with disease activity parameters......, radiograph of the hands (Larsen score), and bone mineral density (BMD) of the lumbar spine, distal forearm and hand. At one year 26 patients had withdrawn from the investigation leaving 76 patients for evaluation. RESULTS: The results showed that disease activity in the prednisolone treated group was reduced...

  2. Cardiovascular Magnetic Resonance Imaging—Incremental Value in a Series of 361 Patients Demonstrating Cost Savings and Clinical Benefits: An Outcome-Based Study

    Science.gov (United States)

    Hegde, Vinayak A; Biederman, Robert WW; Mikolich, J Ronald

    2017-01-01

    BACKGROUND This study was designed to assess the clinical impact and cost-benefit of cardiovascular magnetic resonance imaging (CMR). In the face of current health care cost concerns, cardiac imaging modalities have come under focused review. Data related to CMR clinical impact and cost-benefit are lacking. METHODS AND RESULTS Retrospective review of 361 consecutive patients (pts) who underwent CMR exams was conducted. Indications for CMR were tabulated for appropriateness criteria. Components of the CMR exam were identified along with evidence of clinical impact. The cost of each CMR exam was ascertained along with cost savings attributable to the CMR exam for calculation of an incremental cost-effectiveness ratio. A total of 354 of 361 pts (98%) had diagnostic quality studies. Of the 361 pts, 350 (97%) had at least 1 published Appropriateness Criterion for CMR. A significant clinical impact attributable to CMR exam results was observed in 256 of 361 pts (71%). The CMR exam resulted in a new diagnosis in 69 of 361 (27%) pts. Cardiovascular magnetic resonance imaging results avoided invasive procedures in 38 (11%) pts and prevented additional diagnostic testing in 26 (7%) pts. Comparison of health care savings using CMR as opposed to current standards of care showed a net cost savings of $833 037, ie, per patient cost savings of $2308. CONCLUSIONS Cardiovascular magnetic resonance imaging provides diagnostic image quality in >98% of cases. Cardiovascular magnetic resonance imaging findings have documentable clinical impact on patient management in 71% of pts undergoing the exam, in a cost beneficial manner. PMID:28579858

  3. Cardiovascular Magnetic Resonance Imaging—Incremental Value in a Series of 361 Patients Demonstrating Cost Savings and Clinical Benefits: An Outcome-Based Study

    Directory of Open Access Journals (Sweden)

    Vinayak A Hegde

    2017-05-01

    Full Text Available Background: This study was designed to assess the clinical impact and cost-benefit of cardiovascular magnetic resonance imaging (CMR. In the face of current health care cost concerns, cardiac imaging modalities have come under focused review. Data related to CMR clinical impact and cost-benefit are lacking. Methods and Results: Retrospective review of 361 consecutive patients (pts who underwent CMR exams was conducted. Indications for CMR were tabulated for appropriateness criteria. Components of the CMR exam were identified along with evidence of clinical impact. The cost of each CMR exam was ascertained along with cost savings attributable to the CMR exam for calculation of an incremental cost-effectiveness ratio. A total of 354 of 361 pts (98% had diagnostic quality studies. Of the 361 pts, 350 (97% had at least 1 published Appropriateness Criterion for CMR. A significant clinical impact attributable to CMR exam results was observed in 256 of 361 pts (71%. The CMR exam resulted in a new diagnosis in 69 of 361 (27% pts. Cardiovascular magnetic resonance imaging results avoided invasive procedures in 38 (11% pts and prevented additional diagnostic testing in 26 (7% pts. Comparison of health care savings using CMR as opposed to current standards of care showed a net cost savings of $833 037, ie, per patient cost savings of $2308. Conclusions: Cardiovascular magnetic resonance imaging provides diagnostic image quality in >98% of cases. Cardiovascular magnetic resonance imaging findings have documentable clinical impact on patient management in 71% of pts undergoing the exam, in a cost beneficial manner.

  4. Growing insights into the potential benefits and risks of activated protein C administration in sepsis: a review of preclinical and clinical studies

    Directory of Open Access Journals (Sweden)

    Laith Altaweel

    2009-09-01

    Full Text Available Laith Altaweel, Daniel Sweeney, Xizhong Cui, Amisha Barochia, Charles Natanson, Peter Q EichackerCritical Care Medicine Department, Clinical Center, National Institutes of Health, Bethesda, MD, USAAbstract: Recombinant human activated protein C (rhAPC was developed to reduce excessive coagulant and inflammatory activity during sepsis. Basic and clinical research has suggested these pathways contribute to the pathogenesis of this lethal syndrome and are inhibited by rhAPC. Based in large part on the results of a single multicenter randomized controlled trial, rhAPC was first approved in 2001 by the US Food and Drug Administration (FDA as adjunctive therapy in septic patients with a high risk of death. This was followed closely by approval in Europe, Australia, and New Zealand. At the original FDA review of rhAPC, concerns were raised as to whether a confirmatory trial should be done before final regulatory approval because of concerns that rhAPCs bleeding risk might outweigh its potential benefit during clinical use. Since 2001, continuing basic and clinical research has further elucidated the complex role activated protein C may have in both adaptive and maladaptive responses during sepsis. Moreover, subsequent controlled trials in other types of septic patients and observational studies appear to support earlier concerns that the benefit-to-risk ratio of rhAPC may not support its clinical use. This experience has prompted additional trials presently underway, to define whether treatment with rhAPC as it was originally indicated in septic patients with persistent shock, is safe and effective. Until such trials are complete, physicians employing this agent must carefully consider which patients may be appropriate candidates for rhAPC administration.Keywords: rhAPC, treatment, sepsis

  5. Noncontrast chest computed tomography immediately after transarterial chemoembolization in patients with hepatocellular carcinoma: Clinical benefits and effect of radiation reduction on image quality in low-dose scanning

    International Nuclear Information System (INIS)

    Choi, Joon-Il; Kim, Hyun Beom; Kim, Min Ju; Lee, Jong Seok; Koh, Young Whan; An, Sang Bu; Ko, Heung-kyu; Park, Joong-Won

    2011-01-01

    Purpose: To evaluate the clinical benefits of noncontrast chest computed tomography (CT) immediately after transarterial chemoembolization in patients with hepatocellular carcinoma and to assess the effect of radiation reduction on image quality in low-dose scanning. Materials and methods: From June to October 2010, we performed standard-dose, noncontrast chest CTs immediately after transarterial chemoembolization in 160 patients and low-dose CTs in 88 patients. We reviewed the entire noncontrast chest CTs and follow-up CTs to reveal the clinical benefits of CT evaluation immediately after transarterial chemoembolization. Using two independent readers, we also retrospectively evaluated the radiation dose and image quality in terms of the image noise, contrast between the liver parenchyma and iodized oil and diagnostic acceptability for the evaluation of treatment response after transarterial chemoembolization. Results: In 5.2% of the patients, additional treatment was performed immediately after the interpretation of the noncontrast chest CT, and additional pulmonary lesions were found in 8.5% of the patients. The measured mean dose-length product for the low-dose scanning was 18.4% of that of the standard-dose scanning. The image noise was significantly higher with the low-dose scanning (p < 0.001). However, all of the low-dose CT scans were diagnostically acceptable, and the mean scores for the subjective assessments of the contrast and diagnostic acceptability showed no significant differences for either reader. Conclusion: A noncontrast chest CT immediately after transarterial chemoembolization has some clinical benefits for immediate decision making and detecting pulmonary lesions. Low-dose, noncontrast chest CTs immediately after transarterial chemoembolization consistently provide diagnostically acceptable images and information on treatment response in patients who have undergone transarterial chemoembolization.

  6. Doing well by doing good. The 7 benefits of a meaningful corporate social responsibility program.

    Science.gov (United States)

    Macdonald, Deborah

    2008-08-01

    You want your medical group to be a good community player--but you need to attract new patients, retain top staff and manage your bottom line. A corporate social responsibility program may be the shrewd solution.

  7. [Beta lactam antibiotics and the question of dose regimen for severe infection. Prolonged infusion theoretically appealing--yet no evidence of clinical benefit].

    Science.gov (United States)

    Leander, Gunilla; Eliasson, Erik; Hanberger, Håkan; Giske, Christian

    2015-03-24

    Patients with severe sepsis/septic shock have a high mortality. Beta-lactam antibiotics are normally first line treatment. This antimicrobial class has been associated with time-dependent efficacy. It is therefore plausible that administration as prolonged infusion will increase the therapeutic effect, as compared to short term bolus injections, which is the most common practice today. We have reviewed 14 randomized controlled studies to investigate whether prolonged infusion provides lower mortality and/or increased clinical cure. In summary, convincing advantages with prolonged infusion could not be found, however randomized studies are heterogeneous, and it cannot be excluded that some subgroups of critically ill patients could benefit from such treatment.

  8. Experience as a doctor in the developing world: does it benefit the clinical and organisational performance in general practice?

    Directory of Open Access Journals (Sweden)

    de Wit Niek J

    2009-12-01

    Full Text Available Abstract Background Many physicians have medical experience in developing countries early in their career, but its association with their medical performance later is not known. To explore possible associations we compared primary care physicians (GPs with and without professional experience in a developing country in performance both clinical and organisational. Methods A retrospective survey using two databases to analyse clinical and organisational performance respectively. Analysis was done at the GP level and practice level. 517 GPs received a questionnaire regarding relevant working experience in a developing country. Indicators for clinical performance were: prescription, referral, external diagnostic procedures and minor procedures. We used the district health insurance data base covering 570.000 patients. Explorative secondary analysis of practice visits of 1004 GPs in 566 practices in the Netherlands from 1999 till 2001. We used a validated practice visit method (VIP; 385 indicators in 51 dimensions of practice management to compare having experience in a developing country or not. Results Almost 8% of the GPs had experience in a developing country of at least two years. These GPs referred 9,5% less than their colleagues and did more surgical procedures. However, in the multivariate analysis 'experience in a developing country' was not significantly associated with clinical performance or with other GP- and practice characteristics. 16% of the practices a GP or GPs with at least two years experience in a developing country. They worked more often in group and rural practices with less patients per fte GP and more often part-time. These practices are more hygienic, collaborate more with the hospital and score better on organisation of the practice. These practices score less on service and availability, spend less time on patients in the consultation and the quality of recording in the EMD is lower. Conclusions We found interesting

  9. An empirically based conceptual framework for fostering meaningful patient engagement in research.

    Science.gov (United States)

    Hamilton, Clayon B; Hoens, Alison M; Backman, Catherine L; McKinnon, Annette M; McQuitty, Shanon; English, Kelly; Li, Linda C

    2018-02-01

    Patient engagement in research (PEIR) is promoted to improve the relevance and quality of health research, but has little conceptualization derived from empirical data. To address this issue, we sought to develop an empirically based conceptual framework for meaningful PEIR founded on a patient perspective. We conducted a qualitative secondary analysis of in-depth interviews with 18 patient research partners from a research centre-affiliated patient advisory board. Data analysis involved three phases: identifying the themes, developing a framework and confirming the framework. We coded and organized the data, and abstracted, illustrated, described and explored the emergent themes using thematic analysis. Directed content analysis was conducted to derive concepts from 18 publications related to PEIR to supplement, confirm or refute, and extend the emergent conceptual framework. The framework was reviewed by four patient research partners on our research team. Participants' experiences of working with researchers were generally positive. Eight themes emerged: procedural requirements, convenience, contributions, support, team interaction, research environment, feel valued and benefits. These themes were interconnected and formed a conceptual framework to explain the phenomenon of meaningful PEIR from a patient perspective. This framework, the PEIR Framework, was endorsed by the patient research partners on our team. The PEIR Framework provides guidance on aspects of PEIR to address for meaningful PEIR. It could be particularly useful when patient-researcher partnerships are led by researchers with little experience of engaging patients in research. © 2017 The Authors Health Expectations Published by John Wiley & Sons Ltd.

  10. The Clinical and Economic Benefits of Co-Testing Versus Primary HPV Testing for Cervical Cancer Screening: A Modeling Analysis.

    Science.gov (United States)

    Felix, Juan C; Lacey, Michael J; Miller, Jeffrey D; Lenhart, Gregory M; Spitzer, Mark; Kulkarni, Rucha

    2016-06-01

    Consensus United States cervical cancer screening guidelines recommend use of combination Pap plus human papillomavirus (HPV) testing for women aged 30 to 65 years. An HPV test was approved by the Food and Drug Administration in 2014 for primary cervical cancer screening in women age 25 years and older. Here, we present the results of clinical-economic comparisons of Pap plus HPV mRNA testing including genotyping for HPV 16/18 (co-testing) versus DNA-based primary HPV testing with HPV 16/18 genotyping and reflex cytology (HPV primary) for cervical cancer screening. A health state transition (Markov) model with 1-year cycling was developed using epidemiologic, clinical, and economic data from healthcare databases and published literature. A hypothetical cohort of one million women receiving triennial cervical cancer screening was simulated from ages 30 to 70 years. Screening strategies compared HPV primary to co-testing. Outcomes included total and incremental differences in costs, invasive cervical cancer (ICC) cases, ICC deaths, number of colposcopies, and quality-adjusted life years for cost-effectiveness calculations. Comprehensive sensitivity analyses were performed. In a simulation cohort of one million 30-year-old women modeled up to age 70 years, the model predicted that screening with HPV primary testing instead of co-testing could lead to as many as 2,141 more ICC cases and 2,041 more ICC deaths. In the simulation, co-testing demonstrated a greater number of lifetime quality-adjusted life years (22,334) and yielded $39.0 million in savings compared with HPV primary, thereby conferring greater effectiveness at lower cost. Model results demonstrate that co-testing has the potential to provide improved clinical and economic outcomes when compared with HPV primary. While actual cost and outcome data are evaluated, these findings are relevant to U.S. healthcare payers and women's health policy advocates seeking cost-effective cervical cancer screening

  11. Clinical and economic benefit of enzymatic debridement of pressure ulcers compared to autolytic debridement with a hydrogel dressing.

    Science.gov (United States)

    Waycaster, Curtis; Milne, Catherine T

    2013-07-01

    The purpose of this study was to determine the cost-effectiveness of enzymatic debridement using collagenase relative to autolytic debridement with a hydrogel dressing for the treatment of pressure ulcers. A 3-stage Markov model was used to determine the expected costs and outcomes of wound care for collagenase and hydrogel dressings. Outcome data used in the analysis were taken from a randomized clinical trial that directly compared collagenase and hydrogel dressings. The primary outcome in the clinical trial was the proportion of patients achieving a closed epithelialized wound. Transition probabilities for the Markov states were estimated from the clinical trial. A 1-year time horizon was used to determine the expected number of closed wound days and the expected costs for the two alternative debridement therapies. Resource utilization was based on the wound care treatment regimen used in the clinical trial. Resource costs were derived from standard cost references and medical supply wholesalers. The economic perspective taken was that of the long-term care facility. No cost discounting was performed due to the short time horizon of the analysis. A deterministic sensitivity analysis was conducted to analyze economic uncertainty. The number of expected wound days for the collagenase and hydrogel cohorts are estimated at 48 and 147, respectively. The expected direct cost per patient for pressure ulcer care was $2003 for collagenase and $5480 for hydrogel debridement. The number of closed wound days was 1.5-times higher for collagenase (317 vs 218 days) than with the hydrogel. The estimated cost/closed wound day was 4-times higher for the hydrogel ($25) vs collagenase ($6). In this Markov model based on a randomized trial of pressure ulcer care in a long-term care setting collagenase debridement was economically dominant over autolytic debridement, yielding better outcomes at a lower total cost. Since it was a single institution study with a small sample size, the

  12. Pleiotropic benefit of monomeric and oligomeric flavanols on vascular health--a randomized controlled clinical pilot study.

    Science.gov (United States)

    Weseler, Antje R; Ruijters, Erik J B; Drittij-Reijnders, Marie-José; Reesink, Koen D; Haenen, Guido R M M; Bast, Aalt

    2011-01-01

    Cardiovascular diseases are expanding to a major social-economic burden in the Western World and undermine man's deep desire for healthy ageing. Epidemiological studies suggest that flavanol-rich foods (e.g. grapes, wine, chocolate) sustain cardiovascular health. For an evidenced-based application, however, sound clinical data on their efficacy are strongly demanded. In a double-blind, randomized, placebo-controlled intervention study we supplemented 28 male smokers with 200 mg per day of monomeric and oligomeric flavanols (MOF) from grape seeds. At baseline, after 4 and 8 weeks we measured macro- and microvascular function and a cluster of systemic biomarkers for major pathological processes occurring in the vasculature: disturbances in lipid metabolism and cellular redox balance, and activation of inflammatory cells and platelets. In the MOF group serum total cholesterol and LDL decreased significantly (P ≤ 0.05) by 5% (n = 11) and 7% (n = 9), respectively in volunteers with elevated baseline levels. Additionally, after 8 weeks the ratio of glutathione to glutathione disulphide in erythrocytes rose from baseline by 22% (n = 15, Pbenefit of an 8 weeks supplementation with 200 mg/d MOF in humans. ClinicalTrials.gov NCT00742287.

  13. Feasibility of resistance training in adult McArdle patients: Clinical outcomes and muscle strength and mass benefits

    Directory of Open Access Journals (Sweden)

    Alfredo eSantalla

    2014-12-01

    Full Text Available We analyzed the effects of a 4-month resistance (weight lifting training program followed by a 2-month detraining period in 7 adult McArdle patients (5 female on: muscle mass (assessed by DXA, strength, serum creatine kinase (CK activity and clinical severity. Adherence to training was ≥ 84% in all patients and no major contraindication or side effect was noted during the training or strength assessment sessions. The training program had a significant impact on total and lower extremities’ lean mass (P0.05 was noted for baseline or post strength assessment values of serum CK activity, which remained essentially within the range reported in our laboratory for McArdle patients. All the patients changed to a lower severity class with training, such that none of them were in the highest disease severity class (3 after the intervention and, as such, they did not have fixed muscle weakness after training. Clinical improvements were retained, in all but one patient, after detraining, such that after detraining all patients were classed as class 1 for

  14. Clinical and economic benefits of professional CGM among people with type 2 diabetes in the United States: analysis of claims and lab data.

    Science.gov (United States)

    Sierra, Joseph A; Shah, Mona; Gill, Max S; Flores, Zachery; Chawla, Hiten; Kaufman, Francine R; Vigersky, Robert

    2018-03-01

    It is estimated that one in 10 people in the US have a diagnosis of diabetes. Type 2 diabetes accounts for 95% of all cases in the US, with annual costs estimated to be $246 billion per year. This study investigated the impact of a glucose-measuring intervention to the burden of type 2 diabetes. This analysis seeks to understand how professional continuous glucose monitoring (professional CGM) impacts clinical and economic outcomes when compared to patients who are not prescribed professional CGM. This study utilized a large healthcare claims and lab dataset from the US, and identified a cohort of patients who were prescribed professional CGM as identified by CPT codes 95250 and 95251. It calculated economic and clinical outcomes 1 year before and 1 year after the use of professional CGM, using a generalized linear model. Patients who utilized professional CGM saw an improvement in hemoglobin A1C. The "difference-in-difference" calculation for A1C was shown to be -0.44%. There was no statistically significant difference in growth of total annual costs for people who used professional CGM compared to those who did not ($1,270, p = .08). Patients using professional CGM more than once per year had a -$3,376 difference in the growth of total costs (p = .05). Patients who used professional CGM while changing their diabetes treatment regimen also had a difference of -$3,327 in growth of total costs (p = .0023). Significant clinical benefits were observed for patients who used professional CGM. Economic benefits were observed for patients who utilized professional CGM more than once within a 1-year period or who used it during a change of diabetes therapy. This suggests that professional CGM may help decrease rising trends in healthcare costs for people with type 2 diabetes, while also improving clinical outcomes.

  15. A sequential erythropoietin and GM-CSF schedule offers clinical benefits in the treatment of anaemia in myelodysplastic syndromes.

    Science.gov (United States)

    Bernell, P; Stenke, L; Wallvik, J; Hippe, E; Hast, R

    1996-08-01

    In order to reduce anaemia in patients with myelodysplastic syndromes (MDS) a stepwise treatment protocol including erythropoietin (EP) and granulocyte-macrophage colony-stimulating factor (GM-CSF) was designed. Thirty-seven MDS patients (stages I-III) with symptomatic anaemia were first given EPO 10,000 U s.c. 3 times weekly for 6 weeks. Those not responding, i.e. increased their haemoglobin levels > 15 g/l, proceeded into the second phase of the study where GM-CSF (200 micrograms/d. s.c. on weeks 1-6) was combined with EPO (10,000 U s.c. 3 times weekly on weeks 5-14). Following the initial EPO treatment phase, 14 of the 37 patients (38%) responded with increased haemoglobin levels. Responders were significantly different from non-responders in that their pre-treatment values of s-EPO, s-LDH and bone marrow blast cell counts were lower, their baseline haemoglobin levels higher and their transfusion dependency less pronounced. Eighteen of the 23 non-responders proceeded into the second phase, 13 of those were evaluable having completed the entire schedule. Three of the 13 initially EPO resistant patients (23%) responded to the GM-CSF/EPO combination with increased haemoglobin levels, suggesting a positive synergy between the two cytokines. Thus, the overall response rate to the present protocol was 46% (17 of 37 cases), but only a limited subset of the patients did clearly benefit from the combined GM-CSF/EPO administration. Therefore, we believe this step-wise approach to multiple growth factor treatment in MDS, starting with EPO alone and reserving the combination for refractory cases, has considerable advantages, taking into account both medical and socio-economical aspects.

  16. [Breastfeeding (part one): Frequency, benefits and drawbacks, optimal duration and factors influencing its initiation and prolongation. Clinical guidelines for practice].

    Science.gov (United States)

    Chantry, A A; Monier, I; Marcellin, L

    2015-12-01

    The objectives were to on assess the frequency and the duration of breastfeeding in France. On the other hand, the objectives were to identify its benefits and drawbacks, and to study the factors influencing its initiation and its extension. Bibliographic research in Medline, Google Scholar and in the Cochrane Library. Breastfeeding concerns in France about 70% of children at birth (EL2). Its median duration is about 15 weeks and 3 weeks ½ for exclusive breastfeeding. At three months, only one third of children breastfed at birth are still being breastfed (EL2). Whether this is due to the composition of breast milk or the behavior of mothers with their children or their socio-cultural level, or even by all these components at once, breastfeeding is associated with better cognitive development children (EL2). This effect is even more reinforced that mothers breastfeed exclusively and prolonged (EL2). As part of the prevention of many diseases (ear infections, gastrointestinal infections, atopic diseases, obesity and cardiovascular diseases…), exclusive and prolonged breastfeeding (grade B) between 4 to 6 months is recommended (professional consensus). Breastfeeding is not a means of preventing postpartum depression (professional consensus). To reduce the incidence of breast cancer, prolonged breastfeeding is recommended (grade B). In order to increase the rate of initiation of breastfeeding as well as its duration, it is recommended that health professionals work closely with mothers in their project (grade A), the breastfeeding promotion messages include message to husbands (grade B), and to promote breastfeeding on demand without fixed interval between feedings (grade B). However, there is not enough data to recommend the use of a specific position during breastfeeding, or the use of one or two breast or to early start breastfeeding or not (professional consensus). Exclusive and extended breastfeeding is recommended (grade B) between 4 to 6 months (professional

  17. Hospital budget increase for information technology during phase 1 meaningful use.

    Science.gov (United States)

    Neumeier, Harold; Berner, Eta S; Burke, Darrell E; Azuero, Andres

    2015-01-01

    Federal policies have a significant effect on how businesses spend money. The 2009 HITECH (Health Information Technology for Economic and Clinical Health Act) authorized incentive payments through Medicare and Medicaid to clinicians and hospitals when they use certified electronic health records privately and securely to achieve specified improvements in care delivery. Federal incentive payments were offered in 2011 for hospitals that had satisfied "meaningful use" criteria. A longitudinal study of nonfederal hospital information technology (IT) budgets (N = 493) during the years 2009 to 2011 found increases in the percentage of hospital annual operating budgets allocated to IT in the years leading up to these federal incentives. This increase was most pronounced among hospitals receiving high proportions of their reimbursements from Medicaid, followed by hospitals receiving high proportions of their reimbursements from Medicare, possibly indicating a budget shift during this period to more IT spending to achieve meaningful-use policy guidelines.

  18. Designing Meaningful Game Experiences for Rehabilitation and Sustainable Mobility Settings

    Directory of Open Access Journals (Sweden)

    Silvia Gabrielli

    2014-03-01

    Full Text Available This paper presents the approach followed in two ongoing research projects aimed to designing meaningful game-based experiences to support home rehabilitation, eco-sustainable mobility goals and more in general better daily lifestyles. We first introduce the need for designing meaningful game-based experiences that are well-connected to the relevant non-game settings and can be customized by/for users, then, we show examples of how this approach can be realized in the rehabilitation and sustainable mobility contexts.

  19. Clinical benefit of a gluten-free diet in type 1 diabetic children with screening-detected celiac disease

    DEFF Research Database (Denmark)

    Hansen, Dorte; Brock-Jacobsen, Bendt; Lund, Elisabeth

    2006-01-01

    OBJECTIVE: This study was performed to 1) determine the prevalence of celiac disease in Danish children with type 1 diabetes and 2) estimate the clinical effects of a gluten-free diet (GFD) in patients with diabetes and celiac disease. RESEARCH DESIGN AND METHODS: In a region comprising 24......% of the Danish population, all patients diabetes were identified and 269 (89%) were included in the study. The diagnosis of celiac disease was suspected in patients with endomysium and tissue transglutaminase antibodies in serum and confirmed by intestinal biopsy. Patients with celiac...... a lower SD score (SDS) for height (P diabetes onset (P = 0.041). A GFD was obtained in 31 of 33 patients. After 2 years of follow-up, there was an increase in weight SDS (P = 0.006) and in children

  20. Magnetic resonance imaging for assessing hamstring injuries: clinical benefits and pitfalls – a review of the current literature

    Directory of Open Access Journals (Sweden)

    Greenky M

    2017-07-01

    Full Text Available Max Greenky, Steven B Cohen Department of Orthopedic Surgery, Rothman Institute, Thomas Jefferson University, Philadelphia, PA, USA Abstract: Hamstring injuries are common injuries in all levels of athletics. Hamstring injuries can cause prolonged absence from sports and have a notorious rate of reinjury. Magnetic resonance imaging (MRI is being increasingly utilized following a hamstring injury. Physicians are being increasingly asked to utilize MRI to predict clinical outcomes, including time frame for return to play and risk of reinjury. In spite of numerous studies in this area, no clear consensus exists. The purpose of this paper is to summarize the literature and evidence regarding the role of MRI in treating hamstring injuries. Keywords: hamstring injury, MRI, return to play

  1. Differential benefits of amoxicillin-metronidazole in different phases of periodontal therapy in a randomized controlled crossover clinical trial.

    Science.gov (United States)

    Mombelli, Andrea; Almaghlouth, Adnan; Cionca, Norbert; Courvoisier, Delphine S; Giannopoulou, Catherine

    2015-03-01

    The specific advantage of administering systemic antibiotics during initial, non-surgical therapy or in the context of periodontal surgery is unclear. This study assesses the differential outcomes of periodontal therapy supplemented with amoxicillin-metronidazole during either the non-surgical or the surgical treatment phase. This is a single-center, randomized placebo-controlled crossover clinical trial with a 1-year follow-up. Eighty participants with Aggregatibacter actinomycetemcomitans-associated moderate to advanced periodontitis were randomized into two treatment groups: group A, antibiotics (500 mg metronidazole plus 375 mg amoxicillin three times per day for 7 days) during the first, non-surgical phase of periodontal therapy (T1) and placebo during the second, surgical phase (T2); and group B, placebo during T1 and antibiotics during T2. The number of sites with probing depth (PD) >4 mm and bleeding on probing (BOP) per patient was the primary outcome. A total of 11,212 sites were clinically monitored on 1,870 teeth. T1 with antibiotics decreased the number of sites with PD >4 mm and BOP per patient significantly more than without (group A: from 34.5 to 5.7, 84%; group B: from 28.7 to 8.7, 70%; P antibiotics, but only eight treated with placebo, achieved a 10-fold reduction of diseased sites (P = 0.007). Consequently, fewer patients of group A needed additional therapy, the mean number of surgical interventions was lower, and treatment time in T2 was shorter. Six months after T2, the mean number of residual pockets (group A: 2.8 ± 5.2; group B: 2.2 ± 5.0) was not significantly different and was sustained over 12 months in both groups. Giving the antibiotics during T1 or T2 yielded similar long-term outcomes, but antibiotics in T1 resolved the disease quicker and thus reduced the need for additional surgical intervention.

  2. Clinical and economic benefits of integrated pump/CGM technology therapy in patients with type 1 diabetes in Colombia.

    Science.gov (United States)

    Gomez, Ana Maria; Alfonso-Cristancho, Rafael; Orozco, John Jairo; Lynch, Peter Matthew; Prieto, Diana; Saunders, Rhodri; Roze, Stephane; Valencia, Juan Esteban

    2016-11-01

    To assess the long-term clinical and economic impact of integrated pump/CGM technology therapy as compared to multiple daily injections (MDI), for the treatment of type 1 diabetes (T1D) in Colombia. The CORE Diabetes Model was used to simulate a hypothetical cohort of patients with T1D. Mean baseline characteristics were taken from a clinical study conducted in Colombia and a healthcare payer perspective was adopted, with a 5% annual discount rate applied to both costs and outcomes. The integrated pump/CGM improved mean life expectancy by 3.51 years compared with MDI. A similar increase occurred in mean quality-adjusted life expectancy with an additional 3.81 quality-adjusted life years (QALYs). Onset of diabetes-related complications was also delayed as compared to MDI, and mean survival time free of complication increased by 1.74 years with integrated pump/CGM. Although this increased treatment costs of diabetes as compared to MDI, savings were achieved thanks to reduced expenditure on diabetes-related complications. The estimated incremental cost-effectiveness ratio (ICER) for SAP was Colombian Pesos (COP) 44,893,950 (approximately USD$23,200) per QALY gained. Improved blood glucose control associated to integrated pump/CGM results in a decreased incidence of diabetes-related complications and improves life expectancy as compared to MDI. Using recommended thresholds from the World Health Organization and previous coverage decisions about health technologies in Colombia, it is a cost-effective alternative to MDI for the treatment of type 1 diabetes in Colombia. Copyright © 2016 SEEN. Publicado por Elsevier España, S.L.U. All rights reserved.

  3. Feasibility of resistance training in adult McArdle patients: clinical outcomes and muscle strength and mass benefits.

    Science.gov (United States)

    Santalla, Alfredo; Munguía-Izquierdo, Diego; Brea-Alejo, Lidia; Pagola-Aldazábal, Itziar; Díez-Bermejo, Jorge; Fleck, Steven J; Ara, Ignacio; Lucia, Alejandro

    2014-01-01

    We analyzed the effects of a 4-month resistance (weight lifting) training program followed by a 2-month detraining period in 7 adult McArdle patients (5 female) on: muscle mass (assessed by DXA), strength, serum creatine kinase (CK) activity and clinical severity. Adherence to training was ≥84% in all patients and no major contraindication or side effect was noted during the training or strength assessment sessions. The training program had a significant impact on total and lower extremities' lean mass (P training by +855 g (95% confidence interval (CI): 30, 1679) and +547 g (95%CI: 116, 978), respectively, and significantly decreasing with detraining. Body fat showed no significant changes over the study period. Bench press and half-squat performance, expressed as the highest value of average muscle power (W) or force (N) in the concentric-repetition phase of both tests showed a consistent increase over the 4-month training period, and decreased with detraining. Yet muscle strength and power detraining values were significantly higher than pre-training values, indicating that a training effect was still present after detraining. Importantly, all the participants, with no exception, showed a clear gain in muscle strength after the 4-month training period, e.g., bench press: +52 W (95% CI: 13, 91); half-squat: +173 W (95% CI: 96, 251). No significant time effect (P > 0.05) was noted for baseline or post strength assessment values of serum CK activity, which remained essentially within the range reported in our laboratory for McArdle patients. All the patients changed to a lower severity class with training, such that none of them were in the highest disease severity class (3) after the intervention and, as such, they did not have fixed muscle weakness after training. Clinical improvements were retained, in all but one patient, after detraining, such that after detraining all patients were classed as class 1 for disease severity.

  4. Risk of Recurrence and Chemotherapy Benefit for Patients With Node-Negative, Estrogen Receptor–Positive Breast Cancer: Recurrence Score Alone and Integrated With Pathologic and Clinical Factors

    Science.gov (United States)

    Tang, Gong; Cuzick, Jack; Costantino, Joseph P.; Dowsett, Mitch; Forbes, John F.; Crager, Michael; Mamounas, Eleftherios P.; Shak, Steven; Wolmark, Norman

    2011-01-01

    Purpose The 21-gene breast cancer assay recurrence score (RS) is widely used for assessing recurrence risk and predicting chemotherapy benefit in patients with estrogen receptor (ER) –positive breast cancer. Pathologic and clinical factors such as tumor size, grade, and patient age also provide independent prognostic utility. We developed a formal integration of these measures and evaluated its prognostic and predictive value. Patients and Methods From the National Surgical Adjuvant Breast and Bowel (NSABP) B-14 and translational research cohort of the Arimidex, Tamoxifen Alone or in Combination (TransATAC) studies, we included patients who received hormonal monotherapy, had ER-positive tumors, and RS and traditional clinicopathologic factors assessed (647 and 1,088, respectively). Individual patient risk assessments from separate Cox models were combined using meta-analysis to form an RS-pathology-clinical (RSPC) assessment of distant recurrence risk. Risk assessments by RS and RSPC were compared in node-negative (N0) patients. RSPC was compared with RS for predicting chemotherapy benefit in NSABP B-20. Results RSPC had significantly more prognostic value for distant recurrence than did RS (P < .001) and showed better separation of risk in the study population. RSPC classified fewer patients as intermediate risk (17.8% v 26.7%, P < .001) and more patients as lower risk (63.8% v 54.2%, P < .001) than did RS among 1,444 N0 ER-positive patients. In B-20, the interaction of RSPC with chemotherapy was not statistically significant (P = .10), in contrast to the previously reported significant interaction of RS with chemotherapy (P = .037). Conclusion RSPC refines the assessment of distant recurrence risk and reduces the number of patients classified as intermediate risk. Adding clinicopathologic measures did not seem to enhance the value of RS alone nor the individual biology RS identifies in predicting chemotherapy benefit. PMID:22010013

  5. Risk of recurrence and chemotherapy benefit for patients with node-negative, estrogen receptor-positive breast cancer: recurrence score alone and integrated with pathologic and clinical factors.

    Science.gov (United States)

    Tang, Gong; Cuzick, Jack; Costantino, Joseph P; Dowsett, Mitch; Forbes, John F; Crager, Michael; Mamounas, Eleftherios P; Shak, Steven; Wolmark, Norman

    2011-11-20

    The 21-gene breast cancer assay recurrence score (RS) is widely used for assessing recurrence risk and predicting chemotherapy benefit in patients with estrogen receptor (ER) -positive breast cancer. Pathologic and clinical factors such as tumor size, grade, and patient age also provide independent prognostic utility. We developed a formal integration of these measures and evaluated its prognostic and predictive value. From the National Surgical Adjuvant Breast and Bowel (NSABP) B-14 and translational research cohort of the Arimidex, Tamoxifen Alone or in Combination (TransATAC) studies, we included patients who received hormonal monotherapy, had ER-positive tumors, and RS and traditional clinicopathologic factors assessed (647 and 1,088, respectively). Individual patient risk assessments from separate Cox models were combined using meta-analysis to form an RS-pathology-clinical (RSPC) assessment of distant recurrence risk. Risk assessments by RS and RSPC were compared in node-negative (N0) patients. RSPC was compared with RS for predicting chemotherapy benefit in NSABP B-20. RSPC had significantly more prognostic value for distant recurrence than did RS (P < .001) and showed better separation of risk in the study population. RSPC classified fewer patients as intermediate risk (17.8% v 26.7%, P < .001) and more patients as lower risk (63.8% v 54.2%, P < .001) than did RS among 1,444 N0 ER-positive patients. In B-20, the interaction of RSPC with chemotherapy was not statistically significant (P = .10), in contrast to the previously reported significant interaction of RS with chemotherapy (P = .037). RSPC refines the assessment of distant recurrence risk and reduces the number of patients classified as intermediate risk. Adding clinicopathologic measures did not seem to enhance the value of RS alone nor the individual biology RS identifies in predicting chemotherapy benefit.

  6. High-Risk Premenopausal Luminal A Breast Cancer Patients Derive no Benefit from Adjuvant Cyclophosphamide-based Chemotherapy: Results from the DBCG77B Clinical Trial.

    Science.gov (United States)

    Nielsen, Torsten O; Jensen, Maj-Brit; Burugu, Samantha; Gao, Dongxia; Jørgensen, Charlotte L Tykjaer; Balslev, Eva; Ejlertsen, Bent

    2017-02-15

    Purpose: Luminal A breast cancers have better prognosis than other molecular subtypes. Luminal A cancers may also be insensitive to adjuvant chemotherapy, although there is little high-level evidence to confirm this concept. The primary hypothesis in this formal prospective-retrospective analysis was to assess interaction between subtype (Luminal A vs. other) and treatment (chemotherapy vs. not) for the primary endpoint (10-year invasive disease-free survival) of a breast cancer trial randomizing women to adjuvant chemotherapy, analyzed in multivariate Cox proportional hazards models using the Wald interaction test. Experimental Design: The Danish Breast Cancer Cooperative Group 77B clinical trial randomized 1,072 premenopausal women to no systematic treatment (control), levamisole, cyclophosphamide, or cyclophosphamide-methotrexate-fluorouracil arms. All arms included radiotherapy but no endocrine therapy. Researchers with no access to clinical data performed intrinsic subtype analysis on tissue microarrays using published immunohistochemical methods based on estrogen receptor, progesterone receptor, HER2, Ki67, and basal markers. Results: Patients ( n = 709) had tissue available; chemotherapy benefit in these patients was similar to the original trial (HR, 0.56). Immunohistochemistry classified 165 as Luminal A, 319 Luminal B, 58 HER2-enriched, and 82 core basal (among 91 triple-negative). Patients with Luminal A breast tumors did not benefit from chemotherapy [HR, 1.06; 95% confidence interval (CI), 0.53-2.14; P = 0.86], whereas patients with non-luminal A subtypes did (HR, 0.50; 95% CI, 0.38-0.66; P benefit from adjuvant cyclophosphamide-based chemotherapy. Clin Cancer Res; 23(4); 946-53. ©2016 AACR . ©2016 American Association for Cancer Research.

  7. Benefits of Repetitive Transcranial Magnetic Stimulation (rTMS for Spastic Subjects: Clinical, Functional, and Biomechanical Parameters for Lower Limb and Walking in Five Hemiparetic Patients

    Directory of Open Access Journals (Sweden)

    Luc Terreaux

    2014-01-01

    Full Text Available Introduction. Spasticity is a disabling symptom resulting from reorganization of spinal reflexes no longer inhibited by supraspinal control. Several studies have demonstrated interest in repetitive transcranial magnetic stimulation in spastic patients. We conducted a prospective, randomized, double-blind crossover study on five spastic hemiparetic patients to determine whether this type of stimulation of the premotor cortex can provide a clinical benefit. Material and Methods. Two stimulation frequencies (1 Hz and 10 Hz were tested versus placebo. Patients were assessed clinically, by quantitative analysis of walking and measurement of neuromechanical parameters (H and T reflexes, musculoarticular stiffness of the ankle. Results. No change was observed after placebo and 10 Hz protocols. Clinical parameters were not significantly modified after 1 Hz stimulation, apart from a tendency towards improved recruitment of antagonist muscles on the Fügl-Meyer scale. Only cadence and recurvatum were significantly modified on quantitative analysis of walking. Neuromechanical parameters were modified with significant decreases in Hmax⁡ /Mmax⁡ and T/Mmax⁡ ratios and stiffness indices 9 days or 31 days after initiation of TMS. Conclusion. This preliminary study supports the efficacy of low-frequency TMS to reduce reflex excitability and stiffness of ankle plantar flexors, while clinical signs of spasticity were not significantly modified.

  8. Benefits of repetitive transcranial magnetic stimulation (rTMS) for spastic subjects: clinical, functional, and biomechanical parameters for lower limb and walking in five hemiparetic patients.

    Science.gov (United States)

    Terreaux, Luc; Gross, Raphael; Leboeuf, Fabien; Desal, Hubert; Hamel, Olivier; Nguyen, Jean Paul; Pérot, Chantal; Buffenoir, Kévin

    2014-01-01

    Introduction. Spasticity is a disabling symptom resulting from reorganization of spinal reflexes no longer inhibited by supraspinal control. Several studies have demonstrated interest in repetitive transcranial magnetic stimulation in spastic patients. We conducted a prospective, randomized, double-blind crossover study on five spastic hemiparetic patients to determine whether this type of stimulation of the premotor cortex can provide a clinical benefit. Material and Methods. Two stimulation frequencies (1 Hz and 10 Hz) were tested versus placebo. Patients were assessed clinically, by quantitative analysis of walking and measurement of neuromechanical parameters (H and T reflexes, musculoarticular stiffness of the ankle). Results. No change was observed after placebo and 10 Hz protocols. Clinical parameters were not significantly modified after 1 Hz stimulation, apart from a tendency towards improved recruitment of antagonist muscles on the Fügl-Meyer scale. Only cadence and recurvatum were significantly modified on quantitative analysis of walking. Neuromechanical parameters were modified with significant decreases in H max⁡ /M max⁡ and T/M max⁡ ratios and stiffness indices 9 days or 31 days after initiation of TMS. Conclusion. This preliminary study supports the efficacy of low-frequency TMS to reduce reflex excitability and stiffness of ankle plantar flexors, while clinical signs of spasticity were not significantly modified.

  9. Long-term clinical benefit and cost-effectiveness of an 8-week multimodal knee osteoarthritis management program incorporating intra-articular sodium hyaluronate (Hyalgan® injections

    Directory of Open Access Journals (Sweden)

    Miller LE

    2017-05-01

    -to-pay limits was 97.2%, 98.9%, and 99.4% for the $50,000, $100,000, and $150,000 per QALY thresholds, respectively. Conclusion: Participation in a single 8-week knee OA treatment program, which included one cycle of five intra-articular knee injections of sodium hyaluronate given at weekly intervals, is highly cost-effective and provides clinically meaningful reductions in patient symptoms that are maintained over 3.7 years mean follow-up. Keywords: arthroplasty, economic model, hyaluronic acid, pragmatic, viscosupplementation, Hyalgan®

  10. 8D.04: CLINICAL BENEFITS OF ADMINISTERING SUPER-SELECTIVE SEGMENTAL ADRENAL VENOUS SAMPLING AND PERFORMING ADRENAL SPARING SURGERY IN THE PATIENTS WITH PRIMARY ALDOSTERONISM.

    Science.gov (United States)

    Satoh, F; Morimoto, R; Ono, Y; Iwakura, Y; Omata, K; Kudo, M; Satani, N; Ota, H; Seiji, K; Takase, K; Nakamura, Y; Sasano, H; Ito, S

    2015-06-01

    Adrenal venous sampling (AVS) has been well known to play pivotal roles in clinical differential diagnosis of unilateral aldosterone producing adenoma (APA) from bilateral idiopathic hyperaldosteronism (IHA). However, it is also true that a central vein AVS or c-AVS which collects the blood from right and left central adrenal veins can by no means discriminate bilateral APA from BHA. There have been no published studies reporting the reliable clinical differential diagnosis between bilateral APA and IHA, especially IHA cases with bilateral non-functioning adenomas (NFA), which has been considered practically impossible in clinical differential diagnosis. As an attempt to this clinical dilemma, segmental AVS (S-AVS), which could evaluate segmental effluents from adrenal tributary veins, has been recently developed. We have performed S-AVS in these patients above following C-AVS, via the insertion of a microcatheter in up to three intra-adrenal first-degree tributary veins on bilateral adrenals. S-AVS did enable us to evaluate the intra-adrenal localization of corticosteroidogenesis. These data did indicate that S-AVS should be performed in the PA patients who had increased aldosterone levels in bilateral central vein and demonstrated space occupying lesions in the bilateral adrenals in order to avoid bilateral adrenalectomy or long lasting medical treatment toward persistent PA. In addition to the situations above, we have administere S-AVS to the following patients; those who had clinically suspected APA but not sufficiently high lateralization indexes according to the results of C-AVS, very young ones with higher clinical probability of recurrence and those who could benefit from partial adrenalectomy by demonstrating the sites of specific steroidogenesis. However, it is also entirely true that S-AVS is more expensive, time-consuming and labor-intensive compared to C-AVS.(Figure is included in full-text article.)The angiography during S-AVS (A, B), the coronal CT

  11. Economic and clinical benefit of collagenase ointment compared to a hydrogel dressing for pressure ulcer debridement in a long-term care setting.

    Science.gov (United States)

    Waycaster, Curtis; Milne, Catherine

    2013-06-01

    The purpose of this study is to determine the cost-effectiveness of collagenase ointment relative to autolysis with a hydrogel dressing when debriding necrotic pressure ulcers in a long-term care setting. A Markov decision process model with 2 states (necrotic nonviable wound bed transitioning to a granulated viable wound bed) was developed using data derived from a prospective, randomized, 6-week, single-center trial of 27 institutionalized subjects with pressure ulcers that were ≥ 85% necrotic nonviable tissue. Direct medical costs from the payer perspective included study treatments, wound treatment supplies, and nursing time. Clinical benefit was measured as "granulation days" and was derived from the time-dependent debridement rates of the alternative products. The average cost per patient for 42 days of pressure ulcer care was $1,817 in 2012 for the collagenase group and $1,611 for the hydrogel group. Days spent with a granulated wound were 3.6 times higher for collagenase (23.4 vs 6.5) than with the hydrogel. The estimated cost per granulation day was > 3.2 times higher for hydrogel ($249) vs collagenase ($78). In this economic analysis based on a randomized, controlled clinical trial, collagenase ointment resulted in a faster time to complete debridement and was more cost-effective than hydrogel autolysis for pressure ulcers in a long-term care setting. Even though collagenase ointment has a higher acquisition cost than hydrogel, the clinical benefit offsets the initial cost difference, resulting in lower cost per granulation day to the nursing home over the course of the 42-day analysis.

  12. Can repeat injection provide clinical benefit in patients with cervical disc herniation and stenosis when the first epidural injection results only in partial response?

    Science.gov (United States)

    Lee, Jung Hwan; Lee, Sang-Ho

    2016-07-01

    Epidural steroid injection (ESI) is known to be an effective treatment for neck or radicular pain due to herniated intervertebral disc (HIVD) and spinal stenosis (SS). Although repeat ESI has generally been indicated to provide more pain relief in partial responders after single ESI, there has been little evidence supporting the usefulness of this procedure. The purpose of this study, therefore, was to determine whether repeat ESI at a prescribed interval of 2 to 3 weeks after the first injection would provide greater clinical benefit in patients with partial pain reduction than intermittent ESI performed only when pain was aggravated. One hundred eighty-four patients who underwent transforaminal ESI (TFESI) for treatment of axial neck and radicular arm pain due to HIVD or SS and could be followed up for 1 year were enrolled. We divided the patients into 2 groups. Group A (N = 108) comprised partial responders (numeric rating scale (NRS) ≥ 3 after the first injection) who underwent repeat injection at a prescribed interval of 2 to 3 weeks after the first injection. Group B (N = 76) comprised partial responders who did not receive repeat injection at the prescribed interval, but received intermittent injections only for aggravation of pain. Various clinical data were assessed, including total number of injections during 1 year, NRS duration of Group A, or after first injection in Group B (time to reinjection). Groups A and B were compared in terms of total population, HIVD, and SS. In the whole population, HIVD subgroup, and SS subgroup, patients in Group A required significantly fewer injections to obtain satisfactory pain relief during the 1-year follow-up period. Group A showed a significantly longer time to reinjection and longer NRS Group B did. Repeat TFESI conducted at 2- to 3-week intervals after the first injection in partial responders contributed to greater clinical benefit compared with intermittent TFESI performed only upon pain

  13. Benefit of general anesthesia monitored by bispectral index compared with monitoring guided only by clinical parameters. Systematic review and meta-analysis

    Directory of Open Access Journals (Sweden)

    Carlos Rogério Degrandi Oliveira

    Full Text Available Abstract Background: The bispectral index parameter is used to guide the titration of general anesthesia; however, many studies have shown conflicting results regarding the benefits of bispectral index monitoring. The objective of this systematic review with meta-analysis is to evaluate the clinical impact of monitoring with the bispectral index parameter. Methods: The search for evidence in scientific information sources was conducted during December 2013 to January 2015, the following primary databases: Medline/PubMed, LILACS, Cochrane, CINAHL, Ovid, SCOPUS and TESES. The criteria for inclusion in the study were randomized controlled trials, comparing general anesthesia monitored, with bispectral index parameter with anesthesia guided solely by clinical parameters, and patients aged over 18 years. The criteria for exclusion were studies involving anesthesia or sedation for diagnostic procedures, and intraoperative wake-up test for surgery of the spine. Results: The use of monitoring with the bispectral index has shown benefits reducing time to extubation, orientation in time and place, and discharge from both the operating room and post anesthetic care unit. The risk of nausea and vomiting after surgery was reduced by 12% in patients monitored with bispectral index. Occurred a reduction of 3% in the risk of cognitive impairment postoperatively at 3 months postoperatively and 6% reduction in the risk of postoperative delirium in patients monitored with bispectral index. Furthermore, the risk of intraoperative memory has been reduced by 1%. Conclusion: Clinically, anesthesia monitoring with the BIS can be justified because it allows advantages from reducing the recovery time after waking, mainly by reducing the administration of general anesthetics as well as the risk of adverse events.

  14. Anti-inflammatory effect as a mechanism of effectiveness underlying the clinical benefits of pelotherapy in osteoarthritis patients: regulation of the altered inflammatory and stress feedback response

    Science.gov (United States)

    Ortega, E.; Gálvez, I.; Hinchado, M. D.; Guerrero, J.; Martín-Cordero, L.; Torres-Piles, S.

    2017-10-01

    The purpose of the present investigation was to evaluate whether an anti-inflammatory effect together with an improvement of the regulation of the interaction between the inflammatory and stress responses underlies the clinical benefits of pelotherapy in osteoarthritis (OA) patients. This study evaluated the effects of a 10-day cycle of pelotherapy at the spa centre `El Raposo' (Spain) in a group of 21 OA patients diagnosed with primary knee OA. Clinical assessments included pain intensity using a visual analog scale; pain, stiffness and physical function using the Western Ontario and McMaster Universities Arthritis Index; and health-related quality of life using the EuroQol-5D questionnaire. Serum inflammatory cytokine levels (IL-1β, TNF-α, IL-8, IL-6, IL-10 and TGF-β) were evaluated using the Bio-Plex® Luminex® system. Circulating neuroendocrine-stress biomarkers, such as cortisol and extracellular 72 kDa heat shock protein (eHsp72), were measured by ELISA. After the cycle of mud therapy, OA patients improved the knee flexion angle and OA-related pain, stiffness and physical function, and they reported a better health-related quality of life. Serum concentrations of IL-1β, TNF-α, IL-8, IL-6 and TGF-β, as well as eHsp72, were markedly decreased. Besides, systemic levels of cortisol increased significantly. These results confirm that the clinical benefits of mud therapy may well be mediated, at least in part, by its systemic anti-inflammatory effects and neuroendocrine-immune regulation in OA patients. Thus, mud therapy could be an effective alternative treatment in the management of OA.

  15. Clinical Response to Gefitinib Retreatment of Lung Adenocarcinoma Patients Who Benefited from An Initial Gefitinib Therapy: A Retrospective Analysis

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    Junling LI

    2012-01-01

    Full Text Available Background and objective Gefitinib is an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI that has been widely used for the treatment of non-small cell lung cancer (NSCLC. It is most effective in women, as well as in patients who have never smoked, have pulmonary adenocarcinomas, or are of Asian origin. Several treatment options are available for NSCLC patients who responded to initial gefitinib therapy but demonstrated tumor progression, of which gefitinib readministration is the chosen therapeutic option. The present study aims to evaluate the efficacy and toxicity of gefitinib readministration. Methods The clinical data of 18 patients with NSCLC who had shown partial response (PR or achieved a stable disease (SD status after gefitinib administration and were retreated with gefitinib due to failure of the initial therapy were reviewed and retrospectively analyzed. Results Of the 18 patients studied, 1 (6% showed partial remission (PR, 11 (61% achieved SD, and 6 (33% experienced disease progression. The disease control rate was 67%, and the median progression-free survival was 5.16 months (range, 1 to 24.8 months. The median overall survival from the start of the gefitinib therapy was 39.4 months (range, 15.38 to 52.44 months. Moreover, the median overall survival from the beginning of the 2nd therapy was 12.41 months (range, 3.98 to 38.24 months. Mild toxicity was observed with the 2nd gefitinib therapy. Conclusion The results of the present study indicate that patients with NSCLC may still be expected to achieve prolonged survival through gefitinib readministration if they initially responded to gefitinib and underwent various subsequent treatments.

  16. Meaningful Work and Secondary School Teachers' Intention to Leave

    Science.gov (United States)

    Janik, M.; Rothmann, S.

    2015-01-01

    The study investigates the relations between secondary school teachers' work-role fit, job enrichment, supervisor relationships, co-worker relationships, psychological meaningfulness of work and intention to leave. A cross-sectional survey was used. The participants were 502 secondary school teachers in Namibia. The following measuring instruments…

  17. Meaningful community involvement in protected area issues: a dialogue session

    Science.gov (United States)

    Laurie Yung

    2000-01-01

    The current effort to rethink public involvement in decision-making processes for federal lands is gaining momentum. Advocates of alternative decision-making processes seek to involve communities in more meaningful ways than traditional NEPA-style public participation. These new processes take the form of citizen monitoring, partnerships, and most often, collaboration...

  18. Pedagogical Principles of Learning to Teach Meaningful Physical Education

    Science.gov (United States)

    Ní Chróinín, Déirdre; Fletcher, Tim; O'Sullivan, Mary

    2018-01-01

    Background: Concerns that current forms of physical education teacher education (PETE) are not adequately providing teachers with the tools necessary for working with the realities and challenges of teaching physical education in contemporary schools has led some scholars to advocate for an approach that prioritises meaningfulness in physical…

  19. Callings, work role fit, psychological meaningfulness and work ...

    African Journals Online (AJOL)

    Our aim in this study was to investigate the relationships among a calling orientation, work role fit, psychological meaningfulness and work engagement of teachers in Zambia. A quantitative approach was followed and a cross-sectional survey was used. The sample (n = 150) included 75 basic and 75 secondary school ...

  20. Morality and a Meaningful Life | Thomas | Philosophical Papers

    African Journals Online (AJOL)

    ... healthy dovetail with respect to leading a meaningful life. With this argument regarding psychological health I draw upon, and extend, P. F. Strawson's seminal essay “Freedom and Resentment”. Also in this regard, I extend Wittgenstein's argument against the possibility of a private language to social behavior generally.

  1. Water Habitat Study: Prediction Makes It More Meaningful.

    Science.gov (United States)

    Glasgow, Dennis R.

    1982-01-01

    Suggests a teaching strategy for water habitat studies to help students make a meaningful connection between physiochemical data (dissolved oxygen content, pH, and water temperature) and biological specimens they collect. Involves constructing a poster and using it to make predictions. Provides sample poster. (DC)

  2. Cultural study in design : In search of a meaningful approach

    NARCIS (Netherlands)

    van Boeijen, A.G.C.

    2014-01-01

    Does the Circuit of Culture help design students to do a cultural study that is meaningful for their design project? Indeed, it provides a good view on the phenomenon culture, its complexity and how contemporary cultures can be studied, providing an overview and structure of the processes that

  3. Meaningful Gamification in an Industrial/Organizational Psychology Course

    Science.gov (United States)

    Stansbury, Jessica A.; Earnest, David R.

    2017-01-01

    Motivation and game research continue to demonstrate that the implementation of game design characteristics in the classroom can be engaging and intrinsically motivating. The present study assessed the extent to which an industrial organizational psychology course designed learning environment created with meaningful gamification elements can…

  4. Using Meaningful Contexts to Promote Understanding of Pronumerals

    Science.gov (United States)

    Linsell, Chris; Cavanagh, Michael; Tahir, Salma

    2013-01-01

    Developing a conceptual understanding of elementary algebra has been the focus of a number of recent articles in this journal. Baroudi (2006) advocated problem solving to assist students' transition from arithmetic to algebra, and Shield (2008) described the use of meaningful contexts for developing the concept of function. Samson (2011, 2012)…

  5. Comprehension for What? Preparing Students for Their Meaningful Future

    Science.gov (United States)

    Conley, Mark W.; Wise, Antoinette

    2011-01-01

    Researchers, policymakers, and educators face a daunting task these days concerning literacy education for the here and now and literacy for the future. Even though one clings to the romantic notion that education provides the building blocks in a straight line to a meaningful future, the reality is that mixed goals and instructional messages…

  6. Concept maps and the meaningful learning of science

    Directory of Open Access Journals (Sweden)

    José Antonio C. S. Valadares

    2013-03-01

    Full Text Available The foundations of the Meaningful Learning Theory (MLT were laid by David Ausubel. The MLT was highly valued by the contributions of Joseph Novak and D. B. Gowin. Unlike other learning theories, the MLT has an operational component, since there are some instruments based on it and with the meaningful learning facilitation as aim. These tools were designated graphic organizers by John Trowbridge and James Wandersee (2000, pp. 100-129. One of them is the concept map created by Novak to extract meanings from an amalgam of information, having currently many applications. The other one is the Vee diagram or knowledge Vee, also called epistemological Vee or heuristic Vee. It was created by Gowin, and is an excellent organizer, for example to unpack and make transparent the unclear information from an information source. Both instruments help us in processing and becoming conceptually transparent the information, to facilitate the cognitive process of new meanings construction. In this work, after a brief introduction, it will be developed the epistemological and psychological grounds of MLT, followed by a reference to constructivist learning environments facilitators of the meaningful learning, the characterization of concept maps and exemplification of its use in various applications that have proved to be very effective from the standpoint of meaningful learning.

  7. Synonyms, Antonyms, and Retroactive Inhibition with Meaningful Material

    Science.gov (United States)

    Weisshed, Ethel

    1973-01-01

    The determination of the extent to which generalizations derived from studies of rote verbal learning, particularly paired-associate learning applied to highly meaningful materials, was the focus of this study. It was found that discriminating tags to synonyms and antonyms permitting the application of appropriate transfer rules may be attached.…

  8. Types of Meaningfulness of Life and Values of Future Teachers

    Science.gov (United States)

    Salikhova, Nailia R.

    2016-01-01

    The leading role of meaning of life in regulation of human's activity of all types provides the relevance of the research. The goal of the paper is to identify and describe types of meaningfulness of life in future teachers, and to reveal the specificity of values hierarchy indicative of each type. The leading approach applied in the research was…

  9. How Do Novice Art Teachers Define and Implement Meaningful Curriculum?

    Science.gov (United States)

    Bain, Christina; Newton, Connie; Kuster, Deborah; Milbrandt, Melody

    2010-01-01

    Four researchers collaborated on this qualitative case study that examined 11 first-year novice art teachers' understanding and implementation of meaningful curriculum. Participants were selected through a criterion method sampling strategy; the subjects were employed in rural, urban, and suburban public school districts. In order to conduct a…

  10. Authentic Leadership and Altruism: The Mediating Role of Meaningfulness

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    Sagnak, Mesut; Kuruöz, Mehmet

    2017-01-01

    The purpose of this study was to investigate the mediating effects of meaningfulness on the relationship between authentic leadership and altruistic behavior. The participants consisted of 356 teachers randomly selected from 14 primary and secondary schools in Nigde. Three different instruments were used in this study. The scales were translated…

  11. Modeling Meaningful Learning in Chemistry Using Structural Equation Modeling

    Science.gov (United States)

    Brandriet, Alexandra R.; Ward, Rose Marie; Bretz, Stacey Lowery

    2013-01-01

    Ausubel and Novak's construct of "meaningful learning" stipulates that substantive connections between new knowledge and what is already known requires the integration of thinking, feeling, and performance (Novak J. D., (2010), "Learning, creating, and using knowledge: concept maps as facilitative tools in schools and…

  12. Net clinical benefit of new oral anticoagulants (dabigatran, rivaroxaban, apixaban) versus no treatment in a 'real world' atrial fibrillation population: a modelling analysis based on a nationwide cohort study.

    Science.gov (United States)

    Banerjee, Amitava; Lane, Deirdre A; Torp-Pedersen, Christian; Lip, Gregory Y H

    2012-03-01

    The concept of net clinical benefit has been used to quantify the balance between risk of ischaemic stroke (IS) and risk of intracranial haemorrhage (ICH) with the use oral anticoagulant therapy (OAC) in the setting of non-valvular atrial fibrillation (AF), and has shown that patients at highest risk of stroke and thromboembolism gain the greatest benefit from OAC with warfarin. There are no data for the new OACs, that is, dabigatran, rivaroxaban and apixaban, as yet. We calculated the net clinical benefit balancing IS against ICH using data from the Danish National Patient Registry on patients with non-valvular AF between 1997-2008, for dabigatran, rivaroxaban and apixaban on the basis of recent clinical trial outcome data for these new OACs. In patients with CHADS(2)=0 but at high bleeding risk, apixaban and dabigatran 110 mg bid had a positive net clinical benefit. At CHA(2)DS(2)-VASc=1, apixaban and both doses of dabigatran (110 mg and 150 mg bid) had a positive net clinical benefit. In patients with CHADS(2) score≥1 or CHA(2)DS(2)-VASc≥2, the three new OACs (dabigatran, rivaroxaban and apixaban) appear superior to warfarin for net clinical benefit, regardless of risk of bleeding. When risk of bleeding and stroke are both high, all three new drugs appear to have a greater net clinical benefit than warfarin. In the absence of head-to-head trials for these new OACs, our analysis may help inform decision making processes when all these new OACs become available to clinicians for stroke prevention in AF. Using 'real world' data, our modelling analysis has shown that when the risk of bleeding and stroke are both high, all three new drugs appear to have a greater net clinical benefit compared to warfarin.

  13. Long-term benefit of sunitinib in patients with metastatic renal cell carcinoma in Latin America: retrospective analysis of patient clinical characteristics

    Directory of Open Access Journals (Sweden)

    Smaletz O

    2016-11-01

    Full Text Available Oren Smaletz,1 Matias Chacón,2 Ludmila de Oliveira Koch,1 Daniela R de Carvalho Rocha,1 Fernanda C Cardoso1 1Department of Oncology, Hospital Israelita Albert Einstein, São Paulo, Brazil; 2Medical Oncology Department, Alexander Fleming Institute, Buenos Aires, Argentina Objective: To describe the clinical characteristics of Latin American patients with metastatic renal cell carcinoma (mRCC who experienced a progression-free survival (PFS for at least 15 months following treatment with sunitinib. Patients and methods: In this retrospective analysis, mRCC patients in two institutions in Latin America received sunitinib at a starting dose of either 50 mg/day for 4 weeks followed by 2 weeks off treatment (Schedule 4/2 in repeated 6-week cycles or sunitinib 37.5 mg on a continuous daily dosing schedule. Clinical characteristics, tolerability, and PFS data were collected. Results: Twenty-nine patients with long-term clinical benefit from sunitinib were identified between September 2005 and August 2009. Median PFS was 23 months (range: 15–54 months. Two of the 29 patients with prolonged PFS achieved a complete response and additional eleven had a partial response. Most patients were aged <60 years, had good performance status, favorable or intermediate Memorial Sloan Kettering Cancer Center prognostic risk, and disease limited to one or two sites. Dose reduction was necessary in all patients who started sunitinib at 50 mg/day administered on Schedule 4/2. Adverse events leading to dose reduction included grade 3 hand–foot syndrome, mucositis, fatigue, and hypertension. At the time of data cutoff, four patients were still receiving sunitinib treatment. Conclusion: Extended PFS can be achieved in Latin American patients with mRCC treated with sunitinib. Although the small sample size and retrospective nature of this evaluation preclude the identification of pretreatment predictive factors contributing to this benefit, the current analysis warrants

  14. A preliminary case series evaluating the safety and immediate to short-term clinical benefits of joint mobilization in hemophilic arthritis of the lower limb.

    Science.gov (United States)

    Scaddan, Emma; Rowell, John; O'Leary, Shaun

    2017-09-01

    Arthritis resulting from recurrent intra-articular bleeding in individuals with hemophilia can be severely debilitating due to joint pain and stiffness with subsequent loss of mobility and function. Very limited studies have investigated the potential benefits of joint mobilization for this condition. This case series is a preliminary investigation of safety, as well as immediate and short-term clinical benefits, associated with gentle knee and ankle joint mobilization in people with hemophilic arthropathy. A single intervention of joint mobilization was applied to the affected knees and/or ankles of 16 individuals with severe or moderate hemophilia within a public hospital setting. Adverse events, as well as immediate (pain-free passive joint range, Timed Up and Go Test with maximum pain numerical rating scale) and short-term (Lower Extremity Functional Scale) effects of the intervention were evaluated with a repeated measures ANOVA. There were no adverse events. An immediate significant increase was observed in pain-free passive ankle joint range of motion ( p  < 0.05) following the joint mobilization intervention. The findings of this case series suggest that gentle joint mobilization techniques may be safely considered as part of a multimodal management approach for hemophilic arthropathy.

  15. A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Additional Benefit of a Multistrain Synbiotic (Prodefen® in the Clinical Management of Acute Viral Diarrhea in Children

    Directory of Open Access Journals (Sweden)

    Emilia García-Menor MD

    2016-11-01

    Full Text Available This randomized, open-label study evaluated the additional benefits of the synbiotic Prodefen® in the clinical management of acute diarrhea of suspected viral origin in children between 6 months and 12 years of age. Study outcomes included the duration of diarrhea, the recovery from diarrhea, and the tolerability and acceptance of the treatment. The proportion of patients without diarrhea over the study period was greater in the synbiotic group than in the control group at all study time points, showing a statistically significant difference on the fifth day (95% vs 79%, p < 0.001. The duration of diarrhea (median and interquartile range was reduced by 1 day in the synbiotic-treated patients (3 [2-5] vs 4 [3-5], p = 0.377. The tolerability of the treatment regimen, as evaluated by the parents, was significantly better in those receiving the synbiotic than in the control group. Overall, 96% of the parents of children receiving the synbiotic reported being satisfied to very satisfied with the treatment regimen. The results of this study indicate that the addition of the synbiotic Prodefen® is a well-tolerated and well-accepted approach that provides an additional benefit to the standard supportive therapy in the management of acute viral diarrhea in children.

  16. Evaluating meaningful learning using concept mapping in dental hygiene education: a pilot study.

    Science.gov (United States)

    Canasi, Dina M; Amyot, Cynthia; Tira, Daniel

    2014-02-01

    Concept mapping, as a teaching strategy, has been shown to promote critical thinking and problem solving in educational settings. Dental clinicians must distinguish between critical and irrelevant characteristics in the delivery of care, thus necessitating reasoning skills to do so. One of the aims of the American Dental Education Association Commission on Change and Innovation (ADEA-CCI) is to identify deficiencies in curriculum which were meant to improve critical thinking and problem solving skills necessary in clinical practice. The purpose of this study was to compare 2 teaching strategies, traditional lecture and lecture supported by concept mapping exercises within collaborative working groups, to determine if there is a beneficial effect on meaningful learning. For this pilot study, the study population consisted of students from 2 geographically separated associate level dental hygiene programs in the southeastern U.S. A quasi-experimental control group pre- and post-test design was used. The degree of meaningful learning achieved by both programs was assessed by comparing pre- and post-test results. Both programs experienced a significant degree of meaningful learning from pre- to post-test. However, there was no statistically significant difference between the programs on the post-test. These results were in direct contrast to research in other disciplines on concept mapping and its effect on promoting meaningful learning. Further investigation into the study's outcome was obtained through a follow-up focus group. In spite of careful attention to methodology in the development of this research project, the focus group illuminated methodological failings that potentially impacted the outcome of the study. Recommendations are underscored for future conduct of educational research of this kind.

  17. Verification of the sensitivity of functional scores for treatment results - Substantial clinical benefit thresholds for the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ).

    Science.gov (United States)

    Kasai, Yuichi; Fukui, Mitsuru; Takahashi, Kazuhisa; Ohtori, Seiji; Takeuchi, Daisaku; Hashizume, Hiroshi; Kanamori, Masahiko; Hosono, Noboru; Kanchiku, Tsukasa; Wada, Eiji; Sekiguchi, Miho; Konno, Shinichi; Kawakami, Mamoru

    2017-07-01

    Validity and reliability of the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) had already been verified as the patients' self-rating assessment of low back pain and lumbar spinal disease and, the present study demonstrated the responsiveness of this measure. 192 subjects who were determined by medical instructors of the Japanese Society for Spine Surgery and Related Research were analyzed. They had completed a series of treatment and both surveys before and after the treatment. Authors investigated rates of concordance between assessment by physicians and subjective assessment by patients. The mean, standard deviation, minimum, 25th percentile, median, 75th percentile and maximum values for pre-treatment, post-treatment, and acquired points were calculated, and then, we also investigated the trend between subjective assessment by patients and mean acquired points for each JOABPEQ domain and substantial clinical benefit thresholds for the JOABPEQ. Symptom changes as assessed by physicians did not coincide with those by patients, and acquired points in each JOABPEQ domain were significantly increased with improved self-rating by patients. In addition, patients who rated symptom changes as "slightly improved" showed a mean acquired points of ≥20, and those reporting "improved" showed a 25th percentile points of the acquired points of ≥20 approximately. A significant correlation was noted between the self-rating of patients and acquired points JOABPEQ, suggesting that ≥20 acquired points can be interpreted as substantial clinical benefit thresholds for the JOABPEQ. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  18. Gratitude and well being: the benefits of appreciation.

    Science.gov (United States)

    Sansone, Randy A; Sansone, Lori A

    2010-11-01

    The word "gratitude" has a number of different meanings, depending on the context. However, a practical clinical definition is as follows-gratitude is the appreciation of what is valuable and meaningful to oneself; it is a general state of thankfulness and/or appreciation. The majority of empirical studies indicate that there is an association between gratitude and a sense of overall well being. However, there are several studies that indicate potential nuances in the relationship between gratitude and well being as well as studies with negative findings. In terms of assessing gratitude, numerous assessment measures are available. From a clinical perspective, there are suggested therapeutic exercises and techniques to enhance gratitude, and they appear relatively simple and easy to integrate into psychotherapy practice. However, the therapeutic efficacy of these techniques remains largely unknown. Only future research will clarify the many questions around assessment, potential benefits, and enhancement of gratitude.

  19. Meaningful Human Control over Autonomous Systems: A Philosophical Account

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    Filippo Santoni de Sio

    2018-02-01

    Full Text Available Debates on lethal autonomous weapon systems have proliferated in the past 5 years. Ethical concerns have been voiced about a possible raise in the number of wrongs and crimes in military operations and about the creation of a “responsibility gap” for harms caused by these systems. To address these concerns, the principle of “meaningful human control” has been introduced in the legal–political debate; according to this principle, humans not computers and their algorithms should ultimately remain in control of, and thus morally responsible for, relevant decisions about (lethal military operations. However, policy-makers and technical designers lack a detailed theory of what “meaningful human control” exactly means. In this paper, we lay the foundation of a philosophical account of meaningful human control, based on the concept of “guidance control” as elaborated in the philosophical debate on free will and moral responsibility. Following the ideals of “Responsible Innovation” and “Value-sensitive Design,” our account of meaningful human control is cast in the form of design requirements. We identify two general necessary conditions to be satisfied for an autonomous system to remain under meaningful human control: first, a “tracking” condition, according to which the system should be able to respond to both the relevant moral reasons of the humans designing and deploying the system and the relevant facts in the environment in which the system operates; second, a “tracing” condition, according to which the system should be designed in such a way as to grant the possibility to always trace back the outcome of its operations to at least one human along the chain of design and operation. As we think that meaningful human control can be one of the central notions in ethics of robotics and AI, in the last part of the paper, we start exploring the implications of our account for the design and use of non

  20. Meaningful Watershed Experiences for Middle and High School Students

    Science.gov (United States)

    Landry, Melinda; Smith, Cynthia; Greene, Joy

    2014-05-01

    Prince William County Public Schools and George Mason University in Virginia, USA, partnered to provide Meaningful Watershed Educational Experiences (MWEEs) for over 25,000 middle and high school students (11-18 year olds) across 34 schools. This school district, situated in a rapidly growing region 55 km southwest of Washington DC, has over 82,000 K-12 students. As native forest cover has been replaced with farming and urbanization, water quality has significantly degraded in the 166,534 km2 Chesapeake Bay watershed. This project was designed to increase student awareness of their impact on the land and waters of the largest estuary in the United States. MWEE is a long-term comprehensive project that incorporates a classroom preparation phase, a hands-on outdoor field investigation, and a reflection and data-sharing component. Training and technical assistance enhances the capacity of teachers of 6th grade, high school Earth Science and Environmental Science to deliver MWEEs which includes schoolyard stewardship, inquiry driven field study, use of hand-held technology and computer based mapping and analysis, project sharing and outreach. George Mason University researchers worked closely with K-12 science educators to create a comprehensive watershed-focused curriculum. Graduate and undergraduate students with strong interests in environmental science and education were trained to deliver the field investigation component of the MWEE. Representative teachers from each school were provided 3 days of professional development and were responsible for the training of their school's science education team. A comprehensive curriculum provided teachers with activities and tools designed to enhance students' mastery of state science objectives. Watershed concepts were used as the unifying theme to support student understanding of curriculum and STEM objectives including: scientific investigation, data collection and communication, chemistry, energy, erosion, human

  1. Romidepsin for the treatment of relapsed/refractory peripheral T cell lymphoma: prolonged stable disease provides clinical benefits for patients in the pivotal trial

    Directory of Open Access Journals (Sweden)

    Francine Foss

    2016-03-01

    Full Text Available Abstract Background Achievement of durable responses in patients with relapsed/refractory peripheral T cell lymphoma (PTCL is challenging with current therapies, and there are few data regarding the potential benefits of continuing treatment in patients with the best response of stable disease (SD. Histone deacetylase inhibitors are a novel class of drugs with activity in T cell malignancies. Romidepsin was approved by the US Food and Drug Administration for the treatment of relapsed/refractory PTCL based on a pivotal trial demonstrating an objective response rate of 25 % (33/130, including 15 % with confirmed/unconfirmed complete response and a median duration of response of 28 months. Our objective was to further study the clinical benefits of romidepsin in patients that had the best response of SD. Methods Patients with PTCL relapsed/refractory to ≥1 prior therapy were treated with the approved dose of 14 mg/m2 romidepsin on days 1, 8, and 15 of six 28-day cycles; patients with SD or response after cycle 6 were allowed to continue on study until progression. By protocol amendment, patients treated for ≥12 cycles could receive maintenance dosing twice per cycle; after cycle 24, dosing could be further reduced to once per cycle in those who had received maintenance dosing for ≥6 months. Results Of the 32 patients (25 % with the best response of SD, 22 had SD for ≥90 days (SD90; cycle 4 response assessment. The longest SD was >3 years in a patient who received maintenance dosing of 14 mg/m2 on days 1 and 15 beginning in cycle 13. Patients with the best response of SD90 or partial response achieved similar overall and progression-free survival. Prolonged dosing of romidepsin was well tolerated. Conclusions We concluded that patients who achieve SD may consider continuing treatment because the clinical benefits of romidepsin may extend beyond objective responses. Trial registration NCT00426764

  2. In search of meaningfulness: nostalgia as an antidote to boredom.

    Science.gov (United States)

    van Tilburg, Wijnand A P; Igou, Eric R; Sedikides, Constantine

    2013-06-01

    We formulated, tested, and supported, in 6 studies, a theoretical model according to which individuals use nostalgia as a way to reinject meaningfulness in their lives when they experience boredom. Studies 1-3 established that induced boredom causes increases in nostalgia when participants have the opportunity to revert to their past. Studies 4 and 5 examined search for meaning as a mediator of the effect of boredom on nostalgia. Specifically, Study 4 showed that search for meaning mediates the effect of state boredom on nostalgic memory content, whereas Study 5 demonstrated that search for meaning mediates the effect of dispositional boredom on dispositional nostalgia. Finally, Study 6 examined the meaning reestablishment potential of nostalgia during boredom: Nostalgia mediates the effect of boredom on sense of meaningfulness and presence of meaning in one's life. Nostalgia counteracts the meaninglessness that individuals experience when they are bored.

  3. Concept Mapping Using Cmap Tools to Enhance Meaningful Learning

    Science.gov (United States)

    Cañas, Alberto J.; Novak, Joseph D.

    Concept maps are graphical tools that have been used in all facets of education and training for organizing and representing knowledge. When learners build concept maps, meaningful learning is facilitated. Computer-based concept mapping software such as CmapTools have further extended the use of concept mapping and greatly enhanced the potential of the tool, facilitating the implementation of a concept map-centered learning environment. In this chapter, we briefly present concept mapping and its theoretical foundation, and illustrate how it can lead to an improved learning environment when it is combined with CmapTools and the Internet. We present the nationwide “Proyecto Conéctate al Conocimiento” in Panama as an example of how concept mapping, together with technology, can be adopted by hundreds of schools as a means to enhance meaningful learning.

  4. [Benefits of nursing care service in the assisted reproduction clinic to self-cycle-management and self-efficiency of infertility patients].

    Science.gov (United States)

    Li, Xiao-Qin; Sun, Chao-Feng; Guo, Mei

    2017-06-01

    To investigate the benefits of nursing care service in the assisted reproduction clinic to self-cycle-management and self-efficiency of the outpatients with infertility. We randomly divided 600 females preliminarily diagnosed with infertility into a control and an experimental group, 288 in the former and 285 in the latter group excluding those whose husbands had azoospermia. For the women patients of the experimental group, we conducted nursing care intervention concerning related knowledge, skills, diet, excise, medication, and psychology, by one-to-one consultation, individualized or group communication, establishing files, telephone follow-up, and wechat guidance. After 3 months of intervention, we compared the compliance of medical visits, effectiveness of cycle management, sense of self-efficiency, satisfaction, and anxiety score between the two groups of patients. In comparison with the controls, the patients of the experimental group showed significantly better knowledge about assisted reproduction and higher effectiveness of self-cycle-management, self-efficiency, and satisfaction (P <0.05), but a markedly lower degree of anxiety (P <0.05). Nursing care service in the assisted reproduction clinic can improve the compliance of medical visits, effectiveness of self-cycle-management, self-efficiency, and satisfaction and reduce the anxiety of the patients.

  5. Formestane, a steroidal aromatase inhibitor after failure of non-steroidal aromatase inhibitors (anastrozole and letrozole): is a clinical benefit still achievable?

    Science.gov (United States)

    Carlini, P; Frassoldati, A; De Marco, S; Casali, A; Ruggeri, E M; Nardi, M; Papaldo, P; Fabi, A; Paoloni, F; Cognetti, F

    2001-11-01

    There are few clinical data on the sequential use of aromatase inhibitors (AI). This paper focuses on the relevance of clinical benefit CB (CR + PR + SD > or = 6 months) in postmenopausal metastatic breast cancer (MBC) patients treated with the steroidal aromatase inhibitor (SAI) formestane (FOR). who had already received non-steroidal aromatase inhibitor (nSAI): letrozole (LTZ) or anastrozole (ANZ). Twenty postmenopausal women with MBC were analysed in this retrospective two-centre study with the sequence nSAI-FOR. When receiving ANZ, 1 of 11 achieved a complete response and 9 of 11 a stable disease > or = 6 months, and receiving LTZ 1 of 9 achieved a partial response and 4 of 9 a stable disease > or = 6 months. The analysis of the entire population treated with FOR showed an overall CB of 55% (11 of 20) with a median duration of 15 months and median time to progression (TTP) of 6 months. Formestane 250 mg once bi-weekly seems to be an attractive alternative third-line hormonal therapy for the treatment of patients with MBC, previously treated with nSAI.

  6. Meaningful Use of a Confidential Adolescent Patient Portal.

    Science.gov (United States)

    Thompson, Lindsay A; Martinko, Thomas; Budd, Pamela; Mercado, Rebeccah; Schentrup, Anzeela M

    2016-02-01

    To design and evaluate the usage of an adolescent patient portal specifically adapted for adolescent health care needs that also satisfied institutional meaningful use guidelines regarding electronic health records. Key stakeholders at one academic health care center adopted an online portal and opted to designate a patient portal specifically for adolescents to maximize confidentiality in compliance with state privacy laws. This study analyzed aggregate electronic health record data of adolescents' (ages 12-17.9 years) uptake, usage, and functionality of this portal and compared it to parent portal usage for younger children (ages 0-11 years). Differences in means were calculated using paired t tests. The portal was used similarly between parents of young children and adolescents, with almost 1,000 enrollees in each group from September 1, 2012 to March 31, 2015. There were no gender differences in enrollment. Adolescents were less likely than parents of younger children to review appointments (73% vs. 85%), laboratory tests (67% vs. 79%), problem lists (40% vs. 78%), or allergies (45% vs. 77%, all p values adolescents sent 1,397 confidential messages. Institutional decisions for implementing meaningful use requirements can align with goals of adolescent health. Patient portals can enhance adolescent health care quality and adolescents readily use a confidential portal. Implementation of meaningful use requirements should be checked against adolescent health care needs to maximize confidentiality and promote health communication. Copyright © 2016 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

  7. Genetic risk, coronary heart disease events, and the clinical benefit of statin therapy: an analysis of primary and secondary prevention trials.

    Science.gov (United States)

    Mega, J L; Stitziel, N O; Smith, J G; Chasman, D I; Caulfield, M; Devlin, J J; Nordio, F; Hyde, C; Cannon, C P; Sacks, F; Poulter, N; Sever, P; Ridker, P M; Braunwald, E; Melander, O; Kathiresan, S; Sabatine, M S

    2015-06-06

    Genetic variants have been associated with the risk of coronary heart disease. In this study, we tested whether or not a composite of these variants could ascertain the risk of both incident and recurrent coronary heart disease events and identify those individuals who derive greater clinical benefit from statin therapy. A community-based cohort study (the Malmo Diet and Cancer Study) and four randomised controlled trials of both primary prevention (JUPITER and ASCOT) and secondary prevention (CARE and PROVE IT-TIMI 22) with statin therapy, comprising a total of 48,421 individuals and 3477 events, were included in these analyses. We studied the association of a genetic risk score based on 27 genetic variants with incident or recurrent coronary heart disease, adjusting for traditional clinical risk factors. We then investigated the relative and absolute risk reductions in coronary heart disease events with statin therapy stratified by genetic risk. We combined data from the different studies using a meta-analysis. When individuals were divided into low (quintile 1), intermediate (quintiles 2-4), and high (quintile 5) genetic risk categories, a significant gradient in risk for incident or recurrent coronary heart disease was shown. Compared with the low genetic risk category, the multivariable-adjusted hazard ratio for coronary heart disease for the intermediate genetic risk category was 1·34 (95% CI 1·22-1·47, pgenetic risk category was 1·72 (1·55-1·92, pgenetic risk categories. Similarly, we noted greater absolute risk reductions in those individuals in higher genetic risk categories (p=0·0101), resulting in a roughly threefold decrease in the number needed to treat to prevent one coronary heart disease event in the primary prevention trials. Specifically, in the primary prevention trials, the number needed to treat to prevent one such event in 10 years was 66 in people at low genetic risk, 42 in those at intermediate genetic risk, and 25 in those at high

  8. Benefits of a comprehensive quality program for cryopreserved PBMC covering 28 clinical trials sites utilizing an integrated, analytical web-based portal.

    Science.gov (United States)

    Ducar, Constance; Smith, Donna; Pinzon, Cris; Stirewalt, Michael; Cooper, Cristine; McElrath, M Juliana; Hural, John

    2014-07-01

    cellular assays (mean, 91.46% ±4.5%), and 96.2% had acceptable recoveries (50%-130%) with a mean of recovery of 85.8% ±19.12% of the originally cryopreserved cells. EQC testing revealed that since August 2009, failed recoveries dropped from 4.1% to 1.6% and failed viabilities dropped from 1.0% to 0.3%. The HVTN PBMC quality program provides for laboratory assessment, training and tools for identifying problems, implementing corrective action and monitoring for improvements. These data support the benefits of implementing a comprehensive, web-based PBMC quality program for large clinical trials networks. Copyright © 2014 Elsevier B.V. All rights reserved.

  9. Clinical characteristics predict benefits from eptifibatide therapy during coronary stenting: insights from the Enhanced Suppression of the Platelet IIb/IIIa Receptor With Integrilin Therapy (ESPRIT) trial.

    Science.gov (United States)

    Puma, Joseph A; Banko, Lesan T; Pieper, Karen S; Sacchi, Terrence J; O'Shea, J Conor; Dery, Jean Pierre; Tcheng, James E

    2006-02-21

    In order to determine a differential benefit from treatment, we compared the long-term outcome of high-risk versus low-risk patients and evaluated survival free from death or myocardial infarction at one year. Newer anticoagulant strategies during percutaneous coronary intervention have necessitated a reanalysis of the role of intravenous GP IIb/IIIa inhibitors. The Enhanced Suppression of the Platelet IIb/IIIa Receptor with Integrilin Therapy trial randomized 2,064 patients undergoing nonurgent coronary stent implantation to eptifibatide or placebo. High-risk characteristics were defined as age >75 years, diabetes, elevated cardiac markers, ST-segment elevation myocardial infarction within 7 days, or unstable angina within 48 h of randomization. Age <5 years, absence of diabetes, and any other reason for admission were considered low risk characterstics. There were 1,018 patients in the high-risk group (50.8% eptifibatide, 49.2% placebo) and 1,045 patients in the low-risk group (50.0% eptifibatide, 50.0% placebo). Baseline demographics were similar in both groups except for more hypertension (63% vs. 55%, respectively), peripheral vascular disease (8.2% vs. 5.2%, respectively), prior stroke (5.5% vs. 3.2%, respectively), and female gender (33% vs. 22%, respectively) in the high-risk than the low-risk group. At one year, the composite end point of death or myocardial infarction occurred in 15.89% of placebo patients and 7.99% of eptifibatide patients in the high-risk group and 9.02% of the placebo and 8.11% of eptifibatide patients in the low-risk group. Although eptifibatide treatment improved outcomes for all patients, preprocedural clinical characteristics can define a subgroup of patients who may derive greatest benefit from its use during coronary stent placement.

  10. Clinical Trials

    Medline Plus

    Full Text Available ... medical centers and doctors' offices around the country. Benefits and Risks Possible Benefits Taking part in a clinical trial can have many benefits. For example, you may gain access to new ...

  11. QUALITY MANAGEMENT SYSTEM IN CLINICAL LABORATORIES ACCORDING TO THE ISO 15189:2007 STANDARD - EVALUATION OF THE BENEFITS OF IMPLEMENTATION IN AN ASSISTED REPRODUCTION LABORATORY

    Directory of Open Access Journals (Sweden)

    A.D. Sialakouma

    2011-03-01

    in the provision of human resources, equipment, supplies and working environment and the resolution of organisational problems. This article deals with the planning and the implementation of a Quality Management System, in accordance with ISO 15189 (2007, in the Assisted Reproduction Laboratory in one of the biggest Maternity Clinics in Greece. The benefits resulted; both for medical laboratory service and patients are also presented and discussed.

  12. Meaningful Ways of Understanding and Measuring Change for People with Borderline Personality Disorder: A Thematic Analysis.

    Science.gov (United States)

    McCusker, Louise; Turner, Marie-Louise; Pike, Georgina; Startup, Helen

    2018-02-19

    The effective treatment of Borderline Personality Disorder (BPD) presents healthcare providers with a significant challenge. The evidence base remains limited partially due to a lack of professional consensus and service user involvement regarding ways of measuring change. As a result, the limited evidence that is available draws on such a wide range of outcome measures, that comparison across treatment types is hindered, maintaining a lack of clarity regarding the clinical needs of this group. This investigation aimed to follow the National Institute of Clinical Excellence (NICE, 2009) research recommendations by asking service users about meaningful change within their recovery. This forms a starting point for the future development of a tailored outcome measure. Fifteen service users with a diagnosis of BPD participated in three focus groups across two specialist Personality Disorder services. The focus groups were analysed using Thematic Analysis. Two superordinate themes were synthesized from the data: (1) recovery to what?: 'How do you rewrite who you are?'; and (2) conditions for change. Each superordinate theme further consisted of three subordinate themes which elucidated the over-arching themes. This investigation highlights the complex nature of measuring change in people who have received a BPD diagnosis. Further research is needed to develop meaningful ways of measuring change according to the needs and priorities of people with BPD.

  13. Reducing TNF receptor 2+ regulatory T cells via the combined action of azacitidine and the HDAC inhibitor, panobinostat for clinical benefit in acute myeloid leukemia patients.

    Science.gov (United States)

    Govindaraj, Chindu; Tan, Peter; Walker, Patricia; Wei, Andrew; Spencer, Andrew; Plebanski, Magdalena

    2014-02-01

    Acute myeloid leukemia (AML) provides an environment that enables immune suppression, resulting in functionally defective effector T cells; regulatory T cells (Treg) are significant contributors to the impaired antitumor immune response. As TNF is present at high levels in AML and TNF receptor-2 (TNFR2)-expressing Tregs identify highly functional Tregs, we examine the hypothesis that TNFR2(+) Tregs are a relevant Treg subset in this cancer. We also determine the effect of the novel combinatorial therapy of the demethylating agent, azacitidine with the histone deacetylase inhibitor, panobinostat on Tregs, particularly TNFR2(+) Tregs. Thirty healthy donors and 14 patients with AML were enrolled in this study. Patients were treated with azacitidine and panobinostat for 28-day cycles. The frequency and functional relevance of TNFR2(+) Tregs were analyzed subsequently. We report that TNFR2(+) Tregs are increased in AML and have a high migration potential toward the bone marrow. Furthermore, we demonstrate that the level of TNFR2(+) Tregs in the peripheral blood and the bone marrow of patients are decreased in vivo after exposure to panobinostat and azacitidine. Reductions in TNFR2(+) Tregs were associated with increases in Interferon (IFN)-γ and interleukin (IL)-2 production by effector T cells within the bone marrow and beneficial clinical responses. In vitro mechanistic studies indicated panobinostat as the primary driver for the reduction of Tregs. Our study provides for the first time, in vivo validation of the ability of panobinostat in combination with azacitidine to suppress prevalent TNFR2(+) Tregs, resulting in clinical benefits within patients with AML. ©2013 AACR.

  14. Locoregional Confinement and Major Clinical Benefit of 188Re-Loaded CXCR4-Targeted Nanocarriers in an Orthotopic Human to Mouse Model of Glioblastoma.

    Science.gov (United States)

    Séhédic, Delphine; Chourpa, Igor; Tétaud, Clément; Griveau, Audrey; Loussouarn, Claire; Avril, Sylvie; Legendre, Claire; Lepareur, Nicolas; Wion, Didier; Hindré, François; Davodeau, François; Garcion, Emmanuel

    2017-01-01

    Gold standard beam radiation for glioblastoma (GBM) treatment is challenged by resistance phenomena occurring in cellular populations well prepared to survive or to repair damage caused by radiation. Among signals that have been linked with radio-resistance, the SDF1/CXCR4 axis, associated with cancer stem-like cell, may be an opportune target. To avoid the problem of systemic toxicity and blood-brain barrier crossing, the relevance and efficacy of an original system of local brain internal radiation therapy combining a radiopharmaceutical with an immuno-nanoparticle was investigated. The nanocarrier combined lipophilic thiobenzoate complexes of rhenium-188 loaded in the core of a lipid nanocapsule (LNC 188 Re) with a function-blocking antibody, 12G5 directed at the CXCR4, on its surface. The efficiency of 12G5-LNC 188 Re was investigated in an orthotopic and xenogenic GBM model of CXCR4-positive U87MG cells implanted in the striatum of Scid mice. We demonstrated that 12G5-LNC 188 Re single infusion treatment by convection-enhanced delivery resulted in a major clinical improvement in median survival that was accompanied by locoregional effects on tumor development including hypovascularization and stimulation of the recruitment of bone marrow derived CD11b- or CD68-positive cells as confirmed by immunohistochemistry analysis. Interestingly, thorough analysis by spectral imaging in a chimeric U87MG GBM model containing CXCR4-positive/red fluorescent protein (RFP)-positive- and CXCR4-negative/RFP-negative-GBM cells revealed greater confinement of DiD-labeled 12G5-LNCs than control IgG2a-LNCs in RFP compartments. Main conclusion: These findings on locoregional impact and targeting of disseminated cancer cells in tumor margins suggest that intracerebral active targeting of nanocarriers loaded with radiopharmaceuticals may have considerable benefits in clinical applications.

  15. Identifying who will benefit from non-invasive ventilation in amyotrophic lateral sclerosis/motor neurone disease in a clinical cohort.

    Science.gov (United States)

    Berlowitz, David J; Howard, Mark E; Fiore, Julio F; Vander Hoorn, Stephen; O'Donoghue, Fergal J; Westlake, Justine; Smith, Anna; Beer, Fiona; Mathers, Susan; Talman, Paul

    2016-03-01

    Respiratory failure is associated with significant morbidity and is the predominant cause of death in motor neurone disease/amyotrophic lateral sclerosis (MND/ALS). This study aimed to determine the effect of non-invasive ventilatory (NIV) support on survival and pulmonary function decline across MND/ALS phenotypes. Cohort recruited via a specialist, multidisciplinary clinic. Patients were categorised into four clinical phenotypes (ALS, flail arm, flail leg and primary lateral sclerosis) according to site of presenting symptom and the pattern of upper versus lower motor neurone involvement. NIV was initiated according to current consensus practice guidelines. Between 1991 and 2011, 1198 patients diagnosed with ALS/MND were registered. 929 patients (77.5%) fulfilled the selection criteria and their data were analysed. Median tracheostomy free survival from symptom onset was 28 months in NIV-treated patients compared to 15 months in untreated (Univariate Cox regression HR=0.61 (0.51 to 0.73), pNIV persisted when the model was adjusted for age, gender, riluzole and percutaneous endoscopic gastrostomy use (HR=0.72 (0.60 to 0.88, p=0.001). In contrast with the only randomised controlled trial, NIV statistically significantly increased survival by 19 months in those with ALS-bulbar onset (Univariate HR=0.50 (0.36 to 0.70), multivariate HR=0.59 (0.41 to 0.83)). These data confirm that NIV improves survival in MND/ALS. The overall magnitude of benefit is 13 months and was largest in those with ALS-bulbar disease. Future research should explore the optimal timing of NIV initiation within phenotypes in order to optimise respiratory function, quality of life and survival. 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/

  16. Measuring meaningful learning in the undergraduate chemistry laboratory

    Science.gov (United States)

    Galloway, Kelli R.

    The undergraduate chemistry laboratory has been an essential component in chemistry education for over a century. The literature includes reports on investigations of singular aspects laboratory learning and attempts to measure the efficacy of reformed laboratory curriculum as well as faculty goals for laboratory learning which found common goals among instructors for students to learn laboratory skills, techniques, experimental design, and to develop critical thinking skills. These findings are important for improving teaching and learning in the undergraduate chemistry laboratory, but research is needed to connect the faculty goals to student perceptions. This study was designed to explore students' ideas about learning in the undergraduate chemistry laboratory. Novak's Theory of Meaningful Learning was used as a guide for the data collection and analysis choices for this research. Novak's theory states that in order for meaningful learning to occur the cognitive, affective, and psychomotor domains must be integrated. The psychomotor domain is inherent in the chemistry laboratory, but the extent to which the cognitive and affective domains are integrated is unknown. For meaningful learning to occur in the laboratory, students must actively integrate both the cognitive domain and the affective domains into the "doing" of their laboratory work. The Meaningful Learning in the Laboratory Instrument (MLLI) was designed to measure students' cognitive and affective expectations and experiences within the context of conducting experiments in the undergraduate chemistry laboratory. Evidence for the validity and reliability of the data generated by the MLLI were collected from multiple quantitative studies: a one semester study at one university, a one semester study at 15 colleges and universities across the United States, and a longitudinal study where the MLLI was administered 6 times during two years of general and organic chemistry laboratory courses. Results from

  17. Novel study guides for biochemistry meaningful learning in biology: a design-based research

    Directory of Open Access Journals (Sweden)

    Caetano da Costa

    2017-12-01

    Full Text Available To address the usually decontextualized transmission of information in biochemistry teaching, three interventions in a discipline (Metabolism for Biology majors were applied as innovative study guides. We describe the development, application, and evaluation of two study guides, contextualized with a real problem or an integrative view, using broad themes like evolution and metabolic adaptation. In order to evaluate the impact of both interventions on interest, motivation, and learning of the metabolic pathways, a design-based research with cycles of application and assessment was carried out, by means of classroom observation, grade analysis in written exams, and students’ interviews. Analysis and interpretation of the results point to benefits for teaching and learning, with helpful information to guide elaboration and refinement of new teaching materials and to make active learning more meaningful.

  18. Clinical benefit of liver stiffness measurement at 3 months after Kasai hepatoportoenterostomy to predict the liver related events in biliary atresia.

    Directory of Open Access Journals (Sweden)

    Seung Min Hahn

    Full Text Available BACKGROUND: The progression of hepatic fibrosis may result in decompensated hepatic failure with cirrhosis, liver related events (LRE such as ascites, variceal bleeding, and death after successful and timely Kasai hepatoportoenterostomy (HPE in biliary atresia. The aim of this study is to suggest clinical benefit of the liver stiffness measurement (LSM using transient elastography at 3 months after the Kasai operation to predict LRE. METHODS: Between January 2007 and December 2011, 69 eligible biliary atresia patients who underwent Kasai HPE and performed transient elastography before and 3 months after HPE were included. The occurrences of LRE were analyzed for all patients. All patients were divided into 2 groups (with and without LRE for comparison. Multivariate analysis was used to detect the independent risk factors of LRE. The area under the receiver operation characteristics curve (AUROC was used to establish the LSM optimal cutoff value of 3 months after Kasai operation in predicting LRE. RESULTS: LSM value, aminotransferase, albumin, bilirubin, and PT-INR significantly differed among the two groups. Multivariate analysis demonstrated LSM value as the most powerful independent factor of the development of LRE. The cut-off value of 19.9 kPa was calculated to be optimal for predicting LRE development with total sensitivity and specificity of 1.804. AUROC resulted in 0.943, with sensitivity of 85.3% and specificity of 95.2%. CONCLUSIONS: The LSM value of 3 months after Kasai HPE can be a useful predictor of LRE development.

  19. Who benefits most from therapist-assisted internet-delivered cognitive behaviour therapy in clinical practice? Predictors of symptom change and dropout.

    Science.gov (United States)

    Edmonds, M; Hadjistavropoulos, H D; Schneider, L H; Dear, B F; Titov, N

    2018-03-01

    Internet-delivered cognitive behavioral therapy (ICBT) is effective for treating anxiety and depression, but not for all patients. Predictors of dropout and outcomes from ICBT remain unclear and the literature could benefit from study of response to ICBT among larger community samples using advanced statistical techniques. In this study, we sought to identify predictors of dropout and symptom change in a large community sample (n = 1201) who received therapist-assisted transdiagnostic ICBT targeting anxiety and/or depression. Logistic regression was used to assess dropout, and showed that those who fully completed ICBT lessons (n = 880) were older and endorsed lower psychological distress at intake than those who only partially completed ICBT lessons (n = 321). During the course of therapy, patients responded to the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 at six time points. Autoregressive latent trajectory models were fitted to this data to assess the ability of demographic variables, program engagement, psychological and medical service usage, and psychological distress to explain individual variance in initial symptom levels and symptom change over time. Higher symptom scores at pre-treatment were predictive of greater symptom improvement. Symptom improvement was greater in those who were off work on disability and those without higher post-secondary education. Clinical implications are discussed. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

  20. A randomized clinical trial of diabetes self-management for Mexican Americans: Are there serendipitous health benefits for supporters of study participants?

    Directory of Open Access Journals (Sweden)

    Sharon A Brown

    2017-01-01

    Full Text Available Objectives: Studies of social support in diabetes have focused on the effects of support on the person with type 2 diabetes. We explored diabetes prevention effects of a culturally tailored diabetes self-management intervention in individuals without diabetes who were supporters of intervention participants. Methods: This is a secondary analysis of data from a randomized clinical trial that involved 256 Mexican Americans with diabetes. Each study participant designated a supporter—spouse, relative, friend—who attended intervention sessions and assisted participants in attaining effective diabetes self-management. Supporter’s glycosylated hemoglobin (A1C data were tracked for 1 year to determine diabetes conversion rates in supporters without diabetes at baseline. Results: Fewer individuals in the intervention group (n = 9 converted to an A1C above the 7% threshold, compared to the 1-year wait-listed control group (n = 16. We found a statistically significant difference (p = .021 at 12 months in the number of individuals whose A1C was ⩽8%, with fewer supporters above threshold in the intervention group (reduction of 48%. Supporters in the intervention group with prediabetes, based on baseline A1C, experienced a slight reduction in A1C, while control group supporters with prediabetes experienced an increase. Discussion: The results suggest that there are potential benefits for family members and other supporters of persons with diabetes who participated in diabetes self-management programs.

  1. Clinical Trials

    Medline Plus

    Full Text Available ... Children and Clinical Studies Program has been successfully developed and evaluated to fill an important gap in ... Possible Benefits Taking part in a clinical trial can have many benefits. For example, you may gain ...

  2. Clinical Trials

    Medline Plus

    Full Text Available ... and doctors' offices around the country. Benefits and Risks Possible Benefits Taking part in a clinical trial ... volunteer because they want to help others. Possible Risks Clinical trials do have risks and some downsides, ...

  3. Multiple Benefits.

    Science.gov (United States)

    Kreider, Beth

    1997-01-01

    Discusses the benefits of dome architecture for a community's middle- and high-school multi-purpose facility. The dome construction is revealed as being cost effective in construction and in maintenance and energy costs. (GR)

  4. An integrative approach to inferring biologically meaningful gene modules

    Directory of Open Access Journals (Sweden)

    Wang Kai

    2011-07-01

    Full Text Available Abstract Background The ability to construct biologically meaningful gene networks and modules is critical for contemporary systems biology. Though recent studies have demonstrated the power of using gene modules to shed light on the functioning of complex biological systems, most modules in these networks have shown little association with meaningful biological function. We have devised a method which directly incorporates gene ontology (GO annotation in construction of gene modules in order to gain better functional association. Results We have devised a method, Semantic Similarity-Integrated approach for Modularization (SSIM that integrates various gene-gene pairwise similarity values, including information obtained from gene expression, protein-protein interactions and GO annotations, in the construction of modules using affinity propagation clustering. We demonstrated the performance of the proposed method using data from two complex biological responses: 1. the osmotic shock response in Saccharomyces cerevisiae, and 2. the prion-induced pathogenic mouse model. In comparison with two previously reported algorithms, modules identified by SSIM showed significantly stronger association with biological functions. Conclusions The incorporation of semantic similarity based on GO annotation with gene expression and protein-protein interaction data can greatly enhance the functional relevance of inferred gene modules. In addition, the SSIM approach can also reveal the hierarchical structure of gene modules to gain a broader functional view of the biological system. Hence, the proposed method can facilitate comprehensive and in-depth analysis of high throughput experimental data at the gene network level.

  5. Breaking the Glass Ceiling: Increasing the Meaningful Involvement of Women Living With HIV/AIDS (MIWA) in the Design and Delivery of HIV/AIDS Services.

    Science.gov (United States)

    Carter, Allison; Greene, Saara; Nicholson, Valerie; O'Brien, Nadia; Sanchez, Margarite; de Pokomandy, Alexandra; Loutfy, Mona; Kaida, Angela

    2015-01-01

    The meaningful involvement of women living with HIV/AIDS (MIWA) is a key feature of women-centred HIV care, yet little is known about transforming MIWA from principle to practice. Drawing on focus group data from the Canadian HIV Women's Sexual and Reproductive Health Cohort Study (CHIWOS), we explored HIV-positive women's meaningful involvement in the design and delivery of HIV/AIDS services in British Columbia, Canada. In this article, we highlight the benefits and tensions that emerge as women traverse multiple roles as service users and service providers within their care communities, and the impact this has on their access to care and overall health.

  6. Methylphenidate treatment of attention deficit hyperactivity disorder in young people with learning disability and difficult-to-treat epilepsy: Evidence of clinical benefit

    Science.gov (United States)

    Fosi, Tangunu; Lax-Pericall, Maria T; Scott, Rod C; Neville, Brian G; Aylett, Sarah E

    2013-01-01

    Purpose To establish the efficacy and safety of methylphenidate (MPH) treatment for attention deficit hyperactivity disorder (ADHD) in a group of children and young people with learning disability and severe epilepsy. Methods This retrospective study systematically reviewed the case notes of all patients treated with methylphenidate (MPH) for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) ADHD at a specialist epilepsy center between 1998 and 2005. Treatment efficacy was ascertained using clinical global impressions (CGI) scores, and safety was indexed by instances of >25% increase in monthly seizure count within 3 months of starting MPH. Key Findings Eighteen (18) patients were identified with refractory epilepsies (14 generalized, 4 focal), IQ <70, and ADHD. Male patients predominated (13:5) and ADHD was diagnosed at a median age of 11.5 years (range 6–18 years). With use of a combination of a behavioral management program and MPH 0.3–1 mg/kg/day, ADHD symptoms improved in 61% of patients (11/18; type A intraclass correlation coefficient of CGI 0.85, 95% confidence interval [CI] 0.69–0.94). Daily MPH dose, epilepsy variables, and psychiatric comorbidity did not relate to treatment response across the sample. MPH adverse effects led to treatment cessation in three patients (dysphoria in two, anxiety in one). There was no statistical evidence for a deterioration of seizure control in this group with the use of MPH. Significance Methylphenidate with behavioral management was associated with benefit in the management of ADHD in more than half of a group of children with severe epilepsy and additional cognitive impairments. Eighteen percent had significant side effects but no attributable increase in seizures. Methylphenidate is useful in this group and is likely to be under employed. PMID:24304474

  7. Similar clinical benefits from below-target and target dose enalapril in patients with heart failure in the SOLVD Treatment trial.

    Science.gov (United States)

    Lam, Phillip H; Dooley, Daniel J; Fonarow, Gregg C; Butler, Javed; Bhatt, Deepak L; Filippatos, Gerasimos S; Deedwania, Prakash; Forman, Daniel E; White, Michel; Fletcher, Ross D; Arundel, Cherinne; Blackman, Marc R; Adamopoulos, Chris; Kanonidis, Ioannis E; Aban, Inmaculada B; Patel, Kanan; Aronow, Wilbert S; Allman, Richard M; Anker, Stefan D; Pitt, Bertram; Ahmed, Ali

    2018-02-01

    To examine associations of below-target and target dose of enalapril, an angiotensin-converting enzyme (ACE) inhibitor, with outcomes in patients with heart failure and reduced ejection fraction (HFrEF) in the Studies of Left Ventricular Dysfunction (SOLVD) Treatment trial. Two thousand five hundred and sixty-nine patients with HFrEF (ejection fraction ≤35%) were randomized to below-target (5-10 mg/day) dose placebo (n = 1284) or enalapril (n = 1285). One month post-randomization, blind up-titration to target (20 mg/day) dose was attempted for both study drugs in 2458 patients. Among the 1444 patients who achieved dose up-titration (placebo, n = 748; enalapril, n = 696; mean dose for both groups, 20.0 mg/day), target dose enalapril (vs. target dose placebo) was associated with a 9% absolute lower risk of the combined endpoint of heart failure hospitalization or all-cause mortality [adjusted hazard ratio (HR) 0.70; 95% confidence interval (CI) 0.60-0.81; P target dose (placebo, n = 486; enalapril, n = 528; mean dose for both groups, 8.8 mg/day), below-target dose enalapril (vs. below-target dose placebo) was associated with a 12% absolute lower risk of the combined endpoint of heart failure hospitalization or all-cause mortality (adjusted HR 0.68; 95% CI 0.57-0.81; P target (vs. below-target) dose had no association with the combined endpoint of heart failure hospitalization or all-cause mortality (adjusted HR 1.04; 95% CI 0.87-1.23; P = 0.695). In patients with HFrEF, the clinical benefits of ACE inhibitors appear to be similar at both below-target and target doses. © 2017 The Authors. European Journal of Heart Failure © 2017 European Society of Cardiology.

  8. Reduced benefit from mnemonic strategies in early-stage Alzheimer's disease: a brief testing-the-limits paradigm for clinical practice.

    Science.gov (United States)

    Uttner, Ingo; Schurig, Niklas; von Arnim, Christine A F; Lange-Asschenfeldt, Christian; Tumani, Hayrettin; Riepe, Matthias W

    2010-10-01

    Discriminating incipient Alzheimer's disease (AD) from major depression (MD) and age related memory decline is a challenge in clinical practice. Since AD is characterized by an early loss of neuronal and functional plasticity, a dynamic test strategy, such as the testing-the-limits (TtL) approach, that measures learning capacity can be a helpful diagnostic tool. To evaluate this, a short recognition paradigm consisting of a pre-test (baseline) and two post-test conditions with an interposed encoding instruction was developed and administered to individuals with incipient AD (n = 19; Mini Mental Status Examination (MMSE) 26.5), patients with depressive disorders (n = 11; MMSE 30), and healthy controls (n = 11; MMSE 30). In addition, participants completed a set of traditional neuropsychological tests that focused on the subjects' cognitive baseline performance. Intergroup comparisons (Kruskal-Wallis, U test) revealed significantly higher post-test failure rates in AD patients. Pre-test performance of MD and AD patients did not differ. Intra-group comparisons (Friedman, Wilcoxon test) showed that all three subject samples benefit from intervention in post-test 1. In contrast to MD and healthy individuals, who revealed significantly lower failure rates in post-test 2 compared to the pre-test, AD patients did not improve. Out of the 15 traditional test scores obtained, only two discriminated simultaneously between AD and each of the other groups. Our data confirm the finding of an impaired cognitive plasticity already present in very early stages of AD and illustrate the efficiency of a dynamic test approach in identifying incipient dementia.

  9. Economic and clinical benefits of endometrial radiofrequency ablation compared with other ablation techniques in women with menorrhagia: a retrospective analysis with German health claims data

    Directory of Open Access Journals (Sweden)

    Bischoff-Everding C

    2016-01-01

    Full Text Available Christoph Bischoff-Everding,1 Ruediger Soeder,2 Benno Neukirch3 1HGC GesundheitsConsult GmbH, Duesseldorf, Germany; 2Gynecological Joint Practice, Mainz, Germany; 3Faculty of Health Care, Hochschule Niederrhein – University of Applied Sciences, Krefeld, Germany Objective: To evaluate the economic and clinical benefits of endometrial radiofrequency ablation (RFA compared with other ablation techniques for the treatment of menorrhagia.Methods: Using German health claims data, women meeting defined inclusion criteria for the intervention group (RFA were selected. A comparable control group (other endometrial ablations was established using propensity score matching. These two groups were compared during the quarter of treatment (QoT and a follow-up of 2 years for the following outcomes: costs during QoT and during follow-up, repeated menorrhagia diagnoses during follow-up and necessary retreatments during follow-up. Results: After performing propensity score matching, 50 cases could be allocated to the intervention group, while 38 were identified as control cases. Patients in the RFA group had 5% fewer repeat menorrhagia diagnoses (40% vs 45%; not significant and 5% fewer treatments associated with recurrent menorrhagia (6% vs 11%; not significant than cases in the control group. During the QoT, the RFA group incurred €578 additional costs (€2,068 vs €1,490; ns. However, during follow-up, the control group incurred €1,254 additional costs (€4,561 vs €5,815; ns, with medication, outpatient physician consultations, and hospitals costs being the main cost drivers. However, none of the results were statistically significant. Conclusion: Although RFA was more cost-intensive in the QoT compared with other endometrial ablation techniques, an average total savings of €676 was generated during the follow-up period. While having evidence that RFA is clinically equivalent to other endometrial ablation procedures, we generated indications that

  10. Clinical benefit of bone-targeted radiometabolic therapy with 153Sm-EDTMP combined with chemotherapy in patients with metastatic hormone-refractory prostate cancer

    International Nuclear Information System (INIS)

    Ricci, Sergio; Pastina, Ilaria; Cianci, Claudia; Orlandini, Cinzia; Chioni, Aldo; Di Donato, Samantha; Boni, Giuseppe; Genovesi, Dario; Grosso, Mariano; AlSharif, Abedallatif; Mariani, Giuliano; Francesca, Francesco

    2007-01-01

    PSA response, with minimal toxicity. When it was administered in combination with chemotherapy, prolonged survival indicated actual clinical benefit, while there were no additive toxicities. These results provide the rationale for future prospective evaluation of combined therapeutic strategies. (orig.)

  11. WE-FG-BRA-05: Potential Clinical Benefit of LINAC Flattening-Filter-Free (FFF) Mode - Improvement of Treatment Therapeutic Ratio

    International Nuclear Information System (INIS)

    Chang, S; Rivera, J; Tian, H; Price, A; Santos, C; Zhang, Y

    2016-01-01

    the added clinical benefit of improving treatment therapeutic ratio. Animal Studies were performed within the LCCC Animal Studies Core Facility at the University of North Carolina at Chapel Hill. The LCCC Animal Studies Core is supported in part by an NCI Center Core Support Grant (CA16086) to the UNC Lineberger Comprehensive Cancer Center

  12. The clinical impact of continuing to prescribe antiretroviral therapy in patients with advanced AIDS who manifest no virologic or immunologic benefit.

    Directory of Open Access Journals (Sweden)

    David A Wohl

    Full Text Available Despite the efficacy and tolerability of modern antiretroviral therapy (ART, many patients with advanced AIDS prescribed these regimens do not achieve viral suppression or immune reconstitution as a result of poor adherence, drug resistance, or both. The clinical outcomes of continued ART prescription for such patients have not been well characterized.We examined the causes and predictors of all-cause mortality, AIDS-defining conditions, and serious non-AIDS-defining events among a cohort of participants in a clinical trial of pre-emptive therapy for CMV disease. We focused on participants who, despite ART had failed to achieve virologic suppression and substantive immune reconstitution.233 ART-receiving participants entered with a median baseline CD4+ T cell count of 30/mm(3 and plasma HIV RNA of 5 log10 copies/mL. During a median 96 weeks of follow-up, 24.0% died (a mortality rate of 10.7/100 patient-years; 27.5% reported a new AIDS-defining condition, and 22.3% a new serious non-AIDS event. Of the deaths, 42.8% were due to an AIDS-defining condition, 44.6% were due to a non-AIDS-defining condition, and 12.5% were of unknown etiology. Decreased risk of mortality was associated with baseline CD4+ T cell count ≥25/mm(3 and lower baseline HIV RNA.Among patients with advanced AIDS prescribed modern ART who achieve neither virologic suppression nor immune reconstitution, crude mortality percentages appear to be lower than reported in cohorts of patients studied a decade earlier. Also, in contrast to the era before modern ART became available, nearly half of the deaths in our modern-era study were caused by serious non-AIDS-defining events. Even among the most advanced AIDS patients who were not obtaining apparent immunologic and virologic benefit from ART, continued prescription of these medications appears to alter the natural history of AIDS--improving survival and shifting the causes of death from AIDS- to non-AIDS-defining conditions.

  13. WE-FG-BRA-05: Potential Clinical Benefit of LINAC Flattening-Filter-Free (FFF) Mode - Improvement of Treatment Therapeutic Ratio

    Energy Technology Data Exchange (ETDEWEB)

    Chang, S [Department of Radiation Oncology, UNC School of Medicine, Chapel Hill, NC (United States); Department of Biomedical Engineering, University of North Carolina- Chapel Hill/ North Carolina State University, Chapel Hill, North Carolina (United States); Lineberger Clinical Cancer Center, University of North Carolina, Chapel Hill, NC (United States); Rivera, J [Department of Biomedical Engineering, University of North Carolina- Chapel Hill/ North Carolina State University, Chapel Hill, North Carolina (United States); Tian, H [Xuzhou Medical College, Xuzhou, Jiangsu (China); Lineberger Clinical Cancer Center, University of North Carolina, Chapel Hill, NC (United States); Price, A [Department of Radiation Oncology, UNC School of Medicine, Chapel Hill, NC (United States); Santos, C [Lineberger Clinical Cancer Center, University of North Carolina, Chapel Hill, NC (United States); Zhang, Y [Department of Radiation Oncology, UNC School of Medicine, Chapel Hill, NC (United States); Xuzhou Medical College, Xuzhou, Jiangsu (China); Lineberger Clinical Cancer Center, University of North Carolina, Chapel Hill, NC (United States)

    2016-06-15

    the added clinical benefit of improving treatment therapeutic ratio. Animal Studies were performed within the LCCC Animal Studies Core Facility at the University of North Carolina at Chapel Hill. The LCCC Animal Studies Core is supported in part by an NCI Center Core Support Grant (CA16086) to the UNC Lineberger Comprehensive Cancer Center.

  14. A Prospective, Descriptive Study to Assess the Clinical Benefits of Using Calendula officinalis Hydroglycolic Extract for the Topical Treatment of Diabetic Foot Ulcers.

    Science.gov (United States)

    Buzzi, Marcelo; de Freitas, Franciele; Winter, Marcos

    2016-03-01

    Diabetic foot ulcers (DFUs) have a significant impact on patient quality of life. A prospective, descriptive pilot study was conducted between May 2012 and December 2013 through the dermatology outpatient unit in a Brazilian hospital to evaluate the clinical benefits of using Calendula officinalis hydroglycolic extract in the treatment of DFUs. Patients diagnosed with a stable neuropathic ulcer of >3 months' duration; ranging in size from 0.5-40 cm(2); without osteomyelitis, gangrene, bone exposure, cancer, or deep tissue infection; ages 18-90 years; with adequate glycemic control and no history of an allergy to C. officinalis were enrolled. Patients provided demographic and diabetes-related information and were evaluated biweekly for 30 weeks or until healing (ie, full epithelialization with no wound drainage). DFUs were measured and clinically examined for microbiological flora and presence of odor, tissue type (eg, granulation, fibrin sloth, necrosis), exudate, and retraction rate using planimetry images. Patients' blood tests and neuropathic pain assessment (the latter by clinician-directed questionnaire) were performed at baseline and the end of treatment; pain also was assessed during dressing changes using a 10-point rating scale. Patients' ulcers were treated twice daily with C. officinalis hydroglycolic extract spray solution and covered with saline-moistened, sterile, nonadherent gauze and bandages followed by foot offloading with adequate protective footwear. Patients received their first treatment in the clinic then performed care at home. From a potential population of 109 patients, 25 did not meet the inclusion criteria. Of the remaining 84 participants enrolled, 43 withdrew before study completion; cited reasons included lost to follow-up (16), medical judgment (2), failure to attend >3 scheduled visits (17), protocol violation (5), and death (3). Forty-one (41) - 17 women, average age 62 years (range 44-82 years), average glycemic level 153 mg

  15. The measurement of water scarcity: Defining a meaningful indicator.

    Science.gov (United States)

    Damkjaer, Simon; Taylor, Richard

    2017-09-01

    Metrics of water scarcity and stress have evolved over the last three decades from simple threshold indicators to holistic measures characterising human environments and freshwater sustainability. Metrics commonly estimate renewable freshwater resources using mean annual river runoff, which masks hydrological variability, and quantify subjectively socio-economic conditions characterising adaptive capacity. There is a marked absence of research evaluating whether these metrics of water scarcity are meaningful. We argue that measurement of water scarcity (1) be redefined physically in terms of the freshwater storage required to address imbalances in intra- and inter-annual fluxes of freshwater supply and demand; (2) abandons subjective quantifications of human environments and (3) be used to inform participatory decision-making processes that explore a wide range of options for addressing freshwater storage requirements beyond dams that include use of renewable groundwater, soil water and trading in virtual water. Further, we outline a conceptual framework redefining water scarcity in terms of freshwater storage.

  16. School nurse evaluations: making the process meaningful and motivational.

    Science.gov (United States)

    McDaniel, Kathryn H; Overman, Muriel; Guttu, Martha; Engelke, Martha Keehner

    2013-02-01

    The professional standards of school nursing practice provide a framework to help school nurses focus on their unique mission of promoting health and academic achievement for all students. Without the standards, the nurse's role can become task oriented and limited in scope. By using an evaluation tool that reflects the standards, nurses not only become aware and begin to understand the standards; they also become directly accountable for meeting them. In addition, developing an evaluation process based on the standards of school nurse practice increases the visibility of school nurses and helps school administrators understand the role of the school nurse. This article describes how one school district integrated the scope and standards of school nursing into the job description and performance evaluation of the nurse. The process which is used to complete the evaluation in a manner that is meaningful and motivational to the school nurse is described.

  17. Health Information Technology: Meaningful Use and Next Steps to Improving Electronic Facilitation of Medication Adherence.

    Science.gov (United States)

    Bosworth, Hayden B; Zullig, Leah L; Mendys, Phil; Ho, Michael; Trygstad, Troy; Granger, Christopher; Oakes, Megan M; Granger, Bradi B

    2016-03-15

    The use of health information technology (HIT) may improve medication adherence, but challenges for implementation remain. The aim of this paper is to review the current state of HIT as it relates to medication adherence programs, acknowledge the potential barriers in light of current legislation, and provide recommendations to improve ongoing medication adherence strategies through the use of HIT. We describe four potential HIT barriers that may impact interoperability and subsequent medication adherence. Legislation in the United States has incentivized the use of HIT to facilitate and enhance medication adherence. The Health Information Technology for Economic and Clinical Health (HITECH) was recently adopted and establishes federal standards for the so-called "meaningful use" of certified electronic health record (EHR) technology that can directly impact medication adherence. The four persistent HIT barriers to medication adherence include (1) underdevelopment of data reciprocity across clinical, community, and home settings, limiting the capture of data necessary for clinical care; (2) inconsistent data definitions and lack of harmonization of patient-focused data standards, making existing data difficult to use for patient-centered outcomes research; (3) inability to effectively use the national drug code information from the various electronic health record and claims datasets for adherence purposes; and (4) lack of data capture for medication management interventions, such as medication management therapy (MTM) in the EHR. Potential recommendations to address these issues are discussed. To make meaningful, high quality data accessible, and subsequently improve medication adherence, these challenges will need to be addressed to fully reach the potential of HIT in impacting one of our largest public health issues.

  18. Benefits | NREL

    Science.gov (United States)

    flexible work environment that enables and encourages a good work/life balance A growing, changing exceptional work. A woman riding her bike past the NREL entrance sign. Hundreds of NREL employees opt out of their cars, cycling to work, to take part in Bike To Work Day each year. Benefits Package NREL's

  19. Fringe Benefits.

    Science.gov (United States)

    Podgursky, Michael

    2003-01-01

    Uses statistics from the National Center for Education Statistics and the Bureau of Labor Statistics to examine teacher salaries and benefits. Discusses compensation of teachers compared with nonteachers. Asserts that statistics from the American Federation of Teachers and the National Education Association underestimate teacher compensation…

  20. Concept and benefits of the Inverted Classroom method for a competency-based biochemistry course in the pre-clinical stage of a human medicine course of studies.

    Science.gov (United States)

    Kühl, Susanne J; Toberer, Matthias; Keis, Oliver; Tolks, Daniel; Fischer, Martin R; Kühl, Michael

    2017-01-01

    Background: Medical students often have a problem recognising the relevance of basic science subjects for their later professional work in the pre-clinical stage of their studies. This can lead to a lower motivation to learn biochemical content and dissatisfaction in the courses amongst the students. Alternative teaching methods such as the Inverted Classroom (IC) method can address this deficiency. The goal of this study was: to analyse the motivation and satisfaction of the students in a biochemistry seminar through the use of the e-learning-based IC method, to investigate the acceptance against the IC teaching method in biochemistry, and to compare the learning success achieved using the IC approach with that of a traditional course. We also investigated how a biochemistry course in the pre-clinical stage of a human medicine course of studies can be successfully organised according to the IC method. Furthermore, we examined the benefits of the IC method over conventional teaching formats. Method: The IC method was implemented in accordance with the guidelines of the GMA committee "New Media" [30] in a biochemistry seminar for two student IC intervention groups with 42 students. A part of the factual knowledge from the on-site phase in the form of teaching videos together with self-learning control tasks were provided online before the seminar for both IC intervention groups. Exporting content to the self-learning phase creates new free time in the on-site phase, during which the content can be critically considered and processed and additional competency-based learning objectives can be taught. Identical biochemistry teaching content was taught in parallel control groups (14 student groups with n=299 students), but no material was handed out beforehand for a self-learning phase. These students only received the materials after the on-site phase. Motivation and satisfaction as well as the acceptance for the teaching methods were recorded by questionnaires, the

  1. Concept and benefits of the Inverted Classroom method for a competency-based biochemistry course in the pre-clinical stage of a human medicine course of studies

    Directory of Open Access Journals (Sweden)

    Kühl, Susanne J.

    2017-08-01

    Full Text Available Background: Medical students often have a problem recognising the relevance of basic science subjects for their later professional work in the pre-clinical stage of their studies. This can lead to a lower motivation to learn biochemical content and dissatisfaction in the courses amongst the students. Alternative teaching methods such as the Inverted Classroom (IC method can address this deficiency. The goal of this study was: We also investigated how a biochemistry course in the pre-clinical stage of a human medicine course of studies can be successfully organised according to the IC method. Furthermore, we examined the benefits of the IC method over conventional teaching formats. Method: The IC method was implemented in accordance with the guidelines of the GMA committee “New Media” in a biochemistry seminar for two student IC intervention groups with 42 students. A part of the factual knowledge from the on-site phase in the form of teaching videos together with self-learning control tasks were provided online before the seminar for both IC intervention groups. Exporting content to the self-learning phase creates new free time in the on-site phase, during which the content can be critically considered and processed and additional competency-based learning objectives can be taught. Identical biochemistry teaching content was taught in parallel control groups (14 student groups with n=299 students, but no material was handed out beforehand for a self-learning phase. These students only received the materials after the on-site phase. Motivation and satisfaction as well as the acceptance for the teaching methods were recorded by questionnaires, the acquisition of knowledge by MC exams.Results: On a Likert scale from 1 (strongly disagree to 6 (strongly agree, the students in the IC intervention groups could be seen to be much more motivated (5.53 than students in the control group (4.01. Students in the IC intervention groups also recognised the

  2. Clinical and Demographic Profile of Patients Receiving Fingolimod in Clinical Practice in Germany and the Benefit-Risk Profile of Fingolimod After 1 Year of Treatment: Initial Results From the Observational, Noninterventional Study PANGAEA.

    Science.gov (United States)

    Ziemssen, Tjalf; Lang, Michael; Tackenberg, Björn; Schmidt, Stephan; Albrecht, Holger; Klotz, Luisa; Haas, Judith; Lassek, Christoph; Medin, Jennie; Cornelissen, Christian

    2018-01-01

    The population with multiple sclerosis receiving treatment in clinical practice differs from that in randomized controlled trials (RCTs). An assessment of the real-world benefit-risk profile of therapies is needed. This analysis used data from the large, noninterventional, observational German study Post-Authorization Non-interventional German sAfety study of GilEnyA (PANGAEA) to assess prospectively baseline characteristics and outcomes after 12 months (± 90 days) of fingolimod treatment. Patients were divided into 2 cohorts: fingolimod starter [first received fingolimod in PANGAEA (n = 3315)] and previous study [received fingolimod before enrollment in PANGAEA in RCTs (n = 875), some of whom also had baseline data at entry into RCTs (n = 505)]. At PANGAEA baseline, patients in the fingolimod starter versus the previous study cohort had a higher annualized relapse rate [ARR (95% confidence interval): 1.79 (1.75-1.83) vs 1.32 (1.25-1.40)] and Expanded Disability Status Scale score [3.11 (3.04-3.17) vs 2.55 (2.44-2.66)]. A greater proportion in the fingolimod starter versus previous study cohort had diabetes (2.0% vs 0.7%). After 12 months of fingolimod, ARRs were lower than in the 12 months before PANGAEA enrollment in the fingolimod starter [0.386 (0.360-0.414)] and previous study [0.276 (0.238-0.320)] cohorts. Expanded Disability Status Scale scores were stable versus baseline. Adverse events were experienced by similar proportions in both cohorts during fingolimod treatment. Relevant differences exist in disease activity and comorbidities between patients receiving fingolimod in clinical practice versus RCTs. Irrespective of baseline differences indicating a higher proportion at an advanced stage of multiple sclerosis in the real world versus RCTs, fingolimod remains effective, with a manageable safety profile.

  3. Qualitative Insights from a Canadian Multiinstitutional Research Study: In Search of Meaningful E-learning

    Directory of Open Access Journals (Sweden)

    Lorraine M. Carter

    2014-11-01

    Full Text Available This paper reports the qualitative findings of a mixed methods research study conducted at three Canadian post-secondary institutions. Called the Meaningful E-learning or MEL project, the study was an exploration of the teaching and learning experiences of faculty and students as well as their perceptions of the benefits and challenges of e-learning. Importantly, e-learning was conceptualized as the integration of pedagogy, instructional technology, and the Internet into teaching and learning environments. Based on this definition, participants reflected on e-learning in relation to one or more of the following contexts: face-to-face (f2f classrooms in which instructional technologies (e.g. learning management systems, video and webconferencing, mobile devices, etc. are used; blended or web-enhanced learning environments; and fully online learning environments. Data collected for the study included survey data (n=1377 for students, n=187 for faculty; narrative comments (n=269 for students, n=74 for faculty; and focus groups (n=16 for students, n=33 for faculty. The latter two sets of data comprise the basis of this paper. Four major themes emerged based on the responses of students and faculty. Represented by the acronym HIDI, the themes include human connection (H, IT support (I, design (D, and institutional infrastructure (I. These themes and sub-themes are presented in the paper as well as recommendations for educators and administrators who aspire to make e-learning a pedagogically meaningful experience for both learners and their teachers.

  4. Binge eating as a meaningful experience in bulimia nervosa and anorexia nervosa: a qualitative analysis.

    Science.gov (United States)

    Eli, Karin

    2015-12-01

    Clinical studies describe binge eating as a reaction to hunger, negative affect, or the need to dissociate. However, little is known about the meanings that women with bulimia nervosa and anorexia nervosa associate with binge eating. To examine how women with anorexia nervosa and bulimia nervosa interpret their experiences of binge eating. Sixteen women who engaged in binge eating and had been diagnosed with anorexia nervosa, bulimia nervosa, or their subclinical variants were interviewed about their experiences of eating disorder. Interview data were analyzed using phenomenologically-informed thematic analysis. Participants described binge eating as a practice through which the self experiences a sense of release, and existential emptiness is replaced by overwhelming fullness. Meaningful experiences of release and fullness are central to binge eating in bulimia nervosa and anorexia nervosa, and may contribute to the long-term maintenance of this practice.

  5. The electronic patient record as a meaningful audit tool - Accountability and autonomy in general practitioner work

    DEFF Research Database (Denmark)

    Winthereik, Brit Ross; van der Ploeg, I.; Berg, Marc

    2007-01-01

    Health authorities increasingly request that general practitioners (GPs) use information and communication technologies such as electronic patient records (EPR) for accountability purposes. This article deals with the use of EPRs among general practitioners in Britain. It examines two ways in which...... makes them active in finding ways that turn the EPR into a meaningful tool for them, that is, a tool that helps them provide what they see as good care. The article's main contribution is to show how accountability and autonomy are coproduced; less professional autonomy does not follow from more...... GPs use the EPR for accountability purposes. One way is to generate audit reports on the basis of the information that has been entered into the record. The other is to let the computer intervene in the clinical process through prompts. The article argues that GPs' ambivalence toward using the EPR...

  6. Clinical benefits of antimicrobial de-escalation in adults with community-onset monomicrobial Escherichia coli, Klebsiella species and Proteus mirabilis bacteremia.

    Science.gov (United States)

    Lee, Ching-Chi; Wang, Jiun-Ling; Lee, Chung-Hsun; Hung, Yuan-Pin; Hong, Ming-Yuan; Tang, Hung-Jen; Ko, Wen-Chien

    2017-09-01

    The clinical benefits of an antimicrobial de-escalation strategy were compared with those of a no-switch strategy in bacteremic patients. Adults with community-onset monomicrobial Escherichia coli, Klebsiella species and Proteus mirabilis bacteremia treated empirically using broad-spectrum beta-lactams, including third-generation cephalosporins (GCs), fourth-GC or carbapenems, were treated definitively with first- or second-GCs (de-escalation group), the same regimens as empirical antibiotics (no-switch group), or antibiotics with a broader-spectrum than empirical antibiotics (escalation group). The eligible 454 adults were categorized as the de-escalation (231 patients, 50.9%), no-switch (177, 39.0%), and escalation (46, 10.1%) groups. Patients with de-escalation therapy were more often female, had less critical illness and fatal comorbidity, and had a higher survival rate than patients in the other two groups. After propensity score matching in the de-escalation and no-switch groups, critical illness at onset (Pitt bacteremia score ≥ 4; 16.5% vs. 12.7%; P = 0.34) or day 3 (2.5% vs. 2.5%; P = 1.00), fatal comorbidity (16.5% vs. 21.5%; P = 0.25), time to defervescence (4.6 vs. 4.7 days; P = 0.89), hospital stays (11.5 vs. 10.3 days; P = 0.13) and 4-week crude mortality rate (4.4% vs. 4.4%; P = 1.00) were similar. However, lower antibiotic cost (mean: 212.1 vs. 395.6 US$, P <0.001) and fewer complications of bloodstream infections due to resistant pathogens (0% vs. 5.1%, P = 0.004) were observed in the de-escalation group. De-escalation to narrower-spectrum cephalosporins is safe and cost-effective for adults with community-onset EKP bacteremia stabilized by empirical broad-spectrum beta-lactams. Copyright © 2017 Elsevier B.V. and International Society of Chemotherapy. All rights reserved.

  7. SU-E-T-361: Clinical Benefit of Automatic Beam Gating Mixed with Breath Hold in Radiation Therapy of Left Breast

    International Nuclear Information System (INIS)

    Wu, J; Hill, G; Spiegel, J; Ye, J; Mehta, V

    2014-01-01

    Purpose: To investigate the clinical and dosimetric benefits of automatic gating of left breast mixed with breath-hold technique. Methods: Two Active Breathing Control systems, ABC2.0 and ABC3.0, were used during simulation and treatment delivery. The two systems are different such that ABC2.0 is a breath-hold system without beam control capability, while ABC3.0 has capability in both breath-hold and beam gating. At simulation, each patient was scanned twice: one with free breathing (FB) and one with breath hold through ABC. Treatment plan was generated on the CT with ABC. The same plan was also recalculated on the CT with FB. These two plans were compared to assess plan quality. For treatments with ABC2.0, beams with MU > 55 were manually split into multiple subfields. All subfields were identical and shared the total MU. For treatment with ABC3.0, beam splitting was unnecessary. Instead, treatment was delivered in gating mode mixed with breath-hold technique. Treatment delivery efficiency using the two systems was compared. Results: The prescribed dose was 50.4Gy at 1.8Gy/fraction. The maximum heart dose averaged over 10 patients was 46.0±2.5Gy and 24.5±12.2Gy for treatments with FB and with ABC respectively. The corresponding heart V10 was 13.2±3.6% and 1.0±1.6% respectively. The averaged MUs were 99.8±7.5 for LMT, 99.2±9.4 for LLT. For treatment with ABC2.0, normally the original beam was split into 2 subfields. The averaged total time to delivery all beams was 4.3±0.4min for treatments with ABC2.0 and 3.3±0.6min for treatments with ABC3.0 in gating mode. Conclusion: Treatment with ABC tremendously reduced heart dose. Compared to treatments with ABC2.0, gating with ABC3.0 reduced the total treatment time by 23%. Use of ABC3.0 improved the delivery efficiency, and eliminated the possibility of mistreatments. The latter may happen with ABC2.0 where beam is not terminated when breath signal falls outside of the treatment window

  8. Who benefits?

    DEFF Research Database (Denmark)

    Hjorth, Frederik Georg

    2016-01-01

    Cross-border welfare rights for citizens of European Union member states are intensely contested, yet there is limited research into voter opposition to such rights, sometimes denoted ‘welfare chauvinism’. We highlight an overlooked aspect in scholarly work: the role of stereotypes about benefici...... recipient identity. These effects are strongest among respondents high in ethnic prejudice and economic conservatism. The findings imply that stereotypes about who benefits from cross-border welfare rights condition public support for those rights....

  9. Sacrifice: an ethical dimension of caring that makes suffering meaningful.

    Science.gov (United States)

    Helin, Kaija; Lindström, Unni A

    2003-07-01

    This article is intended to raise the question of whether sacrifice can be regarded stituting a deep ethical structure in the relationship between patient and carer. The significance of sacrifice in a patient-carer relationship cannot, however, be fully understood from the standpoint of the consistently utilitarian ethic that characterizes today's ethical discourse. Deontological ethics, with its universal principles, also does not provide a suitable point of departure. Ethical recommendations and codices are important and serve as general sources of knowledge when making decisions, but they should be supplemented by an ethic that takes into consideration contextual and situational factors that make every encounter between patient and carer unique. Caring science research literature presents, on the whole, general agreement on the importance of responsibility and devotian with regard to sense of duty, warmth and genuine engagement in caring. That sacrifice may also constitute an important ethical element in the patient-carer relationship is, however, a contradictory and little considered theme. Caring literature that deals with sacrifice/self-sacrifice indicates contradictory import. It is nevertheless interesting to notice that both the negative and the positive aspects bring out importance of the concept for the professional character of caring. The tradition of ideas in medieval Christian mysticism with reference to Lévinas' ethic of responsibility offers a deeper perspective in which the meaningfulness of sacrifice in the caring relationship can be sought. The theme of sacrifice is not of interest merely as a carer's ethical outlook, but sacrifice can also be understood as a potential process of transformation health. The instinctive or conscious experience of sacrifice on the part of the individual patient can, on a symbolic level, be regarded as analogous to the cultic or religious sacrifice aiming at atonement. Sacrifice appears to the patient as an act of

  10. Establishing meaningful cut points for online user ratings.

    Science.gov (United States)

    Hirschfeld, Gerrit; Thielsch, Meinald T

    2015-01-01

    Subjective perceptions of websites can be reliably measured with questionnaires. But it is unclear how such scores should be interpreted in practice, e.g. is an aesthetics score of 4 points on a seven-point-scale satisfactory? The current paper introduces a receiver-operating characteristic (ROC)-based methodology to establish meaningful cut points for the VisAWI (visual aesthetics of websites inventory) and its short form the VisAWI-S. In two studies we use users' global ratings (UGRs) and website rankings as anchors. A total of 972 participants took part in the studies which yielded similar results. First, one-item UGRs correlate highly with the VisAWI. Second, cut points on the VisAWI reliably differentiate between sites that are perceived as attractive versus unattractive. Third, these cut points are variable, but only within a certain range. Together the research presented here establishes a score of 4.5 on the VisAWI which is a reasonable goal for website designers and highlights the utility of the ROC methodology to derive relevant scores for rating scales.

  11. Contributions of meaningful experiences gatherings to artistic education field

    Directory of Open Access Journals (Sweden)

    Bernardo Bustamante Cardona

    2012-06-01

    Full Text Available This article shows a theoretical approach to and a description of some contributions of a work of transformation of educational and sociocultural reality carried out by a group of people and institutions, among which are San Buenaventura University, Antioquia Museum, Ediarte Inc. and Antioquia University. Such intervention aims at contributing to the improvement of Artistic Education quality in Antioquia and the nation. In order to understand the significance of these Gatherings, a short historical framework is explained in which global and regional processes of academic activities having an impact on the structure of the Artistic Education field are pointed out. Likewise, some perspectives in the definition of artistic education are tackled and then a definition of Pierre Bourdieu´s concept of fieldis presented. Therefore, Meaningful Experiences Gatherings in Artistic Education (MEGAE are presented and the three first gatherings are described. Finally, it is shown the panorama of the contributions of the gatherings both in the theoretical formulation and relational structure of the field.

  12. Do family physicians electronic health records support meaningful use?

    Science.gov (United States)

    Peterson, Lars E; Blackburn, Brenna; Ivins, Douglas; Mitchell, Jason; Matson, Christine; Phillips, Robert L

    2015-03-01

    Spurred by government incentives, the use of electronic health records (EHRs) in the United States has increased; however, whether these EHRs have the functionality necessary to meet meaningful use (MU) criteria remains unknown. Our objective was to characterize family physician access to MU functionality when using a MU-certified EHR. Data were obtained from a convenience survey of family physicians accessing their American Board of Family Medicine online portfolio in 2011. A brief survey queried MU functionality. We used descriptive statistics to characterize the responses and bivariate statistics to test associations between MU and patient communication functions by presence of a MU-certified EHR. Out of 3855 respondents, 60% reported having an EHR that supports MU. Physicians with MU-certified EHRs were more likely than physicians without MU-certified EHRs to report patient registry activities (49.7% vs. 32.3%, p-valuevs. 56.4%, p-valuecommunication abilities were low regardless of EHR capabilities. Family physicians with MU-certified EHRs are more likely to report MU functionality; however, a sizeable minority does not report MU functions. Many family physicians with MU-certified EHRs may not successfully meet the successively stringent MU criteria and may face significant upgrade costs to do so. Cross sectional survey. Copyright © 2014 Elsevier Inc. All rights reserved.

  13. Measuring Patient Experiences: Is It Meaningful and Actionable?

    Science.gov (United States)

    Wong, Sabrina T; Johnston, Sharon; Burge, Fred; McGrail, Kim; Hogg, William

    2017-10-01

    Performance measurement must be meaningful to those being asked to contribute data and to the clinicians who are collecting the information. It must be actionable if performance measurement and reporting is to influence health system transformation. To date, measuring patient experiences in all parts of the healthcare system in Canada lags behind other countries. More attention needs to be paid to capturing patients with complex intersecting health and social problems that result from inequitable distribution of wealth and/or underlying structural inequities related to systemic issues such as racism and discrimination, colonialism and patriarchy. Efforts to better capture the experiences of patients who do not regularly access care and who speak English or French as a second language are also needed. Before investing heavily into collecting patient experience data as part of a performance measurement system the following ought to be considered: (1) ensuring value for and buy-in from clinicians who are being asked to collect the data and/or act on the results; (2) investment in the infrastructure to administer iterative, cost-effective patient/family experience data collection, analysis and reporting (e.g., automated software tools) and (3) incorporating practice support (e.g., facilitation) and health system opportunities to integrate the findings from patient experience surveys into policy and practice. Investment into the infrastructure of measuring, reporting and engaging clinicians in improving practice is needed for patient/caregiver experiences to be acted upon. © 2017 Longwoods Publishing.

  14. Possibilities of creating meaningful encounters in anesthesia nursing

    DEFF Research Database (Denmark)

    Aagaard, Karin

    Anesthesia nursing is performed in a highly technological environment with restricted time for interaction with patients. Patients are in a vulnerable position, which can be characterized by anxiety regarding the anesthetic and surgical procedure. The bedrock of effective nursing care is to facil......Anesthesia nursing is performed in a highly technological environment with restricted time for interaction with patients. Patients are in a vulnerable position, which can be characterized by anxiety regarding the anesthetic and surgical procedure. The bedrock of effective nursing care...... of nursing. In this dissertation, focused ethnography is used to explore the interactions between patients and nurse anesthetists before general anesthesia. Moreover, it will explore the professional identity of nurse anesthetists, in relation to the situation of preparing patients for general anesthesia....... A micro-substantive theory is developed regarding the opportunities for creating meaningful encounters between patients and nurse anesthetists. The theory is based on three dominant motivations for interaction in anesthesia nursing. The context of care is not committed and responsive to the core elements...

  15. Negative emotions and the meaningful sides of media entertainment

    NARCIS (Netherlands)

    Oliver, M. B.; Bartsch, A.; Hartmann, T.; Parrott, G.

    2014-01-01

    This unique volume brings together state-of-the-art research showing the value of emotions that many believe to be undesirable. Leading investigators explore the functions and benefits of sadness, anxiety, anger, embarrassment, shame, guilt, jealousy, and envy. The role of these emotions in social

  16. Benefits of switching from latanoprost to preservative-free tafluprost eye drops: a meta-analysis of two Phase IIIb clinical trials

    Directory of Open Access Journals (Sweden)

    Uusitalo H

    2016-03-01

    Full Text Available Hannu Uusitalo,1 Evgeniy Egorov,2 Kai Kaarniranta,3 Yuri Astakhov,4 Auli Ropo5 On behalf of the Switch Study Tafluprost Study Groups 1Department of Ophthalmology, SILK, University of Tampere, Tampere University Hospital, Tampere, Finland; 2Department of Ophthalmology, The Russian National Research Medical University, Moscow, Russia; 3Department of Ophthalmology, University of Eastern Finland, Kuopio University Hospital, Kuopio, Finland, 4Department of Ophthalmology, First Pavlov State Medical University of St Petersburg, Saint Petersburg, Russia, 5Global Medical Affairs, Santen Oy, Tampere, Finland Introduction: Glaucoma patients frequently exhibit ocular surface side effects during treatment with prostaglandin eye drops. The present work investigated whether glaucoma patients suffering from signs and symptoms of ocular surface disease while using preserved latanoprost eye drops benefited from switching to preservative-free tafluprost eye drops. Patients and methods: The analysis was based on 339 glaucoma patients enrolled in two Phase IIIb trials. The patients were required to have two symptoms, or one sign and one symptom of ocular surface disease at baseline, and at least 6 months preceding treatment with latanoprost eye drops preserved with benzalkonium chloride. All eligible patients were switched from latanoprost to preservative-free tafluprost for a total of 12 weeks. Ocular symptoms and ocular signs were evaluated at baseline and at 2 weeks, 6 weeks, and 12 weeks after commencing treatment with tafluprost. Intraocular pressure (IOP, drop discomfort, and treatment preference were evaluated to investigate the clinical efficacy and patient-related outcomes. Results: After 12 weeks of treatment with preservative-free tafluprost, the incidences of irritation/burning/stinging, foreign body sensation, tearing, itching, and dry eye sensation had diminished to one-third of those reported for preserved latanoprost at baseline. The incidences

  17. Which Benefits and Harms of Using Fenugreek as a Galactogogue Need to Be Discussed during Clinical Consultations? A Delphi Study among Breastfeeding Women, Gynecologists, Pediatricians, Family Physicians, Lactation Consultants, and Pharmacists

    Science.gov (United States)

    Qiblawi, Sara; Ghanayem, Haifa

    2018-01-01

    Background Breastfeeding women with hypogalactia are commonly recommended to use fenugreek as a galactogogue. This study aimed to achieve formal consensus among breastfeeding women and healthcare providers on which potential harms and benefits of using fenugreek need to be communicated and discussed during clinical consultations. Methods A two-iterative round Delphi technique was used in two separate panels of breastfeeding women (n = 65) and healthcare providers (n = 56) to achieve formal consensus on a list of 24 and 16 items related to potential harms and benefits of fenugreek. Results About 70% of the healthcare providers recommended quite often herbal remedies for breastfeeding women and about 68% of the women had been recommended to use herbal remedies many times by their healthcare providers. Consensus was achieved on 21 potential harms and 14 potential benefits of using fenugreek to enhance human milk supply that need to be discussed with breastfeeding women during consultations. Conclusion Probably, potential harms and benefits of recommending fenugreek as herbal galactogogue for breastfeeding women seeking recommendations to increase their human milk supply need to be discussed during clinical consultations. Further observational studies are needed to assess what is being discussed in daily consultations when herbal remedies are recommended. PMID:29849697

  18. Knowledge construction in the classroom: a meaningful pedagogical dialogue

    Directory of Open Access Journals (Sweden)

    Jesuína Lopes de Almeida Pacca

    2015-12-01

    Full Text Available Teacher’s performance at their real classroom was analyzed in regard to the applied pedagogical interaction. These teachers were participating in a long range continuous formation course that uses the strategy of analyzing pedagogical planning while it was being elaborated , applied and continuously evaluated by the teacher; the course aimed to the construction of professional competence with an adequate sight of the classroom interaction, within constructivist parameters. The teacher pedagogical planning was the study object: it was discussed continuously by the peers group and the coordinator who intended to point out to the explicit pedagogical content and to the content objectives that were declared for every class plan. The learning objectives and the procedures contained within it were confronted with the real evidence of learning. In these discussions learning concepts that were coherent with constructivism were invoked in addition to science contents and their nature. Dialogue was important in these discussions and stressed as a means for teaching and continuous evaluation. In this dynamical process, the teacher planning was being constantly redrafted, changing the adjustment of that classroom students to the planned knowledge acquisition. This course dynamics, led by the coordinator, intended to be reproduced by participants with their students, at least in part. We noticed surprising results in these teachers professional development besides those that were concretely planned: the transference of the course procedures to the classroom seems to happen in regard to the presence of dialogue but the most meaningful part was individual and particular progress that was included in the development of their classes and led to an improvement of abilities. We concluded that unexpected results can be converted into poles of professional performance growth and performance evolution . These results have led us to give special importance to the

  19. Risks of thromboembolism and bleeding with thromboprophylaxis in patients with atrial fibrillation: A net clinical benefit analysis using a 'real world' nationwide cohort study

    DEFF Research Database (Denmark)

    Olesen, Jonas Bjerring; Lip, Gregory Y H; Lindhardsen, Jesper

    2011-01-01

    lowered the risk of thromboembolism compared to ASA and no treatment; the combination of VKA+ASA did not yield any additional benefit. In patients at high thromboembolic risk, hazard ratios (95% confidence interval) for thromboembolism were: 1.81 (1.73-1.90), 1.14 (1.06-1.23), and 1.86 (1.78-1.95) for ASA...

  20. The clinical factors associated with benefit finding of complementary medicine use in patients with back pain: A cross-sectional study with cluster analysis.

    Science.gov (United States)

    Kavadar, Gulis; Demircioğlu, Demet Tekdos; Can, Halil; Emre, Tuluhan Yunus; Civelek, Erdinç; Senyigit, Abdulhalim

    2017-01-01

    Complementary and alternative medicine (CAM) use has been increasing. To identify the factors associated with perceived benefit from CAM methods in back problems. The study was conducted on patients who practiced any CAM methods due to complaints of back pain. Social-demographic properties, details of CAM methods employed were questioned. Severity of pain was measured by visual analog scale (VAS); benefits were evaluated by the Likert scale. Hierarchical cluster analysis was used to discover relationships among variables. In total, 500 patients (265 female, 235 male) were included in the study. Mostly used methods were herbal therapy (32%), balneotherapy (31%), cupping (19.4%) and massage-manipulation (19.2%). Of patients, 355 (71%) were satisfied. The variables associated with benefit finding were female gender, age, chronicity and severity of pain, high educational level, upper middle income status, use as a result of recommendation, dissatisfaction with conventional methods, residence in an urban area, non-herbal method use, being married, and social insurance (p CAM perceived benefits; in particular, women living in urban areas, highly educated, aged more than 40, who suffer from severe chronic back pain, may be more inclined to go to CAM therapists.

  1. Are there specific benefits of amoxicillin plus metronidazole in Aggregatibacter actinomycetemcomitans-associated periodontitis? Double-masked, randomized clinical trial of efficacy and safety.

    Science.gov (United States)

    Mombelli, Andrea; Cionca, Norbert; Almaghlouth, Adnan; Décaillet, Fabien; Courvoisier, Delphine S; Giannopoulou, Catherine

    2013-06-01

    It has been suggested that prescription of amoxicillin plus metronidazole in the context of periodontal therapy should be limited to patients with specific microbiologic profiles, especially those testing positive for Aggregatibacter actinomycetemcomitans. The main purpose of this analysis is to determine if patients positive for A. actinomycetemcomitans with moderate to advanced periodontitis benefit specifically from amoxicillin plus metronidazole given as an adjunct to full-mouth scaling and root planing. This is a double-masked, placebo-controlled, randomized longitudinal study including 41 participants who were positive for A. actinomycetemcomitans and 41 participants who were negative for A. actinomycetemcomitans. All 82 patients received full-mouth periodontal debridement performed within 48 hours. Patients then received either systemic antibiotics (375 mg amoxicillin and 500 mg metronidazole, three times daily) or placebo for 7 days. The primary outcome variable was persistence of sites with a probing depth (PD) >4 mm and bleeding on probing (BOP) at the 3-month reevaluation. Using multilevel logistic regression, the effect of the antibiotics was analyzed according to the following factors (interaction effect): A. actinomycetemcomitans-positive or -negative at baseline, sex, age, smoking, tooth being a molar, and interdental location. At reevaluation, participants in the test group had significantly fewer sites with a persisting PD >4 mm and BOP than control patients (P antibiotics. Patients benefited from the antibiotics irrespective of sex, age, or smoking status. Molars benefited significantly more from the antibiotics than non-molars (P for interaction effect = 0.03). Patients who were positive for A. actinomycetemcomitans had no specific benefit from amoxicillin plus metronidazole. Sites on molars benefited significantly more from the antibiotics than non-molar sites.

  2. Sensitivity of Claims-Based Algorithms to Ascertain Smoking Status More Than Doubled with Meaningful Use.

    Science.gov (United States)

    Huo, Jinhai; Yang, Ming; Tina Shih, Ya-Chen

    2018-03-01

    The "meaningful use of certified electronic health record" policy requires eligible professionals to record smoking status for more than 50% of all individuals aged 13 years or older in 2011 to 2012. To explore whether the coding to document smoking behavior has increased over time and to assess the accuracy of smoking-related diagnosis and procedure codes in identifying previous and current smokers. We conducted an observational study with 5,423,880 enrollees from the year 2009 to 2014 in the Truven Health Analytics database. Temporal trends of smoking coding, sensitivity, specificity, positive predictive value, and negative predictive value were measured. The rate of coding of smoking behavior improved significantly by the end of the study period. The proportion of patients in the claims data recorded as current smokers increased 2.3-fold and the proportion of patients recorded as previous smokers increased 4-fold during the 6-year period. The sensitivity of each International Classification of Diseases, Ninth Revision, Clinical Modification code was generally less than 10%. The diagnosis code of tobacco use disorder (305.1X) was the most sensitive code (9.3%) for identifying smokers. The specificities of these codes and the Current Procedural Terminology codes were all more than 98%. A large improvement in the coding of current and previous smoking behavior has occurred since the inception of the meaningful use policy. Nevertheless, the use of diagnosis and procedure codes to identify smoking behavior in administrative data is still unreliable. This suggests that quality improvements toward medical coding on smoking behavior are needed to enhance the capability of claims data for smoking-related outcomes research. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  3. Creating a career legacy map to help assure meaningful work in nursing.

    Science.gov (United States)

    Hinds, Pamela S; Britton, Dorienda R; Coleman, Lael; Engh, Eileen; Humbel, Tina Kunze; Keller, Susan; Kelly, Katherine Patterson; Menard, Johanna; Lee, Marlene A; Roberts-Turner, Renee; Walczak, Dory

    2015-01-01

    When nurses declare a professional legacy (or what they intend to be better in health care because of their efforts), they are likely to maintain a focus on achieving their legacy and to experience meaning in the process. We depict the legacy and involved steps in creating a legacy map, which is a concrete guide forward to intended career outcomes. Informed by the "meaningful work" literature, we describe a legacy map, its function, the process to create one, and the application of a legacy map to guide careers. We also describe an administrative benefit of the legacy map-the map can be used by team leaders and members to secure needed resources and opportunities to support the desired legacy of team members. Legacy mapping can be a self-use career guidance tool for nurses and other health care professionals or a tool that links the career efforts of a team member with the career support efforts of a team leader. Copyright © 2015 Elsevier Inc. All rights reserved.

  4. Five-Year Follow-up of Knee Joint Distraction: Clinical Benefit and Cartilaginous Tissue Repair in an Open Uncontrolled Prospective Study.

    Science.gov (United States)

    van der Woude, Jan-Ton A D; Wiegant, Karen; van Roermund, Peter M; Intema, Femke; Custers, Roel J H; Eckstein, Felix; van Laar, Jaap M; Mastbergen, Simon C; Lafeber, Floris P J G

    2017-07-01

    Objective In end-stage knee osteoarthritis, total knee arthroplasty (TKA) may finally become inevitable. At a relatively young age, this comes with the risk of future revision surgery. Therefore, in these cases, joint preserving surgery such as knee joint distraction (KJD) is preferred. Here we present 5-year follow-up data of KJD. Design Patients ( n = 20; age cartilaginous tissue repair that provides a long-term tissue structure benefit as compared to natural progression. Level of evidence, II.

  5. Meaning in meaninglessness: The propensity to perceive meaningful patterns in coincident events and randomly arranged stimuli is linked to enhanced attention in early sensory processing.

    Science.gov (United States)

    Rominger, Christian; Schulter, Günter; Fink, Andreas; Weiss, Elisabeth M; Papousek, Ilona

    2018-05-01

    Perception of objectively independent events or stimuli as being significantly connected and the associated proneness to perceive meaningful patterns constitute part of the positive symptoms of schizophrenia, which are associated with altered attentional processes in lateralized speech perception. Since perceiving meaningful patterns is to some extent already prevalent in the general population, the aim of the study was to investigate whether the propensity to experience meaningful patterns in co-occurring events and random stimuli may be associated with similar altered attentional processes in lateralized speech perception. Self-reported and behavioral indicators of the perception of meaningful patterns were assessed in non-clinical individuals, along with EEG auditory evoked potentials during the performance of an attention related lateralized speech perception task (Dichotic Listening Test). A greater propensity to perceive meaningful patterns was associated with higher N1 amplitudes of the evoked potentials to the onset of the dichotically presented consonant-vowel syllables, indicating enhanced automatic attention in early sensory processing. The study suggests that more basic mechanisms in how people associate events may play a greater role in the cognitive biases that are manifest in personality expressions such as positive schizotypy, rather than that positive schizotypy moderates these cognitive biases directly. Copyright © 2017 Elsevier B.V. All rights reserved.

  6. Behavioral meaningful opioidergic stimulation activates kappa receptor gene expression

    International Nuclear Information System (INIS)

    Teodorov, E.; Ferrari, M.F.R.; Fior-Chadi, D.R.; Camarini, R.; Felício, L.F.

    2012-01-01

    The periaqueductal gray (PAG) has been reported to be a location for opioid regulation of pain and a potential site for behavioral selection in females. Opioid-mediated behavioral and physiological responses differ according to the activity of opioid receptor subtypes. The present study investigated the effects of the peripheral injection of the kappa-opioid receptor agonist U69593 into the dorsal subcutaneous region of animals on maternal behavior and on Oprk1 gene activity in the PAG of female rats. Female Wistar rats weighing 200-250 g at the beginning of the study were randomly divided into 2 groups for maternal behavior and gene expression experiments. On day 5, pups were removed at 7:00 am and placed in another home cage that was distant from their mother. Thirty minutes after removing the pups, the dams were treated with U69593 (0.15 mg/kg, sc) or 0.9% saline (up to 1 mL/kg) and after 30 min were evaluated in the maternal behavior test. Latencies in seconds for pup retrieval, grouping, crouching, and full maternal behavior were scored. The results showed that U69593 administration inhibited maternal behavior (P < 0.05) because a lower percentage of U69593 group dams showed retrieval of first pup, retrieving all pups, grouping, crouching and displaying full maternal behavior compared to the saline group. Opioid gene expression was evaluated using real-time reverse-transcription polymerase chain reaction (RT-PCR). A single injection of U69593 increased Oprk1 PAG expression in both virgin (P < 0.05) and lactating female rats (P < 0.01), with no significant effect on Oprm1 or Oprd1 gene activity. Thus, the expression of kappa-opioid receptors in the PAG may be modulated by single opioid receptor stimulation and behavioral meaningful opioidergic transmission in the adult female might occur simultaneously to specific changes in gene expression of kappa-opioid receptor subtype. This is yet another alert for the complex role of the opioid system in female

  7. Behavioral meaningful opioidergic stimulation activates kappa receptor gene expression

    Energy Technology Data Exchange (ETDEWEB)

    Teodorov, E. [Centro de Matemática, Computação e Cognição, Universidade Federal do ABC, São Paulo, SP (Brazil); Ferrari, M.F.R. [Departamento de Genética e Biologia Evolutiva, Instituto de Biociências, Universidade de São Paulo, São Paulo, SP (Brazil); Fior-Chadi, D.R. [Departamento de Fisiologia, Instituto de Biociências, Universidade de São Paulo, São Paulo, SP (Brazil); Camarini, R. [Departamento de Farmacologia, Instituto de Ciências Biomédicas, Universidade de São Paulo, São Paulo, SP (Brazil); Felício, L.F. [Departamento de Patologia, Faculdade de Medicina Veterinária e Zootecnia, Universidade de São Paulo, São Paulo, SP (Brazil)

    2012-06-01

    The periaqueductal gray (PAG) has been reported to be a location for opioid regulation of pain and a potential site for behavioral selection in females. Opioid-mediated behavioral and physiological responses differ according to the activity of opioid receptor subtypes. The present study investigated the effects of the peripheral injection of the kappa-opioid receptor agonist U69593 into the dorsal subcutaneous region of animals on maternal behavior and on Oprk1 gene activity in the PAG of female rats. Female Wistar rats weighing 200-250 g at the beginning of the study were randomly divided into 2 groups for maternal behavior and gene expression experiments. On day 5, pups were removed at 7:00 am and placed in another home cage that was distant from their mother. Thirty minutes after removing the pups, the dams were treated with U69593 (0.15 mg/kg, sc) or 0.9% saline (up to 1 mL/kg) and after 30 min were evaluated in the maternal behavior test. Latencies in seconds for pup retrieval, grouping, crouching, and full maternal behavior were scored. The results showed that U69593 administration inhibited maternal behavior (P < 0.05) because a lower percentage of U69593 group dams showed retrieval of first pup, retrieving all pups, grouping, crouching and displaying full maternal behavior compared to the saline group. Opioid gene expression was evaluated using real-time reverse-transcription polymerase chain reaction (RT-PCR). A single injection of U69593 increased Oprk1 PAG expression in both virgin (P < 0.05) and lactating female rats (P < 0.01), with no significant effect on Oprm1 or Oprd1 gene activity. Thus, the expression of kappa-opioid receptors in the PAG may be modulated by single opioid receptor stimulation and behavioral meaningful opioidergic transmission in the adult female might occur simultaneously to specific changes in gene expression of kappa-opioid receptor subtype. This is yet another alert for the complex role of the opioid system in female

  8. Behavioral meaningful opioidergic stimulation activates kappa receptor gene expression

    Directory of Open Access Journals (Sweden)

    E. Teodorov

    2012-10-01

    Full Text Available The periaqueductal gray (PAG has been reported to be a location for opioid regulation of pain and a potential site for behavioral selection in females. Opioid-mediated behavioral and physiological responses differ according to the activity of opioid receptor subtypes. The present study investigated the effects of the peripheral injection of the kappa-opioid receptor agonist U69593 into the dorsal subcutaneous region of animals on maternal behavior and on Oprk1 gene activity in the PAG of female rats. Female Wistar rats weighing 200-250 g at the beginning of the study were randomly divided into 2 groups for maternal behavior and gene expression experiments. On day 5, pups were removed at 7:00 am and placed in another home cage that was distant from their mother. Thirty minutes after removing the pups, the dams were treated with U69593 (0.15 mg/kg, sc or 0.9% saline (up to 1 mL/kg and after 30 min were evaluated in the maternal behavior test. Latencies in seconds for pup retrieval, grouping, crouching, and full maternal behavior were scored. The results showed that U69593 administration inhibited maternal behavior (P < 0.05 because a lower percentage of kappa group dams showed retrieval of first pup, retrieving all pups, grouping, crouching and displaying full maternal behavior compared to the saline group. Opioid gene expression was evaluated using real-time reverse-transcription polymerase chain reaction (RT-PCR. A single injection of U69593 increased Oprk1 PAG expression in both virgin (P < 0.05 and lactating female rats (P < 0.01, with no significant effect on Oprm1 or Oprd1 gene activity. Thus, the expression of kappa-opioid receptors in the PAG may be modulated by single opioid receptor stimulation and behavioral meaningful opioidergic transmission in the adult female might occur simultaneously to specific changes in gene expression of kappa-opioid receptor subtype. This is yet another alert for the complex role of the opioid system in

  9. Merit-Based Incentive Payment System: Meaningful Changes in the Final Rule Brings Cautious Optimism.

    Science.gov (United States)

    Manchikanti, Laxmaiah; Helm Ii, Standiford; Calodney, Aaron K; Hirsch, Joshua A

    2017-01-01

    The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) eliminated the flawed Sustainable Growth Rate (SGR) act formula - a longstanding crucial issue of concern for health care providers and Medicare beneficiaries. MACRA also included a quality improvement program entitled, "The Merit-Based Incentive Payment System, or MIPS." The proposed rule of MIPS sought to streamline existing federal quality efforts and therefore linked 4 distinct programs into one. Three existing programs, meaningful use (MU), Physician Quality Reporting System (PQRS), value-based payment (VBP) system were merged with the addition of Clinical Improvement Activity category. The proposed rule also changed the name of MU to Advancing Care Information, or ACI. ACI contributes to 25% of composite score of the four programs, PQRS contributes 50% of the composite score, while VBP system, which deals with resource use or cost, contributes to 10% of the composite score. The newest category, Improvement Activities or IA, contributes 15% to the composite score. The proposed rule also created what it called a design incentive that drives movement to delivery system reform principles with the inclusion of Advanced Alternative Payment Models (APMs).Following the release of the proposed rule, the medical community, as well as Congress, provided substantial input to Centers for Medicare and Medicaid Services (CMS),expressing their concern. American Society of Interventional Pain Physicians (ASIPP) focused on 3 important aspects: delay the implementation, provide a 3-month performance period, and provide ability to submit meaningful quality measures in a timely and economic manner. The final rule accepted many of the comments from various organizations, including several of those specifically emphasized by ASIPP, with acceptance of 3-month reporting period, as well as the ability to submit non-MIPS measures to improve real quality and make the system meaningful. CMS also provided a mechanism for

  10. Identifying health facilities outside the enterprise: challenges and strategies for supporting health reform and meaningful use.

    Science.gov (United States)

    Dixon, Brian E; Colvard, Cyril; Tierney, William M

    2014-06-24

    Objective: To support collation of data for disability determination, we sought to accurately identify facilities where care was delivered across multiple, independent hospitals and clinics. Methods: Data from various institutions' electronic health records were merged and delivered as continuity of care documents to the United States Social Security Administration (SSA). Results: Electronic records for nearly 8000 disability claimants were exchanged with SSA. Due to the lack of standard nomenclature for identifying the facilities in which patients received the care documented in the electronic records, SSA could not match the information received with information provided by disability claimants. Facility identifiers were generated arbitrarily by health care systems and therefore could not be mapped to the existing international standards. Discussion: We propose strategies for improving facility identification in electronic health records to support improved tracking of a patient's care between providers to better serve clinical care delivery, disability determination, health reform and meaningful use. Conclusion: Accurately identifying the facilities where health care is delivered to patients is important to a number of major health reform and improvement efforts underway in many nations. A standardized nomenclature for identifying health care facilities is needed to improve tracking of care and linking of electronic health records.

  11. Moderate efficiency of clinicians' predictions decreased for blurred clinical conditions and benefits from the use of BRASS index. A longitudinal study on geriatric patients' outcomes.

    Science.gov (United States)

    Signorini, Giulia; Dagani, Jessica; Bulgari, Viola; Ferrari, Clarissa; de Girolamo, Giovanni

    2016-01-01

    Accurate prognosis is an essential aspect of good clinical practice and efficient health services, particularly for chronic and disabling diseases, as in geriatric populations. This study aims to examine the accuracy of clinical prognostic predictions and to devise prediction models combining clinical variables and clinicians' prognosis for a geriatric patient sample. In a sample of 329 consecutive older patients admitted to 10 geriatric units, we evaluated the accuracy of clinicians' prognosis regarding three outcomes at discharge: global functioning, length of stay (LoS) in hospital, and destination at discharge (DD). A comprehensive set of sociodemographic, clinical, and treatment-related information were also collected. Moderate predictive performance was found for all three outcomes: area under receiver operating characteristic curve of 0.79 and 0.78 for functioning and LoS, respectively, and moderate concordance, Cohen's K = 0.45, between predicted and observed DD. Predictive models found the Blaylock Risk Assessment Screening Score together with clinicians' judgment relevant to improve predictions for all outcomes (absolute improvement in adjusted and pseudo-R(2) up to 19%). Although the clinicians' estimates were important factors in predicting global functioning, LoS, and DD, more research is needed regarding both methodological aspects and clinical measurements, to improve prognostic clinical indices. Copyright © 2016 Elsevier Inc. All rights reserved.

  12. Illustrative cases for monitoring by quantitative analysis of BRAF/NRAS ctDNA mutations in liquid biopsies of metastatic melanoma patients who gained clinical benefits from anti-PD1 antibody therapy.

    Science.gov (United States)

    Seremet, Teofila; Planken, Simon; Schreuer, Max; Jansen, Yanina; Delaunoy, Mélanie; El Housni, Hakim; Lienard, Danielle; Del Marmol, Véronique; Heimann, Pierre; Neyns, Bart

    2018-02-01

    Anti-programmed death 1 (PD-1) monoclonal antibodies improve the survival of metastatic melanoma patients. Predictive or monitoring biomarkers for response to this therapy could improve the clinical management of these patients. To date, no established biomarkers are available for monitoring the response to immunotherapy. Tumor- specific mutations in circulating tumor DNA (ctDNA) such as BRAF and NRAS mutations for melanoma patients have been proposed for monitoring of immunotherapy response. We present seven illustrative cases for the use of ctDNA BRAF and NRAS mutations' monitoring in plasma. The cases described exemplify four distinct clinical benefit patterns: rapid and durable complete response (CR), early progression, followed by CR, CR followed by early progression after interrupting treatment and long-term disease stabilization. These representative cases suggest that comprehensive BRAF/NRAS ctDNA monitoring during anti-PD1 therapy is informative and can be of added value for the monitoring of melanoma patients gaining clinical benefit on anti-PD1 treatment. An important advantage of our approach is that using the cartridge system on the Idylla platform for mutation analysis, the results become available the same day 2 h after plasma collection. Therefore, in the future, the ctDNA level can be an element in the clinical management of the patients.

  13. Development of an Assessment Tool to Measure Students' Meaningful Learning in the Undergraduate Chemistry Laboratory

    Science.gov (United States)

    Galloway, Kelli R.; Bretz, Stacey Lowery

    2015-01-01

    Research on learning in the undergraduate chemistry laboratory necessitates an understanding of students' perspectives of learning. Novak's Theory of Meaningful Learning states that the cognitive (thinking), affective (feeling), and psychomotor (doing) domains must be integrated for meaningful learning to occur. The psychomotor domain is the…

  14. Meaningful Experiences in Physical Education and Youth Sport: A Review of the Literature

    Science.gov (United States)

    Beni, Stephanie; Fletcher, Tim; Ní Chróinín, Déirdre

    2017-01-01

    The purpose of this research is to review the literature about young people's meaningful experiences in physical education and youth sport. We reviewed 50 empirical peer-reviewed articles published in English since 1987. Five themes were identified as central influences to young people's meaningful experiences in physical education and sport:…

  15. Relationship between attachment to God and meaningful life parents of mentally retarded children in Zahedan city

    Directory of Open Access Journals (Sweden)

    H Jenaabadi

    2014-07-01

    Conclusion: Given a significant positive correlation between appeal to God and meaningful life, it is suggested including spirituality therapy sessions and teaching religious coping methods to reduce stress and thus make meaningful life in these parents by welfare, education of exceptional children, and radio and television organizations.

  16. The Meaningful Activity Participation Assessment: A Measure of Engagement in Personally Valued Activities

    Science.gov (United States)

    Eakman, Aaron M.; Carlson, Mike E.; Clark, Florence A.

    2010-01-01

    The Meaningful Activity Participation Assessment (MAPA), a recently developed 28-item tool designed to measure the meaningfulness of activity, was tested in a sample of 154 older adults. The MAPA evidenced a sufficient level of internal consistency and test-retest reliability and correlated as theoretically predicted with the Life Satisfaction…

  17. A Continuum of Learning: From Rote Memorization to Meaningful Learning in Organic Chemistry

    Science.gov (United States)

    Grove, Nathaniel P.; Bretz, Stacey Lowery

    2012-01-01

    The Assimilation Theory of Ausubel and Novak has typically been used in the research literature to describe two extremes to learning chemistry: meaningful learning "versus" rote memorization. It is unlikely, however, that such discrete categories of learning exist. Rote and meaningful learning, rather, are endpoints along a continuum of…

  18. Driving Meaningful Adaptation Action through an Adaptation Market Mechanism

    Energy Technology Data Exchange (ETDEWEB)

    Butzengeiger-Geyer, Sonja; Koehler, Michel; Michaelowa, Axel

    2011-07-01

    Approaches and criteria for allocating adaptation funds vary significantly among current sources - UN-backed funds and bilateral cooperation - and to some extent lack transparency and consistency. Such funding risks being spent in a haphazard way that repeats many of the mistakes made in development assistance over the past decades. An Adaptation Market Mechanism (AMM) could contribute to efficient allocation of adaptation funds, promote adaptation activities by private and public actors through additional financial incentives, and raise additional and reliable adaptation money. This would help to avoid future public criticism of the effectiveness and efficiency of spending adaptation funding.The proposed AMM would specify mandatory adaptation targets, on international, regional or domestic level. Participants who achieve their targets either by generating adaptation units or by buying them in the market would incentivize private, commercial and institutional actors to develop adaptation projects that create verified adaptation units. A universally accepted and verifiable trading unit applicable to all types of adaptation activities would help to maximize the cost reduction potential for the AMM. We suggest applying net present value (NPV) for property saved; Disability Adjusted Life Years Saved (DALYS) for health benefits; and potentially a separate unit to consider the environmental benefits of an adaptation activity.(Author)

  19. Clinical benefit of fixed-dose dual bronchodilation with glycopyrronium and indacaterol once daily in patients with chronic obstructive pulmonary disease

    DEFF Research Database (Denmark)

    Ulrik, Charlotte Suppli

    2014-01-01

    BACKGROUND AND AIM: Long-acting bronchodilators are the preferred option for maintenance therapy of patients with chronic obstructive pulmonary disease (COPD). The aim of this review is to provide an overview of the clinical studies evaluating the clinical efficacy of the once-daily fixed-dose du...... for chronic Obstructive Lung Disease [GOLD] spirometric criteria). Furthermore, a very recent study has shown that fixed-dose indacaterol/glycopyrronium improves exercise endurance time compared with placebo, although no significant difference was observed between fixed-dose indacaterol...

  20. How health leaders can benefit from predictive analytics.

    Science.gov (United States)

    Giga, Aliyah

    2017-11-01

    Predictive analytics can support a better integrated health system providing continuous, coordinated, and comprehensive person-centred care to those who could benefit most. In addition to dollars saved, using a predictive model in healthcare can generate opportunities for meaningful improvements in efficiency, productivity, costs, and better population health with targeted interventions toward patients at risk.

  1. Understanding quantitative DCE-MRI of the breast : towards meaningful clinical application

    NARCIS (Netherlands)

    Heisen, M.

    2010-01-01

    In most industrialized countries breast cancer will affect one out of eight women during her lifetime. In the USA, after continuously increasing for more than two decades, incidence rates are slowly decreasing since 2001. Since 1990, death rates from breast cancer have steadily decreased in women,

  2. Analysis of Mitral Valve Replacement Outcomes is Enhanced by Meaningful Clinical Use of Electronic Health Records

    Science.gov (United States)

    Chen, John C; Pfeffer, Thomas; Johnstone, Shelley; Chen, Yuexin; Kiley, Mary-Lou; Richter, Richard; Lee, Hon

    2013-01-01

    Objective: Cardiac surgical mortality has improved during the last decade despite the aging of the population. An integrated US health plan developed a heart valve registry to track outcomes and complications of heart valve operations. This database was used for longitudinal evaluation of mitral valve (MV) outcomes from 1999 to 2008 at four affiliated hospitals. Methods: We identified 3130 patients in the Apollo database who underwent 3180 initial MV procedures. Internal administrative and Social Security Administration databases were merged to determine survival rates. Electronic health records were searched to ascertain demographics, comorbidities, and postoperative complications. Cox regression was used to evaluate mean survival and identify risk factors. Results: The procedures included 1160 mechanical valve replacements, 1159 tissue valve replacements, and 861 annuloplasties. The mean age of patients undergoing these procedures was 58 ± 11 years, 69 ± 12 years, and 62 ± 12 years, respectively. Mean survival was 8.9 ± 0.1 years for mechanical valve replacement, 7.0 ± 0.1 years for tissue valve replacement, and 7.7 ± 0.1 years for annuloplasty. Early in the study, there was a preference for implanting mechanical MVs. Beginning in 2003, more patients received tissue valve replacements rather than mechanical valves. Over time, there was an increasing trend of annuloplasty. Cox regression analysis identified the following risk factors for increased ten-year mortality: tissue valve implantation; advanced age; female sex; nonelective, nonisolated procedure; diabetes; postoperative use of banked blood products; previous cardiovascular intervention; dialysis; and longer perfusion time. Hospital location, reoperation, preoperative anticoagulation, and cardiogenic shock were not statistically significant risk factors. Conclusions: When controlling for other risk factors, we observed a lower long-term survival rate for tissue valve replacement compared with mechanical valve replacement. Integrating electronic health records with existing electronic databases provided near-real-time analysis of longitudinal cardiac surgical outcomes. PMID:23704837

  3. Net clinical benefit of combination anticoagulant and antiplatelet therapy versus anticoagulation alone in atrial fibrillation patients: Results from the amadeus trial

    NARCIS (Netherlands)

    Lane, Deirdre; Kamphuisen, Pieter; Minini, Pascal; De Peuter, Olaf R.; Buller, Harry R.; Lip, Gregory Y. H.

    2010-01-01

    Background: To compare the effect of combination anticoagulant and antiplatelet (AP) therapy with anticoagulation alone on stroke and bleeding risk in atrial fibrillation (AF) patients and examine predictors of clinically relevant bleeding. Methods: Post-hoc analysis of 4576 AF patients [mean (SD)

  4. Increased trunk extension endurance is associated with meaningful improvement in balance among older adults with mobility problems.

    Science.gov (United States)

    Suri, Pradeep; Kiely, Dan K; Leveille, Suzanne G; Frontera, Walter R; Bean, Jonathan F

    2011-07-01

    To determine whether trunk extension endurance changes with training are associated with clinically meaningful improvements in balance among mobility-limited older adults. Longitudinal data from a randomized controlled trial. Outpatient rehabilitation research center. Community-dwelling older adults (N=64; mean age, 75.9y) with mobility limitations as defined by a score of 4 to 10 on the Short Physical Performance Battery. Sixteen weeks of progressive resistance training. Outcomes were the Berg Balance Scale (BBS) and the Unipedal Stance Time (UST). Predictors included leg strength, leg power, trunk extension endurance, and the product of heart rate and blood pressure (RPP) at the final stage of an exercise tolerance test. We performed an analysis of data from participants who completed 16 weeks of training by using binary outcomes defined by a clinically meaningful change (CMC) from baseline to completion of the intervention (BBS=4 units; UST=5s). The association of predictor variables with balance outcomes was examined separately and together in multivariate adjusted logistic regression models. Trunk extension endurance in seconds (1.04 [1.00-1.09]) was independently associated with CMC on the BBS. Trunk extension endurance (1.02 [1.00-1.03]) was independently associated with CMC on the UST. Other physical attributes were not associated with meaningful change in balance. Improvements in trunk extension endurance were independently associated with CMCs in balance in older adults. Leg strength, leg power, and RPP were not associated with CMC in balance. Poor trunk extension endurance may be a rehabilitative impairment worthy of further study as a modifiable factor linked to balance among older adults. Copyright © 2011 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  5. A noise-reduction program in a pediatric operation theatre is associated with surgeon's benefits and a reduced rate of complications: a prospective controlled clinical trial.

    Science.gov (United States)

    Engelmann, Carsten R; Neis, Jan Philipp; Kirschbaum, Clemens; Grote, Gudela; Ure, Benno M

    2014-05-01

    We assessed the impact of a noise-reduction program in a pediatric operating theatre. Adverse effects from noise pollution in theatres have been demonstrated. In 156 operations spatially resolved, sound levels were measured before and after a noise-reduction program on the basis of education, rules, and technical devices (Sound Ear). Surgical complications were recorded. The surgeon's biometric (saliva cortisol, electrodermal activity) and behavioral stress responses (questionnaires) were measured and correlated with mission protocols and individual noise sensitivity. Median noise levels in the control group versus the interventional group were reduced by -3 ± 3 dB(A) (63 vs 59 dB(A), P 0.05). Spontaneous noise during pediatric operations attains the magnitude of a lawn mower and peaks resemble a passing truck. The sound intensity could be reduced by 50% by specific measures. This reduction was associated with a significantly lowered number of postoperative complications. The surgeon's benefits are idiosyncratic with "responders" experiencing marked improvements.

  6. Clinical Trials

    Medline Plus

    Full Text Available ... risks that outweigh any possible benefits. Clinical Trial Phases Clinical trials of new medicines or medical devices are done in phases. These phases have different purposes and help researchers ...

  7. The clinical benefit of imaging striatal dopamine transporters with [123I]FP-CIT SPET in differentiating patients with presynaptic parkinsonism from those with other forms of parkinsonism

    International Nuclear Information System (INIS)

    Booij, J.; Speelman, J.DE.; Horstink, M. W.I.M.; Wolters, E.C.

    2001-01-01

    [ 123 I]FP-CIT (N-ω-fluoropropyl-2β-carbomethoxy-3β-(4-iodophenyl)nortropane) has been developed successfully as a radioligand for single-photon emission tomography (SPET) imaging of dopamine transporters, which are situated in the membrane of dopaminergic neurons. Imaging of these transporters has shown promise as a clinical tool to detect degeneration of the dopaminergic nigrostriatal pathway. Several ''presynaptic parkinsonian'' syndromes, such as Parkinson's disease or multiple system atrophy, are characterised by degeneration of the nigrostriatal pathway. [ 123 I]FP-CIT SPET imaging studies have shown the ability to detect loss of striatal dopamine transporters in such syndromes. However, in clinical practice it is sometimes difficult, but important, to discriminate patients with ''presynaptic parkinsonism'' from those with other forms of parkinsonism not characterised by loss of presynaptic dopaminergic cells (e.g. psychogenic parkinsonism or drug-induced postsynaptic parkinsonism). In these inconclusive cases, it may be of value to confirm or exclude the existence of degeneration of nigrostriatal dopaminergic cells by using imaging techniques such as [ 123 I]FP-CIT SPET. Using [ 123 I]FP-CIT SPET, we have imaged the striatal dopamine transporters in a group of patients with inconclusive forms of parkinsonism, and, moreover, have been able to perform clinical follow-up of these patients 2-4 years after imaging. In 33 inconclusive cases, ratios of specific to non-specific binding were calculated for the caudate nucleus and putamen following [ 123 I]FP-CIT SPET imaging and compared with ratios obtained in healthy controls. In nine of the patients, degeneration of the nigrostriatal pathway was found scintigraphically and in all these cases, presynaptic parkinsonism was confirmed by clinical follow-up. In the other 24 subjects no degeneration was found scintigraphically. Forms of parkinsonism other than the presynaptic were confirmed at follow-up in 19 cases

  8. Maximizing Effectiveness Trials in PTSD and SUD Through Secondary Analysis: Benefits and Limitations Using the National Institute on Drug Abuse Clinical Trials Network "Women and Trauma" Study as a Case Example.

    Science.gov (United States)

    Hien, Denise A; Campbell, Aimee N C; Ruglass, Lesia M; Saavedra, Lissette; Mathews, Abigail G; Kiriakos, Grace; Morgan-Lopez, Antonio

    2015-09-01

    Recent federal legislation and a renewed focus on integrative care models underscore the need for economical, effective, and science-based behavioral health care treatment. As such, maximizing the impact and reach of treatment research is of great concern. Behavioral health issues, including the frequent co-occurrence of substance use disorders (SUD) and posttraumatic stress disorder (PTSD), are often complex, with a myriad of factors contributing to the success of interventions. Although treatment guides for comorbid SUD/PTSD exist, most patients continue to suffer symptoms following the prescribed treatment course. Further, the study of efficacious treatments has been hampered by methodological challenges (e.g., overreliance on "superiority" designs (i.e., designs structured to test whether or not one treatment statistically surpasses another in terms of effect sizes) and short term interventions). Secondary analyses of randomized controlled clinical trials offer potential benefits to enhance understanding of findings and increase the personalization of treatment. This paper offers a description of the limits of randomized controlled trials as related to SUD/PTSD populations, highlights the benefits and potential pitfalls of secondary analytic techniques, and uses a case example of one of the largest effectiveness trials of behavioral treatment for co-occurring SUD/PTSD conducted within the National Drug Abuse Treatment Clinical Trials Network (NIDA CTN) and producing 19 publications. The paper concludes with implications of this secondary analytic approach to improve addiction researchers' ability to identify best practices for community-based treatment of these disorders. Innovative methods are needed to maximize the benefits of clinical studies and better support SUD/PTSD treatment options for both specialty and non-specialty healthcare settings. Moving forward, planning for and description of secondary analyses in randomized trials should be given equal

  9. Durable Clinical Benefit of Pertuzumab in a Young Patient with BRCA2 Mutation and HER2-Overexpressing Breast Cancer Involving the Brain

    Directory of Open Access Journals (Sweden)

    Anna Koumarianou

    2016-01-01

    Full Text Available Patients with HER2-positive breast cancer and brain metastases have limited treatment options, and, as a result of their poor performance status and worse prognosis, they are underrepresented in clinical trials. Not surprisingly, these patients may not be fit enough to receive any active treatment and are offered supportive therapy. BRCA2 mutations are reported to be rarely associated with HER2-overexpressing advanced breast cancer and even more rarely with brain metastases at diagnosis. We report on a BRCA2-positive breast cancer patient with metastatic disease in multiple sites, including the brain, and poor performance status who exhibited an extraordinary clinical and imaging response to the novel anti-HER2 therapy pertuzumab after multiple lines of therapy including anti-HER2 targeting. To our knowledge, the clinicopathologic and therapeutic characteristics of this patient point to a unique case and an urgent need for further investigation of pertuzumab in patients with brain metastases.

  10. Active Video Gaming for Children with Cerebral Palsy: Does a Clinic-Based Virtual Reality Component Offer an Additive Benefit? A Pilot Study.

    Science.gov (United States)

    Levac, Danielle; McCormick, Anna; Levin, Mindy F; Brien, Marie; Mills, Richard; Miller, Elka; Sveistrup, Heidi

    2018-02-01

    To compare changes in gross motor skills and functional mobility between ambulatory children with cerebral palsy who underwent a 1-week clinic-based virtual reality intervention (VR) followed by a 6-week, therapist-monitored home active video gaming (AVG) program and children who completed only the 6-week home AVG program. Pilot non-randomized controlled trial. Five children received 1 hour of VR training for 5 days followed by a 6-week home AVG program, supervised online by a physical therapist. Six children completed only the 6-week home AVG program. The Gross Motor Function Measure Challenge Module (GMFM-CM) and Six Minute Walk Test (6MWT) evaluated change. There were no significant differences between groups. The home AVG-only group demonstrated a statistically and clinically significant improvement in GMFM-CM scores following the 6-week AVG intervention (median difference 4.5 points, interquartile range [IQR] 4.75, p = 0.042). The VR + AVG group demonstrated a statistically and clinically significant decrease in 6MWT distance following the intervention (median decrease 68.2 m, IQR 39.7 m, p = 0.043). All 6MWT scores returned to baseline at 2 months post-intervention. Neither intervention improved outcomes in this small sample. Online mechanisms to support therapist-child communication for exercise progression were insufficient to individualize exercise challenge.

  11. Retirement as Meaningful: Positive Retirement Stereotypes Associated with Longevity

    Science.gov (United States)

    Ng, Reuben; Allore, Heather G.; Monin, Joan K.; Levy, Becca R.

    2016-01-01

    Studies examining the association between retirement and health have produced mixed results. This may be due to previous studies treating retirement as merely a change in job status rather than a transition associated with stereotypes or societal beliefs (e.g., retirement is a time of mental decline or retirement is a time of growth). To examine whether these stereotypes are associated with health, we studied retirement stereotypes and survival over a 23-year period among 1,011 older adults. As predicted by stereotype embodiment theory, it was found that positive stereotypes about physical health during retirement showed a survival advantage of 4.5 years (hazard ratio = 0.88, p = .022) and positive stereotypes about mental health during retirement tended to show a survival advantage of 2.5 years (hazard ratio = 0.87, p = .034). Models adjusted for relevant covariates such as age, gender, race, employment status, functional health, and self-rated health. These results suggest that retirement preparation could benefit from considering retirement stereotypes. PMID:27346893

  12. Meaningful lives: Supporting young people with psychosis in education, training and employment: an international consensus statement.

    Science.gov (United States)

    2010-11-01

    Unemployment is the major disability faced by people with psychotic illness. Unemployment rates of 75–95% are found among those with schizophrenia. Unemployment is associated with poorer social and economic inclusion, greater symptomatology, decreased autonomy and generally poorer life functioning. Unemployment also makes up over half of the total costs associated with psychotic illness. A meeting was convened in London in June 2008. Invitees to this meeting included people from the USA, Canada and the UK interested in vocational intervention in early psychosis from either a research, clinical, economic or policy point of view. From this meeting a larger group–the International First Episode Vocational Recovery (iFEVR) group–has developed an international consensus statement about vocational recovery in first episode psychosis. The document is a basic statement of the rights of young people with psychosis to pursue employment, education and training; the evidence which exists to help them do this; and ways in which individuals, organizations and governments can assist the attainment of these ends. It is hoped that the Meaningful Lives consensus statement will increase the focus on the area of functional recovery and lift it to be seen in parallel with symptomatic recovery in the approach to treating early psychosis.

  13. Values-led Participatory Design as a pursuit of meaningful alternatives

    DEFF Research Database (Denmark)

    Leong, Tuck Wah; Iversen, Ole Sejer

    2015-01-01

    Participatory Design (PD) is inherently concerned with inquiring into and supporting human values when designing IT. We argue that a PD approach that is led by a focus upon participants' values can allow participants to discover meaningful alternatives -- alternative uses and alternative...... conceptualizations for IT that are particularly meaningful to them. However, how PD works with values in the design process has not been made explicit. In this paper, we aim to (i) explicate this values-led PD approach, (ii) illustrate how this approach can lead to outcomes that are meaningful alternatives, and (iii...

  14. Six weeks of continuous joint distraction appears sufficient for clinical benefit and cartilaginous tissue repair in the treatment of knee osteoarthritis.

    Science.gov (United States)

    van der Woude, J A D; van Heerwaarden, R J; Spruijt, S; Eckstein, F; Maschek, S; van Roermund, P M; Custers, R J H; van Spil, W E; Mastbergen, S C; Lafeber, F P J G

    2016-10-01

    Knee joint distraction (KJD) is a surgical joint-preserving treatment in which the knee joint is temporarily distracted by an external frame. It is associated with joint tissue repair and clinical improvement. Initially, patients were submitted to an eight-week distraction period, and currently patients are submitted to a six-week distraction period. This study evaluates whether a shorter distraction period influences the outcome. Both groups consisted of 20 patients. Clinical outcome was assessed by WOMAC questionnaires and VAS-pain. Cartilaginous tissue repair was assessed by radiographic joint space width (JSW) and MRI-observed cartilage thickness. Baseline data between both groups were comparable. Both groups showed an increase in total WOMAC score; 24±4 in the six-week group and 32±5 in the eight-week group (both p<0.001). Mean JSW increased 0.9±0.3mm in the six-week group and 1.1±0.3mm in the eight-week group (p=0.729 between groups). The increase in mean cartilage thickness on MRI was 0.6±0.2mm in the eight-week group and 0.4±0.1mm in the six-week group (p=0.277). A shorter distraction period does not influence short-term clinical and structural outcomes statistically significantly, although effect sizes tend to be smaller in six week KJD as compared to eight week KJD. Copyright © 2016 Elsevier B.V. All rights reserved.

  15. Does Problem-Solving Training for Family Caregivers Benefit Their Care Recipients With Severe Disabilities? A Latent Growth Model of the Project CLUES Randomized Clinical Trial

    Science.gov (United States)

    Berry, Jack W.; Elliott, Timothy R.; Grant, Joan S.; Edwards, Gary; Fine, Philip R.

    2012-01-01

    Objective To examine whether an individualized problem-solving intervention provided to family caregivers of persons with severe disabilities provides benefits to both caregivers and their care recipients. Design Family caregivers were randomly assigned to an education-only control group or a problem-solving training (PST) intervention group. Participants received monthly contacts for 1 year. Participants Family caregivers (129 women, 18 men) and their care recipients (81 women, 66 men) consented to participate. Main Outcome Measures Caregivers completed the Social Problem-Solving Inventory–Revised, the Center for Epidemiological Studies-Depression scale, the Satisfaction with Life scale, and a measure of health complaints at baseline and in 3 additional assessments throughout the year. Care recipient depression was assessed with a short form of the Hamilton Depression Scale. Results Latent growth modeling was used to analyze data from the dyads. Caregivers who received PST reported a significant decrease in depression over time, and they also displayed gains in constructive problem-solving abilities and decreases in dysfunctional problem-solving abilities. Care recipients displayed significant decreases in depression over time, and these decreases were significantly associated with decreases in caregiver depression in response to training. Conclusions PST significantly improved the problem-solving skills of community-residing caregivers and also lessened their depressive symptoms. Care recipients in the PST group also had reductions in depression over time, and it appears that decreases in caregiver depression may account for this effect. PMID:22686549

  16. Comparison of clinical outcome parameters, the Patient Benefit Index (PBI-k) and patient satisfaction after ablative fractional laser treatment of peri-orbital rhytides.

    Science.gov (United States)

    Karsai, Syrus; Raulin, Christian

    2010-03-01

    Laser treatment of facial rhytides has evolved as a major modality of aesthetic surgery. Published results, while generally encouraging, feature highly diverse evaluation methods, which makes an evidence-based assessment of treatment efficacy and safety all but impossible. To compare the results of different instruments of measurement. Twenty-eight patients were enrolled and completed the entire study. They received a single ablative fractional treatment of the peri-orbital region. The evaluation included the Fitzpatrick wrinkle score, the profilometric measurement of wrinkle depth and the Patient Benefit Index (both before and 3 months after treatment) as well as the assessment of patient satisfaction (1, 3, 6 days and 3 months after treatment). All assessment instruments showed a significant, albeit moderate, improvement. The agreement between assessment methods was poor. Despite claiming to assess basically the same parameter, the Fitzpatrick wrinkle score and profilometry differed significantly, and neither assessment instrument showed any appreciable correlation with any other. The outcome assessment of rhytide therapy-regardless of the method used-shows substantial room for improvement. Strict methodological precautions ought to be applied for 'objective' evaluation methods like photographic scoring and profilometry. Subjective methods of assessment are essential and might serve as a main outcome parameter. Finally, critical reappraisal of published treatment results seems warranted to review the quality of their methodology.

  17. Novel Study Guides for Biochemistry Meaningful Learning in Biology: a Design-Based Research

    Directory of Open Access Journals (Sweden)

    Costa, C ; Galembeck, E. Costa, C ; Galembeck, E.

    2017-07-01

    Full Text Available One of the difficulties for biochemistry learning is the persistence of traditional teaching methods, based on transmission and memorization of abstract and detailed information, usually in a decontextualized way. Such scenario results in surface learning and content reproduction. In order to address these problems, three interventions in a discipline (Metabolism for Biology majors were applied, in the form of innovative teaching tools (study guides. OBJECTIVES: The main goal is to evaluate the impact of these interventions on interest, motivation, and learning of the metabolic pathways. MATERIALS AND METHODS: We describe the development, application, and evaluation of two study guides – one created from a problem used as a contextual connection for glycogen metabolism study and another embedding an integrative view based on glutamate metabolism. Both materials were guided by broad themes like evolution, metabolic adaptation, and comparative biochemistry. The development of the study guides combined submicroscopic (molecular and macroscopic (body, environment levels, aiming to motivate reading and discussion. A design-based research with cycles of application and assessment was carried out, by means of classroom observation, grade analysis in written exams, and students’ interviews. RESULTS AND DISCUSSION: In general, based on in-class student feedback to professors and to the researcher in the interviews, the study guides arouse curiosity and fostered peer discussion. Final average grades indicate a good global performance in all proposed activities. Whole data from study guides’ application in classroom evidenced their impact on interest, motivation, and learning. The strategy of developing problem or integrative situation linking molecular (micro and contextual (macro levels were helpful to foster critical thinking and to value topics of scientific literacy. CONCLUSIONS: Analysis and interpretation of the results point to benefits for

  18. Genetically meaningful phenotypic subgroups in autism spectrum disorders.

    Science.gov (United States)

    Veatch, O J; Veenstra-Vanderweele, J; Potter, M; Pericak-Vance, M A; Haines, J L

    2014-03-01

    Autism spectrum disorder (ASD) is a complex neurodevelopmental disorder with strong evidence for genetic susceptibility. However, the effect sizes for implicated chromosomal loci are small, hard to replicate and current evidence does not explain the majority of the estimated heritability. Phenotypic heterogeneity could be one phenomenon complicating identification of genetic factors. We used data from the Autism Diagnostic Interview-Revised, Autism Diagnostic Observation Schedule, Vineland Adaptive Behavior Scales, head circumferences, and ages at exams as classifying variables to identify more clinically similar subgroups of individuals with ASD. We identified two distinct subgroups of cases within the Autism Genetic Resource Exchange dataset, primarily defined by the overall severity of evaluated traits. In addition, there was significant familial clustering within subgroups (odds ratio, OR ≈ 1.38-1.42, P definition that should increase power to detect genetic factors influencing risk for ASD. © 2013 John Wiley & Sons Ltd and International Behavioural and Neural Genetics Society.

  19. Health care professionals' experience, understanding and perception of need of advanced cancer patients with cachexia and their families: The benefits of a dedicated clinic.

    Science.gov (United States)

    Scott, David; Reid, Joanne; Hudson, Peter; Martin, Peter; Porter, Sam

    2016-12-30

    Cachexia is defined as the on-going loss of skeletal muscle mass that cannot be fully reversed by conventional nutritional support. It is found in up to 80% of patients with advanced cancer and has profound psycho-social consequences for patients and their families. Previous studies demonstrate that many healthcare professionals receive little formal education in cachexia management leading them to feel that they have limited understanding of the syndrome and cannot intervene effectively. This study aims to examine the value of a dedicated cachexia clinic and its influence on staff understanding and practice. An exploratory qualitative study was conducted. The study employed semi-structured interviews with a range of healthcare professionals responsible for designing and delivering cancer care in a large teaching hospital in Australia. This hospital had a dedicated cachexia clinic. In-depth interviews were conducted with 8 healthcare professionals and senior manage