WorldWideScience

Sample records for major clinical benefit

  1. 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...

  2. 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

  3. 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.

  4. 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....

  5. Exploring Pair Programming Benefits for MIS Majors

    Science.gov (United States)

    Dongo, Tendai; Reed, April H.; O'Hara, Margaret

    2016-01-01

    Pair programming is a collaborative programming practice that places participants in dyads, working in tandem at one computer to complete programming assignments. Pair programming studies with Computer Science (CS) and Software Engineering (SE) majors have identified benefits such as technical productivity, program/design quality, academic…

  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. Exploring Pair Programming Benefits for MIS Majors

    Directory of Open Access Journals (Sweden)

    April H. Reed

    2016-12-01

    Full Text Available Pair programming is a collaborative programming practice that places participants in dyads, working in tandem at one computer to complete programming assignments. Pair programming studies with Computer Science (CS and Software Engineering (SE majors have identified benefits such as technical productivity, program/design quality, academic performance, and increased satisfaction for their participants. In this paper, pair programming is studied with Management Information Systems (MIS majors, who (unlike CS and SE majors taking several programming courses typically take only one programming course and often struggle to develop advanced programming skills within that single course. The researchers conducted two pair programming experiments in an introductory software development course for MIS majors over three semesters to determine if pair programming could enhance learning for MIS students. The program results, researchers’ direct observations, and participants’ responses to a survey questionnaire were analyzed after each experiment. The results indicate that pair programming appears to be beneficial to MIS students’ technical productivity and program design quality, specifically the ability to create programs using high-level concepts. Additionally, results confirmed increased student satisfaction and reduced frustration, as the pairs worked collaboratively to produce a program while actively communicating and enjoying the process.

  8. 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.

  9. 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

  10. 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...

  11. US major crops’ uncertain climate change risks and greenhouse gas mitigation benefits

    International Nuclear Information System (INIS)

    Wing, Ian Sue; Monier, Erwan; Stern, Ari; Mundra, Anupriya

    2015-01-01

    We estimate the costs of climate change to US agriculture, and associated potential benefits of abating greenhouse gas emissions. Five major crops’ yield responses to climatic variation are modeled empirically, and the results combined with climate projections for a no-policy, high-warming future, as well as moderate and stringent mitigation scenarios. Unabated warming reduces yields of wheat and soybeans by 2050, and cotton by 2100, but moderate warming increases yields of all crops except wheat. Yield changes are monetized using the results of economic simulations within an integrated climate-economy modeling framework. Uncontrolled warming’s economic effects on major crops are slightly positive—annual benefits <$4 B. These are amplified by emission reductions, but subject to diminishing returns—by 2100 reaching $17 B under moderate mitigation, but only $7 B with stringent mitigation. Costs and benefits are sensitive to irreducible uncertainty about the fertilization effects of elevated atmospheric carbon dioxide, without which unabated warming incurs net costs of up to $18 B, generating benefits to moderate (stringent) mitigation as large as $26 B ($20 B). (letter)

  12. 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...

  13. 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

  14. 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.

  15. 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

  16. 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.

  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. [Benefits of epidural analgesia in major neonatal surgery].

    Science.gov (United States)

    Gómez-Chacón, J; Encarnación, J; Couselo, M; Mangas, L; Domenech, A; Gutiérrez, C; García Sala, C

    2012-07-01

    The aim of this paper is to describe and evaluate the benefits of epidural anesthesia in major surgery neonatal. We have performed a matched case-control (2:1) study of patients undergoing neonatal major surgery (NMSs) who received intra-and postoperative epidural anesthesia (EA) and controls with conventional general anesthesia. The matching criteria were age, weight and baseline pathology. EA was administered by caudal puncture and epidural catheter placed with ultrasound support. Levobupivacaine was selected as anesthetic drug. The time to extubation, intestinal transit time, type of analgesia and complications were studied. This study is based on 11 cases (2 esophageal atresia, 2 diaphragmatic hernias, 1 necrotizing enterocolitis, 3 intestinal atresia, 2 anorectal malformation and 1 bladder exstrophy) and 22 controls. We observed statistically significant differences in time to extubation (95% CI OR 12 1.99 to 72.35; Chi2 p = 0.004, Mann U Whytney p = 0.013) and intestinal transit time (Mann Whitney U p analgesia. Therefore we believe that the intra-and postoperative EA helps improve postoperative management in neonates and should be preferred in centers where this technique is available.

  19. 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.

  20. 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.

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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.

  7. 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.

  8. 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/.

  9. 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.

  10. 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

  11. Which Benefits Are Mentioned Most Often in Drug Development Publications?

    Directory of Open Access Journals (Sweden)

    Vanessa Strüver, MSc

    2017-01-01

    Conclusions: Both theoretically expected and actually reported benefits in the majority of the included publications emphasized the importance of individual patient benefits from drug development rather than the collective benefits to society in general. The authors of these publications emphasized the right of each individual patient or subject to look for and expect some personal benefit from participating in a clinical trial rather than considering societal benefit as a top priority. From an ethical point of view, the benefits each individual patient receives from his or her participation in a clinical trial might also be seen as a societal benefit, especially when the drug or device tested, if approved for marketing, would eventually be made available for other similar patients from the country in which the clinical trial was conducted.

  12. 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

  13. 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

  14. Benefits of and Barriers to Pharmacogenomics-Guided Treatment for Major Depressive Disorder.

    Science.gov (United States)

    Ahmed, Ahmed T; Weinshilboum, Richard; Frye, Mark A

    2018-05-01

    Antidepressants have reduced the symptom burden for many Major Depressive Disorder (MDD) patients, but drug-related side effects and treatment resistance continue to present major challenges. Pharmacogenomics represents one approach to enhance antidepressant efficacy and avoid adverse reactions, but concerns remain with regard to the overall "value equation," and several barriers must be overcome to achieve the full potential of MDD pharmacogenomics. © 2018 American Society for Clinical Pharmacology and Therapeutics.

  15. The varied clinical presentations of major depressive disorder.

    Science.gov (United States)

    Rush, A John

    2007-01-01

    DSM-IV major depressive disorder (MDD) is a clinical syndrome notable for heterogeneity of its clinical presentation, genetics, neurobiology, clinical course, and treatment responsiveness. In an attempt to make sense of this heterogeneity, clinicians and researchers have proposed a number of MDD "subtypes" based on differences in characteristic symptoms (e.g., atypical, melancholic, psychotic), onset (e.g., early vs. late, post-partum, seasonal), course of illness (e.g., single vs. recurrent, chronic, double), and severity. This article provides a brief review of the status of several of the most common subtypes in terms of their clinical features, biological correlates, course of illness, and treatment implications.

  16. 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...

  17. 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...

  18. 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.

  19. 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.

  20. The Clinical Impact of Cardiology Consultation Prior to Major Vascular Surgery.

    Science.gov (United States)

    Davis, Frank M; Park, Yeo June; Grey, Scott F; Boniakowski, Anna E; Mansour, M Ashraf; Jain, Krishna M; Nypaver, Timothy; Grossman, Michael; Gurm, Hitinder; Henke, Peter K

    2018-01-01

    To understand statewide variation in preoperative cardiology consultation prior to major vascular surgery and to determine whether consultation was associated with differences in perioperative myocardial infarction (poMI). Medical consultation prior to major vascular surgery is obtained to reduce perioperative risk. Despite perceived benefit of preoperative consultation, evidence is lacking specifically for major vascular surgery on the effect of preoperative cardiac consultation. Patient and clinical data were obtained from a statewide vascular surgery registry between January 2012 and December 2014. Patients were risk stratified by revised cardiac risk index category and compared poMI between patients who did or did not receive a preoperative cardiology consultation. We then used logistic regression analysis to compare the rate of poMI across hospitals grouped into quartiles by rate of preoperative cardiology consultation. Our study population comprised 5191 patients undergoing open peripheral arterial bypass (n = 3037), open abdominal aortic aneurysm repair (n = 332), or endovascular aneurysm repair (n = 1822) at 29 hospitals. At the patient level, after risk-stratification by revised cardiac risk index category, there was no association between cardiac consultation and poMI. At the hospital level, preoperative cardiac consultation varied substantially between hospitals (6.9%-87.5%, P 66%) had a reduction in poMI (OR, 0.52; confidence interval: 0.28-0.98; P cardiology consultation for vascular surgery varies greatly between institutions, and does not appear to impact poMI at the patient level. However, reduction of poMI was noted at the hospitals with the highest rate of preoperative cardiology consultation as well as a variety of medical services, suggesting that other hospital culture effects play a role.

  1. 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...

  2. 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...

  3. 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.

  4. 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

  5. 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.

  6. Communicating Risks and Benefits in Informed Consent for Research: A Qualitative Study

    Science.gov (United States)

    Nusbaum, Lika; Douglas, Brenda; Damus, Karla; Paasche-Orlow, Michael; Estrella-Luna, Neenah

    2017-01-01

    Multiple studies have documented major limitations in the informed consent process for the recruitment of clinical research participants. One challenging aspect of this process is successful communication of risks and benefits to potential research participants. This study explored the opinions and attitudes of informed consent experts about conveying risks and benefits to inform the development of a survey about the perspectives of research nurses who are responsible for obtaining informed consent for clinical trials. The major themes identified were strategies for risks and benefits communication, ensuring comprehension, and preparation for the role of the consent administrator. From the experts’ perspective, inadequate education and training of the research staff responsible for informed consent process contribute to deficiencies in the informed consent process and risks and benefits communication. Inconsistencies in experts’ opinions and critique of certain widely used communication practices require further consideration and additional research. PMID:28975139

  7. [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.

  8. Effects of dry period length on clinical mastitis and other major clinical health disorders

    DEFF Research Database (Denmark)

    Enevoldsen, Carsten; Sørensen, J.T.

    1992-01-01

    Four, 7-, and 10-wk dry periods were randomly assigned to 366 dairy cows in eight herds. A multiple polytomous logistic regression analysis was conducted with the objective to reveal possible important effects of the dry period on the risk of contracting major clinical health disorders. Several...... complex statistical interactions were revealed. Complications around and after drying off occurred least frequently at 7-wk dry periods. There was little evidence of an effect of the dry period on the risk of clinical mastitis and other severe clinical disorders around and after calving. With short...... like milk yield at drying off and previous mastitis are much more important predisposing factors....

  9. 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.

  10. 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

  11. 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

  12. 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.

  13. Does age at onset of first major depressive episode indicate the subtype of major depressive disorder?: the clinical research center for depression study.

    Science.gov (United States)

    Park, Seon-Cheol; Hahn, Sang-Woo; Hwang, Tae-Yeon; Kim, Jae-Min; Jun, Tae-Youn; Lee, Min-Soo; Kim, Jung-Bum; Yim, Hyeon-Woo; Park, Yong Chon

    2014-11-01

    The purpose of this study was to evaluate the effects of age at onset of the first major depressive episode on the clinical features of individuals with major depressive disorder (MDD) in a large cohort of Korean depressed patients. We recruited 419 MDD patients of age over 18 years from the Clinical Research Center for Depression study in South Korea. At the start of the study, the onset age of the first major depressive episode was self-reported by the subjects. The subjects were divided into four age-at-onset subgroups: childhood and adolescent onset (ages depressive episodes (F=3.475, p=0.016) and higher scores on the brief psychiatric rating scale (F=3.254, p=0.022), its negative symptom subscale (F=6.082, pdepressive episode is a promising clinical indicator for the clinical presentation, course, and outcome of MDD.

  14. 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

  15. 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

  16. Is placebo useful in the treatment of major depression in clinical practice?

    Directory of Open Access Journals (Sweden)

    Marchesi C

    2013-06-01

    Full Text Available Carlo Marchesi, Chiara De Panfilis, Matteo Tonna, Paolo Ossola University of Parma, Department of Neuroscience, Psychiatric Unit, Parma, Italy Background: For many years, placebo has been defined by its inert content and use in clinical trials. In recent years, several studies have demonstrated its effect in the treatment of major depression. The aim of this paper is to present the conclusions of recent meta-analyses of the placebo effect in major depression, to explain the mechanism by which placebo exerts its effect, and to discuss whether placebo can be used in the treatment of patients with major depression in clinical practice. Recent meta-analyses have demonstrated that the placebo effect is estimated to account for 67% of the treatment effect in patients receiving antidepressants, and furthermore that placebo is as effective as antidepressants in patients with mild to moderate major depression (reporting a Hamilton Depression Rating Scale score lower than 25, whereas placebo is less effective than antidepressants in severely depressed patients. However, several limitations make the translation of these conclusions into clinical practice impracticable. Clinicians should learn from the "placebo lesson" to maximize the nonspecific effects of treatment when they prescribe an antidepressant, particularly in less severely depressed patients, who show a higher placebo response in randomized controlled trials. This strategy can increase the antidepressant effect and may reduce nonadherence with treatment. Keywords: placebo effect, major depressive disorder, subthreshold depressive disorder, antidepressants

  17. 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. ...

  18. 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.

  19. Comparison of benefit between dabigatran and warfarin among patients with atrial fibrillation: A systematic review

    Directory of Open Access Journals (Sweden)

    Amal K Sulieman

    2016-01-01

    Full Text Available Warfarin is recognized as the standard antithrombotic agent for stroke prevention. However, new oral anticoagulant such as dabigatran constitutes huge improvement to compensate for the limitation of warfarin. A literature review was performed to compare and contrast the overall benefit of dabigatran and warfarin among patients with atrial fibrillation. We utilized HighWire as the data source for randomized controlled trials based on inclusion and exclusion criteria (from January 2007 to September 2013. Descriptive and quantitative information related to stroke and major bleeding were extracted from each trial. After a comprehensive screening of 298 search results, 17 studies which enrolled a total of 127,594 patients were included. Warfarin was found to have higher mean event rates for incidence of stroke, major bleeding, and net clinical benefit compared to dabigatran 110 mg and dabigatran 150 mg. Dabigatran 110 mg has higher rate of stroke and net clinical benefit than dabigatran 150 mg with less major hemorrhage. Overall, dabigatran had higher efficacy and safety profile than warfarin. Further research is required to determine the clinical feasibility of dabigatran in real-life practice.

  20. 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.

  1. The effect of the publication of a major clinical trial in a high impact journal on clinical practise: the ORACLE Trial experience.

    Science.gov (United States)

    Kenyon, Sara; Taylor, David J

    2002-12-01

    To estimate the short term effect of the publication of a major clinical trial on clinical practise. Questionnaire survey of clinical practise. UK. All maternity units in the UK. A self-administered questionnaire completed by lead consultants on delivery suite of maternity units. Changes in antibiotic prescription. Within six months of publication, approximately 50% of maternity units had changed their guidelines for the care of women with preterm prelabour rupture of the fetal membranes. Publication of a major clinical trial does impact on clinical practise but the impact is heterogeneous in terms of time and consistency.

  2. 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

  3. Acute Psychosis as Major Clinical Presentation of Legionnaires’ Disease

    Directory of Open Access Journals (Sweden)

    Ricardo Coentre

    2016-01-01

    Full Text Available We report a case of a 61-year-old woman who presented with acute psychosis as a major manifestation of Legionnaires’ disease in the absence of other neuropsychiatric symptoms. Clinical history revealed dry cough and nausea. Observation showed fever and auscultation crackles in the lower lobe of the right lung. Laboratory testing demonstrated elevated C-reactive protein and lung chest radiograph showed patchy peribronchial and right lower lobe consolidation. Soon after admission, she started producing purulent sputum. Epidemiological data suggested Legionella pneumophila as possible cause of the clinical picture that was confirmed by urinary antigen detection and polymerase chain reaction of the sputum. She was treated with levofloxacin 750 mg/day for 10 days with complete remission of pulmonary and psychiatric symptoms. She has not had further psychotic symptoms.

  4. 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.

  5. Comparison of demographic and clinical characteristics between children and adolescents with major depressive disorder.

    Science.gov (United States)

    Fu-I, Lee; Wang, Yuan Pang

    2008-06-01

    To compare clinical characteristics of major depressive disorder symptoms between children and adolescents. The subjects were 58 patients of a Child and Adolescent Affective Disorder Clinic consecutively admitted during a six-month period. Children aged 5-9 years old and adolescents from 10-17 years old currently meeting DSM-IV criteria diagnosis of major depressive disorder were chosen. Current MDD diagnosis and depressive psychopathology were assessed by a clinical interview and the Diagnostic Interview for Children and Adolescents-DSM-IV version. The Children's Depression Rating Scale-Revised Version and the Children Global Assessment Scale rated the severity and global functioning of major depressive disorder. The most common depressive symptoms were: anhedonia (72.4%), depressed mood (72.4%), decreased concentration (62.1%), and irritability (58.6%). The intensity of depressive episodes of this sample ranged from mild to moderate. Fifty percent reported thoughts of death, and 29.3% presented a variety of psychotic symptoms. When compared with children, adolescents reported a significantly more depressed mood (p = 0.043), lower self-esteem (p = 0.002), and had more difficulty concentrating (p = 0.020). Female adolescents had lower self-esteem (p = 0.003), and male adolescents showed more decreased concentration (p = 0.016). This study suggests that age and gender differences might influence the clinical presentation of major depressive disorder in children and adolescents. Further studies with larger samples are needed.

  6. 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)

  7. 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

  8. 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.

  9. 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.

  10. A clinically relevant major cross-reactive allergen from mesquite tree pollen.

    Science.gov (United States)

    Dhyani, A; Singh, B P; Arora, N; Jain, V K; Sridhara, S

    2008-10-01

    Prosopis juliflora (mesquite) is one of the major sources of pollinosis in tropical and semi-arid countries of the world. The present study was undertaken to purify and characterize a major cross-reactive allergen from this tree species. Mesquite pollen extract was purified using reverse-phase chromatography. Allergen characterization was done by electrophoresis, enzyme-linked immunosorbent assay (ELISA) and Western blotting. Clinical relevance of the purified protein was analyzed by in vivo (skin tests) and in vitro experiments such as ELISA, histamine release, peripheral blood mononuclear cells (PBMC) proliferation and cytokine assays. Cross-reactivity of purified protein with allergenic tree species and lima bean (food) was assessed by inhibition assays. A 66-kDa protein was purified from mesquite pollen extract using octadecyl silica resin. Purified protein recognized 90% of mesquite-sensitized patients in skin test and ELISA. It induced significant histamine release in allergic patients' blood and interleukin-4 secretion in the PBMC culture supernatants. Inhibition assays suggested close allergenic relationship of this protein with Ailanthus excelsa, Cassia siamea, Salvadora persica pollen and Phaseolus lunatus (lima bean - an edible legume). A 66-kDa major cross-reactive allergen was isolated from mesquite pollen using single-step purification procedure. The protein seems relevant for clinical applications in allergic disorders.

  11. What do we know about the cardiac benefits of exercise?

    Science.gov (United States)

    Wei, Xin; Liu, Xiaojun; Rosenzweig, Anthony

    2015-08-01

    Exercise has long been considered an essential element for sustaining cardiovascular health. A vast literature of clinical studies suggests that exercise serves as an effective intervention for the primary and secondary prevention of cardiovascular disease, although the optimal nature, intensity, and duration of exercise for maximizing these cardiovascular benefits remain unclear. On a molecular level, exercise induces physiologic growth of the heart primarily by driving cardiomyocyte hypertrophy, notably through the interconnected IGF-1-PI3K-AKT1 and C/EBPβ-CITED4 pathways. Here, we explore the range of clinical evidence supporting the cardiovascular benefits of exercise and outline the molecular pathways that play major roles in regulating these protective effects. Copyright © 2015 Elsevier Inc. All rights reserved.

  12. Potential Strategies to Address the Major Clinical Barriers Facing Stem Cell Regenerative Therapy for Cardiovascular Disease: A Review.

    Science.gov (United States)

    Nguyen, Patricia K; Neofytou, Evgenios; Rhee, June-Wha; Wu, Joseph C

    2016-11-01

    Although progress continues to be made in the field of stem cell regenerative medicine for the treatment of cardiovascular disease, significant barriers to clinical implementation still exist. To summarize the current barriers to the clinical implementation of stem cell therapy in patients with cardiovascular disease and to discuss potential strategies to overcome them. Information for this review was obtained through a search of PubMed and the Cochrane database for English-language studies published between January 1, 2000, and July 25, 2016. Ten randomized clinical trials and 8 systematic reviews were included. One of the major clinical barriers facing the routine implementation of stem cell therapy in patients with cardiovascular disease is the limited and inconsistent benefit observed thus far. Reasons for this finding are unclear but may be owing to poor cell retention and survival, as suggested by numerous preclinical studies and a small number of human studies incorporating imaging to determine cell fate. Additional studies in humans using imaging to determine cell fate are needed to understand how these factors contribute to the limited efficacy of stem cell therapy. Treatment strategies to address poor cell retention and survival are under investigation and include the following: coadministration of immunosuppressive and prosurvival agents, delivery of cardioprotective factors packaged in exosomes rather than the cells themselves, and use of tissue-engineering strategies to provide structural support for cells. If larger grafts are achieved using these strategies, it will be imperative to carefully monitor for the potential risks of tumorigenicity, immunogenicity, and arrhythmogenicity. Despite important achievements to date, stem cell therapy is not yet ready for routine clinical implementation. Significant research is still needed to address the clinical barriers outlined herein before the next wave of large clinical trials is under way.

  13. New graphic AUC-based method to estimate overall survival benefit: pomalidomide reanalysis.

    Science.gov (United States)

    Fenix-Caballero, S; Diaz-Navarro, J; Prieto-Callejero, B; Rios-Sanchez, E; Alegre-del Rey, E J; Borrero-Rubio, J M

    2016-02-01

    Difference in median survival is an erratic measure and sometimes does not provide a good assessment of survival benefit. The aim of this study was to reanalyse the overall survival benefit of pomalidomide from pivotal clinical trial using a new area under curve (AUC)-based method. In the pivotal trial, pomalidomide plus low-dose dexamethasone showed a significant survival benefit over high-dose dexamethasone, with a difference between medians of 4.6 months. The new AUC method applied to the survival curves, obtained an overall survival benefit of 2.6 months for the pomalidomide treatment. This average difference in OS was calculated for the 61.5% of patients for whom the time to event is reliable enough. This 2-month differential would have major clinical and pharmacoeconomic implications, on both cost-effectiveness studies and on the willingness of the healthcare systems to pay for this treatment. © 2015 John Wiley & Sons Ltd.

  14. Risk-benefit assessment of cold-smoked salmon: microbial risk versus nutritional benefit

    DEFF Research Database (Denmark)

    Berjia, Firew Lemma; Hoekstra, Jeljer; Andersen, Rikke

    2012-01-01

    Heart Disease (CHD) mortality and stroke, as well as enhanced cognitive (IQ) development of unborns following maternal intake, are identified as the main health benefits of omega-3 fatty acid from CSS. Contrary, risk of meningitis, septicemia and abortion/stillborn are identified as a major health risk......The objective of the study is to perform an integrated analysis of microbiological risks and nutritional benefits in a fish product, Cold Smoked Salmon (CSS). Literature study identified the major health risks and benefits in connection with CSS consumption. The reduction of the risk of Coronary...

  15. 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

  16. 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.

  17. Benefit-risk trade-offs in retrospect: how major stakeholders perceive the decision-making process in the Barents Sea oil field development

    DEFF Research Database (Denmark)

    Renn, Ortwin; Grieger, Khara Deanne; Øien, Knut

    2013-01-01

    review of the decision-making process seen through the lenses of the major stakeholders involved in this process. The research design used qualitative methods of empirical research including stakeholder interviews during a five-day period in 2011 in Northern Norway. Results showed that the siting process...... additional benefits to the communities which would then be fairly distributed among the beneficiaries have been disappointed. We review the reasons behind these results as well as formulate recommendations regarding potential improvements to the risk-benefit communication process in addition to future siting...

  18. Epidemiology and clinical impact of major comorbidities in patients with COPD

    Science.gov (United States)

    Smith, Miranda Caroline; Wrobel, Jeremy P

    2014-01-01

    Comorbidities are frequent in chronic obstructive pulmonary disease (COPD) and significantly impact on patients’ quality of life, exacerbation frequency, and survival. There is increasing evidence that certain diseases occur in greater frequency amongst patients with COPD than in the general population, and that these comorbidities significantly impact on patient outcomes. Although the mechanisms are yet to be defined, many comorbidities likely result from the chronic inflammatory state that is present in COPD. Common problems in the clinical management of COPD include recognizing new comorbidities, determining the impact of comorbidities on patient symptoms, the concurrent treatment of COPD and comorbidities, and accurate prognostication. The majority of comorbidities in COPD should be treated according to usual practice, and specific COPD management is infrequently altered by the presence of comorbidities. Unfortunately, comorbidities are often under-recognized and under-treated. This review focuses on the epidemiology of ten major comorbidities in patients with COPD. Further, we emphasize the clinical impact upon prognosis and management considerations. This review will highlight the importance of comorbidity identification and management in the practice of caring for patients with COPD. PMID:25210449

  19. A comprehensive approach to benefit-risk assessment in drug development

    DEFF Research Database (Denmark)

    Sarac, Sinan B; Rasmussen, Christian H; Rasmussen, Morten A.

    2012-01-01

    Major regulatory agencies, for example, FDA and EMA, have started to request comprehensive benefit-risk analyses of pharmaceutical products prior to approval or labelling expansion. The purpose of this study is to develop a generally applicable and reliable data-driven benefit-risk assessment......) discussion and formulation of an overall conclusion. To reduce the impact of subjective judgements, scores are assigned to each criterion on the basis of objective information (data) wherever possible. The proposed benefit-risk evaluation approach offers comprehensive, data-driven assessments that can...... method, where two or more drugs/doses can be compared. Our aim is to formulate an approach that is simple to apply, allows direct comparison of different types of risks and benefits, and is tailored for application in different disease areas both during clinical development and in the marketing approval...

  20. A POC Clinical Trial for PTSD with a First-In-Class Vasopressin 1a Receptor Antagonist

    Science.gov (United States)

    2017-10-01

    clinical benefit of SRX246 for the treatment of anger, irritability, and aggression; major depression ; disturbed sleep; and quality of life that...safety and tolerability of SRX246 (160 mg PO BID) and ii) clinical benefit of SRX246 for the treatment of major depression , anger, irritability, and...colleagues. Changes that had a significant impact on expenditures Nothing to Report Significant changes in use or care of human subjects, vertebrate

  1. Major depression

    Science.gov (United States)

    Depression - major; Depression - clinical; Clinical depression; Unipolar depression; Major depressive disorder ... providers do not know the exact causes of depression. It is believed that chemical changes in the ...

  2. 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...

  3. Volunteer motivators for participating in HIV vaccine clinical trials in Nairobi, Kenya.

    Science.gov (United States)

    Nyaoke, Borna A; Mutua, Gaudensia N; Sajabi, Rose; Nyasani, Delvin; Mureithi, Marianne W; Anzala, Omu A

    2017-01-01

    1.5 million Kenyans are living with HIV/AIDS as per 2015 estimates. Though there is a notable decline in new HIV infections, continued effort is still needed to develop an efficacious, accessible and affordable HIV vaccine. HIV vaccine clinical trials bear risks, hence a need to understand volunteer motivators for enrolment, retention and follow-up. Understanding the factors that motivate volunteers to participate in a clinical trial can help to strategize, refine targeting and thus increase enrolment of volunteers in future HIV vaccine clinical trials. The health belief model classifies motivators into social benefits such as 'advancing research' and collaboration with science, and personal benefits such as health benefits and financial interests. A thematic analysis was carried out on data obtained from four HIV clinical trials conducted at KAVI-Institute of Clinical Research in Nairobi Kenya from 2009 to 2015. Responses were obtained from a Questionnaire administered to the volunteers during their screening visit at the research site. Of the 281 healthy, HIV-uninfected volunteers participating in this study; 38% were motivated by personal benefits including, 31% motivated by health benefits and 7% motivated by possible financial gains. In addition, 62% of the volunteers were motivated by social benefits with 20% of who were seeking to help their family/society/world while 42% were interested in advancing research. The majority of volunteers in the HIV vaccine trials at our site were motivated by social benefits, suggesting that altruism can be a major contributor to participation in HIV vaccine studies. Personal benefits were a secondary motivator for the volunteers. The motivators to volunteer in HIV clinical trials were similar across ages, education level and gender. Education on what is needed (including volunteer participation) to develop an efficacious vaccine could be the key to greater volunteer motivation to participate in HIV vaccine clinical trials.

  4. Volunteer motivators for participating in HIV vaccine clinical trials in Nairobi, Kenya.

    Directory of Open Access Journals (Sweden)

    Borna A Nyaoke

    Full Text Available 1.5 million Kenyans are living with HIV/AIDS as per 2015 estimates. Though there is a notable decline in new HIV infections, continued effort is still needed to develop an efficacious, accessible and affordable HIV vaccine. HIV vaccine clinical trials bear risks, hence a need to understand volunteer motivators for enrolment, retention and follow-up. Understanding the factors that motivate volunteers to participate in a clinical trial can help to strategize, refine targeting and thus increase enrolment of volunteers in future HIV vaccine clinical trials. The health belief model classifies motivators into social benefits such as 'advancing research' and collaboration with science, and personal benefits such as health benefits and financial interests.A thematic analysis was carried out on data obtained from four HIV clinical trials conducted at KAVI-Institute of Clinical Research in Nairobi Kenya from 2009 to 2015. Responses were obtained from a Questionnaire administered to the volunteers during their screening visit at the research site.Of the 281 healthy, HIV-uninfected volunteers participating in this study; 38% were motivated by personal benefits including, 31% motivated by health benefits and 7% motivated by possible financial gains. In addition, 62% of the volunteers were motivated by social benefits with 20% of who were seeking to help their family/society/world while 42% were interested in advancing research.The majority of volunteers in the HIV vaccine trials at our site were motivated by social benefits, suggesting that altruism can be a major contributor to participation in HIV vaccine studies. Personal benefits were a secondary motivator for the volunteers. The motivators to volunteer in HIV clinical trials were similar across ages, education level and gender. Education on what is needed (including volunteer participation to develop an efficacious vaccine could be the key to greater volunteer motivation to participate in HIV vaccine

  5. 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

  6. 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

  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. [What are Considerations for Clinical Investigation of New Drugs and Treatment Techniques for Major Depressive Disorders?].

    Science.gov (United States)

    Nakabayashi, Tetsuo

    2015-01-01

    Major depressive disorder treatments remain unsatisfactory, and the development of novel antidepressants is continuing. Therefore, not only the establishment of therapeutic strategies to accumulate evidence on existing therapies, but also the development of novel therapies is required in order to improve the medical standards. In principle, parallel, double-blind, randomized, placebo-controlled trials are necessary to assess new compounds for the treatment of major depressive disorders from a scientific perspective. To provide unambiguous evidence of antidepressant activity, well-controlled studies with adequate designs must show efficacy with a statistically significant effect on a clinically meaningful endpoint. For this purpose, it is important to examine all aspects of factors that adversely affect the efficacy and safety assessment in the planning stage of clinical trials and reduce these factors. There are several specific characteristics of clinical trials for neuropsychiatric disorders. Some typical features are as follows: 1) a high and variable response, 2) impact on the effect of the baseline severity of disorders, 3) high dropout rates, 4) biases related to subjective measures of clinical symptoms. In this paper, considerations for the planning and performing of clinical trials for major depressive disorders will be discussed based on these features.

  9. Traveling by Bus Instead of Car on Urban Major Roads: Safety Benefits for Vehicle Occupants, Pedestrians, and Cyclists.

    Science.gov (United States)

    Morency, Patrick; Strauss, Jillian; Pépin, Félix; Tessier, François; Grondines, Jocelyn

    2018-04-01

    Some studies have estimated fatality and injury rates for bus occupants, but data was aggregated at the country level and made no distinction between bus types. Also, injured pedestrians and cyclists, as a result of bus travel, were overlooked. We compared injury rates for car and city bus occupants on specific urban major roads, as well as the cyclist and pedestrian injuries associated with car and bus travel. We selected ten bus routes along major urban arterials (in Montreal, Canada). Passenger-kilometers traveled were estimated from vehicle counts at intersections (2002-2010) and from bus passenger counts (2008). Police accident reports (2001-2010) provided injury data for all modes. Injury rates associated with car and bus travel were calculated for vehicle occupants, pedestrians, and cyclists. Injury rate ratios were also computed. The safety benefits of bus travel, defined as the number of vehicle occupant, cyclist, and pedestrian injuries saved, were estimated for each route. Overall, for all ten routes, the ratio between car and bus occupant injury rates is 3.7 (95% CI [3.4, 4.0]). The rates of pedestrian and cyclist injuries per hundred million passenger-kilometers are also significantly greater for car travel than that for bus travel: 4.1 (95% CI [3.5, 4.9]) times greater for pedestrian injuries; 5.3 (95% CI [3.8, 7.6]) times greater for cyclist injuries. Similar results were observed for fatally and severely injured vehicle occupants, cyclists, and pedestrians. At the route level, the safety benefits of bus travel increase with the difference in injury rate associated with car and bus travel but also with the amount of passenger-kilometers by bus. Results show that city bus is a safer mode than car, for vehicle occupants but also for cyclists and pedestrians traveling along these bus routes. The safety benefits of bus travel greatly vary across urban routes; this spatial variation is most likely linked to environmental factors. Understanding the

  10. 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

  11. 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.

  12. 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.

  13. Transcranial magnetic stimulation (TMS) for major depression: a multisite, naturalistic, observational study of quality of life outcome measures in clinical practice.

    Science.gov (United States)

    Janicak, Philip G; Dunner, David L; Aaronson, Scott T; Carpenter, Linda L; Boyadjis, Terrence A; Brock, David G; Cook, Ian A; Lanocha, Karl; Solvason, Hugh B; Bonneh-Barkay, Dafna; Demitrack, Mark A

    2013-12-01

    Transcranial magnetic stimulation (TMS) is an effective and safe therapy for major depressive disorder (MDD). This study assessed quality of life (QOL) and functional status outcomes for depressed patients after an acute course of TMS. Forty-two, U.S.-based, clinical TMS practice sites treated 307 outpatients with a primary diagnosis of MDD and persistent symptoms despite prior adequate antidepressant pharmacotherapy. Treatment parameters were based on individual clinical considerations and followed the labeled procedures for use of the approved TMS device. Patient self-reported QOL outcomes included change in the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and the EuroQol 5-Dimensions (EQ-5D) ratings from baseline to end of the acute treatment phase. Statistically significant improvement in functional status on a broad range of mental health and physical health domains was observed on the SF-36 following acute TMS treatment. Similarly, statistically significant improvement in patient-reported QOL was observed on all domains of the EQ-5D and on the General Health Perception and Health Index scores. Improvement on these measures was observed across the entire range of baseline depression symptom severity. These data confirm that TMS is effective in the acute treatment of MDD in routine clinical practice settings. This symptom benefit is accompanied by statistically and clinically meaningful improvements in patient-reported QOL and functional status outcomes.

  14. 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....

  15. 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.

  16. 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

  17. 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.

  18. [Homicide and major mental disorder: what are the social, clinical, and forensic differences between murderers with a major mental disorder and murderers without any mental disorder?].

    Science.gov (United States)

    Richard-Devantoy, S; Chocard, A-S; Bourdel, M-C; Gohier, B; Duflot, J-P; Lhuillier, J-P; Garré, J-B

    2009-09-01

    To establish the social, clinical, and forensic differences between murderers suffering from a major mental disorder and murderers without any psychiatric disorder and, in particular, to compare their respective records of psychiatric symptoms and their respective relationship with their victims. We studied 210 forensic examinations of murderers, the offences related to the murders, and the social and clinical information collected from psychiatric court reports on persons convicted of homicide. Firstly, we identified the socio-demographic, clinical and criminological profiles of 210 murderers from which were distinguished murderers with major mental disorder. Then, we compared the profiles of murderers suffering from a major mental disorder with those of murderers without any mental disease. In other words, we compared 37 persons affected with major mental disorder (schizophrenia, paranoiac delusional disorder, and affective disorder) with 73 persons without any mental disorder. We deliberately excluded subjects with personality disorder or abuse of/dependency on drugs, mental retardation or dementia. With the exception of certain variables, murderers with major mental disorder have the same characteristics as others murderers: young man, living alone, with psychiatric and offence records and substance abuse. Murderers with major mental disorder are older (37.8 versus 31.7 years old) than perpretators without any mental disorder, and the former have a psychiatric record more often than the latter (81 versus 32.9%). In addition, contrary to the latter, the former show clinical symptoms of a psychopathological process. Depression, delusional and suicidal ideas are frequent among murderers with a major mental disorder, whereas the persons without mental disorder quarrel or have a row with their victim just before their crime. The victim was known to the perpetrator significantly more often in the major mental disorder group than in the no mental disorder group (94

  19. 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

    Full Text Available BACKGROUND: 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. METHODS: 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. RESULTS: 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, P<0.05 in MOF supplemented subjects. We also observed that MOF supplementation exerts anti-inflammatory effects in blood towards ex vivo added bacterial endotoxin and significantly reduces expression of inflammatory genes in leukocytes. Conversely, alterations in macro- and microvascular function, platelet aggregation, plasma levels of nitric oxide surrogates, endothelin-1, C-reactive protein, fibrinogen, prostaglandin F2alpha, plasma antioxidant capacity and gene expression levels of antioxidant defense enzymes did not reach statistical significance after 8 weeks MOF supplementation. However, integrating all measured effects into a global, so-called vascular health index revealed a significant improvement of overall vascular health by MOF compared to placebo (P ≤ 0.05. CONCLUSION: Our

  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. "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.

  2. A clinical prediction rule for detecting major depressive disorder in primary care : the PREDICT-NL study

    NARCIS (Netherlands)

    Zuithoff, Nicolaas P A; Vergouwe, Yvonne; King, Michael; Nazareth, Irwin; Hak, Eelko; Moons, Karel G M; Geerlings, Mirjam I

    BACKGROUND: Major depressive disorder often remains unrecognized in primary care. OBJECTIVE: Development of a clinical prediction rule using easily obtainable predictors for major depressive disorder in primary care patients. METHODS: A total of 1046 subjects, aged 18-65 years, were included from

  3. [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.

  4. 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.

  5. Clinical validity of a population database definition of remission in patients with major depression.

    Science.gov (United States)

    Sicras-Mainar, Antoni; Blanca-Tamayo, Milagrosa; Gutiérrez-Nicuesa, Laura; Salvatella-Pasant, Jordi; Navarro-Artieda, Ruth

    2010-02-11

    Major depression (MD) is one of the most frequent diagnoses in Primary Care. It is a disabling illness that increases the use of health resources. To describe the concordance between remission according to clinical assessment and remission obtained from the computerized prescription databases of patients with MD in a Spanish population. multicenter cross-sectional. The population under study was comprised of people from six primary care facilities, who had a MD episode between January 2003 and March 2007. A specialist in psychiatry assessed a random sample of patient histories and determined whether a certain patient was in remission according to clinical criteria (ICPC-2). Regarding the databases, patients were considered in remission when they did not need further prescriptions of AD for at least 6 months after completing treatment for a new episode. Validity indicators (sensitivity [S], specificity [Sp]) and clinical utility (positive and negative probability ratio [PPR] and [NPR]) were calculated. The concordance index was established using Cohen's kappa coefficient. Significance level was p Reliability analysis: Cronbach's alpha: 90.6% (CI was 95%: 85.6 - 95.6%). Results show an acceptable level of concordance between remission obtained from the computerized databases and clinical criteria. The major discrepancies were found in diagnostic accuracy.

  6. Epidemiology and clinical impact of major comorbidities in patients with COPD

    Directory of Open Access Journals (Sweden)

    Smith MC

    2014-08-01

    Full Text Available Miranda Caroline Smith,1 Jeremy P Wrobel2 1Respiratory Medicine, Royal Perth Hospital, Perth, WA, Australia; 2Advanced Lung Disease Unit, Royal Perth Hospital, Perth, WA, Australia Abstract: Comorbidities are frequent in chronic obstructive pulmonary disease (COPD and significantly impact on patients' quality of life, exacerbation frequency, and survival. There is increasing evidence that certain diseases occur in greater frequency amongst patients with COPD than in the general population, and that these comorbidities significantly impact on patient outcomes. Although the mechanisms are yet to be defined, many comorbidities likely result from the chronic inflammatory state that is present in COPD. Common problems in the clinical management of COPD include recognizing new comorbidities, determining the impact of comorbidities on patient symptoms, the concurrent treatment of COPD and comorbidities, and accurate prognostication. The majority of comorbidities in COPD should be treated according to usual practice, and specific COPD management is infrequently altered by the presence of comorbidities. Unfortunately, comorbidities are often under-recognized and under-treated. This review focuses on the epidemiology of ten major comorbidities in patients with COPD. Further, we emphasize the clinical impact upon prognosis and management considerations. This review will highlight the importance of comorbidity identification and management in the practice of caring for patients with COPD. Keywords: cardiovascular disease, prevalence, mortality, chronic bronchitis, emphysema

  7. "Metabolic staging" after major trauma - a guide for clinical decision making?

    Directory of Open Access Journals (Sweden)

    Moore Ernest E

    2010-06-01

    Full Text Available Abstract Metabolic changes after major trauma have a complex underlying pathophysiology. The early posttraumatic stress response is associated with a state of hyperinflammation, with increased oxygen consumption and energy expenditure. This hypercatabolic state must be recognized early and mandates an early nutritional management strategy. A proactive concept of early enteral "immunonutrition" in severely injured patients, is aimed at counterbalancing the negative aspects of hyperinflammation and hypercatabolism in order to reduce the risk of late complications, including infections and posttraumatic organ failure. Recently, the concept of "metabolic staging" has been advocated, which takes into account the distinct inflammatory phases and metabolic phenotypes after major trauma, including the "ischemia/reperfusion phenotype", the "leukocytic phenotype", and the "angiogenic phenotype". The potential clinical impact of metabolic staging, and of an appropriately adapted "metabolic control" and nutritional support, remains to be determined.

  8. 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

  9. Audit of Clinical Coding of Major Head and Neck Operations

    Science.gov (United States)

    Mitra, Indu; Malik, Tass; Homer, Jarrod J; Loughran, Sean

    2009-01-01

    INTRODUCTION Within the NHS, operations are coded using the Office of Population Censuses and Surveys (OPCS) classification system. These codes, together with diagnostic codes, are used to generate Healthcare Resource Group (HRG) codes, which correlate to a payment bracket. The aim of this study was to determine whether allocated procedure codes for major head and neck operations were correct and reflective of the work undertaken. HRG codes generated were assessed to determine accuracy of remuneration. PATIENTS AND METHODS The coding of consecutive major head and neck operations undertaken in a tertiary referral centre over a retrospective 3-month period were assessed. Procedure codes were initially ascribed by professional hospital coders. Operations were then recoded by the surgical trainee in liaison with the head of clinical coding. The initial and revised procedure codes were compared and used to generate HRG codes, to determine whether the payment banding had altered. RESULTS A total of 34 cases were reviewed. The number of procedure codes generated initially by the clinical coders was 99, whereas the revised codes generated 146. Of the original codes, 47 of 99 (47.4%) were incorrect. In 19 of the 34 cases reviewed (55.9%), the HRG code remained unchanged, thus resulting in the correct payment. Six cases were never coded, equating to £15,300 loss of payment. CONCLUSIONS These results highlight the inadequacy of this system to reward hospitals for the work carried out within the NHS in a fair and consistent manner. The current coding system was found to be complicated, ambiguous and inaccurate, resulting in loss of remuneration. PMID:19220944

  10. Optimizing the Use of Aripiprazole Augmentation in the Treatment of Major Depressive Disorder: From Clinical Trials to Clinical Practice

    Science.gov (United States)

    Han, Changsu; Wang, Sheng-Min; Lee, Soo-Jung; Jun, Tae-Youn

    2015-01-01

    Major depressive disorder (MDD) is a recurrent, chronic, and devastating disorder leading to serious impairment in functional capacity as well as increasing public health care costs. In the previous decade, switching therapy and dose adjustment of ongoing antidepressants was the most frequently chosen subsequent treatment option for MDD. However, such recommendations were not based on firmly proven efficacy data from well-designed, placebo-controlled, randomized clinical trials (RCTs) but on practical grounds and clinical reasoning. Aripiprazole augmentation has been dramatically increasing in clinical practice owing to its unique action mechanisms as well as proven efficacy and safety from adequately powered and well-controlled RCTs. Despite the increased use of aripiprazole in depression, limited clinical information and knowledge interfere with proper and efficient use of aripiprazole augmentation for MDD. The objective of the present review was to enhance clinicians' current understanding of aripiprazole augmentation and how to optimize the use of this therapy in the treatment of MDD. PMID:26306301

  11. 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.

  12. 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

  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. 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.

  15. A clinical risk stratification tool for predicting treatment resistance in major depressive disorder.

    Science.gov (United States)

    Perlis, Roy H

    2013-07-01

    Early identification of depressed individuals at high risk for treatment resistance could be helpful in selecting optimal setting and intensity of care. At present, validated tools to facilitate this risk stratification are rarely used in psychiatric practice. Data were drawn from the first two treatment levels of a multicenter antidepressant effectiveness study in major depressive disorder, the STAR*D (Sequenced Treatment Alternatives to Relieve Depression) cohort. This cohort was divided into training, testing, and validation subsets. Only clinical or sociodemographic variables available by or readily amenable to self-report were considered. Multivariate models were developed to discriminate individuals reaching remission with a first or second pharmacological treatment trial from those not reaching remission despite two trials. A logistic regression model achieved an area under the receiver operating characteristic curve exceeding .71 in training, testing, and validation cohorts and maintained good calibration across cohorts. Performance of three alternative models with machine learning approaches--a naïve Bayes classifier and a support vector machine, and a random forest model--was less consistent. Similar performance was observed between more and less severe depression, men and women, and primary versus specialty care sites. A web-based calculator was developed that implements this tool and provides graphical estimates of risk. Risk for treatment resistance among outpatients with major depressive disorder can be estimated with a simple model incorporating baseline sociodemographic and clinical features. Future studies should examine the performance of this model in other clinical populations and its utility in treatment selection or clinical trial design. Copyright © 2013 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.

  16. [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

  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)

    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

  18. Weaving History through the Major

    Science.gov (United States)

    Mayfield, Betty

    2014-01-01

    The benefits of including the study of the history of mathematics in the education of mathematics majors have been discussed at length elsewhere. Many colleges and universities now offer a History of Mathematics course for mathematics majors, for mathematics education majors, or for general credit. At Hood College, we emphasize our commitment to…

  19. Clinical validity of a population database definition of remission in patients with major depression

    Directory of Open Access Journals (Sweden)

    Salvatella-Pasant Jordi

    2010-02-01

    Full Text Available Abstract Background Major depression (MD is one of the most frequent diagnoses in Primary Care. It is a disabling illness that increases the use of health resources. Aim: To describe the concordance between remission according to clinical assessment and remission obtained from the computerized prescription databases of patients with MD in a Spanish population. Methods Design: multicenter cross-sectional. The population under study was comprised of people from six primary care facilities, who had a MD episode between January 2003 and March 2007. A specialist in psychiatry assessed a random sample of patient histories and determined whether a certain patient was in remission according to clinical criteria (ICPC-2. Regarding the databases, patients were considered in remission when they did not need further prescriptions of AD for at least 6 months after completing treatment for a new episode. Validity indicators (sensitivity [S], specificity [Sp] and clinical utility (positive and negative probability ratio [PPR] and [NPR] were calculated. The concordance index was established using Cohen's kappa coefficient. Significance level was p Results 133 patient histories were reviewed. The kappa coefficient was 82.8% (confidence intervals [CI] were 95%: 73.1 - 92.6, PPR 9.8% and NPR 0.1%. Allocation discrepancies between both criteria were found in 11 patients. S was 92.5% (CI was 95%: 88.0 - 96.9% and Sp was 90.6% (CI was 95%: 85.6 - 95.6%, p Conclusions Results show an acceptable level of concordance between remission obtained from the computerized databases and clinical criteria. The major discrepancies were found in diagnostic accuracy.

  20. The impact of major trauma network triage systems on patients with major burns.

    Science.gov (United States)

    Nizamoglu, Metin; O'Connor, Edmund Fitzgerald; Bache, Sarah; Theodorakopoulou, Evgenia; Sen, Sankhya; Sherren, Peter; Barnes, David; Dziewulski, Peter

    2016-12-01

    Trauma is a leading cause of death and disability worldwide. Patients presenting with severe trauma and burns benefit from specifically trained multidisciplinary teams. Regional trauma systems have shown improved outcomes for trauma patients. The aim of this study is to determine whether the development of major trauma systems have improved the management of patients with major burns. A retrospective study was performed over a four-year period reviewing all major burns in adults and children received at a regional burns centre in the UK before and after the implementation of the regional trauma systems and major trauma centres (MTC). Comparisons were drawn between three areas: (1) Patients presenting before the introduction of MTC and after the introduction of MTC. (2) Patients referred from MTC and non-MTC within the region, following the introduction of MTC. (3) Patients referred using the urban trauma protocol and the rural trauma protocol. Following the introduction of regional trauma systems and major trauma centres (MTC), isolated burn patients seen at our regional burns centre did not show any significant improvement in transfer times, admission resuscitation parameters, organ dysfunction or survival when referred from a MTC compared to a non-MTC emergency department. There was also no significant difference in survival when comparing referrals from all hospitals pre and post establishment of the major trauma network. No significant outcome benefit was demonstrated for burns patients referred via MTCs compared to non-MTCs. We suggest further research is needed to ascertain whether burns patients benefit from prolonged transfer times to a MTC compared to those seen at their local hospitals prior to transfer to a regional burns unit for further specialist care. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

  1. 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

  2. [Evidence-based quality assessment of 10-year orthodontic clinical trials in 4 major dental journals].

    Science.gov (United States)

    Sun, Yan-nan; Lei, Fei-fei; Cao, Yan-li; Fu, Min-kui

    2010-02-01

    To assess the quality of orthodontic clinical trials published in 4 major dental journals in the past 10 years and establish the reference standard for orthodontic clinical trials and quality control of dental journals. All the clinical trials published in Chinese Journal of Stomatology, West China Journal of Stomatology, Journal of Practice Stomatology and Chinese Journal of Orthodontics from 1999 to 2008 were searched. The demographic information of the papers was extracted and the quality of the clinical trials according to the consolidated standards of reporting trials (CONSORT) was assessed. Four hundred and ninety-four clinical trials were retrieved, and 21.3% (105/494) of them were supported by grants. For the study design, only 26.1% (129/494) were prospective studies, and 3.8% (19/494) were randomized clinical trials. It was hard to evaluate precisely due to the lack of information about the details of the study designs. For the randomized clinical trials, the lack of details for randomization, allocation concealment, blinding and intention to treat compromised the quality. The general quality of clinical trials in orthodontics is poor. It needs to be improved both in the clinical study design and the paper writing.

  3. Identification of major rice allergen and their clinical significance in children

    Directory of Open Access Journals (Sweden)

    You Hoon Jeon

    2011-10-01

    Full Text Available Purpose : Recently, an increase in the number of patients sensitized to rice allergen with or without clinical symptoms has been reported. This study was designed to determine the major allergens in rice and their clinical significance. Methods : Twenty-four children (15 boys and 9 girls; mean age, 16.3 months with allergic disease, who were sensitized to rice antigen (by UniCAP in the Pediatric Allergy Respiratory Center at Soonchunhyang University Hospital, were enrolled in this study. The allergenicity of various types of rice (raw, cooked, and heat-treated, simulated gastric fluid [SGF], and simulated intestinal fluid [SIF] was investigated using sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE and immunoglobulin E (IgE immunoblots. The patients’ medical records, including laboratory data and allergy symptoms after ingestion of rice were reviewed. Results : Patients were sensitized to an average of 13.5 food antigens and their mean total IgE was 6,888.7 kU/L. In SDS-PAGE, more than 16 protein bands were observed in the raw rice, whereas only 14-16 kDa and 31-35 kDa protein bands were observed in cooked rice. The common SDS-PAGE protein bands observed in SGF-, SIF-, and heattreated rice were 9, 14, and 31 kDa. In a heated-rice IgE immunoblot, protein bands of 9, 14, and 31-33 kDa were found in 27.8%, 38.9%, and 38.9% of all sera, respectively, and in 50%, 50%, and 75%, of ser a from the 4 symptomatic patients, respectively. Conclusion : The 9-, 14-, and 31-kDa protein bands appeared to be the major allergens responsible for rice allergy symptoms.

  4. "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.

  5. 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.

  6. A comparison of heart function and arrhythmia in clinically asymptomatic patients with beta thalassemia intermedia and beta thalassemia major.

    Science.gov (United States)

    Amoozgar, Hamid; Zeighami, Samaneh; Haghpanah, Sezaneh; Karimi, Mehran

    2017-01-01

    The goal of this study was to compare heart function and arrhythmia in clinically asymptomatic patients with beta thalassemia intermedia and beta thalassemia major. In this cross-sectional study, 60 patients with beta thalassemia major and 60 patients with beta thalassemia intermedia who had clinically no symptoms of arrhythmia and clinically normal heart function were evaluated using 24-hour ambulatory electrocardiogram monitoring and echocardiography. For data analysis SPSS ver.20 software was used. A P-value of less than 0.05 was considered statistically significant. The mean age of the beta thalassemia intermedia patients was 24.18 ± 7.9 years and the mean age in beta thalassemia major was 24.38 ± 7.7 years (P>0.05). Premature atrial contractions (PACs) were observed in 14 (23.3%) patients with beta thalassemia intermedia and in 22 (36.6%) beta thalassemia major patients. Premature ventricular contractions (PVCs) were detected in 8 (13.3%) patients in the beta thalassemia intermediate group and 16 (26.6) patients in the beta thalassemia major group, respectively. The left ventricular diastolic dimension, end-diastolic volume, and stroke volume were significantly higher in beta thalassemia intermedia group (Pintermedia group. Both atrial and ventricular arrhythmias were more common in the beta thalassemia major group. Higher end-diastolic volume and stroke volume were detected in the beta thalassemia intermedia group. Pulmonary acceleration time was lower in the beta thalassemia intermedia group, which can be an indicator of higher pulmonary pressure.

  7. 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.

  8. [Clinical and biological predictors of ketamine response in treatment-resistant major depression: Review].

    Science.gov (United States)

    Romeo, B; Choucha, W; Fossati, P; Rotge, J-Y

    2017-08-01

    The aim of this review was to determine the clinical and biological predictors of the ketamine response. A systematic research on PubMed and PsycINFO database was performed without limits on year of publication. The main predictive factors of ketamine response, which were found in different studies, were (i) a family history of alcohol dependence, (ii) unipolar depressive disorder, and (iii) neurocognitive impairments, especially a slower processing speed. Many other predictive factors were identified, but not replicated, such as personal history of alcohol dependence, no antecedent of suicide attempt, anxiety symptoms. Some biological factors were also found such as markers of neural plasticity (slow wave activity, brain-derived neurotrophic factor Val66Met polymorphism, expression of Shank 3 protein), other neurologic factors (anterior cingulate activity, concentration of glutamine/glutamate), inflammatory factors (IL-6 concentration) or metabolic factors (concentration of B12 vitamin, D- and L-serine, alterations in the mitochondrial β-oxidation of fatty acids). This review had several limits: (i) patients had exclusively resistant major depressive episodes which represent a sub-type of depression and not all depression, (ii) response criteria were more frequently assessed than remission criteria, it was therefore difficult to conclude that these predictors were similar, and finally (iii) many studies used a very small number of patients. In conclusion, this review found that some predictors of ketamine response, like basal activity of anterior cingulate or vitamin B12 concentration, were identical to other therapeutics used in major depressive episode. These factors could be more specific to the major depressive episode and not to the ketamine response. Others, like family history of alcohol dependence, body mass index, or D- and L-serine were different from the other therapeutics. Neurocognitive impairments like slower speed processing or alterations in

  9. The discrepancy between patients and informants on clinician-rated measures in major depressive disorder: implications for clinical trials and clinical practice.

    Science.gov (United States)

    Peselow, Eric D; Karamians, Reneh; Lord, Marie; Tobia, Gabriel; IsHak, Waguih William

    2014-03-01

    Clinician-rated measures are used in clinical trials and measurement-based clinical care settings to assess baseline symptoms and treatment outcomes of major depressive disorder (MDD), with a widely held dictum that they are sufficient in assessing the patient's clinical status. In this study, we examined clinician-rated measures of depressive and global symptom severity, obtained by interviewing patients as well as informants in an attempt to examine the potential difference or similarity between these two sources of information. The sample consisted of 89 treatment seeking, DSM-IV diagnosed MDD outpatients treated between 1995 and 2004. The clinician-rated measures used included the Montgomery Åsberg Depression Rating Scale (MADRS), and the Clinical Global Impression Scale (CGI) for Severity. The scores of the clinician-rated measures collected from patients' interviews were compared with those collected from informants' interviews. Clinician-rated scores, collected by interviewing patients, were significantly higher and indicative of greater symptom severity when compared with those collected by interviewing informants. This was true for both the MADRS before (Ppractical in MDD clinical trials or everyday clinical care. The discrepancies observed between the clinician-rated scores obtained from patients and informants emphasize the importance of incorporating collateral information during the assessment and rating of depressive symptom severity in both clinical trials as well as in clinical practice.

  10. 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.

  11. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients.

    Science.gov (United States)

    Schulman, S; Angerås, U; Bergqvist, D; Eriksson, B; Lassen, M R; Fisher, W

    2010-01-01

    The definition of major bleeding varies between studies on surgical patients, particularly regarding the criteria for surgical wound-related bleeding. This diversity contributes to the difficulties in comparing data between trials. The Scientific and Standardization Committee (SSC), through its subcommittee on Control of Anticoagulation, of the International Society on Thrombosis and Haemostasis has previously published a recommendation for a harmonized definition of major bleeding in non-surgical studies. That definition has been adopted by the European Medicines Agency and is currently used in several non-surgical trials. A preliminary proposal for a parallel definition for surgical studies was presented at the 54(th) Annual Meeting of the SSC in Vienna, July 2008. Based on those discussions and further consultations with European and North American surgeons with experience from clinical trials a definition has been developed that should be applicable to all agents that interfere with hemostasis. The definition and the text that follows have been reviewed and approved by relevant co-chairs of the subcommittee and by the Executive Committee of the SSC. The intention is to seek approval of this definition from the regulatory authorities to enhance its incorporation into future clinical trial protocols.

  12. 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.

  13. 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.

  14. Below knee angioplasty in elderly patients: predictors of major adverse clinical outcomes.

    LENUS (Irish Health Repository)

    Keeling, Aoife N

    2012-02-01

    AIM: To determine predictors of clinical outcome following percutaneous transluminal angioplasty (PTA) in elderly patients with below knee atherosclerotic lesions causing intermittent claudication (IC) or critical limb ischaemia (CLI). MATERIALS AND METHODS: Over 7.5 years, 76 patients (CLI 72%, n = 55) underwent below knee PTA. The composite end-point of interest was major adverse clinical outcome (MACO) of the treated limb at follow-up which was defined as clinical failure, need for subsequent endovascular or surgical revascularization or amputation. Actuarial freedom from MACO was assessed using Kaplan-Meier curves and multivariable Cox proportional hazards regression. RESULTS: IC was improved in 95% at mean 3.4 years (range 0.5-108 months). Successful limb salvage and ulcer healing were seen in 73% with CLI. Most failures were in the CLI group (27% CLI vs. 5% IC), with an amputation rate of 16% for CLI vs. 5% for IC and persistent ulceration in 24% of CLI. Significant independent predictors of MACO were ulceration (hazard ratio 4.02, 95% CI = 1.55-10.38) and family history of atherosclerosis (hazard ratio 2.53, 95% CI = 1.1-5.92). CONCLUSION: Primary below knee PTA is a feasible therapeutic option in this elderly population. Limb ulceration and family history of atherosclerosis may be independent predictors of adverse outcome.

  15. Below knee angioplasty in elderly patients: Predictors of major adverse clinical outcomes

    International Nuclear Information System (INIS)

    Keeling, Aoife N.; Khalidi, Karim; Leong, Sum; Wang, Tim T.; Ayyoub, Alaa S.; McGrath, Frank P.; Athanasiou, Thanos; Lee, Michael J.

    2011-01-01

    Aim: To determine predictors of clinical outcome following percutaneous transluminal angioplasty (PTA) in elderly patients with below knee atherosclerotic lesions causing intermittent claudication (IC) or critical limb ischaemia (CLI). Materials and methods: Over 7.5 years, 76 patients (CLI 72%, n = 55) underwent below knee PTA. The composite end-point of interest was major adverse clinical outcome (MACO) of the treated limb at follow-up which was defined as clinical failure, need for subsequent endovascular or surgical revascularization or amputation. Actuarial freedom from MACO was assessed using Kaplan-Meier curves and multivariable Cox proportional hazards regression. Results: IC was improved in 95% at mean 3.4 years (range 0.5-108 months). Successful limb salvage and ulcer healing were seen in 73% with CLI. Most failures were in the CLI group (27% CLI vs. 5% IC), with an amputation rate of 16% for CLI vs. 5% for IC and persistent ulceration in 24% of CLI. Significant independent predictors of MACO were ulceration (hazard ratio 4.02, 95% CI = 1.55-10.38) and family history of atherosclerosis (hazard ratio 2.53, 95% CI = 1.1-5.92). Conclusion: Primary below knee PTA is a feasible therapeutic option in this elderly population. Limb ulceration and family history of atherosclerosis may be independent predictors of adverse outcome.

  16. Below knee angioplasty in elderly patients: Predictors of major adverse clinical outcomes

    Energy Technology Data Exchange (ETDEWEB)

    Keeling, Aoife N.; Khalidi, Karim; Leong, Sum [Department of Academic Radiology, Beaumont Hospital, Beaumont Road, Dublin 9 (Ireland); Wang, Tim T. [Department of Biosurgery and Surgical Technology, Imperial College London, St. Mary' s Hospital, London W2 1NY (United Kingdom); Ayyoub, Alaa S.; McGrath, Frank P. [Department of Academic Radiology, Beaumont Hospital, Beaumont Road, Dublin 9 (Ireland); Athanasiou, Thanos [Department of Biosurgery and Surgical Technology, Imperial College London, St. Mary' s Hospital, London W2 1NY (United Kingdom); Lee, Michael J., E-mail: mlee@rcsi.ie [Department of Academic Radiology, Beaumont Hospital, Beaumont Road, Dublin 9 (Ireland)

    2011-03-15

    Aim: To determine predictors of clinical outcome following percutaneous transluminal angioplasty (PTA) in elderly patients with below knee atherosclerotic lesions causing intermittent claudication (IC) or critical limb ischaemia (CLI). Materials and methods: Over 7.5 years, 76 patients (CLI 72%, n = 55) underwent below knee PTA. The composite end-point of interest was major adverse clinical outcome (MACO) of the treated limb at follow-up which was defined as clinical failure, need for subsequent endovascular or surgical revascularization or amputation. Actuarial freedom from MACO was assessed using Kaplan-Meier curves and multivariable Cox proportional hazards regression. Results: IC was improved in 95% at mean 3.4 years (range 0.5-108 months). Successful limb salvage and ulcer healing were seen in 73% with CLI. Most failures were in the CLI group (27% CLI vs. 5% IC), with an amputation rate of 16% for CLI vs. 5% for IC and persistent ulceration in 24% of CLI. Significant independent predictors of MACO were ulceration (hazard ratio 4.02, 95% CI = 1.55-10.38) and family history of atherosclerosis (hazard ratio 2.53, 95% CI = 1.1-5.92). Conclusion: Primary below knee PTA is a feasible therapeutic option in this elderly population. Limb ulceration and family history of atherosclerosis may be independent predictors of adverse outcome.

  17. Multiple myeloma in Nigeria: An insight to the clinical, laboratory ...

    African Journals Online (AJOL)

    ... the clinician to investigate along the lines of MM. Majority of patients have osteolytic lesions on X‑ray and pathological fractures, and benefit from melphalan based combinations in situations where facilities for transplant are not available. Key words: Clinical features, chemotherapy, laboratory features, multiple myeloma, ...

  18. Pharmacological Treatment of Major Depressive Disorder in Adolescents

    Directory of Open Access Journals (Sweden)

    Rachel L. Farley

    2005-01-01

    Full Text Available Major depressive disorder (MDD affects a significant number of adolescents today. Its consequences (including social isolation, failure to achieve crucial developmental milestones, and suicide mandate close attention in clinical practice. While tricyclics and monoamine oxidase inhibitors (MAOIs have been used infrequently and with questionable efficacy, selective serotonin reuptake inhibitors (SSRIs, particularly fluoxetine, consistently have been shown to be of benefit in treating outpatient adolescents with MDD. Despite some success with other drugs in its class, fluoxetine remains the only SSRI that is FDA approved for treatment of children and adolescents with depression. A review of recent studies is presented, including the controversy regarding the relationship of antidepressants and suicidal behavior in this patient population.

  19. Influence of family history of major depression, bipolar disorder, and suicide on clinical features in patients with major depression and bipolar disorder.

    Science.gov (United States)

    Serretti, Alessandro; Chiesa, Alberto; Calati, Raffaella; Linotte, Sylvie; Sentissi, Othman; Papageorgiou, Konstantinos; Kasper, Siegfried; Zohar, Joseph; De Ronchi, Diana; Mendlewicz, Julien; Amital, Daniela; Montgomery, Stuart; Souery, Daniel

    2013-03-01

    The extent to which a family history of mood disorders and suicide could impact on clinical features of patients suffering from major depression (MD) and bipolar disorder (BD) has received relatively little attention so far. The aim of the present work is, therefore, to assess the clinical implications of the presence of at least one first- and/or second-degree relative with a history of MD, BD and suicide in a large sample of patients with MD or BD. One thousand one hundred and fifty-seven subjects with MD and 686 subjects with BD were recruited within the context of two large projects. The impact of a family history of MD, BD, and suicide-considered both separately and together-on clinical and socio-demographic variables was investigated. A family history of MD, BD, and suicide was more common in BD patients than in MD patients. A positive family history of mood disorders and/or suicide as well as a positive family history of MD and BD separately considered, but not a positive history of suicide alone, were significantly associated with a comorbidity with several anxiety disorders and inversely associated with age of onset. The clinical implications as well as the limitations of our findings are discussed.

  20. Predictors, moderators, and mediators (correlates) of treatment outcome in major depressive disorder.

    Science.gov (United States)

    Papakostas, George I; Fava, Maurizio

    2008-01-01

    Major Depressive Disorder (MDD) is a prevalent illness that is frequently associated with significant disability, morbidity and mortality Despite the development and availability of numerous treatment options for MDD, studies have shown that antidepressant monotherapy yields only modest rates of response and remission. Clearly, there is an urgent need to develop more effective treatment strategies for patients with MDD. One possible approach towards the development of novel pharmacotherapeutic strategies for MDD involves identifying subpopulations of depressed patients who are more likely to experience the benefits of a given (existing) treatment versus placebo, or versus a second treatment. Attempts have been made to identify such "subpopulations", specifically by testing whether a given biological or clinical marker also serves as a moderator, mediator (correlate), or predictor of clinical improvement following the treatment of MDD with standard, first-line antidepressants. In the following article, we will attempt to summarize the literature focusing on several major areas ("leads") where preliminary evidence exists regarding clinical and biologic moderators, mediators, and predictors of symptom improvement in MDD. Such clinical leads will include the presence of hopelessness, anxious symptoms, or medical comorbidity. Biologic leads will include gene polymorphisms, brain metabolism, quantitative electroencephalography, loudness dependence of auditory evoked potentials, and functional brain asymmetry.

  1. 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.

  2. Costs, Benefits and Challenges of Sustainable Livestock Intensification in a Major Deforestation Frontier in the Brazilian Amazon

    Directory of Open Access Journals (Sweden)

    Edenise Garcia

    2017-01-01

    Full Text Available Extensive livestock production is a major deforestation driver in the Brazilian Amazon. This study presents an assessment of the economic and environmental feasibility of sustainable livestock intensification in São Félix do Xingu municipality, a deforestation frontier with an area of more than 8.5 million hectares, and home to the largest cattle herd in Brazil. Proposed intensification was limited to approximately three animal units per hectare to avoid negative environmental impacts. Transition costs to sustainable cattle intensification were estimated for thirteen pilot farms taking into account adoption of good agriculture practices, pasture maintenance/restoration, and restoration of environmental liabilities. To move to sustainable intensification practices, a mean total annual investment of US$1335/ha ± US$619/ha would be necessary, varying from US$750 to US$2595/ha. Internal rate of return and net present value estimates indicated that the sustainable livestock intensification approach proposed was profitable in farms with more than 400 hectares of pastureland, but not in those where the pasture areas were smaller than 150 hectares. Livestock sustainable intensification also had the potential to promote social and environmental benefits, including a 54% increase in the number of contract workers, improvement of landowners’ managerial skills, and workers’ training, in addition to avoiding emission of 1.9 Mt CO2eq and sequestration of 0.36 Mt CO2eq. We conclude that the sustainable intensification of pasture areas has the potential to prevent further deforestation in the Amazon while generating social and other environmental benefits.

  3. 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.

  4. Deserving social benefits?

    DEFF Research Database (Denmark)

    Esmark, Anders; Richardt Schoop, Sarah

    2017-01-01

    welfare reforms involving reductions of social benefits in Denmark in 2005 and 2013, the article analyses the frames used by politicians supporting and opposing reform, as well as the frames used by the media. The article shows, first, that political reforms reducing social benefits are followed...... by increased framing of recipients as undeserving. The article finds a strong correlation between the political objective of reducing benefits and the reliance on frames that position recipients as undeserving. Second, the article shows that media framing remains significantly different from political framing......The article contributes to the growing literature on framing of deservingness as an alternative to ‘blame avoidance’ strategies in the politics of welfare retrenchment. In particular, the article focuses on the interplay between political framing and media framing. Based on an analysis of two major...

  5. Benefits Management of Cloud Computing Investments

    OpenAIRE

    Richard Greenwell; Xiaodong Liu; Kevin Chalmers

    2014-01-01

    This paper examines investments in cloud computing using the Benefits Management approach. The major contribution of the paper is to provide a unique insight into how organizations derive value from cloud computing investments. The motivation for writing this paper is to consider the business benefits generated from utilizing cloud computing in a range of organizations. Case studies are used to describe a number of organizations approaches to benefits exploitation using cloud computing. It wa...

  6. Is there a future for andrographolide to be an anti-inflammatory drug? Deciphering its major mechanisms of action.

    Science.gov (United States)

    Tan, W S Daniel; Liao, Wupeng; Zhou, Shuo; Wong, W S Fred

    2017-09-01

    Andrographis paniculata has long been part of the traditional herbal medicine system in Asia and in Scandinavia. Andrographolide was isolated as a major bioactive constituent of A. paniculata in 1951, and since 1984, andrographolide and its analogs have been scrutinized with modern drug discovery approach for anti-inflammatory properties. With this accumulated wealth of pre-clinical data, it is imperative to review and consolidate different sources of information, to decipher the major anti-inflammatory mechanisms of action in inflammatory diseases, and to provide direction for future studies. Andrographolide and its analogs have been shown to provide anti-inflammatory benefits in a variety of inflammatory disease models. Among the diverse signaling pathways investigated, inhibition of NF-κB activity is the prevailing anti-inflammatory mechanism elicited by andrographolide. There is also increasing evidence supporting endogenous antioxidant defense enhancement by andrographolide through Nrf2 activation. However, the exact pathway leading to NF-κB and Nrf2 activation by andrographolide has yet to be elucidated. Validation and consensus on the major mechanistic actions of andrographolide in different inflammatory conditions are required before translating current findings into clinical settings. There are a few clinical trials conducted using andrographolide in fixed combination formulation which have shown anti-inflammatory benefits and good safety profile. A concerted effort is definitely needed to identify potent andrographolide lead compounds with improved pharmacokinetics and toxicological properties. Taken together, andrographolide and its analogs have great potential to be the next new class of anti-inflammatory agents, and more andrographolide molecules are likely moving towards clinical study stage in the near future. Copyright © 2017 Elsevier Inc. All rights reserved.

  7. 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 ...

  8. 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, ...

  9. Arbuscular mycorrhizal fungi in phytoremediation of contaminated areas by trace elements: mechanisms and major benefits of their applications.

    Science.gov (United States)

    Cabral, Lucélia; Soares, Claúdio Roberto Fonsêca Sousa; Giachini, Admir José; Siqueira, José Oswaldo

    2015-11-01

    In recent decades, the concentration of trace elements has increased in soil and water, mainly by industrialization and urbanization. Recovery of contaminated areas is generally complex. In that respect, microorganisms can be of vital importance by making significant contributions towards the establishment of plants and the stabilization of impacted areas. Among the available strategies for environmental recovery, bioremediation and phytoremediation outstand. Arbuscular mycorrhizal fungi (AMF) are considered the most important type of mycorrhizae for phytoremediation. AMF have broad occurrence in contaminated soils, and evidences suggest they improve plant tolerance to excess of certain trace elements. In this review, the use of AMF in phytoremediation and mechanisms involved in their trace element tolerance are discussed. Additionally, we present some techniques used to study the retention of trace elements by AMF, as well as a summary of studies showing major benefits of AMF for phytoremediation.

  10. 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.

  11. Patients prefer pictures to numbers to express cardiovascular benefit from treatment.

    Science.gov (United States)

    Goodyear-Smith, Felicity; Arroll, Bruce; Chan, Lydia; Jackson, Rod; Wells, Sue; Kenealy, Timothy

    2008-01-01

    This study aimed to determine which methods of expressing a preventive medication's benefit encourage patients with known cardiovascular disease to decide to take the medication and which methods patients prefer. We identified patients in Auckland, New Zealand, family practices located in areas of differing socioeconomic status who had preexisting heart disease (myocardial infarction, angina, or both) and were taking statins. The patients were interviewed about their preference for methods of expressing the benefit of a hypothetical medication. Benefits were expressed numerically (relative risk, absolute risk, number needed to treat, odds ratio, natural frequency) and graphically. Statistical testing was adjusted for practice. We interviewed 100 eligible patients, representing a 53% response rate. No matter how the risk was expressed, the majority of patients indicated they would be encouraged to take the medication. Two-thirds (68) of the patients preferred 1 method of expressing benefit over others. Of this group, 57% preferred the information presented graphically. This value was significantly greater (P framing preferred positive framing (description of the benefit of treatment) over negative framing (description of the harm of not being treated). Although number needed to treat is a useful tool for communicating risk and benefit to clinicians, this format was the least likely to encourage patients to take medication. As graphical representation of benefit was the method patients preferred most, consideration should be given to developing visual aids to support shared clinical decision making.

  12. 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.

  13. Comparative Benefits and Harms of Complementary and Alternative Medicine Therapies for Initial Treatment of Major Depressive Disorder: Systematic Review and Meta-Analysis.

    Science.gov (United States)

    Asher, Gary N; Gartlehner, Gerald; Gaynes, Bradley N; Amick, Halle R; Forneris, Catherine; Morgan, Laura C; Coker-Schwimmer, Emmanuel; Boland, Erin; Lux, Linda J; Gaylord, Susan; Bann, Carla; Pierl, Christiane Barbara; Lohr, Kathleen N

    2017-12-01

    To report the comparative benefits and harms of exercise and complementary and alternative medicine (CAM) treatments with second-generation antidepressants (SGA) for major depressive disorder (MDD). Systematic review and meta-analysis. Outpatient clinics. Adults, aged 18 years and older, with MDD receiving an initial treatment attempt with SGA. Any CAM or exercise intervention compared with an SGA. Treatment response, remission, change in depression rating, adverse events, treatment discontinuation, and treatment discontinuation due to adverse events. We found 22 randomized controlled trials for direct comparisons and 127 trials for network meta-analyses, including trials of acupuncture, omega-3 fatty acids, S-adenosyl methionine, St. John's wort, and exercise. For most treatment comparisons, we found no differences between treatment groups for response and remission. However, the risk of bias of these studies led us to conclude that the strength of evidence for these findings was either low or insufficient. The risk of treatment harms and treatment discontinuation attributed to adverse events was higher for selective serotonin receptor inhibitors than for St. John's wort. Although we found little difference in the comparative efficacy of most CAM therapies or exercise and SGAs, the overall poor quality of the available evidence base tempers any conclusions that we might draw from those trials. Future trials should incorporate patient-oriented outcomes, treatment expectancy, depressive severity, and harms assessments into their designs; antidepressants should be administered over their full dosage ranges; and larger trials using methods to reduce sampling bias are needed.

  14. What are the benefits of hosting a major league sports franchise?

    OpenAIRE

    Jordan Rappaport; Chad R. Wilkerson

    2001-01-01

    Over the last few decades the number of U.S. metropolitan areas large enough to host a franchise from one of the four major professional sports leagues has soared. Even as major league baseball, football, basketball and hockey have expanded to include more franchises, demand by metro areas continues to exceed supply. Metro areas have thus been forced to compete with each other to retain and attract franchises. ; The resulting large public spending on new sports facilities has been quite contr...

  15. 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.

  16. 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

  17. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients

    DEFF Research Database (Denmark)

    Schulman, S; Angerås, U; Bergqvist, D

    2010-01-01

    subcommittee on Control of Anticoagulation, of the International Society on Thrombosis and Haemostasis has previously published a recommendation for a harmonized definition of major bleeding in non-surgical studies. That definition has been adopted by the European Medicines Agency and is currently used......The definition of major bleeding varies between studies on surgical patients, particularly regarding the criteria for surgical wound-related bleeding. This diversity contributes to the difficulties in comparing data between trials. The Scientific and Standardization Committee (SSC), through its...... in several non-surgical trials. A preliminary proposal for a parallel definition for surgical studies was presented at the 54(th) Annual Meeting of the SSC in Vienna, July 2008. Based on those discussions and further consultations with European and North American surgeons with experience from clinical trials...

  18. Balancing the benefits and costs of antibiotic drugs: the TREAT model.

    Science.gov (United States)

    Leibovici, L; Paul, M; Andreassen, S

    2010-12-01

    TREAT is a computerized decision support system aimed at improving empirical antibiotic treatment of inpatients with suspected bacterial infections. It contains a model that balances, for each antibiotic choice (including 'no antibiotics'), expected benefit and expected costs. The main benefit afforded by appropriate, empirical, early antibiotic treatment in moderate to severe infections is a better chance of survival. Each antibiotic drug was consigned three cost components: cost of the drug and administration; cost of side effects; and costs of future resistance. 'No treatment' incurs no costs. The model worked well for decision support. Its analysis showed, yet again, that for moderate to severe infections, a model that does not include costs of resistance to future patients will always return maximum antibiotic treatment. Two major moral decisions are hidden in the model: how to take into account the limited life-expectancy and limited quality of life of old or very sick patients; and how to assign a value for a life-year of a future, unnamed patient vs. the present, individual patient. © 2010 The Authors. Clinical Microbiology and Infection © 2010 European Society of Clinical Microbiology and Infectious Diseases.

  19. Risks and Benefits of Bisphosphonate Therapies

    DEFF Research Database (Denmark)

    Reyes, Carlen; Hitz, Mette; Prieto-Alhambra, Daniel

    2016-01-01

    -term adverse effects. Some of the adverse effects identified include an increased risk of atypical femur fractures, osteonecrosis of the jaw, gastrointestinal side effects, or atrial fibrillation. The harm/benefit thinking and the constant update regarding these medications are vital in the day-to-day decision-making...... in clinical practices. The aims of this review are to compile the basic characteristics of these drugs and outline the most important benefits and side effects and provide a clinical context as well as a research agenda to fill the gaps in our knowledge....

  20. 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

  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 outcomes of patients with major bleeding after primary coronary intervention for acute ST-segment elevation myocardial infarction

    International Nuclear Information System (INIS)

    Zheng Hongchao; Zhang Qi; Zhang Ruiyan; Hu Jian; Yang Zhenkun; Zhang Jiansheng; Shen Weifeng

    2009-01-01

    Objective: To evaluate the clinical outcomes of patients complicated with major bleeding after primary coronary intervention (PCI) for acute ST-segment elevation myocardial infarction (STEMI). Methods: During the period of January 2004-January 2008, primary PCI was performed in 412 consecutive patients with acute STEMI at Shanghai Ruijin Hospital. The clinical data were retrospectively analyzed. Major adverse cardiac events (MACE), including death, reoccurrence of myocardial infarction and target vessel revascularization, in patients with major bleeding were compared with that in patients without major bleeding. Results: Compared to patients without bleeding, the patients with bleeding were older (70.0 ± 8.9 years vs 64.9 ± 12.7 years, P=0.04), mainly the females (51.9% vs 23.1%, P=0.001) and treated more often with glycoprotein (GP) IIb / IIIa receptor inhibitor (88.9% vs 69.4%, P=0.03) or intra-aortic balloon pump (7.4% vs 1.3%, P=0.02). In-hospital and one-year MACE rate in the patients with bleeding was 18.5% and 37.0% respectively,which were significantly higher than that in the patients without bleeding (5.7% and 14.3%, with P=0.008 and P=0.002, respectively). Multivariate analysis indicated that patient aged over 70 years, feminine gender and use of GP IIb/IIIa receptor inhibitor were independent predictors for the occurrence of major bleeding. The occurrence of major bleeding after primary PCI was significantly correlated with MACE occurred within one year after the procedure (OR 2.79, 95% CI: 2.21-5.90, P<0.001). Conclusion: In patients with acute STEMI, the occurrence of major bleeding after primary PCI is closely linked to the increased MACE rate within one year after the treatment.Feminine gender, aged patient and use of GPIIb/IIIa receptor inhibitor are independent predictors to increase the danger of major bleeding. (authors)

  3. The impact of educational status on the clinical features of major depressive disorder among Chinese women

    Science.gov (United States)

    Gan, Zhaoyu; Li, Yihan; Xie, Dong; Shao, Chunhong; Yang, Fuzhong; Shen, Yuan; Zhang, Ning; Zhang, Guanghua; Tian, Tian; Yin, Aihua; Chen, Ce; Liu, Jun; Tang, Chunling; Zhang, Zhuoqiu; Liu, Jia; Sang, Wenhua; Wang, Xumei; Liu, Tiebang; Wei, Qinling; Xu, Yong; Sun, Ling; Wang, Sisi; Li, Chang; Hu, Chunmei; Cui, Yanping; Liu, Ying; Li, Ying; Zhao, Xiaochuan; Zhang, Lan; Sun, Lixin; Chen, Yunchun; Zhang, Yueying; Ning, Yuping; Shi, Shenxun; Chen, Yiping; Kendler, Kenneth S.; Flint, Jonathan; Zhang, Jinbei

    2012-01-01

    Background Years of education are inversely related to the prevalence of major depressive disorder (MDD), but the relationship between the clinical features of MDD and educational status is poorly understood. We investigated this in 1970 Chinese women with recurrent MDD identified in a clinical setting. Methods Clinical and demographic features were obtained from 1970 Han Chinese women with DSM-IV major depression between 30 and 60 years of age across China. Analysis of linear, logistic and multiple logistic regression models were used to determine the association between educational level and clinical features of MDD. Results Subjects with more years of education are more likely to have MDD, with an odds ratio of 1.14 for those with more than ten years. Low educational status is not associated with an increase in the number of episodes, nor with increased rates of co-morbidity with anxiety disorders. Education impacts differentially on the symptoms of depression: lower educational attainment is associated with more biological symptoms and increased suicidal ideation and plans to commit suicide. Limitations Findings may not generalize to males or to other patient populations. Since the threshold for treatment seeking differs as a function of education there may an ascertainment bias in the sample. Conclusions The relationship between symptoms of MDD and educational status in Chinese women is unexpectedly complex. Our findings are inconsistent with the simple hypothesis from European and US reports that low levels of educational attainment increase the risk and severity of MDD. PMID:21824664

  4. The impact of educational status on the clinical features of major depressive disorder among Chinese women.

    Science.gov (United States)

    Gan, Zhaoyu; Li, Yihan; Xie, Dong; Shao, Chunhong; Yang, Fuzhong; Shen, Yuan; Zhang, Ning; Zhang, Guanghua; Tian, Tian; Yin, Aihua; Chen, Ce; Liu, Jun; Tang, Chunling; Zhang, Zhuoqiu; Liu, Jia; Sang, Wenhua; Wang, Xumei; Liu, Tiebang; Wei, Qinling; Xu, Yong; Sun, Ling; Wang, Sisi; Li, Chang; Hu, Chunmei; Cui, Yanping; Liu, Ying; Li, Ying; Zhao, Xiaochuan; Zhang, Lan; Sun, Lixin; Chen, Yunchun; Zhang, Yueying; Ning, Yuping; Shi, Shenxun; Chen, Yiping; Kendler, Kenneth S; Flint, Jonathan; Zhang, Jinbei

    2012-02-01

    Years of education are inversely related to the prevalence of major depressive disorder (MDD), but the relationship between the clinical features of MDD and educational status is poorly understood. We investigated this in 1970 Chinese women with recurrent MDD identified in a clinical setting. Clinical and demographic features were obtained from 1970 Han Chinese women with DSM-IV major depression between 30 and 60 years of age across China. Analysis of linear, logistic and multiple logistic regression models were used to determine the association between educational level and clinical features of MDD. Subjects with more years of education are more likely to have MDD, with an odds ratio of 1.14 for those with more than ten years. Low educational status is not associated with an increase in the number of episodes, nor with increased rates of co-morbidity with anxiety disorders. Education impacts differentially on the symptoms of depression: lower educational attainment is associated with more biological symptoms and increased suicidal ideation and plans to commit suicide. Findings may not generalize to males or to other patient populations. Since the threshold for treatment seeking differs as a function of education there may an ascertainment bias in the sample. The relationship between symptoms of MDD and educational status in Chinese women is unexpectedly complex. Our findings are inconsistent with the simple hypothesis from European and US reports that low levels of educational attainment increase the risk and severity of MDD. Copyright © 2011 Elsevier B.V. All rights reserved.

  5. A comparison of the clinical characteristics of Chinese patients with recurrent major depressive disorder with and without dysthymia☆

    Science.gov (United States)

    Sang, Wenhua; Li, Yihan; Su, Liang; Yang, Fuzhong; Wu, Wenyuan; Shang, Xiaofang; Zhang, Guanghua; Shen, Jianhua; Sun, Mengmeng; Guo, Liyang; Li, Zheng; Yan, Lijuan; Zhang, Bo; Wang, Gang; Liu, Guo; Liu, Tiebang; Zhang, Jinbei; Wang, Yanfang; Yu, Bin; Pan, Jiyang; Li, Yi; Hu, Chunmei; Yang, Lijun; Huang, Yongjin; Xie, Shoufu; Wang, Xueyi; Liu, Jiannin; Lv, Luxian; Chen, Yunchun; Zhang, Lina; Dang, Yamei; Shi, Shenxun; Chen, Yiping; Kendler, Kenneth S.; Flint, Jonathan; Li, Keqing

    2011-01-01

    Background The relationship between major depressive disorder (MDD) and dysthymia, a form of chronic depression, is complex. The two conditions are highly comorbid and it is unclear whether they are two separate disease entities. We investigated the extent to which patients with dysthymia superimposed on major depression can be distinguished from those with recurrent MDD. Methods We examined the clinical features in 1970 Han Chinese women with MDD (DSM-IV) between 30 and 60 years of age across China. Logistic regression was used to determine the association between clinical features of MDD and dysthymia and between dysthymia and disorders comorbid with major depression. Results The 354 cases with dysthymia had more severe MDD than those without, with more episodes of MDD and greater co-morbidity for anxiety disorders. Patients with dysthymia had higher neuroticism scores and were more likely to have a family history of MDD. They were also more likely to have suffered serious life events. Limitations Results were obtained in a clinically ascertained sample of Chinese women and may not generalize to community-acquired samples or to other populations. It is not possible to determine whether the associations represent causal relationships. Conclusions The additional diagnosis of dysthymia in Chinese women with recurrent MDD defines a meaningful and potentially important subtype. We conclude that in some circumstances it is possible to distinguish double depression from recurrent MDD. PMID:21824660

  6. 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

  7. 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

  8. 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.

  9. Medical table: A major tool for antimicrobial stewardship policy.

    Science.gov (United States)

    Roger, P-M; Demonchy, E; Risso, K; Courjon, J; Leroux, S; Leroux, E; Cua, É

    2017-09-01

    Infectious diseases are unpredictable, with heterogeneous clinical presentations, diverse pathogens, and various susceptibility rates to anti-infective agents. These features lead to a wide variety of clinical practices, which in turn strongly limits their evaluation. We have been using a medical table since 2005 to monitor the medical activity in our department. The observation of heterogeneous therapeutic practices led to drafting up our own antibiotic guidelines and to implementing a continuous evaluation of their observance and impact on morbidity and mortality associated with infectious diseases, including adverse effects of antibiotics, duration of hospital stay, use of intensive care, and deaths. The 10-year analysis of medical practices using the medical table is based on more than 10,000 hospitalizations. It shows simplified antibiotic therapies and a reduction in infection-related morbidity and mortality. The medical table is a major tool for antimicrobial stewardship, leading to constant benefits for patients. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  10. 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...

  11. A clinical prediction rule for detecting major depressive disorder in primary care: the PREDICT-NL study.

    Science.gov (United States)

    Zuithoff, Nicolaas P A; Vergouwe, Yvonne; King, Michael; Nazareth, Irwin; Hak, Eelko; Moons, Karel G M; Geerlings, Mirjam I

    2009-08-01

    Major depressive disorder often remains unrecognized in primary care. Development of a clinical prediction rule using easily obtainable predictors for major depressive disorder in primary care patients. A total of 1046 subjects, aged 18-65 years, were included from seven large general practices in the center of The Netherlands. All subjects were recruited in the general practice waiting room, irrespective of their presenting complaint. Major depressive disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Text Revision edition criteria was assessed with the Composite International Diagnostic Interview. Candidate predictors were gender, age, educational level, being single, number of presented complaints, presence of non-somatic complaints, whether a diagnosis was assigned, consultation rate in past 12 months, presentation of depressive complaints or prescription of antidepressants in past 12 months, number of life events in past 6 months and any history of depression. The first multivariable logistic regression model including only predictors that require no confronting depression-related questions had a reasonable degree of discrimination (area under the receiver operating characteristic curve or concordance-statistic (c-statistic) = 0.71; 95% Confidence Interval (CI): 0.67-0.76). Addition of three simple though more depression-related predictors, number of life events and history of depression, significantly increased the c-statistic to 0.80 (95% CI: 0.76-0.83). After transforming this second model to an easily to use risk score, the lowest risk category (sum score depression, which increased to 49% in the highest category (sum score > or = 30). A clinical prediction rule allows GPs to identify patients-irrespective of their complaints-in whom diagnostic workup for major depressive disorder is indicated.

  12. 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 ...

  13. Incidental Findings in Imaging Research: Evaluating Incidence, Benefit and Burden

    Science.gov (United States)

    Orme, Nicholas M.; Fletcher, Joel G.; Siddiki, Hassan A.; Harmsen, W. Scott; O’Byrne, Megan M.; Port, John D.; Tremaine, William J.; Pitot, Henry C.; McFarland, Beth; Robinson, Marguerite E.; Koenig, Barabara A.; King, Bernard F.; Wolf, Susan M.

    2013-01-01

    Context Little information exists concerning the frequency of clinically significant incidental findings (IFs) identified in the course of imaging research across a broad spectrum of imaging modalities and body regions. Objective To estimate the frequency with which research imaging IFs generate further clinical action, and the medical benefit/burden of identifying these IFs. Design, Setting, and Participants Retrospective review of subjects undergoing a research imaging exam that was interpreted by a radiologist for IFs in the first quarter of 2004, with 3-year clinical follow-up. An expert panel reviewed IFs generating clinical action to determine medical benefit/burden based on predefined criteria. Main Outcome Measures Frequency of (1) IFs that generated further clinical action by modality, body part, age, gender, and (2) IFs resulting in clear medical benefit or burden. Results 1376 patients underwent 1426 research imaging studies. 40% (567/1426) of exams had at least one IF (1055 total). Risk of an IF increased significantly by age (OR=1.5; [1.4–1.7=95% C.I.] per decade increase). Abdominopelvic CT generated more IFs than other exams (OR=18.9 compared with ultrasound; 9.2% with subsequent clinical action), with CT Thorax and MR brain next (OR=11.9 and 5.9; 2.8% and 2.2% with action, respectively). Overall 6.2% of exams (35/567) with an IF generated clinical action, resulting in clear medical benefit in 1.1% (6/567) and clear medical burden in 0.5% (3/567). In most instances, medical benefit/burden was unclear (4.6%; 26/567). Conclusions The frequency of IFs in imaging research exams varies significantly by imaging modality, body region and age. Research imaging studies at high risk for generating IFs can be identified. Routine evaluation of research images by radiologists may result in identification of IFs in a substantial number of cases and subsequent clinical action to address them in much smaller number. Such clinical action can result in medical

  14. Major obstetric haemorrhage of 2000 ml or greater: a clinical audit.

    Science.gov (United States)

    O'Sullivan, J; Mansfield, R; Talbot, R; Cairns, A E

    2018-05-04

    Haemorrhage remains a leading cause of maternal death. We conducted an audit to identify strategies to improve the management at our local NHS Trust. A data collection form was based on our local guideline. A coded database search was conducted for all deliveries where the estimated blood loss was ≥2000 ml (from June 1 2015 to December 31 2015), returning 68 search results (13.7/1000 births). Fifty-six records were included. Poor compliance (<75%) was seen in some key areas including the major obstetric haemorrhage (MOH) call activation (52%), the presence of an anaesthetic consultant (63%) and tranexamic acid administration (46%). Thirty out of 56 cases (54%) were acutely transfused. Women, who were not transfused acutely, appeared to be more likely to need a secondary transfusion if no MOH call had been activated (9/27 (33%) versus 3/29 (10%), p = .052). A key area for improvement was the activation of MOH calls. Following this audit, we adjusted our guideline to make it more clinically useful and staff training sessions were held, including simulation training. Impact statement What is already known on this subject? A postpartum haemorrhage (PPH) is an obstetric emergency. A structured approach is important to optimise the care of the mothers during this dangerous time, and has been shown to reduce the transfusion requirements. However, clinical practice may not adhere to the guideline recommendations. What the results of this study add? With the objective evidence of increased rates of PPH ≥2000 ml at our institution, our work identifying the flaws in management was a critical component of the work to improve the outcomes. This study gives impetus to find innovative ways to improve adherence to guidelines, and inspired an update of our local guideline to improve the applicability and utility. This project suggests a new marker for the adequacy of an acute management (a requirement for secondary blood transfusion without having received an acute

  15. Clinical Significance of the Number of Depressive Symptoms in Major Depressive Disorder: Results from the CRESCEND Study.

    Science.gov (United States)

    Park, Seon-Cheol; Sakong, Jeongkyu; Koo, Bon Hoon; Kim, Jae-Min; Jun, Tae-Youn; Lee, Min-Soo; Kim, Jung-Bum; Yim, Hyeon-Woo; Park, Yong Chon

    2016-04-01

    Our study aimed to establish the relationship between the number of depressive symptoms and the clinical characteristics of major depressive disorder (MDD). This would enable us to predict the clinical significance of the number of depressive symptoms in MDD patients. Using data from the Clinical Research Center for Depression (CRESCEND) study in Korea, 853 patients with DSM-IV MDD were recruited. The baseline and clinical characteristics of groups with different numbers of depressive symptoms were compared using the χ(2) test for discrete variables and covariance (ANCOVA) for continuous variables. In addition, the scores of these groups on the measurement tools were compared by ANCOVA after adjusting the potential effects of confounding variables. After adjusting the effects of monthly income and history of depression, a larger number of depressive symptoms indicated higher overall severity of depression (F [4, 756] = 21.458, P depressive symptoms (F [4, 767] = 19.145, P depressive symptoms can be used as an index of greater illness burden in clinical psychiatry.

  16. A comparison of the clinical characteristics of Chinese patients with recurrent major depressive disorder with and without dysthymia.

    Science.gov (United States)

    Sang, Wenhua; Li, Yihan; Su, Liang; Yang, Fuzhong; Wu, Wenyuan; Shang, Xiaofang; Zhang, Guanghua; Shen, Jianhua; Sun, Mengmeng; Guo, Liyang; Li, Zheng; Yan, Lijuan; Zhang, Bo; Wang, Gang; Liu, Guo; Liu, Tiebang; Zhang, Jinbei; Wang, Yanfang; Yu, Bin; Pan, Jiyang; Li, Yi; Hu, Chunmei; Yang, Lijun; Huang, Yongjin; Xie, Shoufu; Wang, Xueyi; Liu, Jiannin; Lv, Luxian; Chen, Yunchun; Zhang, Lina; Dang, Yamei; Shi, Shenxun; Chen, Yiping; Kendler, Kenneth S; Flint, Jonathan; Li, Keqing

    2011-12-01

    The relationship between major depressive disorder (MDD) and dysthymia, a form of chronic depression, is complex. The two conditions are highly comorbid and it is unclear whether they are two separate disease entities. We investigated the extent to which patients with dysthymia superimposed on major depression can be distinguished from those with recurrent MDD. We examined the clinical features in 1970 Han Chinese women with MDD (DSM-IV) between 30 and 60 years of age across China. Logistic regression was used to determine the association between clinical features of MDD and dysthymia and between dysthymia and disorders comorbid with major depression. The 354 cases with dysthymia had more severe MDD than those without, with more episodes of MDD and greater co-morbidity for anxiety disorders. Patients with dysthymia had higher neuroticism scores and were more likely to have a family history of MDD. They were also more likely to have suffered serious life events. Results were obtained in a clinically ascertained sample of Chinese women and may not generalize to community-acquired samples or to other populations. It is not possible to determine whether the associations represent causal relationships. The additional diagnosis of dysthymia in Chinese women with recurrent MDD defines a meaningful and potentially important subtype. We conclude that in some circumstances it is possible to distinguish double depression from recurrent MDD. Copyright © 2011 Elsevier B.V. All rights reserved.

  17. 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.

  18. Major adverse cardiovascular event reduction with GLP-1 and SGLT2 agents: evidence and clinical potential

    Science.gov (United States)

    Røder, Michael E.

    2017-01-01

    Treatment of patients with type 2 diabetes is directed against treating symptoms of hyperglycemia, minimizing the risk of hypoglycemia, and the risk of microvascular and macrovascular complications. The majority of patients with type 2 diabetes die from cardiovascular or cerebrovascular disease. Future therapies should therefore focus on reducing cardiovascular morbidity in this high-risk population. Glucagon-like peptide-1 receptor agonists (GLP-1RA) and sodium-glucose co-transporter 2 inhibitors (SGLT2-i) are two drug classes with proven antihyperglycemic effect in type 2 diabetes. However, these drugs seem to have other effects such as weight reduction, low risk of hypoglycemia, and blood pressure reduction. Emerging evidence suggests pleiotropic effects, which potentially could be important in reducing cardiovascular risk. Prompted by regulatory authorities demanding cardiovascular outcome trials (CVOTs) assessing the cardiovascular safety of new antihyperglycemic drug candidates, many CVOTs are ongoing and a few of these are finalized. Somewhat surprising recent CVOTs in both drug classes have shown promising data on cardiovascular morbidity and mortality in patients with a very high risk of cardiovascular events. It is uncertain whether this is a class effect of the two drug classes, and it is yet unproven whether long-term cardiovascular benefits of these drugs can be extrapolated to populations at lower risk of cardiovascular disease. The aim of the present review is to give an overview of our current knowledge of the GLP-1RA and SGLT2-i classes, with specific focus on mechanisms of action, effects on cardiovascular risk factors and cardiovascular morbidity and mortality from the CVOTs presently available. The clinical potential of these data is discussed. PMID:29344329

  19. [Assessment of actual benefits of new drugs by the Transparency Committee].

    Science.gov (United States)

    Le Jeunne, C

    2008-01-01

    When a drug has been granted a marketing authorization, if the pharmaceutical company wants it to be covered by the National Health Insurance, the company has to submit a file with all the studies concerning the drug, especially drug-drug comparative studies, to be assessed by the Transparency Committee. Drugs are assessed on two criteria: actual or expected benefit (AB) and improvement in actual benefit (IAB). Actual benefit mainly takes into account the severity of the disease concerned, the level of efficacy relative to known side effects (risk-benefit ratio), and the place the drug is intended to take in the therapeutic strategy. At the end of the assessment, AB is considered as important, moderate, poor or insufficient (to justify inclusion of the drug on the list of products to be reimbursed). After actual benefit is determined, improvement of actual benefit is assessed, comparing the estimated benefit of this drug with one of drugs with the same indication that is already reimbursed, to assess whether this drug will improve the patient's disease. This can be assessed by direct comparison (two drugs compared in the same clinical trial) or by indirect comparison (separate studies with the same design). There are four levels of added value, from I (major improvement) to IV (minor improvement). Level V represents no improvement. This second assessment is always relative to another drug. It never provides an absolute score. However, IAB is very important for pharmaceutical companies, because it is a fundamental criterion to determine the price of the drug, which is discussed with the Economic Committee of Health Products in a final phase. Actual benefit and improvement in actual benefit are allocated for each indication of a drug.

  20. Non-clinical influences on clinical decision-making: a major challenge to evidence-based practice.

    Science.gov (United States)

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

    2010-05-01

    This article reviews an aspect of daily clinical practice which is of critical importance in virtually every clinical consultation, but which is seldom formally considered. Non-clinical influences on clinical decision-making profoundly affect medical decisions. These influences include patient-related factors such as socioeconomic status, quality of life and patient's expectations and wishes, physician-related factors such as personal characteristics and interaction with their professional community, and features of clinical practice such as private versus public practice as well as local management policies. This review brings together the different strands of knowledge concerning non-clinical influences on clinical decision-making. This aspect of decision-making may be the biggest obstacle to the reality of practising evidence-based medicine. It needs to be understood in order to develop clinical strategies that will facilitate the practice of evidence-based medicine.

  1. A framework for quantifying net benefits of alternative prognostic models

    OpenAIRE

    Rapsomaniki, E.; White, I.R.; Wood, A.M.; Thompson, S.G.; Ford, I.

    2012-01-01

    New prognostic models are traditionally evaluated using measures of discrimination and risk reclassification, but these do not take full account of the clinical and health economic context. We propose a framework for comparing prognostic models by quantifying the public health impact (net benefit) of the treatment decisions they support, assuming a set of predetermined clinical treatment guidelines. The change in net benefit is more clinically interpretable than changes in traditional measure...

  2. 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.

  3. 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

  4. Costs and benefits with public and investor-owned electric systems

    International Nuclear Information System (INIS)

    Bronner, K.M.

    1990-01-01

    This article discusses the analysis of the costs and benefits associated with public ownership of major utility projects and systems as opposed to private ownership. The topics discussed include the alleged benefits of public power systems, principles of cost benefit analysis, tax-exempt debt, state and local taxes and federal income taxes, benefit of 100 percent debt financing

  5. Cognitive Deficit in Heart Failure and the Benefits of Aerobic Physical Activity

    Directory of Open Access Journals (Sweden)

    Maria Luíza de Medeiros Rêgo

    Full Text Available Abstract Heart Failure is a clinical syndrome prevalent throughout the world and a major contribution to mortality of cardiac patients in Brazil. In addition, this pathology is strongly related to cerebral dysfunction, with a high prevalence of cognitive impairment. Many mechanisms may be related to cognitive loss, such as cerebral hypoperfusion, atrophy and loss of gray matter of the brain, and dysfunction of the autonomic nervous system. The literature is clear regarding the benefits of aerobic physical activity in healthy populations in the modulation of the autonomic nervous system and in brain functions. Studies have shown that in the population of patients with heart failure, exercise is associated with an improvement in cognitive function, as well as in cardiac autonomic regulation. However, little emphasis has been given to the mechanisms by which aerobic physical activity can benefit brain functioning, the autonomic nervous system and result in better cognitive performance, particularly in patients with heart failure. Therefore, the present work presents the ways in which brain areas responsible for cognition also act in the modulation of the autonomic nervous system, and emphasizes its importance for the understanding of cognitive impairment in relation to the pathophysiology of heart failure. It is also described the way in which aerobic physical activity can promote benefits when it is integrated into the therapy, associated to a better prognosis of the clinical picture of these patients.

  6. 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

  7. 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.

  8. Season of birth, clinical manifestations and Dexamethasone Suppression Test in unipolar major depression

    Directory of Open Access Journals (Sweden)

    Kaprinis George S

    2007-08-01

    Full Text Available Abstract Background Reports in the literature suggest that the season of birth might constitute a risk factor for the development of a major psychiatric disorder, possibly because of the effect environmental factors have during the second trimester of gestation. The aim of the current paper was to study the possible relationship of the season of birth and current clinical symptoms in unipolar major depression. Methods The study sample included 45 DSM-IV major depressive patients and 90 matched controls. The SCAN v. 2.0, Hamilton Depression Rating Scale (HDRS and Hamilton Anxiety Scale (HAS were used to assess symptomatology, and the 1 mg Dexamethasone Suppression Test (DST was used to subcategorize patients. Results Depressed patients as a whole did not show differences in birth season from controls. However, those patients born during the spring manifested higher HDRS while those born during the summer manifested the lowest HAS scores. DST non-suppressors were almost exclusively (90% likely to be born during autumn and winter. No effect from the season of birth was found concerning the current severity of suicidal ideation or attempts. Discussion The current study is the first in this area of research using modern and rigid diagnostic methodology and a biological marker (DST to categorize patients. Its disadvantages are the lack of data concerning DST in controls and a relatively small size of patient sample. The results confirm the effect of seasonality of birth on patients suffering from specific types of depression.

  9. Agenda-setting for Canadian caregivers: using media analysis of the maternity leave benefit to inform the compassionate care benefit.

    Science.gov (United States)

    Dykeman, Sarah; Williams, Allison M

    2014-04-24

    The Compassionate Care Benefit was implemented in Canada in 2004 to support employed informal caregivers, the majority of which we know are women given the gendered nature of caregiving. In order to examine how this policy might evolve over time, we examine the evolution of a similar employment insurance program, Canada's Maternity Leave Benefit. National media articles were reviewed (n = 2,698) and, based on explicit criteria, were analyzed using content analysis. Through the application of Kingdon's policy agenda-setting framework, the results define key recommendations for the Compassionate Care Benefit, as informed by the developmental trajectory of the Maternity Leave Benefit. Recommendations for revising the Compassionate Care Benefit are made.

  10. Benefit of early discharge among patients with low-risk pulmonary embolism.

    Directory of Open Access Journals (Sweden)

    Li Wang

    Full Text Available Clinical guidelines recommend early discharge of patients with low-risk pulmonary embolism (LRPE. This study measured the overall impact of early discharge of LRPE patients on clinical outcomes and costs in the Veterans Health Administration population. Adult patients with ≥1 inpatient diagnosis for pulmonary embolism (PE (index date between 10/2011-06/2015, continuous enrollment for ≥12 months pre- and 3 months post-index date were included. PE risk stratification was performed using the simplified Pulmonary Embolism Stratification Index. Propensity score matching (PSM was used to compare 90-day adverse PE events (APEs [recurrent venous thromboembolism, major bleed and death], hospital-acquired complications (HACs, healthcare utilization, and costs among short (≤2 days versus long length of stay (LOS. Net clinical benefit was defined as 1 minus the combined rate of APE and HAC. Among 6,746 PE patients, 95.4% were men, 22.0% were African American, and 1,918 had LRPE. Among LRPE patients, only 688 had a short LOS. After 1:1 PSM, there were no differences in APE, but short LOS had fewer HAC (1.5% vs 13.3%, 95% CI: 3.77-19.94 and bacterial pneumonias (5.9% vs 11.7%, 95% CI: 1.24-3.23, resulting in better net clinical benefit (86.9% vs 78.3%, 95% CI: 0.84-0.96. Among long LOS patients, HACs (52 exceeded APEs (14 recurrent DVT, 5 bleeds. Short LOS incurred lower inpatient ($2,164 vs $5,100, 95% CI: $646.8-$5225.0 and total costs ($9,056 vs $12,544, 95% CI: $636.6-$6337.7. LRPE patients with short LOS had better net clinical outcomes at lower costs than matched LRPE patients with long LOS.

  11. 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

  12. 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.

  13. 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.

  14. 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.

  15. 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/.

  16. Non-clinical influences on clinical decision-making: a major challenge to evidence-based practice

    OpenAIRE

    Hajjaj, FM; Salek, MS; Basra, MKA; Finlay, AY

    2010-01-01

    This article reviews an aspect of daily clinical practice which is of critical importance in virtually every clinical consultation, but which is seldom formally considered. Non-clinical influences on clinical decision-making profoundly affect medical decisions. These influences include patient-related factors such as socioeconomic status, quality of life and patient's expectations and wishes, physician-related factors such as personal characteristics and interaction with their professional co...

  17. 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.

  18. Clinical Features of Anthroponotic Cutaneous Leishmaniasis in a Major Focus, Southeastern Iran, 1994-2014

    Directory of Open Access Journals (Sweden)

    Ahmad KHOSRAVI

    2017-12-01

    Full Text Available AbstractBackground: Cutaneous leishmaniasis (CL is associated with a broad and complex clinical spectrum of diseases. The objectives of this study were to assess the clinical features and identification of the causative agents of CL in a well-known focus of anthroponotic CL (ACL caused by Leishmania tropica, southeast Iran.Methods: This study was performed randomly as a descriptive cross-sectional survey to evaluate 2000 CL patients by active and passive case-detection approaches in Kerman Province from 1994 to 2014. The ACL patients were confirmed by direct smear and 600 cases by one or a combination of intrinsic methods.Results: Children aged <10 yr old were the most infected patients (P<0.001. The majority of the CL lesions were located in hands (46.3%, face (34.1%, legs (14.3%, and other parts of the body (5.3%. The mean number of lesions was 1.5 and most of the patients had single lesion (65%.Typical clinical lesions included papule (36.8%, followed by ulcerated nodule (20.7%, plaque (18.4%, and ulcerated plaque (18.5%. While among atypical clinical features, leishmaniasis recidivans (LR (4.7% and leishmanid (0.3% were the dominant forms, followed by diffuse, disseminated, sporotrichoid, and erysipeloid types, 0.1% each, and then lymphedematous, lymphadenic, hyperkeratotic, paronychial, and mutilating types, 0.05% each. Based on various intrinsic methods the parasites isolated from the lesions were characterized as L. tropica.Conclusion: ACL due to L. tropica presents numerous cases of localized form and diverse uncommon clinical presentations, which mimic other disease conditions. Therefore, physicians should be aware of such manifestations for selecting appropriate treatment modality.

  19. What is Clinical Safety in Electronic Health Care Record Systems?

    Science.gov (United States)

    Davies, George

    There is mounting public awareness of an increasing number of adverse clinical incidents within the National Health Service (NHS), but at the same time, large health care projects like the National Programme for IT (NPFIT) are claiming that safer care is one of the benefits of the project and that health software systems in particular have the potential to reduce the likelihood of accidental or unintentional harm to patients. This paper outlines the approach to clinical safety management taken by CSC, a major supplier to NPFIT; discusses acceptable levels of risk and clinical safety as an end-to-end concept; and touches on the future for clinical safety in health systems software.

  20. Relationships of Cerebrospinal Fluid Monoamine Metabolite Levels With Clinical Variables in Major Depressive Disorder.

    Science.gov (United States)

    Yoon, Hyung Shin; Hattori, Kotaro; Ogawa, Shintaro; Sasayama, Daimei; Ota, Miho; Teraishi, Toshiya; Kunugi, Hiroshi

    Many studies have investigated cerebrospinal fluid (CSF) monoamine metabolite levels in depressive disorders. However, their clinical significance is still unclear. We tried to determine whether CSF monoamine metabolite levels could be a state-dependent marker for major depressive disorder (MDD) based on analyses stratified by clinical variables in a relatively large sample. Subjects were 75 patients with MDD according to DSM-IV criteria and 87 healthy controls, matched for age, sex, and ethnicity (Japanese). They were recruited between May 2010 and November 2013. We measured homovanillic acid (HVA), 5-hydroxyindoleacetic acid (5-HIAA), and 3-methoxy-4-hydroxyphenylethyleneglycol (MHPG) in CSF samples by high-performance liquid chromatography. We analyzed the relationships of the metabolite levels with age, sex, diagnosis, psychotropic medication use, and depression severity. There was a weak positive correlation between age and 5-HIAA levels in controls (ρ = 0.26, P 12) were significantly lower than those in controls (P .1), were related to depression severity. CSF 5-HIAA and HVA levels could be state-dependent markers in MDD patients. Since 5-HIAA levels greatly decrease with the use of antidepressants, HVA levels might be more useful in the clinical setting. © Copyright 2017 Physicians Postgraduate Press, Inc.

  1. Distinguishing bipolar II depression from major depressive disorder with comorbid borderline personality disorder: demographic, clinical, and family history differences.

    Science.gov (United States)

    Zimmerman, Mark; Martinez, Jennifer H; Morgan, Theresa A; Young, Diane; Chelminski, Iwona; Dalrymple, Kristy

    2013-09-01

    Because of the potential treatment implications, it is clinically important to distinguish between bipolar II depression and major depressive disorder with comorbid borderline personality disorder. The high frequency of diagnostic co-occurrence and resemblance of phenomenological features has led some authors to suggest that borderline personality disorder is part of the bipolar spectrum. Few studies have directly compared patients with bipolar disorder and borderline personality disorder. In the present study from the Rhode Island Methods to Improve Diagnostic Assessment and Services project, we compared these 2 groups of patients on demographic, clinical, and family history variables. From December 1995 to May 2012, 3,600 psychiatric patients presenting to the outpatient practice at Rhode Island Hospital (Providence, Rhode Island) were evaluated with semistructured diagnostic interviews for DSM-IV Axis I and Axis II disorders. The focus of the present study is the 206 patients with DSM-IV major depressive disorder and borderline personality disorder (MDD-BPD) and 62 patients with DSM-IV bipolar II depression without borderline personality disorder. The patients with MDD-BPD were significantly more often diagnosed with posttraumatic stress disorder (P depression had a significantly higher morbid risk for bipolar disorder in their first-degree relatives than the MDD-BPD patients (P depression and major depressive disorder with comorbid borderline personality disorder differed on a number of clinical and family history variables, thereby supporting the validity of this distinction. © Copyright 2013 Physicians Postgraduate Press, Inc.

  2. Combination therapy of hyaluronic acid mesotherapic injections and sclerotherapy for treatment of lower leg telangiectasia without major venous insufficiency: a preliminary clinical study.

    Science.gov (United States)

    Iannitti, Tommaso; Rottigni, Valentina; Torricelli, Federica; Palmieri, Beniamino

    2014-04-01

    Telangiectasia is the dilation of dermal capillaries mainly due to hypertension and vein insufficiency. Treatments of choice for this condition are sclerotherapy with foam liquid or intradermal fiber optic laser energy delivery. The aim of this study was to assess the efficacy of a new therapeutic approach consisting in the use of polymerized hyaluronic acid mesotherapic injections following sclerotherapy in the areas of the skin affected by telangiectasia in patients without major vein insufficiency. A total of 20 women, aged between 19 and 64 years, affected by recurrent lower leg telangiectasia, were included in this study. Patients were preliminarily submitted to echo color Doppler sonography to rule out severe saphenofemoral valve and lower limb major vein insufficiency. All patients underwent 3 sessions a month of polidocanol 1% capillary injections for 2 months. This was followed by 0.1 ml cross-linked hyaluronic acid introduction in the polidocanol 1% needle track. A total of 50 mesotherapic injections (0.05 ml each) were performed on the skin surface where an ice pack was previously applied for 4 to 5 minutes. A follow-up visit was performed at 3 months. The results, based on photographic examination, were rated as follows: poor improvement (0%-50%), good improvement (51%-75%), and very good improvement (76%-100%). The side effects of the clinical procedure, in terms of pain, itching, paresthesia, ecchymosis, and relapse of telangiectasia over the treated skin surface, as well as a persisting pigmentation in the injection spots and induced benefits related to leg heaviness and comfort, were recorded. In total, 6 patients displayed a slight venous insufficiency, 3 patients displayed patent venous insufficiency, and 11 patients did not show any venous insufficiency. Before treatment, itching was present in 18 out of 20 patients, paresthesia in 15 out of 20 patients, ecchymosis in 16 out of 20 patients, and leg heaviness in 15 out of 20 patients. At the 3

  3. Cost-benefit analysis in decision making for diagnostic radiology

    International Nuclear Information System (INIS)

    Fabrikant, J.I.; Hilberg, A.W.

    1982-02-01

    This paper reviews certain current concepts and methods relating to benefit-risk analysis, in terms of economic costs and raidation risks to health, in relation to the benefits from diagnostic radiology in clinical medicine

  4. Bridging between basic medical science and clinical practice

    Directory of Open Access Journals (Sweden)

    Bakir Mehić

    2012-02-01

    Full Text Available Translating the extraordinary scientific and technological advances from the biomedical research laboratory into actual patient care practices and other processes aimed at promoting health has been a major challenge, particularly for patients in community settings. Because of that the increased participation of clinicians from primary health care in clinical research would have a number of benefits. As experts in the delivery of clinical care in one society, they have much to contribute providing health care for patients in the whole spectrum of illnesses1. They are among the first to recognize changes in patients’ which come us as result of disease and conditions associated with demographic shiftings. Very often these are unexpected events such as trauma, natural disasters, pandemic infections, etc. They are also directly in contact with the policy-related matters (e.g., health consequences associated with increase in price of medications or the clinical consequences of war, such as the rapid increase in the number of individuals with prosthetic limbs and post traumatic stress syndrome2. Finally, participation in clinical research would benefit clinicians from primary health care in more ways, such as: contributing the mission of medicine and improving the scientific basis for medical practice; allowing clinicians to stay with new innovations ie. the development up to-date of information systems to improve data-gathering associated with the research3.A major goal is the development of teams of investigators from various research disciplines, is to turm the scientific discoveries from the laboratories into treatments and strategies for patients in communities. However, even with that introduction only a small part of the community will provide participation in clinical research. The barriers for this in USA recognised from clinicians community and showed in down table4.

  5. PET/MRI: a novel hybrid imaging technique. Major clinical indications and preliminary experience in Brazil.

    Science.gov (United States)

    Vitor, Taise; Martins, Karine Minaif; Ionescu, Tudor Mihai; Cunha, Marcelo Livorsi da; Baroni, Ronaldo Hueb; Garcia, Marcio Ricardo Taveira; Wagner, Jairo; Campos, Guilherme de Carvalho; Nogueira, Solange Amorim; Guerra, Elaine Gonçalves; Amaro, Edson

    2017-01-01

    In recent years, medical imaging with hybrid techniques has widely accepted and employed in clinical routine. PET/MRI offers significant advantages, including excellent contrast and resolution and reduced ionizing radiation, as compared to well-established PET/CT. Therefore, PET/MRI is a promising modality for oncologic imaging of some regions, such as brain, head and neck, liver and pelvis. This article set out to analyze clinical conditions that could benefit from PET/MRI imaging based on our caseload. The potential of PET/MRI to become the imaging modality of choice for assessment of neurologic and oncologic conditions associated with soft tissues is highlighted. Clinical aspects of PET/MRI and its application to clinical cases are illustrated with examples extracted from the authors' preliminary experience. RESUMO Nos últimos anos, imagens médicas com tecnologias híbridas tornaram-se amplamente aceitas e utilizadas na prática clínica. O PET/RM possui vantagens importantes, incluindo excelentes contrastes e resolução, e menor radiação ionizante, em comparação ao PET/TC. Por isto, é uma modalidade promissora para exames de imagem de pacientes oncológicos, para avaliar o cérebro, cabeça e pescoço, o fígado e a pelve. O objetivo deste artigo foi analisar as situações clínicas que se beneficiariam de exames de PET/RM a partir de uma casuística. Destacamos o potencial desta técnica se tornar o método de imagem de escolha para doenças neurológicas e oncológicas que envolvam partes moles. Os aspectos clínicos de PET/RM e sua aplicação aos casos clínicos são ilustrados com exemplos da experiência inicial dos autores.

  6. Benefit/risk comparisons in diagnostic radiology

    International Nuclear Information System (INIS)

    Oosterkamp, W.J.

    1976-01-01

    Benefit and risks in radiodiagnostic examination, either with X-rays or with radioactive isotopes, can be expressed in restored health and health impaired by radiation or: lives saved and estimated lives lost as a result of genetic or somatic radiation damage. Published data on benefit-risk comparisons for mass stomach and chest surveys show a considerable benefit surplus. It is demonstrated that this is also true in the case of clinical examinations of the sick. Efforts should be concentrated on better ways and means to reduce the number of diagnostic errors. Risk estimates should be made as realistic as possible

  7. 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.

  8. 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.

  9. Barriers and facilitators of adherence to antidepressants among outpatients with major depressive disorder: A qualitative study.

    Science.gov (United States)

    Ho, Siew Ching; Jacob, Sabrina Anne; Tangiisuran, Balamurugan

    2017-01-01

    One of the major challenges in treating major depressive disorder (MDD) is patients' non-adherence to medication. This study aimed to explore the barriers and facilitators of patients' adherence to antidepressants among outpatients with MDD. Semi-structured and individual in-depth interviews were conducted among patients with MDD who were taking antidepressants, in the psychiatric clinic of a government-run hospital in Malaysia. Participants were purposively sampled from different genders and ethnicities. Interviews were conducted using a validated topic guide, and responses were audio-recorded, transcribed verbatim, checked, and analyzed using the grounded theory approach. A total of 30 patients were interviewed. Forty different themes and sub-themes were identified which were conceptually divided into two distinct categories related to barriers and facilitators to adherence. The barriers were: patient-specific, medication-specific, healthcare provision and system, social-cultural, and logistics. The facilitators were: having insight, perceived health benefits, regular activities, patient-provider relationship, reminders, and social support networks. Patient-specific barriers and medication side effects were the major challenges for adhering to treatment. Perceived health benefits and having insight on the need for treatment were the most frequently cited facilitators. Targeted interventions should be developed to address the key barriers, and promote measures to facilitate adherence in this group of patients.

  10. 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

  11. 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.

  12. Clinical, immunological and genetic features in eleven Algerian patients with major histocompatibility complex class II expression deficiency

    Directory of Open Access Journals (Sweden)

    Djidjik Réda

    2012-08-01

    Full Text Available Abstract Presenting processed antigens to CD4+ lymphocytes during the immune response involves major histocompatibility complex class II molecules. MHC class II genes transcription is regulated by four transcription factors: CIITA, RFXANK, RFX5 and RFXAP. Defects in these factors result in major histocompatibility complex class II expression deficiency, a primary combined immunodeficiency frequent in North Africa. Autosomal recessive mutations in the RFXANK gene have been reported as being the principal defect found in North African patients with this disorder. In this paper, we describe clinical, immunological and genetic features of 11 unrelated Algerian patients whose monocytes display a total absence of MHC class II molecules. They shared mainly the same clinical picture which included protracted diarrhoea and respiratory tract recurrent infections. Genetic analysis revealed that 9 of the 11 patients had the same RFXANK founder mutation, a 26 bp deletion (named I5E6-25_I5E6+1, also known as 752delG26. Immunological and genetic findings in our series may facilitate genetic counselling implementation for Algerian consanguineous families. Further studies need to be conducted to determine 752delG26 heterozygous mutation frequency in Algerian population.

  13. Risks and Benefits of Helicobacter pylori Eradication: Current Status

    Directory of Open Access Journals (Sweden)

    Richard H Hunt

    2002-01-01

    Full Text Available In patients with diseases known to be associated with Helicobacter pylori infection, such as peptic ulcer, treatment of the underlying infection is the standard of care. However, in most major consensus management guidelines, including those published in Canada, widespread testing for H pylori infection is not recommended. This practice is not encouraged because of insufficient evidence of cost-benefit in gastric cancer prevention, the potential for increases in antibiotic resistance and the controversial hypothesis of potential negative effects of eradication in certain clinical entities. For example, there is insufficient evidence to recommend against eradicating H pylori discovered in a patient with symptoms of gastroesophageal reflux disease. The management guidelines designed specifically in Canada should, therefore, continue to be applied, with H pylori diagnosed and treated in appropriately selected patients.

  14. Prescribing patterns of psychotropic medications and clinical features in patients with major depressive disorder with and without comorbid dysthymia in China.

    Science.gov (United States)

    Feng, Yuan; Sha, Sha; Hu, Chen; Wang, Gang; Ungvari, Gabor S; Chiu, Helen F K; Ng, Chee H; Si, Tian-Mei; Chen, Da-Fang; Fang, Yi-Ru; Lu, Zheng; Yang, Hai-Chen; Hu, Jian; Chen, Zhi-Yu; Huang, Yi; Sun, Jing; Wang, Xiao-Ping; Li, Hui-Chun; Zhang, Jin-Bei; Xiang, Yu-Tao

    2017-03-01

    Little has been reported about the demographic and clinical features of major depressive disorder (MDD) with comorbid dysthymia in Chinese patients. This study examined the frequency of comorbid dysthymia in Chinese MDD patients together with the demographic and clinical correlates and prescribing patterns of psychotropic drugs. Consecutively collected sample of 1178 patients with MDD were examined in 13 major psychiatric hospitals in China. Patients' demographic and clinical characteristics and psychotropic drugs prescriptions were recorded using a standardized protocol and data collection procedure. The diagnosis of dysthymia was established using the Mini International Neuropsychiatric Interview. Medications ascertained included antidepressants, antipsychotics, benzodiazepines, and mood stabilizers. One hundred and three (8.7%) patients fulfilled criteria for dysthymia. In multiple logistic regression analyses, compared to non-dysthymia counterparts, MDD patients with dysthymia had more depressive episodes with atypical features including increased appetite, sleep, and weight gain, more frequent lifetime depressive episodes, and less likelihood of family history of psychiatric disorders. There was no significant difference in the pattern of psychotropic prescription between the 2 groups. There are important differences in the demographic and clinical features of comorbid dysthymia in Chinese MDD patients compared with previous reports. The clinical profile found in this study has implications for treatment decisions. © 2016 John Wiley & Sons Australia, Ltd.

  15. 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

  16. A framework for quantifying net benefits of alternative prognostic models

    DEFF Research Database (Denmark)

    Rapsomaniki, Eleni; White, Ian R; Wood, Angela M

    2012-01-01

    New prognostic models are traditionally evaluated using measures of discrimination and risk reclassification, but these do not take full account of the clinical and health economic context. We propose a framework for comparing prognostic models by quantifying the public health impact (net benefit......) of the treatment decisions they support, assuming a set of predetermined clinical treatment guidelines. The change in net benefit is more clinically interpretable than changes in traditional measures and can be used in full health economic evaluations of prognostic models used for screening and allocating risk...... reduction interventions. We extend previous work in this area by quantifying net benefits in life years, thus linking prognostic performance to health economic measures; by taking full account of the occurrence of events over time; and by considering estimation and cross-validation in a multiple...

  17. A comparison of patients with major depressive disorder recruited through newspaper advertising versus consultation referrals for clinical drug trials.

    Science.gov (United States)

    Miller, C A; Hooper, C L; Bakish, D

    1997-01-01

    Difficulties in recruiting patients for clinical trials have plagued investigators for many years. One concern is the generalizability of clinical trial results to community practice, that is, whether volunteers recruited through advertising are homogeneous with those seeking treatment in a clinical setting. This article retrospectively compares the baseline characteristics of patients recruited through newspaper advertisements with those recruited through consultation referrals by reviewing the charts of 54 patients enrolled in two clinical trials for major depressive disorder (MDD). We examined demographic data, background information, clinical histories, and baseline status. Results indicated homogeneity for most variables. The consultation group was significantly more likely to have had previous treatment for the current episode of depression. These results suggest that, although the advertisement and consultation groups were very similar, the drug naivety of the advertisement group may make them a preferred source in terms of generalizability to community practice.

  18. Episodic Visual Learning/Memory and Attentional Flexibility in Patients With Major Depressive Disorder After Clinically Effective Electroconvulsive Therapy.

    Science.gov (United States)

    Kalogerakou, Stamatina; Oulis, Panagiotis; Anyfandi, Eleni; Konstantakopoulos, George; Papakosta, Vasiliki-Maria; Kontis, Dimitrios; Theochari, Eirini; Angelopoulos, Elias; Zervas, Ioannis M; Mellon, Robert C; Papageorgiou, Charalambos C; Tsaltas, Eleftheria

    2015-12-01

    This study is a follow-up of a previous one reporting that the neuropsychological profile of pharmacoresistant patients with major depressive disorder referred for electroconvulsive therapy (ECT, ECT group) contrasted with that of their pharmacorespondent counterparts (NECT group). The NECT group exhibited severe visuospatial memory and minor executive deficits; the ECT group presented the reverse pattern. In that same ECT group, the current follow-up study examined the effects of clinically effective ECT on both cognitive domains 2 months later. Fifteen ECT patients were administered Hamilton Depression (HAMD-24), Hamilton Anxiety (HAMA), Mini-Mental State Examination Scales and 5 tests of Cambridge Neuropsychological Test Automated Battery at intake (pre-ECT), end of ECT course (post-ECT), and 2 months thereafter (follow-up). Electroconvulsive therapy was effective in relieving clinical depression. After a post-ECT decline, the patients exhibited significant improvement in both Cambridge Neuropsychological Test Automated Battery, paired associate learning, and Stockings of Cambridge. By contrast, their major pre-ECT deficit in intra/extradimensional set shifting remained virtually unaffected. Our findings suggest that attentional flexibility deficits may constitute a neuropsychological trait-like feature of pharmacoresistant, ECT-referred major depressive disorder patients. However, this deficit does not seem generalized, given patient improvement in episodic visual learning/memory and some indication of improvement in spatial planning after ECT.

  19. Major benefits of guarding behavior in subsocial bees: implications for social evolution.

    Science.gov (United States)

    Mikát, Michael; Černá, Kateřina; Straka, Jakub

    2016-10-01

    Parental care is a behavior that increases the growth and survival of offspring, often at a cost to the parents' own survival and/or future reproduction. In this study, we focused on nest guarding, which is one of the most important types of extended parental care; we studied this behavior in two solitary bee species of the genus Ceratina with social ancestors. We performed the experiment of removing the laying female, who usually guards the nest after completing its provisioning, to test the effects of nest guarding on the offspring survival and nest fate. By dissecting natural nests, we found that Ceratina cucurbitina females always guarded their offspring until the offspring reached adulthood. In addition, the females of this species were able to crawl across the nest partitions and inspect the offspring in the brood cells. In contrast, several Ceratina chalybea females guarded their nests until the offspring reached adulthood, but others closed the nest entrance with a plug and deserted the nest. Nests with a low number of provisioned cells were more likely to be plugged and abandoned than nests with a higher number of cells. The female removal experiment had a significantly negative effect on offspring survival in both species. These nests frequently failed due to the attacks of natural enemies (e.g., ants, chalcidoid wasps, and other competing Ceratina bees). Increased offspring survival is the most important benefit of the guarding strategy. The abandonment of a potentially unsuccessful brood might constitute a benefit of the nest plugging behavior. The facultative nest desertion strategy is a derived behavior in the studied bees and constitutes an example of an evolutionary reduction in the extent of parental care.

  20. 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

  1. The benefits of reduced morbidity

    Energy Technology Data Exchange (ETDEWEB)

    Krupnick, A; Hood, C; Harrison, K

    1994-07-01

    Morbidity benefits refer to increases in utility arising from reductions in incidents of acute health impairments and from increases in the probability of developing chronic diseases. The impairments would run the gamut from a cough-day to a bed-disability-day, while the chronic diseases include classic pollution-related diseases, such as cancer, to in utero effects and learning disabilities. As with mortality benefits, there could be benefits to oneself and family and friends as well as benefits based on altruism. A major difference between the mortality and morbidity valuation literatures is that while estimates of the former are always based on risk (one is never trying to obtain values for avoiding certain death), estimates of the latter generally are not. That is, most of the theory and empirical estimates are based on models where the effect to be avoided is certain. This assumption holds reasonably well for estimating common acute effects, for example, the willingness to pay (WTP) for one less cough-day. It works less well, if at all, for chronic illness endpoints, where benefits seem to be appropriately expressed in terms of reduced risk of developing a disease or impairment.

  2. The benefits of reduced morbidity

    International Nuclear Information System (INIS)

    Krupnick, A.; Hood, C.; Harrison, K.

    1994-01-01

    Morbidity benefits refer to increases in utility arising from reductions in incidents of acute health impairments and from increases in the probability of developing chronic diseases. The impairments would run the gamut from a cough-day to a bed-disability-day, while the chronic diseases include classic pollution-related diseases, such as cancer, to in utero effects and learning disabilities. As with mortality benefits, there could be benefits to oneself and family and friends as well as benefits based on altruism. A major difference between the mortality and morbidity valuation literatures is that while estimates of the former are always based on risk (one is never trying to obtain values for avoiding certain death), estimates of the latter generally are not. That is, most of the theory and empirical estimates are based on models where the effect to be avoided is certain. This assumption holds reasonably well for estimating common acute effects, for example, the willingness to pay (WTP) for one less cough-day. It works less well, if at all, for chronic illness endpoints, where benefits seem to be appropriately expressed in terms of reduced risk of developing a disease or impairment

  3. 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.

  4. Ethics and epistemology of accurate prediction in clinical research.

    Science.gov (United States)

    Hey, Spencer Phillips

    2015-07-01

    All major research ethics policies assert that the ethical review of clinical trial protocols should include a systematic assessment of risks and benefits. But despite this policy, protocols do not typically contain explicit probability statements about the likely risks or benefits involved in the proposed research. In this essay, I articulate a range of ethical and epistemic advantages that explicit forecasting would offer to the health research enterprise. I then consider how some particular confidence levels may come into conflict with the principles of ethical research. 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.

  5. Patient benefit index (PBI) in the treatment of psoriasis--results of the National Care Study "PsoHealth".

    Science.gov (United States)

    Radtke, Marc Alexander; Schäfer, Ines; Blome, Christine; Augustin, Matthias

    2013-04-01

    Psoriasis vulgaris is a common disease that follows a chronic course. So far, few studies have addressed outcome methods which evaluate the benefits of drugs and medical devices by measuring patient preferences. Assessment of patients' outcomes using the "Patient benefit index" (PBI), a validated goal attainment scaling tool, in the treatment of psoriasis. Data were obtained within an epidemiological study in 2,009 patients with psoriasis vulgaris and/or psoriatic arthritis. Cross-sectional study in 133 nationwide German dermatological practices and hospital departments. The following were recorded a) in the doctors' questionnaire--previous treatments and diseases, clinical characteristics and psoriasis area and severity index (PASI), b) in the patients' questionnaire--quality of life (LQ), patient-relevant therapeutic benefits and satisfaction with care. On average, patients achieved a total PBI of 2.5±1.1. 86.7% of patients showed a more than minimum benefit (PBI>1). Patients treated with biologicals had a higher benefit (mean PBI 3.0) than patients in other groups (e.g. PBI 2.6 in systemics). PBI values indicate that systemic agents and biologics are of high therapeutic benefit to the vast majority of patients. The development of the PBI has enabled a decisive step to be taken in the area of scientifically-based outcome assessments.

  6. Social media and physicians: Exploring the benefits and challenges.

    Science.gov (United States)

    Panahi, Sirous; Watson, Jason; Partridge, Helen

    2016-06-01

    Healthcare professionals' use of social media platforms, such as blogs, wikis, and social networking web sites has grown considerably in recent years. However, few studies have explored the perspectives and experiences of physicians in adopting social media in healthcare. This article aims to identify the potential benefits and challenges of adopting social media by physicians and demonstrates this by presenting findings from a survey conducted with physicians. A qualitative survey design was employed to achieve the research goal. Semi-structured interviews were conducted with 24 physicians from around the world who were active users of social media. The data were analyzed using the thematic analysis approach. The study revealed six main reasons and six major challenges for physicians adopting social media. The main reasons to join social media were as follows: staying connected with colleagues, reaching out and networking with the wider community, sharing knowledge, engaging in continued medical education, benchmarking, and branding. The main challenges of adopting social media by physicians were also as follows: maintaining confidentiality, lack of active participation, finding time, lack of trust, workplace acceptance and support, and information anarchy. By revealing the main benefits as well as the challenges of adopting social media by physicians, the study provides an opportunity for healthcare professionals to better understand the scope and impact of social media in healthcare, and assists them to adopt and harness social media effectively, and maximize the benefits for the specific needs of the clinical community. © The Author(s) 2014.

  7. Optimal use of MRI in clinical trials, clinical care and clinical registries of patients with rheumatoid arthritis

    DEFF Research Database (Denmark)

    Østergaard, Mikkel; Møller-Bisgaard, Signe

    2014-01-01

    the benefits of including MRI in treat-to-target strategies. The benefits of incorporating MRI into clinical registries are not yet known, but may include improved knowledge about the real-life advantages of MRI, as well as opportunities to develop better clinical and laboratory composite measures to monitor......Magnetic resonance imaging (MRI) clearly is more sensitive than clinical examination and conventional radiography (x-ray) for detection of inflammation (synovitis, bone marrow oedema (osteitis) and tenosynovitis) and damage (bone erosion and cartilage loss/joint space narrowing) in patients...... with rheumatoid arthritis (RA). The question is when and how MRI should be used. The present article reviews our knowledge about, and provides suggestions for, the use of MRI in clinical trials, clinical care and clinical registries. In clinical trials, the OMERACT RA MRI scoring system (RAMRIS) is a thoroughly...

  8. 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.

  9. 20 CFR 625.5 - Unemployment caused by a major disaster.

    Science.gov (United States)

    2010-04-01

    ... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Unemployment caused by a major disaster. 625... DISASTER UNEMPLOYMENT ASSISTANCE § 625.5 Unemployment caused by a major disaster. (a) Unemployed worker. The unemployment of an unemployed worker is caused by a major disaster if— (1) The individual has a...

  10. Clinical and Serological Predictors of Suicide in Schizophrenia and Major Mood Disorders.

    Science.gov (United States)

    Dickerson, Faith; Origoni, Andrea; Schweinfurth, Lucy A B; Stallings, Cassie; Savage, Christina L G; Sweeney, Kevin; Katsafanas, Emily; Wilcox, Holly C; Khushalani, Sunil; Yolken, Robert

    2018-03-01

    Persons with serious mental illness are at high risk for suicide, but this outcome is difficult to predict. Serological markers may help to identify suicide risk. We prospectively assessed 733 persons with a schizophrenia spectrum disorder, 483 with bipolar disorder, and 76 with major depressive disorder for an average of 8.15 years. The initial evaluation consisted of clinical and demographic data as well as a blood samples from which immunoglobulin G antibodies to herpes viruses and Toxoplasma gondii were measured. Suicide was determined using data from the National Death Index. Cox proportional hazard regression models examined the role of baseline variables on suicide outcomes. Suicide was associated with male sex, divorced/separated status, Caucasian race, and elevated levels of antibodies to Cytomegalovirus (CMV). Increasing levels of CMV antibodies were associated with increasing hazard ratios for suicide. The identification of serological variables associated with suicide might provide more personalized methods for suicide prevention.

  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. Equitable benefit-sharing or self-interest?

    Energy Technology Data Exchange (ETDEWEB)

    Swiderska, Krystyna

    2010-09-15

    A legally binding protocol on access to genetic resources and benefit-sharing is to be adopted by the 193 governments that are party to the Convention on Biological Diversity in October 2010 in Nagoya, Japan. The protocol aims to ensure that the benefits derived from the use of genetic resources are shared fairly and equitably with biodiversity-rich but financially poor countries. This could help reverse the rapid loss of biodiversity and genetic resources. But unless governments make some major progress in their final negotiating session, the protocol will make little difference.

  13. Biologic and clinical significance of molecular profiling in Chronic Lymphocytic Leukemia.

    Science.gov (United States)

    Butler, Tom; Gribben, J G

    2010-05-01

    CLL is extremely heterogeneous in its clinical course, with some patients living decades with no need for treatment whilst others have a rapidly aggressive clinical course. A major focus of research has been to try to identify those biological factors that influence this heterogeneity. The goal of therapy has been to maintain the best quality of life and treat only when patients become symptomatic from their disease. For the majority of patients this means following a "watch and wait" approach to determine the rate of progression of the disease and assess for development of symptoms. Any alteration to this approach will require identification of criteria that define patients sufficiently "high-risk" that they gain benefit by introduction of early therapy. The use of molecular profiling to suggest particular therapies is currently appropriate only in defining the treatment of the minority of patients with 17p deletions or p53 mutations and in all other circumstances remains a clinical trial question. Copyright 2010 Elsevier Ltd. All rights reserved.

  14. Exercise for patients with major depression

    DEFF Research Database (Denmark)

    Krogh, Jesper; Speyer, Helene; Gluud, Christian

    2015-01-01

    is to investigate the beneficial and harmful effects of exercise, in terms of severity of depression, lack of remission, suicide, and so on, compared with treatment as usual with or without co-interventions in randomized clinical trials involving adults with a clinical diagnosis of major depression. A meta......BACKGROUND: The lifetime prevalence of major depression is estimated to affect 17% of the population and is considered the second largest health-care problem globally in terms of the number of years lived with disability. The effects of most antidepressant treatments are poor; therefore, exercise...... has been assessed in a number of randomized clinical trials. A number of reviews have previously analyzed these trials; however, none of these reviews have addresses the effect of exercise for adults diagnosed with major depression. METHODS/DESIGN: The objective of this systematic review...

  15. 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 ...

  16. [The effects of Omega-3 fatty acids in clinical medicine].

    Science.gov (United States)

    Reiner, Martin F; Stivala, Simona; Camici, Giovanni G; Beer, Jürg H

    2014-03-12

    Effects of Omega-3 fatty acids (n-3 FA) in particular on the development of cardiovascular disease (CVD) are of major interest. Many experimental studies reported their anti-inflammatory, anti-thrombotic and anti-atherosclerotic properties and suggested favourable effects on the prevention of CVD. While the majority of former studies showed a benefit of n-3 FA acid intake, recent clinical trials using n-3 supplements on top of established medication and prudent nutrition did not confirm these findings. The conflicting data may be due to several factors such as the selection of study population with different sizes or characteristics as well as choosing different doses or types of n-3 FA. The most recent meta-analyses observed clear benefits of fish consumption, but not of n-3 capsules intake. Furthermore, a nutrition rich in plant-derived n-3 FA alpha-linolenic acid has been found to have beneficial effects on the development of cardio- and cerebrovascular diseases.

  17. Rivaroxaban for venous thromboembolism prevention after major orthopedic surgery: translating trial data into routine clinical practice

    Directory of Open Access Journals (Sweden)

    Beyer-Westendorf J

    2017-01-01

    Full Text Available Jan Beyer-Westendorf,1 Patrick Mouret,2 Alexander GG Turpie3 1Thrombosis Research and Angiology, Dresden University Clinic, Dresden, Germany; 2Orthopedic Clinic, Klinikum Frankfurt Höchst GmbH, Frankfurt, Germany; 3Department of Medicine, General Division, Hamilton Health Sciences, Hamilton, ON, Canada Abstract: An established standard of care for the prevention of venous thromboembolism after major orthopedic surgery has been subcutaneous low-molecular-weight heparin. The non-vitamin K antagonist oral anticoagulant rivaroxaban has demonstrated superior efficacy and similar safety to all tested regimens of enoxaparin in large Phase III clinical studies of venous thromboembolism prevention after elective hip and knee arthroplasty. Despite regulatory approval of rivaroxaban for this indication, concerns remain among physicians regarding its optimal and effective use in routine clinical practice. Real-life studies, such as XAMOS and ORTHO-TEP, are providing physicians with more information on the routine use of rivaroxaban for venous thromboembolism prevention after orthopedic surgery, helping to establish its safety and effectiveness in everyday clinical care. Among the most important issues are the risk of bleeding complications, wound healing, timing of first dose, impact of type of anesthesia on thromboprophylaxis effectiveness, patient comorbidities and comedication use, periprocedural management, associated costs, and clinical outcomes in trauma-related fractures. Many of these issues are difficult to study in randomized, double-blind, Phase III trials, and can be assessed more readily using real-life data. In particular, real-life or noninterventional studies lack many of the strict inclusion and exclusion criteria associated with Phase III trials and involve unselected patients who often present with significant comorbidities or comedication use. Keywords: anticoagulants, arthroplasty, orthopedics, rivaroxaban, thrombosis

  18. Benefit sharing: an exploration on the contextual discourse of a changing concept.

    Science.gov (United States)

    Dauda, Bege; Dierickx, Kris

    2013-09-12

    The concept of benefit sharing has been a topical issue on the international stage for more than two decades, gaining prominence in international law, research ethics and political philosophy. In spite of this prominence, the concept of benefit sharing is not devoid of controversies related to its definition and justification. This article examines the discourses and justifications of benefit sharing concept. We examine the discourse on benefit sharing within three main spheres; namely: common heritage of humankind, access and use of genetic resources according to the Convention on Biological Diversity (CBD), and international clinical research. Benefit sharing has changed from a concept that is enshrined in a legally binding regulation in the contexts of common heritage of humankind and CBD to a non-binding regulation in international clinical research. Nonetheless, there are more ethical justifications that accentuate benefit sharing in international clinical research than in the contexts of common heritage of humankind and the CBD. There is a need to develop a legal framework in order to strengthen the advocacy and decisiveness of benefit sharing practice in international health research. Based on this legal framework, research sponsors would be required to provide a minimum set of possible benefits to participants and communities in research. Such legal framework on benefit sharing will encourage research collaboration with local communities; and dispel mistrust between research sponsors and host communities. However, more research is needed, drawing from other international legal frameworks, to understand how such a legal framework on benefit sharing can be successfully formulated in international health research.

  19. Predictors of Response to Ketamine in Treatment Resistant Major Depressive Disorder and Bipolar Disorder

    Directory of Open Access Journals (Sweden)

    Carola Rong

    2018-04-01

    Full Text Available Objectives: Extant evidence indicates that ketamine exerts rapid antidepressant effects in treatment-resistant depressive (TRD symptoms as a part of major depressive disorder (MDD and bipolar disorder (BD. The identification of depressed sub-populations that are more likely to benefit from ketamine treatment remains a priority. In keeping with this view, the present narrative review aims to identify the pretreatment predictors of response to ketamine in TRD as part of MDD and BD. Method: Electronic search engines PubMed/MEDLINE, ClinicalTrials.gov, and Scopus were searched for relevant articles from inception to January 2018. The search term ketamine was cross-referenced with the terms depression, major depressive disorder, bipolar disorder, predictors, and response and/or remission. Results: Multiple baseline pretreatment predictors of response were identified, including clinical (i.e., Body Mass Index (BMI, history of suicide, family history of alcohol use disorder, peripheral biochemistry (i.e., adiponectin levels, vitamin B12 levels, polysomnography (abnormalities in delta sleep ratio, neurochemistry (i.e., glutamine/glutamate ratio, neuroimaging (i.e., anterior cingulate cortex activity, genetic variation (i.e., Val66Met BDNF allele, and cognitive functioning (i.e., processing speed. High BMI and a positive family history of alcohol use disorder were the most replicated predictors. Conclusions: A pheno-biotype of depression more, or less likely, to benefit with ketamine treatment is far from complete. Notwithstanding, metabolic-inflammatory alterations are emerging as possible pretreatment response predictors of depressive symptom improvement, most notably being cognitive impairment. Sophisticated data-driven computational methods that are iterative and agnostic are more likely to provide actionable baseline pretreatment predictive information.

  20. Clinical Trials

    Medline Plus

    Full Text Available ... need to travel or stay in hospitals to take part in clinical trials. For example, the National Institutes of Health Clinical Center in ... Maryland, runs clinical trials. Many other clinical trials take place in medical centers and ... trial can have many benefits. For example, you may gain access to new treatments before ...

  1. Novel cancer immunotherapy agents with survival benefit: recent successes and next steps

    Science.gov (United States)

    Sharma, Padmanee; Wagner, Klaus; Wolchok, Jedd D.; Allison, James P.

    2012-01-01

    The US Food and Drug Administration (FDA) recently approved two novel immunotherapy agents, sipuleucel-T and ipilimumab, which showed a survival benefit for patients with metastatic prostate cancer and melanoma, respectively. The mechanisms by which these agents provide clinical benefit are not completely understood. However, knowledge of these mechanisms will be crucial for probing human immune responses and tumour biology in order to understand what distinguishes responders from non-responders. The following next steps are necessary: first, the development of immune-monitoring strategies for the identification of relevant biomarkers; second, the establishment of guidelines for the assessment of clinical end points; and third, the evaluation of combination therapy strategies to improve clinical benefit. PMID:22020206

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

    Science.gov (United States)

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

    2011-10-04

    Preterm birth (PTB) is a major cause of infant morbidity and mortality, but the relationship between comorbidity and PTB by clinical subtype and severity of gestational age remains poorly understood. We evaluated associations between maternal comorbidities and PTB by clinical subtype and gestational age. We conducted a retrospective cohort study of 1,329,737 singleton births delivered in hospitals in the province of Québec, Canada, 1989-2006. PTB was classified by clinical subtype (medically indicated, preterm premature rupture of membranes (PPROM), spontaneous preterm labour) and gestational age (PTBs across all gestational ages (OR > 2.0). At the population level, several major comorbidities (placental abruption, chorioamnionitis, oliogohydramnios, structural abnormality, cervical incompetence) were key contributors to all clinical subtypes of PTB, especially at PTBs. The relationship between comorbidity and clinical subtypes of PTB depends on gestational age. Prevention of PPROM and spontaneous PTB may benefit from greater attention to preeclampsia, anemia and comorbidities localized to the reproductive system.

  3. Clinical Trials

    Medline Plus

    Full Text Available ... benefits of lowering high blood pressure in the elderly outweighed the risks. Other examples of clinical trials ... child to enroll. Also, children aged 7 and older often must agree (assent) to ... as clinical trials for adults. For more information, go to "How Do Clinical ...

  4. Benefits and drawbacks of electronic health record systems

    Directory of Open Access Journals (Sweden)

    Menachemi N

    2011-05-01

    Full Text Available Nir Menachemi¹, Taleah H Collum²¹Department of Health Care Organization and Policy, University of Alabama at Birmingham, Birmingham, AL, USA; ²Department of Health Services Administration, University of Alabama at Birmingham, Birmingham, AL, USAAbstract: The Health Information Technology for Economic and Clinical Health (HITECH Act of 2009 that was signed into law as part of the "stimulus package" represents the largest US initiative to date that is designed to encourage widespread use of electronic health records (EHRs. In light of the changes anticipated from this policy initiative, the purpose of this paper is to review and summarize the literature on the benefits and drawbacks of EHR systems. Much of the literature has focused on key EHR functionalities, including clinical decision support systems, computerized order entry systems, and health information exchange. Our paper describes the potential benefits of EHRs that include clinical outcomes (eg, improved quality, reduced medical errors, organizational outcomes (eg, financial and operational benefits, and societal outcomes (eg, improved ability to conduct research, improved population health, reduced costs. Despite these benefits, studies in the literature highlight drawbacks associated with EHRs, which include the high upfront acquisition costs, ongoing maintenance costs, and disruptions to workflows that contribute to temporary losses in productivity that are the result of learning a new system. Moreover, EHRs are associated with potential perceived privacy concerns among patients, which are further addressed legislatively in the HITECH Act. Overall, experts and policymakers believe that significant benefits to patients and society can be realized when EHRs are widely adopted and used in a “meaningful” way.Keywords: EHR, health information technology, HITECH, computerized order entry, health information exchange 

  5. 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.

  6. 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.

  7. 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

  8. Harnessing natural ventilation benefits.

    Science.gov (United States)

    O'Leary, John

    2013-04-01

    Making sure that a healthcare establishment has a good supply of clean fresh air is an important factor in keeping patients, staff, and visitors, free from the negative effects of CO2 and other contaminants. John O'Leary of Trend Controls, a major international supplier of building energy management solutions (BEMS), examines the growing use of natural ventilation, and the health, energy-saving, and financial benefits, that it offers.

  9. New EORTC clinical trials for BNCT

    International Nuclear Information System (INIS)

    Hideghety, K.; Moss, R.; Vries, M. de

    2000-01-01

    Due to ethical reasons, a separated optimization of the two components of BNCT in the frame of clinical investigations can only be performed applying the whole binary system. The ongoing trial at HFR (High Flux Reactor Petten) has proven the feasibility of BNCT under defined conditions. On that basis the European Commission supported a comprehensive research project on boron imaging including three further clinical studies. In the first trial the boron uptake related to the blood boron concentration and surrounding normal tissue in various solid tumours will be examined using BSH (Sodiumborocaptate), BPA (Boronophenylalanine) or both in order to explore tumour entities, which may gain benefit from BNCT. The major objectives of the second trial are to define the maximum tolerated single and cumulative dose, and the dose limiting toxicity of BSH. The third clinical trial, a phase II study is designed to evaluate the anti-tumour effect of fractionated BNCT at the Petten treatment facility against cerebral metastasis of malignant melanoma using BPA. (author)

  10. Maximize Benefits, Minimize Risk: Selecting the Right HVAC Firm.

    Science.gov (United States)

    Golden, James T.

    1993-01-01

    An informal survey of 20 major urban school districts found that 40% were currently operating in a "break down" maintenance mode. A majority, 57.9%, also indicated they saw considerable benefits in contracting for heating, ventilating, and air conditioning (HVAC) maintenance services with outside firms. Offers guidelines in selecting…

  11. Beyond Salaries: Employee Benefits for Teachers in the SREB States.

    Science.gov (United States)

    Gaines, Gale F.

    This report summarizes teachers' and employers' contribution rates to retirement, Social Security and Medicare, and major medical plans. Several Southern Regional Education Board (SREB) states have adopted multi-year goals to raise teacher pay, which involves additional costs for benefits tied to those salary increases. These benefits can add…

  12. Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder

    DEFF Research Database (Denmark)

    Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn

    2014-01-01

    OBJECTIVE: To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. DESIGN: Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events...... identification number, we attempted to reconcile data on the same event between the different formats for presenting data on adverse events within the clinical study report. SETTING: 9 randomised placebo controlled trials of duloxetine for major depressive disorder submitted to the European Medicines Agency...... for marketing approval. DATA SOURCES: Clinical study reports obtained from the EMA in 2011. RESULTS: Six trials used the medical coding dictionary COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) and three used MedDRA (Medical Dictionary for Regulatory Activities). Suicides were clearly...

  13. Defining optimal duration and predicting benefit from chemotherapy in patients with luminal-like subtypes.

    Science.gov (United States)

    Hart, Christopher D; Sanna, Giuseppina; Siclari, Olimpia; Biganzoli, Laura; Di Leo, Angelo

    2015-11-01

    The molecular subtypes of breast cancer have individual patterns of behaviour, prognosis and sensitivity to treatment, with subsequent implications for the choice of, or indeed role for adjuvant therapy. The luminal A and B subtypes make up the majority of breast cancers, but despite sharing expression of the oestrogen receptor (ER), they are molecularly distinct. It follows then that they would have different sensitivities to chemotherapy. Clinically, luminal A disease has a better prognosis than luminal B, and may not derive significant benefit from adjuvant chemotherapy. However no prospective trials have specifically investigated the benefit of adjuvant chemotherapy in each subtype, nor do we know if certain agents are more or less effective. This paper will briefly summarise the role of molecular profiles in assessing the need for chemotherapy and predicting its effectiveness, followed by an assessment of the relative value of newer anthracycline- or taxane-containing regimes in the luminal-like subtypes, providing a review of retrospective analyses. Copyright © 2015 Elsevier Ltd. All rights reserved.

  14. [Assessing the benefits of digital health solutions in the societal reimbursement context].

    Science.gov (United States)

    Albrecht, Urs-Vito; Kuhn, Bertolt; Land, Jörg; Amelung, Volker E; von Jan, Ute

    2018-03-01

    For a number of reasons, achieving reimbursability for digital health products has so far proven difficult. Demonstrating the benefits of the technology is the main hurdle in this context. The generally accepted evaluation processes, especially parallel group comparisons in randomized controlled trials (RCTs) for (clinical) benefit assessment, are primarily intended to deal with questions of (added) medical benefit. In contrast to drugs or classical medical devices, users of digital health solutions often profit from gaining autonomy, increased awareness and mindfulness, better transparency in the provision of care, and improved comfort, although there are also digital solutions with an interventional character targeting clinical outcomes (e. g. for indications such as anorexia, depression). Commonly accepted methods for evaluating (clinical) benefits primarily rely on medical outcomes, such as morbidity and mortality, but do not adequately consider additional benefits unique to digital health. The challenge is therefore to develop evaluation designs that respect the particularities of digital health without reducing the validity of the evaluations (especially with respect to safety). There is an increasing need for concepts that include both continuous feedback loops for adapting and improving an application while at the same time generate sufficient evidence for complex benefit assessments. This approach may help improve risk benefit ratio assessments of digital health when it comes to implementing digital innovations in healthcare.

  15. 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

  16. Draft Genome Sequences of Six Multidrug-Resistant Clinical Strains of Acinetobacter baumannii, Isolated at Two Major Hospitals in Kuwait.

    Science.gov (United States)

    Nasser, Kother; Mustafa, Abu Salim; Khan, Mohd Wasif; Purohit, Prashant; Al-Obaid, Inaam; Dhar, Rita; Al-Fouzan, Wadha

    2018-04-19

    Acinetobacter baumannii is an important opportunistic pathogen in global health care settings. Its dissemination and multidrug resistance pose an issue with treatment and outbreak control. Here, we present draft genome assemblies of six multidrug-resistant clinical strains of A. baumannii isolated from patients admitted to one of two major hospitals in Kuwait. Copyright © 2018 Nasser et al.

  17. Clinical Trials

    Medline Plus

    Full Text Available ... clinical trials. If you're thinking about taking part in a clinical trial, find out ahead of time about costs and coverage. You should learn about the risks and benefits of any clinical trial before you agree to take part in the trial. Talk with your doctor about ...

  18. Is Early-onset in Major Depression a Predictor of Specific Clinical Features with More Impaired Social Function?

    Institute of Scientific and Technical Information of China (English)

    Yan-Hong Liu; Lin Chen; Yun-Ai Su; Yi-Ru Fang; Manit Srisurapanont; Jin Pyo Hong; Ahmad Hatim

    2015-01-01

    Background:Early-onset major depressive disorder (MDD) (EOD) is often particularly malignant due to its special clinical features,accompanying impaired social function,protracted recovery time,and frequent recurrence.This study aimed to observe the effects of age onset on clinical characteristics and social function in MDD patients in Asia.Methods:In total,547 out-patients aged 18-65 years who were from 13 study sites in five Asian countries were included.These patients had MDD diagnose according to the Diagnostic and Statistical Manual of Mental Disorders,4th Edition criteria.Clinical features and social function were assessed using Symptom Checklist-90-revised (SCL-90-R) and Sheehan Disability Scale (SDS).Quality of life was assessed by a 36-item Short-form Health Survey (SF-36).Analyses were performed using a continuous or dichotomous (cut-off:30 years)age-of-onset indicator.Results:Early-onset MDD (EOD,<30 years) was associated with longer illness (P =0.003),unmarried status (P < 0.001),higher neuroticism (P ≤ 0.002) based on the SCL-90-R,and more limited social function and mental health (P =0.006,P =0.007) based on the SF-36 and SDS.The impairment of social function and clinical severity were more prominent at in-patients with younger onset ages.Special clinical features and more impaired social function and quality of life were associated with EOD,as in western studies.Conclusions:EOD often follows higher levels of neuroticism.Age of onset of MDD may be a predictor of clinical features and impaired social function,allowing earlier diagnosis and treatment.

  19. Benefits of investing in ecosystem restoration.

    Science.gov (United States)

    DE Groot, Rudolf S; Blignaut, James; VAN DER Ploeg, Sander; Aronson, James; Elmqvist, Thomas; Farley, Joshua

    2013-12-01

    Measures aimed at conservation or restoration of ecosystems are often seen as net-cost projects by governments and businesses because they are based on incomplete and often faulty cost-benefit analyses. After screening over 200 studies, we examined the costs (94 studies) and benefits (225 studies) of ecosystem restoration projects that had sufficient reliable data in 9 different biomes ranging from coral reefs to tropical forests. Costs included capital investment and maintenance of the restoration project, and benefits were based on the monetary value of the total bundle of ecosystem services provided by the restored ecosystem. Assuming restoration is always imperfect and benefits attain only 75% of the maximum value of the reference systems over 20 years, we calculated the net present value at the social discount rates of 2% and 8%. We also conducted 2 threshold cum sensitivity analyses. Benefit-cost ratios ranged from about 0.05:1 (coral reefs and coastal systems, worst-case scenario) to as much as 35:1 (grasslands, best-case scenario). Our results provide only partial estimates of benefits at one point in time and reflect the lower limit of the welfare benefits of ecosystem restoration because both scarcity of and demand for ecosystem services is increasing and new benefits of natural ecosystems and biological diversity are being discovered. Nonetheless, when accounting for even the incomplete range of known benefits through the use of static estimates that fail to capture rising values, the majority of the restoration projects we analyzed provided net benefits and should be considered not only as profitable but also as high-yielding investments. Beneficios de Invertir en la Restauración de Ecosistemas. © 2013 Society for Conservation Biology.

  20. Brain perfusion single photon emission computed tomography in major psychiatric disorders: From basics to clinical practice

    International Nuclear Information System (INIS)

    Santra, Amburanjan; Kumar, Rakesh

    2014-01-01

    Brain single photon emission computed tomography (SPECT) is a well-established and reliable method to assess brain function through measurement of regional cerebral blood flow (rCBF). It can be used to define a patient's pathophysiological status when neurological or psychiatric symptoms cannot be explained by anatomical neuroimaging findings. Though there is ample evidence validating brain SPECT as a technique to track human behavior and correlating psychiatric disorders with dysfunction of specific brain regions, only few psychiatrists have adopted brain SPECT in routine clinical practice. It can be utilized to evaluate the involvement of brain regions in a particular patient, to individualize treatment on basis of SPECT findings, to monitor the treatment response and modify treatment, if necessary. In this article, we have reviewed the available studies in this regard from existing literature and tried to present the evidence for establishing the clinical role of brain SPECT in major psychiatric illnesses

  1. 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.

  2. Cardiovascular Benefits of Dark Chocolate?

    Science.gov (United States)

    Higginbotham, Erin; Taub, Pam R

    2015-12-01

    The use of cacao for health benefits dates back at least 3000 years. Our understanding of cacao has evolved with modern science. It is now felt based on extensive research the main health benefits of cacao stem from epicatechin, a flavanol found in cacao. The process of manufacturing dark chocolate retains epicatechin, whereas milk chocolate does not contain significant amounts of epicatechin. Thus, most of the current research studies are focused on dark chocolate. Both epidemiological and clinical studies suggest a beneficial effect of dark chocolate on blood pressure, lipids, and inflammation. Proposed mechanisms underlying these benefits include enhanced nitric oxide bioavailability and improved mitochondrial structure/function. Ultimately, further studies of this promising compound are needed to elucidate its potential for prevention and treatment of cardiovascular and metabolic diseases as well as other diseases that have underlying mechanisms of mitochondrial dysfunction and nitric oxide deficiency.

  3. Major Depressive Disorder

    Directory of Open Access Journals (Sweden)

    G Grobler

    2013-08-01

    Full Text Available The treatment guideline draws on several international guidelines: (iPractice Guidelines of the American Psychiatric Association (APAfor the Treatment of Patients with Major Depressive Disorder, SecondEdition;[1](ii Clinical Guidelines for the Treatment of DepressiveDisorders by the Canadian Psychiatric Association and the CanadianNetwork for Mood and Anxiety Treatments (CANMAT;[2](iiiNational Institute for Clinical Excellence (NICE guidelines;[3](iv RoyalAustralian and New Zealand College of Psychiatrists Clinical PracticeGuidelines Team for Depression (RANZCAP;[4](v Texas MedicationAlgorithm Project (TMAP Guidelines;[5](vi World Federation ofSocieties of Biological Psychiatry (WFSBP Treatment Guideline forUnipolar Depressive Disorder;[6]and (vii British Association forPsychopharmacology Guidelines.[7

  4. Major life events and development of major depression in Parkinson's disease patients

    DEFF Research Database (Denmark)

    Rod, Naja Hulvej; Bordelon, Y; Thompson, A

    2012-01-01

    BACKGROUND AND PURPOSE: Non-motor symptoms including depression are important features of Parkinson's disease (PD). We aim to address the relationship between major life events and depression amongst PD patients free of depressive symptoms at baseline. METHODS: New-onset PD patients from California...... were recruited in 2001-2007 and followed up for 3-4 years. The participants (n = 221) were examined by neurologists and responded to comprehensive interviews that included major life events, social support, and coping measures from validated scales. Major depression was assessed using the Structured...... Clinical Interview for the DSM-IV depression module (SCID). RESULTS: More than half of all patients had experienced major life events since diagnosed with PD, and 22 patients developed a major depression. The number of life events was associated with risk of depression in an exposure-dependent manner...

  5. Sleep benefit in Parkinson's disease: time to revive an enigma?

    Science.gov (United States)

    van Gilst, Merel M; Louter, Maartje; Baumann, Christian R; Bloem, Bastiaan R; Overeem, Sebastiaan

    2012-01-01

    Some patients with Parkinson's disease (PD) reportedly experience 'sleep benefit': an improved motor functioning upon awaking in the morning. In this questionnaire study, 114 out of 243 consecutive outpatients with PD (46.9%) subjectively experienced sleep benefit. Among those patients that regularly took an afternoon nap, 33.7% experienced sleep benefit after the nap as well. Between patients with and without sleep benefit, there were no differences in demographic or clinical variables, including age, disease duration, dopaminergic treatment, and nocturnal sleep quality. Sleep benefit remains an intriguing but elusive phenomenon, which deserves renewed attention and further research.

  6. A Benefit-Risk Analysis Approach to Capture Regulatory Decision-Making: Multiple Myeloma.

    Science.gov (United States)

    Raju, G K; Gurumurthi, Karthik; Domike, Reuben; Kazandjian, Dickran; Landgren, Ola; Blumenthal, Gideon M; Farrell, Ann; Pazdur, Richard; Woodcock, Janet

    2018-01-01

    Drug regulators around the world make decisions about drug approvability based on qualitative benefit-risk analysis. In this work, a quantitative benefit-risk analysis approach captures regulatory decision-making about new drugs to treat multiple myeloma (MM). MM assessments have been based on endpoints such as time to progression (TTP), progression-free survival (PFS), and objective response rate (ORR) which are different than benefit-risk analysis based on overall survival (OS). Twenty-three FDA decisions on MM drugs submitted to FDA between 2003 and 2016 were identified and analyzed. The benefits and risks were quantified relative to comparators (typically the control arm of the clinical trial) to estimate whether the median benefit-risk was positive or negative. A sensitivity analysis was demonstrated using ixazomib to explore the magnitude of uncertainty. FDA approval decision outcomes were consistent and logical using this benefit-risk framework. © 2017 American Society for Clinical Pharmacology and Therapeutics.

  7. Anticipated Benefits of Care (ABC): psychometrics and predictive value in psychiatric disorders.

    Science.gov (United States)

    Warden, D; Trivedi, M H; Carmody, T J; Gollan, J K; Kashner, T M; Lind, L; Crismon, M L; Rush, A J

    2010-06-01

    Attitudes and expectations about treatment have been associated with symptomatic outcomes, adherence and utilization in patients with psychiatric disorders. No measure of patients' anticipated benefits of treatment on domains of everyday functioning has previously been available. The Anticipated Benefits of Care (ABC) is a new, 10-item questionnaire used to measure patient expectations about the impact of treatment on domains of everyday functioning. The ABC was collected at baseline in adult out-patients with major depressive disorder (MDD) (n=528), bipolar disorder (n=395) and schizophrenia (n=447) in the Texas Medication Algorithm Project (TMAP). Psychometric properties of the ABC were assessed, and the association of ABC scores with treatment response at 3 months was evaluated. Evaluation of the ABC's internal consistency yielded Cronbach's alpha of 0.90-0.92 for patients across disorders. Factor analysis showed that the ABC was unidimensional for all patients and for patients with each disorder. For patients with MDD, lower anticipated benefits of treatment was associated with less symptom improvement and lower odds of treatment response [odds ratio (OR) 0.72, 95% confidence interval (CI) 0.57-0.87, p=0.0011]. There was no association between ABC and symptom improvement or treatment response for patients with bipolar disorder or schizophrenia, possibly because these patients had modest benefits with treatment. The ABC is the first self-report that measures patient expectations about the benefits of treatment on everyday functioning, filling an important gap in available assessments of attitudes and expectations about treatment. The ABC is simple, easy to use, and has acceptable psychometric properties for use in research or clinical settings.

  8. 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

  9. 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.

  10. Relationship of premenstrual syndrome and premenstrual dysphoric disorder with major depression: relevance to clinical practice.

    Science.gov (United States)

    Padhy, Susanta Kumar; Sarkar, Sidharth; Beherre, Prakash B; Rathi, Rajesh; Panigrahi, Mahima; Patil, Pradeep Sriram

    2015-01-01

    Premenstrual syndrome (PMS), premenstrual dysphoric disorder (PMDD) and depressive disorder are fairly common; symptoms do overlap, often under-identified and under-emphasized, particularly in rural India. The objective was to assess the occurrence of PMS and PMDD in a sample of students and staff of a nursing college and to find their correlation with depression. A prospective cohort study; Tertiary Care Hospital in Rural India (Wardha, Maharashtra); 118 female nursing students or staff aged between 18 and 40 years, who were likely to stay within the institution for the study period. The participants were rated on Penn daily symptom report prospectively for a period of 3-month. Those who scored positive were applied diagnostic and statistical manual of mental disorders, 4(th) edition, text revision (DSM-IV TR) criteria for PMDD; and were applied primary care evaluation of mental disorders depression screening followed by DSM-IV TR criteria for depression. Severity of depression was measured using Hamilton Depression Rating Scale. Main outcome measures were frequency and severity of depression in individuals with PMS and PMDD and their clinical and sociodemographic correlation. The age range of the sample was 18-37 years. Some PMS symptoms were observed in 67%; diagnosis of PMDD in 10%; depressive symptoms in 28% of the sample. 46.4% of those with depressive symptoms had major depression. The diagnosis of major depression was significantly associated with the severity of PMS symptoms as well as the presence of PMDD. Premenstrual syndrome is present in a substantial proportion of young females. Concurrent depression is increased by the severity of PMS symptoms and the presence of PMDD. Gynecologist needs to screen such subjects for depression and refer to mental-health professional early, in routine clinical practice.

  11. Health benefits for the terminally ill: reality and perception.

    Science.gov (United States)

    Gabel, J R; Hurst, K M; Hunt, K A

    1998-01-01

    This paper examines the availability and scope of hospice benefits as well as employers' attitudes and knowledge about care for the terminally ill. Data are drawn from a national random sample of 1,502 employers with 200 or more workers and from focus groups with employee benefits managers and their insurance advisers, brokers, and consultants. Major findings are that 83 percent of employers offer explicit hospice benefits, with most other firms covering hospice through high-cost case management. Most employers support the concept of hospice care because they believe that it reduces medical expenses.

  12. Longitudinal assessment of neuropsychological function in major depression.

    Science.gov (United States)

    Douglas, Katie M; Porter, Richard J

    2009-12-01

    Neuropsychological impairment is a core component of major depression, yet its relationship to clinical state is unclear. The aims of the present review were to determine which neuropsychological domains and tasks were most sensitive to improvement in clinical state in major depression and to highlight the methodological issues in such research. Studies that included a baseline and at least one follow-up neuropsychological testing session in adults with major depression were identified using MEDLINE, Web of Science and ScienceDirect databases. Thirty studies were included in the review. Findings in younger adult populations suggested that improvement in mood was most strongly related to improved verbal memory and verbal fluency, while measures of executive functioning and attention tended to remain impaired across treatment. In late-life major depression, improved psychomotor speed was most closely related to treatment response, but there was much inconsistency between study findings, which may be due to methodological issues. In major depression, particular neuropsychological domains are more strongly related to clinical state than others. The findings from the present review suggest that the domains most sensitive to clinical state are verbal learning and memory, verbal fluency and psychomotor speed. In contrast, measures of attention and executive functioning perhaps represent more trait-like markers of major depression. With further methodologically sound research, the changes in neuropsychological function associated with treatment response may provide a means of evaluating different treatment strategies in major depression.

  13. Rewards and advancements for clinical pharmacists.

    Science.gov (United States)

    Goodwin, S Diane; Kane-Gill, Sandra L; Ng, Tien M H; Melroy, Joel T; Hess, Mary M; Tallian, Kimberly; Trujillo, Toby C; Vermeulen, Lee C

    2010-01-01

    The American College of Clinical Pharmacy charged the Clinical Practice Affairs Committee to review and update the College's 1995 White Paper, "Rewards and Advancements for Clinical Pharmacy Practitioners." Because of the limited data on the present state of rewards and advancements for clinical pharmacists, an online survey of "front-line" clinical pharmacists and pharmacy managers was conducted (1126 total respondents, 14% response rate). The resulting White Paper discusses motivators and existing systems of rewards and advancements for clinical pharmacists, as well as perceived barriers to implementation of these systems. Clinical pharmacists reported work-life balance, a challenging position, and opportunities for professional advancement as the most important factors for career success. At the time of the survey, financial rewards appeared not to be a major motivator for clinical pharmacists. Managers underestimated the importance that clinical pharmacists place on work-life balance and favorable work schedules. Although almost two thirds of the clinical pharmacists surveyed had not developed a professional development plan, 84% indicated an interest in career planning. Both clinical pharmacists and managers rated the lack of a clear reward and advancement structure as the most important barrier to effective systems of rewards and advancements. Pharmacy managers and administrators are encouraged to develop effective systems of rewards and advancements for clinical pharmacists that positively impact patient care and the institution's mission; these systems will benefit the clinical pharmacist, the health care institution, and the patient.

  14. Design and methods for a randomized clinical trial treating comorbid obesity and major depressive disorder.

    Science.gov (United States)

    Schneider, Kristin L; Bodenlos, Jamie S; Ma, Yunsheng; Olendzki, Barbara; Oleski, Jessica; Merriam, Philip; Crawford, Sybil; Ockene, Ira S; Pagoto, Sherry L

    2008-09-15

    Obesity is often comorbid with depression and individuals with this comorbidity fare worse in behavioral weight loss treatment. Treating depression directly prior to behavioral weight loss treatment might bolster weight loss outcomes in this population, but this has not yet been tested in a randomized clinical trial. This randomized clinical trial will examine whether behavior therapy for depression administered prior to standard weight loss treatment produces greater weight loss than standard weight loss treatment alone. Obese women with major depressive disorder (N = 174) will be recruited from primary care clinics and the community and randomly assigned to one of the two treatment conditions. Treatment will last 2 years, and will include a 6-month intensive treatment phase followed by an 18-month maintenance phase. Follow-up assessment will occur at 6-months and 1- and 2 years following randomization. The primary outcome is weight loss. The study was designed to provide 90% power for detecting a weight change difference between conditions of 3.1 kg (standard deviation of 5.5 kg) at 1-year assuming a 25% rate of loss to follow-up. Secondary outcomes include depression, physical activity, dietary intake, psychosocial variables and cardiovascular risk factors. Potential mediators (e.g., adherence, depression, physical activity and caloric intake) of the intervention effect on weight change will also be examined. Treating depression before administering intensive health behavior interventions could potentially boost the impact on both mental and physical health outcomes. NCT00572520.

  15. Movement of Genetic Counselors from Clinical to Non-clinical Positions: Identifying Driving Forces.

    Science.gov (United States)

    Cohen, Stephanie A; Tucker, Megan E

    2018-03-05

    A previous study of genetic counselors (GCs) in the state of Indiana identified movement out of clinical positions within the past 2 years. The aims of this study were to determine if this trend is nationwide and identify reasons why GCs are leaving their positions and factors that might help employers attract and retain GCs. An email was sent to members of the American Board of Genetic Counseling with a link to an online confidential survey. There were 939 responses (23.5% response rate). Overall, 52% of GCs report being highly satisfied in their current position, although almost two thirds think about leaving and one third had changed jobs within the past 2 years. Of those who had changed jobs (n = 295), 74.9% had been working in a hospital/clinic setting but only 46.3% currently do, demonstrating a major shift out of the clinic (p < 0.001). The top three reasons cited for leaving a position were work environment/institutional climate, salary/benefits, and a lack of feeling valued/recognized as a professional. These results confirm that GCs are moving out of clinical positions and document elements of job satisfaction. We suggest points for employers to consider when trying to recruit or retain GCs.

  16. Citrus medica: nutritional, phytochemical composition and health benefits - a review.

    Science.gov (United States)

    Chhikara, Navnidhi; Kour, Ragni; Jaglan, Sundeep; Gupta, Pawan; Gat, Yogesh; Panghal, Anil

    2018-04-25

    Citrus medica (Citron) is an underutilized fruit plant having various bioactive components in all parts of the plant. The major bioactive compounds present are iso-limonene, citral, limonene, phenolics, flavonones, vitamin C, pectin, linalool, decanal, and nonanal, accounting for several health benefits. Pectin and heteropolysachharides also play a major role as dietary fibers. The potential impact of citron and its bioactive components to prevent or reverse destructive deregulated processes responsible for certain diseases has attracted different researchers' attention. The fruit has numerous nutraceutical benefits, proven by pharmacological studies; for example, anti-catarrhal, capillary protector, anti-hypertensive, diuretic, antibacterial, antifungal, anthelmintic, antimicrobial, analgesic, strong antioxidant, anticancerous, antidiabetic, estrogenic, antiulcer, cardioprotective, and antihyperglycemic. The present review explores new insights into the benefits of citron in various body parts. Throughout the world, citron has been used in making carbonated drinks, alcoholic beverages, syrup, candied peels, jams, marmalade, cordials, and many other value added products, which suggests it is an appropriate raw material to develop healthy processed food. In the present review, the fruit taxonomical classification, beneficial phytochemicals, antioxidant activities, and health benefits are discussed.

  17. Is Early-onset in Major Depression a Predictor of Specific Clinical Features with More Impaired Social Function?

    Science.gov (United States)

    Liu, Yan-Hong; Chen, Lin; Su, Yun-Ai; Fang, Yi-Ru; Srisurapanont, Manit; Hong, Jin Pyo; Hatim, Ahmad; Chua, Hong Choon; Bautista, Dianne; Si, Tian-Mei

    2015-01-01

    Background: Early-onset major depressive disorder (MDD) (EOD) is often particularly malignant due to its special clinical features, accompanying impaired social function, protracted recovery time, and frequent recurrence. This study aimed to observe the effects of age onset on clinical characteristics and social function in MDD patients in Asia. Methods: In total, 547 out-patients aged 18–65 years who were from 13 study sites in five Asian countries were included. These patients had MDD diagnose according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition criteria. Clinical features and social function were assessed using Symptom Checklist-90-revised (SCL-90-R) and Sheehan Disability Scale (SDS). Quality of life was assessed by a 36-item Short-form Health Survey (SF-36). Analyses were performed using a continuous or dichotomous (cut-off: 30 years) age-of-onset indicator. Results: Early-onset MDD (EOD, <30 years) was associated with longer illness (P = 0.003), unmarried status (P < 0.001), higher neuroticism (P ≤ 0.002) based on the SCL-90-R, and more limited social function and mental health (P = 0.006, P = 0.007) based on the SF-36 and SDS. The impairment of social function and clinical severity were more prominent at in-patients with younger onset ages. Special clinical features and more impaired social function and quality of life were associated with EOD, as in western studies. Conclusions: EOD often follows higher levels of neuroticism. Age of onset of MDD may be a predictor of clinical features and impaired social function, allowing earlier diagnosis and treatment. PMID:25758278

  18. Risk versus benefit in radiology

    International Nuclear Information System (INIS)

    Samuel, E.

    1985-01-01

    The risks of radiology may be grouped into a) those inherent in the use of ionizing radiation which today are well known and b) those associated with the use of any scientific method in medicine. Inherent risks of scientific methods like inadequate examination and the interpretation of results are discussed. Radiology brought major benefits in medical care and some of the newer methods are considered

  19. Health benefits of tai chi: What is the evidence?

    Science.gov (United States)

    Huston, Patricia; McFarlane, Bruce

    2016-11-01

    To summarize the evidence on the health benefits of tai chi. A literature review was conducted on the benefits of tai chi for 25 specific conditions, as well as for general health and fitness, to update a 2014 review of systematic reviews. Systematic reviews and recent clinical trials were assessed and organized into 5 different groups: evidence of benefit as excellent, good, fair, or preliminary, or evidence of no direct benefit. During the past 45 years more than 500 trials and 120 systematic reviews have been published on the health benefits of tai chi. Systematic reviews of tai chi for specific conditions indicate excellent evidence of benefit for preventing falls, osteoarthritis, Parkinson disease, rehabilitation for chronic obstructive pulmonary disease, and improving cognitive capacity in older adults. There is good evidence of benefit for depression, cardiac and stroke rehabilitation, and dementia. There is fair evidence of benefit for improving quality of life for cancer patients, fibromyalgia, hypertension, and osteoporosis. Current evidence indicates no direct benefit for diabetes, rheumatoid arthritis, or chronic heart failure. Systematic reviews of general health and fitness benefits show excellent evidence of benefit for improving balance and aerobic capacity in those with poor fitness. There is good evidence for increased strength in the lower limbs. There is fair evidence for increased well-being and improved sleep. There were no studies that found tai chi worsened a condition. A recent systematic review on the safety of tai chi found adverse events were typically minor and primarily musculoskeletal; no intervention-related serious adverse events have been reported. There is abundant evidence on the health and fitness effects of tai chi. Based on this, physicians can now offer evidence-based recommendations to their patients, noting that tai chi is still an area of active research, and patients should continue to receive medical follow-up for any

  20. 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.

  1. Distributed generation: definition, benefits and issues

    International Nuclear Information System (INIS)

    Pepermans, G.; Driesen, J.; Haeseldonckx, D.; Belmans, R.; D'haeseleer, W.

    2005-01-01

    This paper starts from the observation that there is a renewed interest in small-scale electricity generation. The authors start with a survey of existing small-scale generation technologies and then move on with a discussion of the major benefits and issues of small-scale electricity generation. Different technologies are evaluated in terms of their possible contribution to the listed benefits and issues. Small-scale generation is also commonly called distributed generation, embedded generation or decentralised generation. In a final section, an attempt is made to define the latter concepts more precisely. It appears that there is no consensus on a precise definition as the concept encompasses many technologies and applications

  2. Topical Benefits of Two Fucoidan-Rich Extracts from Marine Macroalgae

    Directory of Open Access Journals (Sweden)

    J. Helen Fitton

    2015-04-01

    Full Text Available Two concentrated and well-characterized fucoidan-rich extracts were investigated to determine their benefits in topical applications. An Undaria pinnatifida extract, containing 85% fucoidan, and a Fucus vesiculosus co-extract, containing 60% fucoidan and 30% polyphenol, were assessed in a number of in vitro assays to measure the effect of the extracts on enzyme inhibition, glycation, antioxidant activity and Sirtuin 1 (SIRT1 protein expression. Double-blind, placebo-controlled clinical studies were also conducted to measure soothing, protection, wrinkle depth, brightness and skin spot intensity. Both extracts demonstrated marked inhibitory effects on processes linked to skin aging, including the increased expression of SIRT1 in vitro. Clinical testing established the efficacy of the extracts in a range of the tested applications, relative to placebo. The Fucus vesiculosus extract with high polyphenol content demonstrated additional in vitro antioxidant activity, as well as improved efficacy in skin brightening applications, relative to placebo. The major effects of the Undaria pinnatifida extract aided skin immunity, soothing and protection, while the Fucus vesiculosus extract most significantly affected age spot reduction and increased brightness, soothing and protection.

  3. ‘Third wave’ cognitive therapy versus mentalization-based therapy for major depressive disorder. A protocol for a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Jakobsen Janus Christian

    2012-12-01

    Full Text Available Abstract Background Most interventions for depression have shown small or no effects. ‘Third wave‘ cognitive therapy and mentalization-based therapy have both gained some ground as treatments of psychological problems. No randomised trial has compared the effects of these two interventions for patients with major depression. Methods/ design We plan a randomised, parallel group, assessor-blinded superiority clinical trial. During two years we will include 84 consecutive adult participants diagnosed with major depressive disorder. The participants will be randomised to either ‘third wave‘ cognitive therapy versus mentalization-based therapy. The primary outcome will be the Hamilton Rating Scale for Depression at cessation of treatment at 18 weeks. Secondary outcomes will be the proportion of patients with remission, Symptom Checklist 90 Revised, Beck’s Depression Inventory, and The World Health Organisation-Five Well-being Index 1999. Discussion Interventions for depression have until now shown relatively small effects. Our trial results will provide knowledge about the effects of two modern psychotherapeutic interventions. Trial registration ClinicalTrials: NCT01070134

  4. 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...

  5. Employee benefits managers' opinions about addiction treatment.

    Science.gov (United States)

    McFarland, Bentson H; Lierman, Walter K; Penner, Norman R; McCamant, Lynn E; Zani, Brigid G

    2003-01-01

    Employee benefits managers arrange addictive disease treatment insurance coverage for the majority of people in the United States but little is known about these decision-makers. Managers were surveyed to learn their opinions about addiction treatment. Subjects were 131 people (61 percent female, 94 percent white, average age 46, average of 14 years in the human resources field). Managers were asked to rank health benefits (physical health, dental, alcohol-drug, vision, mental health, employee assistance program, and pharmaceuticals) on 15 dimensions. Managers ranked alcohol-drug abuse treatment worst on fiveitems and second to the worst on another four of the 15 dimensions. On the item considered most important by the managers, respondents noted that employees often (2.8) ask for improved physical health benefits but rarely do so for alcohol and drug (4.1) benefits (p < .001). Education of workers and payers will be needed to change opinions about treatment of addictive disorders.

  6. Major Chronic Respiratory Diseases in Chiang Mai: Prevalence, Clinical Characteristics, and Their Correlations.

    Science.gov (United States)

    Pothirat, Chaicharn; Phetsuk, Nittaya; Liwsrisakun, Chalerm; Bumroongkit, Chaiwat; Deesomchok, Athavudh; Theerakittikul, Theerakorn

    2016-09-01

    To identify the prevalence, clinical characteristics, disease severity, and correlations of major chronic respiratory diseases (CRDs) among the adult population living in Chiang Mai. A cross-sectional study was conducted with adults living in municipal areas of Chiang Mai. All clinical relevant data collected by face-to-face interview was confirmed by pulmonologists. The chest radiographic findings and post-bronchodilator spirometry were done in all subjects. The aeroallergen skin test and rhinoscopy were performed in all chronic rhinitis and asthma subjects. Five hundred seventy four subjects with mean age 52.9±10.0 years, 59.6% female, and 37.5% smokers were recruited. The prevalence of overall CRDs was 59.2%. Chronic rhinitis was the most prevalent chronic respiratory disease (n = 239, 41.6%), followed by asthma (n = 58, 10.1%), and chronic obstructive pulmonary disease (COPD) (n = 21, 3.7%). The most common abnormal pulmonary function test was restrictive lung disorders (n = 53, 9.6%). Asthma subjects were determined to be more allergic than chronic rhinitis subjects (58.1% vs. 39.9%, p-value = 0.033). Regarding the disease severity, 14.9% of chronic rhinitis and 10.3% of asthma subjects were classified as moderate to severe degree, whereas 81% of chronic obstructive pulmonary disease subjects were classified as moderate to very severe degrees. In asthma patients, there were positive association with chronic rhinitis (OR 3.9, 95% CI 2.1-7.0, p-value Chiang Mai population was significantly high with overlapped respiratory symptoms and varying disease severity. Additionally, chronic rhinitis had correlation with asthma but not with COPD.

  7. 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.

  8. Medical Paraclinical Standards, Political Economy of Clinic, and Patients’ Clinical Dependency; A Critical Conversation Analysis of Clinical Counseling in South of Iran

    Science.gov (United States)

    Kalateh Sadati, Ahmad; Iman, Mohammad Taghi; Bagheri Lankarani, Kamran

    2014-01-01

    Background: Despite its benefits and importance, clinical counseling affects the patient both psychosocially and socially. Illness labeling not only leads to many problems for patient and his/her family but also it imposes high costs to health care system. Among various factors, doctor-patient relationship has an important role in the clinical counseling and its medical approach. The goal of this study is to evaluate the nature of clinical counseling based on critical approach. Methods: The context of research is the second major medical training center in Shiraz, Iran. In this study, Critical Conversation Analysis was used based on the methodologies of critical theories. Among about 50 consultation meetings digitally recorded, 33 were selected for this study. Results: Results show that the nature of doctor-patient relationship in these cases is based on paternalistic model. On the other hand, in all consultations, the important values that were legitimated with physicians were medical paraclinical standards. Paternalism in one hand and standardization on the other leads to dependency of patients to the clinic. Conclusion: Although we can’t condone the paraclinical standards, clinical counseling and doctor-patient relationship need to reduce its dominance over counseling based on interpretation of human relations, paying attention to social and economical differences of peoples and biosocial and biocultural differences, and focusing on clinical examinations. Also, we need to accept that medicine is an art of interaction that can’t reduce it to instrumental and linear methods of body treatment. PMID:25349858

  9. Medical paraclinical standards, political economy of clinic, and patients' clinical dependency; a critical conversation analysis of clinical counseling in South of iran.

    Science.gov (United States)

    Kalateh Sadati, Ahmad; Iman, Mohammad Taghi; Bagheri Lankarani, Kamran

    2014-07-01

    Despite its benefits and importance, clinical counseling affects the patient both psychosocially and socially. Illness labeling not only leads to many problems for patient and his/her family but also it imposes high costs to health care system. Among various factors, doctor-patient relationship has an important role in the clinical counseling and its medical approach. The goal of this study is to evaluate the nature of clinical counseling based on critical approach. The context of research is the second major medical training center in Shiraz, Iran. In this study, Critical Conversation Analysis was used based on the methodologies of critical theories. Among about 50 consultation meetings digitally recorded, 33 were selected for this study. RESULTS show that the nature of doctor-patient relationship in these cases is based on paternalistic model. On the other hand, in all consultations, the important values that were legitimated with physicians were medical paraclinical standards. Paternalism in one hand and standardization on the other leads to dependency of patients to the clinic. Although we can't condone the paraclinical standards, clinical counseling and doctor-patient relationship need to reduce its dominance over counseling based on interpretation of human relations, paying attention to social and economical differences of peoples and biosocial and biocultural differences, and focusing on clinical examinations. Also, we need to accept that medicine is an art of interaction that can't reduce it to instrumental and linear methods of body treatment.

  10. Nursing staff perceptions of student contributions in clinical settings.

    Science.gov (United States)

    Slaughter-Smith, Cheryl; Helms, Jennifer E; Burris, Rebecca

    2012-01-01

    Because nursing is a practice discipline, students are placed in clinical settings to collaborate with professional nurses in caring for patients. This descriptive study aimed to explore the benefits and limitations of undergraduate nursing students in the clinical setting. A 54-item instrument, Nursing Students' Contributions to Clinical Agencies, was used to collect data from staff nurses (N = 84) at three hospitals. The instrument also provided space for participants to share qualitative data, which revealed perceptions with which staff nurses were likely to agree and three key themes: Eager to Learn, Willing to Help, and Serving Their Time. The major implication for students is that they are often judged on their assertiveness skills and should offer assistance so they appear eager to learn. Faculty must ascertain that students understand their objectives for the clinical rotation and share those objectives with the staff nurses to enhance their learning experience. Copyright 2012, SLACK Incorporated.

  11. Clinical and sociodemographic correlates of suicidality in patients with major depressive disorder from six Asian countries

    Science.gov (United States)

    2014-01-01

    Background East Asian countries have high suicide rates. However, little is known about clinical and sociodemographic factors associated with suicidality in Asian populations. The aim of this study was to evaluate the factors associated with suicidality in patients with major depressive disorder (MDD) from six Asian countries. Methods The study cohort consisted of 547 outpatients with MDD. Patients presented to study sites in China (n = 114), South Korea (n = 101), Malaysia (n = 90), Singapore (n = 40), Thailand (n = 103), and Taiwan (n = 99). All patients completed the Mini-International Neuropsychiatric Interview (MINI), the Montgomery–Asberg Depression Rating Scale (MADRS), the Global Severity Index(SCL-90R), the Fatigue Severity Scale, the 36-item short-form health survey, the Sheehan Disability Scale, and the Multidimensional Scale of Perceived Social Support (MSPSS). Patients were classified as showing high suicidality if they scored ≥6 on the MINI suicidality module. Multivariate logistic regression analysis was used to examine sociodemographic and clinical factors related to high suicidality. Results One hundred and twenty-five patients were classed as high suicidality. Unemployed status (adjusted odds ratio [OR] 2.43, p suicidality. Hindu (adjusted OR 0.09, p suicidality. Conclusions A variety of sociodemographic and clinical factors were associated with high suicidality in Asian patients with MDD. These factors may facilitate the identification of MDD patients at risk of suicide. PMID:24524225

  12. Therapeutic benefit in patients switching tolterodine to other novel antimuscarinic agents.

    Science.gov (United States)

    Sánchez-Ballester, F; Miranda, P; Lizarraga, I; Rejas, J; Arumi, D

    2014-04-01

    To explore in the daily clinical practice setting that antimuscarinic, Fesoterodine or Solifenacin, provides a greater clinical benefit after changing their prior Overactive Bladder (OAB) therapy with tolterodine extended-release (ER) to other novel antimuscarinic agents. A post-hoc analysis of data from an observational multicenter, cross-sectional, retrospective study. Adult patients of both sexes, with OAB and OAB-V8 score≥8, who switched to fesoterodine or solifenacin within the 3-4 months before study visit from their prior tolterodine-ER-based therapy due to poor response were included. 92 patients were selected for each treatment group, matched (1:1) according to conditioned probability using the propensity score. Benefit of treatment change perceived by the physician and patient was evaluated by means of the Clinical Global Impression of Improvement subscale (CGI-I) and Treatment Benefit Scale (TBS), respectively. Degree of worry, bother and interference with daily living activities due to urinary symptoms, level of satisfaction, and preference for current treatment were also assessed. Fesoterodine provided a significantly greater improvement than solifenacina in terms of therapeutic benefit perceived by the physician according to ICG-I. 96.7% of the patients on fesoterodine treatment vs. 81.6% of the solifenacin group showed a score of improvement in TBS (P<.05). Fesoterodine was also better rated than solifenacin with regard to satisfaction and preference for the new treatment (93.4 vs. 78.2% P<.05). In daily clinical practice the switch from tolterodine LP to fesoterodine seems to provide greater benefits both from the physician's and the patient's point of view compared with those provided by solifenacin. Copyright © 2013 AEU. Published by Elsevier Espana. All rights reserved.

  13. The child neurology clinical workforce in 2015

    Science.gov (United States)

    Bale, James F.; Mintz, Mark; Joshi, Sucheta M.; Gilbert, Donald L.; Radabaugh, Carrie; Ruch-Ross, Holly

    2016-01-01

    Objectives: More than a decade has passed since the last major workforce survey of child neurologists in the United States; thus, a reassessment of the child neurology workforce is needed, along with an inaugural assessment of a new related field, neurodevelopmental disabilities. Methods: The American Academy of Pediatrics and the Child Neurology Society conducted an electronic survey in 2015 of child neurologists and neurodevelopmental disabilities specialists. Results: The majority of respondents participate in maintenance of certification, practice in academic medical centers, and offer subspecialty care. EEG reading and epilepsy care are common subspecialty practice areas, although many child neurologists have not had formal training in this field. In keeping with broader trends, medical school debts are substantially higher than in the past and will often take many years to pay off. Although a broad majority would choose these fields again, there are widespread dissatisfactions with compensation and benefits given the length of training and the complexity of care provided, and frustrations with mounting regulatory and administrative stresses that interfere with clinical practice. Conclusions: Although not unique to child neurology and neurodevelopmental disabilities, such issues may present barriers for the recruitment of trainees into these fields. Creative approaches to enhance the recruitment of the next generation of child neurologists and neurodevelopmental disabilities specialists will benefit society, especially in light of all the exciting new treatments under development for an array of chronic childhood neurologic disorders. PMID:27566740

  14. Psychodramatic psychotherapy combined with pharmacotherapy in major depressive disorder: an open and naturalistic study

    Directory of Open Access Journals (Sweden)

    Costa Elisabeth Maria Sene

    2006-01-01

    Full Text Available OBJETIVE: Recent literature has highlighted the role of psychotherapy in the treatment of major depressive disorder. Combined therapies comprising both psychotherapy and pharmacotherapy have presented the best results. Although several kinds of psychotherapies have been studied in the treatment of depressive disorders, there remains a lack of data on psychodramatic psychotherapy in the treatment of major depressive disorder. The objective of this study was to evaluate the impact of psychodramatic psychotherapy (in a sample of major depressive disorder patients. METHOD: This is an open, naturalistic, controlled, non-randomized study. Twenty major depressive disorder patients (according to the DSM-IV criteria, under pharmacological treatment for depression, with Hamilton Depression Scale total scores between 7 and 20 (mild to moderate depression, were divided into two groups. Patients in the psychotherapeutic group took part in 4 individual and 24 structured psychodramatic group sessions, whilst subjects in the control group did not participate in this psychodramatic psychotherapy. Both groups were evaluated with the Social Adjustment Scale - Self Report and the Hamilton Depression Scale. RESULTS: Psychotherapeutic group patients showed a significant improvement according to the Social Adjustment Scale - Self Report and the Hamilton Depression Scale scores at endpoint, compared to those of the control group. CONCLUSIONS: Results suggest that individual and group psychodramatic psychotherapy, associated to pharmacological treatment, provides good clinical benefits in the treatment of major depressive disorder.

  15. The Perception of Tertiary Institutions Prospective Teachers on the Benefits of Teaching Practice

    Directory of Open Access Journals (Sweden)

    Hassan Olusola

    2017-03-01

    Full Text Available This study assessed the perception of two tertiary institutions prospective teachers’ on the Benefits of Teaching Practice in Ogun State. Survey research design was adopted for the study. A sample of four hundred students was randomly selected for the study. Prospective Teachers Perception on Teaching practice Benefits Questionnaire (PTPTPBQ with the reliability coefficient of 0.80 was administered on the respondents. Data collected was analyzed using Mean Score, Charts, Percentages and t-test of significance. The study reveals that prospective teachers have low perception on the benefits of teaching practice also, finance and housing were the two major challenges faced by prospective teachers.. It is evident from the findings that there is need for concerted effort by school to orientate prospective teachers on the benefits of teaching practice. Also the major challenges faced by prospective teachers should also be addressed to allow them have good grasp from the benefits of teaching practice.

  16. Design and methods for a randomized clinical trial treating comorbid obesity and major depressive disorder

    Directory of Open Access Journals (Sweden)

    Crawford Sybil

    2008-09-01

    Full Text Available Abstract Background Obesity is often comorbid with depression and individuals with this comorbidity fare worse in behavioral weight loss treatment. Treating depression directly prior to behavioral weight loss treatment might bolster weight loss outcomes in this population, but this has not yet been tested in a randomized clinical trial. Methods and design This randomized clinical trial will examine whether behavior therapy for depression administered prior to standard weight loss treatment produces greater weight loss than standard weight loss treatment alone. Obese women with major depressive disorder (N = 174 will be recruited from primary care clinics and the community and randomly assigned to one of the two treatment conditions. Treatment will last 2 years, and will include a 6-month intensive treatment phase followed by an 18-month maintenance phase. Follow-up assessment will occur at 6-months and 1- and 2 years following randomization. The primary outcome is weight loss. The study was designed to provide 90% power for detecting a weight change difference between conditions of 3.1 kg (standard deviation of 5.5 kg at 1-year assuming a 25% rate of loss to follow-up. Secondary outcomes include depression, physical activity, dietary intake, psychosocial variables and cardiovascular risk factors. Potential mediators (e.g., adherence, depression, physical activity and caloric intake of the intervention effect on weight change will also be examined. Discussion Treating depression before administering intensive health behavior interventions could potentially boost the impact on both mental and physical health outcomes. Trial registration NCT00572520

  17. A review of the benefits and rationale of viewing liver window settings for abdominal computed tomography scans

    International Nuclear Information System (INIS)

    Dang, Tan; Mandarano, Giovanni

    2006-01-01

    There have been many different opinions over the efficacy of routinely incorporating liver-window settings in abdominal computed tomography (CT) scans. As a result, different clinical centres have varying protocols for incorporating liver-windows for abdominal CT scans. This investigation aims to explore and determine whether various clinical centres throughout Victoria use liver-window settings selectively or routinely and their justification for doing so. An additional purpose is also to assess the benefits and rationale of liver-window settings in supplementing routine soft-tissue-windows for abdominal CT examinations by reviewing evidenced-based studies. Surveys were sent out to CT supervisors at various clinical centres, including private and public institutions. This achieved an overall response rate of 74 per cent. Results indicate that the majority of clinical centres throughout Victoria routinely incorporate liver-window settings for all abdominal CT examinations. Forty four per cent (11/25) of respondents stated that they utilise liver-window settings selectively for abdominal CT examinations. Most of these respondents (7/11 = 63 per cent) believed that soft-tissue-window settings alone are adequate to demonstrate hepatic lesions; particularly if intravenous contrast media is used and the liver is captured in the arterial, venous and/or delayed phases. The benefits and rationale of incorporating liver-window settings for all abdominal computed tomography scans has been questioned by two well noted studies in the United States. These evidence-based studies suggest that such additional settings do not offer further advantages in detecting hepatic disease, when compared to soft-tissue-windows alone. Review of the available literature provides additional evidence suggesting that the routine use of liver-window settings in conjunction with soft-tissue-windows offers no further advantages in the detection of hepatic diseases. This investigation found, however

  18. Demand side management. Benefits and challenges

    International Nuclear Information System (INIS)

    Strbac, Goran

    2008-01-01

    In this paper, the major benefits and challenges of electricity demand side management (DSM) are discussed in the context of the UK electricity system. The relatively low utilisation of generation and networks (of about 50%) means that there is significant scope for DSM to contribute to increasing the efficiency of the system investment. The importance of the diversity of electricity load is discussed and the negative effects of DSM on load diversity illustrated. Ageing assets, the growth in renewable and other low-carbon generation technologies and advances in information and communication technologies are identified as major additional drivers that could lead to wider applications of DSM in the medium term. Potential benefits of DSM are discussed in the context of generation and of transmission and distribution networks. The provision of back-up capacity by generation may not be efficient as it will be needed relatively infrequently, and DSM may be better placed to support security. We also present an analysis of the value of DSM in balancing generation and demand in a future UK electricity system with significant variable renewable generation. We give a number of reasons for the relatively slow uptake of DSM, particularly in the residential, commercial and small business sectors. They include a lack of metering, information and communication infrastructure, lack of understanding of the benefits of DSM, problems with the competitiveness of DSM when compared with traditional approaches, an increase in the complexity of system operation and inappropriate market incentives. (author)

  19. 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.

  20. Functional imaging in oncology. Clinical applications. Vol. 2

    Energy Technology Data Exchange (ETDEWEB)

    Luna, Antonio [Case Western Reserve Univ., Cleveland, OH (United States). Dept. of Radiology; MRI Health Time Group, Jaen (Spain); Vilanova, Joan C. [Girona Univ. (Spain). Clinica Girona - Hospital Sta. Caterina; Hygino da Cruz, L. Celso Jr. (ed.) [CDPI and IRM, Rio de Janeiro (Brazil). Dept. of Radiology; Rossi, Santiago E. [Centro de Diagnostico, Buenos Aires (Argentina)

    2014-06-01

    Easy-to-read manual on new functional imaging techniques in oncology. Explains current clinical applications and outlines future avenues. Includes numerous high-quality illustrations to highlight the major teaching points. In the new era of functional and molecular imaging, both currently available imaging biomarkers and biomarkers under development are expected to lead to major changes in the management of oncological patients. This two-volume book is a practical manual on the various imaging techniques capable of delivering functional information on cancer, including diffusion MRI, perfusion CT and MRI, dual-energy CT, spectroscopy, dynamic contrast-enhanced ultrasonography, PET, and hybrid modalities. This second volume considers the applications and benefits of these techniques in a wide range of tumor types, including their role in diagnosis, prediction of treatment outcome, and early evaluation of treatment response. Each chapter addresses a specific malignancy and is written by one or more acclaimed experts. The lucid text is complemented by numerous high-quality illustrations that highlight key features and major teaching points.

  1. Functional imaging in oncology. Clinical applications. Vol. 2

    International Nuclear Information System (INIS)

    Luna, Antonio; Vilanova, Joan C.

    2014-01-01

    Easy-to-read manual on new functional imaging techniques in oncology. Explains current clinical applications and outlines future avenues. Includes numerous high-quality illustrations to highlight the major teaching points. In the new era of functional and molecular imaging, both currently available imaging biomarkers and biomarkers under development are expected to lead to major changes in the management of oncological patients. This two-volume book is a practical manual on the various imaging techniques capable of delivering functional information on cancer, including diffusion MRI, perfusion CT and MRI, dual-energy CT, spectroscopy, dynamic contrast-enhanced ultrasonography, PET, and hybrid modalities. This second volume considers the applications and benefits of these techniques in a wide range of tumor types, including their role in diagnosis, prediction of treatment outcome, and early evaluation of treatment response. Each chapter addresses a specific malignancy and is written by one or more acclaimed experts. The lucid text is complemented by numerous high-quality illustrations that highlight key features and major teaching points.

  2. 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 ...

  3. Factors in Outcomes of Short-Term Dynamic Psychotherapy for Chronic vs. Nonchronic Major Depression

    Science.gov (United States)

    LUBORSKY, LESTER; DIGUER, LOUIS; CACCIOLA, JOHN; BARBER, JACQUES P.; MORAS, KARLA; SCHMIDT, KELLY; DERUBEIS, ROBERT J.

    1996-01-01

    The benefits, and variables influencing the benefits, of short-term dynamic psychotherapy for chronic major depression versus nonchronic major depression were examined for 49 patients. The two diagnostic groups started at the same level on the Beck Depression Inventory (BDI) and Global Assessment of Functioning Scale (GAF) and benefited similarly. The bases for the benefits were examined by linear models explaining 35% of termination BDI variance and 47% of termination GAF scores. By far the largest contributor to outcome was initial GAF, followed by presence of more than one comorbid Axis I diagnosis. Initial level of depression on the BDI was not a significant predictor of termination BDI. The chronic/ nonchronic distinction accounted for less than 1% of explained variance, and little was added by personality disorder, age, or gender. PMID:22700274

  4. Comparing diagnostic tests on benefit-risk.

    Science.gov (United States)

    Pennello, Gene; Pantoja-Galicia, Norberto; Evans, Scott

    2016-01-01

    Comparing diagnostic tests on accuracy alone can be inconclusive. For example, a test may have better sensitivity than another test yet worse specificity. Comparing tests on benefit risk may be more conclusive because clinical consequences of diagnostic error are considered. For benefit-risk evaluation, we propose diagnostic yield, the expected distribution of subjects with true positive, false positive, true negative, and false negative test results in a hypothetical population. We construct a table of diagnostic yield that includes the number of false positive subjects experiencing adverse consequences from unnecessary work-up. We then develop a decision theory for evaluating tests. The theory provides additional interpretation to quantities in the diagnostic yield table. It also indicates that the expected utility of a test relative to a perfect test is a weighted accuracy measure, the average of sensitivity and specificity weighted for prevalence and relative importance of false positive and false negative testing errors, also interpretable as the cost-benefit ratio of treating non-diseased and diseased subjects. We propose plots of diagnostic yield, weighted accuracy, and relative net benefit of tests as functions of prevalence or cost-benefit ratio. Concepts are illustrated with hypothetical screening tests for colorectal cancer with test positive subjects being referred to colonoscopy.

  5. A clinically useful self-report measure of the DSM-5 anxious distress specifier for major depressive disorder.

    Science.gov (United States)

    Zimmerman, Mark; Chelminski, Iwona; Young, Diane; Dalrymple, Kristy; Walsh, Emily; Rosenstein, Lia

    2014-06-01

    To acknowledge the clinical significance of anxiety in depressed patients, DSM-5 included criteria for an anxious distress specifier for major depressive disorder. In the present report from the Rhode Island Methods to Improve Diagnostic Assessment and Services (MIDAS) project, we modified our previously published depression scale to include a subscale assessing the DSM-5 anxious distress specifier. From December 1995 to August 2013, 773 psychiatric outpatients with major depressive disorder completed the Clinically Useful Depression Outcome Scale (CUDOS) supplemented with questions for the DSM-5 anxious distress specifier (CUDOS-A). To examine discriminant and convergent validity, the patients were rated on clinician severity indices of depression, anxiety, and irritability. Discriminant and convergent validity was further examined in a subset of patients who completed other self-report symptom severity scales. Test-retest reliability was examined in a subset who completed the CUDOS-A twice. We compared patients who did and did not meet the DSM-5 anxious distress specifier on indices of psychosocial functioning and quality of life. The CUDOS-A subscale had high internal consistency and test-retest reliability; was more highly correlated with other self-report measures of anxiety than with measures of depression, substance use problems, eating disorders, and anger; and was more highly correlated with clinician severity ratings of anxiety than depression and irritability. CUDOS-A scores were significantly higher in depressed outpatients with a current anxiety disorder than in depressed patients without a comorbid anxiety disorder (P depressive disorder. © Copyright 2014 Physicians Postgraduate Press, Inc.

  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. IT and security considerations for online clinical records.

    Science.gov (United States)

    Williams, Patricia A H

    2010-03-01

    E-health and the national electronic medical record are on our doorstep. As an integral part of the healthcare system, dentistry needs to get on board with this national initiative. How prepared is the dental profession for this? How can a culture of online clinical records be promoted and what protocols and infrastructure exist for this to occur? The lack of government restriction means that dentistry should be taking full advantage of what is possible. The benefits and barriers to adoption of online records will be presented to provide a frame of reference for the next major shift in electronic communication.

  8. Expression Analysis of Multiple Genes May Involve in Antimony Resistance among Leishmania major Clinical Isolates from Fars Province, Central Iran

    Directory of Open Access Journals (Sweden)

    Nafiseh GHOBAKHLOO

    2016-10-01

    Full Text Available Background: Treatment of Cutaneous Leishmaniasis (CL is being faced with serious difficulties in Fars Province, due to emerging of resistance against meglumine antimonite (Glucantime®. In this context, determining some biomarkers for drug sensitivity monitoring seems to be highly essential. Different studies have been carried out to decipher the genes might be involved in antimony resistant phenotype in Leishmania spp. Here, we selected three genes: AQP (as drug transporter, TDR-1-1(as drug activator, and γ-GCS (inducing reduction environment for comparative expression analysis on clinical resistant and sensitive isolates of L. major.Methods: The clinical isolates of L. major were collected from CL patients referred to Valfajr Health Center, Shiraz from Oct 2011 to Feb 2012. The susceptibility test was performed to confirm drug sensitivity of strains in vitro as well. Then, the gene expression analysis was performed by quantitative real-time PCR using SYBR® Green.Results: By comparison of expression level between strains, up regulation of γ-GCS gene and down regulation of AQP gene were observed in resistant strains compared to the sensitive isolates; however, down regulation of AQP was not statistically specific. Analysis of TDR-1-1 gene unexpectedly showed a high level of expression in the non-responsive cases.Conclusion: The γ-GCS, at least, can be considered as a suitable molecular marker for screening antimony sensitivity in clinical isolates, although AQP and TDR-1-1gene seem not to be reliable resistant markers. 

  9. Clinical, Immunological, and Molecular Findings in Five Patients with Major Histocompatibility Complex Class II Deficiency from India

    Directory of Open Access Journals (Sweden)

    Jahnavi Aluri

    2018-02-01

    Full Text Available Major histocompatibility complex (MHC class II deficiency is a rare autosomal recessive form of primary immunodeficiency disorder (PID characterized by the deficiency of MHC class II molecules. This deficiency affects the cellular and humoral immune response by impairing the development of CD4+ T helper (Th cells and Th cell-dependent antibody production by B cells. Affected children typically present with severe respiratory and gastrointestinal tract infections. Hematopoietic stem cell transplantation (HSCT is the only curative therapy available for treating these patients. This is the first report from India wherein we describe the clinical, immunological, and molecular findings in five patients with MHC class II deficiency. Our patients presented with recurrent lower respiratory tract infection as the most common clinical presentation within their first year of life and had a complete absence of human leukocyte antigen-antigen D-related (HLA-DR expression on B cells and monocytes. Molecular characterization revealed novel mutations in RFAXP, RFX5, and CIITA genes. Despite genetic heterogeneity, these patients were clinically indistinguishable. Two patients underwent HSCT but had a poor survival outcome. Detectable level of T cell receptor excision circles (TRECs were measured in our patients, highlighting that this form of PID may be missed by TREC-based newborn screening program for severe combined immunodeficiency.

  10. A benefit-risk review of systemic haemostatic agents - Part 1 : In major surgery

    NARCIS (Netherlands)

    Fraser, Ian S.; Porte, Robert J.; Kouides, Peter A.; Lukes, Andrea S.

    2008-01-01

    Systemic haemostatic agents play an important role in the management of blood loss during major surgery where significant blood loss is likely and their use has increased in recent times as a consequence of demand for blood products outstripping supply and the risks associated with transfusions.

  11. Improving the clinical impact of biomaterials in cancer immunotherapy

    Science.gov (United States)

    Gammon, Joshua M.; Dold, Neil M.; Jewell, Christopher M.

    2016-01-01

    Immunotherapies for cancer have progressed enormously over the past few decades, and hold great promise for the future. The successes of these therapies, with some patients showing durable and complete remission, demonstrate the power of harnessing the immune system to eradicate tumors. However, the effectiveness of current immunotherapies is limited by hurdles ranging from immunosuppressive strategies employed by tumors, to inadequate specificity of existing therapies, to heterogeneity of disease. Further, the vast majority of approved immunotherapies employ systemic delivery of immunomodulators or cells that make addressing some of these challenges more difficult. Natural and synthetic biomaterials–such as biocompatible polymers, self-assembled lipid particles, and implantable biodegradable devices–offer unique potential to address these hurdles by harnessing the benefits of therapeutic targeting, tissue engineering, co-delivery, controlled release, and sensing. However, despite the enormous investment in new materials and nanotechnology, translation of these ideas to the clinic is still an uncommon outcome. Here we review the major challenges facing immunotherapies and discuss how the newest biomaterials and nanotechnologies could help overcome these challenges to create new clinical options for patients. PMID:26871948

  12. The balance of benefit: a review of intergenerational transfers in Australia.

    Science.gov (United States)

    Legge, V; O'Loughlin, K

    2000-10-01

    This article reviews the financial and nonfinancial transfers taking place intergenerationally and between older people and the community. Secondary data were used in the analysis and discussion to provide an overview of the Australian context. Within the public arena, governments provide major financial contributions through money transfers and the provision of residential support. Older people provide considerable community support by undertaking voluntary services. This article concludes that the balance of benefit is difficult to determine; however, in terms of public expenditure older people are major recipients. Within the family, the balance of benefit is reversed. Older people are major monetary contributors to adult children and their families in the transition to an independent status. Older people are also the principal carers of their frail-aged partners, thus reducing both the burden of care on their adult children and government institutions. The analysis reported here has major implications for the development of policy and structural change and for reducing negative stereotypes of dependency in old age.

  13. Daily Aspirin Therapy: Understand the Benefits and Risks

    Science.gov (United States)

    Daily aspirin therapy: Understand the benefits and risks Daily aspirin therapy can be a lifesaving option, but it's not ... everyone. Get the facts before considering a daily aspirin. By Mayo Clinic Staff Daily aspirin therapy may ...

  14. Direct benefits and the evolution of female-biased cooperative breeding in Seychelles warblers

    NARCIS (Netherlands)

    Richardson, David S.; Burke, Terry; Komdeur, Jan; Dunn, P.

    2002-01-01

    Inclusive fitness benefits have been suggested to be a major selective force behind the evolution of cooperative breeding. We investigated the fitness benefits selecting for cooperative breeding in the Seychelles warbler, Acroccphalus sechellensis. A microsatellite-based genotyping method was used

  15. Benefits and Barriers of University Industry Collaborations from a Researcher's Perspective

    DEFF Research Database (Denmark)

    Kilian, Thomas; Schubert, Petra; Bjørn-Andersen, Niels

    2015-01-01

    parsimonious formative measures for the benefits and barriers of UIC and we found that academic and economic benefits positively influence the intention to conduct UIC in the future, while economic barriers negatively influence the intention to engage in UIC. A cluster analysis found five clusters (groups...... of researchers) that differ in their perception of benefits and barriers and the future intention to conduct UIC. However, the majority of the researchers have a very high intention to conduct UIC in the future....

  16. 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)

  17. 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.

  18. 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.

  19. Factors Influencing Clinical Performance of Baccalaureate Nursing Majors: A Retrospective Audit.

    Science.gov (United States)

    Johnston, Sandra; Fox, Amanda; Coyer, Fiona Maree

    2018-06-01

    Transition of nursing student to new graduate depends on successful completion of clinical work placement during an undergraduate course. Supporting students during the clinical placement is imperative. This study examined associations between grade point average, domestic or international status, course entry qualification, and single or dual nursing degree to successful completion of clinical placement. A retrospective audit of 665 students in a baccalaureate nursing program was conducted to examine factors influencing clinical performance of baccalaureate nursing students. A significant association between entry qualification, lower grade point average, international status, and receipt of a constructive note was found: χ 2 = 8.678, df = 3, p = .034, t(3.862), df = 663, p ⩽ .001, and Fisher's exact test = 8.581, df = 1, p = .003, respectively. Understanding factors that affect clinical performance may help early identification of students at risk and allow for supportive intervention during placement and subsequent program completion. [J Nurs Educ. 2018;57(6):333-338.]. Copyright 2018, SLACK Incorporated.

  20. Importance of mutual benefits in online knowledge sharing communities

    OpenAIRE

    Tian, Y.; Lau, L.M.S.; Dew, P.M.

    2004-01-01

    The sustainability of knowledge sharing e-communities is a major issue at present. A hypothesis was\\ud proposed at the outset in the paper that the provision of mutual benefits among participants will lead to positive\\ud participation. Drawing from the economic and social theories, a framework for analysis was developed and tested in\\ud an empirical study. The preliminary results demonstrated a direct relationship between mutual benefits and the level\\ud of participation, and hence supported ...

  1. Impact of a pain protocol including hypnosis in major burns.

    Science.gov (United States)

    Berger, Mette M; Davadant, Maryse; Marin, Christian; Wasserfallen, Jean-Blaise; Pinget, Christophe; Maravic, Philippe; Koch, Nathalie; Raffoul, Wassim; Chiolero, René L

    2010-08-01

    Pain is a major issue after burns even when large doses of opioids are prescribed. The study focused on the impact of a pain protocol using hypnosis on pain intensity, anxiety, clinical course, and costs. All patients admitted to the ICU, aged >18 years, with an ICU stay >24h, accepting to try hypnosis, and treated according to standardized pain protocol were included. Pain was scaled on the Visual Analog Scale (VAS) (mean of daily multiple recordings), and basal and procedural opioid doses were recorded. Clinical outcome and economical data were retrieved from hospital charts and information system, respectively. Treated patients were matched with controls for sex, age, and the burned surface area. Forty patients were admitted from 2006 to 2007: 17 met exclusion criteria, leaving 23 patients, who were matched with 23 historical controls. Altogether patients were 36+/-14 years old and burned 27+/-15%BSA. The first hypnosis session was performed after a median of 9 days. The protocol resulted in the early delivery of higher opioid doses/24h (ppatient. A pain protocol including hypnosis reduced pain intensity, improved opioid efficiency, reduced anxiety, improved wound outcome while reducing costs. The protocol guided use of opioids improved patient care without side effects, while hypnosis had significant psychological benefits.

  2. 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

  3. Plasma fluoxetine concentrations and clinical improvement in an adolescent sample diagnosed with major depressive disorder, obsessive-compulsive disorder, or generalized anxiety disorder.

    Science.gov (United States)

    Blázquez, Ana; Mas, Sergi; Plana, Maria Teresa; Gassó, Patricia; Méndez, Iria; Torra, Mercè; Arnaiz, Joan Albert; Lafuente, Amàlia; Lázaro, Luisa

    2014-06-01

    Fluoxetine (FLX) has been one of the most widely studied selective serotonin reuptake inhibitors in adolescents. Despite its efficacy, however, 30% to 40% of patients do not respond to treatment. The aim of this study was to evaluate whether clinical improvement or adverse events are related to the corrected dose of FLX at 8 and 12 weeks after starting treatment in a sample of adolescents diagnosed with major depressive disorder, obsessive-compulsive disorder, or generalized anxiety disorder. Seventy-four subjects aged between 10 and 17 years participated in the study. Clinical improvement was measured with the Clinical Global Impression-Improvement Scale, whereas the UKU (Udvalg for Klinske Undersogelser) scale was administered to assess adverse effects of treatment. Fluoxetine per kilograms of body weight was related to serum concentration of FLX, NORFLX (norfluoxetine), FLX + NORFLX, and FLX/NORFLX. No relationship was found between dose-corrected FLX levels and therapeutic or adverse effects. No differences in serum concentrations were found between responders and nonresponders to treatment. Sex differences were observed in relation to dose and FLX serum concentration. The analysis by diagnosis revealed differences in FLX dose between obsessive-compulsive disorder patients and both generalized anxiety disorder and major depressive disorder patients. Fluoxetine response seems to be influenced by factors such as sex, diagnosis, or certain genes that might be involved in the drug's pharmacokinetics and pharmacodynamics. Clinical and pharmacogenetic studies are needed to elucidate further the differences between treatment responders and nonresponders.

  4. Work ability as a major determinant of clinical nurses' quality of life.

    Science.gov (United States)

    Milosevic, Milan; Golubic, Rajna; Knezevic, Bojana; Golubic, Karlo; Bubas, Marija; Mustajbegovic, Jadranka

    2011-10-01

    To examine quality of life determinants among clinical nurses in Croatia with an emphasis on their work ability. An important personnel management challenge is to explore factors that stimulate or hinder the development of individual work ability and quality of life throughout a career. A cross-sectional study. The study was performed during 2007-2008 in six randomly selected hospitals in Croatia. The self-administered questionnaires included the Work Ability Index (WAI) developed by the Finnish Institute of Occupational Health, the Quality of Life questionnaire (WHOQL-BREF) developed by the World Health Organization and additional socio-demographic questions. A total number of 1212 nurses completed the questionnaires, giving a response rate of 67(.) 3%. Binary logistic regression was performed to assess how socio-demographic characteristics and work ability groups predict each of the WHOQL-BREF domains. Having a satisfactory WAI score (WAI ≥ 37) was significantly the most important predictor for all quality of life domains, with the odds ratios (OR) being as follows: OR = 6(.) 8 (95% CI: 4(.) 8-9(.) 6) for the physical domain, OR = 2(.) 3 (95% CI: 1(.) 7-3(.) 1) for the psychological domain, OR = 1(.) 7 (95% CI: 1(.) 3-2(.) 4) for the social relationship domain and OR = 1(.) 7 (95% CI: 1(.) 3-2(.) 3) for the environmental domain. Satisfactory work ability was a major quality of life determinant in all WHOQL-BREF domains with the highest odds ratio for the physical domain. Maintaining clinical nurses' work ability is an important issue, because it is foundational for the quality of life of the workforce. Our study provides quantified estimates of the extent to which a satisfactory WAI score predicts a better score in physical, psychosocial, social relationships and environmental domain of nurses' quality of life. Therefore, maintaining or improving nurses' work ability remains the essential aim of hospital managers. © 2011 Blackwell Publishing Ltd.

  5. QUANTIFYING BENEFITS FOR COST-BENEFIT ANALYSIS

    OpenAIRE

    Attila GYORGY; Nicoleta VINTILA; Florian GAMAN

    2014-01-01

    Cost Benefit Analysis is one of the most widely used financial tools to select future investment projects in public and private sector. This method is based on comparing costs and benefits in terms of constant prices. While costs are easier to predict and monetize, the benefits should be identified not only in direct relation with the investment, but also widening the sphere of analysis to indirect benefits experienced by the community from the neighbourhood or the whole society. During finan...

  6. Genetic parameters of subclinical macromineral disorders and major clinical diseases in postparturient Holstein cows.

    Science.gov (United States)

    Tsiamadis, V; Banos, G; Panousis, N; Kritsepi-Konstantinou, M; Arsenos, G; Valergakis, G E

    2016-11-01

    The main objective of this study was to assess the genetic parameters of subclinical disorders associated with subclinical hypocalcemia, hypophosphatemia, subclinical hypomagnesemia, hypokalemia, and hyperphosphatemia, as well as major clinical diseases after calving in Holstein cows. The secondary objective was to estimate the associated genetic and phenotypic correlations among these subclinical and clinical conditions after calving in Holstein cows. The study was conducted in 9dairy herds located in Northern Greece. None of the herds used any kind of preventive measures for milk fever (MF). A total of 1,021 Holstein cows with pedigree information were examined from November 2010 until November 2012. The distribution across parities was 466 (parity 1), 242 (parity 2), 165 (parity 3), and 148 (parity 4 and above) cows. All cows were subjected to a detailed clinical examination and blood was sampled on d 1, 2, 4, and 8 after calving. Serum concentrations of Ca, P, Mg, and K were measured in all samples, whereas β-hydroxybutyrate (BHB) was measured only for d 8. The final data set included 4,064 clinical and 16,848 biochemical records (4,020 Ca, 4,019 P, 4,020Mg, 3,792K, and 997 BHB). Data of 1,988 observations of body condition score at d 1 and 8 were also available. All health traits were analyzed with a univariate random regression model. The genetic analysis for macromineral-related disorders included 986 cows with no obvious signs of MF (35 cows with MF were excluded). Analysis for other health traits included all 1,021 cows. A similar single record model was used for the analysis of BHB. Genetic correlations among traits were estimated with a series of bivariate analyses. Statistically significant daily heritabilities of subclinical hypocalcemia (0.13-0.25), hypophosphatemia (0.18-0.33), subclinical hypomagnesemia (0.11-0.38), and hyperphosphatemia (0.14-0.22) were low to moderate, whereas that of hypokalemia was low (0.08-0.10). The heritability of body

  7. Benefit and harms of new anti-cancer drugs.

    Science.gov (United States)

    Vera-Badillo, Francisco E; Al-Mubarak, Mustafa; Templeton, Arnoud J; Amir, Eitan

    2013-06-01

    Phase III randomized controlled trials (RCTs) assess clinically important differences in endpoints that reflect benefit to and harm of patients. Defining benefit of cancer drugs can be difficult. Overall survival and quality of life are the most relevant primary endpoints, but difficulty in measuring these mean that other endpoints are often used, although their surrogacy or clinical relevance has not always been established. In general, advances in drug development have led to numerous new drugs to enter the market. Pivotal RCT of several new drugs have shown that benefit appeared greater for targeted anticancer agents than for chemotherapeutic agents. This effect seems particularly evident with targeted agents evaluated in biomarker-driven studies. Unfortunately, new therapies have also shown an increase in toxicity. Such toxicity is not always evident in the initial reports of RCTs. This may be a result of a statistical inability to detect differences between arms of RCTs, or occasionally due to biased reporting. There are several examples where reports of new toxicities could only be found in drug labels. In some cases, the small improvement in survival has come at a cost of substantial excess toxicity, leading some to consider such therapy as having equipoise.

  8. Third-wave cognitive therapy versus mentalisation-based treatment for major depressive disorder

    DEFF Research Database (Denmark)

    Jakobsen, Janus Christian; Gluud, Christian; Kongerslev, Mickey

    2014-01-01

    OBJECTIVE: To compare the benefits and harms of third-wave cognitive therapy versus mentalisation-based therapy in a small sample of depressed participants. SETTING: The trial was conducted at an outpatient psychiatric clinic for non-psychotic patients in Roskilde, Denmark. PARTICIPANTS: 44...... consecutive adult participants diagnosed with major depressive disorder. INTERVENTIONS: 18 weeks of third-wave cognitive therapy (n=22) versus 18 weeks of mentalisation-based treatment (n=22). OUTCOMES: The primary outcome was the Hamilton Rating Scale for Depression (HDRS) at end of treatment (18 weeks...... for baseline HDRS score, the difference was favouring third-wave cognitive therapy (p=0.039). At 18 weeks, five of the third-wave participants (22.7%) were in remission versus none of the mentalisation-based participants (p=0.049). We recorded no suicide attempts or suicides during the intervention period...

  9. 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.

  10. 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

  11. 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

  12. Differential diagnosis of bipolar disorder and major depressive disorder.

    Science.gov (United States)

    Hirschfeld, R M

    2014-12-01

    Patients with bipolar disorder spend approximately half of their lives symptomatic and the majority of that time suffering from symptoms of depression, which complicates the accurate diagnosis of bipolar disorder. Challenges in the differential diagnosis of bipolar disorder and major depressive disorder are reviewed, and the clinical utility of several screening instruments is evaluated. The estimated lifetime prevalence of major depressive disorder (i.e., unipolar depression) is over 3 and one-half times that of bipolar spectrum disorders. The clinical presentation of a major depressive episode in a bipolar disorder patient does not differ substantially from that of a patient with major depressive disorder (unipolar depression). Therefore, it is not surprising that without proper screening and comprehensive evaluation many patients with bipolar disorder may be misdiagnosed with major depressive disorder (unipolar depression). In general, antidepressants have demonstrated little or no efficacy for depressive episodes associated with bipolar disorder, and treatment guidelines recommend using antidepressants only as an adjunct to mood stabilizers for patients with bipolar disorder. Thus, correct identification of bipolar disorder among patients who present with depression is critical for providing appropriate treatment and improving patient outcomes. Clinical characteristics indicative of bipolar disorder versus major depressive disorder identified in this review are based on group differences and may not apply to each individual patient. The overview of demographic and clinical characteristics provided by this review may help medical professionals distinguish between major depressive disorder and bipolar disorder. Several validated, easily administered screening instruments are available and can greatly improve the recognition of bipolar disorder in patients with depression. Copyright © 2014 Elsevier B.V. All rights reserved.

  13. 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.

  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. 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

  16. Interpersonal boundaries in clinical nursing education: An exploratory Canadian qualitative study.

    Science.gov (United States)

    Zieber, Mark P; Hagen, Brad

    2009-11-01

    Clinical nursing instructors and students spend considerable time together, and share clinical experiences that can be intense and emotionally charged. Yet despite clinical teaching being so commonplace, little is known about how clinical instructors experience relationships with their students, and how they negotiate interpersonal boundaries within these relationships. In-depth unstructured interviews were conducted with eight clinical nursing instructors in Western Canada, to explore how they defined and constructed interpersonal boundaries with their students during clinical nursing teaching rotations. The data analysis resulted in four major themes: "the fluidity of boundaries", "personal sharing and self-disclosure", "time dependent", and "the touchy topic of touch". All participants agreed that rigid boundaries were occasionally needed to prevent flagrant boundary violations, such as sexual relations with students. However, participants also stated that overall, the unique and complex nature of clinical teaching called for instructors to have fluid and flexible interpersonal boundaries with students. The nature of clinical nursing education may encourage instructors to form relationships with their students that are characterized by flexible and fluid interpersonal boundaries. Clinical nursing instructors may benefit from opportunities to dialogue with trusted colleagues about the unique nature of relationships and boundaries with students during clinical teaching.

  17. Clinical supervision, is it mutually beneficial

    International Nuclear Information System (INIS)

    Adams, E.J.

    2000-01-01

    Full text: Clinical education in Nuclear Medicine is essential for student learning as it enables them to develop knowledge and competence and put theory into practice. While the benefit to the student is clear, the clinical education experience should be mutually beneficial. The role of the clinical supervisor involves teaching, role modelling, management and assessment. It could be assumed that the Supervisor would find the teaching role leading to increased knowledge; role modelling leading to increased reflection which improves practice; management skills being enhanced and assessment improving critical evaluation skills. The aim of this study was to assess the perceived benefits of taking on the role of a clinical supervisor. Clinical Supervisors participating in the Nuclear Medicine program were surveyed. Questions were grouped into three main categories - professional, interpersonal and communication. A Likert scale was used to assess perceived level of benefit and open-ended questions were included to obtain additional understanding of Supervisors' perceptions. Results from the survey indicate that 64% of supervisors felt an increase in work satisfaction by taking students, 68% agreed their level of performance was improved and 61% agreed that it deepened their understanding of Nuclear Medicine. It is concluded that respondents perceived a positive benefit to areas within the role of Clinical Supervisor. Copyright (2000) The Australian and New Zealand Society of Nuclear Medicine Inc

  18. The Validity of the Different Versions of the Hamilton Depression Scale in Separating Remission Rates of Placebo and Antidepressants in Clinical Trials of Major Depression

    DEFF Research Database (Denmark)

    Kyle, Phillip Raphael; Lemming, Ole Michael; Timmerby, Nina

    2016-01-01

    . The traditional HAM-D17 version was compared with the shorter HAM-D6 and the longer HAM-D21 or HAM-D24 in a fixed-dose placebo-controlled vortioxetine study. Clinical Global Impression of Severity scores were used to establish standardized cutoff scores for remission across each scale. Using these cutoff scores......Our objective was to validate the different versions of the Hamilton Depression Scale (HAM-D) both psychometrically (scalability) and clinically in discriminating antidepressants from placebo in terms of remission rates in an 8-week clinical trial in the acute treatment of major depression...... in the longer HAM-D versions indicated smaller discriminating validity over placebo. The HAM-D6 indicated a dose effect on remission for vortioxetine in both moderate and severe major depression. The brief HAM-D6 was thus found superior to HAM-D17, HAM-D21, and HAM-D24 both in terms of scalability...

  19. Decision-making when data and inferences are not conclusive: risk-benefit and acceptable regret approach.

    Science.gov (United States)

    Hozo, Iztok; Schell, Michael J; Djulbegovic, Benjamin

    2008-07-01

    The absolute truth in research is unobtainable, as no evidence or research hypothesis is ever 100% conclusive. Therefore, all data and inferences can in principle be considered as "inconclusive." Scientific inference and decision-making need to take into account errors, which are unavoidable in the research enterprise. The errors can occur at the level of conclusions that aim to discern the truthfulness of research hypothesis based on the accuracy of research evidence and hypothesis, and decisions, the goal of which is to enable optimal decision-making under present and specific circumstances. To optimize the chance of both correct conclusions and correct decisions, the synthesis of all major statistical approaches to clinical research is needed. The integration of these approaches (frequentist, Bayesian, and decision-analytic) can be accomplished through formal risk:benefit (R:B) analysis. This chapter illustrates the rational choice of a research hypothesis using R:B analysis based on decision-theoretic expected utility theory framework and the concept of "acceptable regret" to calculate the threshold probability of the "truth" above which the benefit of accepting a research hypothesis outweighs its risks.

  20. Semuloparin for prevention of venous thromboembolism after major orthopedic surgery

    DEFF Research Database (Denmark)

    Lassen, M R; Fisher, W; Mouret, P

    2012-01-01

    BACKGROUND: Semuloparin is a novel ultra-low-molecular-weight heparin under development for venous thromboembolism (VTE) prevention in patients at increased risk, such as surgical and cancer patients. OBJECTIVES: Three Phase III studies compared semuloparin and enoxaparin after major orthopedic...... was to be performed between days 7 and 11. The primary efficacy endpoint was a composite of any deep vein thrombosis, non-fatal pulmonary embolism or all-cause death. Safety outcomes included major bleeding, clinically relevant non-major (CRNM) bleeding, and any clinically relevant bleeding (major bleeding plus CRNM...

  1. 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

  2. Quality of Life and Sexual Function Benefits of Long-Term Testosterone Treatment: Longitudinal Results From the Registry of Hypogonadism in Men (RHYME).

    Science.gov (United States)

    Rosen, Raymond C; Wu, Frederick; Behre, Hermann M; Porst, Hartmut; Meuleman, Eric J H; Maggi, Mario; Romero-Otero, Javier; Martinez-Salamanca, Juan I; Jones, Thomas Hugh; Debruyne, Frans M J; Kurth, Karl-Heinz; Hackett, Geoff I; Quinton, Richard; Stroberg, Peter; Reisman, Yacov; Pescatori, Edoardo S; Morales, Antonio; Bassas, Lluis; Cruz, Natalio; Cunningham, Glenn R; Wheaton, Olivia A

    2017-09-01

    The benefits and risks of long-term testosterone administration have been a topic of much scientific and regulatory interest in recent years. To assess long-term quality of life (QOL) and sexual function benefits of testosterone replacement therapy (TRT) prospectively in a diverse, multinational cohort of men with hypogonadism. A multinational patient registry was used to assess long-term changes associated with TRT in middle-age and older men with hypogonadism. Comprehensive evaluations were conducted at 6, 12, 24, and 36 months after enrollment into the registry. QOL and sexual function were evaluated by validated measures, including the Aging Males' Symptom (AMS) Scale and the International Index of Erectile Function (IIEF). A total of 999 previously untreated men with hypogonadism were enrolled at 25 European centers, 750 of whom received TRT at at least one visit during the period of observation. Patients on TRT reported rapid and sustained improvements in QOL, with fewer sexual, psychological, and somatic symptoms. Modest improvements in QOL and sexual function, including erectile function, also were noted in RHYME patients not on TRT, although treated patients showed consistently greater benefit over time in all symptom domains compared with untreated patients. AMS total scores for patients on TRT were 32.8 (95% confidence interval = 31.3-34.4) compared with 36.6 (95% confidence interval = 34.8-38.5) for untreated patients (P treatment. The major strengths are the large, diverse patient population being treated in multidisciplinary clinical settings. The major limitation is the frequency of switching from one formulation to another. Overall, we confirmed the broad and sustained benefits of TRT across major QOL dimensions, including sexual, somatic, and psychological health, which were sustained over 36 months in our treatment cohort. Rosen RC, Wu F, Behre H, et al. Quality of Life and Sexual Function Benefits Effects of Long-Term Testosterone Treatment

  3. Noncontraceptive use of oral combined hormonal contraceptives in polycystic ovary syndrome-risks versus benefits.

    Science.gov (United States)

    Dokras, Anuja

    2016-12-01

    The use of steroid sex hormones for noncontraceptive benefits has been endorsed by several medical societies. In women with polycystic ovary syndrome (PCOS), hormonal contraceptives are first-line therapy for concurrent treatment of menstrual irregularity, acne, and hirsutism. The association of PCOS with obesity, diabetes, and dyslipidemia frequently brings up the debate regarding risks versus benefits of hormonal contraceptives in this population. In women with PCOS, the lack of large-scale studies evaluating the risks with varying doses of ethinyl estradiol, types of progestins, and presence of confounding factors such as obesity, smoking, and other cardiometabolic comorbidities is a significant limitation in these deliberations. Although it is important to assess the absolute risk for major morbidities including cardiovascular events, currently, there are a paucity of long-term data for these outcomes in PCOS. Most of the current studies do not suggest an increase in risk of prediabetes/diabetes, clinically significant dyslipidemia, inflammatory changes, or depressive/anxiety symptoms with oral contraceptive pill use. Screening of women with PCOS for cardiometabolic and psychiatric comorbidities is routinely recommended. This information should be used by health care providers to individualize the choice of hormonal contraceptive treatment, adequately counsel patients regarding risks and benefits, and formulate an appropriate follow-up plan. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  4. Current technological advances in magnetic resonance with critical impact for clinical diagnosis and therapy.

    Science.gov (United States)

    Runge, Val M

    2013-12-01

    The last 5 years of technological advances with major impact on clinical magnetic resonance (MR) are discussed, with greater emphasis on those that are most recent. These developments have already had a critical positive effect on clinical diagnosis and therapy and presage continued rapid improvements for the next 5 years. This review begins with a discussion of 2 topics that encompass the breadth of MR, in terms of anatomic applications, contrast media, and MR angiography. Subsequently, innovations are discussed by anatomic category, picking the areas with the greatest development, starting with the brain, moving forward to the liver and kidney, and concluding with the musculoskeletal system, breast, and prostate. Two final topics are then considered, which will likely, with time, become independent major fields in their own right, interventional MR and MR positron emission tomography (PET).The next decade will bring a new generation of MR contrast media, with research focused on substantial improvements (>100-fold) in relaxivity (contrast effect), thus providing greater efficacy, safety, and tissue targeting. Magnetic resonance angiography will see major advances because of the use of compressed sensing, in terms of spatial and temporal resolution, with movement away from nondynamic imaging. The breadth of available techniques and tissue contrast has greatly expanded in brain imaging, benefiting both from the introduction of new basic categories of imaging techniques, such as readout-segmented echo planar imaging and 3D fast spin echo imaging with variable flip angles, and from new refinements specific to anatomic areas, such as double inversion recovery and MP2RAGE. Liver imaging has benefited from the development of techniques to easily and rapidly assess lipid, and will see, overall, a marked improvement in the next 5 years from new techniques on the verge of clinical introduction, such as controlled aliasing in parallel imaging results in higher acceleration

  5. Community benefit: what it is and isn't.

    Science.gov (United States)

    Dean, Natalie; Trocchio, Julie

    2005-01-01

    "Community benefit" is the measurable contribtution made by Catholic and other tax-exempt organizations to support the health needs of disadvantaged persons and to improve the overall health and well-being of local communities. Community benefit activities include outreach to low-income and other vulnerable persons; charity care for people unable to afford services; health education and illness prevention; special health care initiatives for at-risk school children; free or low-cost clinics; and efforts to improve and revitalize communities. These activities are often provided in collaboration with community members and other community organizations to improve local health and quality of life for everyone. Since 1989, the Catholic health ministry has utilized a systematic approach to plan, monitor, report, and evaluate the community benefit activities and services it provides to its communities. This approach, first described in CHA's Social Accountability Budget, was updated in the recent Community Benefit Reporting: Guidelines and Standard Definitions for the Community Benefit Inventory for Social Accountability. By using credible and consistent information, health care organizations can improve their strategic response to demands for information that demonstrates their worth.

  6. Benefit-Risk Analysis for Decision-Making: An Approach.

    Science.gov (United States)

    Raju, G K; Gurumurthi, K; Domike, R

    2016-12-01

    The analysis of benefit and risk is an important aspect of decision-making throughout the drug lifecycle. In this work, the use of a benefit-risk analysis approach to support decision-making was explored. The proposed approach builds on the qualitative US Food and Drug Administration (FDA) approach to include a more explicit analysis based on international standards and guidance that enables aggregation and comparison of benefit and risk on a common basis and a lifecycle focus. The approach is demonstrated on six decisions over the lifecycle (e.g., accelerated approval, withdrawal, and traditional approval) using two case studies: natalizumab for multiple sclerosis (MS) and bedaquiline for multidrug-resistant tuberculosis (MDR-TB). © 2016 American Society for Clinical Pharmacology and Therapeutics.

  7. Compost benefits for agriculture evaluated by life cycle assessment. A review

    DEFF Research Database (Denmark)

    Martínez-Blanco, Julie; Lazcano, Cristina; Christensen, Thomas Højlund

    2013-01-01

    not available. (4) Weed suppression was not proved. Different research efforts are required for a full assessment of the benefits, apart from nutrient supply and carbon sequestration; additional impact categories—dealing with phosphorus resources, biodiversity, soil losses, and water depletion—may be needed...... assessment (LCA). A total of nine environmental benefits were identified in an extensive literature review and quantitative figures for each benefit were drawn and classified into short-, mid-, and long-term. The major findings are the following: (1) for nutrient supply and carbon sequestration, the review...

  8. Cost-benefit and cost-savings analyses of antiarrhythmic medication monitoring.

    Science.gov (United States)

    Snider, Melissa; Carnes, Cynthia; Grover, Janel; Davis, Rich; Kalbfleisch, Steven

    2012-09-15

    The economic impact of pharmacist-managed antiarrhythmic drug therapy monitoring on an academic medical center's electrophysiology (EP) program was investigated. Data were collected for the initial two years of patient visits (n = 816) to a pharmacist-run clinic for antiarrhythmic drug therapy monitoring. A retrospective cost analysis was conducted to assess the direct costs associated with three appointment models: (1) a clinic office visit only, (2) a clinic visit involving electrocardiography and basic laboratory tests, and (3) a clinic visit including pulmonary function testing and chest x-rays in addition to electrocardiography and laboratory testing. A subset of patient cases (n = 18) were included in a crossover analysis comparing pharmacist clinic care and usual care in an EP physician clinic. The primary endpoints were the cost benefits and cost savings associated with pharmacy-clinic care versus usual care. A secondary endpoint was improvement of overall EP program efficiency. The payer mix was 61.6% (n = 498) Medicare, 33.2% (n = 268) managed care, and 5.2% (n = 42) other. Positive contribution margins were demonstrated for all appointment models. The pharmacist-managed clinic also yielded cost savings by reducing overall patient care charges by 21% relative to usual care. By the second year, the pharmacy clinic improved EP program efficiency by scheduling an average of 24 patients per week, in effect freeing up one day per week of EP physician time to spend on other clinical activities. Pharmacist monitoring of antiarrhythmic drug therapy in an out-patient clinic provided cost benefits, cost savings, and improved overall EP program efficiency.

  9. Clinical pharmacology review of escitalopram for the treatment of depression.

    Science.gov (United States)

    Pastoor, Devin; Gobburu, Joga

    2014-01-01

    Depression is a serious and debilitating psychiatric condition with serious societal health and economic implications. Escitalopram , the S-enantiomer of racemic citalopram, is an effective treatment for major depressive disorder. This review covers the clinical pharmacology of escitalopram, with emphasis on regulatory approval. Its pharmacokinetics, pharmacodynamics and clinical efficacy for major depressive disorder are evaluated, along with data regarding safety and tolerability. Drug development of escitalopram was heavily guided by prior approval of citalopram. Select safety and efficacy studies for escitalopram in combination with supportive evidence from the results of prior citalopram studies allowed for regulatory approval for acute and maintenance claims in both adults and adolescents, while minimizing burden on the sponsor. Escitalopram has been shown to have better efficacy and safety profile than other selective serotonin reuptake inhibitor and serotonin norepinephrine reuptake inhibitor drugs, including racemic citalopram. The first generic escitalopram was approved in 2012, along with Abbreviated New Drug Applications. The associated cost savings have helped reduce the burden of weighing the benefits of escitalopram over less-expensive alternatives.

  10. Exercise Attenuates the Major Hallmarks of Aging

    Science.gov (United States)

    Garatachea, Nuria; Pareja-Galeano, Helios; Santos-Lozano, Alejandro; Fiuza-Luces, Carmen; Morán, María; Emanuele, Enzo; Joyner, Michael J.; Lucia, Alejandro

    2015-01-01

    Abstract Regular exercise has multi-system anti-aging effects. Here we summarize how exercise impacts the major hallmarks of aging. We propose that, besides searching for novel pharmaceutical targets of the aging process, more research efforts should be devoted to gaining insights into the molecular mediators of the benefits of exercise and to implement effective exercise interventions for elderly people. PMID:25431878

  11. Clinicopathological predictors of benefit from adjuvant chemotherapy for stage C colorectal cancer: Microsatellite unstable cases benefit.

    Science.gov (United States)

    Thomas, Michelle L; Hewett, Peter J; Ruszkiewicz, Andrew R; Moore, James W E

    2015-12-01

    In colorectal cancer (CRC), adjuvant therapy is offered on the basis of stage and attempts to identify factors to better target treatment have not been successful. Recent work suggested that mismatch repair deficient CRCs may not benefit from 5FU adjuvant chemotherapy but studies remain conflicting. We aimed to determine if gender, tumor site, tumor pathological characteristics and microsatellite instability (MSI) predict survival benefit from adjuvant chemotherapy in stage C CRC. Data were collated on ACPS (Australian Clinico-pathological Staging System) stage C CRC cases that underwent curative resection over a 23-year period. Pathology was reevaluated, DNA was extracted from the formalin-fixed paraffin specimen, and MSI status was established by BAT26 instability. Multivariate analysis was performed using Cox proportional hazard model and effects modification interaction testing. In total 814 unselected cases were included, of whom 37% received chemotherapy. Seventy-seven cases exhibited MSI. Overall, adjuvant chemotherapy produced a cancer-specific survival benefit (HR 0.52, 95% CI 0.39-0.70; P benefit. Chemotherapy was beneficial in both the MSI (HR 0.08, 95% CI 0.02-0.27; P = benefit from 5FU adjuvant chemotherapy for stage C CRC does not vary according to gender, site of tumor, pathological characteristics or MSI status. This study suggests that it would be unwise to exclude patients from being offered adjuvant chemotherapy on the basis of MSI. © 2015 The Authors. Asia-Pacific Journal of Clinical Oncology Published by Wiley Publishing Asia Pty Ltd.

  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. A clinical investigation of motivation to change standards and cognitions about failure in perfectionism.

    Science.gov (United States)

    Egan, Sarah J; Piek, Jan P; Dyck, Murray J; Rees, Clare S; Hagger, Martin S

    2013-10-01

    Clinical perfectionism is a transdiagnostic process that has been found to maintain eating disorders, anxiety disorders and depression. Cognitive behavioural models explaining the maintenance of clinical perfectionism emphasize the contribution of dichotomous thinking and resetting standards higher following both success and failure in meeting their goals. There has been a paucity of research examining the predictions of the models and motivation to change perfectionism. Motivation to change is important as individuals with clinical perfectionism often report many perceived benefits of their perfectionism; they are, therefore, likely to be ambivalent regarding changing perfectionism. The aim was to compare qualitative responses regarding questions about motivation to change standards and cognitions regarding failure to meet a personal standard in two contrasting groups with high and low negative perfectionism. Negative perfectionism refers to concern over not meeting personal standards. A clinical group with a range of axis 1 diagnoses who were elevated on negative perfectionism were compared to a group of athletes who were low on negative perfectionism. Results indicated that the clinical group perceived many negative consequences of their perfectionism. They also, however, reported numerous benefits and the majority stated that they would prefer not to change their perfectionism. The clinical group also reported dichotomous thinking and preferring to either keep standards the same or reset standards higher following failure, whilst the athlete group reported they would keep standards the same or set them lower. The findings support predictions of the cognitive behavioural model of clinical perfectionism.

  14. 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...

  15. 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

  16. In 'big bang' major incidents do triage tools accurately predict clinical priority?: a systematic review of the literature.

    Science.gov (United States)

    Kilner, T M; Brace, S J; Cooke, M W; Stallard, N; Bleetman, A; Perkins, G D

    2011-05-01

    The term "big bang" major incidents is used to describe sudden, usually traumatic,catastrophic events, involving relatively large numbers of injured individuals, where demands on clinical services rapidly outstrip the available resources. Triage tools support the pre-hospital provider to prioritise which patients to treat and/or transport first based upon clinical need. The aim of this review is to identify existing triage tools and to determine the extent to which their reliability and validity have been assessed. A systematic review of the literature was conducted to identify and evaluate published data validating the efficacy of the triage tools. Studies using data from trauma patients that report on the derivation, validation and/or reliability of the specific pre-hospital triage tools were eligible for inclusion.Purely descriptive studies, reviews, exercises or reports (without supporting data) were excluded. The search yielded 1982 papers. After initial scrutiny of title and abstract, 181 papers were deemed potentially applicable and from these 11 were identified as relevant to this review (in first figure). There were two level of evidence one studies, three level of evidence two studies and six level of evidence three studies. The two level of evidence one studies were prospective validations of Clinical Decision Rules (CDR's) in children in South Africa, all the other studies were retrospective CDR derivation, validation or cohort studies. The quality of the papers was rated as good (n=3), fair (n=7), poor (n=1). There is limited evidence for the validity of existing triage tools in big bang major incidents.Where evidence does exist it focuses on sensitivity and specificity in relation to prediction of trauma death or severity of injury based on data from single or small number patient incidents. The Sacco system is unique in combining survivability modelling with the degree by which the system is overwhelmed in the triage decision system. The

  17. 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

  18. The cost utility of a multi-disciplinary foot protection clinic (MDFPC) in an Irish hospital setting.

    LENUS (Irish Health Repository)

    Nason, G J

    2012-04-21

    BACKGROUND: Foot ulceration which may result in lower limb amputation is one of the most feared complications among patients with diabetes and the prevention of both ulceration and amputation is a major challenge facing the health service. Many studies have proposed dedicated diabetic foot teams as the future of diabetic foot care. AIMS: We aimed to quantify the cost benefit and sustainability of a multi-disciplinary foot protection clinic (MDFPC) in an Irish university hospital setting. METHODS: A dedicated bi-weekly consultant-led MDFPC including Vascular Surgery, Endocrinology, Orthopaedic Surgery, Podiatry, Orthotics and Tissue Viability was established in June 2008. RESULTS: Between 2006 and 2010, a total of 221 lower limb procedures (major\\/minor amputations and debridement) were performed. The number of major amputations decreased from 12 during the control period (2 years before the clinic) to 7 in the study period (2 years after the clinic). After costing all activity associated with the clinic, there was an overall saving of 114,063 per year associated with the introduction of the MDFPC. CONCLUSION: This is the first study in an Irish context, and one of few international studies, to demonstrate that an aggressive-coordinated approach to diabetic foot care is both cost effective and clinically efficient in reducing the burden of foot-related complications in a diabetic population.

  19. Physician to investigator: clinical practice to clinical research--ethical, operational, and financial considerations.

    Science.gov (United States)

    Pierre, Christine

    2008-01-01

    Physicians who participate in clinical research studies gain benefits for themselves, their practice, and their patients. Historically, private practice physicians have chosen to defer to their counterparts in academic medicine when it comes to contributing to scientific advancement through clinical studies. A growing number of private practice physicians are now taking a serious second look and deciding that there are unique benefits for both the practice and the patient. Physicians who decide to participate in clinical research should give serious consideration to the time and resources that are required to meet both federal regulations and industry standards. In addition, ethical and scientific principles for assuring the protection of human research subjects must be a paramount commitment.

  20. Global health training and international clinical rotations during residency: current status, needs, and opportunities.

    Science.gov (United States)

    Drain, Paul K; Holmes, King K; Skeff, Kelley M; Hall, Thomas L; Gardner, Pierce

    2009-03-01

    Increasing international travel and migration have contributed to globalization of diseases. Physicians today must understand the global burden and epidemiology of diseases, the disparities and inequities in global health systems, and the importance of cross-cultural sensitivity. To meet these needs, resident physicians across all specialties have expressed growing interest in global health training and international clinical rotations. More residents are acquiring international experience, despite inadequate guidance and support from most accreditation organizations and residency programs. Surveys of global health training, including international clinical rotations, highlight the benefits of global health training as well as the need for a more coordinated approach. In particular, international rotations broaden a resident's medical knowledge, reinforce physical examination skills, and encourage practicing medicine among underserved and multicultural populations. As residents recognize these personal and professional benefits, a strong majority of them seek to gain international clinical experience. In conclusion, with feasible and appropriate administrative steps, all residents can receive global health training and be afforded the accreditation and programmatic support to participate in safe international rotations. The next steps should address accreditation for international rotations and allowance for training away from continuity clinics by residency accreditation bodies, and stipend and travel support for six or more weeks of call-free elective time from residency programs.

  1. The benefits of improved technologies in agricultural aviation. [economic impact and aircraft configurations

    Science.gov (United States)

    1978-01-01

    The economic benefits attributable to a variety of potential technological improvements in agricultural aviation are discussed. Topics covered include: the ag-air industry, the data base used to estimate the potential benefits and a summary of the potential benefits from technological improvements; ag-air activities in the United States; foreign ag-air activities; major ag-air aircraft is use and manufacturers' sales and distribution networks; and estimates of the benefits to the United States of proposed technological improvements to the aircraft and dispersal equipment. A bibliography of references is appended.

  2. Age at onset of major depressive disorder in Han Chinese women: Relationship with clinical features and family history☆

    Science.gov (United States)

    Yang, Fuzhong; Li, Yihan; Xie, Dong; Shao, Chunhong; Ren, Jianer; Wu, Wenyuan; Zhang, Ning; Zhang, Zhen; Zou, Ying; Zhang, Jiulong; Qiao, Dongdong; Gao, Chengge; Li, Youhui; Hu, Jian; Deng, Hong; Wang, Gang; Du, Bo; Wang, Xumei; Liu, Tiebang; Gan, Zhaoyu; Peng, Juyi; Wei, Bo; Pan, Jiyang; Chen, Honghui; Sun, Shufan; Jia, Hong; Liu, Ying; Chen, Qiaoling; Wang, Xueyi; Cao, Juling; Lv, Luxian; Chen, Yunchun; Ha, Baowei; Ning, Yuping; Chen, YiPing; Kendler, Kenneth S.; Flint, Jonathan; Shi, Shenxun

    2011-01-01

    Background Individuals with early-onset depression may be a clinically distinct group with particular symptom patterns, illness course, comorbidity and family history. This question has not been previously investigated in a Han Chinese population. Methods We examined the clinical features of 1970 Han Chinese women with DSM-IV major depressive disorder (MDD) between 30 and 60 years of age across China. Analysis of linear, logistic and multiple logistic regression models was used to determine the association between age at onset (AAO) with continuous, binary and discrete characteristic clinical features of MDD. Results Earlier AAO was associated with more suicidal ideation and attempts and higher neuroticism, but fewer sleep, appetite and weight changes. Patients with an earlier AAO were more likely to suffer a chronic course (longer illness duration, more MDD episodes and longer index episode), increased rates of MDD in their parents and a lower likelihood of marriage. They tend to have higher comorbidity with anxiety disorders (general anxiety disorder, social phobia and agoraphobia) and dysthymia. Conclusions Early AAO in MDD may be an index of a more severe, highly comorbid and familial disorder. Our findings indicate that the features of MDD in China are similar to those reported elsewhere in the world. PMID:21782247

  3. Age at onset of major depressive disorder in Han Chinese women: relationship with clinical features and family history.

    Science.gov (United States)

    Yang, Fuzhong; Li, Yihan; Xie, Dong; Shao, Chunhong; Ren, Jianer; Wu, Wenyuan; Zhang, Ning; Zhang, Zhen; Zou, Ying; Zhang, Jiulong; Qiao, Dongdong; Gao, Chengge; Li, Youhui; Hu, Jian; Deng, Hong; Wang, Gang; Du, Bo; Wang, Xumei; Liu, Tiebang; Gan, Zhaoyu; Peng, Juyi; Wei, Bo; Pan, Jiyang; Chen, Honghui; Sun, Shufan; Jia, Hong; Liu, Ying; Chen, Qiaoling; Wang, Xueyi; Cao, Juling; Lv, Luxian; Chen, Yunchun; Ha, Baowei; Ning, Yuping; Chen, Yiping; Kendler, Kenneth S; Flint, Jonathan; Shi, Shenxun

    2011-12-01

    Individuals with early-onset depression may be a clinically distinct group with particular symptom patterns, illness course, comorbidity and family history. This question has not been previously investigated in a Han Chinese population. We examined the clinical features of 1970 Han Chinese women with DSM-IV major depressive disorder (MDD) between 30 and 60 years of age across China. Analysis of linear, logistic and multiple logistic regression models was used to determine the association between age at onset (AAO) with continuous, binary and discrete characteristic clinical features of MDD. Earlier AAO was associated with more suicidal ideation and attempts and higher neuroticism, but fewer sleep, appetite and weight changes. Patients with an earlier AAO were more likely to suffer a chronic course (longer illness duration, more MDD episodes and longer index episode), increased rates of MDD in their parents and a lower likelihood of marriage. They tend to have higher comorbidity with anxiety disorders (general anxiety disorder, social phobia and agoraphobia) and dysthymia. Early AAO in MDD may be an index of a more severe, highly comorbid and familial disorder. Our findings indicate that the features of MDD in China are similar to those reported elsewhere in the world. Copyright © 2011 Elsevier B.V. All rights reserved.

  4. 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.

  5. Institution-wide peer mentoring: Benefits for mentors

    Directory of Open Access Journals (Sweden)

    Susan Beltman

    2012-08-01

    Full Text Available Extensive research has shown the benefits of mentoring, including peer mentoring, for higher education students, especially in their first year. However, few studies have focussed exclusively on the outcomes for the mentors themselves. This paper reports the findings of data gathered over three years about a university-wide peer mentoring program. Benefits identified by 858 mentors were coded inductively and four major categories emerged: altruistic, cognitive, social and personal growth. The findings have implications for the promotion of mentor programs to administrators and to prospective mentors. The study provides evidence that university-wide peer mentoring programs offer multiple positive outcomes for the mentors involved, and potentially for higher education institutions administering and supporting such programs. 

  6. 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

  7. Clinical Pharmacopsychology

    DEFF Research Database (Denmark)

    Fava, Giovanni A.; Tomba, Elena; Bech, Per

    2017-01-01

    of its most representative expressions and reference to current challenges of clinical research, with particular reference to clinimetrics. The domains of clinical pharmacopsychology encompass the clinical benefits of psychotropic drugs, the characteristics that predict responsiveness to treatment...... effects, (b) treatment-induced unwanted side effects, and (c) the patient's own personal experience of a change in terms of well-being and/or quality of life. Clinical pharmacopsychology offers a unifying framework for the understanding of clinical phenomena in medical and psychiatric settings. Research......The aim of this critical review was to outline emerging trends and perspectives of clinical pharmacopsychology, an area of clinical psychology that is concerned with the psychological effects of medications. The historical development of clinical pharmacopsychology is outlined, with discussion...

  8. The construct validity of the Major Depression Inventory

    DEFF Research Database (Denmark)

    Nielsen, Marie Germund; Ørnbøl, Eva; Vestergaard, Mogens

    2017-01-01

    Objective We aimed to assess the measurement properties of the ten-item Major Depression Inventory when used on clinical suspicion in general practice by performing a Rasch analysis. Methods General practitioners asked consecutive persons to respond to the web-based Major Depression Inventory...... on clinical suspicion of depression. We included 22 practices and 245 persons. Rasch analysis was performed using RUMM2030 software. The Rasch model fit suggests that all items contribute to a single underlying trait (defined as internal construct validity). Mokken analysis was used to test dimensionality...... for gender, age, work status and education. The Rasch and Mokken analyses revealed two dimensions, but the Major Depression Inventory showed fit to one scale if items 9 and 10 were excluded. Conclusion Our study indicated scalability problems in the current version of the Major Depression Inventory...

  9. Training benefits from NSSS owners group participation

    International Nuclear Information System (INIS)

    Hine, R.C.; Jones, J.E.; Ruzich, K.C.

    1987-01-01

    Even though the event at Three Mile Island was a bleak moment in the history of nuclear power, many advances in the nuclear industry have evolved as a result. One such advancement involves the establishment of NSSS Vendor Owners Groups. These groups were organized on a voluntary basis with nearly all utilities participating. The main purpose was to achieve mutual benefit, both technical and financial, through joint engineering and plant operation programs. This paper focuses on the Westinghouse Owners Group, which is commonly referred to as the WOG, and how it has benefited and could further benefit utility training. The paper consists of three sections. The first section provides an overview of the WOG structure and how it functions. The second section focuses on the major accomplishments of the WOG with emphasis on the development of the Emergency Response Guidelines (ERGs). The third section provides some recommendations as to how utility training departments can better utilize their owners groups

  10. Cost/benefit analyses of reactor safety systems

    International Nuclear Information System (INIS)

    1988-01-01

    The study presents a methodology for quantitative assessment of the benefit yielded by the various engineered safety systems of a nuclear reactor containment from the standpoint of their capacity to protect the environment compared to their construction costs. The benefit is derived from an estimate of the possible damage from which the environment is protected, taking account of the probabilities of occurrence of malfunctions and accidents. For demonstration purposes, the methodology was applied to a 1 300-MWe PWR nuclear power station. The accident sequence considered was that of a major loss-of-coolant accident as investigated in detail in the German risk study. After determination of the benefits and cost/benefit ratio for the power plant and the containment systems as designed, the performance characteristics of three subsystems, the leakoff system, annulus exhaust air handling system and spray system, were varied. For this purpose, the parameters which describe these systems in the activity release programme were altered. The costs were simultaneously altered in order to take account of the performance divergences. By varying the performance of the individual sub-systems an optimization in design of these systems can be arrived at

  11. Stenting of major airway constriction

    International Nuclear Information System (INIS)

    Wu Xiaomei

    2002-01-01

    Objective: To investigate the correlated issues in the stenting treatment of major airway constriction. Methods: Nineteen cases of major airway stenting procedure were studied retrospectively. The clinical choice of stents of different advantages or deficiencies were discussed. The importance of intravenous anesthesia supporting, life-parameters monitoring during the procedures and the prevention of complications were analysed. Results: Under intravenous and local anesthesia, 19 Wallstents had been successively placed and relieved 19 cases of major airway constrictions due to malignant or benign diseases (15 of tumors, 3 of tuberculosis, 1 of tracheomalacia). Intravenous anesthesia and life-parameters monitoring had made the procedures more safe and precise. Conclusions: Major airway stenting is an reliable method for relieving tracheobronchial stenosis; and intravenous anesthesia supporting and life-parameters monitoring guarantee the satisfactions of procedures

  12. Bayesian joint modelling of benefit and risk in drug development.

    Science.gov (United States)

    Costa, Maria J; Drury, Thomas

    2018-05-01

    To gain regulatory approval, a new medicine must demonstrate that its benefits outweigh any potential risks, ie, that the benefit-risk balance is favourable towards the new medicine. For transparency and clarity of the decision, a structured and consistent approach to benefit-risk assessment that quantifies uncertainties and accounts for underlying dependencies is desirable. This paper proposes two approaches to benefit-risk evaluation, both based on the idea of joint modelling of mixed outcomes that are potentially dependent at the subject level. Using Bayesian inference, the two approaches offer interpretability and efficiency to enhance qualitative frameworks. Simulation studies show that accounting for correlation leads to a more accurate assessment of the strength of evidence to support benefit-risk profiles of interest. Several graphical approaches are proposed that can be used to communicate the benefit-risk balance to project teams. Finally, the two approaches are illustrated in a case study using real clinical trial data. Copyright © 2018 John Wiley & Sons, Ltd.

  13. Hydropower - internalized costs and externalized benefits

    International Nuclear Information System (INIS)

    Koch, F.H.

    2002-01-01

    The benefits of hydropower consist of the minimal level of noxious and greenhouse gas emissions, it's energy security from political instability, and its renewable, non-depletable nature. The costs of hydropower consist of negative effects on the river ecosystem and of social changes in communities in the vicinity of large projects. Public awareness of these costs has increased dramatically during the past two decades, and new hydro projects will not get approval unless adequate mitigation measures are taken to avoid, offset, or compensate for adverse environmental and social effects. To a very large extent, the hydropower industry has internalized what were previously social and environmental externalities. However, hydropower operators do not receive any compensation for the benefits, and to date their competitors (coal, natural gas, oil) have not been required to internalize their adverse environmental externalities. (emissions, depletion of supplies, and sometimes dependence on imported primary energy sources). This creates an uneven playing field, and the hydropower industry enthusiastically welcomes a discussion of this issue, and eventually measures to rectify the situation. The IEA Hydropower Agreement has completed a major international study on the environmental and social impacts of hydropower, and one major component of this study was a Life Cycle Assessment and comparison of all the most important electricity generation technologies. (author)

  14. The Benefits and Challenges of Multiple Health Behavior Change in Research and in Practice

    Science.gov (United States)

    Prochaska, Judith J.; Nigg, Claudio R.; Spring, Bonnie; Velicer, Wayne F.; Prochaska, James O.

    2009-01-01

    Objective The major chronic diseases are caused by multiple risks, yet the science of multiple health behavior change (MHBC) is at an early stage, and factors that facilitate or impede scientists’ involvement in MHBC research are unknown. Benefits and challenges of MHBC interventions were investigated to strengthen researchers’ commitment and prepare them for challenges. Method An online anonymous survey was emailed to listservs of the Society of Behavioral Medicine between May 2006 and 2007. Respondents (N = 69) were 83% female; 94% held a doctoral degree; 64% were psychologists, 24% were in public health; 83% targeted MHBC in their work. Results A sample majority rated 23 of the 24 benefits, but only 1 of 31 challenge items, as very-to-extremely important. Those engaged in MHBC rated the total benefits significantly higher than respondents focused on single behaviors, F(1,69) = 4.21, pbehaviors do not fully appreciate the benefits that impress MHBC researchers; it is not that substantial barriers are holding them back. Benefits of MHBC interventions need emphasizing more broadly to advance this research area. PMID:19948184

  15. Nuclear energy risks and benefits in perspective

    International Nuclear Information System (INIS)

    Gordelier, S.

    2007-01-01

    Energy demand, rising prices, security of supply, climate change... these are major issues facing today's energy policy makers. In response, the NEA has recently published a study on Risks and Benefits of Nuclear Energy in order to provide these policy makers with authoritative information in support of their decision making. The study has also provided much of the basis for this article. (author)

  16. Major issues associated with DOE commercial recycling initiatives

    International Nuclear Information System (INIS)

    Motl, G.P.; Burns, D.D.; Rast, D.M.

    1994-01-01

    Major initiatives are underway within DOE to recycle large volumes of scrap material generated during cleanup of the DOE Weapons Complex. These recycling initiatives are driven not only by the desire to conserve natural resources, but also by the recognition that shallow level burial is not a politically acceptable option. The Fernald facility is in the vanguard of a number of major DOE recycling efforts. These early efforts have brought issues to light that can have a major impact on the ability of Fernald and other major DOE sites to expand recycling efforts in the future. Some of these issues are; secondary waste deposition, title to material and radioactive contaminants, mixed waste generated during recycling, special nuclear material possession limits, cost benefit, transportation of waste to processing facilities, release criteria, and uses for beneficially reused products

  17. Why providers participate in clinical trials: considering the National Cancer Institute's Community Clinical Oncology Program.

    Science.gov (United States)

    McAlearney, Ann Scheck; Song, Paula H; Reiter, Kristin L

    2012-11-01

    The translation of research evidence into practice is facilitated by clinical trials such as those sponsored by the National Cancer Institute's Community Clinical Oncology Program (CCOP) that help disseminate cancer care innovations to community-based physicians and provider organizations. However, CCOP participation involves unsubsidized costs and organizational challenges that raise concerns about sustained provider participation in clinical trials. This study was designed to improve our understanding of why providers participate in the CCOP in order to inform the decision-making process of administrators, clinicians, organizations, and policy-makers considering CCOP participation. We conducted a multi-site qualitative study of five provider organizations engaged with the CCOP. We interviewed 41 administrative and clinician key informants, asking about what motivated CCOP participation, and what benefits they associated with involvement. We deductively and inductively analyzed verbatim interview transcripts, and explored themes that emerged. Interviewees expressed both "altruistic" and "self-interested" motives for CCOP participation. Altruistic reasons included a desire to increase access to clinical trials and feeling an obligation to patients. Self-interested reasons included the desire to enhance reputation, and a need to integrate disparate cancer care activities. Perceived benefits largely matched expressed motives for CCOP participation, and included internal and external benefits to the organization, and quality of care benefits for both patients and participating physicians. The motives and benefits providers attributed to CCOP participation are consistent with translational research goals, offering evidence that participation can contribute value to providers by expanding access to innovative medical care for patients in need. Copyright © 2012 Elsevier Inc. All rights reserved.

  18. Health Benefits of Particle Filtration

    Energy Technology Data Exchange (ETDEWEB)

    Fisk, William J.

    2013-10-01

    The evidence of health benefits of particle filtration in homes and commercial buildings is reviewed. Prior reviews of papers published before 2000 are summarized. The results of 16 more recent intervention studies are compiled and analyzed. Also, reviewed are four studies that modeled health benefits of using filtration to reduce indoor exposures to particles from outdoors. Prior reviews generally concluded that particle filtration is, at best, a source of small improvements in allergy and asthma health effects; however, many early studies had weak designs. A majority of recent intervention studies employed strong designs and more of these studies report statistically significant improvements in health symptoms or objective health outcomes, particularly for subjects with allergies or asthma. The percent age improvement in health outcomes is typically modest, for example, 7percent to 25percent. Delivery of filtered air to the breathing zone of sleeping allergic or asthmatic persons may be more consistently effective in improving health than room air filtration. Notable are two studies that report statistically significant improvements, with filtration, in markers that predict future adverse coronary events. From modeling, the largest potential benefits of indoor particle filtration may be reductions in morbidity and mortality from reducing indoor exposures to particles from outdoor air.

  19. Health Benefits of Particle Filtration

    Energy Technology Data Exchange (ETDEWEB)

    Fisk, William J.

    2013-10-01

    The evidence of health benefits of particle filtration in homes and commercial buildings is reviewed. Prior reviews of papers published before 2000 are summarized. The results of 16 more recent intervention studies are compiled and analyzed. Also reviewed are four studies that modeled health benefits of using filtration to reduce indoor exposures to particles from outdoors. Prior reviews generally concluded that particle filtration is, at best, a source of small improvements in allergy and asthma health effects; however, many early studies had weak designs. A majority of recent intervention studies employed strong designs and more of these studies report statistically significant improvements in health symptoms or objective health outcomes, particularly for subjects with allergies or asthma. The percentage improvement in health outcomes is typically modest, e.g., 7percent to 25percent. Delivery of filtered air to the breathing zone of sleeping allergic or asthmatic persons may be more consistently effective in improving health than room air filtration. Notable are two studies that report statistically significant improvements, with filtration, in markers that predict future adverse coronary events. From modeling, the largest potential benefits of indoor particle filtration may be reductions in morbidity and mortality from reducing indoor exposures to particles from outdoor air.

  20. Sex differences in the clinical characteristics and brain gray matter volume alterations in unmedicated patients with major depressive disorder.

    Science.gov (United States)

    Yang, Xiao; Peng, Zugui; Ma, Xiaojuan; Meng, Yajing; Li, Mingli; Zhang, Jian; Song, Xiuliu; Liu, Ye; Fan, Huanhuan; Zhao, Liansheng; Deng, Wei; Li, Tao; Ma, Xiaohong

    2017-05-30

    This study was to explore the sex differences in clinical characteristics and brain gray matter volume (GMV) alterations in 29 male patients with major depressive disorder (MDDm), 53 female patients with MDD (MDDf), and in 29 male and 53 female matched healthy controls. Maps of GMV were constructed using magnetic resonance imaging data and compared between groups. We evaluated clinical symptoms using the Hamilton Rating Scale for Depression and obtained a total score and five syndrome scores. A two-factor ANCOVA model was specified using SPM8, with sex and diagnosis as the between-subject factors. We found that: (1) significant GMV increase in the left cerebellum and GMV reduction in the bilateral middle temporal gyrus and left ventral medial prefrontal gyrus occurred selectively in male patients, while the GMV reduction in the left lingual gyrus and dorsal medial prefrontal gyrus occurred selectively in female patients; (2) MDDf may have experienced more severe sleep disturbance than MDDm; and (3) the severity of sleep symptom could be predicted by the sex specific brain structural alterations in depressions. These findings suggest that sex specific anatomical alterations existed in MDD, and these alterations were associated with the clinical symptoms.

  1. HBV DNA Integration: Molecular Mechanisms and Clinical Implications

    Science.gov (United States)

    Tu, Thomas; Budzinska, Magdalena A.; Shackel, Nicholas A.; Urban, Stephan

    2017-01-01

    Chronic infection with the Hepatitis B Virus (HBV) is a major cause of liver-related morbidity and mortality. One peculiar observation in cells infected with HBV (or with closely‑related animal hepadnaviruses) is the presence of viral DNA integration in the host cell genome, despite this form being a replicative dead-end for the virus. The frequent finding of somatic integration of viral DNA suggests an evolutionary benefit for the virus; however, the mechanism of integration, its functions, and the clinical implications remain unknown. Here we review the current body of knowledge of HBV DNA integration, with particular focus on the molecular mechanisms and its clinical implications (including the possible consequences of replication-independent antigen expression and its possible role in hepatocellular carcinoma). HBV DNA integration is likely to influence HBV replication, persistence, and pathogenesis, and so deserves greater attention in future studies. PMID:28394272

  2. Clinical and sociodemographic correlates of suicidality in patients with major depressive disorder from six Asian countries.

    Science.gov (United States)

    Lim, Ah-Young; Lee, Ah-Rong; Hatim, Ahmad; Tian-Mei, Si; Liu, Chia-Yih; Jeon, Hong Jin; Udomratn, Pichet; Bautista, Dianne; Chan, Edwin; Liu, Shen-Ing; Chua, Hong Choon; Hong, Jin Pyo

    2014-02-13

    East Asian countries have high suicide rates. However, little is known about clinical and sociodemographic factors associated with suicidality in Asian populations. The aim of this study was to evaluate the factors associated with suicidality in patients with major depressive disorder (MDD) from six Asian countries. The study cohort consisted of 547 outpatients with MDD. Patients presented to study sites in China (n = 114), South Korea (n = 101), Malaysia (n = 90), Singapore (n = 40), Thailand (n = 103), and Taiwan (n = 99). All patients completed the Mini-International Neuropsychiatric Interview (MINI), the Montgomery-Asberg Depression Rating Scale (MADRS), the Global Severity Index(SCL-90R), the Fatigue Severity Scale, the 36-item short-form health survey, the Sheehan Disability Scale, and the Multidimensional Scale of Perceived Social Support (MSPSS). Patients were classified as showing high suicidality if they scored ≥ 6 on the MINI suicidality module. Multivariate logistic regression analysis was used to examine sociodemographic and clinical factors related to high suicidality. One hundred and twenty-five patients were classed as high suicidality. Unemployed status (adjusted odds ratio [OR] 2.43, p < 0.01), MADRS score (adjusted OR 1.08), p < 0.001, and GSI (SCL-90R) score (adjusted OR 1.06, p < 0.01) were positively related to high suicidality. Hindu (adjusted OR 0.09, p < 0.05) or Muslim (adjusted OR 0.21, p < 0.001) religion and MSPSS score (adjusted OR 0.82, p < 0.05) were protective against high suicidality. A variety of sociodemographic and clinical factors were associated with high suicidality in Asian patients with MDD. These factors may facilitate the identification of MDD patients at risk of suicide.

  3. 42 CFR 411.204 - Medicare benefits secondary to LGHP benefits.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 2 2010-10-01 2010-10-01 false Medicare benefits secondary to LGHP benefits. 411... benefits secondary to LGHP benefits. (a) Medicare benefits are secondary to benefits payable by an LGHP for services furnished during any month in which the individual— (1) Is entitled to Medicare Part A benefits...

  4. Clinical Trials

    Medline Plus

    Full Text Available ... study explored whether the benefits of lowering high blood pressure in the elderly outweighed the risks. Other examples of clinical trials that test principles or strategies include studies that explore whether ...

  5. The benefits of playing video games.

    Science.gov (United States)

    Granic, Isabela; Lobel, Adam; Engels, Rutger C M E

    2014-01-01

    Video games are a ubiquitous part of almost all children's and adolescents' lives, with 97% playing for at least one hour per day in the United States. The vast majority of research by psychologists on the effects of "gaming" has been on its negative impact: the potential harm related to violence, addiction, and depression. We recognize the value of that research; however, we argue that a more balanced perspective is needed, one that considers not only the possible negative effects but also the benefits of playing these games. Considering these potential benefits is important, in part, because the nature of these games has changed dramatically in the last decade, becoming increasingly complex, diverse, realistic, and social in nature. A small but significant body of research has begun to emerge, mostly in the last five years, documenting these benefits. In this article, we summarize the research on the positive effects of playing video games, focusing on four main domains: cognitive, motivational, emotional, and social. By integrating insights from developmental, positive, and social psychology, as well as media psychology, we propose some candidate mechanisms by which playing video games may foster real-world psychosocial benefits. Our aim is to provide strong enough evidence and a theoretical rationale to inspire new programs of research on the largely unexplored mental health benefits of gaming. Finally, we end with a call to intervention researchers and practitioners to test the positive uses of video games, and we suggest several promising directions for doing so. PsycINFO Database Record (c) 2014 APA, all rights reserved.

  6. 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

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

    Science.gov (United States)

    Gillum, Richard F

    2013-10-01

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

  8. Benefits and challenges of practicing taekwondo to adolescents in Addis Ababa City, Ethiopia

    Directory of Open Access Journals (Sweden)

    Michael Emru Tadesse

    2016-03-01

    Full Text Available This study aimed at examining the benefits and challenges of practicing Taekwondo (TKD to adolescents in Addis Ababa. In so doing, the study investigated the nature of TKD training, benefits of practicing TKD, and challenges/problems related with practicing TKD. A descriptive concurrent mixed methods research design was used. Accordingly, the quantitative part of the study had 108 TKD adolescent participants while the qualitative part had 12 participants (eight TKD adolescents and four TKD coaches, from four TKD clubs in Addis Ababa. Both one-stage cluster sampling technique and purposive sampling technique were employed to select participants for the quantitative and qualitative parts of the study, respectively. Questionnaires and in-depth interviews were used to collect data from participants. Results of the study indicated: (1 the TKD training provided by the four TKD clubs was more of a modern/sport form of TKD; (2 TKD adolescents and coaches perceived that the benefits of TKD for adolescents are multifaceted, i.e., social benefits, physical benefits, mental benefits, self-defense, addiction avoidance, and other benefits; and (3 though majority (63.6% of the respondents claimed that they did not face any problem as a result of practicing TKD, the following were identified as major problems that could threaten the wellbeing of TKD adolescents: family-related problems, community-related problems, and competition-related problems. In general, results show that the training of TKD can have a multifaceted positive contribution to adolescents’ wellbeing.

  9. Patient-Centered Medical Home Undergraduate Internship, Benefits to a Practice Manager: Case Study.

    Science.gov (United States)

    Sasnett, Bonita; Harris, Susie T; White, Shelly

    Health services management interns become practice facilitators for primary care clinics interested in pursuing patient-centered recognition for their practice. This experience establishes a collaborative relationship between the university and clinic practices where students apply their academic training to a system of documentation to improve the quality of patient care delivery. The case study presents the process undertaken, benefits, challenges, lessons learned, and recommendations for intern, practice mangers, and educators. The practice manager benefits as interns become Patient-Centered Medical Home facilitators and assist practice managers in the recognition process.

  10. How changes to the Medicare Benefits Schedule could improve the practice of cardiology and save taxpayer money.

    Science.gov (United States)

    Harper, Richard W; Nasis, Arthur; Sundararajan, Vijaya

    2015-09-21

    Rising health care costs above inflation are placing serious strains on the sustainability of the Australian Medicare system in its current structure. The Medicare Benefits Schedule (MBS), which lists rebates payable to patients for private medical services provided on a fee-for-service basis, is the cornerstone of the Australian health care system. Introduced in the 1980s, the MBS has changed little despite major advances in the evidence base for the practice of cardiology. We outline how we believe sensible changes to the MBS listings for four cardiac services--invasive coronary angiography, computed tomography coronary angiography, stress testing and percutaneous coronary intervention--would improve the clinical practice of cardiology and save substantial amounts of taxpayer money.

  11. 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

  12. [Benefits of aromatherapy in dementia special care units].

    Science.gov (United States)

    Bilien, Corinne; Depas, Nathalie; Delaporte, Ghislaine; Baptiste, Nathalie

    2016-01-01

    Aromatherapy is classed as a non-pharmacological treatment, recognised as a therapy for certain disorders. This practice was the subject of a study in a special care unit for patients with dementia. The objective was to demonstrate the benefit of aromatherapy diffusion on major behavioural disorders. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  13. 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.

  14. Potential Relationship between Season of Birth and Clinical Characteristics in Major Depressive Disorder in Koreans: Results from the CRESCEND Study.

    Science.gov (United States)

    Park, Seon-Cheol; Sakong, Jeong-Kyu; Koo, Bon Hoon; Kim, Jae-Min; Jun, Tae-Youn; Lee, Min-Soo; Kim, Jung-Bum; Yim, Hyeon-Woo; Park, Yong Chon

    2016-05-01

    We aimed to examine the potential relationship between season of birth (SOB) and clinical characteristics in Korean patients with unipolar non-psychotic major depressive disorder (MDD). Using data from the Clinical Research Center for Depression (CRESCEND) study in South Korea, 891 MDD patients were divided into two groups, those born in spring/summer (n=457) and those born in autumn/winter (n=434). Measurement tools comprising the Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, Brief Psychiatric Rating Scale, Scale for Suicidal Ideation, Clinical Global Impression of severity, Social and Occupation Functional Assessment Scale, WHO Quality of Life assessment instrument-abbreviated version, Alcohol Use Disorder Identification Test, and Temperament and Character Inventory were used to evaluate depression, anxiety, overall symptoms, suicidal ideation, global severity, social function, quality of life, drinking, and temperament and character, respectively. Using independent t-tests for continuous variables and χ² tests for discrete variables, the clinical characteristics of the two groups were compared. MDD patients born in spring/summer were on average younger at onset of first depressive episode (t=2.084, p=0.038), had greater loss of concentration (χ²=4.589, p=0.032), and were more self-directed (t=2.256, p=0.025) than those born in autumn/winter. Clinically, there was a trend for the MDD patients born in spring/summer to display the contradictory characteristics of more severe clinical course and less illness burden; this may have been partly due to a paradoxical effect of the 5-HT system.

  15. The Society for Vascular Surgery lower extremity threatened limb classification system based on Wound, Ischemia, and foot Infection (WIfI) correlates with risk of major amputation and time to wound healing.

    Science.gov (United States)

    Zhan, Luke X; Branco, Bernardino C; Armstrong, David G; Mills, Joseph L

    2015-04-01

    The purpose of this study was to evaluate whether the new Society for Vascular Surgery (SVS) Wound, Ischemia, and foot Infection (WIfI) classification system correlates with important clinical outcomes for limb salvage and wound healing. A total of 201 consecutive patients with threatened limbs treated from 2010 to 2011 in an academic medical center were analyzed. These patients were stratified into clinical stages 1 to 4 on the basis of the SVS WIfI classification. The SVS objective performance goals of major amputation, 1-year amputation-free survival (AFS) rate, and wound healing time (WHT) according to WIfI clinical stages were compared. The mean age was 58 years (79% male, 93% with diabetes). Forty-two patients required major amputation (21%); 159 (78%) had limb salvage. The amputation group had a significantly higher prevalence of advanced stage 4 patients (P healing. As the clinical stage progresses, the risk of major amputation increases, 1-year AFS declines, and WHT is prolonged. We further demonstrated benefit of revascularization to improve WHT in selected patients, especially those in stage 3. Future efforts are warranted to incorporate the SVS WIfI classification into clinical decision-making algorithms in conjunction with a comorbidity index and anatomic classification. Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

  16. Attitudes of Patients in Developing Countries Toward Participating in Clinical Trials: A Survey of Saudi Patients Attending Primary Health Care Services

    Directory of Open Access Journals (Sweden)

    Lateefa O. Al-Dakhil

    2016-07-01

    Full Text Available Objectives: Clinical trials are experimental projects that include patients as subjects. A number of benefits are directly associated with clinical trials. Healthcare processes and outcomes can be improved with the help of clinical trials. This study aimed to assess the attitudes and beliefs of patients about their contribution to and enrolment in clinical trials. Methods: A cross-sectional study design was used for data collection and analysis. A questionnaire was developed with six categories to derive effective outcomes. Results: Of the 2000 participants approached to take part in the study, 1081 agreed. The majority of the study population was female, well educated, and unaware of clinical trials. Only 324 subjects (30.0% had previously agreed to participate in a clinical trial. The majority (87.1% were motivated to participate in clinical trials due to religious aspects. However, fear of any risk was the principal reason (79.8% that reduced their motivation to participate. Conclusions: The results of this study revealed that patients in Saudi Arabia have a low awareness and are less willing to participate in clinical trials. Different motivational factors and awareness programs can be used to increase patient participation in the future.

  17. What You Get when You Give: How Graduate Students Benefit from Serving as Mentors

    Science.gov (United States)

    Reddick, Richard J.; Griffin, Kimberly A.; Cherwitz, Richard A.; Cerda-Prazak, Aida A.; Bunch, Nathan

    2012-01-01

    This study utilizes a social exchange framework to analyze the qualitative narratives of 81 graduate student mentors participating in the Intellectual Entrepreneurship Pre-Graduate Internship at The University of Texas at Austin. Findings suggest that in addition to personal benefits, mentorship has four major professional benefits: a deeper…

  18. Medicinal benefits of marine invertebrates: sources for discovering natural drug candidates.

    Science.gov (United States)

    De Zoysa, Mahanama

    2012-01-01

    Marine invertebrates are one of the major groups of organisms, which could be diversified under the major taxonomic groups of Porifera, Cnidaria, Mollusca, Arthropoda, Echinodermata, and many other minor phyla. To date, range of medicinal benefits and a significant number of marine natural products (MNPs) have been discovered from marine invertebrates. Seafood diet from edible marine invertebrates such as mollusks and crustaceans has been linked with various medicinal benefits to improve human health. Among marine invertebrates, spongers from phylum Porifera is the most dominant group responsible for discovering large number of MNPs, which have been used as template to develop therapeutic drugs. MNPs isolated from invertebrates have shown wide range of therapeutic properties including antimicrobial, antioxidant, antihypertensive, anticoagulant, anticancer, anti-inflammatory, wound healing and immune modulator, and other medicinal effects. Therefore, marine invertebrates are rich sources of chemical diversity and health benefits for developing drug candidates, cosmetics, nutritional supplements, and molecular probes that can be supported to increase the healthy life span of human. Copyright © 2012 Elsevier Inc. All rights reserved.

  19. 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.

  20. An analysis of correlations among four outcome scales employed in clinical trials of patients with major depressive disorder

    Directory of Open Access Journals (Sweden)

    Ahmed Saeeduddin

    2009-01-01

    Full Text Available Abstract Background The 17-item Hamilton Depression Rating Scale (HAM-D17 remains the 'gold standard' for measuring treatment outcomes in clinical trials of depressed patients. The Montgomery Ǻsberg Depression Rating Scale (MADRS, Clinical Global Impressions-Severity (CGI-S and -Improvement (CGI-I scales are also widely used. Objective This analysis of data from 22 double-blind, placebo-controlled clinical studies of venlafaxine in adult patients with major depressive disorder was aimed at assessing correlations among these 4 scales. Methods Changes from baseline for MADRS, HAM-D17 and CGI-S, and end point CGI-I scores and response (≥50% decrease from baseline HAM-D17 or MADRS, or CGI-S or CGI-I score ≤2 were analysed. Pearson correlation coefficients were calculated for all pairs of the four scales (HAM-D17/MADRS, HAM-D17/CGI-S, HAM-D17/CGI-I, MADRS/CGI-S, MADRS/CGI-I, CGI-S/CGI-I at different time points. Effect sizes were calculated using the Cohen d. Results Correlations were significant at all time points (p 17 or CGI-S for continuous measures and response. Conclusion Although MADRS and CGI-I were more sensitive to treatment effects, HAM-D17, MADRS, CGI-S and CGI-I scores present a consistent picture of response to venlafaxine treatment.

  1. Why Providers Participate in Clinical Trials: Considering the National Cancer Institute’s Community Clinical Oncology Program

    Science.gov (United States)

    McAlearney, Ann Scheck; Song, Paula H.; Reiter, Kristin L.

    2012-01-01

    Background The translation of research evidence into practice is facilitated by clinical trials such as those sponsored by the National Cancer Institute’s Community Clinical Oncology Program (CCOP) that help disseminate cancer care innovations to community-based physicians and provider organizations. However, CCOP participation involves unsubsidized costs and organizational challenges that raise concerns about sustained provider participation in clinical trials. Objectives This study was designed to improve our understanding of why providers participate in the CCOP in order to inform the decision-making process of administrators, clinicians, organizations, and policy-makers considering CCOP participation. Research Methods We conducted a multi-site qualitative study of five provider organizations engaged with the CCOP. We interviewed 41 administrative and clinician key informants, asking about what motivated CCOP participation, and what benefits they associated with involvement. We deductively and inductively analyzed verbatim interview transcripts, and explored themes that emerged. Results Interviewees expressed both “altruistic” and “self-interested” motives for CCOP participation. Altruistic reasons included a desire to increase access to clinical trials and feeling an obligation to patients. Self-interested reasons included the desire to enhance reputation, and a need to integrate disparate cancer care activities. Perceived benefits largely matched expressed motives for CCOP participation, and included internal and external benefits to the organization, and quality of care benefits for both patients and participating physicians. Conclusion The motives and benefits providers attributed to CCOP participation are consistent with translational research goals, offering evidence that participation can contribute value to providers by expanding access to innovative medical care for patients in need. PMID:22925970

  2. Expanding Canada Pension Plan Retirement Benefits: Assessing Big CPP Proposals

    Directory of Open Access Journals (Sweden)

    Jonathan R. Kesselman

    2010-10-01

    Full Text Available Current and growing deficiencies in many workers’ ability to maintain their accustomed living standards in retirement have evoked varied proposals for reform of Canada’s retirement income system. This study focuses on proposals for expanding the retirement benefits of the Canada Pension Plan (CPP, and undertakes comparative analysis with proposals for reforms affecting workplace pensions and individual savings. It begins by reviewing key policy questions for the retirement income system and describing essential features of several proposals for CPP benefit expansion. It then uses these “Big CPP” proposals as a basis to assess the design issues for expanding CPP benefits and the implications for other components of the retirement income system. The paper assesses each of the major private and public savings vehicles based on multifaceted criteria for a well-performing retirement income system; a mandatory public scheme with defined benefits ranks most highly on almost all criteria other than individual flexibility. Additional behavioural and institutional factors also support the use of mandatory public pensions: myopia in savings, individual investment behaviour, scale economies and costs of fund management, adverse selection and annuitization costs, the Samaritan’s Dilemma, and labour market incentives. The study provides an overview analysis of key design issues for the expansion of CPP retirement benefits. Major issues include the desirable scale of expansion for both the percentage of insurable earnings and the insurable earnings ceiling; mandatory versus voluntary coverage and options; the allocation of investment return risk; and the phasing-in of higher premiums and benefits. The study then assesses the implications of CPP expansion for other components of the retirement income system: Old Age Security and the Guaranteed Income Supplement, workplace pensions, tax provisions for savings, and individual savings. A Big CPP fits

  3. [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.

  4. Subcortical brain alterations in major depressive disorder : findings from the ENIGMA Major Depressive Disorder working group

    NARCIS (Netherlands)

    Schmaal, L.; Veltman, D. J.; van Erp, T. G. M.; Saemann, P. G.; Frodl, T.; Jahanshad, N.; Loehrer, E.; Tiemeier, H.; Hofman, A.; Niessen, W. J.; Vernooij, M. W.; Ikram, M. A.; Wittfeld, K.; Grabe, H. J.; Block, A.; Hegenscheid, K.; Voelzke, H.; Hoehn, D.; Czisch, M.; Lagopoulos, J.; Hatton, S. N.; Hickie, I. B.; Goya-Maldonado, R.; Kraemer, B.; Gruber, O.; Couvy-Duchesne, B.; Renteria, M. E.; Strike, L. T.; Mills, N. T.; de Zubicaray, G. I.; McMahon, K. L.; Medland, S. E.; Martin, N. G.; Gillespie, N. A.; Wright, M. J.; Hall, G.B.; MacQueen, G. M.; Frey, E. M.; Carballedo, A.; van Velzen, L. S.; van Tol, M. J.; van der Wee, N. J.; Veer, I. M.; Walter, H.; Schnell, K.; Schramm, E.; Normann, C.; Schoepf, D.; Konrad, C.; Penninx, B. W. J. H.

    The pattern of structural brain alterations associated with major depressive disorder (MDD) remains unresolved. This is in part due to small sample sizes of neuroimaging studies resulting in limited statistical power, disease heterogeneity and the complex interactions between clinical

  5. Clinical outcomes in patients with atrial fibrillation according to sex during anticoagulation with apixaban or warfarin: a secondary analysis of a randomized controlled trial.

    Science.gov (United States)

    Vinereanu, Dragos; Stevens, Susanna R; Alexander, John H; Al-Khatib, Sana M; Avezum, Alvaro; Bahit, Marıa Cecilia; Granger, Christopher B; Lopes, Renato D; Halvorsen, Sigrun; Hanna, Michael; Husted, Steen; Hylek, Elaine M; Mărgulescu, Andrei D; Wallentin, Lars; Atar, Dan

    2015-12-07

    To assess clinical outcomes, efficacy, and safety according to sex during anticoagulation with apixaban compared with warfarin in patients with atrial fibrillation. Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) was a randomized, double-blind, placebo-controlled, multicentre trial that included 11 785 (64.7%) men and 6416 (35.3%) women with atrial fibrillation or flutter randomized to receive either warfarin or apixaban. The primary efficacy endpoint was stroke or systemic embolism; secondary efficacy endpoints were death from any cause and cardiovascular death. The primary safety endpoint was major bleeding; secondary safety endpoints were a composite of major bleeding and non-major clinically relevant bleeding. The risk of stroke or systemic embolism was similar in women vs. men [adjusted hazard ratio (adjHR): 0.91; 95% confidence interval (CI): 0.74-1.12; P = 0.38]. However, among patients with history of stroke or transient ischaemic attack, women had a lower risk of recurrent stroke compared with men (adjHR: 0.70; 95% CI: 0.50-0.97; P = 0.036). Women also had a lower risk of all-cause death (adjHR: 0.63; 95% CI: 0.55-0.73; P < 0.0001) and cardiovascular death (adjHR: 0.62; 95% CI: 0.51-0.75; P < 0.0001), and a trend towards less major bleeding (adjHR: 0.86; 95% CI: 0.74-1.01; P = 0.066) and major or non-major clinically relevant bleeding (adjHR: 0.89; 95% CI: 0.80-1.00; P = 0.049). The efficacy and safety benefits of apixaban compared with warfarin were consistent regardless of sex. In the ARISTOTLE trial, women had a similar rate of stroke or systemic embolism but a lower risk of mortality and less clinically relevant bleeding than men. The efficacy and safety benefits of apixaban compared with warfarin were consistent in men and women. ARISTOTLE ClinicalTrials.gov number, NCT00412984. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please

  6. Clinical Trials

    Medline Plus

    Full Text Available ... patients to find out whether a new approach causes any harm. In later phases of clinical trials, ... device improves patient outcomes; offers no benefit; or causes unexpected harm All of these results are important ...

  7. Clinical Trials

    Medline Plus

    Full Text Available ... harm. In later phases of clinical trials, researchers learn more about the new approach's risks and benefits. ... explore whether surgery or other medical treatments produce better results for certain illnesses or groups of people; ...

  8. A Diffusion Model Incorporating Product Benefits, Price, Income and Information

    OpenAIRE

    Dan Horsky

    1990-01-01

    We start by assuming that a major benefit of many new durable products such as dishwashers and microwave ovens is time savings. Others, such as VCRs, also enhance the value of our leisure time. Using a household production framework we demonstrate that a utility maximizing individual will have a reservation price for the product which is a function of the product benefits and his wage rate. By assuming that the wage rate has an extreme value distribution across the population, we are able to ...

  9. Pathophysiology of major depressive disorder: mechanisms involved in etiology are not associated with clinical progression.

    Science.gov (United States)

    Verduijn, J; Milaneschi, Y; Schoevers, R A; van Hemert, A M; Beekman, A T F; Penninx, B W J H

    2015-09-29

    Meta-analyses support the involvement of different pathophysiological mechanisms (inflammation, hypothalamic-pituitary (HPA)-axis, neurotrophic growth and vitamin D) in major depressive disorder (MDD). However, it remains unknown whether dysregulations in these mechanisms are more pronounced when MDD progresses toward multiple episodes and/or chronicity. We hypothesized that four central pathophysiological mechanisms of MDD are not only involved in etiology, but also associated with clinical disease progression. Therefore, we expected to find increasingly more dysregulation across consecutive stages of MDD progression. The sample from the Netherlands Study of Depression and Anxiety (18-65 years) consisted of 230 controls and 2333 participants assigned to a clinical staging model categorizing MDD in eight stages (0, 1A, 1B, 2, 3A, 3B, 3C and 4), from familial risk at MDD (stage 0) to chronic MDD (stage 4). Analyses of covariance examined whether pathophysiological mechanism markers (interleukin (IL)-6, C-reactive protein (CRP), cortisol, brain-derived neurotrophic factor and vitamin D) showed a linear trend across controls, those at risk for MDD (stages 0, 1A and 1B), and those with full-threshold MDD (stages 2, 3A, 3B, 3C and 4). Subsequently, pathophysiological differences across separate stages within those at risk and with full-threshold MDD were examined. A linear increase of inflammatory markers (CRP P=0.026; IL-6 P=0.090), cortisol (P=0.025) and decrease of vitamin D (P<0.001) was found across the entire sample (for example, from controls to those at risk and those with full-threshold MDD). Significant trends of dysregulations across stages were present in analyses focusing on at-risk individuals (IL-6 P=0.050; cortisol P=0.008; vitamin D P<0.001); however, no linear trends were found in dysregulations for any of the mechanisms across more progressive stages of full-threshold MDD. Our results support that the examined pathophysiological mechanisms are

  10. Insights From Pre-Clinical and Clinical Studies on the Role of Innate Inflammation in Atherosclerosis Regression

    Directory of Open Access Journals (Sweden)

    Karishma Rahman

    2018-05-01

    Full Text Available Atherosclerosis, the underlying cause of coronary artery (CAD and other cardiovascular diseases, is initiated by macrophage-mediated immune responses to lipoprotein and cholesterol accumulation in artery walls, which result in the formation of plaques. Unlike at other sites of inflammation, the immune response becomes maladaptive and inflammation fails to resolve. The most common treatment for reducing the risk from atherosclerosis is low density lipoprotein cholesterol (LDL-C lowering. Studies have shown, however, that while significant lowering of LDL-C reduces the risk of heart attacks to some degree, there is still residual risk for the majority of the population. We and others have observed “residual inflammatory risk” of atherosclerosis after plasma cholesterol lowering in pre-clinical studies, and that this phenomenon is clinically relevant has been dramatically reinforced by the recent Canakinumab Anti-inflammatory Thrombosis Outcomes Study (CANTOS trial. This review will summarize the role of the innate immune system, specifically macrophages, in atherosclerosis progression and regression, as well as the pre-clinical and clinical models that have provided significant insights into molecular pathways involved in the resolution of plaque inflammation and plaque regression. Partnered with clinical studies that can be envisioned in the post-CANTOS period, including progress in developing targeted plaque therapies, we expect that pre-clinical studies advancing on the path summarized in this review, already revealing key mechanisms, will continue to be essential contributors to achieve the goals of dampening plaque inflammation and inducing its resolution in order to maximize the therapeutic benefits of conventional risk factor modifications, such as LDL-C lowering.

  11. There is no benefit to universal carotid artery duplex screening before a major cardiac surgical procedure.

    Science.gov (United States)

    Adams, Brian C; Clark, Ross M; Paap, Christina; Goff, James M

    2014-01-01

    Perioperative stroke is a devastating complication after cardiac surgery. In an attempt to minimize this complication, many cardiac surgeons routinely preoperatively order carotid artery duplex scans to assess for significant carotid stenosis. We hypothesize that the routine screening of preoperative cardiac surgery patients with carotid artery duplex scans detects few patients who would benefit from carotid intervention or that a significant carotid stenosis reliably predicts stroke risk after cardiac surgery. A retrospective review identified 1,499 patients who underwent cardiac surgical procedures between July 1999 and September 2010. Data collected included patient demographics, comorbidities, history of previous stroke, preoperative carotid artery duplex scan results, location of postoperative stroke, and details of carotid endarterectomy (CEA) procedures before, in conjunction with, or after cardiac surgery. Statistical methods included univariate analysis and Fisher's exact test. Twenty-six perioperative strokes were identified (1.7%). In the 21 postoperative stroke patients for whom there is complete carotid artery duplex scan data, 3 patients had a hemodynamically significant lesion (>70%) and 1 patient underwent unilateral carotid CEA for bilateral disease. Postoperative strokes occurred in the anterior cerebral circulation (69.2%), posterior cerebral circulation (15.4%), or both (15.4%). Patient comorbidities, preoperative carotid artery duplex scan screening velocities, or types of cardiac surgical procedure were not predictive for stroke. Thirteen patients (0.86%) underwent CEA before, in conjunction with, or after cardiac surgery. Two of these patients had symptomatic disease, 1 of whom underwent CEA before and the other after his cardiac surgery. Of the 11 asymptomatic patients, 2 underwent CEA before, 3 concurrently, and 6 after cardiac surgery. Left main disease (≥50% stenosis), previous stroke, and peripheral vascular disease were found to be

  12. Clinical Trials

    Medline Plus

    Full Text Available ... groups, companies, and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments ... sponsor trials that test principles or strategies. For example, one NHLBI study explored whether the benefits of ...

  13. Unhealthy smokers: scopes for prophylactic intervention and clinical treatment.

    Science.gov (United States)

    Prasad, Shikha; Kaisar, Mohammad Abul; Cucullo, Luca

    2017-10-04

    Globally, tobacco use causes approximately 6 million deaths per year, and predictions report that with current trends; more than 8 million deaths are expected annually by 2030. Cigarette smokings is currently accountable for more than 480,000 deaths each year in United States (US) and is the leading cause of preventable death in the US. On average, smokers die 10 years earlier than nonsmokers and if smoking continues at its current proportion among adolescents, one in every 13 Americans aged 17 years or younger is expected to die prematurely from a smoking-related illness. Even though there has been a marginal smoking decline of around 5% in recent years (2005 vs 2015), smokers still account for 15% of the US adult population. What is also concerning is that 41,000 out of 480,000 deaths results from secondhand smoke (SHS) exposure. Herein, we provide a detailed review of health complications and major pathological mechanisms including mutation, inflammation, oxidative stress, and hemodynamic and plasma protein changes associated with chronic smoking. Further, we discuss prophylactic interventions and associated benefits and provide a rationale for the scope of clinical treatment. Considering these premises, it is evident that much detailed translational and clinical studies are needed. Factors such as the length of smoking cessation for ex-smokers, the level of smoke exposure in case of SHS, pre-established health conditions, genetics (and epigenetics modification caused by chronic smoking) are few of the criteria that need to be evaluated to begin assessing the prophylactic and/or therapeutic impact of treatments aimed at chronic and former smokers (especially early stage ex-smokers) including those frequently subjected to second hand tobacco smoke exposure. Herein, we provide a detailed review of health complications and major pathological mechanisms including mutation, inflammation, oxidative stress, and hemodynamic and plasma protein changes associated with

  14. Vortioxetine versus placebo in major depressive disorder comorbid with social anxiety disorder.

    Science.gov (United States)

    Liebowitz, Michael R; Careri, Jason; Blatt, Kyra; Draine, Ann; Morita, Junko; Moran, Melissa; Hanover, Rita

    2017-12-01

    Major Depressive Disorder (MDD) and Social Anxiety Disorder (SAD) are highly comorbid, yet the combined condition has not been subject to any placebo-controlled treatment trials. This study reports a trial of vortioxetine, an antidepressant that has also shown benefit in Generalized Anxiety Disorder (GAD), in patients meeting DSM-5 criteria for both MDD and SAD. The study was a 12-week double-blind, placebo-controlled comparison of vortioxetine 10-20 mg/day or placebo administered on a 1:1 ratio. The study was designed to include 40 male or female outpatients aged 18-70 years. The primary endpoint was the "composite" Clinical Global Impression of Improvement (CGI-I) responder rate, factoring in improvement in both MDD and SAD features. Major secondary outcome measures were changes on the Montgomery Asberg Depression Rating Scale (MADRS) and Liebowitz Social Anxiety Scale (LSAS). On the composite CGI-I, 10 of 20 (50%) vortioxetine and six of 20 (30%) placebo-treated patients were rated as responders, a non-significant difference. However, vortioxetine-treated patients did show significantly greater improvement than those on placebo on both the MADRS (effect size 0.672) and LSAS (effect size 0.714). Efficacy in depression was seen before improvement in SAD. Adverse effects were similar to those previously reported. In this preliminary trial vortioxetine appears safe and effective for patients with MDD comorbid with SAD, with robust effect sizes on dimensional measures of both depression and social anxiety, but failure to separate from placebo on the primary outcome measure of composite responder rate. More studies of patients with comorbid conditions are needed, as this mirrors what is often seen in clinical practice. © 2017 Wiley Periodicals, Inc.

  15. [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.

  16. "Clinical-CT mismatch" and the response to systemic thrombolytic therapy in acute ischemic stroke.

    Science.gov (United States)

    Kent, David M; Hill, Michael D; Ruthazer, Robin; Coutts, Shelagh B; Demchuk, Andrew M; Dzialowski, Imanuel; Wunderlich, Olaf; von Kummer, Rudiger

    2005-08-01

    Mismatch between clinical deficits and imaging lesions in acute stroke has been proposed as a method of identifying patients who have hypoperfused but still have viable brain, and may be especially apt to respond to reperfusion therapy. We explored this hypothesis using a combined database including 4 major clinical trials of intravenous (IV) thrombolytic therapy. To determine what the radiological correlates of a "matched" functional deficit are, we calculated the relationship between the ASPECT score of the 24-hour (follow-up) CT scan and the 24-hour National Institutes of Health Stroke Scale (NIHSS) score on the subsample with ASPECT scores performed at this time (n=820). Based on this empirical relationship, we computed the absolute difference between the observed baseline ASPECT score and the "expected" score (ie, matched) based on baseline NIHSS for all patients (n=2131). We tested whether patients with better than expected baseline ASPECTS were more likely to benefit from IV recombinant tissue plasminogen activation (rtPA). At 24 hours, there was a strong, linear, negative correlation between NIHSS and ASPECTS (r2=0.33, P<0.0001); on average, an increase of 10 points on NIHSS corresponded to a decrease of approximately 3 points on ASPECTS. At baseline, the average degree of mismatch between the observed and "expected" ASPECTS was 2.1 points (interquartile range, 1.0 to 3.4). However, multiple analyses failed to reveal a consistent relationship between the degree of clinical-CT mismatch at baseline and a patient's likelihood of benefiting from IV rtPA. Clinical-CT mismatch using ASPECT scoring does not reliably identify patients more or less likely to benefit from IV rtPA.

  17. Health benefits of particle filtration.

    Science.gov (United States)

    Fisk, W J

    2013-10-01

    The evidence of health benefits of particle filtration in homes and commercial buildings is reviewed. Prior reviews of papers published before 2000 are summarized. The results of 16 more recent intervention studies are compiled and analyzed. Also, reviewed are four studies that modeled health benefits of using filtration to reduce indoor exposures to particles from outdoors. Prior reviews generally concluded that particle filtration is, at best, a source of small improvements in allergy and asthma health effects; however, many early studies had weak designs. A majority of recent intervention studies employed strong designs and more of these studies report statistically significant improvements in health symptoms or objective health outcomes, particularly for subjects with allergies or asthma. The percentage improvement in health outcomes is typically modest, for example, 7% to 25%. Delivery of filtered air to the breathing zone of sleeping allergic or asthmatic persons may be more consistently effective in improving health than room air filtration. Notable are two studies that report statistically significant improvements, with filtration, in markers that predict future adverse coronary events. From modeling, the largest potential benefits of indoor particle filtration may be reductions in morbidity and mortality from reducing indoor exposures to particles from outdoor air. Published 2013. This article is a US Government work and is in the public domain in the USA.

  18. Clinical trials transparency and the Trial and Experimental Studies Transparency (TEST) act.

    Science.gov (United States)

    Logvinov, Ilana

    2014-03-01

    Clinical trial research is the cornerstone for successful advancement of medicine that provides hope for millions of people in the future. Full transparency in clinical trials may allow independent investigators to evaluate study designs, perform additional analysis of data, and potentially eliminate duplicate studies. Current regulatory system and publishers rely on investigators and pharmaceutical industries for complete and accurate reporting of results from completed clinical trials. Legislation seems to be the only way to enforce mandatory disclosure of results. The Trial and Experimental Studies Transparency (TEST) Act of 2012 was introduced to the legislators in the United States to promote greater transparency in research industry. Public safety and advancement of science are the driving forces for the proposed policy change. The TEST Act may benefit the society and researchers; however, there are major concerns with participants' privacy and intellectual property protection. Copyright © 2014 Elsevier Inc. All rights reserved.

  19. Best clinical trials reported in 2010.

    Science.gov (United States)

    Garner, John B; Grayburn, Paul A; Yancy, Clyde W

    2011-07-01

    Each year, a number of clinical trials emerge with data sufficient to change clinical practice. Determining which findings will result in practice change and which will provide only incremental benefit can be a dilemma for clinicians. The authors review selected clinical trials reported in 2010 in journals, at society meetings, and at conferences, focusing on those studies that have the potential to change clinical practice. This review offers 3 separate means of analysis: an abbreviated text summary, organized by subject area; a comprehensive table of relevant clinical trials that provides a schematic review of the hypotheses, interventions, methods, primary end points, results, and implications; and a complete bibliography for further reading as warranted. It is hoped that this compilation of relevant clinical trials and their important findings released in 2010 will be of benefit in the everyday practice of cardiovascular medicine. Copyright © 2011 Elsevier Inc. All rights reserved.

  20. 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...

  1. Thromboprophylaxis With Apixaban in Patients Undergoing Major Orthopedic Surgery: Meta-Analysis and Trial-Sequential Analysis

    Directory of Open Access Journals (Sweden)

    Daniel Caldeira

    2017-05-01

    Full Text Available Background: Venous thromboembolism (VTE is a potentially fatal complication of orthopedic surgery, and until recently, few antithrombotic compounds were available for postoperative thromboprophylaxis. The introduction of the non–vitamin K antagonists oral anticoagulants (NOAC, including apixaban, has extended the therapeutic armamentarium in this field. Therefore, estimation of NOAC net clinical benefit in comparison with the established treatment is needed to inform clinical decision making. Objectives: Systematic review to assess the efficacy and safety of apixaban 2.5 mg twice a day versus low-molecular-weight heparins (LMWH for thromboprophylaxis in patients undergoing knee or hip replacement. Data sources: MEDLINE, Embase, and CENTRAL were searched from inception to September 2016, other systematic reviews, reference lists, and experts were consulted. Study eligibility criteria, participants, and intervention: All major orthopedic surgery randomized controlled trials comparing apixaban 2.5 mg twice daily with LMWH, reporting thrombotic and bleeding events. Data extraction: Two independent reviewers, using a predetermined form. Study appraisal and synthesis methods: The Cochrane tool to assess risk bias was used by two independent authors. RevMan software was used to estimate pooled risk ratio (RR and 95% confidence intervals (95% CI using random-effects meta-analysis. Trial sequential analysis (TSA was performed in statistical significant results to evaluate whether cumulative sample size was powered for the obtained effect. Overall confidence in cumulative evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE Working Group methodology. Results: Four studies comparing apixaban 2.5 mg twice daily with LMWH were included, with a total of 11.828 patients (55% undergoing knee and 45% hip replacement. The overall risk of bias across studies was low. In comparison with LMWH (all regimens

  2. The Mersey Barrage - indirect benefits: the economic and regional case

    International Nuclear Information System (INIS)

    Cockle, P.J.; McCormack, J.J.

    1992-01-01

    A major cost-benefit exercise, a regional and an exchequer impact assessment were performed. The cost-benefit net present values (NPV) (1991 prices) of market and non-market streams revealed: capital and operating cost (-Pound 799 million), electricity output (Pound 310 million), CO 2 savings (Pound 627 million), security of energy supply (Pound 18 million), amenity benefit/blight (-Pound 1 million), tourism (Pound 5 million), leisure (Pound 7 million), waders and wildfowl impact (-Pound 8 million) and a road crossing (Pound 132 million). The total mid-range estimate of Pound 370 million confirms the barrage would increase Britain's welfare. During construction the barrage would support up to 2,100 Merseyside jobs and 600 in operation. The cumulative gains to the exchequer are Pound 300 million. (author)

  3. Economic evidence for the clinical management of major depressive disorder: a systematic review and quality appraisal of economic evaluations alongside randomised controlled trials.

    Science.gov (United States)

    Karyotaki, E; Tordrup, D; Buntrock, C; Bertollini, R; Cuijpers, P

    2017-10-01

    The aim of this systematic review of economic evaluations alongside randomised controlled trials (RCTs) was to provide a comprehensive overview of the evidence concerning cost-effectiveness analyses of common treatment options for major depression. An existing database was used to identify studies reporting cost-effectiveness results from RCTs. This database has been developed by a systematic literature search in the bibliographic databases of PubMed, PsychINFO, Embase and Cochrane library from database inception to December 2014. We evaluated the quality of economic evaluations using a 10-item short version of the Drummond checklist. Results were synthesised narratively. The risk of bias of the included RCTs was assessed, based on the Cochrane risk of bias assessment tool. Fourteen RCTs were included from the 5580 articles screened on titles and abstracts. The methodological quality of the health economic evaluations was relatively high and the majority of the included RCTs had low risk of bias in most of Cochrane items except blinding of participants and personnel. Cognitive behavioural therapy was examined in seven trials as part of a variety of treatment protocols and seems cost-effective compared with pharmacotherapy in the long-term. However cost-effectiveness results for the combination of psychotherapy with pharmacotherapy are conflicting and should be interpreted with caution due to limited comparability between the examined trials. For several treatments, only a single economic evaluation was reported as part of a clinical trial. This was the case for comparisons between different classes of antidepressants, for several types of psychotherapy (behavioural activation, occupational therapy, interpersonal psychotherapy, short-term psychotherapy, psychodynamic psychotherapy, rational emotive behavioural therapy, solution focused therapy), and for transcranial magnetic stimulation v. electroconvulsive therapy. The limited evidence base for these interventions

  4. The inflammatory cytokines: molecular biomarkers for major depressive disorder?

    Science.gov (United States)

    Martin, Charlotte; Tansey, Katherine E; Schalkwyk, Leonard C; Powell, Timothy R

    2015-01-01

    Cytokines are pleotropic cell signaling proteins that, in addition to their role as inflammatory mediators, also affect neurotransmitter systems, brain functionality and mood. Here we explore the potential utility of cytokine biomarkers for major depressive disorder. Specifically, we explore how genetic, transcriptomic and proteomic information relating to the cytokines might act as biomarkers, aiding clinical diagnosis and treatment selection processes. We advise future studies to investigate whether cytokine biomarkers might differentiate major depressive disorder patients from other patient groups with overlapping clinical characteristics. Furthermore, we invite future pharmacogenetic studies to investigate whether early antidepressant-induced changes to cytokine mRNA or protein levels precede behavioral changes and act as longer-term predictors of clinical antidepressant response.

  5. Nonoperative management for perforated peptic ulcer: who can benefit?

    Science.gov (United States)

    Cao, Feng; Li, Jia; Li, Ang; Fang, Yu; Wang, Ya-Jun; Li, Fei

    2014-07-01

    Although nonoperative management for perforated peptic ulcer (PPU) has been used for several decades, the indication is still unclear. A clinicoradiological score was sought to predict who can benefit from it. A clinicoradiological protocol for the assessment of patients presenting with PPU was used. A logistic regression model was applied to identify determinant variables and construct a clinical score that would identify patients who can be successfully treated with nonoperative management. Of 241 consecutive patients with PPU, 107 successfully received nonoperative management, and 134 required surgery. In multivariable analysis, the following four variables correlated with surgery and were given one point each toward the clinical score: age ≥70 years, fluid collection detection by ultrasound, contrast extravasation detection by water-soluble contrast examination, and Acute Physiology and Chronic Health Evaluation II (APACHE II) score ≥8. Eighty-five percent of patients with a score of 1 or less were successfully treated with nonoperative management, whereas 23 of 29 patients with a score of 3 or more required surgery. The area under the receiver operating characteristic curve was 0.804 (95% confidence interval = 0.717-0.891). By combining clinical, radiological parameters, and APACHE II score, the clinical score allowed early identification of PPU patients who can benefit from nonoperative management. Copyright © 2013. Published by Elsevier B.V.

  6. PET/MRI: a novel hybrid imaging technique: major clinical indications and preliminary experience in Brazil; PET/RM: um novo metodo de imagem hibrida: principais indicacoes clinicas e experiencia preliminar no Brasil

    Energy Technology Data Exchange (ETDEWEB)

    Vitor, Taise; Martins, Karine Minaif; Ionescu, Tudor Mihai and others, E-mail: taisevitor@gmail.com [Hospital Israelita Albert Einstein, Sao Paulo, SP (Brazil)

    2017-04-01

    In recent years, medical imaging with hybrid techniques has widely accepted and employed in clinical routine. PET/MRI offers significant advantages, including excellent contrast and resolution and reduced ionizing radiation, as compared to well-established PET/ CT. Therefore, PET/MRI is a promising modality for oncologic imaging of some regions, such as brain, head and neck, liver and pelvis. This article set out to analyze clinical conditions that could benefit from PET/MRI imaging based on our caseload. The potential of PET/MRI to become the imaging modality of choice for assessment of neurologic and oncologic conditions associated with soft tissues is highlighted. Clinical aspects of PET/MRI and its application to clinical cases are illustrated with examples extracted from the authors' preliminary experience. (author)

  7. Defining kidney allograft benefit from successful pancreas transplant: separating fact from fiction.

    Science.gov (United States)

    Wiseman, Alexander C; Stites, Erik; Kennealey, Peter

    2018-06-06

    To define the natural history of kidney allograft loss related to recurrent diabetes following transplant, and to understand the potential benefit of pancreas transplantation upon kidney allograft survival. A postulated benefit of simultaneous pancreas kidney transplant is that, unlike kidney transplant alone, euglycemia from the added pancreas allograft may confer a nephroprotective benefit and prevent recurrent diabetic nephropathy in the renal allograft. Recent large database analyses and long-term histological assessments have been published that assist in quantifying the problem of recurrent diabetic nephropathy and answering the question of the potential benefits of euglycemia. Further data may be extrapolated from larger single-center series that follow the prognosis of early posttransplant diabetes mellitus as another barometer of risk from diabetic nephropathy and graft loss. Recurrent diabetic nephropathy following kidney transplant is a relatively rare, late occurrence and its clinical significance is significantly diminished by the competing risks of death and chronic alloimmune injury. Although there are hints of a protective effect upon kidney graft survival with pancreas transplant, these improvements are small and may take decades to appreciate. Clinical decision-making regarding pancreas transplant solely based upon nephroprotective effects of the kidney allograft should be avoided.

  8. A clinical study of major stroke cases of a low-perfusion pattern on a dynamic CT scan

    International Nuclear Information System (INIS)

    Shimada, Tsutomu; Kaneko, Mitsuo; Tanaka, Keisei; Sugiura, Masashi

    1986-01-01

    Preoperative dynamic CT scans have been done for the past 4 years in order to estimate the degree of ischemia in the region responsible. The hemodynamic patterns on the dynamic CT scans were consequently classified into three particular types: Type 1: The collateral flow was preserved considerably, and the peak value of the time-density curve exceeded 50 % of the opposite healthy side. Type 2: The residual flow was moderate, and the peak value was approximately from one-third to one-half of the normal side. Type 3: The residual flow was minimal, and the time-density curve was almost flat or the peak value did not reach even approximately one-third of the opposite side. In general, major stroke cases with a Type 1 pattern on the dynamic CT scan showed a considerably good recovery if the revascularization was completed within 6 hours after the attack. However, cases of the Type 3 pattern often developed into a massive cerebral infarction associated with a marked mid-line shift, and sometimes they were fulminent even after acute revascularization. In this paper, clinical results of 11 major stroke cases with the Type 2 pattern on dynamic CT scans were evaluated. All of them showed hemiplegia, with or without aphasia, just after the onset of the stroke, and dynamic CT scans were performed within 24 hours. The site of the occluded vessel was in the internal carotid artery (ICA) in 4 cases and in the middle cerebral artery (MCA) in 6; severe stenosis in ICA and MCA was found in only one case. The functional recovery was rather poor. Only one was capable of self-care at home; four others required partial care at home, and the other six were bed-ridden. In the 4 surgical cases of acute revascularization, the clinical symptoms did not improve, and the functional recovery was almost equivalent to the natural course. (J.P.N.)

  9. Australian consumer awareness of health benefits associated with vegetable consumption.

    Science.gov (United States)

    Rekhy, Reetica; Khan, Aila; Eason, Jocelyn; Mactavish-West, Hazel; Lister, Carolyn; Mcconchie, Robyn

    2017-04-01

    The present study investigated the perceived health benefits of specific vegetable consumption to guide the use of nutrition and health claims on vegetable marketing collateral. Free elicitation and consumer ranking data were collected through an online survey of 1000 adults from across Australia and analysed for the perceived importance of vegetables in the daily diet, number of serves consumed per day, knowledge about health-related benefits of specific vegetables and perceived health benefits of vegetable consumption. The importance of vegetables in the diet and daily vegetable consumption was higher in people from an English-speaking background, females, people aged 45 years and over and people living in non-metropolitan areas. Digestion was selected as the major health benefit from consumption of specific vegetables. However, understanding of the health benefits of specific vegetable consumption was relatively low among consumers. Half of the respondents were not sure of the health benefits associated with specific vegetables, except for carrots and spinach. Some respondents volunteered nutrient content or other information. There was no clear indication that consumers understand the specific health benefits conferred by consumption of vegetables. Nutrient and health benefit labelling therefore has the capacity to enhance knowledge of vegetable consumers. It is recommended that health benefit labelling be tailored to promote greater consumption of vegetables in those demographic groups where vegetable consumption was lower. The present study assists the Australian vegetable industry in helping consumers make more informed consumption choices. © 2016 Dietitians Association of Australia.

  10. What is the benefit of treatment with multiple lines of chemotherapy for patients with metastatic breast cancer? A retrospective cohort study.

    Science.gov (United States)

    Bakker, J L; Wever, K; van Waesberghe, J H; Beeker, A; Meijers-Heijboer, H; Konings, I R; Verheul, H M W

    2015-12-01

    Despite the extensive clinical experience, it is still under debate to what extent patients with metastatic breast cancer (MBC) benefit from multiple lines of chemotherapy beyond standard first or second line treatment. Selection of patients with MBC who will benefit from treatment is crucial to improve outcome and reduce unnecessary toxicity. In this retrospective study, systemic treatment outcome for patients with metastatic MBC is being evaluated. We evaluated to what extent the clinical benefit of prior chemotherapy can predict the success of a subsequent treatment line. Ninety-one patients treated with chemotherapy for MBC between January 2005 and January 2009 were included in this study. Clinical characteristics of patients, choices of chemotherapy and response at first evaluation of every treatment line was evaluated based on radiologic and clinical data. Patients received multiple systemic cytotoxic and biological (combination) therapies. 30% of these patients received more than five consecutive systemic (combination) treatments. First line chemotherapy was mostly anthracycline-based, followed by taxanes, capecitabine and vinorelbine. The response rate (RR, complete response plus partial response according to RECIST 1.1) decreased from 20% (95% CI 11-28%) upon first line of treatment to 0% upon the fourth line. The clinical benefit rate (combining RR and stable disease) decreased from 85% (95% CI 78-93%) in the first to 54% (95% CI 26-67) upon the fourth line. 24% of the patients with clinical benefit at first evaluation did not receive a subsequent line of treatment when progressive disease occurred, while sixty-one percent of the patients with progressive disease at first evaluation of a treatment did not receive a subsequent line of chemotherapy. When applied, the efficacy of a subsequent line of treatment was similar for patients independent of previous treatment benefit. The clinical benefit at first evaluation from systemic treatment in MBC does not

  11. A framework for quantifying net benefits of alternative prognostic models.

    Science.gov (United States)

    Rapsomaniki, Eleni; White, Ian R; Wood, Angela M; Thompson, Simon G

    2012-01-30

    New prognostic models are traditionally evaluated using measures of discrimination and risk reclassification, but these do not take full account of the clinical and health economic context. We propose a framework for comparing prognostic models by quantifying the public health impact (net benefit) of the treatment decisions they support, assuming a set of predetermined clinical treatment guidelines. The change in net benefit is more clinically interpretable than changes in traditional measures and can be used in full health economic evaluations of prognostic models used for screening and allocating risk reduction interventions. We extend previous work in this area by quantifying net benefits in life years, thus linking prognostic performance to health economic measures; by taking full account of the occurrence of events over time; and by considering estimation and cross-validation in a multiple-study setting. The method is illustrated in the context of cardiovascular disease risk prediction using an individual participant data meta-analysis. We estimate the number of cardiovascular-disease-free life years gained when statin treatment is allocated based on a risk prediction model with five established risk factors instead of a model with just age, gender and region. We explore methodological issues associated with the multistudy design and show that cost-effectiveness comparisons based on the proposed methodology are robust against a range of modelling assumptions, including adjusting for competing risks. Copyright © 2011 John Wiley & Sons, Ltd.

  12. A framework for quantifying net benefits of alternative prognostic models‡

    Science.gov (United States)

    Rapsomaniki, Eleni; White, Ian R; Wood, Angela M; Thompson, Simon G

    2012-01-01

    New prognostic models are traditionally evaluated using measures of discrimination and risk reclassification, but these do not take full account of the clinical and health economic context. We propose a framework for comparing prognostic models by quantifying the public health impact (net benefit) of the treatment decisions they support, assuming a set of predetermined clinical treatment guidelines. The change in net benefit is more clinically interpretable than changes in traditional measures and can be used in full health economic evaluations of prognostic models used for screening and allocating risk reduction interventions. We extend previous work in this area by quantifying net benefits in life years, thus linking prognostic performance to health economic measures; by taking full account of the occurrence of events over time; and by considering estimation and cross-validation in a multiple-study setting. The method is illustrated in the context of cardiovascular disease risk prediction using an individual participant data meta-analysis. We estimate the number of cardiovascular-disease-free life years gained when statin treatment is allocated based on a risk prediction model with five established risk factors instead of a model with just age, gender and region. We explore methodological issues associated with the multistudy design and show that cost-effectiveness comparisons based on the proposed methodology are robust against a range of modelling assumptions, including adjusting for competing risks. Copyright © 2011 John Wiley & Sons, Ltd. PMID:21905066

  13. Clinical Informatics Fellowship Programs: In Search of a Viable Financial Model: An open letter to the Centers for Medicare and Medicaid Services.

    Science.gov (United States)

    Lehmann, C U; Longhurst, C A; Hersh, W; Mohan, V; Levy, B P; Embi, P J; Finnell, J T; Turner, A M; Martin, R; Williamson, J; Munger, B

    2015-01-01

    In the US, the new subspecialty of Clinical Informatics focuses on systems-level improvements in care delivery through the use of health information technology (HIT), data analytics, clinical decision support, data visualization and related tools. Clinical informatics is one of the first subspecialties in medicine open to physicians trained in any primary specialty. Clinical Informatics benefits patients and payers such as Medicare and Medicaid through its potential to reduce errors, increase safety, reduce costs, and improve care coordination and efficiency. Even though Clinical Informatics benefits patients and payers, because GME funding from the Centers for Medicare and Medicaid Services (CMS) has not grown at the same rate as training programs, the majority of the cost of training new Clinical Informaticians is currently paid by academic health science centers, which is unsustainable. To maintain the value of HIT investments by the government and health care organizations, we must train sufficient leaders in Clinical Informatics. In the best interest of patients, payers, and the US society, it is therefore critical to find viable financial models for Clinical Informatics fellowship programs. To support the development of adequate training programs in Clinical Informatics, we request that the Centers for Medicare and Medicaid Services (CMS) issue clarifying guidance that would allow accredited ACGME institutions to bill for clinical services delivered by fellows at the fellowship program site within their primary specialty.

  14. [German fibromyalgia consumer reports. Benefits and harms of fibromyalgia syndrome therapies].

    Science.gov (United States)

    Häuser, W; Jung, E; Erbslöh-Möller, B; Gesmann, M; Kühn-Becker, H; Petermann, F; Langhorst, J; Weiss, T; Thoma, R; Winkelmann, A

    2012-04-01

    Consumer reports provide information on benefits and harms in routine clinical care. We report the first fibromyalgia syndrome (FMS) consumer reports in Europe. The study was carried out from November 2010 to April 2011. The benefits and harms of pharmacological and non-pharmacological therapies experienced by the patient were assessed in an 11-point Likert scale (0=no, 10=very high benefit or harm) by a questionnaire. The questionnaire was distributed by the German League against Rheumatism and the German Fibromyalgia Association to their members and to all consecutive FMS patients of nine clinical centers of different levels of care. A total of 1,661 questionnaires (95% women, mean age 54 years) were analyzed. Self-management strategies (distraction, resting, aerobic exercise), physical therapies (warm and pool therapies), psychological therapies (education, psychotherapy), and inpatient multicomponent therapies were judged to be more efficacious and less harmful than all types of pharmacological therapies. The German fibromyalgia consumer reports highlight the importance of non-pharmcological therapies in the long-term management of FMS.

  15. Analysis of Professional Fringe Benefits, 1978-79. OMNI Report.

    Science.gov (United States)

    Vater, James J.; Riddle, Richard A.

    This report contains data collected from 275 Pennsylvania school districts for the 1978-79 school year. The data reflect policies and practices affecting fringe benefits for professional employees. The report is divided into three major sections. The first section presents comparative data for 30 variables on a statewide, size, and wealth basis.…

  16. Analysis of Professional Fringe Benefits 1977-78. OMNI Report.

    Science.gov (United States)

    Caldwell, William E.; Vater, James J.

    This report contains data collected from 275 Pennsylvania school districts for the 1977-78 school year. The data reflect policies and practices affecting fringe benefits for professional employees. The report is divided into three major sections. The first section presents comparative data for 30 variables on a statewide, size, and wealth basis.…

  17. Evaluating the predictive accuracy and the clinical benefit of a nomogram aimed to predict survival in node-positive prostate cancer patients: External validation on a multi-institutional database.

    Science.gov (United States)

    Bianchi, Lorenzo; Schiavina, Riccardo; Borghesi, Marco; Bianchi, Federico Mineo; Briganti, Alberto; Carini, Marco; Terrone, Carlo; Mottrie, Alex; Gacci, Mauro; Gontero, Paolo; Imbimbo, Ciro; Marchioro, Giansilvio; Milanese, Giulio; Mirone, Vincenzo; Montorsi, Francesco; Morgia, Giuseppe; Novara, Giacomo; Porreca, Angelo; Volpe, Alessandro; Brunocilla, Eugenio

    2018-04-06

    To assess the predictive accuracy and the clinical value of a recent nomogram predicting cancer-specific mortality-free survival after surgery in pN1 prostate cancer patients through an external validation. We evaluated 518 prostate cancer patients treated with radical prostatectomy and pelvic lymph node dissection with evidence of nodal metastases at final pathology, at 10 tertiary centers. External validation was carried out using regression coefficients of the previously published nomogram. The performance characteristics of the model were assessed by quantifying predictive accuracy, according to the area under the curve in the receiver operating characteristic curve and model calibration. Furthermore, we systematically analyzed the specificity, sensitivity, positive predictive value and negative predictive value for each nomogram-derived probability cut-off. Finally, we implemented decision curve analysis, in order to quantify the nomogram's clinical value in routine practice. External validation showed inferior predictive accuracy as referred to in the internal validation (65.8% vs 83.3%, respectively). The discrimination (area under the curve) of the multivariable model was 66.7% (95% CI 60.1-73.0%) by testing with receiver operating characteristic curve analysis. The calibration plot showed an overestimation throughout the range of predicted cancer-specific mortality-free survival rates probabilities. However, in decision curve analysis, the nomogram's use showed a net benefit when compared with the scenarios of treating all patients or none. In an external setting, the nomogram showed inferior predictive accuracy and suboptimal calibration characteristics as compared to that reported in the original population. However, decision curve analysis showed a clinical net benefit, suggesting a clinical implication to correctly manage pN1 prostate cancer patients after surgery. © 2018 The Japanese Urological Association.

  18. 20 CFR 416.421 - Determination of benefits; computation of prorated benefits.

    Science.gov (United States)

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Determination of benefits; computation of prorated benefits. 416.421 Section 416.421 Employees' Benefits SOCIAL SECURITY ADMINISTRATION SUPPLEMENTAL SECURITY INCOME FOR THE AGED, BLIND, AND DISABLED Amount of Benefits § 416.421 Determination of benefits...

  19. Association between total serum cholesterol and suicide attempts in subjects with major depressive disorder: Exploring the role of clinical and biochemical confounding factors.

    Science.gov (United States)

    Bartoli, Francesco; Crocamo, Cristina; Dakanalis, Antonios; Riboldi, Ilaria; Miotto, Alessio; Brosio, Enrico; Clerici, Massimo; Carrà, Giuseppe

    2017-04-01

    We tested whether serum total cholesterol levels might be associated with recent suicide attempts in subjects with major depressive disorder, after controlling for relevant individual characteristics. We conducted a comparative cross-sectional study including consecutive inpatients with major depressive disorder. We differentiated subjects admitted for a recent serious (violent or non-violent) suicide attempt and those without such recent history. Total cholesterol was measured from fasting blood tests. At univariate analyses, suicide attempters had levels of total cholesterol (174.0±45.7mg/dL) lower than non-attempters (193.9±42.6mg/dL) (p=0.004). This was confirmed among both violent (174.1±46.2mg/dL) and non-violent (173.8±46.1mg/dL) suicide attempters (p=0.035 and 0.016, respectively). However, logistic regression analyses, sequentially including demographic, clinical (comorbid alcohol and personality disorders), and biochemical factors, did not show any association between serum cholesterol and recent suicide attempts (p=0.172). Similar findings were observed in multinomial logistic regression analyses, for both violent (p=0.512) and non-violent (p=0.157) suicide attempts. Our findings do not support the hypothesis that serum cholesterol and suicide attempts are associated among subjects with major depressive disorder. The identification of valid and accessible biological markers of suicidal behaviors still represents a challenge for future research. Copyright © 2016 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  20. 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

  1. 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.

  2. BenefitClaimWebServiceBean/BenefitClaimWebService

    Data.gov (United States)

    Department of Veterans Affairs — A formal or informal request for a type of monetary or non-monetary benefit. This service provides benefit claims and benefit claim special issues data, allows the...

  3. Business Cases for Major Public Infrastructure Projects in Canada

    Directory of Open Access Journals (Sweden)

    Mario Iacobacci

    2017-11-01

    Full Text Available When governments announce that they are going to spend vast sums of taxpayers’ money on a new public infrastructure project, you can be certain they will praise all the terrific new benefits that the project will bring to citizens, making everyone’s life easier, safer, greener and better. But this does not tell us whether we are better off as a society, after accounting for the cost of these projects borne by taxpayers today and well into the future. In reality, there is a meaningful risk that a project undertaken without a proper business case could end up making citizens’ lives worse. That new commuter train might look sleek and shiny and seem convenient for some, but a close business case analysis of recent transit projects in Canada’s three largest cities suggests that in as many as four cases out of 21 projects, the burden of paying for the projects does not justify the public investment. In a review of thirteen recent public transit projects in the Greater Toronto and Hamilton Area (GTHA, at least three projects had benefits that fell short of the costs. Yet, all three projects went ahead (or have been funded. Only one project showed large net benefits for citizens once all considerations were accounted for. Three projects showed small net benefits – of a size that can be easily offset by a modest cost over-run. The six remaining projects did not have any publicly available business cases. In the Greater Montreal area, a review of three recent major transit projects turned up no evidence of a publicly available business case for any of them. As a result, Montrealers are in the dark as to how much benefit or value destruction the three projects are responsible for. Things are far more encouraging in Vancouver, however, where three out of the five major transit projects undertaken or funded in recent years were backed by business cases showing a net benefit. Only one project did not show a net benefit and one project did not have a

  4. Novel survey disseminated through Twitter supports its utility for networking, disseminating research, advocacy, clinical practice and other professional goals.

    Science.gov (United States)

    Borgmann, Hendrik; DeWitt, Sasha; Tsaur, Igor; Haferkamp, Axel; Loeb, Stacy

    2015-01-01

    Twitter use has grown exponentially within the urological community. We aimed to determine the perceptions of the impact of Twitter on users' clinical practice, research, and other professional activities. We performed an 11-item online survey of Twitter contributors during two major urological meetings: the European Association of Urology (EAU) and the American Urological Association (AUA) annual meetings. During the EAU 2014 meeting, we distributed the survey via the meeting official Twitter feed. During the AUA 2014 meeting, we applied a new method by directly sending the survey to Twitter contributors. We performed a subset analysis for assessing the perceived impact of Twitter on the clinical practice of physicians. Among 312 total respondents, the greatest perceived benefits of Twitter among users were for networking (97%) and disseminating information (96%), followed by research (75%), advocacy (74%) and career development (62%). In total, 65% of Twitter users have dealt with guidelines on online medical professionalism and 71% of physician users found that Twitter had an impact on their clinical practice, and 33% had made a clinical decision based on an online case discussion. Our results suggest that Twitter users in the urological community perceive important benefits. These benefits extend to multiple professional domains, particularly networking, disseminating information, remote conference participation, research, and advocacy. This is the first study that has been disseminated to targeted individuals from the urological community directly through tweets, providing a proof of principle for this research method.

  5. Medication Adherence and Health Insurance/Health Benefit in Adult Diabetics in Kingston, Jamaica.

    Science.gov (United States)

    Bridgelal-Nagassar, R J; James, K; Nagassar, R P; Maharaj, S

    2015-05-15

    To determine the association between health insurance/health benefit and medication adherence amongst adult diabetic patients in Kingston, Jamaica. This was a cross-sectional study. The target population was diabetics who attended the diabetic outpatient clinics in health centres in Kingston. Two health centres were selectively chosen in Kingston. All diabetic patients attending the diabetic clinics and over the age of 18 years were conveniently sampled. The sample size was 260. An interviewer-administered questionnaire was utilized which assessed health insurance/health benefit. Adherence was measured by patients' self-reports of medication usage in the previous week. The Chi-squared test was used to determine the significance of associations. Sample population was 76% female and 24% male. Type 2 diabetics comprised 93.8%. More than 95% of patients were over the age of 40 years. Approximately 32% of participants were employed. Approximately 75% of patients had health insurance/health benefit. Among those who had health insurance or health benefit, 71.5% were adherent and 28.5% were non-adherent. This difference was statistically significant (χ2 = 6.553, p = 0.01). Prevalence of medication non-adherence was 33%. AIn Kingston, diabetic patients who are adherent are more likely to have health insurance/health benefit ( p = 0.01).

  6. Usage, Risk, and Benefit of Weight-Loss Drugs in Primary Care

    Directory of Open Access Journals (Sweden)

    Tomas Forslund

    2011-01-01

    Conclusions. These results suggest that weight-loss drug treatment was often initiated upon patient request but was of limited clinical benefit as it was managed in a large portion of Swedish primary carecenters.

  7. Participants' perceptions and understanding of a malaria clinical trial in Bangladesh.

    Science.gov (United States)

    Das, Debashish; Cheah, Phaik Yeong; Akter, Fateha; Paul, Dulal; Islam, Akhterul; Sayeed, Abdullah A; Samad, Rasheda; Rahman, Ridwanur; Hossain, Amir; Dondorp, Arjen; Day, Nicholas P; White, Nicholas J; Hasan, Mahtabuddin; Ghose, Aniruddha; Ashley, Elizabeth A; Faiz, Abul

    2014-06-04

    Existing evidence suggests that there is often limited understanding among participants in clinical trials about the informed consent process, resulting in their providing consent without really understanding the purpose of the study, specific procedures, and their rights. The objective of the study was to determine the subjects' understanding of research, perceptions of voluntariness and motivations for participation in a malaria clinical trial. In this study semi-structured interviews of adult clinical trial participants with uncomplicated falciparum malaria were conducted in Ramu Upazila Health Complex, in Bangladesh. Of 16 participants, the vast majority (81%) were illiterate. All subjects had a 'therapeutic misconception' i.e. the trial was perceived to be conducted primarily for the benefit of individual patients when in fact the main objective was to provide information to inform public health policy. From the patients' perspective, getting well from their illness was their major concern. Poor actual understanding of trial specific procedures was reported despite participants' satisfaction with treatment and nursing care. There is frequently a degree of overlap between research and provision of clinical care in malaria research studies. Patients may be motivated to participate to research without a good understanding of the principal objectives of the study despite a lengthy consent process. The findings suggest that use of a standard consent form following the current ICH-GCP guidelines does not result in achieving fully informed consent and the process should be revised, simplified and adapted to individual trial settings.

  8. Involving Communities in Deciding What Benefits They Receive in Multinational Research.

    Science.gov (United States)

    Wendler, David; Shah, Seema

    2015-10-01

    There is wide agreement that communities in lower-income countries should benefit when they participate in multinational research. Debate now focuses on how and to what extent these communities should benefit. This debate has identified compelling reasons to reject the claim that whatever benefits a community agrees to accept are necessarily fair. Yet, those who conduct clinical research may conclude from this rejection that there is no reason to involve communities in the process of deciding how they benefit. Against this possibility, the present manuscript argues that involving host communities in this process helps to promote four important goals: (1) protecting host communities, (2) respecting host communities, (3) promoting transparency, and (4) enhancing social value. Published by Oxford University Press on behalf of the Journal of Medicine and Philosophy, Inc. 2015.

  9. 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.

  10. Financial risk management of pharmacy benefits.

    Science.gov (United States)

    Saikami, D

    1997-10-01

    Financial risk management of pharmacy benefits in integrated health systems is explained. A managed care organization should assume financial risk for pharmacy benefits only if it can manage the risk. Horizontally integrated organizations often do not have much control over the management of drug utilization and costs. Vertically integrated organizations have the greatest ability to manage pharmacy financial risk; virtual integration may also be compatible. Contracts can be established in which the provider is incentivized or placed at partial or full risk. The main concerns that health plans have with respect to pharmacy capitation are formulary management and the question of who should receive rebates from manufacturers. The components needed to managed pharmacy financial risk depend on the type of contract negotiated. Health-system pharmacists are uniquely positioned to take advantage of opportunities opening up through pharmacy risk contracting. Functions most organizations must provide when assuming pharmacy financial risk can be divided into internal and external categories. Internally performed functions include formulary management, clinical pharmacy services and utilization management, and utilization reports for physicians. Functions that can be outsourced include claims processing and administration, provider- and customer support services, and rebates. Organizations that integrate the pharmacy benefit across the health care continuum will be more effective in controlling costs and improving outcomes than organizations that handle this benefit as separate from others. Patient care should not focus on payment mechanisms and unit costs but on developing superior processes and systems that improve health care.

  11. Risk-benefit analysis of preoperative breast MRI in patients with primary breast cancer

    International Nuclear Information System (INIS)

    Siegmann, K.C.; Baur, A.; Vogel, U.; Kraemer, B.; Hahn, M.; Claussen, C.D.

    2009-01-01

    Aim: To analyse and compare the risks and benefits of preoperative breast MRI (BMRI) in patients with primary breast cancer (PBC), and to determine the influence of mammographic breast density (BD) and histological tumour type (TT). Materials and Methods: One hundred and nineteen patients who underwent preoperative bilateral breast MRI for staging of PBC during a 1-year period from July 2005 to August 2006 were prospectively evaluated. Changes in clinical management due to BMRI findings were recorded. MRI-detected lesions were correlated with histology. Additional MRI-detected malignant lesions and spared additional biopsies because of negative MRI in case of unclear ultrasound findings were determined as beneficial for the patient. Biopsies of benign MRI detected lesions were defined as disadvantageous. The influence of BD (ACR 1-4) and TT on the change in clinical management and patient benefit was evaluated. Results: The findings of the BMRI examinations changed the clinical management in 48 patients (40.3%). Seventeen women underwent mastectomy instead of breast conservation, eight patients underwent extended excision, 21 additional lesions were clarified by MRI intervention, and two ultrasound-detected lesions were not biopsied because of negative MRI. Histologically malignant additional or extended biopsies (n = 34) and two cases of spared biopsies resulted in 36 (30.3%) women who benefited from preoperative BMRI. Twelve patients (10.1%) had additional biopsies of MRI-detected benign lesions, and therefore, had an unfavourable outcome due to BMRI. The change in clinical management and patient benefit were independent of BD and TT (p > 0.05). Conclusion: Preoperative BMRI was beneficial for 30.3% of 119 patients with PBC. The percentage of additional biopsies of benign lesions (10.1%) seems acceptable

  12. Bread or games? Social cost-benefit analysis of the World Cup in the Netherlands

    NARCIS (Netherlands)

    de Nooij, M.; van den Berg, M.; Koopmans, C.

    2010-01-01

    Ex post analyses of major sporting events show that the benefits for the organizing countries are often greatly over-estimated in advance. A major portion of the proceeds (e.g., tickets, broadcasting rights, marketing) goes to the organizing sports federation, while most of the costs are borne by

  13. Retiree health benefits-vesting of welfare benefits-early retirement-duty to bargain-termination of benefits-estoppel.

    Science.gov (United States)

    2010-01-01

    Poore v. Simpson Paper Co., 2009 U.S. App. LEXIS 11170 (9th Cir. Or. May 21, 2009). To be able to sue under ERISA, retirement health plan participants need not show that their benefits are vested the same way pension benefits are vested; the rights to the benefits need not be fixed or unalterable, rather, the employee must have an entitlement to the benefits.

  14. 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

  15. Clinical and radiological outcome following pneumothorax after endoscopic lung volume reduction with valves.

    Science.gov (United States)

    Gompelmann, D; Benjamin, N; Kontogianni, K; Herth, Fjf; Heussel, C P; Hoffmann, H; Eberhardt, R

    2016-01-01

    Valve implantation has evolved as a therapy for patients with advanced emphysema. Although it is a minimally invasive treatment, it is associated with complications, the most common being pneumothorax. Pneumothorax occurs due to the rapid target lobe volume reduction and may be a predictor of clinical benefit despite this complication. The objective of this study was to conduct an exploratory data analysis of patients who developed a pneumothorax following endoscopic valve therapy for emphysema. This study performed a retrospective evaluation of pneumothorax management and the impact of pneumothorax on clinical outcomes in 70 patients following valve therapy in 381 consecutive patients. Pneumothorax rate following valve therapy was 18%. Pneumothorax management consisted of chest tube insertion, valve removal, and surgical intervention in 87% (61/70), 44% (31/70), and 19% (13/70) of the patients, respectively. Despite pneumothorax, patients experienced modest but significant improvements in lung function parameters (forced expiratory volume in 1 second: 55±148 mL, residual volume: -390±964 mL, total lung capacity: -348±876; all P pneumothorax, which was associated with relevant clinical improvement, was observed in only 21% (15/70) of the patients. Pneumothorax is a frequent severe complication following valve therapy that requires further intervention. Nevertheless, the pneumothorax does not impair the clinical status in the majority of patients. Patients with lobar atelectasis benefit after recovering from pneumothorax in terms of lung function parameters.

  16. Progression of major depression during pregnancy and postpartum: a preliminary study.

    Science.gov (United States)

    Shivakumar, Geetha; Johnson, Neysa L; McIntire, Donald D; Leveno, Kenneth

    2014-04-01

    The purpose of this pilot study was to investigate major depressive symptoms among a high-risk group of pregnant women managed at a tertiary care setting. The study prospectively evaluated pregnant women who met DSM-IV criteria for a major depressive episode (MDE). Psychiatric measures for depression, anxiety and social impairment were administered at monthly intervals during pregnancy and immediate postpartum period. Twenty-four women provided longitudinal data from mid pregnancy to 2 months of postpartum period. 86% of women were clinically symptomatic at the beginning of study during pregnancy and only 32% remained clinically symptomatic at 2 months following delivery reaching. This difference reached a statistical significance level p depression, comorbid anxiety disorder, histories of domestic violence, and those with uninvolved spouse or partners were more at-risk to be clinically symptomatic in the immediate postpartum period. In a group consisting of largely Latina women at a tertiary care setting, progression of major depression when treated with antidepressant medication(s) is that of an improvement from pregnancy to immediate postpartum period. Further longitudinal studies are needed to assess impact of clinical characteristics and treatment on major depression in larger diverse obstetric group.

  17. The Costs and Benefits of Investing in Universal Preschool: Evidence From a Spanish Reform.

    Science.gov (United States)

    van Huizen, Thomas; Dumhs, Lisa; Plantenga, Janneke

    2017-11-20

    This study provides a cost-benefit analysis of expanding access to universal preschool education, focusing on a Spanish reform that lowered the age of eligibility for publicly provided universal preschool from age 4 to age 3. Benefits in terms of child development and maternal employment are estimated using evidence on the causal effects of this reform. In the baseline estimation the benefit-cost ratio is over 4, indicating sizeable net societal benefits of the preschool investment. The results show that the child development effects are the major determinant of the cost-benefit ratio; the employment gains for parents appear to play a relatively minor role. Overall, the cost-benefit analysis provides support for investing in high-quality preschool education. © 2017 The Authors. Child Development © 2017 Society for Research in Child Development, Inc.

  18. Comparing antecedents of voluntary job turnover among majority and minority employees

    NARCIS (Netherlands)

    Hofhuis, Joep; Van der Zee, Karen I.; Otten, Sabine

    2014-01-01

    Purpose - Cultural minority employees often display higher rates of voluntary turnover than majority employees, which reduces organizations' ability to benefit from diversity in the workplace. The purpose of this paper is to identify specific job domains which are responsible for this difference.

  19. Comparing antecedents of voluntary job turnover among majority and minority employees

    NARCIS (Netherlands)

    Hofhuis, J.; van der Zee, K.I.; Otten, S.

    2014-01-01

    Purpose Cultural minority employees often display higher rates of voluntary turnover than majority employees, which reduces organizations’ ability to benefit from diversity in the workplace. The purpose of this paper is to identify specific job domains which are responsible for this difference.

  20. Best practice for analysis of shared clinical trial data

    Directory of Open Access Journals (Sweden)

    Sally Hollis

    2016-07-01

    Full Text Available Abstract Background Greater transparency, including sharing of patient-level data for further research, is an increasingly important topic for organisations who sponsor, fund and conduct clinical trials. This is a major paradigm shift with the aim of maximising the value of patient-level data from clinical trials for the benefit of future patients and society. We consider the analysis of shared clinical trial data in three broad categories: (1 reanalysis - further investigation of the efficacy and safety of the randomized intervention, (2 meta-analysis, and (3 supplemental analysis for a research question that is not directly assessing the randomized intervention. Discussion In order to support appropriate interpretation and limit the risk of misleading findings, analysis of shared clinical trial data should have a pre-specified analysis plan. However, it is not generally possible to limit bias and control multiplicity to the extent that is possible in the original trial design, conduct and analysis, and this should be acknowledged and taken into account when interpreting results. We highlight a number of areas where specific considerations arise in planning, conducting, interpreting and reporting analyses of shared clinical trial data. A key issue is that that these analyses essentially share many of the limitations of any post hoc analyses beyond the original specified analyses. The use of individual patient data in meta-analysis can provide increased precision and reduce bias. Supplemental analyses are subject to many of the same issues that arise in broader epidemiological analyses. Specific discussion topics are addressed within each of these areas. Summary Increased provision of patient-level data from industry and academic-led clinical trials for secondary research can benefit future patients and society. Responsible data sharing, including transparency of the research objectives, analysis plans and of the results will support appropriate

  1. Using Outcomes to Analyze Patients Rather than Patients to Analyze Outcomes: A Step toward Pragmatism in Benefit:risk Evaluation

    Science.gov (United States)

    Evans, Scott R.; Follmann, Dean

    2016-01-01

    In the future, clinical trials will have an increased emphasis on pragmatism, providing a practical description of the effects of new treatments in realistic clinical settings. Accomplishing pragmatism requires better summaries of the totality of the evidence in ways that clinical trials consumers---patients, physicians, insurers---find transparent and allow for informed benefit:risk decision-making. The current approach to the analysis of clinical trials is to analyze efficacy and safety separately and then combine these analyses into a benefit:risk assessment. Many assume that this will effectively describe the impact on patients. But this approach is suboptimal for evaluating the totality of effects on patients. We discuss methods for benefit:risk assessment that have greater pragmatism than methods that separately analyze efficacy and safety. These include the concepts of within-patient analyses and composite benefit:risk endpoints with a goal of understanding how to analyze one patient before trying to figure out how to analyze many. We discuss the desirability of outcome ranking (DOOR) and introduce the partial credit strategy using an example in a clinical trial evaluating the effects of a new antibiotic. As part of the example we introduce a strategy to engage patients as a resource to inform benefit:risk analyses consistent with the goal of measuring and weighing outcomes that are most important from the patient’s perspective. We describe a broad vision for the future of clinical trials consistent with increased pragmatism. Greater focus on using endpoints to analyze patients rather than patients to analyze endpoints particularly in late-phase/stage clinical trials is an important part of this vision. PMID:28435515

  2. Clinical applications of bovine colostrum therapy

    DEFF Research Database (Denmark)

    Rathe, Mathias; Müller, Klaus; Sangild, Per Torp

    2014-01-01

    Bovine colostrum, the first milk that cows produce after parturition, contains high levels of growth factors and immunomodulatory components. Some healthy and diseased individuals may gain health benefits by consuming bovine colostrum as a food supplement. This review provides a systematic...... to populations, outcomes, and methodological quality, as judged by the Jadad assessment tool. Many studies used surrogate markers to study the effects of bovine colostrum. Studies suggesting clinical benefits of colostrum supplementation were generally of poor methodological quality, and results could...... not be confirmed by other investigators. Bovine colostrum may provide gastrointestinal and immunological benefits, but further studies are required before recommendations can be made for clinical application. Animal models may help researchers to better understand the mechanisms of bovine colostrum supplementation...

  3. Connecting Medical Records: An Evaluation of Benefits and Challenges for Primary Care Practices

    Directory of Open Access Journals (Sweden)

    Deborah Ruth Compeau

    2017-06-01

    Full Text Available Background: Implementation of systems to support health information sharing has lagged other areas of healthcare IT, yet offers a strong possibility for benefitClinical acceptance is a key limiting factor in health IT adoption. Objectives:  To assess the benefits and challenges experienced by clinicians using a custom-developed health information exchange system, and to show how perceptions of benefits and challenges influence perceptions of productivity and care-related outcomes. Methods: We used a mixed methods design with two phases. First, we conducted interviews with stakeholders who were familiar with the health information exchange system to inform the development of a measure of benefits and challenges of the use of this system. Second, using this measure we conducted a survey of current and former users of the health information exchange system using a modified Dillman method. Results: 105 current and former users completed the survey. The results showed information quality, ease of completing tasks and clinical process improvement as key benefits that reduced workload and improved patient care.  Challenges related to system reliability, quality of reports and service quality increased workload and decreased impact on care, though the effect of the challenges was smaller than that of the benefits. Conclusions:  Even very limited health information exchange capabilities can improve outcomes for primary care users.  Improving perceptions of benefits may be even more important the removing challenges to use, though it is likely that a threshold of quality must be achieved for this to be true.

  4. 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

  5. Skeletal and Clinical Effects of Exoskeletal Assisted - Gait

    Science.gov (United States)

    2016-10-01

    clinical func