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.

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)

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...

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

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.

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

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

Co-benefits of including CCS projects in the CDM in India's power sector

International Nuclear Information System (INIS)

Eto, R.; Murata, A.; Uchiyama, Y.; Okajima, K.

2013-01-01

This study examines the effects of the inclusion of the co-benefits on the potential installed capacity of carbon dioxide capture and storage (CCS) projects with a linear programming model by the clean development mechanism (CDM) in India's power sector. It is investigated how different marginal damage costs of air pollutants affect the potential installed capacity of CCS projects in the CDM with a scenario analysis. Three results are found from this analysis. First, large quantity of IGCC with CCS becomes realizable when the certified emission reduction (CER) prices are above US$56/tCO 2 in the integrated Northern, Eastern, Western, and North-Eastern regional grids (NEWNE) and above US $49/tCO 2 in the Southern grid. Second, including co-benefits contributes to decrease CO 2 emissions and air pollutants with introduction of IGCC with CCS in the CDM at lower CER prices. Third, the effects of the co-benefits are limited in the case of CCS because CCS reduces larger amount of CO 2 emissions than that of air pollutants. Total marginal damage costs of air pollutants of US$250/t and US$200/t lead to CER prices of US$1/tCO 2 reduction in the NEWNE grid and the Southern grid. - Highlights: • We estimate effects of co-benefits on installed capacity of CCS projects in the CDM. • We develop a linear programming (LP) model of two grids of India. • Including co-benefits contributes to introduce IGCC with CCS in the CDM at lower CER prices

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

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

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...

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...

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

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.

76 FR 77815 - Ethical Electric Benefit Co.; Supplemental Notice That Initial Market-Based Rate Filing Includes...

Science.gov (United States)

2011-12-14

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER12-543-000] Ethical Electric Benefit Co.; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for... Ethical Electric Benefit Co.'s application for market-based rate authority, with an accompanying rate...

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...

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...

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.

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

Changes in dental care access upon health care benefit expansion to include scaling.

Science.gov (United States)

Park, Hee-Jung; Lee, Jun Hyup; Park, Sujin; Kim, Tae-Il

2016-12-01

This study aimed to evaluate the effects of a policy change to expand Korean National Health Insurance (KNHI) benefit coverage to include scaling on access to dental care at the national level. A nationally representative sample of 12,794 adults aged 20 to 64 years from Korea National Health and Nutritional Examination Survey (2010-2014) was analyzed. To examine the effect of the policy on the outcomes of interest (unmet dental care needs and preventive dental care utilization in the past year), an estimates-based probit model was used, incorporating marginal effects with a complex sampling structure. The effect of the policy on individuals depending on their income and education level was also assessed. Adjusting for potential covariates, the probability of having unmet needs for dental care decreased by 6.1% and preventative dental care utilization increased by 14% in the post-policy period compared to those in the pre-policy period (2010, 2012). High income and higher education levels were associated with fewer unmet dental care needs and more preventive dental visits. The expansion of coverage to include scaling demonstrated to have a significant association with decreasing unmet dental care needs and increasing preventive dental care utilization. However, the policy disproportionately benefited certain groups, in contrast with the objective of the policy to benefit all participants in the KNHI system.

Including public-health benefits of trees in urban-forestry decision making

Science.gov (United States)

Geoffrey H. Donovan

2017-01-01

Research demonstrating the biophysical benefits of urban trees are often used to justify investments in urban forestry. Far less emphasis, however, is placed on the non-bio-physical benefits such as improvements in public health. Indeed, the public-health benefits of trees may be significantly larger than the biophysical benefits, and, therefore, failure to account for...

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

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...

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.

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/.

42 CFR 417.155 - How the HMO option must be included in the health benefits plan.

Science.gov (United States)

2010-10-01

... printed materials that meet the requirements of § 417.124(b). (ii) Access may not be more restrictive or... benefits plan. 417.155 Section 417.155 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT... Organizations in Employee Health Benefits Plans § 417.155 How the HMO option must be included in the health...

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.

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.

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

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

The Diversification Benefits of Including Carbon Assets in Financial Portfolios

Directory of Open Access Journals (Sweden)

Yinpeng Zhang

2017-03-01

Full Text Available Carbon allowances traded in the EU-Emission Trading Scheme (EU-ETS were initially designed as an economic motivation for efficiently curbing greenhouse as emissions, but now it mimics quite a few characteristics of financial assets, and have now been used as a candidate product in building financial portfolios. In this study, we examine the time-varying correlations between carbon allowance prices with other financial indices, during the third phase of EU-ETS. The results show that, at the beginning of this period, carbon price was still strongly corrected with other financial indices. However, this connection was weakened over time. Given the relative independence of carbon assets from other financial assets, we argue for the diversification benefits of including carbon assets in financial portfolios, and building such portfolios, respectively, with the traditional global minimum variance (GMV strategy, the mean-variance-OGARCH (MV-OGARCH strategy, and the dynamic conditional correlation (DCC strategy. It is shown that the portfolio built with the MV-OGARCH strategy far out-performs the others and that including carbon assets in financial portfolios does help reduce investment risks.

[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.

The economic benefits of malaria elimination: do they include increases in tourism?

Science.gov (United States)

Modrek, Sepideh; Liu, Jenny; Gosling, Roland; Feachem, Richard G A

2012-07-28

Policy makers have speculated that one of the economic benefits of malaria elimination includes increases in foreign direct investment, particularly tourism. This study examines the empirical relationship between the demand for travel and malaria cases in two countries with large tourism industries around the time in which they carried out malaria-elimination campaigns. In Mauritius, this analysis examines historical, yearly tourist arrivals and malaria cases from 1978-1999, accounting for the background secular trend of increasing international travel. In Dominican Republic, a country embarking upon malaria elimination, it employs a time-series analysis of the monthly, international tourist arrivals from 1998-2010 to determine whether the timing of significant deviations in tourist arrivals coincides with malaria outbreaks. While naïve relationships exist in both cases, the results show that the relationships between tourist arrivals and malaria cases are relatively weak and statistically insignificant once secular confounders are accounted for. This suggests that any economic benefits from tourism that may be derived from actively pursuing elimination in countries that have high tourism potential are likely to be small when measured at a national level. Rather, tourism benefits are likely to be experienced with greater impact in more concentrated tourist areas within countries, and future studies should seek to assess these relationships at a regional or local level.

Expanding Canadian Medicare to include a national pharmaceutical benefit while controlling expenditures: possible lessons from Israel.

Science.gov (United States)

Rosen, Bruce

2018-02-05

In Canada, there is an ongoing debate about whether to expand Medicare to include a national pharmaceutical benefit on a universal basis. The potential health benefits are understood to be significant, but there are ongoing concerns about affordability. In Israel, the National Health Insurance benefits package includes a comprehensive pharmaceutical benefit. Nonetheless, per capita pharmaceutical spending is well below that of Canada and the Organization for Economic Co-operation and Development average. This paper highlights seven strategies that Israel has employed to constrain pharmaceutical spending: (1) prioritizing new technologies, subject to a global budget constraint; (2) using regulations and market power to secure fair and reasonable prices; (3) establishing an efficient pharmaceutical distribution system; (4) promoting effective prescribing behavior; (5) avoiding artificial inflation of consumer demand; (6) striking an appropriate balance between respect for IP rights, access and cost containment; and (7) developing a shared societal understanding about the value and limits of pharmaceutical spending. Some of these strategies are already in place in some parts of Canada. Others could be introduced into Canada, and might contribute to the affordability of a national pharmaceutical benefit, but substantial adaptation would be needed. For example, in Israel the health maintenance organizations (HMOs) play a central role in promoting effective prescribing behavior, whereas in HMO-free Canada other mechanisms are needed to advance this important goal.

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.

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.

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.

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

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.

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.

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....

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.

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

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

"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.

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

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. ...

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

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...

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

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.

29 CFR 778.214 - Benefit plans; including profit-sharing plans or trusts providing similar benefits.

Science.gov (United States)

2010-07-01

... fide plan for providing old age, retirement, life, accident, or health insurance or similar benefits... employee on account of severance of employment (or for any other reason) would not result in any increase... mechanics performing contract work subject to the Davis-Bacon Act and related statutes, the provisions of...

Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database.

Science.gov (United States)

Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M; Lössl, Kristina

2016-03-22

To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future.

Highly active antiretroviral therapy including protease inhibitors does not confer a unique CD4 cell benefit. The AVANTI and INCAS Study Groups.

Science.gov (United States)

2000-07-07

To determine if triple combination therapy, particularly including HIV protease inhibitors (PI), confers an unique immunological benefit that is independent of reductions of plasma viral load (pVL). The correlation between changes from baseline in CD4 cell count and pVL was examined at all time points up to 52 weeks in three randomized clinical trials (AVANTI-2, AVANTI-3 and INCAS) that compared dual nucleoside therapy with triple combination therapy. Individual pVL and CD4 cell counts changes from baseline were entered into multivariate linear regression models for patients receiving double therapy and for those receiving triple therapy including a PI and/or a non-nucleoside reverse transcriptase inhibitor (NNRTI), and the null hypothesis was tested. After 52 weeks of therapy, the relationship between changes from baseline CD4 cell count and pVL was independent of whether patients were assigned double or triple therapy (P = 0.23 and 0.69 for intercept and slope, respectively), or whether patients were assigned triple therapy including a PI or triple therapy including an NNRTI (P = 0.92 and 0.95, respectively). Less than 5% of patients ever had 'discordant' increases in both CD4 cell count and pVL compared with baseline, and this proportion was unrelated to the class of therapy used. 'Discordant' decreases from baseline in both parameters were observed in up to 35% of individuals. The correlation between pVL and CD4 cell count changes from baseline improved over time on therapy, regardless of the therapeutic regimen involved. The data provide no evidence for a CD4 cell count benefit of highly active antiretroviral therapy (HAART) unique to triple therapy or PI-containing regimens.

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.

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.

Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database

International Nuclear Information System (INIS)

Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M.; Lössl, Kristina

2016-01-01

To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future. The online version of this article (doi:10.1186/s13014-016-0624-8) contains supplementary material, which is available to authorized users

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 

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

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.

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

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.

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.

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.

Oropharyngeal Dysphagia in Dermatomyositis: Associations with Clinical and Laboratory Features Including Autoantibodies

OpenAIRE

Mugii, Naoki; Hasegawa, Minoru; Matsushita, Takashi; Hamaguchi, Yasuhito; Oohata, Sacihe; Okita, Hirokazu; Yahata, Tetsutarou; Someya, Fujiko; Inoue, Katsumi; Murono, Shigeyuki; Fujimoto, Manabu; Takehara, Kazuhiko

2016-01-01

Objective Dysphagia develops with low frequency in patients with dermatomyositis. Our objective was to determine the clinical and laboratory features that can estimate the development of dysphagia in dermatomyositis. Methods This study included 92 Japanese patients with adult-onset dermatomyositis. The associations between dysphagia and clinical and laboratory features including disease-specific autoantibodies determined by immunoprecipitation assays were analyzed. Results Videofluoroscopy sw...

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.

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

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.

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...

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.

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.

Employee benefits under IAS/IFRS and the Czech accounting legislation, the tax point of view including

Directory of Open Access Journals (Sweden)

Milena Otavová

2009-01-01

Full Text Available The regulation of employee benefit is limited in the Czech Accounting Legislation. There are only short-term employee benefits – wages, salaries, when employees has rendered services to an entity during a period – month. Entities could create funds from a net profit –fund for social and cultural benefits which could serve as source of social services financing for employees. There are employee benefits defined very extensive in IAS/IFRS. It is IAS 19 – Employee Benefits which defines four Gross of employee benefits: short-term employee benefits, post employment benefits, other long –term employee benefits and termination benefits. There are defined all conditions for employee benefits re­co­gni­tion and treatments for recording and reporting in IAS 19.The paper is concerned with the employee benefits evaluation. The impact on the tax base is eva­lua­ted. There are the most significant types of employee benefits surveyed. They are divided into five groups with the respect to their impact on the tax base. The impact of these benefits is described from their impact on social insurance and health insurance calculation base point of view, as well.

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.

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.

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....

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.

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

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.

Cost and benefit including value of life, health and environmental damage measured in time units

DEFF Research Database (Denmark)

Ditlevsen, Ove Dalager; Friis-Hansen, Peter

2009-01-01

Key elements of the authors' work on money equivalent time allocation to costs and benefits in risk analysis are put together as an entity. This includes the data supported dimensionless analysis of an equilibrium relation between total population work time and gross domestic product leading...... of this societal value over the actual costs, used by the owner for economically optimizing an activity, motivates a simple risk accept criterion suited to be imposed on the owner by the public. An illustration is given concerning allocation of economical means for mitigation of loss of life and health on a ferry...

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 ...

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.

"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.

[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.

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.

Employee benefits under IAS/IFRS and the Czech accounting legislation, the tax point of view including

OpenAIRE

Milena Otavová; Jana Gláserová

2009-01-01

The regulation of employee benefit is limited in the Czech Accounting Legislation. There are only short-term employee benefits – wages, salaries, when employees has rendered services to an entity during a period – month. Entities could create funds from a net profit –fund for social and cultural benefits which could serve as source of social services financing for employees. There are employee benefits defined very extensive in IAS/IFRS. It is IAS 19 – Employee Benefits which defines four Gro...

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.

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.

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

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 ...

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

Adherence to antiretroviral therapy and clinical outcomes among young adults reporting high-risk sexual behavior, including men who have sex with men, in coastal Kenya.

Science.gov (United States)

Graham, Susan M; Mugo, Peter; Gichuru, Evanson; Thiong'o, Alexander; Macharia, Michael; Okuku, Haile S; van der Elst, Elise; Price, Matthew A; Muraguri, Nicholas; Sanders, Eduard J

2013-05-01

African men who have sex with men (MSM) face significant stigma and barriers to care. We investigated antiretroviral therapy (ART) adherence among high-risk adults, including MSM, participating in a clinic-based cohort. Survival analysis was used to compare attrition across patient groups. Differences in adherence, weight gain, and CD4 counts after ART initiation were assessed. Among 250 HIV-1-seropositive adults, including 108 MSM, 15 heterosexual men, and 127 women, patient group was not associated with attrition. Among 58 participants who were followed on ART, 40 % of MSM had less than 95 % adherence, versus 28.6 % of heterosexual men and 11.5 % of women. Although MSM gained less weight after ART initiation than women (adjusted difference -3.5 kg/year), CD4 counts did not differ. More data are needed on barriers to adherence and clinical outcomes among African MSM, to ensure that MSM can access care and derive treatment and prevention benefits from ART.

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.

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.

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.

[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.

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

Potential Benefit of Singing for People with Parkinson's Disease: A Systematic Review.

Science.gov (United States)

Barnish, Jean; Atkinson, Rachel A; Barran, Susannah M; Barnish, Maxwell S

2016-06-03

There is evidence that participation in performing arts brings psychosocial benefits in the general population and in recent years there has been substantial interest in the potential therapeutic benefit of performing arts, including singing, for people with chronic medical conditions including those of neurological aetiology. To systematically review the existing body of evidence regarding the potential benefit of singing on clinical outcomes of people with PD. Seven online bibliographic databases were systematically searched in January 2016 and supplementary searches were conducted. Full-text original peer-reviewed scientific papers that investigated the potential benefit of singing on at least one of speech, functional communication, cognitive status, motor function and quality of life in human participants with PD were eligible for inclusion. 449 unique records were identified, 25 full-text articles were screened and seven studies included in the review. All seven studies assessed the impact of singing on speech, five found partial evidence of benefit and two found no evidence of benefit. One study assessed each of functional communication and quality of life and no significant benefit was found. No included study assessed the impact of singing on motor function or cognitive status. Singing may benefit the speech of people with PD, although evidence is not unequivocal. Further research is required to assess wider benefits including on functional communication, cognitive status, motor function and quality of life. Substantial methodological limitations were identified in the existing literature. Recommendations are made for advancing the state of the literature.

“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

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.

Ontario Universities Benefits Survey, 1990-91: Part I, Benefits Excluding Pensions.

Science.gov (United States)

Council of Ontario Universities, Toronto.

The report details, in tabular form, non-pension benefits offered by each of 17 Ontario universities. These include: supplementary health insurance; long term disability; sick leave entitlement; sick leave-benefits continuance; long term disability-benefits continuance; life insurance; survivor benefit; dental plan; post-retirement benefits;…

Oropharyngeal Dysphagia in Dermatomyositis: Associations with Clinical and Laboratory Features Including Autoantibodies.

Science.gov (United States)

Mugii, Naoki; Hasegawa, Minoru; Matsushita, Takashi; Hamaguchi, Yasuhito; Oohata, Sacihe; Okita, Hirokazu; Yahata, Tetsutarou; Someya, Fujiko; Inoue, Katsumi; Murono, Shigeyuki; Fujimoto, Manabu; Takehara, Kazuhiko

2016-01-01

Dysphagia develops with low frequency in patients with dermatomyositis. Our objective was to determine the clinical and laboratory features that can estimate the development of dysphagia in dermatomyositis. This study included 92 Japanese patients with adult-onset dermatomyositis. The associations between dysphagia and clinical and laboratory features including disease-specific autoantibodies determined by immunoprecipitation assays were analyzed. Videofluoroscopy swallow study (VFSS) was performed for all patients with clinical dysphagia (n = 13, 14.1%) but not for patients without clinical dysphagia. Typical findings of dysphagia (pharyngeal pooling, n = 11 and/or nasal regurgitation, n = 4) was detected by VFSS in all patients with clinical dysphagia. Eleven patients with dysphagia (84.6%) had anti-transcription intermediary factor 1γ (TIF-1γ) antibody. By univariate analysis, the average age and the male to female ratio, internal malignancy, and anti-TIF-1γ antibody were significantly higher and the frequency of interstitial lung diseases and manual muscle testing (MMT) scores of sternomastoid and dertoid muscles were significantly lower in patients with dysphagia than in patients without dysphagia. Among patients with anti-TIF-1γ antibody, the mean age, the ratios of male to female and internal malignancy were significantly higher and mean MMT scores of sternomastoid muscle were significantly lower in patients with dysphagia compared with patients without dysphagia. By multivariable analysis, the risk of dysphagia was strongly associated with the existence of internal malignancy and ant-TIF-1γ antibody and was also associated with reduced scores of manual muscle test of sternomastoid muscle. Dysphagia was markedly improved after the treatment against myositis in all 13 patients. These findings indicate that dysphagia can develop frequently in patients with internal malignancy, anti-TIF-1γ antibody, or severe muscle weakness of sternomastoid muscle.

Medicare Hospice Benefits

Science.gov (United States)

CENTERS for MEDICARE & MEDICAID SERVICES Medicare Hospice Benefits This official government booklet includes information about Medicare hospice benefits: Who’s eligible for hospice care What services are included in hospice care How ...

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.

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

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.

Online benefits solutions--a new trend in managing employee benefits programs.

Science.gov (United States)

Ala, Mohammad; Brunaczki, Bernadette

2003-01-01

This article focuses on the array of online benefits solutions offered by technology companies and reports the benefits to both employers and employees. Some of the benefits include reduced paperwork, reduced errors, and reduced administration costs. Companies that can deliver these benefits will be in great demand to help manage benefits programs and streamline the administrative processes.

Benefits of Java

Science.gov (United States)

... Wellness Preventing Illness Benefits of Coffee Print Email Benefits of Coffee Reviewed by Taylor Wolfram, MS, RDN, ... your daily cup (or three) provides some health benefits as well. Drinking moderate amounts of coffee (including ...

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.

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.

Integration of Medical Imaging Including Ultrasound into a New Clinical Anatomy Curriculum

Science.gov (United States)

Moscova, Michelle; Bryce, Deborah A.; Sindhusake, Doungkamol; Young, Noel

2015-01-01

In 2008 a new clinical anatomy curriculum with integrated medical imaging component was introduced into the University of Sydney Medical Program. Medical imaging used for teaching the new curriculum included normal radiography, MRI, CT scans, and ultrasound imaging. These techniques were incorporated into teaching over the first two years of the…

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.

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.

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.

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.

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.

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.

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

The benefits of integrating cost-benefit analysis and risk assessment

International Nuclear Information System (INIS)

Fisher, K.; Clarke-Whistler, K.

1995-01-01

It has increasingly been recognized that knowledge of risks in the absence of benefits and costs cannot dictate appropriate public policy choices. Recent evidence of this recognition includes the proposed EPA Risk Assessment and Cost-Benefit Analysis Act of 1995, a number of legislative changes in Canada and the US, and the increasing demand for field studies combining measures of impacts, risks, costs and benefits. Failure to consider relative environmental and human health risks, benefits, and costs in making public policy decisions has resulted in allocating scarce resources away from areas offering the highest levels of risk reduction and improvements in health and safety. The authors discuss the implications of not taking costs and benefits into account in addressing environmental risks, drawing on examples from both Canada and the US. The authors also present the results of their recent field work demonstrating the advantages of considering costs and benefits in making public policy and site remediation decisions, including a study on the benefits and costs of prevention, remediation and monitoring techniques applied to groundwater contamination; the benefits and costs of banning the use of chlorine; and the benefits and costs of Canada's concept of disposing of high-level nuclear waste. The authors conclude that a properly conducted Cost-Benefit Analysis can provide critical input to a Risk Assessment and can ensure that risk management decisions are efficient, cost-effective and maximize improvement to environmental and human health

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.

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

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.

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.

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.

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

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.

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 ...

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, ...

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.

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.

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

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....

Exercise Benefits Coronary Heart Disease.

Science.gov (United States)

Wang, Lei; Ai, Dongmei; Zhang, Ning

2017-01-01

Coronary heart disease (CHD) is a group of diseases that include: no symptoms, angina, myocardial infarction, ischemia cardiomyopathy and sudden cardiac death. And it results from multiple risks factors consisting of invariable factors (e.g. age, gender, etc.) and variable factors (e.g. dyslipidemia, hypertension, diabetes, smoking, etc.). Meanwhile, CHD could cause impact not only localized in the heart, but also on pulmonary function, whole-body skeletal muscle function, activity ability, psychological status, etc. Nowadays, CHD has been the leading cause of death in the world. However, many clinical researches showed that exercise training plays an important role in cardiac rehabilitation and can bring a lot of benefits for CHD patients.

Exercise and well-being: a review of mental and physical health benefits associated with physical activity.

Science.gov (United States)

Penedo, Frank J; Dahn, Jason R

2005-03-01

This review highlights recent work evaluating the relationship between exercise, physical activity and physical and mental health. Both cross-sectional and longitudinal studies, as well as randomized clinical trials, are included. Special attention is given to physical conditions, including obesity, cancer, cardiovascular disease and sexual dysfunction. Furthermore, studies relating physical activity to depression and other mood states are reviewed. The studies include diverse ethnic populations, including men and women, as well as several age groups (e.g. adolescents, middle-aged and older adults). Results of the studies continue to support a growing literature suggesting that exercise, physical activity and physical-activity interventions have beneficial effects across several physical and mental-health outcomes. Generally, participants engaging in regular physical activity display more desirable health outcomes across a variety of physical conditions. Similarly, participants in randomized clinical trials of physical-activity interventions show better health outcomes, including better general and health-related quality of life, better functional capacity and better mood states. The studies have several implications for clinical practice and research. Most work suggests that exercise and physical activity are associated with better quality of life and health outcomes. Therefore, assessment and promotion of exercise and physical activity may be beneficial in achieving desired benefits across several populations. Several limitations were noted, particularly in research involving randomized clinical trials. These trials tend to involve limited sample sizes with short follow-up periods, thus limiting the clinical implications of the benefits associated with physical activity.

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

Clinical and histopathological characteristics of cutaneous Leishmaniasis in Sanliurfa City of Turkey including Syrian refugees.

Science.gov (United States)

Koçarslan, Sezen; Turan, Enver; Ekinci, Turan; Yesilova, Yavuz; Apari, Rabia

2013-01-01

The aim of our study was to investigate the clinical and histopathological characteristics of cutaneous leishmaniasis (CL) in the city of Sanliurfa in Turkey, where Syrian refugees also reside. At the Harran University Hospital outpatient clinics between 2012 and 2013, 54 CL cases, including 24 Syrian patients, underwent punch biopsy of the skin and/or a touch imprint. Patients in whom leishmania parasites were detected were included in the study. The clinical and histopathological data of the patients were obtained by a review of the patients' medical records. All the slides of each patient were re-evaluated histopathologically. Fifty-four cases (mean age; 17 ± 12 years), consisting of 32 males (59.3%) and 22 females (40.7%), were examined. The most common site of involvement was the face (63%). The most common presentation was noduloulcerative lesions (57.4%). Histopathologically, the majority of the cases exhibited hyperkeratosis, follicular plugging of the epidermis, chronic inflammatory infiltration, leishmania amastigotes and non-caseating granulomatous inflammation in the dermis. CL presents with a wide spectrum of expression, both clinically and histologically, and may mimic other inflammatory and neoplastic diseases. The diagnosis of CL relies on the identification of leishmania amastigotes in either a direct smear of the lesion or in a tissue section.

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.

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 ...

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

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

Science.gov (United States)

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

2017-01-01

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

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

Science.gov (United States)

Simon, Sheldon R

2004-12-01

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

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.

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

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.

Clinical and histopathological characteristics of cutaneous Leishmaniasis in Sanliurfa City of Turkey including Syrian refugees

Directory of Open Access Journals (Sweden)

Sezen Koçarslan

2013-01-01

Full Text Available Background: The aim of our study was to investigate the clinical and histopathological characteristics of cutaneous leishmaniasis (CL in the city of Sanliurfa in Turkey, where Syrian refugees also reside. Materials and Methods: At the Harran University Hospital outpatient clinics between 2012 and 2013, 54 CL cases, including 24 Syrian patients, underwent punch biopsy of the skin and/or a touch imprint. Patients in whom leishmania parasites were detected were included in the study. The clinical and histopathological data of the patients were obtained by a review of the patients′ medical records. All the slides of each patient were re-evaluated histopathologically. Results: Fifty-four cases (mean age; 17 ± 12 years, consisting of 32 males (59.3% and 22 females (40.7%, were examined. The most common site of involvement was the face (63%. The most common presentation was noduloulcerative lesions (57.4%. Histopathologically, the majority of the cases exhibited hyperkeratosis, follicular plugging of the epidermis, chronic inflammatory infiltration, leishmania amastigotes and non-caseating granulomatous inflammation in the dermis. Conclusion: CL presents with a wide spectrum of expression, both clinically and histologically, and may mimic other inflammatory and neoplastic diseases. The diagnosis of CL relies on the identification of leishmania amastigotes in either a direct smear of the lesion or in a tissue section.

Use of Tumor Markers in Gastrointestinal Cancers: Surgeon Perceptions and Cost-Benefit Trade-Off Analysis.

Science.gov (United States)

Acharya, Amish; Markar, Sheraz R; Matar, Michael; Ni, Melody; Hanna, George B

2017-05-01

Gastrointestinal cancers constitute the third most common cancers worldwide. Tumor markers have long since been used in the postoperative surveillance of these malignancies; however, the true value in clinical practice remains undetermined. This study aimed to evaluate the clinical utility of three tumor markers in colorectal and esophagogastric cancer. A systematic review of the literature was undertaken to elicit the sensitivity, specificity, statistical heterogeneity and ability to predict recurrence and metastases for carcinoembryonic antigen (CEA), cancer antigen (CA) 19-9 and CA125. European surgeons were surveyed to assess their current practice and the characteristics of tumor markers they most valued. Data from the included studies and survey were combined in a cost-benefit trade-off analysis to assess which tumor markers are of most use in clinical practice. Diagnostic sensitivity and specificity were ranked the most desirable characteristics of a tumor marker by those surveyed. Overall, 156 studies were included to inform the cost-benefit trade-off. The cost-benefit trade-off showed that CEA outperformed both CA19-9 and CA125, with lower financial cost and a higher sensitivity, and diagnostic accuracy for metastases at presentation (area under the curve [AUC] 0.70 vs. 0.61 vs. 0.46), as well as similar diagnostic accuracy for recurrence (AUC 0.46 vs. 0.48). Cost-benefit trade-off analysis identified CEA to be the best performing tumor marker. Further studies should seek to evaluate new tumor markers, with investigation tailored to factors that meet the requirements of practicing clinicians.

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

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...

Contemporary Aspects of Marketing in Clinical Trials Including Segments of IT and Technology Transfer

Science.gov (United States)

Stamenovic, Milorad; Dobraca, Amra; Smajlovic, Mersiha

2018-01-01

Introduction: The aim of this paper is to present the marketing strategy and the application of management (marketing management) and advertising in order to increase the efficiency of innovative approach in clinical trials that include and involve the use of new technologies and transfer of technologies. Material and Methods: This paper has a descriptive character and represents a narrative review of the literature and new model implementation. Results: Marketing models are primarily used to improve the inclusion of a larger (and appropriate) number of patients, but they can be credited for the stay and monitoring of patients in the trial. Regulatory mechanisms play an important role in the application of various marketing strategies within clinical trials. The value for the patient as the most important stakeholder is defined in the field of clinical trials according to Kotler’s value model for the consumer. Conclusion: In order to achieve the best results it is important to adequately examine all the elements of clinical trials and apply this knowledge in creation of a marketing plan that will be made in accordance with the legal regulations defined globally and locally. In this paper, two challenges have been highlighted for the adequate application of marketing tools in the field of clinical trials, namely: defining business elements in order to provide an adequate marketing approach for clinical trials and technology transfer and ensuring uniformity and regulatory affirmation of marketing attitudes in clinical trials in all regions in which they are carried out in accordance with ICH-GCP and valid regulations. PMID:29719318

Contemporary Aspects of Marketing in Clinical Trials Including Segments of IT and Technology Transfer.

Science.gov (United States)

Stamenovic, Milorad; Dobraca, Amra; Smajlovic, Mersiha

2018-01-01

The aim of this paper is to present the marketing strategy and the application of management (marketing management) and advertising in order to increase the efficiency of innovative approach in clinical trials that include and involve the use of new technologies and transfer of technologies. This paper has a descriptive character and represents a narrative review of the literature and new model implementation. Marketing models are primarily used to improve the inclusion of a larger (and appropriate) number of patients, but they can be credited for the stay and monitoring of patients in the trial. Regulatory mechanisms play an important role in the application of various marketing strategies within clinical trials. The value for the patient as the most important stakeholder is defined in the field of clinical trials according to Kotler's value model for the consumer. In order to achieve the best results it is important to adequately examine all the elements of clinical trials and apply this knowledge in creation of a marketing plan that will be made in accordance with the legal regulations defined globally and locally. In this paper, two challenges have been highlighted for the adequate application of marketing tools in the field of clinical trials, namely: defining business elements in order to provide an adequate marketing approach for clinical trials and technology transfer and ensuring uniformity and regulatory affirmation of marketing attitudes in clinical trials in all regions in which they are carried out in accordance with ICH-GCP and valid regulations.

Defining robustness protocols: a method to include and evaluate robustness in clinical plans

International Nuclear Information System (INIS)

McGowan, S E; Albertini, F; Lomax, A J; Thomas, S J

2015-01-01

We aim to define a site-specific robustness protocol to be used during the clinical plan evaluation process. Plan robustness of 16 skull base IMPT plans to systematic range and random set-up errors have been retrospectively and systematically analysed. This was determined by calculating the error-bar dose distribution (ebDD) for all the plans and by defining some metrics used to define protocols aiding the plan assessment. Additionally, an example of how to clinically use the defined robustness database is given whereby a plan with sub-optimal brainstem robustness was identified. The advantage of using different beam arrangements to improve the plan robustness was analysed. Using the ebDD it was found range errors had a smaller effect on dose distribution than the corresponding set-up error in a single fraction, and that organs at risk were most robust to the range errors, whereas the target was more robust to set-up errors. A database was created to aid planners in terms of plan robustness aims in these volumes. This resulted in the definition of site-specific robustness protocols. The use of robustness constraints allowed for the identification of a specific patient that may have benefited from a treatment of greater individuality. A new beam arrangement showed to be preferential when balancing conformality and robustness for this case. The ebDD and error-bar volume histogram proved effective in analysing plan robustness. The process of retrospective analysis could be used to establish site-specific robustness planning protocols in proton therapy. These protocols allow the planner to determine plans that, although delivering a dosimetrically adequate dose distribution, have resulted in sub-optimal robustness to these uncertainties. For these cases the use of different beam start conditions may improve the plan robustness to set-up and range uncertainties. (paper)

Defining robustness protocols: a method to include and evaluate robustness in clinical plans

Science.gov (United States)

McGowan, S. E.; Albertini, F.; Thomas, S. J.; Lomax, A. J.

2015-04-01

We aim to define a site-specific robustness protocol to be used during the clinical plan evaluation process. Plan robustness of 16 skull base IMPT plans to systematic range and random set-up errors have been retrospectively and systematically analysed. This was determined by calculating the error-bar dose distribution (ebDD) for all the plans and by defining some metrics used to define protocols aiding the plan assessment. Additionally, an example of how to clinically use the defined robustness database is given whereby a plan with sub-optimal brainstem robustness was identified. The advantage of using different beam arrangements to improve the plan robustness was analysed. Using the ebDD it was found range errors had a smaller effect on dose distribution than the corresponding set-up error in a single fraction, and that organs at risk were most robust to the range errors, whereas the target was more robust to set-up errors. A database was created to aid planners in terms of plan robustness aims in these volumes. This resulted in the definition of site-specific robustness protocols. The use of robustness constraints allowed for the identification of a specific patient that may have benefited from a treatment of greater individuality. A new beam arrangement showed to be preferential when balancing conformality and robustness for this case. The ebDD and error-bar volume histogram proved effective in analysing plan robustness. The process of retrospective analysis could be used to establish site-specific robustness planning protocols in proton therapy. These protocols allow the planner to determine plans that, although delivering a dosimetrically adequate dose distribution, have resulted in sub-optimal robustness to these uncertainties. For these cases the use of different beam start conditions may improve the plan robustness to set-up and range uncertainties.

Calculations of environmental benefits from using geothermal energy must include the rebound effect

DEFF Research Database (Denmark)

Atlason, Reynir Smari; Unnthorsson, Runar

2017-01-01

and energy production patterns are simulated using data from countries with similar environmental conditions but do not use geothermal or hydropower to the same extent as Iceland. Because of the rapid shift towards renewable energy and exclusion of external energy provision, the country is considered......When considering the environmental benefits from converting to renewable energy sources, the rebound effect is often omitted. In this study, the aim is to investigate greenhouse gas emission reduction inclusive of the rebound effect. We use Iceland as a case study where alternative consumption...

Setting a national minimum standard for health benefits: how do state benefit mandates compare with benefits in large-group plans?

Science.gov (United States)

Frey, Allison; Mika, Stephanie; Nuzum, Rachel; Schoen, Cathy

2009-06-01

Many proposed health insurance reforms would establish a federal minimum benefit standard--a baseline set of benefits to ensure that people have adequate coverage and financial protection when they purchase insurance. Currently, benefit mandates are set at the state level; these vary greatly across states and generally target specific areas rather than set an overall standard for what qualifies as health insurance. This issue brief considers what a broad federal minimum standard might look like by comparing existing state benefit mandates with the services and providers covered under the Federal Employees Health Benefits Program (FEHBP) Blue Cross and Blue Shield standard benefit package, an example of minimum creditable coverage that reflects current standard practice among employer-sponsored health plans. With few exceptions, benefits in the FEHBP standard option either meet or exceed those that state mandates require-indicating that a broad-based national benefit standard would include most existing state benefit mandates.

Data safe havens to combine health and genomic data: benefits and challenges

Directory of Open Access Journals (Sweden)

Kerina H Jones

2017-04-01

Genomic data sets contain vast amounts of valuable information, some of which is currently undefined, but which may have direct bearing on individual health at some point. The use of these data in combination with health-related data has the potential to bring great benefits, better clinical trial stratification, epidemiology project design and clinical improvements. It is, therefore, essential that such data are surrounded by a properly-designed, robust governance framework including technical and procedural access controls that enable the data to be used safely.

OARSI Clinical Trials Recommendations: Soluble biomarker assessments in clinical trials in osteoarthritis.

Science.gov (United States)

Kraus, V B; Blanco, F J; Englund, M; Henrotin, Y; Lohmander, L S; Losina, E; Önnerfjord, P; Persiani, S

2015-05-01

The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from both academia and industry, convened to discuss issues related to soluble biomarkers and to make recommendations for their use in OA clinical trials based on current knowledge and anticipated benefits. This document summarizes current guidance on use of biomarkers in OA clinical trials and their utility at five stages, including preclinical development and phase I to phase IV trials. As demonstrated by this summary, biomarkers can provide value at all stages of therapeutics development. When resources permit, we recommend collection of biospecimens in all OA clinical trials for a wide variety of reasons but in particular, to determine whether biomarkers are useful in identifying those individuals most likely to receive clinically important benefits from an intervention; and to determine whether biomarkers are useful for identifying individuals at earlier stages of OA in order to institute treatment at a time more amenable to disease modification. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

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.

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

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

A survey of cannabis (marijuana) use and self-reported benefit in men with chronic prostatitis/chronic pelvic pain syndrome.

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Tripp, Dean A; Nickel, J Curtis; Katz, Laura; Krsmanovic, Adrijana; Ware, Mark A; Santor, Darcy

2014-11-01

Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a chronic pelvic pain condition largely refractory to treatment. Cannabis (marijuana) use has been reported for a wide variety of chronic pain conditions, but no study has examined prevalence of cannabis use, symptom benefit or side effects, or frequency in CP/CPPS. Participants were recruited from an outpatient CP/CPPS urology clinic (n = 98) and online through the Prostatitis Foundation website (n = 244). Participants completed questionnaires (demographics, CP/CPPS, depression, cannabis). The clinic sample included Canadian patients and the online sample included primarily American patients. Due to differences, groups were examined separately. Almost 50% of respondents reported using cannabis (clinic n = 49; online n = 89). Of the cannabis users, 36.8% of clinic and 75% of online respondents reported that it improved their symptoms. Most of the respondents (from the clinic and online groups) reported that cannabis improved their mood, pain, muscle spasms, and sleep. However, they did not note any improvements for weakness, fatigue, numbness, ambulation, and urination. Overall, the effectiveness of cannabis for CP/CPPS was "somewhat/very effective" (57% clinic; 63% online). There were no differences between side effects or choice of consumption and most reported using cannabis rarely. These are the first estimates in men suffering from CP/CPPS and suggest that while cannabis use is prevalent, its medical use and benefit are unknown. This is an understudied area and the benefit or hazard for cannabis use awaits further study.

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.

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

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.

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.

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/.

Applying Multiple Criteria Decision Analysis to Comparative Benefit-Risk Assessment : Choosing among Statins in Primary Prevention

NARCIS (Netherlands)

Tervonen, Tommi; Naci, Huseyin; van Valkenhoef, Gert; Ades, Anthony E.; Angelis, Aris; Hillege, Hans L.; Postmus, Douwe

2015-01-01

Decision makers in different health care settings need to weigh the benefits and harms of alternative treatment strategies. Such health care decisions include marketing authorization by regulatory agencies, practice guideline formulation by clinical groups, and treatment selection by prescribers and

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.

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.

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

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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

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

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.

The obstetrical and postpartum benefits of continuous support during childbirth.

Science.gov (United States)

Scott, K D; Klaus, P H; Klaus, M H

1999-12-01

The purpose of this article is to review the evidence regarding the effectiveness of continuous support provided by a trained laywoman (doula) during childbirth on obstetrical and postpartum outcomes. Twelve individual randomized trials have compared obstetrical and postpartum outcomes between doula-supported women and women who did not receive doula support during childbirth. Three meta-analyses, which used different approaches, have been performed on the results of the clinical trials. Emotional and physical support significantly shortens labor and decreases the need for cesarean deliveries, forceps and vacuum extraction, oxytocin augmentation, and analgesia. Doula-supported mothers also rate childbirth as less difficult and painful than do women not supported by a doula. Labor support by fathers does not appear to produce similar obstetrical benefits. Eight of the 12 trials report early or late psychosocial benefits of doula support. Early benefits include reductions in state anxiety scores, positive feelings about the birth experience, and increased rates of breastfeeding initiation. Later postpartum benefits include decreased symptoms of depression, improved self-esteem, exclusive breastfeeding, and increased sensitivity of the mother to her child's needs. The results of these 12 trials strongly suggest that doula support is an essential component of childbirth. A thorough reorganization of current birth practices is in order to ensure that every woman has access to continuous emotional and physical support during labor.

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

Co-enrolment of Participants into Multiple Cancer Trials: Benefits and Challenges.

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Cafferty, F H; Coyle, C; Rowley, S; Berkman, L; MacKensie, M; Langley, R E

2017-07-01

Opportunities to enter patients into more than one clinical trial are not routinely considered in cancer research and experiences with co-enrolment are rarely reported. Potential benefits of allowing appropriate co-enrolment have been identified in other settings but there is a lack of evidence base or guidance to inform these decisions in oncology. Here, we discuss the benefits and challenges associated with co-enrolment based on experiences in the Add-Aspirin trial - a large, multicentre trial recruiting across a number of tumour types, where opportunities to co-enrol patients have been proactively explored and managed. The potential benefits of co-enrolment include: improving recruitment feasibility; increased opportunities for patients to participate in trials; and collection of robust data on combinations of interventions, which will ensure the ongoing relevance of individual trials and provide more cohesive evidence to guide the management of future patients. There are a number of perceived barriers to co-enrolment in terms of scientific, safety and ethical issues, which warrant consideration on a trial-by-trial basis. In many cases, any potential effect on the results of the trials will be negligible - limited by a number of factors, including the overlap in trial cohorts. Participant representatives stress the importance of autonomy to decide about trial enrolment, providing a compelling argument for offering co-enrolment where there are multiple trials that are relevant to a patient and no concerns regarding safety or the integrity of the trials. A number of measures are proposed for managing and monitoring co-enrolment. Ensuring acceptability to (potential) participants is paramount. Opportunities to enter patients into more than one cancer trial should be considered more routinely. Where planned and managed appropriately, co-enrolment can offer a number of benefits in terms of both scientific value and efficiency of study conduct, and will increase the

[The informed consent in international clinical trials including developing countries].

Science.gov (United States)

Montenegro Surís, Alexander; Monreal Agüero, Magda Elaine

2008-01-01

The informed consent procedure has been one of the most important controversies of ethical debates about clinical trials in developing countries. In this essay we present our recommendations about important aspects to consider in the informed consent procedure for clinical trials in developing countries. We performed a full publications review identified by MEDLINE using these terms combinations: informed consent, developing countries, less developed countries and clinical trials. To protect volunteers in less developed countries should be valuated the importance of the community in the informed consent proceeding. The signing and dating of the informed consent form is not always the best procedure to document the informed consent. The informed consent form should be written by local translators. Alternative medias of communications could be needed for communicatios of the information to volunteers. Comparing with developed countries the informed consent proceeding in clinical trials in developing countries frequently require additional efforts. The developing of pragmatic researches is needed to implement informed consent proceedings assuring subjects voluntarily in each developing country. The main aspects to define in each clinical trial for each country are the influence of the community, the effective communication of the information, the documentation of the informed consent and local authority's control.

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.

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

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.

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

State-Level Community Benefit Regulation and Nonprofit Hospitals' Provision of Community Benefits.

Science.gov (United States)

Singh, Simone R; Young, Gary J; Loomer, Lacey; Madison, Kristin

2018-04-01

Do nonprofit hospitals provide enough community benefits to justify their tax exemptions? States have sought to enhance nonprofit hospitals' accountability and oversight through regulation, including requirements to report community benefits, conduct community health needs assessments, provide minimum levels of community benefits, and adhere to minimum income eligibility standards for charity care. However, little research has assessed these regulations' impact on community benefits. Using 2009-11 Internal Revenue Service data on community benefit spending for more than eighteen hundred hospitals and the Hilltop Institute's data on community benefit regulation, we investigated the relationship between these four types of regulation and the level and types of hospital-provided community benefits. Our multivariate regression analyses showed that only community health needs assessments were consistently associated with greater community benefit spending. The results for reporting and minimum spending requirements were mixed, while minimum income eligibility standards for charity care were unrelated to community benefit spending. State adoption of multiple types of regulation was consistently associated with higher levels of hospital-provided community benefits, possibly because regulatory intensity conveys a strong signal to the hospital community that more spending is expected. This study can inform efforts to design regulations that will encourage hospitals to provide community benefits consistent with policy makers' goals. Copyright © 2018 by Duke University Press.

Does an employee assistance programme benefit employers and employees alike?

Science.gov (United States)

MacAlister, E

1999-09-01

EAPs are not a psychological sticking plaster. They are a clinically and corporately balanced service which benefits the employee, via the direct services and the employer, via the feedback in the form of usage statistics derived from the continuous tracking of the account through which organizational and employment issues are identified. Well positioned EAPs offer employees confidential counselling, and information services including legal, financial and child-based issues and are able to offer employers tailored training and consultancy.

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.

Is thymectomy in non-thymomatous myasthenia gravis of any benefit?

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Diaz, Andres; Black, Edward; Dunning, Joel

2014-03-01

A best evidence topic in thoracic surgery was written according to a structured protocol. The question addressed was if thymectomy in non-thymomatous myasthenia gravis was of any benefit? Overall, 137 papers were found using the reported search, of which 16 represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. The outcome variables were similar in all of the papers, including complete stable remission (CSR), pharmacological remission, age at presentation, gender, duration of symptoms, preoperative classification (Oosterhius, Osserman or myasthenia gravis Foundation of America (MGFA)), thymic pathology, preoperative medications (steroids, immunosuppressants), mortality and morbidity. We conclude that evidence-based reviews have shown that relative rates of thymectomy patients compared with non-thymectomy patients attaining outcome indicate that the former group of patients is more likely to achieve medication-free remission, become asymptomatic and clinically improve (54%, P benefit rate (BR), P benefits has not been established due to factors such as the confounding differences between myasthenia gravis patients receiving and not receiving thymectomy, the non-randomized nature of class II studies and the lack of Class I evidence to support its use. There is currently a randomized trial ongoing looking at thymectomy by sternotomy vs controls and the results are eagerly awaited.

Feedback: an essential element of student learning in clinical practice.

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Clynes, Mary P; Raftery, Sara E C

2008-11-01

Clinical practice is an essential component of the nursing curriculum. In order for the student to benefit fully from the experience regular performance feedback is required. Feedback should provide the student with information on current practice and offer practical advice for improved performance. The importance of feedback is widely acknowledged however it appears that there is inconsistency in its provision to students. The benefits of feedback include increased student confidence, motivation and self-esteem as well as improved clinical practice. Benefits such as enhanced interpersonal skills and a sense of personal satisfaction also accrue to the supervisor. Barriers to the feedback process are identified as inadequate supervisor training and education, unfavourable ward learning environment and insufficient time spent with students. In addition to the appropriate preparation of the supervisor effective feedback includes an appreciation of the steps of the feedback process, an understanding of the student response to feedback and effective communication skills.

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

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

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...

Maximizing Effectiveness Trials in PTSD and SUD Through Secondary Analysis: Benefits and Limitations Using the National Institute on Drug Abuse Clinical Trials Network "Women and Trauma" Study as a Case Example.

Science.gov (United States)

Hien, Denise A; Campbell, Aimee N C; Ruglass, Lesia M; Saavedra, Lissette; Mathews, Abigail G; Kiriakos, Grace; Morgan-Lopez, Antonio

2015-09-01

Recent federal legislation and a renewed focus on integrative care models underscore the need for economical, effective, and science-based behavioral health care treatment. As such, maximizing the impact and reach of treatment research is of great concern. Behavioral health issues, including the frequent co-occurrence of substance use disorders (SUD) and posttraumatic stress disorder (PTSD), are often complex, with a myriad of factors contributing to the success of interventions. Although treatment guides for comorbid SUD/PTSD exist, most patients continue to suffer symptoms following the prescribed treatment course. Further, the study of efficacious treatments has been hampered by methodological challenges (e.g., overreliance on "superiority" designs (i.e., designs structured to test whether or not one treatment statistically surpasses another in terms of effect sizes) and short term interventions). Secondary analyses of randomized controlled clinical trials offer potential benefits to enhance understanding of findings and increase the personalization of treatment. This paper offers a description of the limits of randomized controlled trials as related to SUD/PTSD populations, highlights the benefits and potential pitfalls of secondary analytic techniques, and uses a case example of one of the largest effectiveness trials of behavioral treatment for co-occurring SUD/PTSD conducted within the National Drug Abuse Treatment Clinical Trials Network (NIDA CTN) and producing 19 publications. The paper concludes with implications of this secondary analytic approach to improve addiction researchers' ability to identify best practices for community-based treatment of these disorders. Innovative methods are needed to maximize the benefits of clinical studies and better support SUD/PTSD treatment options for both specialty and non-specialty healthcare settings. Moving forward, planning for and description of secondary analyses in randomized trials should be given equal

Number needed to benefit from information (NNBI): proposal from a mixed methods research study with practicing family physicians.

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Pluye, Pierre; Grad, Roland M; Johnson-Lafleur, Janique; Granikov, Vera; Shulha, Michael; Marlow, Bernard; Ricarte, Ivan Luiz Marques

2013-01-01

We wanted to describe family physicians' use of information from an electronic knowledge resource for answering clinical questions, and their perception of subsequent patient health outcomes; and to estimate the number needed to benefit from information (NNBI), defined as the number of patients for whom clinical information was retrieved for 1 to benefit. We undertook a mixed methods research study, combining quantitative longitudinal and qualitative research studies. Participants were 41 family physicians from primary care clinics across Canada. Physicians were given access to 1 electronic knowledge resource on handheld computer in 2008-2009. For the outcome assessment, participants rated their searches using a validated method. Rated searches were examined during interviews guided by log reports that included ratings. Cases were defined as clearly described searches where clinical information was used for a specific patient. For each case, interviewees described information-related patient health outcomes. For the mixed methods data analysis, quantitative and qualitative data were merged into clinical vignettes (each vignette describing a case). We then estimated the NNBI. In 715 of 1,193 searches for information conducted during an average of 86 days, the search objective was directly linked to a patient. Of those searches, 188 were considered to be cases. In 53 cases, participants associated the use of information with at least 1 patient health benefit. This finding suggested an NNBI of 14 (715/53). The NNBI may be used in further experimental research to compare electronic knowledge resources. A low NNBI can encourage clinicians to search for information more frequently. If all searches had benefits, the NNBI would be 1. In addition to patient benefits, learning and knowledge reinforcement outcomes are frequently reported.

Benefits of multidisciplinary teamwork in the management of breast cancer

Directory of Open Access Journals (Sweden)

Taylor C

2013-08-01

Full Text Available Cath Taylor,1 Amanda Shewbridge,2 Jenny Harris,1 James S Green3,4 1Florence Nightingale School of Nursing and Midwifery, King’s College London, London UK; 2Breast Cancer Services, Guy’s and St Thomas’ NHS Foundation Trust, London, UK; 3Department of Urology, Barts Health NHS Trust, London, UK; 4Department of Health and Social Care, London South Bank University, London, UK Abstract: The widespread introduction of multidisciplinary team (MDT-work for breast cancer management has in part evolved due to the increasing complexity of diagnostic and treatment decision-making. An MDT approach aims to bring together the range of specialists required to discuss and agree treatment recommendations and ongoing management for individual patients. MDTs are resource-intensive yet we lack strong (randomized controlled trial evidence of their effectiveness. Clinical consensus is generally favorable on the benefits of effective specialist MDT-work. Many studies have shown the benefits of receiving treatment from a specialist center, and evidence continues to accrue from comparative studies of clinical benefits of an MDT approach, including improved survival. Patients’ views of the MDT model of decision-making (and in particular its impact on involvement in decisions about their care have been under-researched. Barriers to effective teamwork and poor decision-making include excessive caseload, low attendance at meetings, lack of leadership, poor communication, role ambiguity, and failure to consider patients’ holistic needs. Breast cancer nurses have a key role in relation to assessing holistic needs, and their specialist contribution has also been associated with improved patient experience and quality of life. This paper examines the evidence for the benefits of MDT-work, in particular for breast cancer. Evidence is considered within a context of growing cancer incidence at a time of increased financial restraint, and it may now be important to

Can repeat injection provide clinical benefit in patients with cervical disc herniation and stenosis when the first epidural injection results only in partial response?

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Lee, Jung Hwan; Lee, Sang-Ho

2016-07-01

Epidural steroid injection (ESI) is known to be an effective treatment for neck or radicular pain due to herniated intervertebral disc (HIVD) and spinal stenosis (SS). Although repeat ESI has generally been indicated to provide more pain relief in partial responders after single ESI, there has been little evidence supporting the usefulness of this procedure. The purpose of this study, therefore, was to determine whether repeat ESI at a prescribed interval of 2 to 3 weeks after the first injection would provide greater clinical benefit in patients with partial pain reduction than intermittent ESI performed only when pain was aggravated. One hundred eighty-four patients who underwent transforaminal ESI (TFESI) for treatment of axial neck and radicular arm pain due to HIVD or SS and could be followed up for 1 year were enrolled. We divided the patients into 2 groups. Group A (N = 108) comprised partial responders (numeric rating scale (NRS) ≥ 3 after the first injection) who underwent repeat injection at a prescribed interval of 2 to 3 weeks after the first injection. Group B (N = 76) comprised partial responders who did not receive repeat injection at the prescribed interval, but received intermittent injections only for aggravation of pain. Various clinical data were assessed, including total number of injections during 1 year, NRS duration of Group A, or after first injection in Group B (time to reinjection). Groups A and B were compared in terms of total population, HIVD, and SS. In the whole population, HIVD subgroup, and SS subgroup, patients in Group A required significantly fewer injections to obtain satisfactory pain relief during the 1-year follow-up period. Group A showed a significantly longer time to reinjection and longer NRS Group B did. Repeat TFESI conducted at 2- to 3-week intervals after the first injection in partial responders contributed to greater clinical benefit compared with intermittent TFESI performed only upon pain

Analysis of Employee Benefits

OpenAIRE

Burešová, Lenka

2013-01-01

The target of this bachelor thesis is to analyze employee benefits from the perspective of employees and to employers suggest possible ideas to improve their provision. The work is divided into two parts: theoretical and practical. The theoretical part describes the overal remuneration of employees, payroll system and employee benefits. Benefits are included in the remuneration system, broken and some of them are defined. The practical part presents a survey among employees in the Czech Repub...

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.

Patient Preferences in Regulatory Benefit-Risk Assessments: A US Perspective.

Science.gov (United States)

Johnson, F Reed; Zhou, Mo

Demands for greater transparency in US regulatory assessments of benefits and risks, together with growing interest in engaging patients in Food and Drug Administration regulatory decision making, have resulted in several recent regulatory developments. Although Food and Drug Administration's Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) have established patient-engagement initiatives, CDRH has proposed guidelines for considering quantitative data on patients' benefit-risk perspectives, while CDER has focused on a more qualitative approach. We summarize two significant studies that were developed in collaboration and consultation with CDER and CDRH. CDER encouraged a patient advocacy group to propose draft guidance on engaging patient and caregiver stakeholders in regulatory decision making for Duchenne muscular dystrophy. CDRH sponsored a discrete-choice experiment case study to quantify obese respondents' perspectives on "meaningful benefits." CDRH and CDER issued draft guidance in May and June 2015, respectively, on including patient-preference data in regulatory submissions. Both organizations face challenges. CDER is working on integrating qualitative data into existing evidence-based review processes and is exploring options for therapeutic areas not included on a priority list. CDRH has adopted an approach that requires patient-preference data to satisfy standards of valid scientific evidence. Although that strategy could facilitate integrating patient perspectives directly with clinical data on benefits and harms, generating such data requires building capacity. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Life-Cycle Cost-Benefit Analysis

DEFF Research Database (Denmark)

Thoft-Christensen, Palle

2010-01-01

The future use of Life-Cycle Cost-Benefit (LCCB) analysis is discussed in this paper. A more complete analysis including not only the traditional factors and user costs, but also factors which are difficult to include in the analysis is needed in the future.......The future use of Life-Cycle Cost-Benefit (LCCB) analysis is discussed in this paper. A more complete analysis including not only the traditional factors and user costs, but also factors which are difficult to include in the analysis is needed in the future....

The employee motivation and benefits

OpenAIRE

Fuhrmannová, Petra

2013-01-01

The aim of this bachelor's study is to describe and analyze the employee motivation and benefits in the payroll system and human recources field. Theoretical part attends to general terms as the employee motivation, the theory of the motivation,the types of the employee benefits, the influence of benefits to the employee's working performance. The practial part focuses on Elanor company, includes introduction of the company, it's history and the present, the offer of the employee benefits. Ne...

HUGO urges genetic benefit-sharing.

Science.gov (United States)

2000-01-01

In view of the fact that for-profit enterprise exceeds public expenditures on genetic research and that benefits from the Human Genome Project may accrue only to rich people in rich nations, the HUGO Ethics Committee discussed the necessity of benefit-sharing. Discussions involved case examples ranging from single-gene to multi-factorial disorders and included the difficulties of defining community, especially when multifactorial diseases are involved. The Committee discussed arguments for benefit-sharing, including common heritage, the genome as a common resource, and three types of justice: compensatory, procedural, and distributive. The Committee also discussed the importance of community participation in defining benefit, agreed that companies involved in health have special obligations beyond paying taxes, and recommended they devote 1-3% of net profits to healthcare infrastructure or humanitarian efforts.

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.

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

Science.gov (United States)

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

2018-03-09

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

Genetic risk, coronary heart disease events, and the clinical benefit of statin therapy: an analysis of primary and secondary prevention trials.

Science.gov (United States)

Mega, J L; Stitziel, N O; Smith, J G; Chasman, D I; Caulfield, M; Devlin, J J; Nordio, F; Hyde, C; Cannon, C P; Sacks, F; Poulter, N; Sever, P; Ridker, P M; Braunwald, E; Melander, O; Kathiresan, S; Sabatine, M S

2015-06-06

Genetic variants have been associated with the risk of coronary heart disease. In this study, we tested whether or not a composite of these variants could ascertain the risk of both incident and recurrent coronary heart disease events and identify those individuals who derive greater clinical benefit from statin therapy. A community-based cohort study (the Malmo Diet and Cancer Study) and four randomised controlled trials of both primary prevention (JUPITER and ASCOT) and secondary prevention (CARE and PROVE IT-TIMI 22) with statin therapy, comprising a total of 48,421 individuals and 3477 events, were included in these analyses. We studied the association of a genetic risk score based on 27 genetic variants with incident or recurrent coronary heart disease, adjusting for traditional clinical risk factors. We then investigated the relative and absolute risk reductions in coronary heart disease events with statin therapy stratified by genetic risk. We combined data from the different studies using a meta-analysis. When individuals were divided into low (quintile 1), intermediate (quintiles 2-4), and high (quintile 5) genetic risk categories, a significant gradient in risk for incident or recurrent coronary heart disease was shown. Compared with the low genetic risk category, the multivariable-adjusted hazard ratio for coronary heart disease for the intermediate genetic risk category was 1·34 (95% CI 1·22-1·47, pgenetic risk category was 1·72 (1·55-1·92, pgenetic risk categories. Similarly, we noted greater absolute risk reductions in those individuals in higher genetic risk categories (p=0·0101), resulting in a roughly threefold decrease in the number needed to treat to prevent one coronary heart disease event in the primary prevention trials. Specifically, in the primary prevention trials, the number needed to treat to prevent one such event in 10 years was 66 in people at low genetic risk, 42 in those at intermediate genetic risk, and 25 in those at high

Teaching clinical reasoning to medical students.

Science.gov (United States)

Gay, Simon; Bartlett, Maggie; McKinley, Robert

2013-10-01

Keele Medical School's new curriculum includes a 5-week course to extend medical students' consultation skills beyond those historically required for competent inductive diagnosis. Clinical reasoning is a core skill for the practice of medicine, and is known to have implications for patient safety, yet historically it has not been explicitly taught. Rather, it has been assumed that these skills will be learned by accumulating a body of knowledge and by observing expert clinicians. This course aims to assist students to develop their own clinical reasoning skills and promote their greater understanding of, and potential to benefit from, the clinical reasoning skills of others. The course takes place in the fourth or penultimate year, and is integrated with students' clinical placements, giving them opportunities to practise and quickly embed their learning. This course emphasises that clinical reasoning extends beyond initial diagnosis into all other aspects of clinical practice, particularly clinical management. It offers students a variety of challenging and interesting opportunities to engage with clinical reasoning across a wide range of clinical practice. It addresses bias through metacognition and increased self-awareness, considers some of the complexities of prescribing and non-pharmacological interventions, and promotes pragmatic evidence-based practice, information management within the consultation and the maximising of patient adherence. This article describes clinical reasoning-based classroom and community teaching. Early evaluation suggests that students value the course and benefit from it. © 2013 John Wiley & Sons Ltd.

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.

Families' perceived benefits of home visits for managing paediatric obesity outweigh the potential costs and barriers.

Science.gov (United States)

Gehring, Nicole D; Ball, Geoff D C; Perez, Arnaldo; Holt, Nicholas L; Neuman, Daniel; Spence, Nicholas; Mercier, Laura; Jetha, Mary

2018-02-01

Home visits have successfully been used to deliver various health services, but what role could they play in paediatric weight management? Low treatment initiation and high attrition prompted our multidisciplinary paediatric weight management clinic to investigate how families perceived the benefits and barriers of home visits. We focused on children with obesity aged 2-17 who were enrolled in our tertiary-level clinic in Alberta, Canada. None had received a home visit. The families were interviewed face-to-face from October 2015 to October 2016, and we used a qualitative description methodological framework and manifest content analysis. The parents were the main interviewees. Of the 56 families, 89% were interested in a home visit, 82% wanted support from a dietician and 54% from an exercise specialist. The perceived benefits of home visits included comprehensive assessment (95%), convenience (86%), tailored care (29%) and family involvement (13%), while the costs and barriers included clinicians' potential judgmental attitudes (30%), loss of privacy (19%) and distractions (10%). Some thought clinicians would find home visits inconvenient (25%), with bureaucratic challenges (14%) and sustainability issues (5%). Families felt home visits were a convenient option for managing paediatric obesity and identified important benefits and barriers that could guide such interventions. ©2017 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

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

Directory of Open Access Journals (Sweden)

Schmidt AE

2016-08-01

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

Clinical Trials

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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 ...

Measuring the individual benefit of a medical or behavioral treatment using generalized linear mixed-effects models.

Science.gov (United States)

Diaz, Francisco J

2016-10-15

We propose statistical definitions of the individual benefit of a medical or behavioral treatment and of the severity of a chronic illness. These definitions are used to develop a graphical method that can be used by statisticians and clinicians in the data analysis of clinical trials from the perspective of personalized medicine. The method focuses on assessing and comparing individual effects of treatments rather than average effects and can be used with continuous and discrete responses, including dichotomous and count responses. The method is based on new developments in generalized linear mixed-effects models, which are introduced in this article. To illustrate, analyses of data from the Sequenced Treatment Alternatives to Relieve Depression clinical trial of sequences of treatments for depression and data from a clinical trial of respiratory treatments are presented. The estimation of individual benefits is also explained. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

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.

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 ...

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

GWAS of clinically defined gout and subtypes identifies multiple susceptibility loci that include urate transporter genes

NARCIS (Netherlands)

Nakayama, A.; Nakaoka, H.; Yamamoto, K.; Sakiyama, M.; Shaukat, A.; Toyoda, Y.; Okada, Y.; Kamatani, Y.; Nakamura, T.; Takada, T.; Inoue, K.; Yasujima, T.; Yuasa, H.; Shirahama, Y.; Nakashima, H.; Shimizu, S.; Higashino, T.; Kawamura, Y.; Ogata, H.; Kawaguchi, M.; Ohkawa, Y.; Danjoh, I.; Tokumasu, A.; Ooyama, K.; Ito, T.; Kondo, T.; Wakai, K.; Stiburkova, B.; Pavelka, K.; Stamp, L.K.; Dalbeth, N.; Sakurai, Y.; Suzuki, H; Hosoyamada, M.; Fujimori, S.; Yokoo, T.; Hosoya, T.; Inoue, I.; Takahashi, A.; Kubo, M.; Ooyama, H.; Shimizu, T.; Ichida, K.; Shinomiya, N.; Merriman, T.R.; Matsuo, H.; Andres, M; Joosten, L.A.; Janssen, M.C.H.; Jansen, T.L.; Liote, F.; Radstake, T.R.; Riches, P.L.; So, A.; Tauches, A.K.

2017-01-01

OBJECTIVE: A genome-wide association study (GWAS) of gout and its subtypes was performed to identify novel gout loci, including those that are subtype-specific. METHODS: Putative causal association signals from a GWAS of 945 clinically defined gout cases and 1213 controls from Japanese males were

Clinical Trials

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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 ...

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

Systemic therapy in men with metastatic castration-resistant prostate cancer:American Society of Clinical Oncology and Cancer Care Ontario clinical practice guideline.

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Basch, Ethan; Loblaw, D Andrew; Oliver, Thomas K; Carducci, Michael; Chen, Ronald C; Frame, James N; Garrels, Kristina; Hotte, Sebastien; Kattan, Michael W; Raghavan, Derek; Saad, Fred; Taplin, Mary-Ellen; Walker-Dilks, Cindy; Williams, James; Winquist, Eric; Bennett, Charles L; Wootton, Ted; Rumble, R Bryan; Dusetzina, Stacie B; Virgo, Katherine S

2014-10-20

To provide treatment recommendations for men with metastatic castration-resistant prostate cancer (CRPC). The American Society of Clinical Oncology and Cancer Care Ontario convened an expert panel to develop evidence-based recommendations informed by a systematic review of the literature. When added to androgen deprivation, therapies demonstrating improved survival, improved quality of life (QOL), and favorable benefit-harm balance include abiraterone acetate/prednisone, enzalutamide, and radium-223 ((223)Ra; for men with predominantly bone metastases). Improved survival and QOL with moderate toxicity risk are associated with docetaxel/prednisone. For asymptomatic/minimally symptomatic men, improved survival with unclear QOL impact and low toxicity are associated with sipuleucel-T. For men who previously received docetaxel, improved survival, unclear QOL impact, and moderate to high toxicity risk are associated with cabazitaxel/prednisone. Modest QOL benefit (without survival benefit) and high toxicity risk are associated with mitoxantrone/prednisone after docetaxel. No benefit and excess toxicity are observed with bevacizumab, estramustine, and sunitinib. Continue androgen deprivation (pharmaceutical or surgical) indefinitely. Abiraterone acetate/prednisone, enzalutamide, or (223)Ra should be offered; docetaxel/prednisone should also be offered, accompanied by discussion of toxicity risk. Sipuleucel-T may be offered to asymptomatic/minimally symptomatic men. For men who have experienced progression with docetaxel, cabazitaxel may be offered, accompanied by discussion of toxicity risk. Mitoxantrone may be offered, accompanied by discussion of limited clinical benefit and toxicity risk. Ketoconazole or antiandrogens (eg, bicalutamide, flutamide, nilutamide) may be offered, accompanied by discussion of limited known clinical benefit. Bevacizumab, estramustine, and sunitinib should not be offered. There is insufficient evidence to evaluate optimal sequences or

20 CFR 404.1013 - Included-excluded rule.

Science.gov (United States)

2010-04-01

... least one-half of your time in the pay period is in covered work. If you spend most of your time in a... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Included-excluded rule. 404.1013 Section 404.1013 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY...

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

[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

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

Science.gov (United States)

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

2015-01-01

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

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

Directory of Open Access Journals (Sweden)

Rory F. McQuillan

2015-12-01

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

Clinical Application of Pharmacogenetics: Where are We Now?

Science.gov (United States)

2014-01-01

Pharmacogenetic (PGx) testing has the potential to improve drug therapy in an individual by informing appropriate drug dosing or drug selection in order to maximize efficacy and safety. Although multiple studies have illustrated the potential benefits of such testing when applied to specific drugs across a broad range of therapy areas, the uptake of PGx testing in routine clinical practice has been relatively limited. Implementation appears to be hampered by the absence of sufficiently strong evidence linking the results of testing with actionable benefits in terms of clinical outcomes. Meanwhile, there are now adequate data to allow dosing recommendations as have been developed by bodies including the Dutch Pharmacogenetics Working Group (DPWG) and the Clinical Pharmacogenetics Implementation Consortium (CPIC) in several settings, including TPMT/thiopurines, CYP2C19/clopidogrel, CYP2D6/codeine, VKORC1-CYP2C9/warfarin, HLA-B*5701/abacavir, SLCO1B1/simvastatin and HLAB*5801/allopurinol. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT) have also recently initiated surveys in order to better understand the extent of, and the role played by, PGx testing in clinical practice. This should help identify where further training and education may be beneficial. To this end, in collaboration with ESPT, the IFCC Pharmacogenetic Laboratory Network has now been formed, with the aim of improving the uptake and quality of PGx testing. PMID:27683445

Acknowledging and Accounting for Employee Benefits

Directory of Open Access Journals (Sweden)

Florentina MOISESCU

2009-01-01

Full Text Available Employee benefits are all forms of counter services granted by anentity in return to services given by the employees. This category includes onlythe benefits covered by the entity, not those from the state or the employee onthe payroll. The employer counting and presenting all the benefits of theemployees, including those provided on the basis of official programs or otherofficial contracts between the entity and the individual employees, groups ofemployees or their representatives, those established on the basis of legalprovisions or by contracts at the level of activity sector, through which theentities are required to contribute to national programs, as well as thoseresulting from unofficial practices give rise to an implicit obligation.Acknowledging and especially assessing these benefits are issues demandingspecial attention.

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

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 ...

Quality of referral: What information should be included in a request for diagnostic imaging when a patient is referred to a clinical radiologist?

Science.gov (United States)

G Pitman, Alexander

2017-06-01

Referral to a clinical radiologist is the prime means of communication between the referrer and the radiologist. Current Australian and New Zealand government regulations do not prescribe what clinical information should be included in a referral. This work presents a qualitative compilation of clinical radiologist opinion, relevant professional recommendations, governmental regulatory positions and prior work on diagnostic error to synthesise recommendations on what clinical information should be included in a referral. Recommended requirements on what clinical information should be included in a referral to a clinical radiologist are as follows: an unambiguous referral; identity of the patient; identity of the referrer; and sufficient clinical detail to justify performance of the diagnostic imaging examination and to confirm appropriate choice of the examination and modality. Recommended guideline on the content of clinical detail clarifies when the information provided in a referral meets these requirements. High-quality information provided in a referral allows the clinical radiologist to ensure that exposure of patients to medical radiation is justified. It also minimises the incidence of perceptual and interpretational diagnostic error. Recommended requirements and guideline on the clinical detail to be provided in a referral to a clinical radiologist have been formulated for professional debate and adoption. © 2017 The Royal Australian and New Zealand College of Radiologists.

Predicting Employer's Benefits from Cooperative Education.

Science.gov (United States)

Wiseman, Richard L.; Page, Norman R.

1983-01-01

Attempts to predict employer benefits resulting from their involvement in cooperative education programs. Benefits include a good source of quality employees, increased worker motivation, and increased respect between students and employers. (JOW)

Ketamine for chronic pain: risks and benefits.

Science.gov (United States)

Niesters, Marieke; Martini, Christian; Dahan, Albert

2014-02-01

The anaesthetic ketamine is used to treat various chronic pain syndromes, especially those that have a neuropathic component. Low dose ketamine produces strong analgesia in neuropathic pain states, presumably by inhibition of the N-methyl-D-aspartate receptor although other mechanisms are possibly involved, including enhancement of descending inhibition and anti-inflammatory effects at central sites. Current data on short term infusions indicate that ketamine produces potent analgesia during administration only, while three studies on the effect of prolonged infusion (4-14 days) show long-term analgesic effects up to 3 months following infusion. The side effects of ketamine noted in clinical studies include psychedelic symptoms (hallucinations, memory defects, panic attacks), nausea/vomiting, somnolence, cardiovascular stimulation and, in a minority of patients, hepatoxicity. The recreational use of ketamine is increasing and comes with a variety of additional risks ranging from bladder and renal complications to persistent psychotypical behaviour and memory defects. Blind extrapolation of these risks to clinical patients is difficult because of the variable, high and recurrent exposure to the drug in ketamine abusers and the high frequency of abuse of other illicit substances in this population. In clinical settings, ketamine is well tolerated, especially when benzodiazepines are used to tame the psychotropic side effects. Irrespective, close monitoring of patients receiving ketamine is mandatory, particularly aimed at CNS, haemodynamic, renal and hepatic symptoms as well as abuse. Further research is required to assess whether the benefits outweigh the risks and costs. Until definite proof is obtained ketamine administration should be restricted to patients with therapy-resistant severe neuropathic pain. © 2013 The Authors. British Journal of Clinical Pharmacology © 2013 The British Pharmacological Society.

Same-level peer-assisted learning in medical clinical placements: a narrative systematic review.

Science.gov (United States)

Tai, Joanna; Molloy, Elizabeth; Haines, Terry; Canny, Benedict

2016-04-01

Peer-assisted learning (PAL) is increasingly used in medical education, and the benefits of this approach have been reported. Previous reviews have focused on the benefits of peer tutoring of junior students by senior students. Forms of PAL such as discussion groups and role-playing have been neglected, as have alternative teacher-learner configurations (e.g. same-level PAL) and the effects on other stakeholders, including clinician educators and patients. This review examines the benefits of same-level PAL for students, clinician educators and patients in pre-registration clinical medical education. Medline, PsycINFO, CINAHL and ERIC were searched in March 2014. A total of 1228 abstracts were retrieved for review; 64 full-text papers were assessed. Data were extracted from empirical studies describing a same-level PAL initiative in a clinical setting, focusing on effects beyond academic performance and student satisfaction. Qualitative thematic analysis was employed to identify types of PAL and to cluster the reported PAL effects. Forty-three studies were included in the review. PAL activities were categorised into role-play, discussion, teaching and assessment. Only 50% of studies reported information beyond self-report and satisfaction with the PAL intervention. Benefits for students (including development of communication and professional skills) and clinician educators (developing less-used facilitation skills) were reported. Direct patient outcomes were not identified. Caveats to the use of PAL emerged, and guidelines for the use of PAL were perceived as useful. Many student-related benefits of PAL were identified. PAL contributes to the development of crucial skills required for a doctor in the workplace. Vertical integration of learning and teaching skills across the curriculum and tools such as feedback checklists may be required for successful PAL in the clinical environment. Benefits for patients and educators were poorly characterised within the

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.

Points to consider for prioritizing clinical genetic testing services

DEFF Research Database (Denmark)

Severin, Franziska; Borry, Pascal; Cornel, Martina C

2015-01-01

Given the cost constraints of the European health-care systems, criteria are needed to decide which genetic services to fund from the public budgets, if not all can be covered. To ensure that high-priority services are available equitably within and across the European countries, a shared set...... testing services available in the next decade. Ethically and economically reflected prioritization criteria are needed. Prioritization should be based on considerations of medical benefit, health need and costs. Medical benefit includes evidence of benefit in terms of clinical benefit, benefit......, following the principles of accountability for reasonableness. We provide points to consider to stimulate this debate across the EU and to serve as a reference for improving patient management.European Journal of Human Genetics advance online publication, 24 September 2014; doi:10.1038/ejhg.2014.190....

[Exploration and demonstration study on drug combination from clinical real world].

Science.gov (United States)

Xie, Yan-ming; Wang, Lian-xin; Wang, Yong-yan

2014-09-01

Drug combination is extensive in the clinical real world,which is an important part and the inherent requirements of the post-marketing evaluation of traditional Chinese medicine (TCM). The key issues and technology include multi-domain and multi-disciplinary such as the rationality, efficacy and safety evaluation of combination drug starting from clinical real world, study on component in vivo and mechanism of combination drug, the risk/benefit assessment and cost-benefit evaluation of combination drug and so on. The topic has been studied as clinical demonstration on combination therapy of variety of diseases such as coronary heart disease, stroke, insomnia, depression, hepatitis, herpes zoster, psoriasis and ectopic pregnancy. Meanwhile, multi-disciplinary dynamic innovation alliance of clinical drug combination has been presented, which can promote the academic development and improving service ability and level of TCM.

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.

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.

40 CFR 46.140 - Benefits.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Benefits. 46.140 Section 46.140 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GRANTS AND OTHER FEDERAL ASSISTANCE FELLOWSHIPS Applying for Fellowships § 46.140 Benefits. EPA fellowships may include funds to help you pay such things...

Immuno-modulation and anti-inflammatory benefits of antibiotics: the example of tilmicosin.

Science.gov (United States)

Buret, André G

2010-01-01

Exaggerated immune responses, such as those implicated in severe inflammatory reactions, are costly to the metabolism. Inflammation and pro-inflammatory mediators negatively affect production in the food animal industry by reducing growth, feed intake, reproduction, milk production, and metabolic health. An ever-increasing number of findings have established that antibiotics, macrolides in particular, may generate anti-inflammatory effects, including the modulation of pro-inflammatory cytokines and the alteration of neutrophil function. The effects are time- and dose-dependent, and the mechanisms responsible for these phenomena remain incompletely understood. Recent studies, mostly using the veterinary macrolide tilmicosin, may have shed new light on the mode of action of some macrolides and their anti-inflammatory properties. Indeed, research findings demonstrate that this compound, amongst others, induces neutrophil apoptosis, which in turn provides anti-inflammatory benefits. Studies using tilmicosin model systems in vitro and in vivo demonstrate that this antibiotic has potent immunomodulatory effects that may explain why at least parts of its clinical benefits are independent of anti-microbial effects. More research is needed, using this antibiotic and others that may have similar properties, to clarify the biological mechanisms responsible for antibiotic-induced neutrophil apoptosis, and how this, in turn, may provide enhanced clinical benefits. Such studies may help establish a rational basis for the development of novel, efficacious, anti-microbial compounds that generate anti-inflammatory properties in addition to their antibacterial effects.

Adult-onset photosensitivity: clinical significance and epilepsy syndromes including idiopathic (possibly genetic) photosensitive occipital epilepsy.

Science.gov (United States)

Koutroumanidis, Michalis; Tsirka, Vasiliki; Panayiotopoulos, Chrysostomos

2015-09-01

To evaluate the clinical associations of adult-onset photosensitivity, we studied the clinical and EEG data of patients who were referred due to a possible first seizure and who had a photoparoxysmal response on their EEG. Patients with clinical evidence of photosensitivity before the age of 20 were excluded. Of a total of 30 patients, four had acute symptomatic seizures, two had vasovagal syncope, and 24 were diagnosed with epilepsy. Nine of the 24 patients had idiopathic (genetic) generalized epilepsies and predominantly generalized photoparoxysmal response, but also rare photically-induced seizures, while 15 had exclusively, or almost exclusively, reflex photically-induced occipital seizures with frequent secondary generalization and posterior photoparoxysmal response. Other important differences included a significantly older age at seizure onset and paucity of spontaneous interictal epileptic discharges in patients with photically-induced occipital seizures; only a quarter of these had occasional occipital spikes, in contrast to the idiopathic (genetic) generalized epilepsy patients with typically generalized epileptic discharges. On the other hand, both groups shared a positive family history of epilepsy, common seizure threshold modulators (such as tiredness and sleep deprivation), normal neurological examination and MRI, a generally benign course, and good response to valproic acid. We demonstrated that photosensitivity can first occur in adult life and manifest, either as idiopathic (possibly genetic) photosensitive occipital epilepsy with secondary generalization or as an EEG, and less often, a clinical/EEG feature of idiopathic (genetic) generalized epilepsies. Identification of idiopathic photosensitive occipital epilepsy fills a diagnostic gap in adult first-seizure epileptology and is clinically important because of its good response to antiepileptic drug treatment and fair prognosis.

Contraceptives with novel benefits.

Science.gov (United States)

Su, Ying; Lian, Qing-Quan; Ge, Ren-Shan

2012-01-01

Progesterone receptor (PR) agonists (progestins) and antagonists are developed for female contraceptives. However, non-contraceptive applications of newer progestins and PR modulators are being given more attention. The newer PR agonists including drospirenone, nomegestrol, trimegestone, dienogest and nestorone are being evaluated as contraceptives with health benefits because of their unique pharmacological properties. The selective PR modulators (SPRM; PR antagonists with PR agonistic properties) are under development not only for emergency contraception but also for other health benefits such as the treatment of endometritis and leiomyoma. After searching the literature from PubMed, clinicaltrials.gov and patent database, this review focuses on the effects and mechanisms of these progestins, and SPRMs as contraceptives with other health benefits. PR agonists and antagonists that have novel properties may generate better contraceptive effects with other health benefits.

Benefits for employees with children with ADHD: findings from the Collaborative Employee Benefit Study.

Science.gov (United States)

Perrin, James M; Fluet, Chris; Kuhlthau, Karen A; Anderson, Betsy; Wells, Nora; Epstein, Susan; Allen, Debby; Tobias, Carol

2005-02-01

Parents of most children with attention-deficit hyperactivity disorder (ADHD) are employed. Employers have interest in decreasing employee absenteeism and improving workplace productivity, partly through employee benefits. The authors interviewed employers to (1) determine how they view the needs of employees with children with ADHD and (2) identify benefits that might help employees with children with ADHD. The authors carried out a systematic interview study of mainly family-friendly, large employers in four U.S. urban markets (Boston, Cleveland, Miami, Seattle). Multidisciplinary interview teams used a protocol to gather basic company information, benefit philosophy, current insurance and other employee benefits, and knowledge of ADHD and its impacts on employees. Initially, the interview team and then the larger project team reviewed all protocols for common themes. The authors interviewed staff of 41 employers (human resource managers, work/life program directors, benefits directors). Only 15 of 41 interviewees knew about ADHD, its prevalence, or its effects on parents. They had little knowledge of how differences in managed behavioral health may affect families' access to diagnostic and treatment services for ADHD, although most had experience with primary care management of depression among employees. Employers offer a variety of other benefits, including work/life and employee assistance programs, occasionally providing employees help with caring for a child with a mental health condition, on-site parent training programs, or assistance with child care. Other potentially useful employee benefits include flexible work and leave policies and information and referral services that can link parents with community programs. Although employers have limited awareness of ADHD and its potential effect on employees' work, this study identified opportunities to improve both health insurance and other benefits for employees with children with ADHD.

Who Benefits from Pension Enhancements?

Science.gov (United States)

Koedel, Cory; Ni, Shawn; Podgursky, Michael

2014-01-01

During the late 1990s public pension funds across the United States accrued large actuarial surpluses. The seemingly flush conditions of the pension funds led legislators in most states to substantially improve retirement benefits for public workers, including teachers. In this study we examine the benefit enhancements to the teacher pension…

The Agile Rapid Global Combat Support (ARGCS) System: A Cost and Benefit Analysis of Including the ARGCS Technologies in the Acquisition of the Enhanced Consolidated Support System (ECASS)

National Research Council Canada - National Science Library

Lund, John N

2007-01-01

...). The ultimate goal of this project is to assist in the analysis of the ARGCS technologies and what benefit they would provide if included in the proposed next generation of Naval Aviation test equipment, currently called the Enhanced Consolidated Automated Support System (ECASS).

Employee benefits or wage increase?

Directory of Open Access Journals (Sweden)

Jiří Duda

2011-01-01

Full Text Available The paper comes from a survey done during the years 2007–2009. It focused on employee satisfaction with the provision of employee benefits. The research included 21 companies, 7 companies were from the engineering sector, 7 companies from the food industry, 3 companies represented the budgetary sphere, 3 companies the services sector and one company operates in pharmaceutical industry.The questionnaire survey consisted of 14 questions, including 5 identification-questions. The paper presents results of the questions on dealing with employees’ awareness of employee benefits and on choosing between employees’ preferences of wage increase or increase in value of benefits provided.Employees are informed about all options of providing employee benefits. Only in 3 cases employees stated dissatisfaction with information. This answer was related with the responses to the second monitored question. Employees of these companies preferred pay increases before benefits’ increases. There was no effect of gender of the respondents, neither the influence of the sector of operation, in the preference of increases in wages or in benefits. Exceptions were the employees of companies operating in the financial sector, who preferred employee benefits before a wage increase. It was found that employees of companies who participated in research in 2009, preferred wage increases before the extension of employee benefits, although the value of the net wage increase is lower than the monetary value of benefits increase.The paper is a part of solution of the research plan MSM 6215648904 The Czech economy in the process of integration and globalization, and the development of agricultural sector and the sector of services under the new conditions of the integrated European market.

Fix my child: The importance of including siblings in clinical assessments.

Science.gov (United States)

Farnfield, Steve

2017-07-01

This study examined concordance in the attachment strategies of school-aged siblings with reference to environmental risk in terms of poverty and maltreatment. It also investigated the effect of child maltreatment and maternal mental illness on children's psychosocial functioning in terms of the Dynamic-Maturational Model of Attachment and Adaptation (DMM) including unresolved trauma and the DMM Depressed modifier. The attachment strategies of 30 sibling pairs, aged 5-14 years, were assessed using the School-age Assessment of Attachment (SAA). Unlike most previous studies, this study included siblings from large families of two to six children. The main finding was that as environmental risk increases, the diversity of sibling attachment strategies decreases with greater recourse to the DMM Type A3-6 and A/C strategies. Unlike previous studies, the highest level of concordance was found in sibling pairs with the opposite gender. Boys whose mothers had a history of mental illness were significantly more likely than girls to be assessed with the DMM-depression modifier. As danger increases, children in the same family experience more of the same childhood. Further research should focus on single case, intra-familial studies to build a systemic model of the shared environment. Research should also evaluate the effects of environmental risk compared with size of the sibling group on children's attachment strategies. The clinical implications point to the importance of assessing all children in the family using a model built around functional formulation rather than diagnosing the symptoms of a particular child.

Importance of nutritional status in recovery from acute cholecystitis: benefit from enteral nutrition supplementation including medium chain triglycerides.

Science.gov (United States)

Nomura, Yukinobu; Inui, Kazuo; Yoshino, Junji; Wakabayashi, Takao; Okushima, Kazumu; Kobayashi, Takashi; Miyoshi, Hironao; Nakamura, Yuta

2007-09-01

This study was undertaken to clarify the importance of nutritional status in patients with acute cholecystitis, and also evaluate whether they benefited from enteral nutrition supplementation, including medium-chain triglycerides (MCT), during the convalescent stage. Patients with acute cholecystitis admitted to our hospital between April 1994 and March 2002 were classified into a poor nutrition group (n=40; total serum proteinnutrition group (n=71; >5.0 g/dl). Patients with poor nutrition were significantly more elderly than those with fair nutrition, and had significantly higher serum C-reactive protein (CRP) concentrations. The two groups did not differ significantly with respect to other laboratory data, gender distribution, or medical treatment. We supplemented ordinary meals with enteral nutrition including MCT in 16 patients during the convalescent stage (MCT group). We compared their length of hospital stay and days required to recovery to pre-admission functional status for activities of daily living (ADL) with the same intervals in 16 patients without supplementation (non-MCT group) selected to match for age, gender, and fair or poor nutritional status from among 111 patients. Hospitalizations were significantly longer in the poor nutrition group (43.0+/-2.2 days) than in the fair nutrition group (27.0+/-8.2 days). Significantly more days were required to recover ADL status in the poor nutrition group (12.0+/-7.2 days) than in the fair group (9.4+/-5.2 days). Hospitalizations were significantly shorter in the MCT group (20.1+/-15 days) than in the non-MCT group (35.4+/-12.8 days). Significantly fewer days were required to recover ADL status in the MCT group (10.9+/-7 days) than in the non-MCT group (13.1+/-6.8 days). Administration of enteral nutrition including MCT during convalescence from acute cholecystitis thus appears to promote functional recovery shorten hospital stay.

Closing the gap between knowledge and clinical application: challenges for genomic translation.

Science.gov (United States)

Burke, Wylie; Korngiebel, Diane M

2015-01-01

Despite early predictions and rapid progress in research, the introduction of personal genomics into clinical practice has been slow. Several factors contribute to this translational gap between knowledge and clinical application. The evidence available to support genetic test use is often limited, and implementation of new testing programs can be challenging. In addition, the heterogeneity of genomic risk information points to the need for strategies to select and deliver the information most appropriate for particular clinical needs. Accomplishing these tasks also requires recognition that some expectations for personal genomics are unrealistic, notably expectations concerning the clinical utility of genomic risk assessment for common complex diseases. Efforts are needed to improve the body of evidence addressing clinical outcomes for genomics, apply implementation science to personal genomics, and develop realistic goals for genomic risk assessment. In addition, translational research should emphasize the broader benefits of genomic knowledge, including applications of genomic research that provide clinical benefit outside the context of personal genomic risk.

Pharmacy benefits management in the Veterans Health Administration: 1995 to 2003.

Science.gov (United States)

Sales, Mariscelle M; Cunningham, Francesca E; Glassman, Peter A; Valentino, Michael A; Good, Chester B

2005-02-01

The Department of Veterans Affairs (VA) Pharmacy Benefits Management Strategic Healthcare Group (VA PBM) oversees the formulary for the entire VA system, which serves more than 4 million veterans and provides more than 108 million prescriptions per year. Since its establishment in 1995, the VA PBM has managed pharmaceuticals and pharmaceutical-related policies, including drug safety and efficacy evaluations, pharmacologic management algorithms, and criteria for drug use. These evidence-based practices promote, optimize, and assist VA providers with the safe and appropriate use of pharmaceuticals while allowing for formulary decisions that can result in substantial cost savings. The VA PBM also has utilized various contracting techniques to standardize generic agents as well as specific drugs and drug classes (eg, antihistamines, angiotensin-converting enzyme inhibitors, alpha-blockers, and 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors [statins]). These methods have enabled the VA to save approximately dollar 1.5 billion since 1996 even as drug expenditures continued to rise from roughly dollar 1 billion in fiscal year (FY) 1996 to more than dollar 3 billion in FY 2003. Furthermore, the VA PBM has established an outcomes research section to undertake quality-improvement and safety initiatives that ultimately monitor and determine the clinical impact of formulary decisions on the VA system nationwide. The experiences of this pharmacy benefits program, including clinical and contracting processes/procedures and their impact on the VA healthcare system, are described.

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

The Risks and Benefits of Cannabis in the Dermatology Clinic.

Science.gov (United States)

Dhadwal, Gurbir; Kirchhof, Mark G

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

Onions--a global benefit to health.

Science.gov (United States)

Griffiths, Gareth; Trueman, Laurence; Crowther, Timothy; Thomas, Brian; Smith, Brian

2002-11-01

Onion (Allium cepa L.) is botanically included in the Liliaceae and species are found across a wide range of latitudes and altitudes in Europe, Asia, N. America and Africa. World onion production has increased by at least 25% over the past 10 years with current production being around 44 million tonnes making it the second most important horticultural crop after tomatoes. Because of their storage characteristics and durability for shipping, onions have always been traded more widely than most vegetables. Onions are versatile and are often used as an ingredient in many dishes and are accepted by almost all traditions and cultures. Onion consumption is increasing significantly, particularly in the USA and this is partly because of heavy promotion that links flavour and health. Onions are rich in two chemical groups that have perceived benefits to human health. These are the flavonoids and the alk(en)yl cysteine sulphoxides (ACSOs). Two flavonoid subgroups are found in onion, the anthocyanins, which impart a red/purple colour to some varieties and flavanols such as quercetin and its derivatives responsible for the yellow and brown skins of many other varieties. The ACSOs are the flavour precursors, which, when cleaved by the enzyme alliinase, generate the characteristic odour and taste of onion. The downstream products are a complex mixture of compounds which include thiosulphinates, thiosulphonates, mono-, di- and tri-sulphides. Compounds from onion have been reported to have a range of health benefits which include anticarcinogenic properties, antiplatelet activity, antithrombotic activity, antiasthmatic and antibiotic effects. Here we review the agronomy of the onion crop, the biochemistry of the health compounds and report on recent clinical data obtained using extracts from this species. Where appropriate we have compared the data with that obtained from garlic (Allium sativum L.) for which more information is widely available. Copyright 2002 John Wiley & Sons

Ketamine for chronic pain: risks and benefits

Science.gov (United States)

Niesters, Marieke; Martini, Christian; Dahan, Albert

2014-01-01

The anaesthetic ketamine is used to treat various chronic pain syndromes, especially those that have a neuropathic component. Low dose ketamine produces strong analgesia in neuropathic pain states, presumably by inhibition of the N-methyl-D-aspartate receptor although other mechanisms are possibly involved, including enhancement of descending inhibition and anti-inflammatory effects at central sites. Current data on short term infusions indicate that ketamine produces potent analgesia during administration only, while three studies on the effect of prolonged infusion (4–14 days) show long-term analgesic effects up to 3 months following infusion. The side effects of ketamine noted in clinical studies include psychedelic symptoms (hallucinations, memory defects, panic attacks), nausea/vomiting, somnolence, cardiovascular stimulation and, in a minority of patients, hepatoxicity. The recreational use of ketamine is increasing and comes with a variety of additional risks ranging from bladder and renal complications to persistent psychotypical behaviour and memory defects. Blind extrapolation of these risks to clinical patients is difficult because of the variable, high and recurrent exposure to the drug in ketamine abusers and the high frequency of abuse of other illicit substances in this population. In clinical settings, ketamine is well tolerated, especially when benzodiazepines are used to tame the psychotropic side effects. Irrespective, close monitoring of patients receiving ketamine is mandatory, particularly aimed at CNS, haemodynamic, renal and hepatic symptoms as well as abuse. Further research is required to assess whether the benefits outweigh the risks and costs. Until definite proof is obtained ketamine administration should be restricted to patients with therapy-resistant severe neuropathic pain. PMID:23432384

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...

Beyond Your Paycheck: An Employee Benefits Primer.

Science.gov (United States)

Stanton, Michael

1990-01-01

Discusses fringe benefits and points out that employee benefits in medium and large firms account for more than 27 percent of total compensation. Differentiates among statutory (required by law), compensatory (wages paid for time not worked such as vacation and sick leave), and supplementary (including insurance and pension plans) benefits and…

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.

Evaluating the benefits of nuclear cardiology

International Nuclear Information System (INIS)

Maisey, M.

1996-01-01

This paper reviews the role of nuclear cardiology in the context of health care evaluation and resource utilisation. Nuclear cardiology procedures are used to detect disease, to define the extent of disease, to predict the outcome of therapy and to monitor the response to treatment. The evaluation of effectiveness will depend on the role for which the tests are being used. The evaluation of diagnostic tests most commonly follows the five level Fineberg classification. I) Technical capacity; II) diagnostic accuracy; III) diagnostic impact; IV) therapeutic impact; V) patient outcome. Tests may succeed or fail at each of these hierarchical levels. In addition to the clinical impact which is evaluated, the appropriate use of health care resources has to be considered , i.e. the cost effectiveness of the investigation. For this the costs of diagnosis and treatment in the resources used, together with the direct cost on the patient and patient carers needs to be considered. In addition to these direct costs to the community and to the patient and the carers the secondary downstream costs and opportunity costs have to be taken into account. The common methods for assessing the costs and benefits include cost minimization, cost effectiveness, cost utility, and cost benefit studies. The advantage and appropriate use of these methods are reviewed. There are seven clinical methods for evaluating diagnostics tests in nuclear cardiology which are: I) Case reports; II) consensus studies; III) databases; IV) management impact studies; V)modeling techniques; VI) management impact studies; VII) randomized control trial. Each of these has a role with advantages and disadvantages which are reviewed. It is no long sufficient to investigate the usefulness of a diagnostic test used in nuclear cardiology in isolation but it as to be within the context of the health care system and the resource used

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.

Weighing the Anti-Ischemic Benefits and Bleeding Risks from Aspirin Therapy: a Rational Approach.

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Dugani, Sagar; Ames, Jeffrey M; Manson, JoAnn E; Mora, Samia

2018-02-21

The role of aspirin in secondary cardiovascular prevention is well understood; however, the role in primary prevention is less clear, and requires careful balancing of potential benefits with risks. Here, we summarize the evidence base on the benefits and risks of aspirin therapy, discuss clinical practice guidelines and decision support tools to assist in initiating aspirin therapy, and highlight ongoing trials that may clarify the role of aspirin in cardiovascular disease prevention. In 2016, the USPSTF released guidelines on the use of aspirin for primary prevention. Based on 11 trials (n = 118,445), aspirin significantly reduced all-cause mortality and nonfatal myocardial infarction, and in 7 trials that evaluated aspirin ≤ 100 mg/day, there was significant reduction in nonfatal stroke. The USPSTF recommends individualized use of aspirin based on factors including age, 10-year atherosclerotic cardiovascular disease risk score, and bleeding risk. Several ongoing trials are evaluating the role of aspirin in primary prevention, secondary prevention, and in combination therapy for atrial fibrillation. Evidence-based approaches to aspirin use should consider the anti-ischemic benefits and bleeding risks from aspirin. In this era of precision medicine, tools that provide the personalized benefit to risk assessment, such as the freely available clinical decision support tool (Aspirin-Guide), can be easily incorporated into the electronic health record and facilitate more informed decisions about initiating aspirin therapy for primary prevention. Aspirin has a complex matrix of benefits and risks, and its use in primary prevention requires individualized decision-making. Results from ongoing trials may guide healthcare providers in identifying appropriate candidates for aspirin therapy.

A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Additional Benefit of a Multistrain Synbiotic (Prodefen® in the Clinical Management of Acute Viral Diarrhea in Children

Directory of Open Access Journals (Sweden)

Emilia García-Menor MD

2016-11-01

Full Text Available This randomized, open-label study evaluated the additional benefits of the synbiotic Prodefen® in the clinical management of acute diarrhea of suspected viral origin in children between 6 months and 12 years of age. Study outcomes included the duration of diarrhea, the recovery from diarrhea, and the tolerability and acceptance of the treatment. The proportion of patients without diarrhea over the study period was greater in the synbiotic group than in the control group at all study time points, showing a statistically significant difference on the fifth day (95% vs 79%, p < 0.001. The duration of diarrhea (median and interquartile range was reduced by 1 day in the synbiotic-treated patients (3 [2-5] vs 4 [3-5], p = 0.377. The tolerability of the treatment regimen, as evaluated by the parents, was significantly better in those receiving the synbiotic than in the control group. Overall, 96% of the parents of children receiving the synbiotic reported being satisfied to very satisfied with the treatment regimen. The results of this study indicate that the addition of the synbiotic Prodefen® is a well-tolerated and well-accepted approach that provides an additional benefit to the standard supportive therapy in the management of acute viral diarrhea in children.

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

Directory of Open Access Journals (Sweden)

P William Conrad

2008-06-01

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

Immuno-modulation and anti-inflammatory benefits of antibiotics: The example of tilmicosin

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Buret, André G.

2010-01-01

Exagerated immune responses, such as those implicated in severe inflammatory reactions, are costly to the metabolism. Inflammation and pro-inflammatory mediators negatively affect production in the food animal industry by reducing growth, feed intake, reproduction, milk production, and metabolic health. An ever-increasing number of findings have established that antibiotics, macrolides in particular, may generate anti-inflammatory effects, including the modulation of pro-inflammatory cytokines and the alteration of neutrophil function. The effects are time- and dose-dependent, and the mechanisms responsible for these phenomena remain incompletely understood. Recent studies, mostly using the veterinary macrolide tilmicosin, may have shed new light on the mode of action of some macrolides and their anti-inflammatory properties. Indeed, research findings demonstrate that this compound, amongst others, induces neutrophil apoptosis, which in turn provides anti-inflammatory benefits. Studies using tilmicosin model systems in vitro and in vivo demonstrate that this antibiotic has potent immunomodulatory effects that may explain why at least parts of its clinical benefits are independent of anti-microbial effects. More research is needed, using this antibiotic and others that may have similar properties, to clarify the biological mechanisms responsible for antibiotic-induced neutrophil apoptosis, and how this, in turn, may provide enhanced clinical benefits. Such studies may help establish a rational basis for the development of novel, efficacious, anti-microbial compounds that generate anti-inflammatory properties in addition to their antibacterial effects. PMID:20357951

A Framework for Including Family Health Spillovers in Economic Evaluation.

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Al-Janabi, Hareth; van Exel, Job; Brouwer, Werner; Coast, Joanna

2016-02-01

Health care interventions may affect the health of patients' family networks. It has been suggested that these "health spillovers" should be included in economic evaluation, but there is not a systematic method for doing this. In this article, we develop a framework for including health spillovers in economic evaluation. We focus on extra-welfarist economic evaluations where the objective is to maximize health benefits from a health care budget (the "health care perspective"). Our framework involves adapting the conventional cost-effectiveness decision rule to include 2 multiplier effects to internalize the spillover effects. These multiplier effects express the ratio of total health effects (for patients and their family networks) to patient health effects. One multiplier effect is specified for health benefit generated from providing a new intervention, one for health benefit displaced by funding this intervention. We show that using multiplier effects to internalize health spillovers could change the optimal funding decisions and generate additional health benefits to society. © The Author(s) 2015.

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 ...

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

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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.

Health benefits of Moringa oleifera.

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Abdull Razis, Ahmad Faizal; Ibrahim, Muhammad Din; Kntayya, Saie Brindha

2014-01-01

Phytomedicines are believed to have benefits over conventional drugs and are regaining interest in current research. Moringa oleifera is a multi-purpose herbal plant used as human food and an alternative for medicinal purposes worldwide. It has been identified by researchers as a plant with numerous health benefits including nutritional and medicinal advantages. Moringa oleifera contains essential amino acids, carotenoids in leaves, and components with nutraceutical properties, supporting the idea of using this plant as a nutritional supplement or constituent in food preparation. Some nutritional evaluation has been carried out in leaves and stem. An important factor that accounts for the medicinal uses of Moringa oleifera is its very wide range of vital antioxidants, antibiotics and nutrients including vitamins and minerals. Almost all parts from Moringa can be used as a source for nutrition with other useful values. This mini-review elaborate on details its health benefits.

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

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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.

Nonconsensual clinical trials: a foreseeable risk of offshoring under global corporatism.

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Spielman, Bethany

2015-03-01

This paper explores the connection of offshoring and outsourcing to nonconsensual global pharmaceutical trials in low-income countries. After discussing reasons why the topic of nonconsensual offshored clinical trials may be overlooked in bioethics literature, I suggest that when pharmaceutical corporations offshore clinical trials today, nonconsensual experiments are often foreseeable and not simply the result of aberrant ethical conduct by a few individuals. Offshoring of clinical trials is structured so that experiments can be presented as health care in a unique form of outsourcing from the host country to pharmaceutical corporations. Bioethicists' assessments of the risks and potential benefits of offshore corporate pharmaceutical trials should therefore systematically include not only the hoped for benefits and the risks of the experimental drug but also the risk that subjects will not have consented, as well as the broader international consequences of nonconsensual experimentation.

Benefits in cash or in kind? A community consultation on types of benefits in health research on the Kenyan Coast.

Directory of Open Access Journals (Sweden)

Maureen Njue

Full Text Available Providing benefits and payments to participants in health research, either in cash or in kind, is a common but ethically controversial practice. While much literature has concentrated on appropriate levels of benefits or payments, this paper focuses on less well explored ethical issues around the nature of study benefits, drawing on views of community members living close to an international health research centre in Kenya.The consultation, including 90 residents purposively chosen to reflect diversity, used a two-stage deliberative process. Five half-day workshops were each followed by between two and four small group discussions, within a two week period (total 16 groups. During workshops and small groups, facilitators used participatory methods to share information, and promote reflection and debate on ethical issues around types of benefits, including cash, goods, medical and community benefits. Data from workshop and field notes, and voice recordings of small group discussions, were managed using Nvivo 10 and analysed using a Framework Analysis approach.The methods generated in-depth discussion with high levels of engagement. Particularly for the most-poor, under-compensation of time in research carries risks of serious harm. Cash payments may best support compensation of costs experienced; while highly valued, goods and medical benefits may be more appropriate as an 'appreciation' or incentive for participation. Community benefits were seen as important in supporting but not replacing individual-level benefits, and in building trust in researcher-community relations. Cash payments were seen to have higher risks of undue inducement, commercialising relationships and generating family conflicts than other benefits, particularly where payments are high. Researchers should consider and account for burdens families may experience when children are involved in research. Careful context-specific research planning and skilled and consistent

Benefits in cash or in kind? A community consultation on types of benefits in health research on the Kenyan Coast.

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Njue, Maureen; Molyneux, Sassy; Kombe, Francis; Mwalukore, Salim; Kamuya, Dorcas; Marsh, Vicki

2015-01-01

Providing benefits and payments to participants in health research, either in cash or in kind, is a common but ethically controversial practice. While much literature has concentrated on appropriate levels of benefits or payments, this paper focuses on less well explored ethical issues around the nature of study benefits, drawing on views of community members living close to an international health research centre in Kenya. The consultation, including 90 residents purposively chosen to reflect diversity, used a two-stage deliberative process. Five half-day workshops were each followed by between two and four small group discussions, within a two week period (total 16 groups). During workshops and small groups, facilitators used participatory methods to share information, and promote reflection and debate on ethical issues around types of benefits, including cash, goods, medical and community benefits. Data from workshop and field notes, and voice recordings of small group discussions, were managed using Nvivo 10 and analysed using a Framework Analysis approach. The methods generated in-depth discussion with high levels of engagement. Particularly for the most-poor, under-compensation of time in research carries risks of serious harm. Cash payments may best support compensation of costs experienced; while highly valued, goods and medical benefits may be more appropriate as an 'appreciation' or incentive for participation. Community benefits were seen as important in supporting but not replacing individual-level benefits, and in building trust in researcher-community relations. Cash payments were seen to have higher risks of undue inducement, commercialising relationships and generating family conflicts than other benefits, particularly where payments are high. Researchers should consider and account for burdens families may experience when children are involved in research. Careful context-specific research planning and skilled and consistent communication about

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

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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.

Daily Aspirin Therapy: Understand the Benefits and Risks

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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 ...

The Measurable Benefits of a Workplace Wellness Program in Canada: Results After One Year.

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Lowensteyn, Ilka; Berberian, Violette; Belisle, Patrick; DaCosta, Deborah; Joseph, Lawrence; Grover, Steven A

2018-03-01

The aim of this study was to evaluate the impact of an employee wellness program in Canada. A comprehensive program including web-based lifestyle challenges was evaluated with annual health screenings. Among 730 eligible employees, 688 (94%) registered for the program, 571 (78%) completed a health screening at baseline, and 314 (43%) at 1 year. Most (66%) employees tracked their activity for more than 6 weeks. At 1-year follow-up, there were significant clinical improvements in systolic blood pressure -3.4 mm Hg, and reductions in poor sleep quality (33% to 28%), high emotional stress (21% to 15%), and fatigue (11% to 6%). A positive dose-response was noted where the greatest improvements were observed among those who participated the most. The program had high employee engagement. After 1 year, the benefits included clinically important improvements in physical and mental health.

Low Cost Benefit Suggestions.

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Doyel, Hoyt W.; McMillan, John D.

1980-01-01

Outlines eight low-cost employee benefits and summarizes their relative advantages. The eight include a stock ownership program, a sick leave pool, flexible working hours, production incentives, and group purchase plans. (IRT)

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)

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.

Ginger for Prevention of Antituberculosis-induced Gastrointestinal Adverse Reactions Including Hepatotoxicity: A Randomized Pilot Clinical Trial.

Science.gov (United States)

Emrani, Zahra; Shojaei, Esphandiar; Khalili, Hossein

2016-06-01

In this study, the potential benefits of ginger in preventing antituberculosis drug-induced gastrointestinal adverse reactions including hepatotoxicity have been evaluated in patients with tuberculosis. Patients in the ginger and placebo groups (30 patients in each group) received either 500 mg ginger (Zintoma)(®) or placebo one-half hour before each daily dose of antituberculosis drugs for 4 weeks. Patients' gastrointestinal complaints (nausea, vomiting, dyspepsia, and abdominal pain) and antituberculosis drug-induced hepatotoxicity were recorded during the study period. In this cohort, nausea was the most common antituberculosis drug-induced gastrointestinal adverse reactions. Forty eight (80%) patients experienced nausea. Nausea was more common in the placebo than the ginger group [27 (90%) vs 21 (70%), respectively, p = 0.05]. During the study period, 16 (26.7%) patients experienced antituberculosis drug-induced hepatotoxicity. Patients in the ginger group experienced less, but not statistically significant, antituberculosis drug-induced hepatotoxicity than the placebo group (16.7% vs 36.7%, respectively, p = 0.07). In conclusion, ginger may be a potential option for prevention of antituberculosis drug-induced gastrointestinal adverse reactions including hepatotoxicity. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

The economic and clinical impact of an inpatient palliative care consultation service: a multifaceted approach.

Science.gov (United States)

Ciemins, Elizabeth L; Blum, Linda; Nunley, Marsha; Lasher, Andrew; Newman, Jeffrey M

2007-12-01

While there has been a rapid increase of inpatient palliative care (PC) programs, the financial and clinical benefits have not been well established. Determine the effect of an inpatient PC consultation service on costs and clinical outcomes. Multifaceted study included: (1) interrupted time-series design utilizing mean daily costs preintervention and postintervention; (2) matched cohort analysis comparing PC to usual care patients; and (3) analysis of symptom control after consultation. Large private, not-for-profit, academic medical center in San Francisco, California, 2004-2006. Time series analysis included 282 PC patients; matched cohorts included 27 PC with 128 usual care patients; clinical outcome analysis of 48 PC patients. Mean daily patient costs and length of stay (LOS); pain, dyspnea, and secretions assessment scores. Mean daily costs were reduced 33% (p reduction in mean daily costs and LOS resulted in an estimated annual savings of $2.2 million in the study hospital. Our results extend the evidence base of financial and clinical benefits associated with inpatient PC programs. We recommend additional study of best practices for identifying patients and providing consultation services, in addition to progressive management support and reimbursement policy.

Line probe assay for differentiation within Mycobacterium tuberculosis complex. Evaluation on clinical specimens and isolates including Mycobacterium pinnipedii

DEFF Research Database (Denmark)

Kjeldsen, Marianne Kirstine; Bek, Dorte; Rasmussen, Erik Michael

2009-01-01

A line probe assay (GenoType MTBC) was evaluated for species differentiation within the Mycobacterium tuberculosis complex (MTBC). We included 387 MTBC isolates, 43 IS6110 low-copy MTBC isolates, 28 clinical specimens with varying microscopy grade, and 30 isolates of non-tuberculous mycobacteria...

Bioethical Issues in Conducting Pediatric Dentistry Clinical Research.

Science.gov (United States)

Garrocho-Rangel, Arturo; Cerda-Cristerna, Bernardino; Pozos-Guillen, Amaury

Pediatric clinical research on new drugs and biomaterials involves children in order to create valid and generalizable knowledge. Research on vulnerable populations, such as children, is necessary but only admissible when researchers strictly follow methodological and ethical standards, together with the respect to human rights; and very especially when the investigation cannot be conducted with other population or when the potential benefits are specifically for that age group. Clinical research in Pediatric Dentistry is not an exception. The aim of the present article was to provide the bioethical principles (with respect to the child/parents' autonomy, benefit/risk analysis, and distributive justice), and recommendations, including informed consent, research ethics committees, conflict of interest, and the "equipoise" concept. Current and future worldwide oral health research in children and adolescents must be conducted incorporating their perspectives in the decision-making process as completely as possible. This concept must be carefully considered when a dental clinical study research is going to be planned and conducted, especially in the case of randomized controlled trials, in which children will be recruited as participants.

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

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

Science.gov (United States)

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

2017-01-01

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

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

Distinguishing community benefits: tax exemption versus organizational legitimacy.

Science.gov (United States)

Byrd, James D; Landry, Amy

2012-01-01

US policymakers continue to call into question the tax-exempt status of hospitals. As nonprofit tax-exempt entities, hospitals are required by the Internal Revenue Service (IRS) to report the type and cost of community benefits they provide. Institutional theory indicates that organizations derive organizational legitimacy from conforming to the expectations of their environment. Expectations from the state and federal regulators (the IRS, state and local taxing authorities in particular) and the community require hospitals to provide community benefits to achieve legitimacy. This article examines community benefit through an institutional theory framework, which includes regulative (laws and regulation), normative (certification and accreditation), and cultural-cognitive (relationship with the community including the provision of community benefits) pillars. Considering a review of the results of a 2006 IRS study of tax-exempt hospitals, the authors propose a model of hospital community benefit behaviors that distinguishes community benefits between cost-quantifiable activities appropriate for justifying tax exemption and unquantifiable activities that only contribute to hospitals' legitimacy.

Developing Federal Clinical Care Recommendations for Women.

Science.gov (United States)

Godfrey, Emily M; Tepper, Naomi K; Curtis, Kathryn M; Moskosky, Susan B; Gavin, Loretta E

2015-08-01

The provision of family planning services has important health benefits for the U.S. Approximately 25 million women in the U.S. receive contraceptive services annually and 44 million make at least one family planning-related clinical visit each year. These services are provided by private clinicians, as well as publicly funded clinics, including specialty family planning clinics, health departments, Planned Parenthoods, community health centers, and primary care clinics. Recommendations for providing quality family planning services have been published by CDC and the Office of Population Affairs of the DHHS. This paper describes the process used to develop the women's clinical services portion of the new recommendations and the rationale underpinning them. The recommendations define family planning services as contraceptive care, pregnancy testing and counseling, achieving pregnancy, basic infertility care, sexually transmitted disease services, and preconception health. Because many women who seek family planning services have no other source of care, the recommendations also include additional screening services related to women's health, such as cervical cancer screening. These clinical guidelines are aimed at providing the highest-quality care and are designed to establish a national standard for family planning in the U.S. Published by Elsevier Inc.

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...

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.

Mutual benefits in academic-service partnership: An integrative review.

Science.gov (United States)

Sadeghnezhad, Maliheh; Heshmati Nabavi, Fatemeh; Najafi, Fereshteh; Kareshki, Hossein; Esmaily, Habibollah

2018-05-30

Academic and service institutions involve with many challenges. Partnership programs are a golden opportunity to achieve mutual benefits to overcome these challenges. Identifying mutual benefits is the cornerstone of forming a successful partnership and guarantee to its continuity. There are definitions and instances of mutual benefits in the literature related to partnership programs, but there is no coherent evidence and clear picture of these benefits. This study is conducted to identify mutual benefits in academic-service partnership by analyzing the definitions and instances of it in the literature. An integrative review of key papers regarding mutual benefits in academic-service partnership was undertaken. This review was guided by the framework described by Whittemore and Knafl. Search of the following databases was conducted: MEDLINE, ERIC, Google Scholar, Emerald Insight and Science Direct. The search terms were mutual benefits, mutual gains, mutual interest, mutual expectations, mutual goals, mutual demand, partnership, collaboration, academic-service partnership and academic service collaboration. Cooper's five-stage integrative review method was used. Quality evaluation of articles was conducted. Data were abstracted from included articles. The analysis was conducted based on the qualitative content analysis of the literature suggested by Zhang and Wildemuth. 28 articles were included in this review. Mutual benefits are described in four categories include: synergy in training and empowerment of human resources, education improvement, access to shared resources, facilitate production and application of beneficial knowledge into practice. Mutual benefits in the academic-service partnership include a range of goals, interests, expectations, and needs of partner organizations that is achievable and measurable through joint planning and collaboration. We suggest academic and service policymakers to consider these benefits in the planning and evaluating

The Business Case for Provider Participation in Clinical Trials Research: An Application to the National Cancer Institute's Community Clinical Oncology Program

Science.gov (United States)

Song, Paula H.; Reiter, Kristin L.; Weiner, Bryan J.; Minasian, Lori; McAlearney, Ann Scheck

2012-01-01

Background Provider-based research networks (PBRNs) make clinical trials available in community-based practice settings, where most people receive their care, but provider participation requires both financial and in-kind contributions. Purpose This study explores whether providers believe there is a business case for participating in PBRNs and what factors contribute to the business case. Methodology/Approach We use a multiple case study methodology approach to examine the National Cancer Institute's Community Clinical Oncology Program, a longstanding federally funded PBRN. Interviews with 41 key informants across five sites, selected on the basis of organizational maturity, were conducted using a semi-structured interview guide. We analyzed interview transcripts using an iterative, deductive process to identify themes and subthemes in the data. Findings We found that a business case for provider participation in PBRNs may exist if both direct and indirect financial benefits are identified and included in the analysis, and if the time horizon is long enough to allow those benefits to be realized. We identified specific direct and indirect financial benefits that were perceived as important contributors to the business case and the perceived length of time required for a positive return to accrue. Practice Implications As the lack of a business case may result in provider reluctance to participate in PBRNs, knowledge of the benefits we identified may be crucial to encouraging and sustaining participation, thereby preserving patient access to innovative community-based treatments. The results are also relevant to federally-funded PBRNs outside of oncology or to providers considering participation in any clinical trials research. PMID:23044836

The business case for provider participation in clinical trials research: an application to the National Cancer Institute's community clinical oncology program.

Science.gov (United States)

Song, Paula H; Reiter, Kristin L; Weiner, Bryan J; Minasian, Lori; McAlearney, Ann Scheck

2013-01-01

Provider-based research networks (PBRNs) make clinical trials available in community-based practice settings, where most people receive their care, but provider participation requires both financial and in-kind contributions. The aim of this study was to explore whether providers believe there is a business case for participating in PBRNs and what factors contribute to the business case. We use a multiple case study methodology approach to examine the National Cancer Institute's community clinical oncology program, a long-standing federally funded PBRN. Interviews with 41 key informants across five sites, selected on the basis of organizational maturity, were conducted using a semistructured interview guide. We analyzed interview transcripts using an iterative, deductive process to identify themes and subthemes in the data. We found that a business case for provider participation in PBRNs may exist if both direct and indirect financial benefits are identified and included in the analysis and if the time horizon is long enough to allow those benefits to be realized. We identified specific direct and indirect financial benefits that were perceived as important contributors to the business case and the perceived length of time required for a positive return to accrue. As the lack of a business case may result in provider reluctance to participate in PBRNs, knowledge of the benefits we identified may be crucial to encouraging and sustaining participation, thereby preserving patient access to innovative community-based treatments. The results are also relevant to federally funded PBRNs outside of oncology or to providers considering participation in any clinical trials research.

The Distribution of Family Oriented Benefits.

Science.gov (United States)

EBRI Issue Brief, 1992

1992-01-01

This issue of a monthly newsletter is devoted to an overview of employee benefits that assist families, including child care, extended unpaid personal leave, and flexible work options. Findings are discussed from a recent study analyzing the distribution of two of those family benefits (child care assistance and flexible work practices) among…

Every team needs a coach: Training for interprofessional clinical placements.

Science.gov (United States)

Grymonpre, Ruby; Bowman, Susan; Rippin-Sisler, Cathy; Klaasen, Kathleen; Bapuji, Sunita B; Norrie, Ola; Metge, Colleen

2016-09-01

Despite growing awareness of the benefits of interprofessional education and interprofessional collaboration (IPC), understanding how teams successfully transition to IPC is limited. Student exposure to interprofessional teams fosters the learners' integration and application of classroom-based interprofessional theory to practice. A further benefit might be reinforcing the value of IPC to members of the mentoring team and strengthening their IPC. The research question for this study was: Does training in IPC and clinical team facilitation and mentorship of pre-licensure learners during interprofessional clinical placements improve the mentoring teams' collaborative working relationships compared to control teams? Statistical analyses included repeated time analysis multivariate analysis of variance (MANOVA). Teams on four clinical units participated in the project. Impact on intervention teams pre- versus post-interprofessional clinical placement was modest with only the Cost of Team score of the Attitudes Towards Healthcare Team Scale improving relative to controls (p = 0.059) although reflective evaluations by intervention team members noted many perceived benefits of interprofessional clinical placements. The significantly higher group scores for control teams (geriatric and palliative care) on three of four subscales of the Assessment of Interprofessional Team Collaboration Scale underscore our need to better understand the unique features within geriatric and palliative care settings that foster superior IPC and to recognise that the transition to IPC likely requires a more diverse intervention than the interprofessional clinical placement experience implemented in this study. More recently, it is encouraging to see the development of innovative tools that use an evidence-based, multi-dimensional approach to support teams in their transition to IPC.

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.

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.

Effects of Subsidies and Prohibitions on Nutrition in a Food Benefit Program

Science.gov (United States)

Harnack, Lisa; Oakes, J. Michael; Elbel, Brian; Beatty, Timothy; Rydell, Sarah; French, Simone

2018-01-01

.1 points, SE 1.4). Fewer improvements were observed in the incentive only and restriction only arms. CONCLUSIONS AND RELEVANCE A food benefit program that pairs incentives for purchasing more fruits and vegetables with restrictions on the purchase of less nutritious foods may reduce energy intake and improve the nutritional quality of the diet of participants compared with a program that does not include incentives or restrictions. CLINICAL TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT02643576 PMID:27653735

Advancing the educational and career pathway for clinical trials nurses.

Science.gov (United States)

Scott, Kathleen; White, Kathryn; Roydhouse, Jessica K

2013-04-01

Clinical trials nurses play a pivotal role in the conduct of clinical research, but the educational and career pathway for these nurses remains unclear. This article reports findings from a survey of nurses working in cancer clinical trials research in Australia. Most participants held postgraduate qualifications (42 of 61); however, clinical trials education was primarily attained through short professional development courses. Interest in pursuing trial-specific postgraduate education was high, but barriers were identified, including cost, time, and unclear benefit for career advancement. Job titles varied substantially, which is indicative of an unclear employment pathway. These findings suggest that initiatives to improve the educational and career pathway for clinical trials nurses are needed and should include the following: formal educational preparation, greater consistency in employment status, and clearer career progression. These strategies should be underpinned by broad professional recognition of the clinical trials nurse as a specialized nursing role. Copyright 2013, SLACK Incorporated.

'Cloud computing' and clinical trials: report from an ECRIN workshop.

Science.gov (United States)

Ohmann, Christian; Canham, Steve; Danielyan, Edgar; Robertshaw, Steve; Legré, Yannick; Clivio, Luca; Demotes, Jacques

2015-07-29

Growing use of cloud computing in clinical trials prompted the European Clinical Research Infrastructures Network, a European non-profit organisation established to support multinational clinical research, to organise a one-day workshop on the topic to clarify potential benefits and risks. The issues that arose in that workshop are summarised and include the following: the nature of cloud computing and the cloud computing industry; the risks in using cloud computing services now; the lack of explicit guidance on this subject, both generally and with reference to clinical trials; and some possible ways of reducing risks. There was particular interest in developing and using a European 'community cloud' specifically for academic clinical trial data. It was recognised that the day-long workshop was only the start of an ongoing process. Future discussion needs to include clarification of trial-specific regulatory requirements for cloud computing and involve representatives from the relevant regulatory bodies.

GWAS of clinically defined gout and subtypes identifies multiple susceptibility loci that include urate transporter genes

OpenAIRE

Nakayama, Akiyoshi; Nakaoka, Hirofumi; Yamamoto, Ken; Sakiyama, Masayuki; Shaukat, Amara; Toyoda, Yu; Okada, Yukinori; Kamatani, Yoichiro; Nakamura, Takahiro; Takada, Tappei; Inoue, Katsuhisa; Yasujima, Tomoya; Yuasa, Hiroaki; Shirahama, Yuko; Nakashima, Hiroshi

2016-01-01

Objective A genome-wide association study (GWAS) of gout and its subtypes was performed to identify novel gout loci, including those that are subtype-specific. Methods Putative causal association signals from a GWAS of 945 clinically defined gout cases and 1213 controls from Japanese males were replicated with 1396 cases and 1268 controls using a custom chip of 1961 single nucleotide polymorphisms (SNPs). We also first conducted GWASs of gout subtypes. Replication with Caucasian and New Zeala...

Dutch guideline for clinical foetal-neonatal and paediatric post-mortem radiology, including a review of literature.

Science.gov (United States)

Sonnemans, L J P; Vester, M E M; Kolsteren, E E M; Erwich, J J H M; Nikkels, P G J; Kint, P A M; van Rijn, R R; Klein, W M

2018-06-01

Clinical post-mortem radiology is a relatively new field of expertise and not common practice in most hospitals yet. With the declining numbers of autopsies and increasing demand for quality control of clinical care, post-mortem radiology can offer a solution, or at least be complementary. A working group consisting of radiologists, pathologists and other clinical medical specialists reviewed and evaluated the literature on the diagnostic value of post-mortem conventional radiography (CR), ultrasonography, computed tomography (PMCT), magnetic resonance imaging (PMMRI), and minimally invasive autopsy (MIA). Evidence tables were built and subsequently a Dutch national evidence-based guideline for post-mortem radiology was developed. We present this evaluation of the radiological modalities in a clinical post-mortem setting, including MIA, as well as the recently published Dutch guidelines for post-mortem radiology in foetuses, neonates, and children. In general, for post-mortem radiology modalities, PMMRI is the modality of choice in foetuses, neonates, and infants, whereas PMCT is advised in older children. There is a limited role for post-mortem CR and ultrasonography. In most cases, conventional autopsy will remain the diagnostic method of choice. Based on a literature review and clinical expertise, an evidence-based guideline was developed for post-mortem radiology of foetal, neonatal, and paediatric patients. What is Known: • Post-mortem investigations serve as a quality check for the provided health care and are important for reliable epidemiological registration. • Post-mortem radiology, sometimes combined with minimally invasive techniques, is considered as an adjunct or alternative to autopsy. What is New: • We present the Dutch guidelines for post-mortem radiology in foetuses, neonates and children. • Autopsy remains the reference standard, however minimal invasive autopsy with a skeletal survey, post-mortem computed tomography, or post

Grape Juice: Same Heart Benefits as Wine?

Science.gov (United States)

... eating Does grape juice offer the same heart benefits as red wine? Answers from Katherine Zeratsky, R.D., L.D. ... juices may provide some of the same heart benefits of red wine, including: Reducing the risk of blood clots Reducing ...

Benefits of CHP Partnership

Science.gov (United States)

Learn about the benefits of being a EPA CHP Partner, which include expert advice and answers to questions, CHP news, marketing resources, publicity and recognition, and being associated with EPA through a demonstrated commitment to CHP.

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

Science.gov (United States)

Kress, Hans Georg; Untersteiner, Gerald

2017-02-01

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

Bottlenecks to Clinical Translation of Direct Brain-Computer Interfaces

Directory of Open Access Journals (Sweden)

Mijail Demian Serruya

2014-12-01

Full Text Available Despite several decades of research into novel brain-implantable devices to treat a range of diseases, only two- cochlear implants for sensorineural hearing loss and deep brain stimulation for movement disorders- have yielded any appreciable clinical benefit. Obstacles to translation include technical factors (e.g., signal loss due to gliosis or micromotion, lack of awareness of current clinical options for patients that the new therapy must outperform, traversing between federal and corporate funding needed to support clinical trials, and insufficient management expertise. This commentary reviews these obstacles preventing the translation of promising new neurotechnologies into clinical application and suggests some principles that interdisciplinary teams in academia and industry could adopt to enhance their chances of success.

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

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.

Hydration benefits to courtship feeding in crickets

OpenAIRE

Ivy, T. M.; Johnson, J. C.; Sakaluk, S. K.

1999-01-01

The spermatophore transferred by male decorated crickets (Gryllodes sigillatus) at mating includes a large gelatinous spermatophylax that the female consumes after copulation. Although previous studies have shown that G. sigillatus females gain no nutritional benefits from consuming food gifts, there may be other benefits to their consumption. We examined potential hydration benefits to females by experimentally manipulating both the availability of water and the number of food gifts that fem...

Quantifying the costs and benefits of occupational health and safety interventions at a Bangladesh shipbuilding company.

Science.gov (United States)

Thiede, Irene; Thiede, Michael

2015-01-01

This study is the first cost-benefit analysis (CBA) of occupational health and safety (OHS) in a low-income country. It focuses on one of the largest shipbuilding companies in Bangladesh, where globally recognised Occupational Health and Safety Advisory Services (OHSAS) 18001 certification was achieved in 2012. The study examines the relative costs of implementing OHS measures against qualitative and quantifiable benefits of implementation in order to determine whether OHSAS measures are economically advantageous. Quantifying past costs and benefits and discounting future ones, this study looks at the returns of OHS measures at Western Marine Shipbuilding Company Ltd. Costs included investments in workplace and environmental safety, a new clinic that also serves the community, and personal protective equipment (PPE) and training. The results are impressive: previously high injury statistics dropped to close to zero. OHS measures decrease injuries, increase efficiency, and bring income security to workers' families. Certification has proven a competitive edge for the shipyard, resulting in access to greater markets. Intangible benefits such as trust, motivation and security are deemed crucial in the CBA, and this study finds the high investments made are difficult to offset with quantifiable benefits alone.

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.

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...

The Risks and Benefits of Calcium Supplementation

Directory of Open Access Journals (Sweden)

Chan Soo Shin

2015-03-01

Full Text Available The association between calcium supplementation and adverse cardiovascular events has recently become a topic of debate due to the publication of two epidemiological studies and one meta-analysis of randomized controlled clinical trials. The reports indicate that there is a significant increase in adverse cardiovascular events following supplementation with calcium; however, a number of experts have raised several issues with these reports such as inconsistencies in attempts to reproduce the findings in other populations and questions concerning the validity of the data due to low compliance, biases in case ascertainment, and/or a lack of adjustment. Additionally, the Auckland Calcium Study, the Women's Health Initiative, and many other studies included in the meta-analysis obtained data from calcium-replete subjects and it is not clear whether the same risk profile would be observed in populations with low calcium intakes. Dietary calcium intake varies widely throughout the world and it is especially low in East Asia, although the risk of cardiovascular events is less prominent in this region. Therefore, clarification is necessary regarding the occurrence of adverse cardiovascular events following calcium supplementation and whether this relationship can be generalized to populations with low calcium intakes. Additionally, the skeletal benefits from calcium supplementation are greater in subjects with low calcium intakes and, therefore, the risk-benefit ratio of calcium supplementation is likely to differ based on the dietary calcium intake and risks of osteoporosis and cardiovascular diseases of various populations. Further studies investigating the risk-benefit profiles of calcium supplementation in various populations are required to develop population-specific guidelines for individuals of different genders, ages, ethnicities, and risk profiles around the world.

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

29 CFR 5.29 - Specific fringe benefits.

Science.gov (United States)

2010-07-01

... benefits which the Congress considered to be common in the construction industry as a whole. These include... illness resulting from occupational activity, or insurance to provide any of the foregoing, unemployment benefits, life insurance, disability and sickness insurance, or accident insurance, vacation and holiday...

Design of clinical trials for therapeutic cancer vaccines development.

Science.gov (United States)

Mackiewicz, Jacek; Mackiewicz, Andrzej

2009-12-25

Advances in molecular and cellular biology as well as biotechnology led to definition of a group of drugs referred to as medicinal products of advanced technologies. It includes gene therapy products, somatic cell therapeutics and tissue engineering. Therapeutic cancer vaccines including whole cell tumor cells vaccines or gene modified whole cells belong to somatic therapeutics and/or gene therapy products category. The drug development is a multistep complex process. It comprises of two phases: preclinical and clinical. Guidelines on preclinical testing of cell based immunotherapy medicinal products have been defined by regulatory agencies and are available. However, clinical testing of therapeutic cancer vaccines is still under debate. It presents a serious problem since recently clinical efficacy of the number of cancer vaccines has been demonstrated that focused a lot of public attention. In general clinical testing in the current form is very expensive, time consuming and poorly designed what may lead to overlooking of products clinically beneficial for patients. Accordingly regulatory authorities and researches including Cancer Vaccine Clinical Trial Working Group proposed three regulatory solutions to facilitate clinical development of cancer vaccines: cost-recovery program, conditional marketing authorization, and a new development paradigm. Paradigm includes a model in which cancer vaccines are investigated in two types of clinical trials: proof-of-principle and efficacy. The proof-of-principle trial objectives are: safety; dose selection and schedule of vaccination; and demonstration of proof-of-principle. Efficacy trials are randomized clinical trials with objectives of demonstrating clinical benefit either directly or through a surrogate. The clinical end points are still under debate.

Slowly progressive fluent aphasia; Clinical features and an imaging study including MRI, SPECT and PET

Energy Technology Data Exchange (ETDEWEB)

Sakurai, Yasuhisa; Momose, Toshimitsu; Watanabe, Toshiaki; Ishikawa, Takashi; Iwata, Makoto (Tokyo Univ. (Japan). Faculty of Medicine); Bando, Mitsuaki

1991-05-01

Three patients with slowly progressive fluent aphasia are reported. One of the patients presented with memory disturbance. They were characterized clinically by having selective deficits in vocabulary, which resulted in impairment of confrontation naming, and auditory comprehension. MRI showed an atrophy not only in the left temporal lobe (including the superior, middle and inferior temporal gyri), hippocampus, parahippocampual gyrus, and fusiform gyrus, but also in the left parietal lobe. I-123 IMP SPECT and F-18 FDG PET were used to determine regional cerebral blood flow and regional cerebral metabolic rate, respectively. In addition to the decreased tracer uptake in the left temporal and/or parietal lobe, a decreased uptake was seen in the bilateral basal ganglia, the inner side of the temporal lobe (including the bilateral hippocampus), the right anterior temporal lobe, and the left thalamus. These findings may deny the previous thought that lesions are localized in slowly progressive fluent aphasia. Furthermore, noticeable difficulty in naming, i.e., patients unable to recognize the right answer, are considered attributable to widespread lesions from the whole left temporal lobe, including the hippocampus, to the right temporal lobe. (N.K.).

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.

Gatekeepers for pragmatic clinical trials.

Science.gov (United States)

Whicher, Danielle M; Miller, Jennifer E; Dunham, Kelly M; Joffe, Steven

2015-10-01

To successfully implement a pragmatic clinical trial, investigators need access to numerous resources, including financial support, institutional infrastructure (e.g. clinics, facilities, staff), eligible patients, and patient data. Gatekeepers are people or entities who have the ability to allow or deny access to the resources required to support the conduct of clinical research. Based on this definition, gatekeepers relevant to the US clinical research enterprise include research sponsors, regulatory agencies, payers, health system and other organizational leadership, research team leadership, human research protections programs, advocacy and community groups, and clinicians. This article provides a framework to help guide gatekeepers' decision-making related to the use of resources for pragmatic clinical trials. Relevant ethical considerations for gatekeepers include (1) concern for the interests of individuals, groups, and communities affected by the gatekeepers' decisions, including protection from harm and maximization of benefits; (2) advancement of organizational mission and values; and (3) stewardship of financial, human, and other organizational resources. Separate from these ethical considerations, gatekeepers' actions will be guided by relevant federal, state, and local regulations. This framework also suggests that to further enhance the legitimacy of their decision-making, gatekeepers should adopt transparent processes that engage relevant stakeholders when feasible and appropriate. We apply this framework to the set of gatekeepers responsible for making decisions about resources necessary for pragmatic clinical trials in the United States, describing the relevance of the criteria in different situations and pointing out where conflicts among the criteria and relevant regulations may affect decision-making. Recognition of the complex set of considerations that should inform decision-making will guide gatekeepers in making justifiable choices regarding

Risk-benefit considerations in the treatment of relapsing-remitting multiple sclerosis

Directory of Open Access Journals (Sweden)

Lugaresi A

2013-06-01

Full Text Available Alessandra Lugaresi,1 Maria di Ioia,1 Daniela Travaglini,1 Erika Pietrolongo,1 Eugenio Pucci,2 Marco Onofrj11Department of Neuroscience and Imaging, University “G d’Annunzio”, Chieti, 2Operative Unit Neurologia ASUR Marche Area Vasta 3, Macerata, ItalyAbstract: Multiple sclerosis (MS is a chronic demyelinating disease of the central nervous system and mainly affects young adults. Its natural history has changed in recent years with the advent of disease-modifying drugs, which have been available since the early 1990s. The increasing number of first-line and second-line treatment options, together with the variable course of the disease and patient lifestyles and expectations, makes the therapeutic decision a real challenge. The aim of this review is to give a comprehensive overview of the main present and some future drugs for relapsing-remitting MS, including risk-benefit considerations, to enable readers to draw their own conclusions regarding the risk-benefit assessment of personalized treatment strategies, taking into account not only treatment-related but also disease-related risks. We performed a Medline literature search to identify studies on the treatment of MS with risk stratification and risk-benefit considerations. We focused our attention on studies of disease-modifying, immunomodulating, and immunosuppressive drugs, including monoclonal antibodies. Here we offer personal considerations, stemming from long-term experience in the treatment of MS and thorough discussions with other neurologists closely involved in the care of patients with the disease. MS specialists need to know not only the specific risks and benefits of single drugs, but also about drug interactions, either in simultaneous or serial combination therapy, and patient comorbidities, preferences, and fears. This has to be put into perspective, considering also the risks of untreated disease in patients with different clinical and radiological characteristics

Universal newborn screening for congenital CMV infection: what is the evidence of potential benefit?

Science.gov (United States)

Cannon, Michael J; Griffiths, Paul D; Aston, Van; Rawlinson, William D

2014-09-01

Congenital CMV infection is a leading cause of childhood disability. Many children born with congenital CMV infection are asymptomatic or have nonspecific symptoms and therefore are typically not diagnosed. A strategy of newborn CMV screening could allow for early detection and intervention to improve clinical outcomes. Interventions might include antiviral drugs or nonpharmaceutical therapies such as speech-language therapy or cochlear implants. Using published data from developed countries, we analyzed existing evidence of potential benefit that could result from newborn CMV screening. We first estimated the numbers of children with the most important CMV-related disabilities (i.e. hearing loss, cognitive deficit, and vision impairment), including the age at which the disabilities occur. Then, for each of the disabilities, we examined the existing evidence for the effectiveness of various interventions. We concluded that there is good evidence of potential benefit from nonpharmaceutical interventions for children with delayed hearing loss that occurs by 9 months of age. Similarly, we concluded that there is fair evidence of potential benefit from antiviral therapy for children with hearing loss at birth and from nonpharmaceutical interventions for children with delayed hearing loss occurring between 9 and 24 months of age and for children with CMV-related cognitive deficits. We found poor evidence of potential benefit for children with delayed hearing loss occurring after 24 months of age and for children with vision impairment. Overall, we estimated that in the United States, several thousand children with congenital CMV could benefit each year from newborn CMV screening, early detection, and interventions. Copyright © 2014 John Wiley & Sons, Ltd.

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.

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...

Type 1 Diabetes TrialNet--an international collaborative clinical trials network.

Science.gov (United States)

Skyler, Jay S; Greenbaum, Carla J; Lachin, John M; Leschek, Ellen; Rafkin-Mervis, Lisa; Savage, Peter; Spain, Lisa

2008-12-01

Type 1 Diabetes TrialNet is an international consortium of clinical research centers aimed at the prevention or delay of type 1 diabetes (T1D). The fundamental goal of TrialNet is to counter the T1D disease process by immune modulation and/or enhancement of beta cell proliferation and regeneration. To achieve this goal, TrialNet researchers are working to better understand the natural history of the disease, to identify persons at risk, and to clinically evaluate novel therapies that balance potential risks and benefits. The particular focus is on studies of preventive measures. In addition, TrialNet evaluates therapies in individuals with newly diagnosed T1D with preserved beta cell function to help determine the risk/benefit profile and gain an initial assessment of potential efficacy in preservation of beta cell function, so that promising agents can be studied in prevention trials. In addition, TrialNet evaluates methodologies that enhance the conduct of its clinical trials, which includes tests of outcome assessment methodology, the evaluation of surrogate markers, and mechanistic studies laying the foundation for future clinical trials.

Productivity benefits of industrial energy efficiency measures

Energy Technology Data Exchange (ETDEWEB)

Worrell, Ernst; Laitner, John A.; Michael, Ruth; Finman, Hodayah

2004-08-30

We review the relationship between energy efficiency improvement measures and productivity in industry. We review over 70 industrial case studies from widely available published databases, followed by an analysis of the representation of productivity benefits in energy modeling. We propose a method to include productivity benefits in the economic assessment of the potential for energy efficiency improvement. The case-study review suggests that energy efficiency investments can provide a significant boost to overall productivity within industry. If this relationship holds, the description of energy-efficient technologies as opportunities for larger productivity improvements has significant implications for conventional economic assessments. The paper explores the implications this change in perspective on the evaluation of energy-efficient technologies for a study of the iron and steel industry in the US. This examination shows that including productivity benefits explicitly in the modeling parameters would double the cost-effective potential for energy efficiency improvement, compared to an analysis excluding those benefits. We provide suggestions for future research in this important area.

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.

Infection by rhinovirus: similarity of clinical signs included in the case definition of influenza IAn/H1N1.

Science.gov (United States)

de Oña Navarro, Maria; Melón García, Santiago; Alvarez-Argüelles, Marta; Fernández-Verdugo, Ana; Boga Riveiro, Jose Antonio

2012-08-01

Although new influenza virus (IAn/H1N1) infections are mild and indistinguishable from any other seasonal influenza virus infections, there are few data on comparisons of the clinical features of infection with (IAn/H1N1) and with other respiratory viruses. The incidence, clinical aspects and temporal distribution of those respiratory viruses circulating during flu pandemic period were studied. Respiratory samples from patients with acute influenza-like symptoms were collected from May 2009 to December 2009. Respiratory viruses were detected by conventional culture methods and genome amplification techniques. Although IAn/H1N1 was the virus most frequently detected, several other respiratory viruses co-circulated with IAn/H1N1 during the pandemic period, especially rhinovirus. The similarity between clinical signs included in the clinical case definition for influenza and those caused by other respiratory viruses, particularly rhinovirus, suggest that a high percentage of viral infections were clinically diagnosed as case of influenza. Our study offers useful information to face future pandemics caused by influenza virus, indicating that differential diagnoses are required in order to not overestimate the importance of the pandemic. Copyright © 2011 Elsevier España, S.L. All rights reserved.

Overcoming practical challenges to conducting clinical research in the inpatient stroke rehabilitation setting.

Science.gov (United States)

Campbell, Grace B; Skidmore, Elizabeth R; Whyte, Ellen M; Matthews, Judith T

2015-10-01

There is a shortage of published empirical studies conducted in acute inpatient stroke rehabilitation, though such studies are greatly needed in order to shed light on the most efficacious inpatient stroke rehabilitation interventions. The inherent challenges of inpatient research may dissuade researchers from undertaking this important work. This paper describes our institution's experience devising practical solutions to research barriers in this setting. Through concentrated efforts to overcome research barriers, such as by cultivating collaborative relationships and capitalizing on unanticipated benefits, we successfully facilitated conduct of five simultaneous inpatient stroke studies. Tangible benefits realized include increased effectiveness of research participant identification and enrollment, novel collaborative projects, innovative clinical care initiatives, and enhanced emotional and practical support for patients and their families. We provide recommendations based on lessons learned during our experience, and discuss benefits of this collaboration for our research participants, clinical staff, and the research team.

Benefits of a comprehensive quality program for cryopreserved PBMC covering 28 clinical trials sites utilizing an integrated, analytical web-based portal.

Science.gov (United States)

Ducar, Constance; Smith, Donna; Pinzon, Cris; Stirewalt, Michael; Cooper, Cristine; McElrath, M Juliana; Hural, John

2014-07-01

The HIV Vaccine Trials Network (HVTN) is a global network of 28 clinical trial sites dedicated to identifying an effective HIV vaccine. Cryopreservation of high-quality peripheral blood mononuclear cells (PBMC) is critical for the assessment of vaccine-induced cellular immune functions. The HVTN PBMC Quality Management Program is designed to ensure that viable PBMC are processed, stored and shipped for clinical trial assays from all HVTN clinical trial sites. The program has evolved by developing and incorporating best practices for laboratory and specimen quality and implementing automated, web-based tools. These tools allow the site-affiliated processing laboratories and the central Laboratory Operations Unit to rapidly collect, analyze and report PBMC quality data. The HVTN PBMC Quality Management Program includes five key components: 1) Laboratory Assessment, 2) PBMC Training and Certification, 3) Internal Quality Control, 4) External Quality Control (EQC), and 5) Assay Specimen Quality Control. Fresh PBMC processing data is uploaded from each clinical site processing laboratory to a central HVTN Statistical and Data Management Center database for access and analysis on a web portal. Samples are thawed at a central laboratory for assay or specimen quality control and sample quality data is uploaded directly to the database by the central laboratory. Four year cumulative data covering 23,477 blood draws reveals an average fresh PBMC yield of 1.45×10(6)±0.48 cells per milliliter of useable whole blood. 95% of samples were within the acceptable range for fresh cell yield of 0.8-3.2×10(6) cells/ml of usable blood. Prior to full implementation of the HVTN PBMC Quality Management Program, the 2007 EQC evaluations from 10 international sites showed a mean day 2 thawed viability of 83.1% and a recovery of 67.5%. Since then, four year cumulative data covering 3338 specimens used in immunologic assays shows that 99.88% had acceptable viabilities (>66%) for use in

Disease management programs: barriers and benefits.

Science.gov (United States)

Magnezi, Racheli; Kaufman, Galit; Ziv, Arnona; Kalter-Leibovici, Ofra; Reuveni, Haim

2013-04-01

The healthcare system in Israel faces difficulties similar to those of most industrialized countries, including limited resources, a growing chronically ill population, and demand for high quality care. Disease management programs (DMPs) for patients with a chronic illness aim to alleviate some of these problems, primarily by improving patient self-management skills and quality of care. This study surveyed the opinions of senior healthcare administrators regarding barriers, benefits, and support for implementing DMPs. Cross-sectional survey. A 21-item questionnaire was self-completed by 87 of 105 (83%) healthcare administrators included in the study. Participants were 65.5% male and 47% physicians, 25.3% nurses, 17.3% administrators, and 10.3% other healthcare professionals. The main perceived benefit of DMPs among all respondents was improving quality of care. Other benefits noted were better contact with patients (81.6%) and better compliance with treatment (75.9%). Efficient long-term utilization of system resources was perceived as a benefit by only 58.6%. The main perceived barriers to implementing DMPs were lack of budgetary resources (69%) and increased time required versus financial compensation received (63.2%). The benefits of DMPs were patient oriented; barriers were perceived as financial and limiting professional autonomy. Information regarding long-term benefits (better patient outcomes) that ultimately provide better value for the system versus short-term barriers (increased costs and expenditures of time without compensation) might encourage the implementation of DMPs in countries faced with a growing population of patients with at least 1 chronic illness.

'It's definitely not Alzheimer's': Perceived benefits and drawbacks of a mild cognitive impairment diagnosis.

Science.gov (United States)

Gomersall, Tim; Smith, Sarah Kate; Blewett, Charlotte; Astell, Arlene

2017-11-01

To understand the perceived benefits and drawbacks of a mild cognitive impairment (MCI) diagnosis from the perspective of those living with the label. Participants were included if they had recently (within 6 months) received a MCI diagnosis. We also recruited close family members to gain their perspectives. Each was interviewed separately with a semi-structured topic guide covering three areas: (1) experience of cognitive impairments and changes in the individual; (2) impact of cognitive impairment(s) on daily activities and social relationships; and (3) experience of the diagnosis process and living with the label. Transcribed interviews were stored in Nvivo ® . Grounded theory procedures of memo writing, open coding, constant comparison, and focused coding were used to derive conceptual themes. Eighteen dyads were interviewed. The overarching themes surrounding diagnosis benefits and drawbacks were as follows: (1) emotional impact of the diagnosis; (2) practical benefits and limitations of the diagnosis, in terms of (a) understanding one's symptoms and (b) access to clinical support. Although participants were glad to have clinical support in place, they expressed frustration at the lack of clarity, and the lack of available treatments for MCI. Consequently, living with MCI can be characterized as an ambivalent experience. As a clinical label, MCI appears to have little explanatory power for people living with cognitive difficulties. Work is needed to clarify how clinicians and patients communicate about MCI, and how people can be helped to live well with the label. Despite an emerging body of prognostic studies, people with MCI are likely to continue living with significant uncertainty. Statement of contribution What is already known on this subject? Mild cognitive impairment is a state of cognitive decline between normal cognitive ageing and dementia. This clinical category has been an important domain of academic debate over recent years. From a clinical

78 FR 68907 - Agency Information Collection (Foot (Including Flatfeet (pes planus)) Conditions Disability...

Science.gov (United States)

2013-11-15

... planus)) Conditions Disability Benefits Questionnaire). Type of Review: New data collection. Abstract... (Including Flatfeet (pes planus)) Conditions Disability Benefits Questionnaire) Under OMB Review AGENCY...)) Conditions Disability Benefits Questionnaire)'' in any correspondence. FOR FURTHER INFORMATION CONTACT...

Employee benefits in terms of accounting and taxation system

OpenAIRE

ŠÍMA, Pavel

2017-01-01

The theme of this bachelor thesis is Employee benefits in terms of accounting and taxation system. Some companies also include non-monetary bonuses as a way of rewarding their employees. Employee benefits substantially affect satisfaction, loyalty and motivation of all employees. The popularity of employee benefits is also supported by the effort of the companies to optimise taxes, which is the outcome of employee benefits. The main goal was to characterise employee benefits and to explain it...

Investment decisions with benefits of control

DEFF Research Database (Denmark)

Poulsen, Thomas

This paper studies how large shareholders with benefits of control affect firms' equity issue behavior and investment decisions. I introduce an explicit agency cost structure based on the large shareholder's benefits of control. In a simple extension of Myers and Majluf [1984], I show that underi......This paper studies how large shareholders with benefits of control affect firms' equity issue behavior and investment decisions. I introduce an explicit agency cost structure based on the large shareholder's benefits of control. In a simple extension of Myers and Majluf [1984], I show...... that underinvestment is aggravated when there are benefits of being in control, and these benefits are diluted if equity is issued to finance the investment project. I assume that large shareholders are constrained from further investments in their firms, and that they maximize their own wealth, which includes...... as a representation of the large shareholders' expected private benefits. Using a large panel of U.S. data, I find that large shareholders' concern with dilution of ownership and control cause firms to issue less equity and to invest less. I also find that it has no significant effect whether new shares are issued...

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.

The Complex Relationship between Antipsychotic-Induced Weight Gain and Therapeutic Benefits: A Systematic Review and Implications for Treatment

Directory of Open Access Journals (Sweden)

Alex T. Raben

2018-01-01

Full Text Available Background: Antipsychotic-induced weight gain (AIWG and other adverse metabolic effects represent serious side effects faced by many patients with psychosis that can lead to numerous comorbidities and which reduce the lifespan. While the pathophysiology of AIWG remains poorly understood, numerous studies have reported a positive association between AIWG and the therapeutic benefit of antipsychotic medications.Objectives: To review the literature to (1 determine if AIWG is consistently associated with therapeutic benefit and (2 investigate which variables may mediate such an association.Data Sources: MEDLINE, Google Scholar, Cochrane Database and PsycINFO databases were searched for articles containing all the following exploded MESH terms: schizophrenia [AND] antipsychotic agents/neuroleptics [AND] (weight gain [OR] lipids [OR] insulin [OR] leptin [AND] treatment outcome. Results were limited to full-text, English journal articles.Results: Our literature search uncovered 31 independent studies which investigated an AIWG-therapeutic benefit association with a total of 6063 enrolled individuals diagnosed with schizophrenia or another serious mental illness receiving antipsychotic medications. Twenty-two studies found a positive association while, 10 studies found no association and one study reported a negative association. Study variables including medication compliance, sex, ethnicity, or prior antipsychotic exposure did not appear to consistently affect the AIWG-therapeutic benefit relationship. In contrast, there was some evidence that controlling for baseline BMI/psychopathology, duration of treatment and specific agent studied [i.e., olanzapine (OLZ or clozapine (CLZ] strengthened the relationship between AIWG and therapeutic benefit.Limitations: There were limitations of the reviewed studies in that many had small sample sizes, and/or were retrospective. The heterogeneity of the studies also made comparisons difficult and publication bias

Changes in information behavior in clinical teams after introduction of a clinical librarian service

Science.gov (United States)

Urquhart, Christine; Turner, Janet; Durbin, Jane; Ryan, Jean

2007-01-01

Objectives: The eighteen-month evaluation of a clinical librarian project (October 2003–March 2005) conducted in North Wales, United Kingdom (UK) assessed the benefits of clinical librarian support to clinical teams, the impact of mediated searching services, and the effectiveness of information skills training, including journal club support. Methods: The evaluation assessed changes in teams' information-seeking behavior and their willingness to delegate searching to a clinical librarian. Baseline (n = 69 responses, 73% response rate) and final questionnaire (n = 57, 77% response rate) surveys were complemented by telephone and face-to-face interviews (n = 33) among 3 sites served. Those attending information skills training sessions (n = 130) completed evaluations at the session and were surveyed 1 month after training (n = 24 questionnaire responses, n = 12 interviews). Results: Health professionals in clinical teams reported that they were more willing to undertake their own searching, but also more willing to delegate some literature searching, than at the start of the project. The extent of change depended on the team and the type of information required. Information skills training was particularly effective when organized around journal clubs. Conclusions: Collaboration with a clinical librarian increased clinician willingness to seek information. Clinical librarian services should leverage structured training opportunities such as journal clubs. PMID:17252062

Topiramate augmentation in clozapine-treated patients with schizophrenia: clinical and metabolic effects.

Science.gov (United States)

Hahn, Margaret K; Remington, Gary; Bois, Daniel; Cohn, Tony

2010-12-01

Clozapine represents the treatment of choice for refractory psychosis, although a significant number of individuals demonstrate suboptimal response to it as well, leading to clozapine augmentation strategies. A variety of agents have been investigated in this regard, including mood stabilizers, such as anticonvulsants. Within this group of medications, topiramate is unique in that it is associated with weight loss, making it an attractive option because of clozapine's notable risk for associated metabolic disturbance. A 12-week naturalistic, open study was carried out to examine the potential benefits of topiramate in clozapine-treated individuals with schizophrenia demonstrating a suboptimal clinical response. We were specifically interested in clinical symptoms, changes in metabolic parameters, and tolerability. A total of 20 subjects were enrolled, and 16 completed the study, including 5 individuals with type 2 diabetes. Topiramate augmentation led to a 14% improvement in total Brief Psychiatric Rating Scale scores (P = 0.0003), a 2.5% decrease in body weight (P = 0.015), and was generally well tolerated, paraesthesia being the most common side effect. These findings support topiramate as a viable augmentation strategy in clozapine partial responders, with evidence of both clinical and metabolic benefits.

Benefits of Laser Therapy in Postmenopausal Vaginal Atrophy

Science.gov (United States)

Brînzan, Daniela; Pǎiuşan, Lucian; Daşcǎu, Voicu; Furǎu, Gheorghe

2011-08-01

Maybe the worst aspect of menopause is the decline of the quality of the sexual life. The aim of the study is to demonstrate the beneficial effects of laser therapy in comparison with topical application of estrogen preparations, for the treatment of vaginal atrophy and sexual dysfunctions induced by menopause. A total of 50 menopausal patients were examined during a one year period. The methods used for objectifying vaginal atrophy and sexual dysfunctions were history taking, local clinical exam and PAP smear. From this group, 40 patients had vaginal atrophy with sexual dysfunctions. They have been treated differently, being included in four groups: patients treated with local estrogens, patients treated with intravaginal laser therapy, patients treated with both laser therapy and estrogens, patients treated with estrogens and placebo laser therapy. Therapeutic benefit, improvement of vaginal atrophy and quality of sexual life, were objectified by anamnesis (questionnaire), local and general clinical examination and PAP smear. The best results have been obtained, by far, in the 3rd group, followed by the women treated only with laser. In conclusion, we can say that laser therapy is the best way for solving the sexual inconveniences of menopause.

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...

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

Energy Technology Data Exchange (ETDEWEB)

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

2016-06-15

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

Assistive devices for balance and mobility: benefits, demands, and adverse consequences.

Science.gov (United States)

Bateni, Hamid; Maki, Brian E

2005-01-01

To provide information on the advantages and possible disadvantages of using canes and walkers. English-language articles were identified by searching MEDLINE and PubMed (1966-May 2003) for key words cane or walker , excluding articles unrelated to mobility aids. Bibliographies were reviewed and ISI Web of Science citation searches were run to identify additional references. Over 1000 articles were selected for further evaluation. We extracted all studies of single-tip canes or pickup walkers addressing: (1) functional, biomechanic, or neuromotor benefits; (2) biomechanic, attentional, neuromotor, metabolic, or physiologic demands; and (3) falls, injuries, or other problems. We included approximately 10% of the articles originally identified. The methodology of each selected article, and findings relevant to the benefits, demands, or adverse effects of cane or walker use were summarized. Findings were synthesized by considering their relation to basic biomechanic principles. Some biomechanic findings appear to support the clinical view that canes and walkers can improve balance and mobility for older adults and people with other clinical conditions. However, a large proportion of users experience difficulties, and the use of such devices is associated with increased risk of falling. A small number of studies have characterized some of the specific demands and problems associated with using mobility aids. Clinical and biomechanic evaluations of canes and walkers confirm that these devices can improve balance and mobility. However, they can also interfere with ones ability to maintain balance in certain situations, and the strength and metabolic demands can be excessive. More research is needed to identify and solve specific problems. Such research may lead to improved designs and guidelines for safer use of canes and walkers.

Patient-Focused Benefit-Risk Analysis to Inform Regulatory Decisions: The European Union Perspective.

Science.gov (United States)

Mühlbacher, Axel C; Juhnke, Christin; Beyer, Andrea R; Garner, Sarah

Regulatory decisions are often based on multiple clinical end points, but the perspectives used to judge the relative importance of those end points are predominantly those of expert decision makers rather than of the patient. However, there is a growing awareness that active patient and public participation can improve decision making, increase acceptance of decisions, and improve adherence to treatments. The assessment of risk versus benefit requires not only information on clinical outcomes but also value judgments about which outcomes are important and whether the potential benefits outweigh the harms. There are a number of mechanisms for capturing the input of patients, and regulatory bodies within the European Union are participating in several initiatives. These can include patients directly participating in the regulatory decision-making process or using information derived from patients in empirical studies as part of the evidence considered. One promising method that is being explored is the elicitation of "patient preferences." Preferences, in this context, refer to the individual's evaluation of health outcomes and can be understood as statements regarding the relative desirability of a range of treatment options, treatment characteristics, and health states. Several methods for preference measurement have been proposed, and pilot studies have been undertaken to use patient preference information in regulatory decision making. This article describes how preferences are currently being considered in the benefit-risk assessment context, and shows how different methods of preference elicitation are used to support decision making within the European context. Copyright © 2016 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

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.

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

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.

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

Science.gov (United States)

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

2015-11-01

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

National evaluation of the benefits and risks of greater structuring and coding of the electronic health record: exploratory qualitative investigation.

Science.gov (United States)

Morrison, Zoe; Fernando, Bernard; Kalra, Dipak; Cresswell, Kathrin; Sheikh, Aziz

2014-01-01

We aimed to explore stakeholder views, attitudes, needs, and expectations regarding likely benefits and risks resulting from increased structuring and coding of clinical information within electronic health records (EHRs). Qualitative investigation in primary and secondary care and research settings throughout the UK. Data were derived from interviews, expert discussion groups, observations, and relevant documents. Participants (n=70) included patients, healthcare professionals, health service commissioners, policy makers, managers, administrators, systems developers, researchers, and academics. Four main themes arose from our data: variations in documentation practice; patient care benefits; secondary uses of information; and informing and involving patients. We observed a lack of guidelines, co-ordination, and dissemination of best practice relating to the design and use of information structures. While we identified immediate benefits for direct care and secondary analysis, many healthcare professionals did not see the relevance of structured and/or coded data to clinical practice. The potential for structured information to increase patient understanding of their diagnosis and treatment contrasted with concerns regarding the appropriateness of coded information for patients. The design and development of EHRs requires the capture of narrative information to reflect patient/clinician communication and computable data for administration and research purposes. Increased structuring and/or coding of EHRs therefore offers both benefits and risks. Documentation standards within clinical guidelines are likely to encourage comprehensive, accurate processing of data. As data structures may impact upon clinician/patient interactions, new models of documentation may be necessary if EHRs are to be read and authored by patients.

Changes in markers associated with dendritic cells driving the differentiation of either TH2 cells or regulatory T cells correlate with clinical benefit during allergen immunotherapy.

Science.gov (United States)

Gueguen, Claire; Bouley, Julien; Moussu, Hélène; Luce, Sonia; Duchateau, Magalie; Chamot-Rooke, Julia; Pallardy, Marc; Lombardi, Vincent; Nony, Emmanuel; Baron-Bodo, Véronique; Mascarell, Laurent; Moingeon, Philippe

2016-02-01

Regulatory dendritic cell (DC) markers, such as C1Q, are upregulated in PBMCs of patients with grass pollen allergy exhibiting clinical benefit during allergen immunotherapy (AIT). We sought to define markers differentially expressed in human monocyte-derived DCs differentiated toward a proallergic (DCs driving the differentiation of TH2 cells [DC2s]) phenotype and investigate whether changes in such markers in the blood correlate with AIT efficacy. Transcriptomes and proteomes of monocyte-derived DCs polarized toward DCs driving the differentiation of TH1 cells (DC1s), DC2s, or DCs driving the differentiation of regulatory T cells (DCreg cells) profiles were compared by using genome-wide cDNA microarrays and label-free quantitative proteomics, respectively. Markers differentially regulated in DC2s and DCreg cells were assessed by means of quantitative PCR in PBMCs from 80 patients with grass pollen allergy before and after 2 or 4 months of sublingual AIT in parallel with rhinoconjunctivitis symptom scores. We identified 20 and 26 new genes/proteins overexpressed in DC2s and DCreg cells, respectively. At an individual patient level, DC2-associated markers, such as CD141, GATA3, OX40 ligand, and receptor-interacting serine/threonine-protein kinase 4 (RIPK4), were downregulated after a 4-month sublingual AIT course concomitantly with an upregulation of DCreg cell-associated markers, including complement C1q subcomponent subunit A (C1QA), FcγRIIIA, ferritin light chain (FTL), and solute carrier organic anion transporter family member 2B1 (SLCO2B1), in the blood of clinical responders as opposed to nonresponders. Changes in such markers were better correlated with clinical benefit than alterations of allergen-specific CD4(+) T-cell or IgG responses. A combination of 5 markers predominantly expressed by blood DCs (ie, C1Q and CD141) or shared with lymphoid cells (ie, FcγRIIIA, GATA3, and RIPK4) reflecting changes in the balance of regulatory/proallergic responses

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.

Clinical target volume delineation including elective nodal irradiation in preoperative and definitive radiotherapy of pancreatic cancer

Directory of Open Access Journals (Sweden)

Caravatta Luciana

2012-06-01

Full Text Available Abstract Background Radiotherapy (RT is widely used in the treatment of pancreatic cancer. Currently, recommendation has been given for the delineation of the clinical target volume (CTV in adjuvant RT. Based on recently reviewed pathologic data, the aim of this study is to propose criteria for the CTV definition and delineation including elective nodal irradiation (ENI in the preoperative and definitive treatment of pancreatic cancer. Methods The anatomical structures of interest, as well as the abdominal vasculature were identified on intravenous contrast-enhanced CT scans of two different patients with pancreatic cancer of the head and the body. To delineate the lymph node area, a margin of 10 mm was added to the arteries. Results We proposed a set of guidelines for elective treatment of high-risk nodal areas and CTV delineation. Reference CT images were provided. Conclusions The proposed guidelines could be used for preoperative or definitive RT for carcinoma of the head and body of the pancreas. Further clinical investigations are needed to validate the defined CTVs.

Subjective cognitive complaints included in diagnostic evaluation of dementia helps accurate diagnosis in a mixed memory clinic cohort

DEFF Research Database (Denmark)

Salem, L C; Vogel, Asmus Mejling; Ebstrup, J

2015-01-01

OBJECTIVE: Our objective was to examine the quantity and profile of subjective cognitive complaints in young patients as compared with elderly patients referred to a memory clinic. METHODS: Patients were consecutively recruited from the Copenhagen University Hospital Memory Clinic at Rigshospitalet....... In total, 307 patients and 149 age-matched healthy controls were included. Patients were classified in 4 diagnostic groups: dementia, mild cognitive impairment, affective disorders and no cognitive impairment. Subjective memory was assessed with subjective memory complaints (SMC) scale. Global cognitive...... with dementia have a significantly higher level and a different profile of subjective cognitive complaints as compared with elderly patients with dementia. Furthermore, young patients, diagnosed with an affective disorder, had the highest level of subjective cognitive complaints of all patients in a memory...

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...

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.

Secondary use of clinical data: the Vanderbilt approach.

Science.gov (United States)

Danciu, Ioana; Cowan, James D; Basford, Melissa; Wang, Xiaoming; Saip, Alexander; Osgood, Susan; Shirey-Rice, Jana; Kirby, Jacqueline; Harris, Paul A

2014-12-01

The last decade has seen an exponential growth in the quantity of clinical data collected nationwide, triggering an increase in opportunities to reuse the data for biomedical research. The Vanderbilt research data warehouse framework consists of identified and de-identified clinical data repositories, fee-for-service custom services, and tools built atop the data layer to assist researchers across the enterprise. Providing resources dedicated to research initiatives benefits not only the research community, but also clinicians, patients and institutional leadership. This work provides a summary of our approach in the secondary use of clinical data for research domain, including a description of key components and a list of lessons learned, designed to assist others assembling similar services and infrastructure. Copyright © 2014 Elsevier Inc. All rights reserved.

Universal newborn screening for congenital CMV infection: what is the evidence of potential benefit?†

Science.gov (United States)

Cannon, Michael J.; Griffiths, Paul D.; Aston, Van; Rawlinson, William D.

2015-01-01

SUMMARY Congenital CMV infection is a leading cause of childhood disability. Many children born with congenital CMV infection are asymptomatic or have nonspecific symptoms and therefore are typically not diagnosed. A strategy of newborn CMV screening could allow for early detection and intervention to improve clinical outcomes. Interventions might include antiviral drugs or nonpharmaceutical therapies such as speech-language therapy or cochlear implants. Using published data from developed countries, we analyzed existing evidence of potential benefit that could result from newborn CMV screening. We first estimated the numbers of children with the most important CMV-related disabilities (i.e. hearing loss, cognitive deficit, and vision impairment), including the age at which the disabilities occur. Then, for each of the disabilities, we examined the existing evidence for the effectiveness of various interventions. We concluded that there is good evidence of potential benefit from nonpharmaceutical interventions for children with delayed hearing loss that occurs by 9 months of age. Similarly, we concluded that there is fair evidence of potential benefit from antiviral therapy for children with hearing loss at birth and from nonpharmaceutical interventions for children with delayed hearing loss occurring between 9 and 24 months of age and for children with CMV-related cognitive deficits. We found poor evidence of potential benefit for children with delayed hearing loss occurring after 24 months of age and for children with vision impairment. Overall, we estimated that in the United States, several thousand children with congenital CMV could benefit each year from newborn CMV screening, early detection, and interventions. Copyright © 2014 John Wiley & Sons, Ltd. PMID:24760655

[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.

Benefits and harms of direct to consumer advertising: a systematic review.

Science.gov (United States)

Gilbody, S; Wilson, P; Watt, I

2005-08-01

Direct to consumer advertising is increasingly used by the pharmaceutical industry, but its benefits and harms have yet to be summarised in a comprehensive and rigorous manner. A systematic review was conducted of robust evaluations of the impact (positive and negative) of direct to consumer advertising. A broad range of databases and data sources (including Cinahl, Embase, HMIC, HSRProj, Medline, PsycInfo, and the internet) were searched from inception to 2004. From 2853 citations only four reports were found that met the strict inclusion criteria and provided usable results. Direct to consumer advertising is associated with increased prescription of advertised products and there is substantial impact on patients' request for specific drugs and physicians' confidence in prescribing. No additional benefits in terms of health outcomes were demonstrated. Direct to consumer advertising is banned in most countries, and the research evidence tends to support the negative impact that is feared by those who support a legislative ban. Further research is needed into the clinical and economic impact of direct to consumer advertising in healthcare systems.

Laser-assisted cataract surgery: benefits and barriers.

Science.gov (United States)

Hatch, Kathryn M; Talamo, Jonathan H

2014-01-01

The use of the femtosecond laser (FSL) in cataract surgery may represent the largest advancement in the field since the inception of phacoemulsification. The goal of this review is to outline the benefits of and barriers to this technology. There are several significant potential benefits of the FSL in cataract surgery over conventional manual cataract surgery: precise capsulotomy formation, clear corneal and limbal relaxing incision construction, lens fragmentation, and lens softening. Evidence suggests that refractive benefits include more precise effective lens position as well as reduced effective phacoemulsification time with the use of FSL compared with manual surgery. Patients with conditions such as Fuchs' endothelial dystrophy, pseudoexfoliation, history of trauma, or brunescent cataracts may particularly benefit from this technology. There are significant financial and logistical issues to consider prior to the purchase of a FSL, including the cost of the laser, and charges to patients, and how the laser affects the patient flow in the operating room. The FSL may significantly change the current approach to cataract surgery.

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 ...

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; ...

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

Broadening Your Employee Benefit Portfolio.

Science.gov (United States)

Blaski, Nancy J.; And Others

1989-01-01

Cost increases and realization of the diverse needs of employees have prompted organizations to review the cost and value of employee benefits. Examines alternatives including "cafeteria plans," managed care programs, and disability income plans. (MLF)

Cost-benefit of infection control interventions targeting methicillin-resistant Staphylococcus aureus in hospitals: systematic review.

Science.gov (United States)

Farbman, L; Avni, T; Rubinovitch, B; Leibovici, L; Paul, M

2013-12-01

Infections caused by methicillin-resistant Staphylococcus aureus (MRSA) incur significant costs. We aimed to examine the cost and cost-benefit of infection control interventions against MRSA and to examine factors affecting economic estimates. We performed a systematic review of studies assessing infection control interventions aimed at preventing spread of MRSA in hospitals and reporting intervention costs, savings, cost-benefit or cost-effectiveness. We searched PubMed and references of included studies with no language restrictions up to January 2012. We used the Quality of Health Economic Studies tool to assess study quality. We report cost and savings per month in 2011 US$. We calculated the median save/cost ratio and the save-cost difference with interquartile range (IQR) range. We examined the effects of MRSA endemicity, intervention duration and hospital size on results. Thirty-six studies published between 1987 and 2011 fulfilled inclusion criteria. Fifteen of the 18 studies reporting both costs and savings reported a save/cost ratio >1. The median save/cost ratio across all 18 studies was 7.16 (IQR 1.37-16). The median cost across all studies reporting intervention costs (n = 31) was 8648 (IQR 2025-19 170) US$ per month; median savings were 38 751 (IQR 14 206-75 842) US$ per month (23 studies). Higher save/cost ratios were observed in the intermediate to high endemicity setting compared with the low endemicity setting, in hospitals with 6 months. Infection control intervention to reduce spread of MRSA in acute-care hospitals showed a favourable cost/benefit ratio. This was true also for high MRSA endemicity settings. Unresolved economic issues include rapid screening using molecular techniques and universal versus targeted screening. © 2013 The Authors Clinical Microbiology and Infection © 2013 European Society of Clinical Microbiology and Infectious Diseases.

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.

Association of TERT Polymorphisms with Clinical Outcome of Non-Small Cell Lung Cancer Patients.

Directory of Open Access Journals (Sweden)

Xueying Zhao

Full Text Available TERT is of great importance in cancer initiation and progression. Many studies have demonstrated the TERT polymorphisms as risk factors for many cancer types, including lung cancer. However, the impacts of TERT variants on cancer progression and treatment efficacy have remained controversial. This study aimed to investigate the association of TERT polymorphisms with clinical outcome of advanced non-small cell lung cancer (NSCLC patients receiving first-line platinum-based chemotherapy, including response rate, clinical benefit, progression-free survival (PFS, overall survival (OS, and grade 3 or 4 toxicity. Seven polymorphisms of TERT were assessed, and a total of 1004 inoperable advanced NSCLC patients treated with platinum-based chemotherapy were enrolled. It is exhibited that the variant heterozygote of rs4975605 showed significant association with a low rate of clinical benefit, and displayed a much stronger effect in never-smoking female subset, leading to the clinical benefit rate decreased from 82.9% (C/C genotype to 56.4% (C/A genotype; adjusted OR, 3.58; P=1.40×10(-4. It is also observed that the polymorphism rs2736109 showed significant correlation with PFS (log-rank P=0.023. In age > 58 subgroup, patients carrying the heterozygous genotype had a longer median PFS than those carrying the wild-type genotypes (P=0.002. The results from the current study, for the first time to our knowledge, provide suggestive evidence of an effect of TERT polymorphisms on disease progression variability among Chinese patients with platinum-treated advanced NSCLC.

The clinical factors associated with benefit finding of complementary medicine use in patients with back pain: A cross-sectional study with cluster analysis.

Science.gov (United States)

Kavadar, Gulis; Demircioğlu, Demet Tekdos; Can, Halil; Emre, Tuluhan Yunus; Civelek, Erdinç; Senyigit, Abdulhalim

2017-01-01

Complementary and alternative medicine (CAM) use has been increasing. To identify the factors associated with perceived benefit from CAM methods in back problems. The study was conducted on patients who practiced any CAM methods due to complaints of back pain. Social-demographic properties, details of CAM methods employed were questioned. Severity of pain was measured by visual analog scale (VAS); benefits were evaluated by the Likert scale. Hierarchical cluster analysis was used to discover relationships among variables. In total, 500 patients (265 female, 235 male) were included in the study. Mostly used methods were herbal therapy (32%), balneotherapy (31%), cupping (19.4%) and massage-manipulation (19.2%). Of patients, 355 (71%) were satisfied. The variables associated with benefit finding were female gender, age, chronicity and severity of pain, high educational level, upper middle income status, use as a result of recommendation, dissatisfaction with conventional methods, residence in an urban area, non-herbal method use, being married, and social insurance (p CAM perceived benefits; in particular, women living in urban areas, highly educated, aged more than 40, who suffer from severe chronic back pain, may be more inclined to go to CAM therapists.

Differential benefit risk assessment of DOACs in the treatment of venous thromboembolism: focus on dabigatran

Directory of Open Access Journals (Sweden)

Leung TS

2015-07-01

Full Text Available Timothy S Leung,1 Ernest H Law2 1Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, BC, Canada; 2Department of Pharmacy Systems, Outcomes and Policy, College of Pharmacy, University of Illinois at Chicago, Chicago, IL, USA Abstract: Venous thromboembolism includes deep vein thrombosis and pulmonary embolism and is a serious medical condition that requires anticoagulation as part of treatment. Currently, standard therapy consists of parenteral anticoagulation followed by a vitamin K antagonist (VKA. The pharmacokinetic and pharmacodynamic profiles of the direct oral anticoagulants (DOACs differ from VKAs, which overcome some of the limitations of VKAs and have practical implications on their use in clinical situations. Dabigatran is a prodrug that undergoes primarily renal elimination and does not affect cytochrome P450 enzymes. Assays to quantify the degree of anticoagulation and the therapeutic level of DOAC are either unavailable for routine clinical use or require specific calibration. Routine monitoring of DOACs is not recommended at this time. Dabigatran, rivaroxaban, and apixaban are DOACs that have been studied for treatment of venous thromboembolism. Clinical trials comparing DOACs with standard therapy have shown them to be non-inferior for acute and extended therapy. Each DOAC has a unique benefit and harm profile that should be considered prior to use. The distinguishing characteristics of dabigatran include a requirement of parenteral anticoagulation prior to acute treatment, clinical trial results comparing it with a VKA for extended treatment, association with upper gastrointestinal adverse events, and increased risk of gastrointestinal bleed. Rivaroxaban is the only DOAC that has once-daily dosing while apixaban is the only DOAC that has lower risk of overall, major, and gastrointestinal bleeding compared with VKA. A common drawback of DOACs is the lack of an available reversal agent. Clinical trials of

18 CFR 367.9260 - Account 926, Employee pensions and benefits.

Science.gov (United States)

2010-04-01

... medical, educational or recreational activities for the benefit of employees, and administrative expenses.... (7) Expenses in connection with educational and recreational activities for the benefit of employees... are only incidentally engaged in employee pension and benefit activities may be included in accounts...

The psychology of neurofeedback: Clinical intervention even if applied placebo.

Science.gov (United States)

Thibault, Robert T; Raz, Amir

2017-10-01

Advocates of neurofeedback make bold claims concerning brain regulation, treatment of disorders, and mental health. Decades of research and thousands of peer-reviewed publications support neurofeedback using electroencephalography (EEG-nf); yet, few experiments isolate the act of receiving feedback from a specific brain signal as a necessary precursor to obtain the purported benefits. Moreover, while psychosocial parameters including participant motivation and expectation, rather than neurobiological substrates, seem to fuel clinical improvement across a wide range of disorders, for-profit clinics continue to sprout across North America and Europe. Here, we highlight the tenuous evidence supporting EEG-nf and sketch out the weaknesses of this approach. We challenge classic arguments often articulated by proponents of EEG-nf and underscore how psychologists and mental health professionals stand to benefit from studying the ubiquitous placebo influences that likely drive these treatment outcomes. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

Clinical and financial considerations for implementing an ICU telemedicine program.

Science.gov (United States)

Kruklitis, Robert J; Tracy, Joseph A; McCambridge, Matthew M

2014-06-01

As the population in the United States increases and ages, the need to provide high-quality, safe, and cost-effective care to the most critically ill patients will be of great importance. With the projected shortage of intensivists, innovative changes to improve efficiency and increase productivity will be necessary. Telemedicine programs in the ICUs (tele-ICUs) are a successful strategy to improve intensivist access to critically ill patients. Although significant capital and maintenance costs are associated with tele-ICUs, these costs can be offset by indirect financial benefits, such as decreased length of stay. To achieve the positive clinical outcomes desired, tele-ICUs must be carefully designed and implemented. In this article, we discuss the clinical benefits of tele-ICUs. We review the financial considerations, including direct and indirect reimbursement and development and maintenance costs. Finally, we review design and implementation considerations for tele-ICUs.

Intellectual property rights, benefit-sharing and development of "improved traditional medicines": A new approach.

Science.gov (United States)

Willcox, Merlin; Diallo, Drissa; Sanogo, Rokia; Giani, Sergio; Graz, Bertrand; Falquet, Jacques; Bodeker, Gerard

2015-12-24

Protection of intellectual property rights and benefit-sharing are key issues for all ethnopharmacological research. The International Society of Ethnobiology has produced helpful guidelines on access and benefit-sharing which are widely viewed as a "gold standard" but the question remains how best to apply these guidelines in practice. Difficult questions include ownership of traditional knowledge, making appropriate agreements, and how appropriately to share benefits. We present the case study of the development of an "improved traditional medicine" for malaria in Mali and we report how benefit-sharing was applied in this case. The knowledge about the selected plant came independently from several families and traditional healers. The IPR approach was to recognise that this traditional knowledge belongs to the people of Mali and was used for their benefit in developing a new "improved traditional medicine" (ITM). The traditional healer whose method of preparation was used, and who collaborated in clinical trials, did not request any financial reward but asked for the ITM to be named after him. The most sustainable benefit for the community was sharing the results of which preparation of which medicinal plant seemed to be the most effective for treating malaria. Attempts at providing a health centre and training a health worker for the village did not prove to be sustainable. Respect for intellectual property rights and benefit-sharing are possible even in a context where the knowledge is not owned by a clearly identified person or group of people. The most sustainable benefits are intangible rather than material: namely recognition, improved knowledge about which traditional treatment is the best and how to prepare and take it. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

[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.

Natural gas benefits

International Nuclear Information System (INIS)

1999-01-01

The General Auditor in the Netherlands studied the natural gas policy in the Netherlands, as has been executed in the past decades, in the period 1997-1999. The purpose of the study is to inform the Dutch parliament on the planning and the backgrounds of the natural gas policy and on the policy risks with respect to the benefits for the Dutch State, taking into account the developments in the policy environment. The final conclusion is that the proposed liberalization of the national natural gas market will result in a considerable deprivation of income for the State in case the benefit policy is not adjusted. This report includes a reaction of the Dutch Minister of Economic Affairs and an afterword of the General Auditor. In the appendix an outline is given of the natural gas policy

The benefits and drawbacks of syringe drivers in palliative care.

Science.gov (United States)

Costello, John; Nyatanga, Brian; Mula, Carole; Hull, Jenny

2008-03-01

This article will outline the use of continuous subcutaneous infusion pumps, known as syringe drivers, including their benefits and drawbacks in a palliative care context. There have been over 5000 articles published globally describing syringe drivers in the medical and nursing literature within the last decade. Many provide guidance on their use, although much of the data are repetitious, disease or age-group specific, and focused on pragmatic issues to do with clinical application. Several trusts and hospices across the UK are carrying out trials of the recently launched McKinley T34 syringe driver. Therefore, it seems timely to consider their wider use internationally. Globally, practitioners in palliative care are very familiar with their use, although the literature lacks specific guidance and, at times, the information is ambiguous. Having briefly reviewed their benefits, the article considers the limitations of using syringe drivers and comments on some of the lesser known/reported practical and patient-focused drawbacks associated with their use. We conclude by considering why, when so much education and training exists to help practitioners use these devices effectively, so many human errors occur.

Time to consider sharing data extracted from trials included in systematic reviews

Directory of Open Access Journals (Sweden)

Luke Wolfenden

2016-11-01

Full Text Available Abstract Background While the debate regarding shared clinical trial data has shifted from whether such data should be shared to how this is best achieved, the sharing of data collected as part of systematic reviews has received little attention. In this commentary, we discuss the potential benefits of coordinated efforts to share data collected as part of systematic reviews. Main body There are a number of potential benefits of systematic review data sharing. Shared information and data obtained as part of the systematic review process may reduce unnecessary duplication, reduce demand on trialist to service repeated requests from reviewers for data, and improve the quality and efficiency of future reviews. Sharing also facilitates research to improve clinical trial and systematic review methods and supports additional analyses to address secondary research questions. While concerns regarding appropriate use of data, costs, or the academic return for original review authors may impede more open access to information extracted as part of systematic reviews, many of these issues are being addressed, and infrastructure to enable greater access to such information is being developed. Conclusion Embracing systems to enable more open access to systematic review data has considerable potential to maximise the benefits of research investment in undertaking systematic reviews.

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.

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.

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

Science.gov (United States)

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

2016-01-01

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

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...

Employment benefits and job retention: evidence among patients with colorectal cancer.

Science.gov (United States)

Veenstra, Christine M; Abrahamse, Paul; Wagner, Todd H; Hawley, Sarah T; Banerjee, Mousumi; Morris, Arden M

2018-03-01

A "health shock," that is, a large, unanticipated adverse health event, can have long-term financial implications for patients and their families. Colorectal cancer is the third most commonly diagnosed cancer among men and women and is an example of a specific health shock. We examined whether specific benefits (employer-based health insurance, paid sick leave, extended sick leave, unpaid time off, disability benefits) are associated with job retention after diagnosis and treatment of colorectal cancer. In 2011-14, we surveyed patients with Stage III colorectal cancer from two representative SEER registries. The final sample was 1301 patients (68% survey response rate). For this study, we excluded 735 respondents who were not employed and 20 with unknown employment status. The final analytic sample included 546 respondents. Job retention in the year following diagnosis was assessed, and multivariable logistic regression was used to evaluate associations between job retention and access to specific employment benefits. Employer-based health insurance (OR = 2.97; 95% CI = 1.56-6.01; P = 0.003) and paid sick leave (OR = 2.93; 95% CI = 1.23-6.98; P = 0.015) were significantly associated with job retention, after adjusting for sociodemographic, clinical, geographic, and job characteristics. © 2018 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Defining the value of community benefits. Analyzing the kinds of goods society produces clarifies hospitals' charity care contribution.

Science.gov (United States)

Sanders, S M

1992-01-01

Community benefits occur when a hospital bears all or part of the relatively unquantifiable costs of promoting, sponsoring, or engaging in religious, educational, scientific, or health-related activities designed to improve community health. By the very nature of their health-related activities, not-for-profit hospitals make extensive and varied contributions to community benefit. When a hospital free clinic inoculates a child for measles, the community as a whole benefits because the inoculation reduces the chance that measles will spread. Not-for-profit hospitals also provide many goods that are "undersupplied" by the for-profit private sector or the public sector, such as research, trauma centers used disproportionately by self-pay patients, and advocacy to rid the community of health hazards. Moreover, a number of factors impose a legal and normative obligation on not-for-profit hospitals to engage in activities that benefit the community. These include Internal Revenue Service rules governing tax exemption, hospitals' fiduciary responsibilities to philanthropic donors, their obligations as "institutional actors" in their communities, and their mission to reach out to the poor and underserved.

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.

Information technology in pharmacovigilance: Benefits, challenges, and future directions from industry perspectives.

Science.gov (United States)

Lu, Zhengwu

2009-01-01

Risk assessment during clinical product development needs to be conducted in a thorough and rigorous manner. However, it is impossible to identify all safety concerns during controlled clinical trials. Once a product is marketed, there is generally a large increase in the number of patients exposed, including those with comorbid conditions and those being treated with concomitant medications. Therefore, postmarketing safety data collection and clinical risk assessment based on observational data are critical for evaluating and characterizing a product's risk profile and for making informed decisions on risk minimization. Information science promises to deliver effective e-clinical or e-health solutions to realize several core benefits: time savings, high quality, cost reductions, and increased efficiencies with safer and more efficacious medicines. The development and use of standard-based pharmacovigilance system with integration connection to electronic medical records, electronic health records, and clinical data management system holds promise as a tool for enabling early drug safety detections, data mining, results interpretation, assisting in safety decision making, and clinical collaborations among clinical partners or different functional groups. The availability of a publicly accessible global safety database updated on a frequent basis would further enhance detection and communication about safety issues. Due to recent high-profile drug safety problems, the pharmaceutical industry is faced with greater regulatory enforcement and increased accountability demands for the protection and welfare of patients. This changing climate requires biopharmaceutical companies to take a more proactive approach in dealing with drug safety and pharmacovigilance.

"There are too many, but never enough": qualitative case study investigating routine coding of clinical information in depression.

Science.gov (United States)

Cresswell, Kathrin; Morrison, Zoe; Kalra, Dipak; Sheikh, Aziz

2012-01-01

We sought to understand how clinical information relating to the management of depression is routinely coded in different clinical settings and the perspectives of and implications for different stakeholders with a view to understanding how these may be aligned. Qualitative investigation exploring the views of a purposefully selected range of healthcare professionals, managers, and clinical coders spanning primary and secondary care. Our dataset comprised 28 semi-structured interviews, a focus group, documents relating to clinical coding standards and participant observation of clinical coding activities. We identified a range of approaches to coding clinical information including templates and order entry systems. The challenges inherent in clearly establishing a diagnosis, identifying appropriate clinical codes and possible implications of diagnoses for patients were particularly prominent in primary care. Although a range of managerial and research benefits were identified, there were no direct benefits from coded clinical data for patients or professionals. Secondary care staff emphasized the role of clinical coders in ensuring data quality, which was at odds with the policy drive to increase real-time clinical coding. There was overall no evidence of clear-cut direct patient care benefits to inform immediate care decisions, even in primary care where data on patients with depression were more extensively coded. A number of important secondary uses were recognized by healthcare staff, but the coding of clinical data to serve these ends was often poorly aligned with clinical practice and patient-centered considerations. The current international drive to encourage clinical coding by healthcare professionals during the clinical encounter may need to be critically examined.

Cancer clinical trials in persons with HIV infection.

Science.gov (United States)

Little, Richard F

2017-01-01

The era of modern HIV therapeutics is well underway. The cancer and infectious disease epidemiology of HIV disease has markedly altered as populations are availed to the benefits of antiretroviral therapy (ARV). The types of cancers occurring among those with HIV infection has broadened but the case burden in absolute numbers is very low relative to the background population. There are fewer incident cases of the AIDS-defining cancers (aggressive B-cell lymphomas, Kaposi's sarcoma, and cervical cancer). There is an increased risk for certain non-AIDS-defining cancers, but these occur somewhat sporadically relative to clinical trial enrollment. The changing epidemiology of cancer in HIV poses challenges as well as opportunities for participation of persons with HIV in cancer therapy clinical trials. There are excellent examples of cancer trials that inform cancer therapy for patients with HIV infection. Examples include those from HIV-specific trials and from trials mainly focused on the background population that included patients with HIV infection. Interpretation of clinical trials to guide therapy for those with HIV infection and cancer largely depends on data that does not include HIV-infected patients. The ability to extend clinical trial findings to populations not included in clinical trials remains problematic for a variety of populations, including those with HIV or AIDS. Careful prioritization of studies designed to bridge this gap is needed. However, there are published studies that serve as excellent examples bridging these gaps and the portfolio of cancer therapy trials underway will inform HIV and cancer better than at any time in the past.

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.

Health benefits of Kung Fu: a systematic review.

Science.gov (United States)

Tsang, Tracey Wai Man; Kohn, Michael; Chow, Chin Moi; Singh, Maria Fiatarone

2008-10-01

The Chinese martial arts (Kung Fu) have existed for centuries and are generally accepted as being beneficial for health without much empirical data. The aim of this systematic review was to assess the health effects of "hard" Kung Fu styles by performing electronic and manual searches of the literature. The aspects of health and the Kung Fu style examined varied between most studies; in some cases, the martial art group consisted of practitioners of other martial art styles also. Of 2103 references identified, only nine papers were eligible and reviewed. All were observational studies, observing a range of health aspects possibly related to Kung Fu training or performance. Our findings suggest that there is no evidence that Kung Fu practice is associated with the prevention or treatment of any health condition. However, as a moderate- to high-intensity form of aerobic exercise, it may confer benefits similar to those attributed to other aerobic training modalities. However, this hypothesis remains to be tested in clinical trials. Physiological benefits (e.g., aerobic capacity and bone density) may be associated with long-term Kung Fu practice. Future research in this area should adopt experimental designs, clearly identifying eligibility criteria, testing and training protocols, and include health-related outcomes and documentation of adverse events, to advance knowledge in this field.

Valuation of climate change mitigation co-benefits

DEFF Research Database (Denmark)

Bakhtiari, Fatemeh

a broad range of economic or, more likely, environmental and social issues. Examples of positive environmental impacts that may not be the primary outcome of a climate change mitigation policy include reduced local air pollution or restored ecosystem health. Examples of positive social impacts include......This document describes tools for valuating in monetary terms the co-benefits associated with climate change mitigation actions. The term co-benefits refers to outcomes of those actions other than their primary outcome (reducing greenhouse-gas emissions). Such non-primary outcomes can fall under...... improved human health or increased access to clean energy....

76 FR 13304 - Benefits Payable in Terminated Single-Employer Plans; Limitations on Guaranteed Benefits

Science.gov (United States)

2011-03-11

... Taxation Staff specifies that UCEBs include benefits payable with respect to ``facility shutdowns or reductions in workforce.'' Joint Committee on Taxation, Technical Explanation of H.R. 4, the ``Pension... event, plan sponsors typically did not make contributions to provide for advance funding of such...

The Performance of Standardized Patients in Portraying Clinical Scenarios in Speech-Language Therapy

Science.gov (United States)

Hill, Anne E.; Davidson, Bronwyn J.; Theodoros, Deborah G.

2013-01-01

Background: Standardized patients (SPs) are frequently included in the clinical preparation of students in the health sciences. An acknowledged benefit of using SPs is the opportunity to provide a standardized method by which students can demonstrate and develop their competency. Relatively little is known, however, about the capacity of SPs to…

Communicating the risks, and the benefits, of nanotechnology

Science.gov (United States)

Schuler, Emmanuelle

2009-01-01

Issues surrounding the wide spectrum of (perceived) risks and possible benefits associated with the rapid advance of modern nanotechnology are deliberated. These include the current realities of nanotechnological hazards, their impact vis-à-vis perceived nanotech-risks and perceived nanotech-benefits, and the consequent repercussions on the public and society. It is argued that both the risks and the benefits of nanoscientific advances must be properly communicated if the public is to support this emerging technology. PMID:19823594

The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials.

Science.gov (United States)

Bloom, Diane; Beetsch, Joel; Harker, Matthew; Hesterlee, Sharon; Moreira, Paulo; Patrick-Lake, Bray; Selig, Wendy; Sherman, Jeffrey; Smith, Sophia K; Valentine, James E; Roberts, Jamie N

2018-03-01

To identify the elements necessary for successful collaboration between patient groups and academic and industry sponsors of clinical trials, in order to develop recommendations for best practices for effective patient group engagement. In-depth interviews, informed by a previously reported survey, were conducted to identify the fundamentals of successful patient group engagement. Thirty-two respondents from 3 sectors participated: patient groups, academic researchers, and industry. The findings were presented to a multistakeholder group of experts in January 2015. The expert group came to consensus on a set of actionable recommendations for best practices for patient groups and research sponsors. Interview respondents acknowledged that not all patient groups are created equal in terms of what they can contribute to a clinical trial. The most important elements for effective patient group engagement include establishing meaningful partnerships, demonstrating mutual benefits, and collaborating as partners from the planning stage forward. Although there is a growing appreciation by sponsors about the benefits of patient group engagement, there remains some resistance and some uncertainty about how best to engage. Barriers include mismatched expectations and a perception that patient groups lack scientific sophistication and that "wishful thinking" may cloud their recommendations. Patient groups are developing diverse skillsets and acquiring assets to leverage in order to become collaborators with industry and academia on clinical trials. Growing numbers of research sponsors across the clinical trials enterprise are recognizing the benefits of continuous and meaningful patient group engagement, but there are still mindsets to change, and stakeholders need further guidance on operationalizing a new model of clinical trial conduct.

The Service Learning Projects: Stakeholder Benefits and Potential Class Topics

Science.gov (United States)

Rutti, Raina M.; LaBonte, Joanne; Helms, Marilyn Michelle; Hervani, Aref Agahei; Sarkarat, Sy

2016-01-01

Purpose: The purpose of this paper is to summarize the benefits of including a service learning project in college classes and focusses on benefits to all stakeholders, including students, community, and faculty. Design/methodology/approach: Using a snowball approach in academic databases as well as a nominal group technique to poll faculty, key…

[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.

Benefit-cost assessment programs: Costa Rica case study

International Nuclear Information System (INIS)

Clark, A.L.; Trocki, L.K.

1991-01-01

An assessment of mineral potential, in terms of types and numbers of deposits, approximate location and associated tonnage and grades, is a valuable input to a nation's economic planning and mineral policy development. This study provides a methodology for applying benefit-cost analysis to mineral resource assessment programs, both to determine the cost effectiveness of resource assessments and to ascertain future benefits to the nation. In a case study of Costa Rica, the benefit-cost ratio of a resource assessment program was computed to be a minimum of 4:1 ($10.6 million to $2.5 million), not including the economic benefits accuring from the creation of 800 mining sector and 1,200 support services jobs. The benefit-cost ratio would be considerably higher if presently proposed revisions of mineral policy were implemented and benefits could be defined for Costa Rica

Cost benefit analysis of power plant database integration

International Nuclear Information System (INIS)

Wilber, B.E.; Cimento, A.; Stuart, R.

1988-01-01

A cost benefit analysis of plant wide data integration allows utility management to evaluate integration and automation benefits from an economic perspective. With this evaluation, the utility can determine both the quantitative and qualitative savings that can be expected from data integration. The cost benefit analysis is then a planning tool which helps the utility to develop a focused long term implementation strategy that will yield significant near term benefits. This paper presents a flexible cost benefit analysis methodology which is both simple to use and yields accurate, verifiable results. Included in this paper is a list of parameters to consider, a procedure for performing the cost savings analysis, and samples of this procedure when applied to a utility. A case study is presented involving a specific utility where this procedure was applied. Their uses of the cost-benefit analysis are also described

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.

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.

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...

Benefits of transmission interconnections

International Nuclear Information System (INIS)

Lyons, D.

2006-01-01

The benefits of new power transmission interconnections from Alberta were discussed with reference to the challenges and measures needed to move forward. Alberta's electricity system has had a long period of sustained growth in generation and demand and this trend is expected to continue. However, no new interconnections have been built since 1985 because the transmission network has not expanded in consequence with the growth in demand. As such, Alberta remains weakly interconnected with the rest of the western region. The benefits of stronger transmission interconnections include improved reliability, long-term generation capability, hydrothermal synergies, a more competitive market, system efficiencies and fuel diversity. It was noted that the more difficult challenges are not technical. Rather, the difficult challenges lie in finding an appropriate business model that recognizes different market structures. It was emphasized that additional interconnections are worthwhile and will require significant collaboration among market participants and governments. It was concluded that interties enable resource optimization between systems and their benefits far exceed their costs. tabs., figs

Clinical grade adult stem cell banking.

Science.gov (United States)

Thirumala, Sreedhar; Goebel, W Scott; Woods, Erik J

2009-07-01

There has been a great deal of scientific interest recently generated by the potential therapeutic applications of adult stem cells in human care but there are several challenges regarding quality and safety in clinical applications and a number of these challenges relate to the processing and banking of these cells ex-vivo. As the number of clinical trials and the variety of adult cells used in regenerative therapy increases, safety remains a primary concern. This has inspired many nations to formulate guidelines and standards for the quality of stem cell collection, processing, testing, banking, packaging and distribution. Clinically applicable cryopreservation and banking of adult stem cells offers unique opportunities to advance the potential uses and widespread implementation of these cells in clinical applications. Most current cryopreservation protocols include animal serum proteins and potentially toxic cryoprotectant additives (CPAs) that prevent direct use of these cells in human therapeutic applications. Long term cryopreservation of adult stem cells under good manufacturing conditions using animal product free solutions is critical to the widespread clinical implementation of ex-vivo adult stem cell therapies. Furthermore, to avoid any potential cryoprotectant related complications, reduced CPA concentrations and efficient post-thaw washing to remove CPA are also desirable. The present review focuses on the current strategies and important aspects of adult stem cell banking for clinical applications. These include current good manufacturing practices (cGMPs), animal protein free freezing solutions, cryoprotectants, freezing & thawing protocols, viability assays, packaging and distribution. The importance and benefits of banking clinical grade adult stem cells are also discussed.

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...

Who Benefits from Pension Enhancements? Working Paper 76

Science.gov (United States)

Koedel, Cory; Ni, Shawn; Podgursky, Michael

2012-01-01

During the late 1990s public pension funds across the United States accrued large actuarial surpluses. The seemingly flush conditions of the pension funds led legislators in most states to substantially improve retirement benefits for public workers, including teachers. In this study we examine the benefit enhancements to the teacher pension…

Clinical review: Riedel's thyroiditis: a clinical review.

Science.gov (United States)

Hennessey, James V

2011-10-01

Riedel's thyroiditis is a rare inflammatory process involving the thyroid and surrounding cervical tissues and is associated with various forms of systemic fibrosis. Riedel's presentation is complex, including a thyroid mass associated with local symptoms, characteristic biochemical abnormalities such as hypocalcemia and hypothyroidism, as well as the involvement of a wide range of other organ systems. Diagnosis of Riedel's thyroiditis requires histopathological confirmation, but due to high complication rates, the role of surgical intervention is limited to airway decompression and diagnostic tissue retrieval. Unique among processes of the thyroid, Riedel's is commonly treated with long-term antiinflammatory medications to arrest progression and maintain a symptom-free course. Due to its rarity, Riedel's may not be immediately diagnosed, so clinicians benefit from recognizing the constellation of findings that should make prompt diagnosis possible. A review of print and electronic reviews was conducted. Source references were identified, and available literature was reviewed. A search of the PubMed database using the search term "Riedel's thyroiditis" was cross-referenced with associated clinical findings, systemic fibrosis diagnoses, and therapeutic search terms. Because most of the literature consisted of case reports and very small series, inclusion of identified articles was based on clinical descriptions of the subjects included and the criteria for diagnosis reported. More weight was attributed to series, using contemporary criteria for diagnosis. Case reports were included if the diagnosis was clear and clinical presentation was unique to illustrate the spectrum of disease. Because the majority of therapeutic intervention data were based upon case reports and very small series, an evidence-based approach was problematic, but information is presented as objectively and with as much balance as the limited quality of the data allows. Clinical awareness of the

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).

Radiographer's impact on improving clinical decision-making, patient care and patient diagnosis: a pilot study

International Nuclear Information System (INIS)

Lam, Daniel; Egan, Ingrid; Baird, Marilyn

2004-01-01

This pilot study attempts to quantify the benefits of a documented radiographic clinical history through the use of the clinical history template form designed by Egan and Baird. Six radiographers completed the clinical history template for 40 patients and four radiologists included the recorded information as part of their reporting process. A focus discussion group was held between the radiographers to ascertain the level of satisfaction and benefits encountered with the use of the template form. A questionnaire was designed for the radiologists to complete regarding the usefulness of the template form with respect to the radiological reporting process. Results/Discussion: 15 cases for which the form was used demonstrated a direct benefit in respect to improved radiographic clinical decision-making. Radiographers agreed the template form aided the establishment of a stronger radiographer-patient relationship during the radiographic examination. Two radiologists agreed the form aided in establishing a radiological diagnosis and suggested the form be implemented as part of the standard departmental protocol. Despite the small sample size, there is evidence the form aided radiographic decision-making and assisted in the establishment of an accurate radiological diagnosis. The overall consensus amongst radiographers was that it enhanced radiographer-patient communication and improved the level of patient care. Copyright (2004) Australian Institute of Radiography

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.

Are there specific benefits of amoxicillin plus metronidazole in Aggregatibacter actinomycetemcomitans-associated periodontitis? Double-masked, randomized clinical trial of efficacy and safety.

Science.gov (United States)

Mombelli, Andrea; Cionca, Norbert; Almaghlouth, Adnan; Décaillet, Fabien; Courvoisier, Delphine S; Giannopoulou, Catherine

2013-06-01

It has been suggested that prescription of amoxicillin plus metronidazole in the context of periodontal therapy should be limited to patients with specific microbiologic profiles, especially those testing positive for Aggregatibacter actinomycetemcomitans. The main purpose of this analysis is to determine if patients positive for A. actinomycetemcomitans with moderate to advanced periodontitis benefit specifically from amoxicillin plus metronidazole given as an adjunct to full-mouth scaling and root planing. This is a double-masked, placebo-controlled, randomized longitudinal study including 41 participants who were positive for A. actinomycetemcomitans and 41 participants who were negative for A. actinomycetemcomitans. All 82 patients received full-mouth periodontal debridement performed within 48 hours. Patients then received either systemic antibiotics (375 mg amoxicillin and 500 mg metronidazole, three times daily) or placebo for 7 days. The primary outcome variable was persistence of sites with a probing depth (PD) >4 mm and bleeding on probing (BOP) at the 3-month reevaluation. Using multilevel logistic regression, the effect of the antibiotics was analyzed according to the following factors (interaction effect): A. actinomycetemcomitans-positive or -negative at baseline, sex, age, smoking, tooth being a molar, and interdental location. At reevaluation, participants in the test group had significantly fewer sites with a persisting PD >4 mm and BOP than control patients (P antibiotics. Patients benefited from the antibiotics irrespective of sex, age, or smoking status. Molars benefited significantly more from the antibiotics than non-molars (P for interaction effect = 0.03). Patients who were positive for A. actinomycetemcomitans had no specific benefit from amoxicillin plus metronidazole. Sites on molars benefited significantly more from the antibiotics than non-molar sites.

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.

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

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.

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

Multimodal interventions including nutrition in the prevention and management of disease-related malnutrition in adults: a systematic review of randomised control trials.

Science.gov (United States)

Thorne, Frances; Baldwin, Christine

2014-06-01

There has been a move to improve nutritional status in malnourished patients through the use of multimodal interventions (MI). There are currently no systematic reviews that have examined their effectiveness. This analysis aimed to examine the effects on nutritional, clinical, functional and patient-centred outcomes. A systematic review and meta-analysis using Cochrane methodology. 15 studies were included in the analysis, 13 comparing MI with usual care and 2 comparing MI with a nutrition intervention alone. Quality of studies varied and studies reported few relevant outcomes. Only 3 outcomes were compatible with meta-analysis; weight, mortality and length of stay (LOS). No statistically significant differences between groups were found. Narrative review was inconclusive. There was no evidence of benefit in the intervention groups in relation to body composition, functional status or quality of life (QoL). Intervention groups appeared to show a trend towards increased energy and protein intake however data was provided by only 2 studies (301 participants). No conclusive evidence of benefit for MI on any of the reviewed outcomes was found. Well designed, high quality trials addressing the impact of MI on relevant nutritional, functional and clinical outcomes are required. Copyright © 2014 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Bedside Teaching in Australian Clinical Schools: A National Study

Directory of Open Access Journals (Sweden)

Praveen L. Indraratna

2013-01-01

Full Text Available Purpose. Bedside teaching (BST of medical students has become less common in recent years; however, there have been strong recommendations made in the literature to continue this teaching modality for the valued benefits it provides. The purpose of the present study is to explore the perceptions and opinions of bedside teaching among senior Australian medical students. Methods. Medical students at Australian universities were surveyed by means of an electronic questionnaire. The results were collected and analysed. Results. A total of 517 responses were received from students at 15 universities and 94 different clinical sites. The percentage of students who identified BST as very important ranged from 62.5% in psychiatry to 90.4% in internal medicine. The optimal class size was nominated as 3-4 students, and students favoured a style where one individual performs a complete examination, with the remainder allowed to elicit the key sign afterwards. Students felt 3-4 hours of BST per week to be ideal. Advantages identified to BST included provision of feedback and elicitation of clinical signs. Disadvantages included time constraints and excessive class sizes. Conclusions. The unique benefits of BST result in its high demand by students, regardless of the discipline being taught.

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...

Clinical benefit of liver stiffness measurement at 3 months after Kasai hepatoportoenterostomy to predict the liver related events in biliary atresia.