Home About us Contact
|
Home About us Contact | ||
|
|
||
Safety
Kinds of Safety Terms modified by Safety Selected AbstractsUSE OF SINGLE-VISION EYEGLASSES IMPROVES STEPPING PRECISION AND SAFETY WHEN ELDERLY HABITUAL MULTIFOCAL WEARERS NEGOTIATE A RAISED SURFACEJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 1 2008Louise Johnson MSc No abstract is available for this article. [source] CLONAL HERBAL EXTRACTS AS ELICITORS OF PHENOLIC SYNTHESIS IN DARK-GERMINATED MUNGBEANS FOR IMPROVING NUTRITIONAL VALUE WITH IMPLICATIONS FOR FOOD SAFETYJOURNAL OF FOOD BIOCHEMISTRY, Issue 3 2002PATRICK McCUE ABSTRACT Plant phenolics are secondary metabolites that confer beneficial properties to the plants that produce them. Extracts made from plants that produce these phytochemicals are increasingly being recognized for their antimicrobial properties. In this study, we investigated extracts made from high-phenolics-producing clonal lines of oregano and thyme for potential as elicitors of phenolic antioxidant production in dark-germinated mungbean (Vigna radiata,). Mungbean was dark-germinated under the rationale that any energy stored in the bean seed in the form of starch may potentially be utilized for enhanced phenolics production, since without a light source the dark-germinated seedling may not stimulate the development of photosynthetic components. Wafer-based herb extracts showed the greatest ability to stimulate phenolic content in dark-germinated mungbeans. Three of the oregano extracts were investigated further and showed an ability to stimulate glucose-6-phosphate dehydrogenase (G6PDH), guaiacol peroxidase (GPX), and antioxidant activity. These results suggest that the extracts contain an active elicitor that stimulates phenolic antioxidant content, as well as activity of the pentose-phosphate pathway. In addition, the results of this study suggest that extracts of high-phenolics-producing clonal plants may have potential in the food and agriculture industry as seed treatments for preventing bacterial infection in germinating sprouts by stimulating phenolic antioxidant-producing pathways, as well as for increasing the nutritional value of sprouts for human consumption. [source] SAFETY and QUALITY EVALUATION of A YOGURT-BASED DRINK PROCESSED BY A PILOT PLANT PEF SYSTEMJOURNAL OF FOOD PROCESS ENGINEERING, Issue 3 2004G.A. EVRENDILEK ABSTRACT Yogurt-based drink samples were prepared by mixing plain yogurt, water, sugar, and strawberry flavored fruit syrup. the samples were treated by both the mild heat (60C for 30 s) combined with a pilot plant pulsed electric field (PEF) system and the mild heat only in order to determine changes in the product safety and quality. Changes in the product safety were measured as microbial count, and changes in the product quality as L, a, b, oBrix and pH values. the treated and control samples were stored at 4 and 22C for microbial, physical and sensory evaluations. Since the 60C-treated samples exploded after 14-day storage, the safety and quality evaluations for 91 days were performed for the 60C? and control samples, only. Microbial count of the 60C? samples was significantly lower than that of the control samples at the two temperatures for the 91-day storage (P < 0.05). There was no significant difference in the L, a, b values, oBrix and pH between the control and 60C? samples (P < 0.05). the control and 60C? samples revealed no significant difference in the selected sensory attributes (P < 0.05). [source] CONSUMER ASSESSMENT OF THE SAFETY OF RESTAURANTS: THE ROLE OF INSPECTION NOTICES AND OTHER INFORMATION CUESJOURNAL OF FOOD SAFETY, Issue 4 2006SPENCER HENSON ABSTRACT This paper explores the ways in which consumers assess the safety of food in restaurants and other eating-out establishments, and the resulting impact on restaurant choice. The analysis builds on the existing literature on restaurant choice more generally and a growing body of studies on the impact of official inspection information on the perceived safety of restaurants. Based on a two-stage consumer study in the City of Hamilton in Ontario, Canada, involving focus groups and a postal survey, the research highlights how consumers base their assessment of food safety in restaurants using a range of visible indicators of the experience and/or credence characteristics associated with foodborne illness. These include their observed judgments of restaurant hygiene, the overall quality of the restaurant, external information, including official inspection certificates, and the level of patronage. The use of these broad groups of indicators varies across consumer subgroups according to gender, age, level of education and recollections of past incidences when a restaurant was closed and/or convicted for food safety reasons. [source] SURVEY OF APPLE GROWING, HARVESTING, AND CIDER MANUFACTURING PRACTICES IN WISCONSIN: IMPLICATIONS FOR SAFETYJOURNAL OF FOOD SAFETY, Issue 2 2000HEIDI E. ULJAS ABSTRACT To evaluate the safety of current apple growing, harvesting and cider manufacturing practices in Wisconsin, cider manufacturers were contacted in a three-phase survey. Results revealed that seasonal, small-scale production was characteristic of the industry. Most cider mills produced less than 5,000 gal/year; only 6% produced more than 20,000 gal/year. Most cider makers used only tree picked apples (86%), inspected apples before washing (94%), washed (93%) and brushed (87%) apples, but only 16% of mills sanitized washed apples. Most mills (92%) sanitized cider making equipment after each use; however, only a few sanitized between custom pressing apples from different customers. Respondents reported that they strived to improve cider safety by pasteurization (43% of all cider), UV light treatment (4%), use of preservatives (30%), and HACCP (17%). For 31% of all cider, however, processors relied solely on refrigeration and/or freezing. These results show that most cider mills practice many steps believed to enhance cider safety, but results also identify procedures that must be addressed to further improve cider safety. [source] SAFETY OF DEXTROAMPHETAMINE AND COCAINE COMBINATIONS IN COCAINE USERSALCOHOLISM, Issue 2008William Murff Two studies evaluated the safety and abuse liability of d-amphetamine in combination with cocaine in twenty cocaine-using research volunteers maintained in a controlled research laboratory. The first study tested low doses of d-amphetamine (15 mg) administered orally as a 1.5-hr pretreatment before low intranasal doses (48 mg) of cocaine. The study was double-blind, double-dummy, and placebo-controlled. A dose run-up procedure was employed to maximize safety. All drug effects were modest and the main finding of the study was diminished subjective effects of cocaine on a replicate determination of the original cocaine dose. The second study examined higher doses of d-amphetamine (30 mg, p.o.) and cocaine (96 mg, i.n.), alone and in combination, without a gradual dose run-up. Cocaine alone increased subjective mood, cocaine craving, and ratings indicating cocaine abuse potential. Again, replicate administration of cocaine produced lesser subjective effects than the first dose. D-amphetamine alone increased systolic and mean arterial pressures, but produced minimal effects on subjective mood. The combination of d-amphetamine and cocaine never produced effects greater than cocaine alone except for one subject who had an asymptomatic hypertensive episode. The data are interpreted in light of the possible use of stimulants for the treatment of cocaine dependence. [source] SAFETY AND ADEQUACY OF NATIVE RENAL BIOPSYNEPHROLOGY, Issue 3 2000Jardine M [source] MEDIA REPORTS OF RURAL HEALTH AND SAFETY: A REVIEW OF ARTICLES PUBLISHED IN THE LAND NEWSPAPERAUSTRALIAN JOURNAL OF RURAL HEALTH, Issue 5 2001Robyn Shea ABSTRACT: The Land is one of the main newspapers that service Australia's rural community. A content analysis of reports on health issues in The Land was undertaken for the period April 1998 to October 1999 (76 editions, 10 336 pages). Fifty-four articles were published, with most being about causes of farm injury. Very few articles concerning non-injury health issues facing rural residents were published. People working in health promotion should consider The Land to be an under-utilised vehicle for news and commentary on rural health and safety issues. [source] Tolerability, Safety, and Efficacy of ,-Blockade in Black Patients With Heart Failure in the Community Setting: Insights From a Large Prospective ,-Blocker RegistryCONGESTIVE HEART FAILURE, Issue 1 2007William T. Abraham MD Heart failure (HF) clinical trials suggest different responses of blacks and whites to ,-blockers. Differences between clinical trial and community settings may also have an impact. The Carvedilol Heart Failure Registry (COHERE) observed experience with carvedilol in 4280 patients with HF in a community setting. This analysis compares characteristics, outcomes, and carvedilol dosing of blacks and whites in COHERE. Compared with whites (n=3433), blacks (n=523) had more severe HF symptoms despite similar systolic function. At similar carvedilol maintenance doses, symptoms improved in 33% of blacks vs 28% of whites, while worsening in 10% and 11%, respectively (both nonsignificant), and HF hospitalization rates were reduced comparably in both groups (,58% vs ,56%, respectively; both P<.001). Incidence and hazard ratios of death were similar in blacks and whites (6.9% vs 7.5%, hazard ratio 1.2 vs 1.0, P=.276). Thus carvedilol was similarly effective in blacks and whites with HF in the community setting, consistent with carvedilol clinical trials. [source] Safety of sertindole versus risperidone in schizophrenia: principal results of the sertindole cohort prospective study (SCoP)ACTA PSYCHIATRICA SCANDINAVICA, Issue 5 2010S. H. L. Thomas Thomas SHL, Drici MD, Hall GC, Crocq MA, Everitt B, Lader MH, Le Jeunne C, Naber D, Priori S, Sturkenboom M, Thibaut F, Peuskens J, Mittoux A, Tanghøj P, Toumi M, Moore ND, Mann RD. Safety of sertindole versus risperidone in schizophrenia: principal results of the sertindole cohort prospective study (SCoP) Objective:, To explore whether sertindole increases all-cause mortality or cardiac events requiring hospitalization, compared with risperidone. Method:, Multinational randomized, open-label, parallel-group study, with blinded classification of outcomes, in 9858 patients with schizophrenia. Results:, After 14147 person-years, there was no effect of treatment on overall mortality (sertindole 64, risperidone 61 deaths, Hazard Ratio (HR) = 1.12 (90% CI: 0.83, 1.50)) or cardiac events requiring hospitalization [sertindole 10, risperidone 6, HR = 1.73 (95% CI: 0.63, 4.78)]: Of these, four were considered arrhythmia-related (three sertindole, one risperidone). Cardiac mortality was higher with sertindole (Independent Safety Committee (ISC): 31 vs. 12, HR=2.84 (95% CI: 1.45, 5.55), P = 0.0022; Investigators 17 vs. 8, HR=2.13 (95% CI: 0.91, 4.98), P = 0.081). There was no significant difference in completed suicide, but fewer sertindole recipients attempted suicide (ISC: 68 vs. 78, HR=0.93 (95% CI: 0.66, 1.29), P = 0.65; Investigators: 43 vs. 65, HR=0.67 (95% CI: 0.45, 0.99), P = 0.044). Conclusion:, Sertindole did not increase all-cause mortality, but cardiac mortality was higher and suicide attempts may be lower with sertindole. [source] Atomoxetine treatment in adults with attention-deficit/hyperactivity disorder and comorbid social anxiety disorderDEPRESSION AND ANXIETY, Issue 3 2009Lenard A. Adler M.D. Abstract Background: To evaluate the effect of atomoxetine (ATX) on attention-deficit/hyperactivity disorder (ADHD) and comorbid social anxiety disorder in adults. Methods: Randomized, double-blind, placebo-controlled, conducted in adults with ADHD and social anxiety disorder. Patients received 40,100,mg ATX (n=224) or placebo (n=218) for 14 weeks following a 2-week placebo lead-in period. Efficacy measures included the Conners' Adult ADHD Rating Scale: Investigator-Rated: Screening Version (CAARS:Inv:SV), Liebowitz Social Anxiety Scale (LSAS), Clinical Global Impression-Overall-Severity (CGI-O-S), State-Trait Anxiety Inventory (STAI), Social Adjustment Scale-Self Report (SAS), and Adult ADHD Quality of Life Scale-29 (AAQoL). Safety and tolerability were also assessed. Results: ATX mean change (,8.7±10.0) from baseline (29.6±10.4) on CAARS:Inv:SV Total ADHD Symptoms score was significantly greater than placebo mean change (,5.6±10.2) from baseline (31.2±9.4; P<.001). ATX mean change (,22.9±25.3) from baseline (85.3±23.6) on LSAS Total score was significant compared to placebo mean change (,14.4±20.3) from baseline (82.1±21.3; P<.001). The visit-wise analysis revealed greater improvement on the CAARS:Inv:SV Total ADHD Symptoms score and LSAS Total score for ATX at every time point throughout the study (P values ,.012). Mean changes in CGI-O-S, STAI-Trait Anxiety scores, and AAQoL Total score were significantly greater for ATX compared to placebo. Mean change for both groups on STAI-State Anxiety scores was comparable. Improvement on SAS for ATX compared to placebo was not significant. Rates of insomnia, nausea, dry mouth, and dizziness were higher with ATX than with placebo. Discontinuation rates due to treatment-emergent adverse events were similar between groups. Conclusions: ATX monotherapy effectively improved symptoms of ADHD and comorbid social anxiety disorder in adults and was well tolerated. Depression and Anxiety, 2009. Published 2009 Wiley-Liss, Inc. [source] Safety of Lidocaine 15% and Prilocaine 5% Topical Ointment Used as Local Anesthesia for Intense Pulsed Light TreatmentDERMATOLOGIC SURGERY, Issue 7 2010J. ALASTAIR CARRUTHERS MD BACKGROUND Literature cautions against applying lidocaine 15%/prilocaine 5% over an area larger than 300 cm2. The area of the face, neck, and chest is 400 cm2 or greater. OBJECTIVE To investigate the safety of lidocaine 15%/prilocaine 5% topical anesthetic ointment used as anesthesia for intense pulsed light (IPL) treatment. METHODS AND MATERIALS Lidocaine 15%/prilocaine 5% ointment was applied to the face only (n=10) for 30 ± 15 minutes or to the face, neck, and chest (n=10) for a total of 60 ± 15 minutes before IPL. Blood lidocaine and prilocaine levels were measured. Adverse events were recorded. RESULTS For the entire cohort, blood was drawn 25.6 ± 6.6 minutes after IPL was completed. In the face only group, the mean lidocaine level was 0.122 ± 0.125 ,g/mL, and the mean prilocaine level was 0.048 ± 0.029 ,g/mL. In the face, neck, and chest group, the mean lidocaine level was 0.272 ± 0.208 ,g/mL, and the mean prilocaine level was 0.087 ± 0.060 ,g/mL. No adverse events related to systemic toxicity were observed or reported to the nurse. At the 24-hour follow-up, no subject reported symptoms of systemic toxicity after leaving the clinic. CONCLUSION Under the conditions of this study, topical lidocaine 15%/prilocaine 5% produces low levels of systemic absorption. The authors have indicated no significant interest with commercial supporters. [source] A Multicenter, 47-Month Study of Safety and Efficacy of Calcium Hydroxylapatite for Soft Tissue Augmentation of Nasolabial Folds and Other Areas of the FaceDERMATOLOGIC SURGERY, Issue 2007NEIL S. SADICK MD OBJECTIVES Each soft tissue filler product has its own unique profile in terms of adverse events. In this large-scale study, we investigated the safety profile of Radiesse, an injectable calcium hydroxylapatite (CaHA) implant, in treatment of nasolabial folds and other areas of the face. We also investigated the efficacy in a subset of the larger patient group. METHODS After obtaining informed consent from the subjects, researchers injected CaHA at two treatment centers into 113 patients (100 women and 13 men, ranging in age from 26 to 78 years) for a variety of facial aesthetic applications over a period of 47 months. Seventy-five patients had a single injection session; 38 had multiple sessions. Most patients (102) received 1.0 mL of CaHA per session; 12 received 2.0 mL per session. Typically, CaHA was administered with a 27-gauge 0.5- or 1 1/4-in. needle. RESULTS Safety. Of 113 patients, only 7 reported minor adverse events that were short-term and resolved within 1 month: transient ecchymosis (3), nongranulatomous submucosal nodules of the lip (2), and inflammation and edema (2). Efficacy. Efficacy ratings were performed for a subset of patients (n=41). On a scale of 1 to 5 (1=unsatisfactory; 5=excellent), the mean patient evaluation score for look and feel of the implant was 4.6; the mean physician scores for the look and feel of the implant were 4.5 and 4.6, respectively. During the 6-month follow-up visit, patients' mean ratings of the look and feel of the implant were 4.8 and 4.9, respectively. The physician's mean ratings for the look and feel of the implant were 4.5 and 4.9, respectively. CONCLUSIONS In our study, CaHA performed well, with a favorable safety profile, high patient satisfaction (90% of patients reported very good or excellent results), and good durability. We are especially pleased with the low incidence of adverse events coupled with the favorable responses from the patients themselves due to longevity of correction. [source] A Review of the Biologic Effects, Clinical Efficacy, and Safety of Silicone Elastomer Sheeting for Hypertrophic and Keloid Scar Treatment and ManagementDERMATOLOGIC SURGERY, Issue 11 2007BRIAN BERMAN MD Silicone elastomer sheeting is a medical device used to prevent the development of and improve the appearance and feel of hypertrophic and keloid scars. The precise mechanism of action of silicone elastomer sheeting has not been defined, but clinical trials report that this device is safe and effective for the treatment and prevention of hypertrophic and keloid scars if worn over the scar for 12 to 24 hours per day for at least 2 to 3 months. Some of the silicone elastomer sheeting products currently on the market are durable and adhere well to the skin. These products are an attractive treatment option because of their ease of use and low risk of adverse effects compared to other treatments, such as surgical excision, intralesional corticosteroid injections, pressure therapy, radiation, laser treatment, and cryotherapy. Additional controlled clinical trials with large patient populations may provide further evidence for the efficacy of silicone elastomer sheeting in the treatment and prevention of hypertrophic and keloid scars. The purpose of this article is to review the literature on silicone elastomer sheeting products and to discuss their clinical application in the treatment and prevention of hypertrophic and keloid scars. [source] Double-Blind, Randomized, Placebo-Controlled, Dose-Response Study of the Safety and Efficacy of Botulinum Toxin Type A in Subjects with Crow's FeetDERMATOLOGIC SURGERY, Issue 3 2005Nicholas J. Lowe MD Background Published evidence suggests that botulinum toxin type A (BTX-A) is an effective treatment for crow's feet. However, few dose-ranging studies have been performed. Objectives To assess the safety and efficacy of a single treatment with one of four doses of BTX-A (Botox/Vistabel, Allergan Inc) compared with placebo for the improvement of crow's feet. Methods Subjects received a single bilateral treatment of 18, 12, 6, or 3 U of BTX-A or placebo injected into the lateral aspect of the orbicularis oculi muscle (parallel-group, double,blind design). Investigators and subjects rated crow's feet severity at maximum smile on day 7 and at 30-day intervals from days 30 to 180. Results As observed by both investigators and subjects, all doses of BTX-A resulted in improvements in crow's feet severity when compared with placebo. A dose-dependent treatment effect for efficacy was observed, with higher doses having an increased magnitude and duration of effect. However, a clear differentiation between the 18 U and 12 U doses was not apparent. Few adverse events were reported, with no statistically significant differences between BTX-A and placebo in the incidence of subjects experiencing adverse events. Conclusion BTX-A is safe and effective in decreasing the severity of crow's feet, with 12 U per side suggested as the most appropriate dose. THIS STUDY WAS FUNDED BY ALLERGAN, WHICH WAS ALSO INVOLVED IN THE DESIGN AND CONDUCT OF THE STUDY; COLLECTION, MANAGEMENT, ANALYSIS, AND INTERPRETATION OF THE DATA; AND PREPARATION, REVIEW, AND APPROVAL OF THE MANUSCRIPT. DRS. LOWE AND FRACZEK ARE PAID CONSULTANTS FOR ALLERGAN, DRS. KUMAR AND EADIE ARE EMPLOYEES OF ALLERGAN, AND DRS. LOWE AND KUMAR HOLD STOCK OPTIONS. [source] Double-Blind, Randomized, Placebo-Controlled Pilot Study of the Safety and Efficacy of Myobloc (Botulinum Toxin Type B) for the Treatment of Palmar HyperhidrosisDERMATOLOGIC SURGERY, Issue 3 2005Leslie Baumann MD Background Palmar hyperhidrosis is a problem of unknown etiology that affects patients both socially and professionally. Botulinum toxin type B (Myobloc), approved by the Food and Drug Administration for use in the treatment of cervical dystonia in the United States in December 2000, has subsequently been used effectively in an off-label indication to treat hyperhidrosis. There are sparse data, however, in the literature evaluating the safety and efficacy of BTX-B for the treatment of palmar hyperhidrosis. Objective We evaluated the safety and efficacy of Myobloc in the treatment of bilateral palmar hyperhidrosis. This was a double-blind, randomized, placebo-controlled study to report on the safety and efficacy of Myobloc. Methods Twenty participants (10 men, 10 women) diagnosed with palmar hyperhidrosis were injected with either Myobloc (5,000 U per palm) or a 1.0 mL vehicle (100 mM NaCl, 10 mM succinate, and 0.5 mg/mL human albumin) into bilateral palms (15 Myobloc, 5 placebo). The participants were followed until sweating returned to baseline levels. The main outcome measures were safety, efficacy versus placebo, and duration of effect. Results A significant difference was found in treatment response at day 30, as determined by participant assessments, between 15 participants injected with Myobloc and 3 participants injected with placebo. The duration of action, calculated in the 17 participants who received Myobloc injections and completed the study, ranged from 2.3 to 4.9 months, with a mean duration of 3.8 months. The single most reported adverse event was dry mouth or throat, which was reported by 18 of 20 participants. The adverse event profile also included indigestion or heartburn (60%), excessively dry hands (60%), muscle weakness (60%), and decreased grip strength (50%). Conclusion Myobloc proved to be efficacious for the treatment of palmar hyperhidrosis. Myobloc had a rapid onset, with most participants responding within 1 week. The duration of action ranged from 2.3 to 4.9 months, with a mean of 3.8 months. The adverse event profile included dry mouth, indigestion or heartburn, excessively dry hands, muscle weakness, and decreased grip strength. MYOBLOC WAS PROVIDED FOR THIS STUDY BY ELAN PHARMACEUTICALS. [source] Multicenter Study of the Safety and Efficacy of a 585 nm Pulsed-Dye Laser for the Nonablative Treatment of Facial RhytidesDERMATOLOGIC SURGERY, Issue 1 2005T. S. Jeffrey Hsu MD Objective The objective of this study was to assess the safety and efficacy of a 585 nm flashlamp pulsed-dye laser for the nonablative treatment of facial rhytides. Methods A multicenter prospective randomized controlled study on 58 volunteers was performed. A split-face approach was adopted, with one periorbital region acting as a control and the other receiving either one or two treatments. Patients were photographed and imaged three-dimensionally before and after treatment. Histologic sections were analyzed. Results Three-dimensional topographic evaluation showed improvements of 9.8% (p= .0022) and 15% (p= .0029) in surface roughness for single and double treatments, respectively. Histology revealed an increase in type I collagen messenger ribonucleic acid expression, type III procollagen, chondroitin sulfate, and grenz zone thickness. Two treatments resulted in greater improvement than one treatment. Conclusion Clinical improvement was achieved following a single treatment. Further improvement was observed following a second treatment. The subjective evaluation of clinical improvement was consistent with both histologic and topographic quantitative measurements. SUZANNE KILMER, MD, AND JAY BURNS, MD, RECEIVED THE USE OF THE LASER FOR RESEARCH AND A DISCOUNTED PURCHASE AGREEMENT. THEY BOTH ACKNOWLEDGE RECEIVING HONORARIA FOR LECTURING FROM THE MANUFACTURER. BRIAN ZELICKSON, MD, RECEIVED RESEARCH GRANTS FROM ICN. [source] Patient Safety in DermatologyDERMATOLOGIC SURGERY, Issue 12p1 2004C. William Hanke MD First page of article [source] Why Are There Differences in the Perceived Safety of Office-Based Surgery?DERMATOLOGIC SURGERY, Issue 11 2004John G. Hancox MD Background. Office-based surgery has become an important method of health-care delivery, but there is controversy about its safety and which practitioners should perform it. Several states have already or are preparing to enact legislation regulating office-based surgery. Objective. The objective was to discuss recent literature pertaining to the safety of office surgery and to discuss reasons why there are perceived differences in its safety. Methods. The pertinent literature is reviewed. Results. The majority of studies suggest that office surgery is safe. A recent study that found to the contrary may have methodologic flaws. Conclusion. The medical and legislative community should seek to scientifically examine office surgery. Overregulation or loss of office surgery would have a tremendous impact on the management of skin cancers and the delivery of quality cosmetic and laser surgery. [source] Efficacy, Safety, and Cost of Office-Based Surgery: A Multidisciplinary PerspectiveDERMATOLOGIC SURGERY, Issue 1 2003Rajesh Balkrishnan PhD An increasing number of media reports on patient safety risks arising from office-based surgery procedures, as well as growing concerns about patient safety issues in general, have brought office-based surgery as well as its practitioners into focus and placed this very cost-effective medical practice in the eye of the media and regulators. Concerted efforts are now being made to understand the causes and true incidence of patient safety risk associated with office-based surgery and to find ways to minimize this risk. [source] Sclerosing Foam in the Treatment of Varicose Veins and Telangiectases: History and Analysis of Safety and ComplicationsDERMATOLOGIC SURGERY, Issue 1 2002Alessandro Frullini MD objective. To review the use of sclerosing foam in the treatment of varicose veins, to describe the different techniques of foam preparation, and to report the complications of our 3-year experience with this treatment. method. From November 1997 to the end of October 2000, 453 patients were treated with a sclerosing foam for large, medium, and minor varicosities with sodium tetradecylsulfate (STS) or polidocanol (POL). A first group of 257 patients (90 for minor varicosities and 167 for medium to large veins) received a sclerosing foam according to the Monfreux technique. From December 1999 to October 2000, 196 patients were treated with a sclerosing foam prepared according to Tessari's method (36 for minor size veins or teleangectasias and 170 for medium-large veins). Every patient was studied with (color-flow) duplex scanning before and after the treatment and large vein injections were administered under duplex guide. results. The immediate success rate was 88.1% in the first group for the medium-large veins. In the same districts we registered an early success rate in 93.3% for the patients treated with the Tessari's method. The complication rate (mostly minor complications) was 8.5% in the first group and 7.1% in the second group. conclusion. The use of sclerosing foam may become an established therapy in the treatment of varicose veins with a high success rate, low cost, and low major complication rate. According to our actual experience and knowledge, the safe amount of foam should not exceed the 3-ml limit, but further advancements could come from standardization of the foam preparation technique. [source] Safety and efficacy of vaccinesDERMATOLOGIC THERAPY, Issue 2 2009Brenda L. Bartlett ABSTRACT For the past two centuries, vaccines have provided a safe and effective means of preventing a number of infectious diseases. Although the safety of some vaccines has been questioned in recent years, the currently available vaccines are more than a millionfold safer than the diseases they are designed to prevent. Vaccines, however, should always be used in conjunction with other public health interventions. One important intervention is education because the general public can be led to believe that vaccines are unsafe and not needed by misinformation readily available electronically and in print. Not only are some vaccines available via injection but other vaccines are also given orally or intranasally. New vaccines are being studied for topical and intravaginal use. In addition, new systems are being developed for more efficient production of vaccines, especially for influenza. Vaccines are currently available for only a limited number of viral and bacterial diseases. In the future, it is anticipated that safe and effective vaccines will be developed against a number of other viral and bacterial infections as well as fungal and protozoan diseases. [source] Profiles in Patient Safety: Antibiotic Timing in Pneumonia and Pay-for-performanceACADEMIC EMERGENCY MEDICINE, Issue 7 2006Jesse M. Pines MD The delivery of antibiotics within four hours of hospital arrival for patients who are admitted with pneumonia, as mandated by the Joint Commission for the Accreditation of Healthcare Organizations and the Centers for Medicare and Medicaid Services, has gained considerable attention recently because of the plan to implement pay-for-performance for adherence to this standard. Although early antibiotic administration has been associated with improved survival for patients with pneumonia in two large retrospective studies, the effect on actual patient care and outcomes for patients with pneumonia and other emergency department patients of providing financial incentives and disincentives to hospitals for performance on this measure currently is unknown. This article provides an in-depth case-based description of the evidence behind antibiotic timing in pneumonia, discusses potential program effects, and analyzes how the practical implementation of pay-for-performance for pneumonia conforms to American Medical Association guidelines on pay-for-performance. [source] Safety of pramlintide added to mealtime insulin in patients with type 1 or type 2 diabetes: a large observational studyDIABETES OBESITY & METABOLISM, Issue 6 2010R. Pencek The objective of this Phase 4, open-label, multicentre, observational study was to fulfil food and drug administration (FDA) postapproval requirement to evaluate in healthcare practices the risk of insulin-induced severe hypoglycaemia following initiation of pramlintide therapy in N = 1297 patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) with inadequate glycaemic control. The duration of the study was approximately 6 months. During the adjustment period (0,3 months), the incidence and event rate of patient-ascertained severe hypoglycaemia (PASH) were 4.8% and 0.33 events/patient-year in patients with T1DM and 2.8% and 0.19 events/patient-year in patients with T2DM. During the maintenance period (>3,6 months), the incidence and event rate of PASH declined in patients with T1DM or T2DM. This study confirms that in healthcare practices, the risk of insulin-induced severe hypoglycaemia following the initiation of pramlintide is low in patients with T1DM or T2DM. [source] Safety, tolerability, and efficacy of endoscopic low-pressure liquid nitrogen spray cryotherapy in the esophagusDISEASES OF THE ESOPHAGUS, Issue 1 2010Bruce D. Greenwald SUMMARY Endoscopic cryotherapy is a new technique for ablation of esophageal dysplasia and neoplasia. Preliminary studies have shown it to be safe and effective for this indication. The objective of this study is to characterize safety, tolerability, and efficacy of low-pressure liquid nitrogen endoscopic spray cryotherapy ablation in a large cohort across multiple study sites. Parallel prospective treatment studies at four tertiary care academic medical centers in the U.S. assessed spray cryotherapy in patients with Barrett's esophagus with or without dysplasia, early stage esophageal cancer, and severe squamous dysplasia who underwent cryotherapy ablation of the esophagus. All patients were contacted between 1 and 10 days after treatment to assess for side effects and complications of treatment. The main outcome measurement was the incidence of serious adverse events and side effects from treatment. Complete response for high-grade dysplasia (HGD) (CR-HGD), all dysplasia (CR-D), intestinal metaplasia (CR-IM) and cancer (CR-C) were assessed in patients completing therapy during the study period. A total of 77 patients were treated for Barrett's high-grade dysplasia (58.4%), intramucosal carcinoma (16.9%), invasive carcinoma (13%), Barrett's esophagus without dysplasia (9.1%), and severe squamous dysplasia (2.6%). Twenty-two patients (28.6%) reported no side effects throughout treatment. In 323 procedures, the most common complaint was chest pain (17.6%) followed by dysphagia (13.3%), odynophagia (12.1%), and sore throat (9.6%). The mean duration of any symptoms was 3.6 days. No side effects were reported in 48% of the procedures (155/323). Symptoms did not correlate with age, gender, diagnosis, or to treatment early versus late in the patient's or site's experience. Logit analysis showed that symptoms were greater in those with a Barrett's segment of 6 cm or longer. Gastric perforation occurred in one patient with Marfan's syndrome. Esophageal stricture developed in three, all successfully treated with dilation. In 17 HGD patients, cryotherapy produced CR-HGD, CR-D, and CR-IM of 94%, 88%, and 53%, respectively. Complete regression of cancer and HGD was seen in all seven patients with intramucosal carcinoma or stage I esophageal cancer. Endoscopic spray cryotherapy ablation using low-pressure liquid nitrogen in the esophagus is safe, well-tolerated, and efficacious. [source] Seismic collapse risk of precast industrial buildings with strong connectionsEARTHQUAKE ENGINEERING AND STRUCTURAL DYNAMICS, Issue 8 2010Miha Kramar Abstract A systematic seismic risk study has been performed on some typical precast industrial buildings that consists of assemblages of cantilever columns with high shear-span ratios connected to an essentially rigid roof system with strong pinned connections. These buildings were designed according to the requirements of Eurocode 8. The numerical models and procedures were modified in order to address the particular characteristics of the analyzed system. They were also verified by pseudo-dynamic and cyclic tests of full-scale large buildings. The intensity measure (IM)-based solution strategy described in the PEER methodology was used to estimate the seismic collapse risk in terms of peak ground acceleration capacity and the probability of exceeding the global collapse limit state. The effect of the uncertainty in the model parameters on the dispersion of collapse capacity was investigated in depth. Reasonable seismic safety (as proposed by the Joint Committee on Structural Safety) was demonstrated for all the regular single-storey precast industrial buildings addressed in this study. However, if the flexural strength required by EC8 was exactly matched, and the additional strength, which results from minimum longitudinal reinforcement, was disregarded as well as large dispersion in records was considered, the seismic risk might in some cases exceed the acceptable limits. Copyright © 2009 John Wiley & Sons, Ltd. [source] Enhanced Left Ventricular Endocardial Border Delineation with an Intravenous Injection of SonoVue, a New Echocardiography Contrast Agent:ECHOCARDIOGRAPHY, Issue 8 2000A European Multicenter Study The safety and efficacy of SonoVue (also referred to as BR1), a new contrast agent for delineating endocardial border of the left ventricle after intravenous administration, was assessed. Two hundred and eighteen patients with suspected coronary artery disease undergoing fundamental echocardiography for the assessment of left ventricle were enrolled in a prospective multicenter, single blind, cross-over study with random sequence allocation of four different doses of SonoVue. Endocardial border definition in the apical and parasternal views was scored as O = not visible, 1 = barely visible, and 2 = well visualized before and after contrast enhancement. Analysis was performed by two pairs of off-site observers. Safety of SonoVue was also assessed. Results of our study indicated that the mean improvements in the endocardial border visualization score were as follows: 3.1 ± 7.8 (95% CI, 2.5 and 3.7) for 0.5 ml, 3.4 ± 8.0 (95% CI, 2.8 and 4.0) for 1 ml, 3.4 ± 7.9 (95% CI, 2.8 and 4.0) for 2 ml, and 3.7 ± 8.0 (95% CI, 3.1 and 4.3) for 4 ml (P < 0.05 for all doses from baseline). Changes from baseline in endocardial visualization scores were also seen in the apical views (P < 0.05) and they were dose-dependent (P < 0.001). Similar enhancements of endocardial visualization scores were observed in the apical views in patients with suboptimal baseline echocardiographic images. Diagnostic confidence for assigning a score and image quality also were significantly better following contrast enhancement. No significant changes in the laboratory parameters and vital signs were noted following contrast enhancement, and the side effects were minimal. It was concluded that SonoVue is safe and effective in delineating endocardial border, including in patients with suboptimal baseline images. [source] Profiles in Patient Safety: Medication Errors in the Emergency DepartmentACADEMIC EMERGENCY MEDICINE, Issue 3 2004Pat Croskerry MD Abstract Medication errors are frequent in the emergency department (ED). The unique operating characteristics of the ED may exacerbate their rate and severity. They are associated with variable clinical outcomes that range from inconsequential to death. Fifteen adult and pediatric cases are described here to illustrate a variety of errors. They may occur at any of the previously described five stages, from ordering a medication to its delivery. A sixth stage has been added to emphasize the final part of the medication administration process in the ED, drawing attention to considerations that should be made for patients being discharged home. The capability for dispensing medication, without surveillance by a pharmacist, provides an error-producing condition to which physicians and nurses should be especially vigilant. Except in very limited and defined situations, physicians should not administer medications. Adherence to defined roles would reduce the team communication errors that are a common theme in the cases described here. [source] Recent developments in frameworks to consider human relevance of hypothesized modes of action for tumours in animals,ENVIRONMENTAL AND MOLECULAR MUTAGENESIS, Issue 2 2008M.E. Bette Meek Abstract This paper summarizes recent developments in the continuing evolution of Human Relevance Frameworks to systematically consider the weight of evidence of hypothesized modes of action in animals and their potential human relevance for both cancer and non-cancer effects. These frameworks have been developed in initiatives of the International Life Sciences Institute Risk Sciences Institute and the International Programme on Chemical Safety engaging large numbers of scientists internationally. They are analytical tools designed to organize information in hazard characterization as a basis to clarify the extent of the weight of evidence for mode of action in animals and human relevance and subsequent implications for dose-response. They are also extremely helpful in identifying critical data gaps. These frameworks which are illustrated by an increasing number of case studies, have been widely adopted into international and national guidance and assessments and continue to evolve, as experience increases in their application. Environ. Mol. Mutagen., 2008. Published 2008 Wiley-Liss, Inc. [source] The Use and Safety of Droperidol in a High-risk, Inner-city Emergency Department Patient PopulationACADEMIC EMERGENCY MEDICINE, Issue 8 2003Sean Keenan MD No abstract is available for this article. [source] | |||||||||||||||||||||||||||||||||||||||||||||||||