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Potential Harm (potential + harm)
Selected AbstractsToxicity testing of the VEGF inhibitors bevacizumab, ranibizumab and pegaptanib in rats both with and without prior retinal ganglion cell damageACTA OPHTHALMOLOGICA, Issue 5 2010Sebastian Thaler Abstract. Purpose:, To evaluate the effects of intravitreally introduced vascular endothelial growth factor (VEGF) inhibitors in rat eyes with healthy retinal ganglion cells (RGC) and into others with N-methyl-D-aspartate (NMDA)-induced RGC damage. Methods:, Bevacizumab, ranibizumab and pegaptanib were intravitreally injected each at two different concentrations. Respective vehicles of the three substances served as controls. In a different group, additionally a rat anti-VEGF antibody was injected after NMDA treatment. Retrogradely labelled RGC were counted on retinal wholemounts 1 week or 2 months after intravitreal introduction of the VEGF inhibitors. Electron microscopy (EM) was performed on normal rat eyes 2 months after introduction of the VEGF inhibitors. Results:, RGC counts in healthy rat eyes were essentially unchanged from those of the control animals after the administration of both low and high concentrations of bevacizumab, ranibizumab or pegaptanib. Compared to the other two substances, however, high doses of pegaptanib and its respective vehicle significantly decreased RGC after 1 week and led to a marked increase of mitochondrial swelling in EM. In eyes with NMDA-induced RGC damage, no changes of RGC numbers were detected after rat anti-VEGF antibody or bevacizumab, ranibizumab and pegaptanib at both tested concentrations. Conclusions:, Even at higher doses, bevacizumab and ranibizumab showed no toxic effects on RGC in vivo in either untreated rats or in the NMDA-induced RGC damage model. Also a rat anti-VEGF antibody showed no adverse effects after NMDA. Anti-VEGF therapy therefore appears safe even for eyes with additional excitotoxic RGC damage. Potential harm from the pegaptanib carrier solution at very high local concentrations cannot be excluded. [source] The impact of atherosclerotic renovascular disease on diabetic renal failureDIABETIC MEDICINE, Issue 11 2002A. J. Nicholls Abstract Atherosclerotic renovascular disease (ARVD) is common in thegeneral population, and its prevalence increases with age. Parallelstudies show it is also common in patients with diabetes. The widespreaduse of angiotensin converting enzyme inhibitors and angiotensin receptorantagonists for heart and kidney disease might therefore expose arteriopathicdiabetic patients to potential harm if they had critical renal arterystenosis. This review looks at the natural history of ARVD in thediabetic and non-diabetic populations: while it is common, it only rarelyleads to renal failure. Hence intervention to revascularize ischaemic kidneyson the basis of radiological appearances alone may subject somepatients to unnecessary therapy. Although untested by randomizedtrial, a policy of watchful waiting may be the simplest strategyfor most diabetic patients with suspected ARVD, reserving angiography andangioplasty (usually backed up by a stent) for those with an abruptdecline in renal function and no other cause for renal deterioration. Futureclinical trials may better define subgroups of patients who will trulybenefit from renal revascularization. [source] Analyses of second-generation ,legal highs' in the UK: Initial findingsDRUG TESTING AND ANALYSIS, Issue 8 2010Simon D. Brandt Abstract In the UK, mephedrone and other so-called ,legal high' derivatives have recently been classified as Class B, Schedule I under the Misuse of Drugs Act 1971. Since then, alternative products have been advertised on a number of websites. In order to obtain an immediate snapshot of the situation, 24 products were purchased online from 18 UK-based websites over a period of 6 weeks following the ban in April 2010. Qualitative analyses were carried out by gas chromatography ion trap mass spectrometry using electron- and chemical ionization modes, nuclear magnetic resonance spectroscopy, and comparison with reference standards. Overall, the purchased products consisted of single cathinones or cathinone mixtures including mephedrone, butylone, 4-methyl- N -ethylcathinone, flephedrone (4-fluoromethcathinone) and MDPV (3,4-methylenedioxypyrovalerone), respectively. Benzocaine, caffeine, lidocaine, and procaine were also detected. The emphasis was placed on ,Energy 1' (NRG-1), a product advertised as a legal replacement for mephedrone-type derivatives usually claiming to contain naphyrone (naphthylpyrovalerone, O-2482). It was found that 70% of NRG-1 and NRG-2 products appeared to contain a mixture of cathinones banned in April 2010 and rebranded as ,new' legal highs, rather than legal chemicals such as naphyrone as claimed by the retailers. Only one out of 13 NRG-1 samples appeared to show analytical data consistent with naphyrone. These findings also suggest that both consumers and online sellers (unlike manufacturers and wholesalers) are, most likely unknowingly, confronted with the risk of criminalization and potential harm. Copyright © 2010 John Wiley & Sons, Ltd. [source] The use of complementary therapy by men with prostate cancer in the UKEUROPEAN JOURNAL OF CANCER CARE, Issue 5 2008S. WILKINSON The study aims were to determine the use of complementary therapies (CT) by men with prostate cancer, and to explore factors influencing CT use and attitudes toward CT use. A cross-sectional survey design was used in which a postal questionnaire was mailed to an eligible sample of 405 patients with prostate cancer receiving outpatient treatment in a London teaching hospital. The primary outcomes were the prevalence of CT use and the relationship between CT use and mental health status. Two hundred and ninety-four patients (73%) responded, of whom 25% were using CT. The most frequently used CTs were vitamins, low-fat diets, lycopene and green tea. Multivariate analyses revealed no differences in mental health scores between CT users and non-users. CT users were younger (OR 0.93, 95% CI 0.89,0.97) and were more likely to be receiving conservative management in the form of ,active surveillance' (OR 5.23, 95% CI 1.78,15.41) compared with non-users. Over half of the participants (55%) wanted to learn more about CT. Forty-three per cent of CT users had not informed any doctor about their CT use. Clinicians need to be aware of the prevalence of CT use amongst patients with prostate cancer, considering the potential harm that could be caused by interactions with conventional treatments. [source] In vivo acute toxicity of titanium dioxide nanoparticles to mice after intraperitioneal injectionJOURNAL OF APPLIED TOXICOLOGY, Issue 4 2009Jinyuan Chen Abstract Because of its excellent optical performance and electrical properties, TiO2 has a wide range of applications in many fields. It is often considered to be physiologically inert to humans. However, some recent studies have reported that nano-sized TiO2 may generate potential harm to the environment and humans. In this paper the in vivo acute toxicity of nano-sized TiO2 particles to adult mice was investigated. Mice were injected with different dosages of nano-sized TiO2 (0, 324, 648, 972, 1296, 1944 or 2592 mg kg,1). The effects of particles on serum biochemical levels were evaluated at various time points (24 h, 48 h, 7 days and 14 days). Tissues (spleen, heart, lung, kidney and liver) were collected for titanium content analysis and histopathological examination. Treated mice showed signs of acute toxicity such as passive behavior, loss of appetite, tremor and lethargy. Slightly elevated levels of the enzymes alanine aminotransferase and aspartate aminotransferase were found from the biochemical tests of serum whereas blood urea nitrogen was not significantly affected (P <0.05). The accumulation of TiO2 was highest in spleen (P <0.05). TiO2 was also deposited in liver, kidney and lung. Histopathological examinations showed that some TiO2 particles had entered the spleen and caused the lesion of spleen. Thrombosis was found in the pulmonary vascular system, which could be induced by the blocking of blood vessels with TiO2 particles. Moreover, hepatocellular necrosis and apoptosis, hepatic fibrosis, renal glomerulus swelling and interstitial pneumonia associated with alveolar septal thickening were also observed in high-dose groups. Copyright © 2009 John Wiley & Sons, Ltd. [source] The impact of an insecticide on insect flower visitation and pollination in an agricultural landscapeAGRICULTURAL AND FOREST ENTOMOLOGY, Issue 3 2010Claire Brittain 1Pesticides are considered a threat to pollinators but little is known about the potential impacts of their widespread use on pollinators. Less still is known about the impacts on pollination, comprising the ecosystem service that pollinators provide to wildflowers and crops. 2The present study measured flower visitation and pollination in an agricultural landscape, by placing potted flowering plants (Petunia sp.) in vine fields sprayed with a highly toxic insecticide (fenitrothion). During two sampling rounds, insect visitors to the petunias were observed and measures of pollination were recorded by counting and weighing seeds. 3In the earlier sampling round, a lower species richness of insect visitors was observed in fields that had received an early application of insecticide. No negative impacts were found from later applications. The results obtained suggest a greater potential harm to insect pollinators and flower visitation as a result of insecticide application early in the season. 4No reduction in pollination was found in fields that received an early insecticide application. Pollination was greater with two insecticide applications between sampling rounds rather than one application. 5In the present study system, insecticide application had a negative effect on pollinators but a possible positive effect on pollination services. In some cases, it may be that actions for conserving biodiversity will not benefit pollination services to all plants. [source] Anticoagulation prophylaxis for central venous catheter-associated thrombosis in cancer patients: An Australian perspectiveASIA-PACIFIC JOURNAL OF CLINICAL ONCOLOGY, Issue 1 2008Suzanne KOSMIDER Abstract Background: The use of indwelling central venous catheters (CVC) for chemotherapy delivery is essential for people receiving therapies by protracted venous infusion and for patients with difficult venous access. Complications include infection and catheter-related thrombosis. Strategies have been suggested to prevent catheter-related thrombosis, however, there is no clear consensus on how to proceed. Guidelines recommend against the use of prophylactic anticoagulation in adult patients with solid organ malignancies and an indwelling CVC. We investigated the practice of Australian medical oncologists. Methods: A written questionnaire was mailed to all members of the Medical Oncology Group of Australia assessing practices of prophylactic anticoagulation in adult patients with solid organ malignancies and CVC. Results: Responses were obtained from 141 (55%) medical oncologists and from 40 advanced trainees. Ten percent (n = 4) of oncology trainees and 18.4% (n = 26) of medical oncologists routinely administered anticoagulants to patients with a CVC without a previous history of line-related thrombus. The most common strategy employed (73% of those using anticoagulation) was to recommend 1 mg of warfarin. Conclusions: The results demonstrate that a significant number of patients in Australia receive routine anticoagulation, the most popular strategy being the use of low-dose warfarin. Based on our results there is a clear need for further education regarding the lack of supporting data and the potential harm that may ensue. [source] The Australian grocery industry: a competition perspective,AUSTRALIAN JOURNAL OF AGRICULTURAL & RESOURCE ECONOMICS, Issue 1 2006Rhonda L. Smith This article discusses whether at a theoretical level the large and growing role of the vertically integrated supermarket chains raises a buyer-power concern because of potential harm to other retailers, suppliers, and/or consumers. Even if this is possible, whether it is a real concern depends on whether provision exists to constrain the exercise of that power through market responses, such as entry, or through regulatory provisions, such as those contained in the Trade Practices Act. [source] A review of guidelines on benign prostatic hyperplasia and lower urinary tract symptoms: are all guidelines the same?BJU INTERNATIONAL, Issue 9 2003J. Irani The Clinical Practice Guidelines on BPH/LUTS are examined by authors from London and Poitiers. They found in their review of the literature that the overall and methodological quality of such guidelines varies widely. They acknowledge the difficulties in developing careful guidelines, but suggest a formal appraisal of quality and methods, as these are the ones more likely to help urologists in decision-making. There are three papers on the prevalence of symptoms relating to lower tract conditions. The first examines male urinary incontinence in four European centres, the second nocturia and its effect on quality of life and sleep in a US community sample, and a further paper describes the prevalence diagnosis and treatment of prostatitis in Italy. A study from Sydney describes the authors use of the Inflow intra-urethral device for managing acontractile bladders in female patients. They found that the device provides an effective method of bladder drainage, with an acceptable side-effect profile and a significant improvement in quality of life. OBJECTIVE To compare overall and methodological quality with content in national and supra-national Clinical Practice Guidelines (CPGs) on benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS), as the purpose of CPGs is to reduce unwanted variation in practice and improve patient care by setting agreed standards based on the best available evidence. METHODS An electronic search was used to identify Internet-based national and supra-national CPGs on BPH and LUTS available in 2001. Two independent assessors analysed the content and appraised the methodological quality of the CPGs using an existing and validated instrument (St. George's Hospital Medical School Health Care Evaluation Unit Appraisal Instrument) comprising 37 items grouped into three broad areas, i.e. rigour of development, context and content, and clinical application. RESULTS Eight CPGs were suitable for appraisal; there was much variation in overall and methodological quality. There was agreement that a patient history and physical examination (including a digital rectal examination) should be used in all symptomatic men. In addition, patients' symptoms should be assessed using a validated symptom score, e.g. the International Prostate Symptom Score. There was considerable variation in the number and type of diagnostic tests recommended for routine assessment. CPGs scoring low on the appraisal instrument (indicating poor overall and methodological quality) were more likely to recommend more diagnostic tests than those scoring high. There was general agreement between the guidelines on the treatment of BPH/LUTS and the importance of the patient's involvement in making management decisions. Guideline quality was independent of local health resources and publication year. CONCLUSION The overall and methodological quality of CPGs on BPH/LUTS varies considerably. There appears to be an inverse relationship between guideline quality and the number of diagnostic tests recommended for routine assessment. Using CPGs of high quality may prevent men with BPH/LUTS being exposed to tests of doubtful utility. Although this may reduce both resource use and exposure to potential harm, moving to a more minimalist approach to diagnosis may itself be potentially harmful to patients. [source] Role of valproate across the ages.ACTA NEUROLOGICA SCANDINAVICA, Issue 2006Treatment of epilepsy in adults A workshop was held in Göteborg in June 2005 to discuss the place of valproate in treating adult epilepsies. Consensus positions were developed on the epilepsy types for which the drug is most suitable and the use of valproate in women of child-bearing age, in men and in patients with psychiatric comorbidity. Valproate was considered to be effective across a broad variety of epilepsy syndromes and seizure types and should be considered a suitable choice for first-line monotherapy of juvenile myoclonic epilepsy and other idiopathic generalized epilepsies. The use of valproate by women of child-bearing age is associated with potential harm to the foetus. A conservative approach to treatment is recommended in these patients whereby alternative antiepileptic drugs should be proposed to women planning pregnancies wherever satisfactory seizure control can be thereby maintained. In cases where valproate is used during pregnancy, either because the pregnancy was unplanned or because alternative treatment options of equivalent efficacy are unavailable, appropriate counselling, precautionary measures and monitoring should be provided. The evidence for an impact of valproate on male reproductive health is equivocal and considerations of male fertility should not be taken into account in deciding whether to prescribe valproate to men. Valproate can be proposed safely to patients with comorbid psychiatric disease or underlying psychiatric vulnerability. [source] In Search of Truth: The Role of Systematic Reviews and Meta-Analyses for Assessing the Effectiveness of Rehabilitation with Oral ImplantsCLINICAL IMPLANT DENTISTRY AND RELATED RESEARCH, Issue 2 2001Marco Esposito DDS Abstract: Background: It is difficult to determine the effectiveness or potential harm of dental therapies. Thus, any tools able to condense reliable scientific information would be of benefit. Purpose: To discuss methods for the assessment of the scientific literature and, in particular, of systematic reviews for evaluating the effectiveness of oral implant rehabilitation procedures. Materials and Methods: Various study designs and methods to identify scientific evidence are described, discussed, and ranked. Issues on how to critically appraise randomized controlled clinical trials (RCTs) and systematic reviews are presented. Results: Properly conducted RCTs and structured critical systematic reviews are the gold standard of clinical research for assessing whether a therapeutic intervention is effective. In the field of oral implantology, there is an urgent need to implement more RCTs and to summarize their results in systematic reviews. Conclusions: Searching of the truth requires training and critical skill. Dentists should be trained on how to integrate their clinical experience with evidence-based research and on how to discriminate between clinically useful scientific information and less useful research. [source] Screening for type 2 diabetes: an update of the evidenceDIABETES OBESITY & METABOLISM, Issue 10 2010R. K. Simmons A growing body of evidence on diabetes screening has been published during the last 10 years. Type 2 diabetes meets many but not all of the criteria for screening. Concerns about potential harms of screening have largely been resolved. Screening identifies a high-risk population with the potential to gain from widely available interventions. However, in spite of the findings of modelling studies, the size of the benefit of earlier initiation of treatment and the overall cost-effectiveness remains uncertain, in contrast to other screening programmes (such as for abdominal aortic aneurysms) that are yet to be fully implemented. There is also uncertainty about optimal specifications and implementation of a screening programme, and further work to complete concerning development and delivery of individual- and population-level preventive strategies. While there is growing evidence of the net benefit of earlier detection of individuals with prevalent but undiagnosed diabetes, there remains limited justification for a policy of universal population-based screening for type 2 diabetes at the present time. Data from ongoing studies should inform the key assumptions in existing modelling studies and further reduce uncertainty. [source] New use of rosiglitazone decreased following publication of a meta-analysis suggesting harmDIABETIC MEDICINE, Issue 7 2008B. R. Shah Abstract Aims It is uncertain whether meta-analyses lead to changes in prescribing practices. We studied trends in the prescribing of glucose-lowering therapy before and after the publication of a meta-analysis suggesting harm from rosiglitazone. Methods We examined the prescription records of all residents of Ontario, Canada, aged , 66 years. For each week between January and December 2007, we identified new users of five categories of glucose-lowering medications: rosiglitazone, pioglitazone, metformin, glibenclamide (glyburide) and insulin. The effect of the meta-analysis was assessed using interventional autoregressive integrated moving-average models. Results Following the release of the meta-analysis, there was a sudden decline in new users of rosiglitazone (P = 0.01), mirrored by a nearly identical but transient increase in new users of pioglitazone (P < 0.001). There was also a net decline in new users of thiazolidinediones as a class (P < 0.001). The number of new users of other glucose-lowering medications did not change. Conclusions A highly-publicized meta-analysis regarding rosiglitazone's potential harms led to an abrupt decline in new users of the drug, as well as a transient surge in new use of pioglitazone. [source] Barriers to reducing the use of restraints in residential elder care facilitiesJOURNAL OF ADVANCED NURSING, Issue 6 2007Kirsten Moore Abstract Title.,Barriers to reducing the use of restraints in residential elder care facilities Aim., This paper is a report of a study to compare perspectives of staff in residential elder care facilities with those of residents and family members from the same facilities about barriers to reducing the use of physical, chemical and environmental restraints. Background., There is growing research evidence of the potential risk of physical and emotional harm of restraining residents in residential elder care facilities. Despite the potential harms, restraints continue to be a common practice in facilities across Australia. Little research has been undertaken to explore the barriers to reducing the use of restraints. Method., Eighteen individual interviews were conducted with staff, general practitioners and a pharmacist and three focus groups were conducted with a total of 12 residents and 17 family members associated with three residential elder care facilities in Melbourne, Australia in 2004. Findings., The three participating facilities were committed to reducing the use of restraints, although physical, chemical and environmental restraints were used in all three facilities. Barriers to reducing restraint use included fear of resident injury, staff and resource limitations, lack of education and information about alternatives to restraints, environmental constraints, policy and management issues, beliefs and expectations (of staff, family and residents), inadequate review practices and communication barriers. Conclusion., Further education and support for staff and family members in evidence-based practice in relation to resident care and restraint use is needed in at least some residential elder care facilities. [source] International health electives: thematic results of student and professional interviewsMEDICAL EDUCATION, Issue 7 2010Andrew Petrosoniak Medical Education 2010: 44: 683,689 Objectives, The purpose of this study was to explore the complexities (including harms and benefits) of international health electives (IHEs) involving medical trainees. This exploration contributes to the ongoing debate about the goals and implications of IHEs for medical trainees. Methods, This qualitative study used anonymous, one-to-one, semi-structured interviews. All participants had previous international health experiences. Between September 2007 and March 2008, we interviewed a convenience sample of health care professionals (n = 10) and medical trainees (n = 10). Using a modified grounded theory methodology, we carried out cycles of data analysis in conjunction with data collection in an iterative and constant comparison process. The study's thematic structure was finalised when theme saturation was achieved. Results, Participants described IHEs in both negative and positive terms. IHEs were described as unsustained short-term contributions that lacked clear educational objectives and failed to address local community needs. Ethical dilemmas were described as IHE challenges. Participants reflected that many IHEs included aspects of medical tourism and the majority of participants described the IHE in negative terms. However, a few participants acknowledged the benefits of the IHE. Specifically, it was seen as an introduction to a career in global health and as a potential foundation for more sustainable projects with positive host community impacts. Finally, despite similar understandings among participants, self-awareness of medical tourism was low. Conclusions, International health electives may include potential harms and benefits for both the trainee and the host community. Educational institutions should encourage and support structured IHEs for trainee participation. We recommend that faculties of medicine and global health educators establish pre-departure training courses for trainees and that IHE opportunities have sufficient structures in place to mitigate the negative effects of medical tourism. We also recommend that trainees be provided with opportunities to conduct self-reflection and critically assess their IHE experiences. [source] Tracking Diabetes: New York City's A1C RegistryTHE MILBANK QUARTERLY, Issue 3 2009SHADI CHAMANY Context: In December 2005, in characterizing diabetes as an epidemic, the New York City Board of Health mandated the laboratory reporting of hemoglobin A1C laboratory test results. This mandate established the United States' first population-based registry to track the level of blood sugar control in people with diabetes. But mandatory A1C reporting has provoked debate regarding the role of public health agencies in the control of noncommunicable diseases and, more specifically, both privacy and the doctor-patient relationship. Methods: This article reviews the rationale for adopting the rule requiring the reporting of A1C test results, experience with its implementation, and criticisms raised in the context of the history of public health practice. Findings: For many decades, public health agencies have used identifiable information collected through mandatory laboratory reporting to monitor the population's health and develop programs for the control of communicable and noncommunicable diseases. The registry program sends quarterly patient rosters stratified by A1C level to more than one thousand medical providers, and it also sends letters, on the provider's letterhead whenever possible, to patients at risk of diabetes complications (A1C level >9 percent), advising medical follow-up. The activities of the registry program are similar to those of programs for other reportable conditions and constitute a joint effort between a governmental public health agency and medical providers to improve patients' health outcomes. Conclusions: Mandatory reporting has proven successful in helping combat other major epidemics. New York City's A1C Registry activities combine both traditional and novel public health approaches to reduce the burden of an epidemic chronic disease, diabetes. Despite criticism that mandatory reporting compromises individuals' right to privacy without clear benefit, the early feedback has been positive and suggests that the benefits will outweigh the potential harms. Further evaluation will provide additional information that other local health jurisdictions may use in designing their strategies to address chronic disease. [source] RESPONSIBILITY FOR CONTROL; ETHICS OF PATIENT PREPARATION FOR SELF-MANAGEMENT OF CHRONIC DISEASEBIOETHICS, Issue 5 2007BARBARA K. REDMAN ABSTRACT Patient self-management (SM) of chronic disease is an evolving movement, with some forms documented as yielding important outcomes. Potential benefits from proper preparation and maintenance of patient SM skills include quality care tailored to the patient's preferences and life goals, and increase in skills in problem solving, confidence and success, generalizable to other parts of the patient's life. Four central ethical issues can be identified: 1) insufficient patient/family access to preparation that will optimize their competence to SM without harm to themselves, 2) lack of acknowledgement that an ethos of patient empowerment can mask transfer of responsibility beyond patient/family competency to handle that responsibility, 3) prevailing assumptions that preparation for SM cannot result in harm and that its main purpose is to deliver physician instructions, and 4) lack of standards for patient selection, which has the potential to exclude individuals who could benefit from learning to SM. Technology assessment offers one framework through which to examine available data about efficacy of patient SM and to answer the central question of what conditions must be put in place to optimize the benefits of SM while assuring that potential harms are controlled. [source] | |||||||||||||