Ethics Committees (ethics + committee)

Distribution by Scientific Domains
Distribution within Medical Sciences

Kinds of Ethics Committees

  • research ethics committee

  • Terms modified by Ethics Committees

  • ethics committee approval

  • Selected Abstracts


    ABSTRACT Objective:, To identify perceived barriers to capacity building for local research ethics oversight in El Salvador, and to set an agenda for international collaborative capacity building. Methods:, Focus groups were formed in El Salvador which included 17 local clinical investigators and members of newly formed research ethics committees. Information about the proposed research was presented to participants during an international bioethics colloquium sponsored and organized by the St. Jude Children's Research Hospital in collaboration with the National Ethics Committee of El Salvador and the University of El Salvador. Interviews with the focus group participants were qualitatively analyzed. Results:, Participants expressed the need to tailor the informed consent process and documentation to the local culture; for example, allowing family members to participate in decision-making, and employing shorter consent forms. Participants indicated that economic barriers often impede efforts in local capacity building. Participants valued international collaboration for mutual capacity building in research ethics oversight. Conclusions:, Research ethics committees in El Salvador possess a basic knowledge of locally relevant ethical principles, though they need more training to optimize the application of bioethical principles and models to their particular contexts. Challenges increase the value of collaborative exchanges with ethics committee members in the United States. Further research on facilitating communication between host country and sponsor country ethics committees can maximize local research ethics expertise, and thus raise the standard of protecting human participants involved in international research. [source]


    BIOETHICS, Issue 8 2009
    ABSTRACT Clinical ethics committees have recently been established in nearly all Norwegian hospital trusts. One important task for these committees is clinical ethics consultations. This qualitative study explores significant barriers confronting the ethics committees in providing such consultation services. The interviews with the committees indicate that there is a substantial need for clinical ethics support services and, in general, the committee members expressed a great deal of enthusiasm for the committee work. They also reported, however, that tendencies to evade moral disagreement, conflict, and ,outsiders' are common in the hospitals. Sometimes even the committees comply with some of these tendencies. The committees agree that there is a need to improve their routines and procedures, clarify the committees' profile and field of responsibility, to make the committees well-known, to secure adequate operating conditions, and to develop organizational integration and support. Various strategies to meet these challenges on a local, regional or national level are also explored in this paper. [source]


    BIOETHICS, Issue 3 2006
    ABSTRACT Prominent international and national ethics commissions such as the UNESCO International Bioethics Committee rarely achieve anything remotely resembling gender equality, although local research and clinical ethics committees are somewhat more egalitarian. Under-representation of women is particularly troubling when the subject matter of modern bioethics so disproportionately concerns women's bodies, and when such committees claim to derive ,universal' standards. Are women missing from many ethics committees because of relatively straightforward, if discriminatory, demographic factors? Or are the methods of analysis and styles of ethics to which these bodies are committed somehow ,anti-female'? It has been argued, for example, that there is a ,different voice' in ethical reasoning, not confined to women but more representative of female experience. Similarly, some feminist writers, such as Evelyn Fox Keller and Donna Haraway, have asked difficult epistemological questions about the dominant ,masculine paradigm' in science. Perhaps the dominant paradigm in ethics committee deliberation is similarly gendered? This article provides a preliminary survey of women's representation on ethics committees in eastern and western Europe, a critical analysis of the supposed ,masculinism' of the principlist approach, and a case example in which a ,different voice' did indeed make a difference. [source]


    ABSTRACT Objective:, To identify perceived barriers to capacity building for local research ethics oversight in El Salvador, and to set an agenda for international collaborative capacity building. Methods:, Focus groups were formed in El Salvador which included 17 local clinical investigators and members of newly formed research ethics committees. Information about the proposed research was presented to participants during an international bioethics colloquium sponsored and organized by the St. Jude Children's Research Hospital in collaboration with the National Ethics Committee of El Salvador and the University of El Salvador. Interviews with the focus group participants were qualitatively analyzed. Results:, Participants expressed the need to tailor the informed consent process and documentation to the local culture; for example, allowing family members to participate in decision-making, and employing shorter consent forms. Participants indicated that economic barriers often impede efforts in local capacity building. Participants valued international collaboration for mutual capacity building in research ethics oversight. Conclusions:, Research ethics committees in El Salvador possess a basic knowledge of locally relevant ethical principles, though they need more training to optimize the application of bioethical principles and models to their particular contexts. Challenges increase the value of collaborative exchanges with ethics committee members in the United States. Further research on facilitating communication between host country and sponsor country ethics committees can maximize local research ethics expertise, and thus raise the standard of protecting human participants involved in international research. [source]

    Electrical Stimulation of the Hippocampal Epileptic Foci for Seizure Control: A Double-Blind, Long-Term Follow-Up Study

    EPILEPSIA, Issue 10 2007
    Ana Luisa Velasco
    Summary:,Purpose: Our aim was to evaluate the safety and efficacy of electrical stimulation of the hippocampus in a long-term follow-up study, as well as its impact on memory performance in the treatment of patients with refractory mesial temporal lobe epilepsy. Methods: Nine patients were included. All had refractory partial complex seizures, some with secondary generalizations. All patients had a 3-month-baseline-seizure count, after which they underwent bilateral hippocampal diagnostic electrode implantation to establish focus laterality and location. Three patients had bilateral, and six, unilateral foci. Diagnostic electrodes were explanted and definitive Medtronic electrodes were implanted directed into the hippocampal foci. Position was confirmed with MRI and afterwards, the deep brain stimulation system internalized. Patients signed the informed consent approved by the Hospital's Ethics Committee and began a double-blind stimulation protocol. Patients attended a medical appointment every 3 months for seizure diary collection, deep brain stimulation system checkup, and neuropsychological testing. Results: Follow-up ranged from 18 months to 7 years. Patients were divided in two groups: five had normal MRIs and seizure reduction of >95%, while four had hippocampal sclerosis and seizure reduction of 50,70%. No patient had neuropsychological deterioration, nor did any patient show side effects. Three patients were explanted after 2 years due to skin erosion in the trajectory of the system. Conclusions: Electrical stimulation of the hippocampus provides a nonlesional method that improves seizure outcome without memory deterioration in patients with hippocampal epileptic foci. [source]

    The role of stem cells in suppurative environments

    Dolores Herreros
    Purpose:,The management of suppurative perianal lesions presents an extremely challenging problem. Stem cells (SC) extracted from certain tissues, such as adipose tissue, can differentiate into various cell types. Therefore, we have tried to use such cells to stimulate healing in a purulent environment. Methods:,In the beginning, we designed a phase I clinical trial, involving five patients with Crohn's disease. We inoculated nine fistulas in four patients with autologous adipose-derived stem cells (ADSC) and were followed at least 8 weeks. Seventy-five percent became healed, and 25% showed a decrease in output flow. No adverse effects were observed in any patient. This study evidenced that such cells are safe. Then, we started a research line using SC in different suppurative environments. During the course of these studies, we had the opportunity to treat a patient with perianal hidradenitis suppurativa using our current protocol of ADSC transplantation. Eight weeks after injection, patient had no perianal suppuration, and a year later remains well. Discussion:,The biological mechanism that underlies the therapeutic success of ADSC transplantation is unknown. Cell differentiation, secretion of growth factors or immunomodulatory effects have been suggested. No ethical conflicts were identified by our Ethics Committee, because the cells were autologous. Conclusions:,Our study shows that ADSC are safe for the treatment of suppurative processes. The actual number of patients included and the uncontrolled nature of these pilot studies do not allow demonstration of the effectiveness of the treatment. However, the results encourage the performance of further studies. [source]

    ,The geriatric hospital felt like a backwater': aspects of older people's nursing in Britain, 1955,1980

    Jane Brooks
    Aims and objectives., The aim of this article is to examine the experiences of ward-level nurses who cared for older people in general hospitals between 1955,1980. Background., There is very little published on the history of older adult nursing and no recent material from the United Kingdom. There are, however, the works of Cecily Hunter in Australia and Erica Roberts in Canada. It is the intention of this study to contribute to this important area of research. Design., This is an oral history project in which 20 nurses who had worked on older adults ward between 1955,1980 were interviewed. Methods., All the interviews were taped, transcribed and data-themed. Ethical clearance for the project was obtained from the University Ethics Committee and all participants were anonymised. Results., Many of the nurses found the experience very difficult, though there were exceptions. Several participants had worked on older adults ward during their training and then had never wanted to return. Most described a paucity of resources and longevity of staff on the wards. Conclusions., Using the sociological theory of Erving Goffman, this article introduces a novel method of understanding nursing history, although his ideas have been used in medical history. The value of his theories for this study is in the identification of nurses as being part of the same system as the patients themselves. Implications for contemporary policy, research and/or practice., For nurses to care effectively for their patients, nurses themselves must be valued. Subordination and regimentation tend to dehumanise the carers which, in turn, dehumanises the cared for. [source]

    Lower urinary tract symptoms: a hermeneutic phenomenological study into men's lived experience

    BSc (Hons), Mark Wareing MSc
    Aim., This was an investigation to discover the lived experience of men with lower urinary tract symptoms arising from benign prostatic hyperplasic. Design., A hermeneutic phenomenological study. Methods., Approval was granted by the local Applied and Qualitative Research Ethics Committee (AQREC) prior to the commencement of the study. Data were gathered via semi-structured interviews that were audio taped, and subsequently transcribed. Each transcripted interview was analysed by the investigator and a team of ,expert readers'. The team agreed on a total of 57 sub-themes divided into seven categories with unanimity, therefore obviating the need for participant validation. Findings., The major findings of the study suggest that men experience a broad and dramatic spectrum of phenomena while living with a benign prostate condition. This includes profound embarrassment, fear, revulsion as well as humour that require a range of methods and life adjustments to manage and contain their symptoms. Conclusions., The participant's narratives provide a thick, rich and meaningful insight into how men understand their bodies, and make sense of prostate disease; a significant men's health issue. Relevance to clinical practice., Several studies have already been published describing men's lived experience of prostate surgery for benign prostatic hyperplasia. This research has captured men's lived experience of lower urinary tract symptoms ahead of surgical intervention. Men experience a broad scope of phenomena resulting from life with a benign prostate condition that encompasses fear and embarrassment and the development of coping mechanisms and changes in life style. Recent media awareness campaigns to raise public awareness of prostate disease as a men's health issue appear to be changing how men perceive their bodies, how they converse with one another, and their help seeking behaviour. [source]

    Genetic polymorphism of CYP2C8 in three Malaysian ethnics: CYP2C8*2 and CYP2C8*3 are found in Malaysian Indians

    Y. D. Muthiah PhD candidate
    Summary Background:,CYP2C8 is genetically polymorphic. Four variants, CYP2C8*2, CYP2C8*3, CYP2C8*4 and CYP2C8*5, which contain mutations in the coding regions have been reported to exhibit different enzyme activity as compared with CYP2C8*1. Objective:, To determine the allele frequency of three codon-changing variants (CYP2C8*2, CYP2C8*3 and CYP2C8*4) in the Malaysian population. Method:, Healthy unrelated volunteers from three major races in Malaysia were recruited. The study was approved by the local Research Ethics Committee. DNA was extracted using a standard protocol. A two-step multiplex PCR method was developed to detect three alleles of CYP2C8. PCR results were confirmed by subsequent direct DNA sequencing. Result:, Only the Indians showed CYP2C8 polymorphism with allele frequency of 98% for CYP2C8*1, 0·8% for CYP2C8*2 and 1·2% for CYP2C8*3. CYP2C8*4 was not detected in any of the ethnic groups. Conclusion:, To the best of our knowledge, the current study described, for the first time polymorphisms of CYP2C8 in Malaysian Indians. [source]

    The efficacy of dietetic intervention in patients with chronic obstructive pulmonary disease

    L. Bottle
    Background:, Clinical trials have shown that pulmonary rehabilitation can improve the functional status and quality of life of chronic obstructive pulmonary disease (COPD) patients (Lacasse, 2006) but there is no research examining the efficacy of group dietetic intervention during standard 8 week rehabilitation courses. Current input is usually limited to a 1 h nutrition education session. This pilot study aimed to investigate whether patients receiving additional dietetic intervention during pulmonary rehabilitation significantly increased their general nutritional knowledge, thereby facilitating improvements in dietary intake and nutritional status. Methods:, Patients were recruited from two courses of pulmonary rehabilitation and randomly allocated to a control group or an intervention group. Anthropometry (height, weight, body mass index, mid arm circumference and triceps skinfold), 3 day food diaries and nutritional knowledge questionnaires covered guidelines, food groups, choosing healthy options and diet and COPD were completed at baseline and at the end of 8 weeks. In week 2 both groups received the same nutrition education session which covered healthy eating during periods of stability as well as advice on coping with loss of appetite and reduced intake during illness and exacerbations. The intervention group was followed up during weeks 4, 6 and 7 when further anthropometric measurements were taken and additional dietary advice was provided, which addressed issues raised by individual patients. Information from food diaries was converted to nutrients using Windiets dietary analysis software. Statistical analyses were carried out using SPSS (v14) and included Mann,Whitney U non parametric tests, paired t -tests and Spearman correlations used for comparisons over time and between groups. For analysis purposes patients were classified as normal weight (NW) and overweight (OW). Approval was obtained from the appropriate Ethics Committee. Results:, Changes reported were not statistically significant (P > 0.05). Complete data sets were obtained for six control (NW = 2, OW = 4) and five intervention (NW = 1, OW = 4) patients. Nutritional knowledge increased in the control group by 5% compared to 3% in the intervention group. Control NW patients increased their energy intake resulting in a mean weight gain of 0.5 kg (SD 3.3). OW control group patients increased their energy intake by 12.4% (16.9) with a mean weight gain of 0.2 kg (2.5). All control patients increased their intake of in total fat, saturated fatty acids (SFA), sugars and sodium. Conversely there was a decrease in energy intake in the intervention group of 14.4% (17.8) and a mean weight loss of 1.5 kg (1.2) (three out of four overweight patients lost weight). Improvements in diet were shown with reduced intakes of total fat, SFA, sugars and sodium. The NW patient in the intervention group regained weight that had previously been lost. These changes did not correlate with changes in nutritional knowledge. Discussion:, An increase in nutritional knowledge was expected to facilitate appropriate changes in dietary intake and nutritional status. Despite the lack of correlation between dietary knowledge and intake, beneficial outcomes were none-the-less observed in the intervention group. The trend for weight gain in OW control group patients, and weight loss in OW intervention group patients contrasted with results seen by Slinde et al. (2002) where the control OW patients lost weight, and OW intervention patients gained weight. It is possible that in the current study, patients in the intervention group were motivated to lose weight with repeated exposure to the dietitian, rather than an increase in nutritional knowledge. Significant anthropometrical changes were unlikely to be observed in 8 weeks, and further follow up may be necessary to establish sufficient evidence for the most efficacious level of dietetic intervention. The small sample sizes, especially with regard to weight sub groups, limits the conclusions which can be drawn. Further research is recommended, using a larger sample size, in order to make recommendations for dietetic best practice. Conclusion:, The results of this study did not show statistical significance and the association between nutritional knowledge and improved nutritional outcomes remains unclear. However, the findings may have clinical significance since they appear to show that additional dietetic intervention may benefit the nutritional status of patients with COPD attending pulmonary rehabilitation. References, Lacasse, Y., Goldstein, R., et al. (2006) Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst. Rev. 4, CD003793. Slinde, F., Gronberg, A.M., et al. (2002) Individual dietary intervention in patients with COPD during multidisciplinary rehabilitation. Respir. Med. 96, 330,336. [source]

    Fluoroscopic guidance of Arndt endobronchial blocker placement for single-lung ventilation in small children

    Background: Thoracoscopic surgery may require single-lung ventilation (SLV) in infants and small children. A variety of balloon-tipped endobronchial blockers exist but the placement is technically challenging if the size of the tracheal tube does not allow the simultaneous passage of the fibreoptic scope and the endobronchial blocker. This report describes a technique for endobronchial blocker insertion using fluoroscopic guidance in children undergoing SLV. Methods: After approval from the local Medical Ethics Committee and parental consent, 18 patients aged 2 years or younger scheduled for thoracic surgery requiring SLV were prospectively included. Following induction of anesthesia, a 5 Fr endobronchial blocker (Cook® Arndt endobronchial blocker) was inserted first into the trachea under direct laryngoscopy. Correct placement in the main bronchus was assessed by fluoroscopy and tracheal intubation next to the endobronchial blocker. Optimal position and balloon inflation was verified using a fibreoptic scope. The duration and number of insertion attempts as well as age, weight and size of the tracheal tube were recorded. Results: Eighteen patients were studied. Median (range) age and weight were 12 (0.2,24) months and 11.2 (4,15) kg, respectively. SLV was successfully achieved in all patients using a 5 Fr endobronchial blocker outside a 3.5,4.5 mm ID tracheal tube within 11.2 (±2.2) min. No side effects were observed during the procedure. Conclusion: Fluoroscopic-guided insertion of extraluminal endobronchial blocker is an effective and reliable tool to place Arndt endobronchial blockers in small children. [source]

    Differences among forced-air warming systems with upper body blankets are small.

    A randomized trial for heat transfer in volunteers
    Background:, Forced-air warming is known as an effective procedure in prevention and treatment of perioperative hypothermia. Significant differences have been described between forced-air warming systems in combination with full body blankets. We investigated four forced-air warming systems in combination with upper body blankets for existing differences in heat transfer. Methods:, After approval of the local Ethics Committee and written informed consent, four forced-air warming systems combined with upper body blankets were investigated in a randomized cross-over trial on six healthy volunteers: (1) BairHuggerŌ 505 and Upper Body Blanket 520, Augustine Medical; (2) ThermaCareŌ TC 3003, GaymarŌ and OptisanŌ Upper Body Blanket, Brinkhaus; (3) WarmAirŌ 134 and FilteredFlowŌ Upper Body Blanket, CSZ; and (4) WarmTouchŌ 5800 and CareDrapeŌ Upper Body Blanket, Mallinckrodt. Heat transfer from the blanket to the body surface was measured with 11 calibrated heat flux transducers (HFTs) with integrated thermistors on the upper body. Additionally, the blanket temperature was measured 1 cm above the HFT. After a preparation time of 60 min measurements were started for 20 min. Mean values were calculated over 20 min. The t -test for matched pairs with Bonferroni-Holm-correcture for multiple testing was used for statistical evaluation at a P -level of 0.05. The values are presented as mean±SD. Results:, The WarmTouchŌ blower with the CareDrapeŌ blanket obtained the best heat flux (17.0±3.5 W). The BairHuggerŌ system gave the lowest heat transfer (8.1±1.1 W). The heat transfer of the ThermaCareŌ system and WarmAirŌ systems were intermediate with 14.3±2.1 W and 11.3±1.0 W. Conclusions:, Based on an estimated heat loss from the covered area of 38 W the heat balance is changed by 46.1 W to 55 W by forced-air warming systems with upper body blankets. Although the differences in heat transfer are significant, the clinical relevance of this difference is small. [source]

    The efficacy of a subhypnotic dose of propofol in preventing laryngospasm following tonsillectomy and adenoidectomy in children

    Summary Background:, Laryngospasm is a well-known problem typically occurring immediately following tracheal extubation. Propofol is known to inhibit airway reflexes. In this study, we sought to assess whether the empiric use of a subhypnotic dose of propofol prior to emergence will decrease the occurrence of laryngospasm following extubation in children. Methods:, After approval from the Institutional Ethics Committee and informed parental consent, we enrolled 120 children ASA physical status I and II, aged 3,14 years who were scheduled to undergo elective tonsillectomy with or without adenoidectomy under standard general anesthesia. Before extubation, the patients were randomized and received in a blinded fashion either propofol 0.5 mg·kg,1 or saline (control) intravenously. Tracheal extubation was performed 60 s after administration of study drug, when the child was breathing regularly and reacting to the tracheal tube. Results:, Laryngospasm was seen in 20% (n = 12) of the 60 children in the control group and in only 6.6% (n = 4) of 60 children in the propofol group (P < 0.05). Conclusions:, During emergence from inhalational anesthesia, propofol in a subhypnotic dose (0.5 mg·kg,1) decreases the likelihood of laryngospasm upon tracheal extubation in children undergoing tonsillectomy with or without adenoidectomy. [source]

    The effects of Masai Barefoot Technology, footwear on posture: an experimental designed study

    Paul New
    Introduction.,This study was approved by the University of Southampton Ethics Committee. The aim of the study was to assess the anatomical changes to upright posture that occur in the sagittal plane as a result of wearing Masai Barefoot Technology (MBT) footwear during standing and walking. MBT claims that its innovative unstable shoes promote a more upright posture in which musculature is strengthened and joint wear reduced (Amann and Amann, 2004). This could be helpful in the management and prevention of conditions such as osteoarthritis and back pain. Method.,Twelve students (six male and six female), aged between 18 and 40 years, at the University of Southampton participated in the study. Participants attended one session at a biomechanics laboratory. The kinematics of posture while wearing MBT shoes during standing and gait were examined, using a two-dimensional motion analysis system, and compared to a control shoe. Statistical significance was tested by use of a paired t -test and a Wilcoxon signed-ranks test. Results.,Students standing in MBT footwear demonstrated a statistically significant increase in plantar flexion at the ankle joint (p = 0.025; mean flexion 3.02°; 95% confidence interval [95% CI] ,5.6 to ,0.4). Walking in MBT shoes showed a decrease in trunk flexion (p = 0.007; mean flexion 1.44°; 95% CI ,2.4 to ,0.4) and a reduction in anterior tilt of the pelvis (p = 0.003; mean tilt 3.20°; 95% CI ,5.06 to ,1.35) at heel strike. At toe-off a significant reduction in anterior pelvic tilt (p = 0.035; mean tilt 2.35°; 95% CI) was found in the MBT shoes. There was no significant difference found between the two shoe conditions at mid-stance, pelvic tilt (p = 0.53; mean tilt 1.83 degrees) trunk flexion (p = 0.05; mean flexion 0.95 deg). Conclusion.,MBT footwear changes certain characteristics of posture in quiet standing and walking. These findings could have positive implications for the management of conditions such as osteoarthritis and back pain; however, further research is needed. Copyright © 2007 John Wiley & Sons, Ltd. [source]

    The Declaration of Istanbul: Review and Commentary by the American Society of Transplant Surgeons Ethics Committee and Executive Committee

    A. I. Reed
    The American Society of Transplant Surgeons (ASTS) was asked to endorse the ,The Declaration of Istanbul on Organ Trafficking and Transplant Tourism.' The document has been reviewed by the ASTS Ethics Committee and their ensuing report was presented, discussed and approved by the ASTS Council. The ASTS vigorously supports the principles outlined in the Declaration and details specific current obstacles to implementation of some of its proposals in the United States. [source]

    Stimulus for Organ Donation: A Survey of the American Society of Transplant Surgeons Membership

    J. R. Rodrigue
    Federal legislation has been proposed to modify the National Organ Transplant Act in a way that would permit government-regulated strategies, including financial incentives, to be implemented and evaluated. The Council and Ethics Committee of the American Society of Transplant Surgeons conducted a brief web-based survey of its members' (n = 449, 41.6% response rate) views on acceptable or unacceptable strategies to increase organ donation. The majority of the membership supports reimbursement for funeral expenses, an income tax credit on the final return of a deceased donor and an income tax credit for registering as an organ donor as strategies for increasing deceased donation. Payment for lost wages, guaranteed health insurance and an income tax credit are strategies most strongly supported by the membership to increase living donation. For both deceased and living donation, the membership is mostly opposed to cash payments to donors, their estates or to next-of-kin. There is strong support for a government-regulated trial to evaluate the potential benefits and harms of financial incentives for both deceased and living donation. Overall, there is strong support within the ASTS membership for changes to NOTA that would permit the implementation and careful evaluation of indirect, government-regulated strategies to increase organ donation. [source]

    Ensuring the Safety of Living Kidney Donors and Recipients in China Through Ethics Committee Oversight: An Early Experience

    Z. Lei
    In 2007, the Regulation on Human Organ Transplantation was enacted in China requiring the establishment of ethics committees to oversee living donor organ transplantation and establishing specific requirements that must be met. We established an Ethics Committee on Organ Transplantation at Peking University Third Hospital, and described its composition, its methods and operating procedures in the examination and approval of living-related donor kidney transplantation (LRDKT) and our initial experience. All 60 proposed cases of LRDKT were presented to the Ethics Committee for discussion, among which 53 cases were approved and seven cases were disapproved due to a variety of reasons that are discussed. The Ethics Committee on Organ Transplantation plays an important role in the ethical oversight of living-related donor organ transplantation in order to ensure to the greatest extent possible the safety, rights and interests of donors and recipients. [source]

    Improving the quality of cervical screening

    Samuel George
    Objective To compare the adequacy of cervical cytology sampling by a newly designed cervical cell sampler (the implement) with a commonly used, extended tip cervical scraper, namely the Jordan's spatula, by assessing the quality of cervical smears obtained. Design Prospective randomised controlled trial, with the approval of the local Ethics Committee after informing the Medical Devices Agency in the UK. Setting Colposcopy Clinic in a District General NHS Trust Hospital in London. Population Women attending the Colposcopy Clinic and having a good command of the English language (to avoid any misinterpretation of the information and enabling them to give informed consent) were invited to take part. Two hundred and twenty patients were recruited. Methods The women were randomised into two groups, each of them having two smears at the same time, half of them having their first smear with the Jordan's spatula and the other half having the first smear with the new implement. Main outcome measure Good quality smears, assessed by evidence of effective sampling of the transformation zone, including immature metaplastic cells and also endocervical cells. Results Fifty-four percent of smears taken by the new implement showed good quality smears, compared with 37% taken by Jordan's spatula, a statistically significant result with P value <0.001. Conclusion A larger number of good quality smears, judged by evidence of sampling of transformation zone and presence of endocervical cells, were obtained with the new implement. The difference was statistically significant. This would enhance the ability to detect dyskaryosis and increase adequate smear rates, reducing unnecessary recall of patients for repeat smears. [source]

    Biosynthetic corneas , evaluation in humans

    Collagen-based biosynthetic corneas, designed to mimic the extracellular matrix of the corneal stroma have been developed and extensively evaluated in animal models over the last 7 years. Human recombinant collagen type III (RHC III) was crosslinked with water-soluble carbodiimides and fabricated into optically transparent corneal substitutes for transplantation. Following study approval of the Medical Product Agency, Sweden and the Human Ethics Committee, University of Linköping, Sweden, a Phase I study was initiated. 10 patients who were scheduled for corneal grafting were enrolled into the study. Nine had keratoconus and one had a deep scar following Pseudomonas keratitis. A central 6 mm diameter deep lamellar button was excised and was replaced by a 6.25 mm diameter 500 µm thick construct. Six overlying sutures were used to anchor the graft. Topical 0.1% dexametasone and chloramphenicol was used for the first 1 month postoperatively. The sutures were removed after 5-7 weeks. The patients were followed clinically and evaluated for UCVA, BSCVA and VA with contact lenses. Corneal touch sensitivity (Cochet-Bonnet) and tear production (Schirmer ) were tested. Photography, OCT (Visante), topography (Orbscan II) and in vivo confocal microscopy (Heidelberg) was documented. After 3 months all patients had stably epithelialized and implants were anchored by recipient keratocyte ingrowth. The mean BSCVA at 6 months (20/133) improved slightly at 12 months (20/90). The mean BCLCVA was 20/50 at 12 months and was notably better in younger patients (mean of 20/40 in the 5 youngest). One patient had BCLVA of 20/20 at 12 months. The mean central corneal thickness was stable between 3 and 12 months at about 400µm. The mean 5min Schirmer values were 20 ± 10mm in operated eyes and 17 ± 8 mm in fellow eyes. At 12 months the mean touch sensitivity was 25mm in operated eyes and 60mm in fellow eyes, which was the same as in penetrating grafts. In-vivo confocal microscopy revealed the ingrowth of corneal nerves at the subbasal epithelium. We have shown for the first time that bioengineered collagen-based corneal substitutes are fully compatible and promote regeneration of corneal cells. The 18 months follow-up results will be presented aswell. [source]

    Physician attitudes towards ventilatory support for spinal muscular atrophy type 1 in Australasia

    Nimeshan Geevasinga
    Background: Without ventilatory support, premature death from respiratory insufficiency is virtually universal in infants with spinal muscular atrophy type 1 (SMA1). With mechanical ventilation, however, long-term survival has been reported from numerous international centres. We aimed to characterize physician attitudes to the various forms of ventilatory support for children with SMA1. Methods: We surveyed neurologists, respiratory physicians, clinical geneticists and intensivists from all major paediatric hospitals in Australia and New Zealand regarding their views on ventilatory management of SMA1. Results: Ninety-two of the 157 (59%) physicians surveyed replied. Respondents included 16 clinical geneticists, 19 intensive care physicians, 28 neurologists and 29 respiratory physicians. Almost half (47%) opposed invasive ventilation of children with SMA1 and respiratory failure precipitated by intercurrent illness. The majority (76%) opposed invasive ventilatory support for chronic respiratory failure in SMA1. In contrast, non-invasive ventilation was felt by 85% to be appropriate for acute respiratory deteriorations, with 49% supporting long-term non-invasive ventilatory support. Most physicians felt that decisions regarding ventilation should be made jointly by parents and doctors, and that hospital Clinical Ethics Committees should be involved in the event of discordant opinion regarding further management. A majority felt that a defined hospital policy would be valuable in guiding management of SMA1. Conclusions: Respiratory support in SMA1 is an important issue with significant ethical, financial and resource management implications. Most physicians in Australian and New Zealand oppose invasive ventilatory support for chronic respiratory failure in SMA1. Non-invasive ventilation is an accepted intervention for acute respiratory decompensation and may have a role in the long-term management of SMA1. Clinical Ethics Committees and institutional policies have a place in guiding physicians and parents in the management of children with SMA1. [source]

    Role of Ethics Committees, Ethics Networks, and Ethics Centers in Improving End-of-Life Care

    PAIN MEDICINE, Issue 2 2001
    Myra Christopher BS
    This article chronicles the work of Midwest Bioethics Center, several community-state partnerships, and other local and national initiatives to determine their proper role and appropriate contribution. Professional education and development, institutional reform, and community engagement are areas of concern because ethics committees, networks, and centers sponsor workshops and conferences on palliative care for healthcare professionals, hold public forums, develop advance care planning projects, and provide expertise to legislators and other policymakers. The leading edge of the work being done by ethics committees, networks, and centers appears to be using continuous quality improvement methods, specifically the development of quality indicators, to promote accountability in end-of-life care reform efforts. This work is something that ethics committees can and should take on. [source]

    Gaining ethical approval for research into sensitive topics: ,two strikes and you're out?',

    Sarah-Jane Hays
    Summary Researching sensitive topics, such as the treatment of men with intellectual disabilities and sexually abusive behaviour, present a number of ethical issues for researchers. This paper describes our experiences in working with Multi-Centre Research Ethics Committees on a research proposal designed to assess the efficacy of cognitive behaviour therapy for men with intellectual disabilities who are at risk of sexual offending. After submitting to three Multi-Centre Research Ethics Committees and spending a year trying to get ethical approval, we questioned whether: , , the issue of study design should be part of the Multi-Centre Research Ethics Committees remit; , , Multi-Centre Research Ethics Committees were sufficiently responsive to concerns raised by researchers; , , Multi-Centre Research Ethics Committees always understood the research; and , , the Central Office for Research Ethics Committees should disallow re-submission after rejection by two Multi-Centre Research Ethics Committees (,two strikes and you're out'). [source]

    The development of pressure ulcers in patients with hip fractures: inadequate nursing documentation is still a problem

    Lena Gunningberg MSC RN
    The aims of the study were to investigate, on a daily basis: (i] the development and progress of pressure ulcers, (ii) the documented nursing interventions for prevention and treatment of pressure ulcers, and (iii) when nursing interventions regarding prevention and treatment of pressure ulcers were documented, in relation to patient risk status and the development of pressure ulcers. The study design was prospective, comparative and descriptive. A total of 55 patients with hip fracture were included. To facilitate the nurse's assessment, a ,pressure ulcer card' was developed, consisting of the Modified Norton Scale (MNS) and descriptions of the four stages of pressure ulcers. The incidence of pressure ulcers was 55%. The mean rank of the lowest MNS score was significantly lower for patients who developed pressure ulcers than for patients without pressure ulcers. The majority of the pressure ulcers occurred between admission to the ward and the fourth day after surgery. Documented interventions regarding prevention and treatment were: repositioning, overlays, cushions, use of lotion and observation. The mean number of interventions per patient was 2·2 for patients who developed pressure ulcers during their hospital stay. The comprehensiveness and quality of the nursing record was unsatisfactory, and only three nursing records reached the level required by Swedish law. Preventive interventions such as repositioning were documented when the pressure ulcer had already occurred. The lack of nursing documentation regarding prevention and treatment of pressure ulcers may indicate that nurses did not identify pressure ulcers as a prioritized nursing problem for this patient group. The Modified Norton Scale could be a valuable tool for nurses, both identifying the patient at risk and acting as a guide for nursing interventions. The study was approved by the ethics committee of the Faculty of Medicine at Uppsala University. [source]

    Lucidity in a woman with severe dementia related to conversation.

    A case study
    Aims and objectives., The aim of this study was to explore the presence of lucidity in a woman with severe dementia during conversations and whether it occurred when conversational partners or the woman with severe dementia initiated the conversation topics about the present, past or future time and whether she was presented with support or demands during the conversation. Background., Communication problems as well as episodes of lucidity in people with dementia are reported in the literature. Design., A researcher held 20 hours of conversation with a woman with severe dementia. A daughter participated for about three and a half hours. The conversation was tape-recorded and transcribed verbatim. Methods., The text was divided into units of analysis. Each unit of analysis was then assessed separately and discussed among the authors. Chi-square tests and logistic regression analysis were performed. An ethics committee approved the study. Results., The woman as initiator of the conversation topic and support to the women during conversation from the conversation partner were found to be the most significant factors explaining lucidity, while conversation about the present or past time showed no connection with lucidity. Very few topics (n = 7) concerned future time and they were not used in the statistical analysis. The researcher initiated 41%, the woman 43% and the daughter 16% of the topics. Support was registered in 49%, demands in 15% and both support and demands in 16% of the units of analysis. There were 58% topics about present and 40% about the past time. Conclusions., The presented study is a case study and the results cannot be generalized. For the woman with severe dementia, lucidity was promoted by the conversational parties carefully focusing on conversation topics initiated by the woman while supporting her during conversation. Relevance to clinical practice., To share the same perception of reality, focusing on the topics initiated by the patient with severe dementia and a supporting attitude to what the patient tells, will hopefully give more episodes of lucidity in the patient. This approach in caring for patients with severe dementia might give more meaning and well-being to the conversational partners in daily care. [source]

    Caterers' experiences and perceptions of implementing the 2006 school meal standards

    C.J. Weir
    Background:, School meal standards were introduced in 2006 (Department for Education and Skills) and caterers are expected to comply with these standards. No research has been conducted looking at the caterer's experiences and perceptions of implementing these standards. This area has 32 school meal provider organisations for 103 schools. Half the schools are with one provider and the others are, mostly, single-handed in-house operations, often managed by a local community member. The aim of the current study was to explore caterers' understanding of the school meal standards, the barriers to implementation, and proposed solutions, to inform local practice. Methods:, A combined quantitative and qualitative design was used. A questionnaire was used to assess understanding and implementation of the standards and distributed to all the catering provider organisations (n = 32), with a good response rate of 78% (n = 25). For each question about achievement of the ten food-based standards the responses were scored 0,4 where: 0 = ,Do not intend to achieve this standard'; to 4 = ,Fully achieved'. This gave a total standards achievement score for each catering provider organisation, where the minimum score that could be achieved was zero which indicated the minimum level of achievement and the maximum score which could be achieved was forty which indicated all ten standards fully achieved. Four focus group were undertaken involving 40 people who considered themselves to be in a management role within a catering provider organisation. Semi structured interviews were undertaken with 11 people (until saturation), using purposive sampling, to explore barriers and solutions to implementation of the standards in detail. Descriptive and appropriate inferential statistics (Fisher's Exact tests and independent samples t- tests) were performedon the datausingStatistical Package for Social Sciences (SPSS). The process undertaken for the qualitative analysis was thematic analysis, and used analytic hierarchy (Richie & Lewis, 2003). Approval for this study was obtained from Leeds Metropolitan University ethics committee. Results:, The qualitative discussions led to caterers' identifying two main themes. These were: support from various groups, and the roles and responsibilities caterers believed these groups had and should be performing in order to achieve successful implementation of the standards ,Think it's good someone's shaken up school meals but who is doing the actually work , it's us isn't it'.(Semi structured interview respondent medium primary provider) ,I've found it really difficult as I'm on my own at the school, totally on my own without anyone to help'. (Focus group participant primary school group). The groups that caterers identified as those who had roles and responsibilities and who should be providing support were the ,whole school'; catering provider organisations; parents; the local authority; and, the broader environment/whole population. Caterers felt the standards had ,gone too far too soon' and did not allow choice. Caterers felt finances were a barrier, and that training was required across all sectors to achieve success. The standards implementation achievement score were statistically higher for caterers who had received formal training compared with those with only food and hygiene (P = 0.001); and, between caterers who provided to a secondary school as opposed to a primary school only (P = 0.034). There was a statistically significant relationship between providers and qualifications with those providing to secondary schools more likely to have had formal qualifications (P = 0.015). Discussion:, Caterers felt all those involved in schools and school meals needed to undertake their roles and responsibilities, to provide support, and, to implement the ethos of a whole school approach. The caterers in this study identified many barriers and practical obstacles either experienced or perceived to implementing the new school meals standards. Conclusions:, The results will be used to inform the Local Authority and Primary Care Trust to ensure the effective implementation of the school meal standards. There may be opportunity to transfer these results to other school caterers, and to develop support and training to assist implementation. [source]

    Improving food purchasing choices through increased understanding of food labels, using itemized till receipts to measure these changes

    P.M. Rigby
    Background:, Rising obesity and the associated risks of diabetes and heart disease require changes in diet to bring about healthier eating. To achieve this, people need to understand nutrition and daily requirements but are frequently confused by nutrition information on food labels. The introduction of the Food Standards Agency's ,Traffic Light' and the alternative ,Guideline Daily Amount' systems may help or further confuse the public. A previous study showed that although 63% of study participants read labels, only 25% claimed to understand them, also knowledge of nutrient requirements and functions was low (Rigby, 2004). Ransley et al., (2001) have shown that till receipts can be used to estimate fat and energy intake. The aim of the current study was to investigate whether an intervention designed to improve understanding of nutrition and labels could improve food purchases and whether these changes could be measured from till receipts. Method:, Participants were recruited from the general public (80 female; 23 males) (age <30 years (23), 31,45 years (25), 46,60 years (30), >60 years (22). Subjects were randomly assigned to either the intervention group (n = 78) who were provided with an information booklet and credit card sized nutrition and labelling information to use when shopping, or the control group (n = 25), who received the information after four weeks of normal shopping. The intervention group provided an initial till receipt pre intervention and was then given the nutrition and labelling material. Further till receipts were returned from successive shopping trips over the following 4 weeks. The nine categories of food used for comparison were: fruit and vegetables, saturated fats, monounsaturated fats, polyunsaturated fats, white cereals, wholegrain cereals, processed foods, full fat and reduced fat items. Ethics approval was obtained from NWW Wales NHS Trust ethics committee. Results:, Each of the nine food categories on till receipts were calculated as a percentage of the total shopping, excluding non-food items. General linear model repeated measures analyses showed differences between study participants' food purchases. For the intervention group, purchases in three of the nine food categories showed significant improvements: increased purchases of fruits and vegetables (P < 0.001); reduction in purchases of saturated fats (P < 0.001); and reduction of white cereal purchases (P < 0.050). The control group showed no differences in any category. Discussion:, Although the intervention group did show improvements in most of the other food categories, they were not statistically significant. Positive changes were found in seven of the nine categories, with only one, wholegrain cereals, showing a decrease in purchases rather than an increase. The control group displayed a random pattern over the four till receipts, with eight categories either showing negative change or no change; only one showed a positive change. The disproportionate group sizes may mean that it is not be possible to draw firm conclusions regarding the effectiveness of the intervention. Conclusions:, This study demonstrates that positive changes in improving food-purchasing choices, as measured by till receipts, can be made by using educational interventions. Further larger studies using routinely collected supermarket data would enable the study to be replicated on a much larger scale. References, Ransley, J.K., Donnelly, J.K., Khara, T.N., Botham, H., Arnott, H., Greenwood, D.C. & Cade, J.E. (1991) The use of supermarket till receipts to determine the fat and energy intake in a UK population. Public Health Nutr. 4, 1279,1286. Rigby, P. (2004) Effecting change. Understanding nutritional information. Can increased knowledge and understanding in relation to nutritional information bring about a change in eating habits? PhD Thesis WA: Bangor University. [source]

    Risk profiles for non-adherence to antipsychotic medications

    T. V. MCCANN rmn rgn phd ma ba dipnurs (lond) rnt rcnt
    Poor adherence to medications is common in individuals with schizophrenia, and can lead to relapse and re-hospitalization. This paper presents the findings of an Australian study of the factors affecting antipsychotic medication taking in individuals with schizophrenia. The Factors Influencing Neuroleptic Medication Taking Scale was used with a non-probability sample of mental health service users. Ethics approval was obtained from a university and a hospital ethics committee. Data were analysed using spss version 15. Most participants had insight into their illness and were aware of the stigma of mental illness. Around 70% experienced annoying side effects, while nearly half admitted alcohol consumption. About one-fifth admitted they had missed taking medications during the previous week. Significant others played a variable role in medication taking. Over 80% were satisfied with their relationships with health professionals, but were less satisfied with access to these professionals, especially psychiatrists. Logistic regression analysis showed that age, impact of medication side effects, and access to psychiatrists were independent predictors of medication omission. It is argued that medication taking is a complex issue, which needs to be taken into consideration in health professional training and measures to promote adherence. [source]

    Mental health professionals' attitudes towards consumer participation in inpatient units

    T. V. MCCANN rmn rgn phd ma ba dipnurs (lond) rnt rcnt
    Consumer participation has been a major focus in mental health services in recent years, but the attitudes of mental health professionals towards this initiative remain variable. The purpose of this study was to describe mental health professionals' attitudes towards mental health consumer participation in inpatient psychiatric units. The Consumer Participation and Consultant Questionnaire was used with a non-probability sample of 47 mental health professionals from two adult inpatient psychiatric units situated in a large Australian public general hospital. Ethics approval was obtained from a university and a hospital ethics committee. Data were analysed using spss, Version 12. Overall, respondents had favourable attitudes towards consumer participation in management, care and treatment, and mental health planning. They were less supportive about matters that directly or indirectly related to their spheres of responsibility. The type of unit that the respondents worked in was not a factor in their beliefs about consumer participation. Recommendations are made about the development of guidelines for consumer participation in inpatient units, the educational preparation of mental health clinicians, and the need for mental health professionals to reflect on, and discuss their own beliefs and practices about, consumer participation. [source]

    An interim analysis of a cohort study on the preoperative anxiety and postoperative behavioural changes in children having repeat anaesthetics

    A. Watson
    Introduction Anxiety in the preoperative period and at induction of anaesthesia in children is associated with disturbances in postoperative behaviour (1,4). There is little work looking at the effects of repeat anaesthetic procedures on anxiety and subsequent postoperative behaviour disturbances. The aim of this study was to see if the effect of repeat anaesthetics was cumulative on postoperative behavioural problems and whether repeated anaesthetics provoke increasing anxiety. We investigated factors that may identify children who are susceptible to behavioural changes following repeat anaesthetics. We present an interim analysis of data on 8 patients as part of a long-term cohort study on 40 children with retinoblastoma who have required repeat anaesthetics for assessment and treatment of their condition. Method Approval for this study was granted by the East London and City Health Authority ethics committee. 40 patients are being recruited and being followed over a two year period. All children have retinoblastoma and are between the ages of 18 months to 4 years. The anaesthetic technique was not standardised but details of it were collected. Data collected were demographic details of child (age, sex, weight, ASA grade, siblings, stressful events in the last 3 months, recent immunisations, number of previous anaesthetics, problems with previous general anaesthetics, medical history of children, temperament of child using the EASI scoring system (4); demographic data of parents (age, parental education, family members affected, baseline measure of parental anxiety using State trait anxiety inventory (STAI). Anxiety on entry into the anaesthetic room and at induction was measured by the modified Yale preoperative anxiety scale (mYPAS), cooperation of the child at induction was measured by the Induction compliance checklist (ICC). Anxiety of the parent after induction was measured by the STAI score. Behaviour was measured at 1 day, 1 week, 1 month and 4 months after each procedure by means of the post hospital behaviour score (PHBQ) (5). A comparison with preoperative behaviour was made and data is presented of the percentage of children with new negative behavioural problems. A detailed analysis of the types of behaviour change was noted. anova for repeat measures with multiple dependent measures was used to analyse data on child anxiety and postoperative behavioural problems. Results Eight patients have had 3 separate anaesthetics over one and a half years. These have been at 4 monthly intervals. There was no significant increase in anxiety levels with repeat anaesthetics. The median mYPAS score at induction were 100 for all 3 anaesthetics. (P = 0.41). The type of behavioural change was variable and demonstrated no trend. No patient was identified as being prone to behavioural changes after every anaesthetic. Patients who displayed new negative behavioural problems would have them after any anaesthetic with no obvious cumulative effect with each repeat anaesthetic. Conclusions Our patients had maximum anxiety scores at induction, so the mYPAS scoring system is not sensitive enough to show that repeat anaesthetics provoke increasing anxiety. There is a very random pattern to behavioural disturbances after repeat anaesthetics with no evidence that negative behavioural changes are compounded with repeated anaesthetics. Collection of complete data from the remaining 32 patients may yield some trends regarding behavioural disturbances but our use of the mYPAS to measure anxiety in this very anxious population is unlikely to be helpful. [source]

    Complementary roles of prenatal sonography and magnetic resonance imaging in diagnosis of fetal renal anomalies

    Ibrahim A. ABDELAZIM
    Objectives:, This study was designed to assess the role of magnetic resonance imaging (MRI) in refining the diagnosis of prenatally suspected fetal renal abnormalities following screening ultrasound. Patients and methods:, Twenty pregnant women, with suspected fetal renal abnormality detected during screening ultrasound and more than 14 weeks' gestation, were included in this observational prospective study at Ain Shams University Maternity Hospital from March 2004 to March 2005 after informed consent and after approval of the study protocol by the institute ethics committee. Results:, The MRI could diagnose correctly 10 cases of hydronephrosis, one case of polycystic kidney disease (PCKD), one case of RA, two normal case and two cases of intra-abdominal masses (IA Mass) (16 of 18 cases). The prenatal ultrasound could diagnose correctly eight cases of hydronephrosis, one case of PCKD, one case of renal agenesis, one case of multicystic kidney disease and one case of IA Mass (12 of 18 cases). The prenatal ultrasound and MRI gave different diagnoses in eight cases and gave the same diagnosis in 12 cases. The MRI could diagnose the aetiology of congenital renal cysts in 10 of the 20 studied cases (50%). Conclusion:, Magnetic resonance imaging can be used as a complementary tool in the assessment of sonographically suspected fetal renal anomalies. [source]