Stakeholder challenges in purchasing medical devices for patient safety.

OBJECTIVE: This study identifies the stakeholders who have a role in medical device purchasing within the wider system of health-care delivery and reports on their particular challenges to promote patient safety during purchasing decisions. METHODS: Data was collected through observational work, participatory workshops, and semi-structured qualitative interviews, which were analyzed and coded. The study takes a systems-based and engineering design approach to the study. Five hospitals took part in this study, and the participants included maintenance, training, clinical end-users, finance, and risk departments. RESULTS: The main stakeholders for purchasing were identified to be staff from clinical engineering (Maintenance), device users (Clinical), device trainers (Training), and clinical governance for analyzing incidents involving devices (Risk). These stakeholders display varied characteristics in terms of interpretation of their own roles, competencies for selecting devices, awareness and use of resources for purchasing devices, and attitudes toward the purchasing process. The role of "clinical engineering" is seen by these stakeholders to be critical in mediating between training, technical, and financial stakeholders but not always recognized in practice. CONCLUSIONS: The findings show that many device purchasing decisions are tackled in isolation, which is not optimal for decisions requiring knowledge that is currently distributed among different people within different departments. The challenges expressed relate to the wider system of care and equipment management, calling for a more systemic view of purchasing for medical devices.

海底金属矿床充水条件及矿坑突水的断层效应研究

The Xinli mine area of Sanshandao mine is adjacent to the Bohai Sea and its main exploitable ore deposit occurs in the undersea rock mass. The mine is the biggest undersea gold mine of China after production. The mine area faces a latent danger of water bursting, even sudden seawater inrush. There is no mature experience in undersea mining in China so far. The vein ore deposit is located in the lower wall of a fault; its possible groundwater sources mainly include bittern, Quaternary pore water and modern seawater. To ensure the safety of undersea mining, to survey the flooding conditions of the ore deposit using proper measures and study the potential seawater inrush pattern are the key technical problems. With the Xinli mine area as a case study, the engineering geological conditions of the Xinli mine area are surveyed in situ, the regional structural pattern and rock mass framework characteristics are found out, the distribution of the structural planes are modeled by a Monte Carlo method and the connectivity coefficients of rock mass structural planes are calculated. The regional hydro-geological conditions are analyzed and the in-situ hydro-geological investigation and sampling are performed in detail, the hydrochemistry and isotopes testing and groundwater dynamic monitoring are conducted, the recharge, runoff, discharge conditions are specified and the sources of flooding are distinguished. Some indices are selected from the testing results to calculate the proportion of each source in some water discharge points and in the whole water discharge of the Xinli mine area. The temporal and spatial variations of each water source of the whole ore deposit flooding are analyzed. According to the special project conditions in the Xinli mine area, the permeability coefficient tensors of the rock mass in Xinli mine area are calculated based on a fracture geometry measurement method, in terms of the connectivity and a few hydraulic testing results, a modified synthetic permeability coefficient are calculated. The hydro-geological conceptual and mathematical model are established，the water yield of mine is predicted using Visual Modflow code. The spreading law of surrounding rock mass deformation and secondary stress are studied by numerical analysis; the intrinsic mechanism of the faults slip caused by the excavation of ore deposit is analyzed. The results show that the development of surrounding rock mass deformation and secondary stress of vein ore deposit in the lower wall of a fault, is different from that in a thick-big ore deposit. The secondary stress caused by the excavation of vein ore deposit in the lower wall of a fault, is mainly distributed in the upper wall of the fault, one surface subsidence center will occur. The influences of fault on the rock mass movement, secondary stress and hydro-geological structures are analyzed; the secondary stress is blocked by the fault and the tensile stress concentration occurs in the rock mass near the fault, the original water blocking structure is destructed and the permeable structure is reconstructed, the primary structural planes begin to expand and newborn fissures occur, so the permeability of the original permeable structure is greatly enhanced, so the water bursting will probably occur. Based on this knowledge, the possible water inrush pattern and position of the Xinli mine area are predicted. Some computer programs are developed using object-oriented design method under the development platform Visual Studio.Net. These programs include a Monte Carlo simulation procedure, a joint diagrammatizing procedure, a structural planes connectivity coefficient calculating procedure, a permeability tensor calculating procedure, a water chemical formula edit and water source fixture conditions calculating procedure. A new computer mapping algorithm of joint iso-density diagram is raised. Based on the powerful spatial data management and icon functions of Geographic Information System, the pit water discharge dynamic monitoring data management information systems are established with ArcView.

Effectiveness and safety of cryotherapy after arthroscopic anterior cruciate ligament reconstruction. A systematic review of the literature

Cryotherapy is widely used in rehabilitation; however, its effectiveness after anterior cruciate ligament (ACL) reconstruction remains uncertain. To investigate the effectiveness and safety of cryotherapy following ACL reconstruction through a systematic review, randomized and quasi-randomized clinical trials were searched in the databases: MEDLINE, EMBASE, CENTRAL PEDro, SportDiscus, CINAHL, LILACS (June 2013). the primary outcomes measures were pain, edema and adverse events; the secondary outcomes were knee function, analgesic medication use, range of motion, blood loss, hospital stay, quality of life and patient satisfaction. the methodological quality of studies was evaluated using the Cochrane Collaboration risk-of-bias tool. Ten trials (a total of 573 patients) were included. Results of meta-analysis showed that the use of cold compression devices produced a significant reduction in pain scores 48 h after surgery (p < 0.00001), compared to no cryotherapy. the risk for adverse events did not differ between patients receiving cryotherapy versus no treatment (p = 1.00). the limited evidence currently available is insufficient to draw definitive conclusions on the effectiveness of cryotherapy for other outcomes. There is a need for well designed, good quality randomized trials to answer other questions related to this intervention and increase the precision of future systematic reviews. (C) 2014 Elsevier B.V. All rights reserved.

Development of process control methodology for tracking the quality and safety of pain, agitation and sedation management in critical care units

Objective: To develop sedation, pain, and agitation quality measures using process control methodology and evaluate their properties in clinical practice. Design: A Sedation Quality Assessment Tool was developed and validated to capture data for 12-hour periods of nursing care. Domains included pain/discomfort and sedation-agitation behaviors; sedative, analgesic, and neuromuscular blocking drug administration; ventilation status; and conditions potentially justifying deep sedation. Predefined sedation-related adverse events were recorded daily. Using an iterative process, algorithms were developed to describe the proportion of care periods with poor limb relaxation, poor ventilator synchronization, unnecessary deep sedation, agitation, and an overall optimum sedation metric. Proportion charts described processes over time (2 monthly intervals) for each ICU. The numbers of patients treated between sedation-related adverse events were described with G charts. Automated algorithms generated charts for 12 months of sequential data. Mean values for each process were calculated, and variation within and between ICUs explored qualitatively. Setting: Eight Scottish ICUs over a 12-month period. Patients: Mechanically ventilated patients. Interventions: None. Measurements and Main Results: The Sedation Quality Assessment Tool agitation-sedation domains correlated with the Richmond Sedation Agitation Scale score (Spearman [rho] = 0.75) and were reliable in clinician-clinician (weighted kappa; [kappa] = 0.66) and clinician-researcher ([kappa] = 0.82) comparisons. The limb movement domain had fair correlation with Behavioral Pain Scale ([rho] = 0.24) and was reliable in clinician-clinician ([kappa] = 0.58) and clinician-researcher ([kappa] = 0.45) comparisons. Ventilator synchronization correlated with Behavioral Pain Scale ([rho] = 0.54), and reliability in clinician-clinician ([kappa] = 0.29) and clinician-researcher ([kappa] = 0.42) comparisons was fair-moderate. Eight hundred twenty-five patients were enrolled (range, 59-235 across ICUs), providing 12,385 care periods for evaluation (range 655-3,481 across ICUs). The mean proportion of care periods with each quality metric varied between ICUs: excessive sedation 12-38%; agitation 4-17%; poor relaxation 13-21%; poor ventilator synchronization 8-17%; and overall optimum sedation 45-70%. Mean adverse event intervals ranged from 1.5 to 10.3 patients treated. The quality measures appeared relatively stable during the observation period. Conclusions: Process control methodology can be used to simultaneously monitor multiple aspects of pain-sedation-agitation management within ICUs. Variation within and between ICUs could be used as triggers to explore practice variation, improve quality, and monitor this over time

Systematic Verification of Safety Properties of Arbitrary Network Protocol Compositions Using CHAIN

Formal correctness of complex multi-party network protocols can be difficult to verify. While models of specific fixed compositions of agents can be checked against design constraints, protocols which lend themselves to arbitrarily many compositions of agents-such as the chaining of proxies or the peering of routers-are more difficult to verify because they represent potentially infinite state spaces and may exhibit emergent behaviors which may not materialize under particular fixed compositions. We address this challenge by developing an algebraic approach that enables us to reduce arbitrary compositions of network agents into a behaviorally-equivalent (with respect to some correctness property) compact, canonical representation, which is amenable to mechanical verification. Our approach consists of an algebra and a set of property-preserving rewrite rules for the Canonical Homomorphic Abstraction of Infinite Network protocol compositions (CHAIN). Using CHAIN, an expression over our algebra (i.e., a set of configurations of network protocol agents) can be reduced to another behaviorally-equivalent expression (i.e., a smaller set of configurations). Repeated applications of such rewrite rules produces a canonical expression which can be checked mechanically. We demonstrate our approach by characterizing deadlock-prone configurations of HTTP agents, as well as establishing useful properties of an overlay protocol for scheduling MPEG frames, and of a protocol for Web intra-cache consistency.

Efficient Nearest Neighbor Classification Using a Cascade of Approximate Similarity Measures

Nearest neighbor classification using shape context can yield highly accurate results in a number of recognition problems. Unfortunately, the approach can be too slow for practical applications, and thus approximation strategies are needed to make shape context practical. This paper proposes a method for efficient and accurate nearest neighbor classification in non-Euclidean spaces, such as the space induced by the shape context measure. First, a method is introduced for constructing a Euclidean embedding that is optimized for nearest neighbor classification accuracy. Using that embedding, multiple approximations of the underlying non-Euclidean similarity measure are obtained, at different levels of accuracy and efficiency. The approximations are automatically combined to form a cascade classifier, which applies the slower approximations only to the hardest cases. Unlike typical cascade-of-classifiers approaches, that are applied to binary classification problems, our method constructs a cascade for a multiclass problem. Experiments with a standard shape data set indicate that a two-to-three order of magnitude speed up is gained over the standard shape context classifier, with minimal losses in classification accuracy.

Comparative Performance Measures of Fuzzy ARTMAP, Learned Vector Quantization, and Back Propagation for Handwritten Character Recognition

This article compares the performance of Fuzzy ARTMAP with that of Learned Vector Quantization and Back Propagation on a handwritten character recognition task. Training with Fuzzy ARTMAP to a fixed criterion used many fewer epochs. Voting with Fuzzy ARTMAP yielded the highest recognition rates.

Longitudinal study of changes in body mass index, anthropometric measures, dietary intake and physical activity in cohorts of school-going Irish adolescents

The prevalence of obesity worldwide has increased dramatically over the last few decades. Poor dietary habits and low levels of exercise in adolescence are often maintained into adulthood where they can impact on the incidence of obesity and chronic diseases. A 3-year longitudinal study of anthropometric, dietary and exercise parameters was carried out annually (2005 - 2007) in 3 Irish secondary schools. Anthropometric measurements were taken in each year and analysed longitudinally. Overweight and obesity were at relatively low levels in these adolescents. Height, weight, BMI, waist and hip circumferences and TST increased significantly over the 3 years. Waist-to-hip ratio (WHR) decreased significantly over time. Boys were significantly taller than girls across the 3 years. A 3-day weighed food diary was used to assess food intake by the adolescents. Analysis of dietary intake data was determined using WISP©. Mean daily energy and nutrient intakes were reported. Mean daily energy and macronutrient intakes were analysed longitudinally. The adolescents’ diet was characterised by relatively high saturated fat intakes and insufficient fruit and vegetable consumption. The dietary pattern did not change significantly over the 3 years. Boys consumed more energy than girls over the study period. A validated questionnaire was used to assess physical activity and sedentary activity levels. Boys were substantially more active and had higher energy expenditure estimates than girls throughout the study. A significant longitudinal decrease in physical activity levels among the adolescents was observed. Both genders spent more than the recommended amount of time (hrs/day) pursing sedentary activities. The dietary pattern in these Irish adolescents is relatively poor. Of additional concern is the overall longitudinal decrease in physical activity levels. Promoting consumption of a balanced diet and increased exercise levels among adolescents will help to reduce future public health care costs due to weight-related diseases.

Early warning sign attributes for the safety of drinking water treatment works

A proactive risk management strategy seeks to prevent accidents from taking place and maintain the safety of a system. In this context, the task of identifying and disseminating early warning signs and signals is among the most important. The problem is that warning signs that are present before an accident takes place are often being overlooked and not picked up or identified as warning signs. If these warning signs were responded to, then an accident may be averted. Accidents occuring in the critical domain of a drinking water treatments works can have serious implications for the public health of consumers of the water supplied. Realising and comprehending early warning signs is a major challenge for the domain of systems safety and especially in the domain of a water treatment works. The approaches that are typically used to enhance the realisation, comprehension and dissemination of early warning signs in the water treatment domain in Ireland mainly involves the creation of accident scenarios, the use of monitoring data and procedures for the dissemination of warnings. While all of these approaches are all useful to inform the mental or process models of possible accident scenarios, nevertheless, accidents are still occurring in this domain. Therefore, a new approach to enhance the comprehension of and effective dissemination of early warning signs is required in order to improve safety and proactive risk management strategies. The contributions of this thesis is the provision of a set of attributes associated with the early warning sign concept that provides meaningful data on the early warning signs and allows recipients to better comprehend them. The values of these attributes were customised for application in the water treatment domain. This research proves that early warning signs at a water treatment works received with information on their attributes are comprehended and communicated more effectively and efficiently than the usual pragmatic approach and thereby improves the safety and proactive risk management strategies.

The effectiveness of using patient-reported outcome measures as quality improvement tools

Aim: To investigate the value of using PROMs as quality improvement tools. Methods: Two systematic reviews were undertaken. The first reviewed the quantitative literature on the impact of PROMs feedback and the second reviewed the qualitative literature on the use of PROMs in practice. These reviews informed the focus of the primary research. A cluster randomised controlled trial (PROFILE) examined the impact of providing peer benchmarked PROMs feedback to consultant orthopaedic surgeons on improving outcomes for hip replacement surgery. Qualitative interviews with surgeons in the intervention arm of the trial examined the view of and reactions to the feedback. Results: The quantitative review of 17 studies found weak evidence to suggest that providing PROMs feedback to professionals improves patient outcomes. The qualitative review of 16 studies identified the barriers and facilitators to the use of PROMs based on four themes: practical considerations, attitudes towards the data, methodological concerns and the impact of feedback on care. The PROFILE trial included 11 surgeons and 215 patients in the intervention arm, and 10 surgeons and 217 patients in the control arm. The trial found no significant difference in the Oxford Hip Score between the arms (-0.7, 95% CI -1.9-0.5, p=0.2). Interviews with surgeons revealed mixed opinions about the value of the PROMs feedback and the information did not promote explicit changes to their practice. Conclusion: It is important to use PROMs which have been validated for the specific purpose of performance measurement, consult with professionals when developing a PROMs feedback intervention, communicate with professionals about the objectives of the data collection, educate professionals on the properties and interpretation of the data, and support professionals in using the information to improve care. It is also imperative that the burden of data collection and dissemination of the information is minimised.

Safety and efficacy of rivastigmine in adolescents with Down syndrome: long-term follow-up.

Following the completion of a 20-week, open-label study of the safety and efficacy of liquid rivastigmine for adolescents with Down syndrome, 5 of the 10 adolescents in the clinical trial continued long-term rivastigmine therapy and 5 did not. After an average period of 38 months, all 10 subjects returned for a follow-up assessment to determine the safety and efficacy of long-term rivastigmine use. Rivastigmine was well tolerated and overall health appeared to be unaffected by long-term rivastigmine use. Performance change on cognitive and language measures administered at the termination of the open-label clinical trial was compared between the two groups. No between-group difference in median performance change across the long-term period was found, suggesting that the long-term use of rivastigmine does not improve cognitive and language performance. However, two subjects demonstrated remarkable improvement in adaptive function over the long-term period. Both subjects had received long-term rivastigmine therapy. The discussion addresses the challenge of assessing cognitive change in clinical trials using adolescents with Down syndrome as subjects and the use of group versus individual data to evaluate the relevance of medication effects.

Herbal Dietary Supplements: Safety, Efficacy, and Use by Breast Cancer Survivors

Gemstone Team IMAC (Integrative Medicine and Cancer)

Two steps forward, one step back: developing the curriculum for training teachers for technical and further education England 1945-1956

This paper discusses the development of provision for the training of teachers in English further and technical education from 1945 to 1956. While these years saw little growth in this provision, they were formative in that the institutional and curricular patterns of teacher training for the diverse fields of technical and further education were developed at this time. The work of the three national centres in Bolton, London and Huddersfield, during the period of the Emergency Training Scheme (ETS) is summarised with particular reference to the influence of the Ministry of Education‟s conditions for ETS colleges and courses. With the ending of the ETS in 1951 the three centres were given permanent status as teacher training colleges which in turn brought them into association with their local universities as constituent colleges of their Area Training Organisations. The consequences of this transfer to the universities for the curriculum and assessment of technical teacher training and the 'policy dichotomy' of teacher training for secondary and technical education are examined.

Training teachers for further and technical education 1950-1982: staff perceptions of changing demands and policies

This paper aims to create a picture of aspects of the working lives of some trainers of technical and further education teachers in a specialist teacher training college in Bolton, Lancashire, from the 1950s to the 1980's. There is little reference to technical teacher training in the literature on teacher training in the second half of the twentieth century. With this gap in mind, this paper sets out to record some memories and impressions of staff involved during these years. Using data from a series of semi-structured interviews, the discussion centres upon their perceptions of their work: of their students, the working environment, the curriculum and their relationships with the technical colleges for whom they were training teachers. The paper has three sections. It begins with a brief discussion of the issues arising from the choice of research methods. The second section contextualises the study and traces the history of Bolton Technical Teachers' Training College from its establishment through to its merger with the Institute of Technology in 1982. This is followed by the presentation and discussion of the interview data.

Polycyclic aromatic hydrocarbons (PAHS) (I): Measures of prevention and control

Measures of prevention and control against polycyclic aromatic hydrocarbons (PAHs) focus on an official food control, a code of best practice to reduce PAHs levels by controlling industry and in the development of a chemopreventive strategy. Regulation (EU) 835/2011 establishes maximum levels of PAHs for each food group. In addition, Regulations (EU) 333/2007 and 836/2011 set up the methods of sampling and analysis for its official control. Scientific studies prove that the chemopreventive strategy is effective against these genotoxic compounds effects. Most chemopreventive compounds studied with proven protective effects against PAHs are found in fruit and vegetables.