A randomised controlled trial and cost-consequence analysis of traditional and digital foot orthoses supply chains in a National Health Service setting: application to feet at risk of diabetic plantar ulceration.

BACKGROUND: Diabetic foot ulceration is a considerable cost to the NHS and foot orthotic provision is a core strategy for the management of the people with diabetes and a moderate to high risk of foot ulceration. The traditional process to produce a custom-made foot orthotic device is to use manual casting of foot shape and physical moulding of orthoses materials. Parts of this process can be undertaken using digital tools rather than manual processes with potential advantages. The aim of this trial was to provide the first comparison of a traditional orthoses supply chain to a digital supply chain over a 6 month period. The trial used plantar pressure, health status, and health service time and cost data to compare the two supply chains. METHODS: Fifty-seven participants with diabetes were randomly allocated to each supply chain. Plantar pressure data and health status (EQ5D, ICECAP) was assessed at point of supply and at six-months. The costs for orthoses and clinical services accessed by participants were assessed over the 6 months of the trial. Primary outcomes were: reduction in peak plantar pressure at the site of highest pressure, assessed for non-inferiority to current care. Secondary outcomes were: reduction in plantar pressure at foot regions identified as at risk (> 200 kPa), cost-consequence analysis (supply chain, clinician time, service use) and health status. RESULTS: At point of supply pressure reduction for the digital supply chain was non-inferior to a predefined margin and superior (p < 0.1) to the traditional supply chain, but both supply chains were inferior to the margin after 6 months. Custom-made orthoses significantly reduced pressure for at risk regions compared to a flat control (traditional - 13.85%, digital - 20.52%). The digital supply chain was more expensive (+£13.17) and required more clinician time (+ 35 min). There were no significant differences in health status or service use between supply chains. CONCLUSIONS: Custom made foot orthoses reduce pressure as expected. Given some assumptions about the cost models we used, the supply chain process adopted to produce the orthoses seems to have marginal impact on overall costs and health status. TRIAL REGISTRATION: Retrospectively registered on ISRCTN registry (ISRCTN10978940, 04/11/2015).

Migration histories of multidrug-resistant tuberculosis patients from the Thailand-Myanmar border, 2012-2014.

SETTING: Multidrug-resistant tuberculosis (MDR-TB) is a growing public health threat in South-East Asia. TB is typically a disease of poverty and can be spread by infectious humans who migrate from one region to another. DESIGN: We interviewed 20 MDR-TB patients on the Thailand-Myanmar border with regard to their migration histories. Migration origins and destinations were mapped. RESULTS: All but one participant had a history of migration, and maps of migration ranges revealed wide geographic dispersal. Most described living and work conditions that could contribute to the spread of drug-resistant TB, including numerous contacts and crowded living quarters. CONCLUSION: Our results show that at least some migrant workers in the region carry MDR-TB, and indicate that this subgroup of the population is important with regard to the transmission of MDR-TB throughout the region. Migrants in this region come into contact with high numbers of people and may be able to spread the disease across wide geographic ranges. Access to diagnosis and treatment and socio-economic development are at least as important as any TB control measures, meaning that innovative and bold approaches that extend across international borders are needed to address these problems.

A critical assessment of the mechanisms governing the formation of aqueous biphasic systems composed of protic ionic liquids and polyethylene glycol.

An extensive study on the formation of aqueous biphasic systems (ABS) using aqueous solutions of protic ionic liquids (PILs) and polyethylene glycol (PEG) was performed in order to understand the mechanisms underlying the phase separation. Aqueous solutions of PEG polymers with different molecular weights (600, 1000, 2000, and 3400 g mol-1) and several N-alkyl-, dialkyl-, and trialkyl-ammonium salts of acetate, propanoate, butanoate, hexanoate and octanoate were prepared and their ability to form ABS at several temperatures assessed. The ternary liquid-liquid phase diagrams were determined at several temperatures, as well as binary PIL (or salt)-PEG-1000 and salt-water solubility data to better clarify the mechanisms responsible for the phase separation. All data gathered indicate that the formation of PEG-PIL-based ABS is mainly governed by the PIL-PEG mutual interactions, where PILs with a higher solubility in the polymer exhibit a lower aptitude to form ABS displaying thus a smaller biphasic region, for which a direct correlation was identified. The effects of the molecular weight and temperature of the polymer were also addressed. The increase of the PEG hydrophobicity or molecular weight favours the phase separation, whereas the effect of temperature was found to be more complex and dependent on the nature of the PIL, with an increase or decrease of the biphasic regime with an increase in temperature.

Moving evidence into practice: cost analysis and assessment of macaques' sustained behavioral engagement with videogames and foraging devices.

Environmental enrichment plans for captive nonhuman primates often include provision of foraging devices. The rationale for using foraging devices is to promote species-typical activity patterns that encourage physical engagement and provide multi-sensory stimulation. However, these devices have been shown to be ineffective at sustaining manipulation over long periods of time, and often produce minimal cognitive engagement. Here we use an evidence-based approach to directly compare the amount of object-directed behavior with a foraging device and a computer-based videogame system. We recorded 11 adult male rhesus monkeys' interactions with a foraging device and two tasks within a joystick videogame cognitive test battery. Both techniques successfully produced high levels of engagement during the initial 20 min of observation. After 1 hr the monkeys manipulated the foraging device significantly less than the joystick, F(2,10) = 43.93, P < 0.0001. Subsequent testing showed that the monkeys engaged in videogame play for the majority of a 5 hr period, provided that they received a 94 mg chow pellet upon successful completion of trials. Using a model approach, we developed previously as a basis for standardized cost:benefit analysis to inform facility decisions, we calculated the comprehensive cost of incorporating a videogame system as an enrichment strategy. The videogame system has a higher initial cost compared to widely-used foraging devices, however, the ongoing labor and supply costs are relatively low. Our findings add to two decades of empirical studies by a number of laboratories that have demonstrated the successful use of videogame-based systems to promote sustained non-social cognitive engagement for macaques. The broader significance of the work lies in the application of a systematic approach to compare and contrast enrichment strategies and encourage evidence-based decision making when choosing an enrichment strategy in a manner that promotes meaningful cognitive enrichment to the animals.

Effects of a team-based assessment and intervention on patient safety culture in general practice: an open randomised controlled trial.

BACKGROUND: The measurement of safety culture in healthcare is generally regarded as a first step towards improvement. Based on a self-assessment of safety culture, the Frankfurt Patient Safety Matrix (FraTrix) aims to enable healthcare teams to improve safety culture in their organisations. In this study we assessed the effects of FraTrix on safety culture in general practice. METHODS: We conducted an open randomised controlled trial in 60 general practices. FraTrix was applied over a period of 9 months during three facilitated team sessions in intervention practices. At baseline and after 12 months, scores were allocated for safety culture as expressed in practice structure and processes (indicators), in safety climate and in patient safety incident reporting. The primary outcome was the indicator error management. RESULTS: During the team sessions, practice teams reflected on their safety culture and decided on about 10 actions per practice to improve it. After 12 months, no significant differences were found between intervention and control groups in terms of error management (competing probability=0.48, 95% CI 0.34 to 0.63, p=0.823), 11 further patient safety culture indicators and safety climate scales. Intervention practices showed better reporting of patient safety incidents, reflected in a higher number of incident reports (mean (SD) 4.85 (4.94) vs 3.10 (5.42), p=0.045) and incident reports of higher quality (scoring 2.27 (1.93) vs 1.49 (1.67), p=0.038) than control practices. CONCLUSIONS: Applied as a team-based instrument to assess safety culture, FraTrix did not lead to measurable improvements in error management. Comparable studies with more positive results had less robust study designs. In future research, validated combined methods to measure safety culture will be required. In addition, more attention should be paid to evaluation of process parameters. Implemented actions and incident reporting may be more appropriate target endpoints. TRIAL REGISTRATION: German Clinical Trials Register (Deutsches Register Klinischer Studien, DRKS) No. DRKS00000145.

Costs and outcomes of total hip and knee joint replacement for rheumatoid arthritis.

The objective of the study was to ascertain costs and outcomes of total joint replacement surgery for rheumatoid arthritis (RA) in Australia from the patients' perspective and to explore whether costs were affected by health status pre- or postsurgery. RA patients, scheduled for primary unilateral total knee replacement (TKR) or total hip replacement (THR) surgery at five Sydney hospitals, were approached. Preoperatively, patients retrospectively recorded expenses incurred over the previous 3 months and the health assessment questionnaire (HAQ). Postoperatively, patients completed detailed prospective cost diaries, short form (SF) 36, and HAQ every 3 months during the first postoperative year. In addition, patients were asked to complete a visual analogue measure for pain at 12 months postsurgery. Arthritis-specific cost information included prescription and nonprescription medication, visits to health professionals, tests, special equipment, alterations to the house, and use of private or community services. Thirty-one TKR and 11 THR patients provided cost data for the first postoperative year. Out-of-pocket costs and service utilization decreased over the first postoperative year for both TKR and THR patients. In addition, there was an improvement in the health status as measured by SF-36 but not the HAQ at 3 and 12 months postoperatively. The small sample size of this analysis is reflective of the current national trends of RA joint replacement surgery. Despite the low incidence of RA joint replacement surgery, it was substantiated that patients consider the positive impact on health outcomes and costs important. The generic SF-36 detected improvements in the health status of these RA patients, while total HAQ scores failed to do so. HAQ was found to be insensitive in reflecting improvements following lower limb replacement surgery. Patient out-of-pocket costs significantly decreased postoperatively; however, these costs remain substantial compared to osteoarthritis total joint replacement patients.

Human factors in anaesthetic practice: insights from a task analysis.

BACKGROUND: Despite a growing recognition of the role of human error in anaesthesia, it remains unclear what should be done to mitigate its effects. We addressed this issue by using task analysis to create a systematic description of the behaviours that are involved during anaesthesia, which can be used as a framework for promoting good practice and highlight areas of concern. METHODS: The task steps involved in preparing and delivering anaesthesia were identified using hierarchical task analysis (HTA). The systematic human error reduction and prediction approach (SHERPA) was then used to identify potential human errors at each task step and suggest ways of preventing these errors. RESULTS: The number and type of behaviours involved vary according to the 'phase' of anaesthesia, with tasks in the induction room, including induction of anaesthesia itself, being the most demanding. Errors during preoperative planning and perioperative maintenance could be avoided by measures to support information handling and decision-making. Errors during machine checking, induction, and emergence could be reduced by streamlining or automating task steps, or by making changes to the physical design of the work environment. CONCLUSIONS: We have demonstrated the value of task analysis in improving anaesthetic practice. Task analysis facilitates the identification of relevant human factors issues and suggests ways in which these issues can be addressed. The output of the task analysis will be of use in focusing future interventions and research in this area.

Likelihood of reporting adverse events in community pharmacy: an experimental study.

BACKGROUND: In the UK the National Reporting and Learning System (NRLS) is designed to coordinate the reporting of patient safety incidents nationally and to improve the ability of the health service to learn from the analysis of these events. Little is known about levels of engagement with the NRLS. OBJECTIVE: To examine the likelihood of community pharmacists and support staff reporting patient safety incidents which occur in community pharmacies. METHODS: Questionnaire survey containing nine incident scenarios. In the scenarios two factors were orthogonally manipulated: the outcome for the patient was reported as good, bad or poor, and the behaviour of the pharmacist was described as either complying with a protocol, not being aware of a protocol (error), or violating a protocol. Respondents were asked to rate whether they would report the incident (1) locally within the pharmacy and (2) nationally to the National Patient Safety Agency (NPSA). RESULTS: 275 questionnaires were returned (79% response rate) from 223 community pharmacists and 52 members of support staff. There were significant main effects for both patient outcome (F(2,520) = 18.19, p<0.001) and behaviour type (F(2,520) = 93.98, p<0.001), indicating that pharmacists and support staff would take into account both the outcome of the behaviour and whether or not it follows a protocol when considering to report an incident within the pharmacy. Likewise, both pharmacists and support staff considered patient outcome (F(2,524) = 12.59, p<0.001) and behaviour type (F(2,524) = 34.82, p<0.001) when considering to report to the NPSA. Both locally and nationally, the likelihood of reporting any incident was low, and judgements on whether to report were more affected by the behaviour of the pharmacist in relation to protocols than the resulting outcome for the patient. CONCLUSIONS: Community pharmacists and their support staff would be unlikely to report adverse incidents if they witnessed them occurring in a community pharmacy. They remain to be convinced that the advantages to them and their patients outweigh the consequences of blame.

Safety culture assessment in community pharmacy: development, face validity, and feasibility of the Manchester Patient Safety Assessment Framework.

OBJECTIVE: To develop a framework that could be used by community pharmacies to self-assess their current level of safety culture maturity, which has high face validity and is both acceptable and feasible for use in this setting. DESIGN: An iterative review process in which the framework was developed and evaluated through a series of 10 focus groups with a purposive sample of 67 community pharmacists and support staff in the UK. MAIN OUTCOME MEASURES: Development of the framework and qualitative process feedback on its acceptability, face validity, and feasibility for use in community pharmacies. RESULTS: Using this process, a version of the Manchester Patient Safety Assessment Framework (MaPSAF) was developed that is suitable for application to community pharmacies. The participants were able to understand the concepts, recognised differences between the five stages of safety culture maturity, and concurred with the descriptions from personal experience. They also indicated that they would be willing to use the framework but recognised that staff would require protected time in order to complete the assessment. CONCLUSIONS: In practice the MaPSAF is likely to have a number of uses including raising awareness about patient safety and illustrating any differences in perception between staff, stimulating discussion about the strengths and weaknesses of patient safety culture within the pharmacy, identifying areas for improvement, and evaluating patient safety interventions and tracking changes over time. This will support the development of a mature safety culture in community pharmacies.

North American performance experience with anoxic and anaerobic selectors for activated sludge bulking control.

Obtaining reliably high compaction characteristics and low SVI values has enormous economic consequences on activated sludge plant design and operation. Now that use of selectors has become more common for achieving low SVI values, the assessment of the full-scale performance characteristics of activated sludge plants incorporating selectors has high value for the design and operation of future plants. Treatment plant effluent quality is seldom analyzed solely on an average basis and the impact peak events have on effluent quality must be considered in design and operation. Descriptive statistics should also be used to assess selector performance, so that the influence of infrequently occurring values on plant design and operation can be assessed. The performance of 21 activated sludge plants incorporating selectors was evaluated. All the selector plants for which post installation data were available showed that the operating SVI values were significantly improved. One plant studied in detail showed that final effluent quality was significantly better after the selector installation. As a group, activated sludge plants with anaerobic selectors outperform those with anoxic selectors. Dissolved oxygen control is just as important in activated sludge plants with selectors as in conventional activated sludge plants.

Psychological contribution to the understanding of adverse events in health care.

In the past it has sometimes been assumed in health care that all adverse events involve individual incompetence and therefore blameworthiness, an assumption that is likely to hinder the development of comprehensive and honest incident reporting systems. At the same time, a full understanding of adverse events in healthcare systems requires that distinctions are drawn between a variety of error types, each of which has different origins and demands different strategies for remediation. In this paper a range of cognitive biases identified by psychologists is described. Examples are given of these biases, which are naturally employed in trying to understand our own behaviour and that of others, and therefore affect our understanding of adverse events. It is suggested that awareness of these biases, which form part of our normal thinking, should help to avoid a narrow focus on individual culpability and facilitate a more sophisticated approach to the investigation of adverse events.

Adsorption kinetics of fluoride on low cost materials.

Adsorption is one important technique in fluoride removal from aqueous solutions. The viability of adsorption techniques is greatly dependent on the development of adsorptive materials. A large number of materials have been tested at a fluoride concentration greater than 2 mg/l, and the lowest limit for fluoride reduction by them is about 2 mg/l. Decreasing the fluoride concentration to less than 2 mg/l, most of the tested materials displayed a very low capacity of fluoride removal. This paper has concentrated on investigating the adsorption kinetics and adsorption capacity of low cost materials at a low initial fluoride concentration. The experiments were carried out at a natural pH, and radioisotope 18F rather than 19F was used since 18F can be rapidly measured by measuring the radioactivity with a resolution of 1 x 10(-13)mg or 0.01 microCi. The tested materials are hydroxyapatite, fluorspar, calcite, quartz and quartz activated by ferric ions. Their adsorption capacities follow the order: Hydroxyapatite>Fluorspar>Quartz activated using ferric ions>Calcite>Quartz. The uptake of fluoride on hydroxyapatite is an ion-exchange procedure and follows the pseudo-first- and second-order equations, while the uptake of fluoride on the others is a surface adsorption and follows the pseudo-second-order equation. Calcite has been seen as a good adsorbent in fluoride removal and has been patented. However, our data suggested that its adsorption capacity is only better than quartz. The external mass transfer is a very slow and rate-determining step during fluoride removal from the aqueous solution. Under static conditions, there was no relative movement between adsorbents and solutions, the fluoride uptake was at a very slow rate and the adsorbent properties did not significantly affect the fluoride uptake. Under shaken conditions, the adsorption of fluoride was controlled by the adsorbent structure and chemical properties.

Barriers to incident reporting in a healthcare system.

BACKGROUND: Learning from mistakes is key to maintaining and improving the quality of care in the NHS. This study investigates the willingness of healthcare professionals to report the mistakes of others. METHODS: The questionnaire used in this research included nine short scenarios describing either a violation of a protocol, compliance with a protocol, or improvisation (where no protocol exists). By developing different versions of the questionnaire, each scenario was presented with a good, poor, or bad outcome for the patient. The participants (n = 315) were doctors, nurses, and midwives from three English NHS trusts who volunteered to take part in the study and represented 53% of those originally contacted. Participants were asked to indicate how likely they were to report the incident described in each scenario to a senior member of staff. RESULTS: The findings of this study suggest that healthcare professionals, particularly doctors, are reluctant to report adverse events to a superior. The results show that healthcare professionals, as might be expected, are most likely to report an incident to a colleague when things go wrong (F(2,520) = 82.01, p < 0.001). The reporting of incidents to a senior member of staff is also more likely, irrespective of outcome for the patient, when the incident involves the violation of a protocol (F(2,520) = 198.77, p < 0.001. It appears that, although the reporting of an incident to a senior member of staff is generally not very likely, particularly among doctors, it is most likely when the incident represents the violation of a protocol with a bad outcome. CONCLUSIONS: An alternative means of organisational learning that relies on the identification of system (latent) failures before, rather than after, an adverse event is proposed.

Comparison of gradient encoding schemes for diffusion-tensor MRI.

The accuracy of single diffusion tensor MRI (DT-MRI) measurements depends upon the encoding scheme used. In this study, the diffusion tensor accuracy of several strategies for DT-MRI encoding are compared. The encoding strategies are based upon heuristic, numerically optimized, and regular polyhedra schemes. The criteria for numerical optimization include the minimum tensor variance (MV), minimum force (MF), minimum potential energy (ME), and minimum condition number. The regular polyhedra scheme includes variations of the icosahedron. Analytical comparisons and Monte Carlo simulations show that the icosahedron scheme is optimum for six encoding directions. The MV, MF, and ME solutions for six directions are functionally equivalent to the icosahedron scheme. Two commonly used heuristic DT-MRI encoding schemes with six directions, which are based upon the geometric landmarks of a cube (vertices, edge centers, and face centers), are found to be suboptimal. For more than six encoding directions, many methods are able to generate a set of equivalent optimum encoding directions including the regular polyhedra, and the ME, MF and MV numerical optimization solutions. For seven directions, a previously described heuristic encoding scheme (tetrahedral plus x, y, z) was also found to be optimum. This study indicates that there is no significant advantage to using more than six encoding directions as long as an optimum encoding is used for six directions. Future DT-MRI studies are necessary to validate these observations. J. Magn. Reson. Imaging 2001;13:769-780.

The emotions and coping strategies of caregivers of family members with a terminal cancer.

This study documents the emotional experiences and coping strategies of a group of caregivers as they move from the diagnosis of a close family member with terminal cancer through the stages of caring and post bereavement. Supportive evidence, matching that of previous literature, was gathered regarding the impact of such care, but additional findings counter the notion of "burden" by revealing that strong positive emotions were experienced by these caregivers regarding the opportunity given to them to express their love through care. By contrast and post bereavement, however, intense grief was reported. There appeared to be a complete lack of emotional support throughout from health professionals, particularly in the bereavement phase when need is very apparent.

Self-motion perception: assessment by real-time computer-generated animations.

We report a new procedure for assessing complex self-motion perception. In three experiments, subjects manipulated a 6 degree-of-freedom magnetic-field tracker which controlled the motion of a virtual avatar so that its motion corresponded to the subjects' perceived self-motion. The real-time animation created by this procedure was stored using a virtual video recorder for subsequent analysis. Combined real and illusory self-motion and vestibulo-ocular reflex eye movements were evoked by cross-coupled angular accelerations produced by roll and pitch head movements during passive yaw rotation in a chair. Contrary to previous reports, illusory self-motion did not correspond to expectations based on semicircular canal stimulation. Illusory pitch head-motion directions were as predicted for only 37% of trials; whereas, slow-phase eye movements were in the predicted direction for 98% of the trials. The real-time computer-generated animations procedure permits use of naive, untrained subjects who lack a vocabulary for reporting motion perception and is applicable to basic self-motion perception studies, evaluation of motion simulators, assessment of balance disorders and so on.

Experimental assessment of lanthanide ion donor preference: spectroscopic and theoretical dissection of static charge and dynamic polarisation contributions to axial ligation in a C4-symmetric chiral europium complex.

Measurements of the equilibrium constants for ligand exchange (MeCN, 295 K) involving the axial donor in a C4-symmetric, mono-capped, square antiprismatic cationic Eu complex, supported by calculations based on an electrostatic perturbation model, have been interpreted in terms of a predominant ligand polarisation interaction defined by observation of the hypersensitive delta J = 2 normalised emission intensity, in association with measurements correlating delta J = 1 band splitting and 1H NMR dipolar shifts that vindicate Bleaney's theory of magnetic anisotropy.

Assessment and documentation of bowel care management in palliative care: incorporating patient preferences into the care regimen.

Nurses in a palliative care unit (PCU) recognized that there were several inconsistencies relating to assessment and documentation of patient preferences in bowel care management. Although bowel care is recognized as of key importance to the wellbeing of palliative care patients, there is little evidence in current literature about accommodation of patient preferences in bowel care management. A questionnaire was developed to assess whether patient preferences were elicited on admission to the PCU, were documented, and were included in the bowel care regimen. Data were collected from 100 patients in two PCUs in Australia. The findings suggested that little was assessed or documented about bowel care management on admission except functional or pharmacological information. According to patients in the study, their preferences were seldom incorporated into the bowel care regimen. Lack of documentation of bowel care preferences was also found following an audit of patient notes. Techniques for eliciting information, awareness of alternative or complementary methods of bowel care and better documentation procedures are all recommended for inclusion in nursing practice in the palliative care setting.

Effect of different types of Medicaid managed care on childhood immunization rates.

Medicaid managed care can improve access to prevention services, such as immunization, for low-income children. The authors studied immunization rates for 7,356 children on Medicaid in three managed care programs: primary care case management (PCCM; n = 4,605), a voluntary HMO program (n = 851), and a mandatory HMO program (n = 1,900). Immunization rates (3:3:1 series) in PCCM (78%) exceeded rates in the voluntary HMO program (71%), which in turn exceeded those in the mandatory HMO program (67%). Adjusting for race, urban residence, and gender, compared to children in PCCM, children in the voluntary HMO program were less likely to complete the 3:3:1 series (OR = 0.75, CI = 0.63, 0.90), and children in the mandatory HMO program were even less likely to complete the series (OR = 0.59, CI = 0.51, 0.68). Results differed by individual HMOs. Monitoring of outcomes for all types of managed care by Medicaid agencies is imperative to assure better disease prevention for low-income children.