Clinical investigation of asmofilcon A silicone hydrogel lenses

Purpose. To investigate the clinical and subjective performance of asmofilcon A, a new third generation silicone hydrogel contact lens during 6-night extended wear (EW) over 6 months. Methods. A prospective, randomized, single-masked study was conducted. Sixty experienced daily wear soft contact lens wearers were randomly assigned to wear either asmofilcon A or senofilcon A contact lenses bilaterally for 6 months on an EW basis. Evaluations were conducted at contact lens delivery and after 1 week, 4 weeks, 3 and 6 months of EW. Results. Fifty subjects (83%) successfully completed the study. Two subjects experienced adverse events; one unilateral red eye with asmofilcon A and one asymptomatic infiltrate with senofilcon A. There were no significant differences in high or low contrast distance visual acuity between asmofilcon A and senofilcon A; however, low contrast distance visual acuity decreased significantly over time with both contact lens types (p < 0.05). The two lens types did not vary significantly with respect to any of the objective and subjective measures assessed (p > 0.05). Superior palpebral conjunctival injection showed a statistically significant increase over time with both lens types (p < 0.05). Both lens types were rated highly with respect to overall comfort, with subjects reporting 14 or 15 h of comfortable lens wearing time per day at each of the study visits (p > 0.05). Overall satisfaction ratings were also very high at all visits, with median scores of 95 (86 to 99) for asmofilcon A and 90 (85 to 96) for senofilcon A at 6 months (p > 0.05). Conclusions. Over 6 months of EW, the asmofilcon A contact lens performed in a similar manner to senofilcon A with respect to visual acuity, ocular health, and contact lens performance measures. Longer-term EW studies are required to investigate the changes over time observed with both lens types.

Clinical indicators of quality for Australian residential aged care facilities : establishing reliability, validity, and quality thresholds

Background: In response to the need for more comprehensive quality assessment within Australian residential aged care facilities, the Clinical Care Indicator (CCI) Tool was developed to collect outcome data as a means of making inferences about quality. A national trial of its effectiveness and a Brisbane-based trial of its use within the quality improvement context determined the CCI Tool represented a potentially valuable addition to the Australian aged care system. This document describes the next phase in the CCI Tool.s development; the aims of which were to establish validity and reliability of the CCI Tool, and to develop quality indicator thresholds (benchmarks) for use in Australia. The CCI Tool is now known as the ResCareQA (Residential Care Quality Assessment). Methods: The study aims were achieved through a combination of quantitative data analysis, and expert panel consultations using modified Delphi process. The expert panel consisted of experienced aged care clinicians, managers, and academics; they were initially consulted to determine face and content validity of the ResCareQA, and later to develop thresholds of quality. To analyse its psychometric properties, ResCareQA forms were completed for all residents (N=498) of nine aged care facilities throughout Queensland. Kappa statistics were used to assess inter-rater and test-retest reliability, and Cronbach.s alpha coefficient calculated to determine internal consistency. For concurrent validity, equivalent items on the ResCareQA and the Resident Classification Scales (RCS) were compared using Spearman.s rank order correlations, while discriminative validity was assessed using known-groups technique, comparing ResCareQA results between groups with differing care needs, as well as between male and female residents. Rank-ordered facility results for each clinical care indicator (CCI) were circulated to the panel; upper and lower thresholds for each CCI were nominated by panel members and refined through a Delphi process. These thresholds indicate excellent care at one extreme and questionable care at the other. Results: Minor modifications were made to the assessment, and it was renamed the ResCareQA. Agreement on its content was reached after two Delphi rounds; the final version contains 24 questions across four domains, enabling generation of 36 CCIs. Both test-retest and inter-rater reliability were sound with median kappa values of 0.74 (test-retest) and 0.91 (inter-rater); internal consistency was not as strong, with a Chronbach.s alpha of 0.46. Because the ResCareQA does not provide a single combined score, comparisons for concurrent validity were made with the RCS on an item by item basis, with most resultant correlations being quite low. Discriminative validity analyses, however, revealed highly significant differences in total number of CCIs between high care and low care groups (t199=10.77, p=0.000), while the differences between male and female residents were not significant (t414=0.56, p=0.58). Clinical outcomes varied both within and between facilities; agreed upper and lower thresholds were finalised after three Delphi rounds. Conclusions: The ResCareQA provides a comprehensive, easily administered means of monitoring quality in residential aged care facilities that can be reliably used on multiple occasions. The relatively modest internal consistency score was likely due to the multi-factorial nature of quality, and the absence of an aggregate result for the assessment. Measurement of concurrent validity proved difficult in the absence of a gold standard, but the sound discriminative validity results suggest that the ResCareQA has acceptable validity and could be confidently used as an indication of care quality within Australian residential aged care facilities. The thresholds, while preliminary due to small sample size, enable users to make judgements about quality within and between facilities. Thus it is recommended the ResCareQA be adopted for wider use.

Patient-specific computational biomechanics for simulating adolescent scoliosis surgery : predicted vs clinical correction for a preliminary series of six patients

Scoliosis is a spinal deformity that requires surgical correction in progressive cases. In order to optimize surgical outcomes, patient-specific finite element models are being developed by our group. In this paper, a single rod anterior correction procedure is simulated for a group of six scoliosis patients. For each patient, personalised model geometry was derived from low-dose CT scans, and clinically measured intra-operative corrective forces were applied. However, tissue material properties were not patient-specific, being derived from existing literature. Clinically, the patient group had a mean initial Cobb angle of 47.3 degrees, which was corrected to 17.5 degrees after surgery. The mean simulated post-operative Cobb angle for the group was 18.1 degrees. Although this represents good agreement between clinical and simulated corrections, the discrepancy between clinical and simulated Cobb angle for individual patients varied between -10.3 and +8.6 degrees, with only three of the six patients matching the clinical result to within accepted Cobb measurement error of +-5 degrees. The results of this study suggest that spinal tissue material properties play an important role in governing the correction obtained during surgery, and that patient-specific modelling approaches must address the question of how to prescribe patient-specific soft tissue properties for spine surgery simulation.

The biological application of cobalt

This review collects and summarises the biological applications of the element cobalt. Small amounts of the ferromagnetic metal can be found in rock, soil, plants and animals, but is mainly obtained as a by-product of nickel and copper mining, and is separated from the ores (mainly cobaltite, erythrite, glaucodot and skutterudite) using a variety of methods. Compounds of cobalt include several oxides, including: green cobalt(II) (CoO), blue cobalt(II,III) (Co3O4), and black cobalt(III) (Co2O3); four halides including pink cobalt(II) fluoride (CoF2), blue cobalt(II) chloride (CoCl2), green cobalt(II) bromide (CoBr2), and blue-black cobalt(II) iodide (CoI2). The main application of cobalt is in its metal form in cobalt-based super alloys, though other uses include lithium cobalt oxide batteries, chemical reaction catalyst, pigments and colouring, and radioisotopes in medicine. It is known to mimic hypoxia on the cellular level by stabilizing the α subunit of hypoxia inducing factor (HIF), when chemically applied as cobalt chloride (CoCl2). This is seen in many biological research applications, where it has shown to promote angiogenesis, erythropoiesis and anaerobic metabolism through the transcriptional activation of genes such as vascular endothelial growth factor (VEGF) and erythropoietin (EPO), contributing significantly to the pathophysiology of major categories of disease, such as myocardial, renal and cerebral ischaemia, high altitude related maladies and bone defects. As a necessary constituent for the formation of vitamin B12, it is essential to all animals, including humans, however excessive exposure can lead to tissue and cellular toxicity. Cobalt has been shown to provide promising potential in clinical applications, however further studies are necessary to clarify its role in hypoxia-responsive genes and the applications of cobalt-chloride treated tissues.

Application of an optimisation algorithm to configure an internal fixation device

Fractures of long bones are sometimes treated using various types of fracture fixation devices including internal plate fixators. These are specialised plates which are used to bridge the fracture gap(s) whilst anatomically aligning the bone fragments. The plate is secured in position by screws. The aim of such a device is to support and promote the natural healing of the bone. When using an internal fixation device, it is necessary for the clinician to decide upon many parameters, for example, the type of plate and where to position it; how many and where to position the screws. While there have been a number of experimental and computational studies conducted regarding the configuration of screws in the literature, there is still inadequate information available concerning the influence of screw configuration on fracture healing. Because screw configuration influences the amount of flexibility at the area of fracture, it has a direct influence on the fracture healing process. Therefore, it is important that the chosen screw configuration does not inhibit the healing process. In addition to the impact on the fracture healing process, screw configuration plays an important role in the distribution of stresses in the plate due to the applied loads. A plate that experiences high stresses is prone to early failure. Hence, the screw configuration used should not encourage the occurrence of high stresses. This project develops a computational program in Fortran programming language to perform mathematical optimisation to determine the screw configuration of an internal fixation device within constraints of interfragmentary movement by minimising the corresponding stress in the plate. Thus, the optimal solution suggests the positioning and number of screws which satisfies the predefined constraints of interfragmentary movements. For a set of screw configurations the interfragmentary displacement and the stress occurring in the plate were calculated by the Finite Element Method. The screw configurations were iteratively changed and each time the corresponding interfragmentary displacements were compared with predefined constraints. Additionally, the corresponding stress was compared with the previously calculated stress value to determine if there was a reduction. These processes were continued until an optimal solution was achieved. The optimisation program has been shown to successfully predict the optimal screw configuration in two cases. The first case was a simplified bone construct whereby the screw configuration solution was comparable with those recommended in biomechanical literature. The second case was a femoral construct, of which the resultant screw configuration was shown to be similar to those used in clinical cases. The optimisation method and programming developed in this study has shown that it has potential to be used for further investigations with the improvement of optimisation criteria and the efficiency of the program.

Clinical education for nephrology nurse practitioner candidates in Australia : a consensus statement

Objectives: To develop recommendations for the clinical education required to prepare Australian Nurse Practitioner candidates for advanced and extended practice in nephrology settings. Methods: Using the Delphi research technique a consensus statement was developed over a nine month period. All endorsed and candidate Nephrology Nurse Practitioners (NNP) were invited to participate as the expert panel. The Delphi research technique uses a systematic and iterative process. The expert panel were asked to generate a list of items which were then circulated to all NNPs. They were asked to determine their degree of agreement or disagreement with each statement using a 5-point Likert scale There was opportunity for free-text comments to be provided if desired. Results from each round were collated; the document was refined and circulated to the experts for a subsequent round. Consensus was demonstrated after three Delphi rounds. Results: The consensus statement comprises four components explaining the role and membership of the mentorship team, the setting and location of NNP clinical education, learning strategies to support the NNP, and outcomes of NNP clinical education. Demographic questions in the final survey revealed information about the qualifications, years of experience, and practice location of Australian NNPs. Conclusions: The consensus statement is not prescriptive but it will inform NNP candidates, university course providers and mentors about the expected extended nephrology specific clinical education that will enable the NNP to provide advanced nursing care for patients regardless of the stage of chronic kidney disease (CKD) and the practice setting.

Development and evaluation of an integrated clinical learning model to inform continuing education for acute care nurses

Background Significant ongoing learning needs for nurses have occurred as a direct result of the continuous introduction of technological innovations and research developments in the healthcare environment. Despite an increased worldwide emphasis on the importance of continuing education, there continues to be an absence of empirical evidence of program and session effectiveness. Few studies determine whether continuing education enhances or develops practice and the relative cost benefits of health professionals’ participation in professional development. The implications for future clinical practice and associated educational approaches to meet the needs of an increasingly diverse multigenerational and multicultural workforce are also not well documented. There is minimal research confirming that continuing education programs contribute to improved patient outcomes, nurses’ earlier detection of patient deterioration or that standards of continuing competence are maintained. Crucially, evidence-based practice is demonstrated and international quality and safety benchmarks are adhered to. An integrated clinical learning model was developed to inform ongoing education for acute care nurses. Educational strategies included the use of integrated learning approaches, interactive teaching concepts and learner-centred pedagogies. A Respiratory Skills Update education (ReSKU) program was used as the content for the educational intervention to inform surgical nurses’ clinical practice in the area of respiratory assessment. The aim of the research was to evaluate the effectiveness of implementing the ReSKU program using teaching and learning strategies, in the context of organisational utility, on improving surgical nurses’ practice in the area of respiratory assessment. The education program aimed to facilitate better awareness, knowledge and understanding of respiratory dysfunction in the postoperative clinical environment. This research was guided by the work of Forneris (2004), who developed a theoretical framework to operationalise a critical thinking process incorporating the complexities of the clinical context. The framework used educational strategies that are learner-centred and participatory. These strategies aimed to engage the clinician in dynamic thinking processes in clinical practice situations guided by coaches and educators. Methods A quasi experimental pre test, post test non–equivalent control group design was used to evaluate the impact of the ReSKU program on the clinical practice of surgical nurses. The research tested the hypothesis that participation in the ReSKU program improves the reported beliefs and attitudes of surgical nurses, increases their knowledge and reported use of respiratory assessment skills. The study was conducted in a 400 bed regional referral public hospital, the central hub of three smaller hospitals, in a health district servicing the coastal and hinterland areas north of Brisbane. The sample included 90 nurses working in the three surgical wards eligible for inclusion in the study. The experimental group consisted of 36 surgical nurses who had chosen to attend the ReSKU program and consented to be part of the study intervention group. The comparison group included the 39 surgical nurses who elected not to attend the ReSKU program, but agreed to participate in the study. Findings One of the most notable findings was that nurses choosing not to participate were older, more experienced and less well educated. The data demonstrated that there was a barrier for training which impacted on educational strategies as this mature aged cohort was less likely to take up educational opportunities. The study demonstrated statistically significant differences between groups regarding reported use of respiratory skills, three months after ReSKU program attendance. Between group data analysis indicated that the intervention group’s reported beliefs and attitudes pertaining to subscale descriptors showed statistically significant differences in three of the six subscales following attendance at the ReSKU program. These subscales included influence on nursing care, educational preparation and clinical development. Findings suggest that the use of an integrated educational model underpinned by a robust theoretical framework is a strong factor in some perceptions of the ReSKU program relating to attitudes and behaviour. There were minimal differences in knowledge between groups across time. Conclusions This study was consistent with contemporary educational approaches using multi-modal, interactive teaching strategies and a robust overarching theoretical framework to support study concepts. The construct of critical thinking in the clinical context, combined with clinical reasoning and purposeful and collective reflection, was a powerful educational strategy to enhance competency and capability in clinicians.

Lessons learnt : complementing good clinical renal questions with an appropriate research strategy

The purpose of this article is to present lessons learnt by nurses when conducting research to encourage colleagues to ask good clinical research questions. This is accomplished by presenting a study designed to challenge current practice which included research flaws. The longstanding practice of weighing renal patients at 0600 hours and then again prior to receiving haemodialysis was examined. Nurses believed that performing the assessment twice, often within a few hours, was unnecessary and that patients were angry when woken to be weighed. An observational study with convenience sampling collected data from 46 individuals requiring haemodialysis, who were repeatedly sampled to provide 139 episodes of data. Although the research hypotheses were rejected, invaluable experience was gained, with research and clinical practice lessons learnt, along with surprising findings.

Malnutrition and clinical outcomes in elderly patients from a Singapore acute hospital

Older adults, especially those acutely ill, are vulnerable to developing malnutrition due to a range of risk factors. The high prevalence and extensive consequences of malnutrition in hospitalised older adults have been reported extensively. However, there are few well-designed longitudinal studies that report the independent relationship between malnutrition and clinical outcomes after adjustment for a wide range of covariates. Acutely ill older adults are exceptionally prone to nutritional decline during hospitalisation, but few reports have studied this change and impact on clinical outcomes. In the rapidly ageing Singapore population, all this evidence is lacking, and the characteristics associated with the risk of malnutrition are also not well-documented. Despite the evidence on malnutrition prevalence, it is often under-recognised and under-treated. It is therefore crucial that validated nutrition screening and assessment tools are used for early identification of malnutrition. Although many nutrition screening and assessment tools are available, there is no universally accepted method for defining malnutrition risk and nutritional status. Most existing tools have been validated amongst Caucasians using various approaches, but they are rarely reported in the Asian elderly and none has been validated in Singapore. Due to the multiethnicity, cultural, and language differences in Singapore older adults, the results from non-Asian validation studies may not be applicable. Therefore it is important to identify validated population and setting specific nutrition screening and assessment methods to accurately detect and diagnose malnutrition in Singapore. The aims of this study are therefore to: i) characterise hospitalised elderly in a Singapore acute hospital; ii) describe the extent and impact of admission malnutrition; iii) identify and evaluate suitable methods for nutritional screening and assessment; and iv) examine changes in nutritional status during admission and their impact on clinical outcomes. A total of 281 participants, with a mean (+SD) age of 81.3 (+7.6) years, were recruited from three geriatric wards in Tan Tock Seng Hospital over a period of eight months. They were predominantly Chinese (83%) and community-dwellers (97%). They were screened within 72 hours of admission by a single dietetic technician using four nutrition screening tools [Tan Tock Seng Hospital Nutrition Screening Tool (TTSH NST), Nutritional Risk Screening 2002 (NRS 2002), Mini Nutritional Assessment-Short Form (MNA-SF), and Short Nutritional Assessment Questionnaire (SNAQ©)] that were administered in no particular order. The total scores were not computed during the screening process so that the dietetic technician was blinded to the results of all the tools. Nutritional status was assessed by a single dietitian, who was blinded to the screening results, using four malnutrition assessment methods [Subjective Global Assessment (SGA), Mini Nutritional Assessment (MNA), body mass index (BMI), and corrected arm muscle area (CAMA)]. The SGA rating was completed prior to computation of the total MNA score to minimise bias. Participants were reassessed for weight, arm anthropometry (mid-arm circumference, triceps skinfold thickness), and SGA rating at discharge from the ward. The nutritional assessment tools and indices were validated against clinical outcomes (length of stay (LOS) >11days, discharge to higher level care, 3-month readmission, 6-month mortality, and 6-month Modified Barthel Index) using multivariate logistic regression. The covariates included age, gender, race, dementia (defined using DSM IV criteria), depression (defined using a single question “Do you often feel sad or depressed?”), severity of illness (defined using a modified version of the Severity of Illness Index), comorbidities (defined using Charlson Comorbidity Index, number of prescribed drugs and admission functional status (measured using Modified Barthel Index; MBI). The nutrition screening tools were validated against the SGA, which was found to be the most appropriate nutritional assessment tool from this study (refer section 5.6) Prevalence of malnutrition on admission was 35% (defined by SGA), and it was significantly associated with characteristics such as swallowing impairment (malnourished vs well-nourished: 20% vs 5%), poor appetite (77% vs 24%), dementia (44% vs 28%), depression (34% vs 22%), and poor functional status (MBI 48.3+29.8 vs 65.1+25.4). The SGA had the highest completion rate (100%) and was predictive of the highest number of clinical outcomes: LOS >11days (OR 2.11, 95% CI [1.17- 3.83]), 3-month readmission (OR 1.90, 95% CI [1.05-3.42]) and 6-month mortality (OR 3.04, 95% CI [1.28-7.18]), independent of a comprehensive range of covariates including functional status, disease severity and cognitive function. SGA is therefore the most appropriate nutritional assessment tool for defining malnutrition. The TTSH NST was identified as the most suitable nutritional screening tool with the best diagnostic performance against the SGA (AUC 0.865, sensitivity 84%, specificity 79%). Overall, 44% of participants experienced weight loss during hospitalisation, and 27% had weight loss >1% per week over median LOS 9 days (range 2-50). Wellnourished (45%) and malnourished (43%) participants were equally prone to experiencing decline in nutritional status (defined by weight loss >1% per week). Those with reduced nutritional status were more likely to be discharged to higher level care (adjusted OR 2.46, 95% CI [1.27-4.70]). This study is the first to characterise malnourished hospitalised older adults in Singapore. It is also one of the very few studies to (a) evaluate the association of admission malnutrition with clinical outcomes in a multivariate model; (b) determine the change in their nutritional status during admission; and (c) evaluate the validity of nutritional screening and assessment tools amongst hospitalised older adults in an Asian population. Results clearly highlight that admission malnutrition and deterioration in nutritional status are prevalent and are associated with adverse clinical outcomes in hospitalised older adults. With older adults being vulnerable to risks and consequences of malnutrition, it is important that they are systematically screened so timely and appropriate intervention can be provided. The findings highlighted in this thesis provide an evidence base for, and confirm the validity of the current nutrition screening and assessment tools used among hospitalised older adults in Singapore. As the older adults may have developed malnutrition prior to hospital admission, or experienced clinically significant weight loss of >1% per week of hospitalisation, screening of the elderly should be initiated in the community and continuous nutritional monitoring should extend beyond hospitalisation.

Timeliness and Clinical Impact of Hospital-Initiated Medication Reviews

Background: Medication-related problems often occur in the immediate post-discharge period. To reduce medication misadventure the Commonwealth Government funds home medicines reviews (HMRs). HMRs are initiated when general practitioners refer consenting patients to their community pharmacists, who then engage accredited pharmacists to review patients' medicines in their homes. Aim: To determine if hospital-initiated medication reviews (HIMRs) can be implemented in a more timely manner than HMRs; and to assess the impact of a bespoke referral form with comorbidity-specific questions on the quality of reports. Method: Eligible medical inpatients at risk of medication misadventure were referred by the hospital liaison pharmacist to participating accredited pharmacists post-discharge from hospital. Social, demographic and laboratory data were collected from medical records and during interviews with consenting patients. Issues raised in the HIMR reports were categorised: intervention/action, information given or recommendation, and assigned a rank of clinical significance. Results: HIMRs were conducted within 11.6 6.6 days postdischarge. 36 HIMR reports were evaluated and 1442 issues identified - information given (n = 1204), recommendations made (n = 88) and actions taken (n = 150). The majority of issues raised (89%) had a minor clinical impact. The bespoke referral form prompted approximately half of the issues raised. Conclusion: HIMRs can be facilitated in a more timely manner than post-discharge HMRs. There was an associated positive clinical impact of issues raised in the HIMR reports.

Sing & Grow : the co-existence of evaluation research and clinical practice in an early intervention music therapy project

Sing & Grow is a short term early intervention music therapy program for at risk families. Sing & Grow uses music to strengthen parent-child relationships by increasing positive parent-child interactions, assisting parents to bond with their children, and extending the repertoire of parents’ skills in relating to their child through interactive . Both the Australian and New Zealand governments are looking for evidence based research to highlight the effectiveness of funded programs in early childhood. As a government funded program, independent evaluation is a requirement of the delivery of the service. This paper explains the process involved in setting up and managing this large scale evaluation from engaging the evaluators and designing the project, to the data gathering stage. It describes the various challenges encountered and concludes that a highly collaborative and communicative partnership bet en researchers and clinicians is essential to ensure data can be gathered with minimal disturbance to clinical music therapy practice.