586 resultados para Clinical validation


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Aim Australian residential aged care does not have a system of quality assessment related to clinical outcomes, or comprehensive quality benchmarking. The Residential Care Quality Assessment was developed to fill this gap; and this paper discusses the process by which preliminary benchmarks representing high and low quality were developed for it. Methods Data were collected from all residents (n = 498) of nine facilities. Numerator–denominator analysis of clinical outcomes occurred at a facility-level, with rank-ordered results circulated to an expert panel. The panel identified threshold scores to indicate excellent and questionable care quality, and refined these through Delphi process. Results Clinical outcomes varied both within and between facilities; agreed thresholds for excellent and poor outcomes were finalised after three Delphi rounds. Conclusion Use of the Residential Care Quality Assessment provides a concrete means of monitoring care quality and allows benchmarking across facilities; its regular use could contribute to improved care outcomes within residential aged care in Australia.

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Hazard perception in driving involves a number of different processes. This paper reports the development of two measures designed to separate these processes. A Hazard Perception Test was developed to measure how quickly drivers could anticipate hazards overall, incorporating detection, trajectory prediction, and hazard classification judgements. A Hazard Change Detection Task was developed to measure how quickly drivers can detect a hazard in a static image regardless of whether they consider it hazardous or not. For the Hazard Perception Test, young novices were slower than mid-age experienced drivers, consistent with differences in crash risk, and test performance correlated with scores in pre-existing Hazard Perception Tests. For drivers aged 65 and over, scores on the Hazard Perception Test declined with age and correlated with both contrast sensitivity and a Useful Field of View measure. For the Hazard Change Detection Task, novices responded quicker than the experienced drivers, contrary to crash risk trends, and test performance did not correlate with measures of overall hazard perception. However for drivers aged 65 and over, test performance declined with age and correlated with both hazard perception and Useful Field of View. Overall we concluded that there was support for the validity of the Hazard Perception Test for all ages but the Hazard Change Detection Task might only be appropriate for use with older drivers.

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Objective Uterine Papillary Serous Carcinoma (UPSC) is uncommon and accounts for less than 5% of all uterine cancers. Therefore the majority of evidence about the benefits of adjuvant treatment comes from retrospective case series. We conducted a prospective multi-centre non-randomized phase 2 clinical trial using four cycles of adjuvant paclitaxel plus carboplatin chemotherapy followed by pelvic radiotherapy, in order to evaluate the tolerability and safety of this approach. Methods This trial enrolled patients with newly diagnosed, previously untreated patients with stage 1b-4 (FIGO-1988) UPSC with a papillary serous component of at least 30%. Paclitaxel (175 mg/m2) and carboplatin (AUC 6) were administered on day 1 of each 3-week cycle for 4 cycles. Chemotherapy was followed by external beam radiotherapy to the whole pelvis (50.4 Gy over 5.5 weeks). Completion and toxicity of treatment (Common Toxicity Criteria, CTC) and quality of life measures were the primary outcome indicators. Results Twenty-nine of 31 patients completed treatment as planned. Dose reduction was needed in 9 patients (29%), treatment delay in 7 (23%), and treatment cessation in 2 patients (6.5%). Hematologic toxicity, grade 3 or 4 occurred in 19% (6/31) of patients. Patients' self-reported quality of life remained stable throughout treatment. Thirteen of the 29 patients with stages 1–3 disease (44.8%) recurred (average follow up 28.1 months, range 8–60 months). Conclusion This multimodal treatment is feasible, safe and tolerated reasonably well and would be suitable for use in multi-institutional prospective randomized clinical trials incorporating novel therapies in patients with UPSC.

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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.

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From Pontryagin’s Maximum Principle to the Duke Kahanamoku Aquatic Complex; we develop the theory and generate implementable time efficient trajectories for a test-bed autonomous underwater vehicle (AUV). This paper is the beginning of the journey from theory to implementation. We begin by considering pure motion trajectories and move into a rectangular trajectory which is a concatenation of pure surge and pure sway. These trajectories are tested using our numerical model and demonstrated by our AUV in the pool. In this paper we demonstrate that the above motions are realizable through our method, and we gain confidence in our numerical model. We conclude that using our current techniques, implementation of time efficient trajectories is likely to succeed.

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This study investigated, validated, and applied the optimum conditions for a modified microwave assisted digestion method for subsequent ICP-MS determination of mercury, cadmium, and lead in two matrices relevant to water quality, that is, sediment and fish. Three different combinations of power, pressure, and time conditions for microwave-assisted digestion were tested, using two certified reference materials representing the two matrices, to determine the optimum set of conditions. Validation of the optimized method indicated better recovery of the studied metals compared to standard methods. The validated method was applied to sediment and fish samples collected from Agusan River and one of its tributaries, located in Eastern Mindanao, Philippines. The metal concentrations in sediment ranged from 2.85 to 341.06 mg/kg for Hg, 0.05 to 44.46 mg/kg for Cd and 2.20 to 1256.16 mg/kg for Pb. The results indicate that the concentrations of these metals in the sediments rapidly decrease with distance downstream from sites of contamination. In the selected fish species, the metals were detected but at levels that are considered safe for human consumption, with concentrations of 2.14 to 6.82 μg/kg for Hg, 0.035 to 0.068 μg/kg for Cd, and 0.019 to 0.529 μg/kg for Pb.

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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.

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Frequently there is a disconnectedness, either perceived or actual, between theoretical principles and laboratory practice in science education and this holds true for clinical microbiology where traditionally knowledge is delivered in ‘chunks’ in a lecture format with the misguided belief that students have to know ‘everything about everything’. This preoccupation with content delivery often leaves no time for active class discussion or reflection. Moreover, laboratory classes are treated as add-ons to the process, rather than an integrated part of the whole learning experience. In redesigning our units (subjects) we have bridged the gap between the theory and practice of clinical bacteriology. In doing so, we have seen a transformation in the learning experiences of our students and in the way we teach.

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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.

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The purpose of this work is to validate and automate the use of DYNJAWS; a new component module (CM) in the BEAMnrc Monte Carlo (MC) user code. The DYNJAWS CM simulates dynamic wedges and can be used in three modes; dynamic, step-and-shoot and static. The step-and-shoot and dynamic modes require an additional input file defining the positions of the jaw that constitutes the dynamic wedge, at regular intervals during its motion. A method for automating the generation of the input file is presented which will allow for the more efficient use of the DYNJAWS CM. Wedged profiles have been measured and simulated for 6 and 10 MV photons at three field sizes (5 cm x 5 cm , 10 cm x10 cm and 20 cm x 20 cm), four wedge angles (15, 30, 45 and 60 degrees), at dmax and at 10 cm depth. Results of this study show agreement between the measured and the MC profiles to within 3% of absolute dose or 3 mm distance to agreement for all wedge angles at both energies and depths. The gamma analysis suggests that dynamic mode is more accurate than the step-and-shoot mode. The DYNJAWS CM is an important addition to the BEAMnrc code and will enable the MC verification of patient treatments involving dynamic wedges.

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To analyse mechanotransduction resulting from tensile loading under defined conditions, various devices for in vitro cell stimulation have been developed. This work aimed to determine the strain distribution on the membrane of a commercially available device and its consistency with rising cycle numbers, as well as the amount of strain transferred to adherent cells. The strains and their behaviour within the stimulation device were determined using digital image correlation (DIC). The strain transferred to cells was measured on eGFP-transfected bone marrow-derived cells imaged with a fluorescence microscope. The analysis was performed by determining the coordinates of prominent positions on the cells, calculating vectors between the coordinates and their length changes with increasing applied tensile strain. The stimulation device was found to apply homogeneous (mean of standard deviations approx. 2% of mean strain) and reproducible strains in the central well area. However, on average, only half of the applied strain was transferred to the bone marrow-derived cells. Furthermore, the strain measured within the device increased significantly with an increasing number of cycles while the membrane's Young's modulus decreased, indicating permanent changes in the material during extended use. Thus, strain magnitudes do not match the system readout and results require careful interpretation, especially at high cycle numbers.

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BACKGROUND. Physical symptoms are common in pregnancy and are predominantly associated with normal physiological changes. These symptoms have a social and economic cost, leading to absenteeism from work and additional medical interventions. There is currently no simple method for identifying common pregnancy related problems in the antenatal period. A validated tool, for use by pregnancy care providers would be useful. AIM: The aim of the project was to develop and validate a Pregnancy Symptoms Inventory for use by healthcare professionals (HCPs). METHODS: A list of symptoms was generated via expert consultation with midwives and obstetrician gynaecologists. Focus groups were conducted with pregnant women in their first, second or third trimester. The inventory was then tested for face validity and piloted for readability and comprehension. For test-re-test reliability, it was administered to the same women 2 to 3 days apart. Finally, outpatient midwives trialled the inventory for 1 month and rated its usefulness on a 10cm visual analogue scale (VAS). The number of referrals to other health care professionals was recorded during this month. RESULTS: Expert consultation and focus group discussions led to the generation of a 41-item inventory. Following face validity and readability testing, several items were modified. Individual item test re-test reliability was between .51 to 1 with the majority (34 items) scoring .0.70. During the testing phase, 211 surveys were collected in the 1 month trial. Tiredness (45.5%), poor sleep (27.5%) back pain (19.5%) and nausea (12.6%) were experienced often. Among the women surveyed, 16.2% claimed to sometimes or often be incontinent. Referrals to the incontinence nurse increased > 8 fold during the study period. The median rating by midwives of the ‘usefulness’ of the inventory was 8.4 (range 0.9 to 10). CONCLUSIONS: The Pregnancy Symptoms Inventory (PSI) was well accepted by women in the 1 month trial and may be a useful tool for pregnancy care providers and aids clinicians in early detection and subsequent treatment of symptoms. It shows promise for use in the research community for assessing the impact of lifestyle intervention in pregnancy.

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This paper develops a general theory of validation gating for non-linear non-Gaussian mod- els. Validation gates are used in target tracking to cull very unlikely measurement-to-track associa- tions, before remaining association ambiguities are handled by a more comprehensive (and expensive) data association scheme. The essential property of a gate is to accept a high percentage of correct associ- ations, thus maximising track accuracy, but provide a su±ciently tight bound to minimise the number of ambiguous associations. For linear Gaussian systems, the ellipsoidal vali- dation gate is standard, and possesses the statistical property whereby a given threshold will accept a cer- tain percentage of true associations. This property does not hold for non-linear non-Gaussian models. As a system departs from linear-Gaussian, the ellip- soid gate tends to reject a higher than expected pro- portion of correct associations and permit an excess of false ones. In this paper, the concept of the ellip- soidal gate is extended to permit correct statistics for the non-linear non-Gaussian case. The new gate is demonstrated by a bearing-only tracking example.

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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.