571 resultados para Pre-Trial


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Background Comparison of a multimodal intervention WE CALL (study initiated phone support/information provision) versus a passive intervention YOU CALL (participant can contact a resource person) in individuals with first mild stroke. Methods and Results This study is a single-blinded randomized clinical trial. Primary outcome includes unplanned use of health services (participant diaries) for adverse events and quality of life (Euroquol-5D, Quality of Life Index). Secondary outcomes include planned use of health services (diaries), mood (Beck Depression Inventory II), and participation (Assessment of Life Habits [LIFE-H]). Blind assessments were done at baseline, 6, and 12 months. A mixed model approach for statistical analysis on an intention-to-treat basis was used where the group factor was intervention type and occasion factor time, with a significance level of 0.01. We enrolled 186 patients (WE=92; YOU=94) with a mean age of 62.5±12.5 years, and 42.5% were women. No significant differences were seen between groups at 6 months for any outcomes with both groups improving from baseline on all measures (effect sizes ranged from 0.25 to 0.7). The only significant change for both groups from 6 months to 1 year (n=139) was in the social domains of the LIFE-H (increment in score, 0.4/9±1.3 [95% confidence interval, 0.1–0.7]; effect size, 0.3). Qualitatively, the WE CALL intervention was perceived as reassuring, increased insight, and problem solving while decreasing anxiety. Only 6 of 94 (6.4%) YOU CALL participants availed themselves of the intervention. Conclusions Although the 2 groups improved equally over time, WE CALL intervention was perceived as helpful, whereas YOU CALL intervention was not used.

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Background More than 60% of new strokes each year are "mild" in severity and this proportion is expected to rise in the years to come. Within our current health care system those with "mild" stroke are typically discharged home within days, without further referral to health or rehabilitation services other than advice to see their family physician. Those with mild stroke often have limited access to support from health professionals with stroke-specific knowledge who would typically provide critical information on topics such as secondary stroke prevention, community reintegration, medication counselling and problem solving with regard to specific concerns that arise. Isolation and lack of knowledge may lead to a worsening of health problems including stroke recurrence and unnecessary and costly health care utilization. The purpose of this study is to assess the effectiveness, for individuals who experience a first "mild" stroke, of a sustainable, low cost, multimodal support intervention (comprising information, education and telephone support) - "WE CALL" compared to a passive intervention (providing the name and phone number of a resource person available if they feel the need to) - "YOU CALL", on two primary outcomes: unplanned-use of health services for negative events and quality of life. Method/Design We will recruit 384 adults who meet inclusion criteria for a first mild stroke across six Canadian sites. Baseline measures will be taken within the first month after stroke onset. Participants will be stratified according to comorbidity level and randomised to one of two groups: YOU CALL or WE CALL. Both interventions will be offered over a six months period. Primary outcomes include unplanned use of heath services for negative event (frequency calendar) and quality of life (EQ-5D and Quality of Life Index). Secondary outcomes include participation level (LIFE-H), depression (Beck Depression Inventory II) and use of health services for health promotion or prevention (frequency calendar). Blind assessors will gather data at mid-intervention, end of intervention and one year follow up. Discussion If effective, this multimodal intervention could be delivered in both urban and rural environments. For example, existing infrastructure such as regional stroke centers and existing secondary stroke prevention clinics, make this intervention, if effective, deliverable and sustainable.

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Purpose: To establish whether there was a difference in health-related quality of life (HRQoL) in people with chronic musculoskeletal disorders (PwCMSKD) after participating in a multimodal physiotherapy program (MPP) either two or three sessions a week. Methods: Total of 114 PwCMSKD participated in this prospective randomised controlled trial. An individualised MPP, consisting of exercises for mobility, motor-control, muscle strengthening, cardiovascular training, and health education, was implemented either twice a week (G2: n = 58) or three times a week) (G3: n = 56) for 1 year. Outcomes: HRQoL physical and mental health state (PHS/MHS), Roland Morris disability Questionnaire (RMQ), Neck-Disability-Index (NDI) and Western Ontario and McMaster Universities’ Arthritis Index (WOMAC) were used to measure outcomes of MPP for people with chronic low back pain, chronic neck pain and osteoarthritis, respectively. Measures were taken at baseline, 8 weeks (8 w), 6 months (6 m), and 1 year (1 y) after starting the programme. Results: No statistically significant differences were found between the two groups (G2 and G3), except in NDI at 8 w (−3.34, (CI 95%: −6.94/0.84, p = 0.025 (scale 0–50)). All variables showed improvement reaching the following values (from baseline to 1 y) G2: PHS: 57.72 (baseline: 41.17; (improvement: 16.55%), MHS: 74.51 (baseline: 47.46, 27.05%), HRQoL 0.90 (baseline: 0.72, 18%)), HRQoL-VAS 84.29 (baseline: 58.04, 26.25%), RMQ 4.15 (baseline: 7.85, 15.42%), NDI 3.96 (baseline: 21.87, 35.82%), WOMAC 7.17 (baseline: 25.51, 19.10%). G3: PHS: 58.64 (baseline: 39.75, 18.89%), MHS: 75.50 (baseline: 45.45, (30.05%), HRQoL 0.67 (baseline: 0.88, 21%), HRQoL-VAS 86.91 (baseline: 52.64, 34.27%), RMQ 4.83 (baseline: 8.93, 17.08%), NDI 4.91 (baseline: 23.82, 37.82%), WOMAC 6.35 (baseline: 15.30, 9.32%). Conclusions: No significant differences between the two groups were found in the outcomes of a MPP except in the NDI at 8 weeks, but both groups improved in all variables during the course of 1 year under study.

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Purpose To test the effectiveness of static and dynamic orthoses using them as an exclusive treatment for proximal interphalangeal (PIP) joint flexion contracture compared with other hand therapy conservative treatments described in the literature. Methods 60 patients who used orthoses were compared with a control group that received other hand therapy treatments. Clinical assessments were measured before the experiment and 3 months after and included active PIP joint extension and function. Results A significant improvement in the extension active range of motion at the PIP joint in the second measurement was found in both groups, but it was significantly greater in the experimental group. Improvement in function (Disabilities of the Arm, Shoulder, and Hand score) between the first and second assessment was similar in the control and experimental groups. Conclusions Using night progressive static and daily dynamic orthoses as an exclusive treatment during the proliferative phase led to significant improvements in the PIP joint active extension, but the improvement did not correlate with increased function as perceived by the patient.

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In the present study, items pre-exposed in a familiarization series were included in a list discrimination task to manipulate memory strength. At test, participants were required to discriminate strong targets and strong lures from weak targets and new lures. This resulted in a concordant pattern of increased "old" responses to strong targets and lures. Model estimates attributed this pattern to either equivalent increases in memory strength across the two types of items (unequal variance signal detection model) or equivalent increases in both familiarity and recollection (dual process signal detection [DPSD] model). Hippocampal activity associated with strong targets and lures showed equivalent increases compared with missed items. This remained the case when analyses were restricted to high-confidence responses considered by the DPSD model to reflect predominantly recollection. A similar pattern of activity was observed in parahippocampal cortex for high-confidence responses. The present results are incompatible with "noncriterial" or "false" recollection being reflected solely in inflated DPSD familiarity estimates and support a positive correlation between hippocampal activity and memory strength irrespective of the accuracy of list discrimination, consistent with the unequal variance signal detection model account.

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Introduction Vascular access devices (VADs), such as peripheral or central venous catheters, are vital across all medical and surgical specialties. To allow therapy or haemodynamic monitoring, VADs frequently require administration sets (AS) composed of infusion tubing, fluid containers, pressure-monitoring transducers and/or burettes. While VADs are replaced only when necessary, AS are routinely replaced every 3–4 days in the belief that this reduces infectious complications. Strong evidence supports AS use up to 4 days, but there is less evidence for AS use beyond 4 days. AS replacement twice weekly increases hospital costs and workload. Methods and analysis This is a pragmatic, multicentre, randomised controlled trial (RCT) of equivalence design comparing AS replacement at 4 (control) versus 7 (experimental) days. Randomisation is stratified by site and device, centrally allocated and concealed until enrolment. 6554 adult/paediatric patients with a central venous catheter, peripherally inserted central catheter or peripheral arterial catheter will be enrolled over 4 years. The primary outcome is VAD-related bloodstream infection (BSI) and secondary outcomes are VAD colonisation, AS colonisation, all-cause BSI, all-cause mortality, number of AS per patient, VAD time in situ and costs. Relative incidence rates of VAD-BSI per 100 devices and hazard rates per 1000 device days (95% CIs) will summarise the impact of 7-day relative to 4-day AS use and test equivalence. Kaplan-Meier survival curves (with log rank Mantel-Cox test) will compare VAD-BSI over time. Appropriate parametric or non-parametric techniques will be used to compare secondary end points. p Values of <0.05 will be considered significant.

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Efficient and accurate geometric and material nonlinear analysis of the structures under ultimate loads is a backbone to the success of integrated analysis and design, performance-based design approach and progressive collapse analysis. This paper presents the advanced computational technique of a higher-order element formulation with the refined plastic hinge approach which can evaluate the concrete and steel-concrete structure prone to the nonlinear material effects (i.e. gradual yielding, full plasticity, strain-hardening effect when subjected to the interaction between axial and bending actions, and load redistribution) as well as the nonlinear geometric effects (i.e. second-order P-d effect and P-D effect, its associate strength and stiffness degradation). Further, this paper also presents the cross-section analysis useful to formulate the refined plastic hinge approach.

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Background Psychological distress is well-documented worldwide among medical and dental students. Few studies have assessed the impact of self-development coaching programs on the students’ psychological health. The aim of the study was to evaluate the effect of a self-development coaching programme on the psychological health and academic performance of preclinical medical and dental students at Umm Al-Qura University, Saudi Arabia. Methods Four-hundred and twenty-two participants (n = 422, 20–22 years) fulfilled the study requirements and were invited into a parallel-randomised controlled trial that was partially blinded. Participants were stratified by faculty, gender, and academic year, and then randomised. A total of 156 students participated in the intervention group (IG) and 163 students participated in the control group (CG). The IG received the selfdevelopment programme, involving skills and strategies aimed to improve students’ psychological health and academic performance, through a two-day workshop. Meanwhile, the CG attended an active placebo programme focussing on theoretical information that was delivered through a five-hour workshop. Both programmes were conducted by the same presenter during Week 1 of the second semester of the 2012–2013 academic year. Data were gathered immediately before (T1), one week after (T2) and five weeks (T3) after the intervention. Psychological health was measured using the Depression Anxiety Stress Scale (DASS-21), the General Self-Efficacy (GSE), and the Satisfaction With Life Scale (SWLS). Academic performance was measured using students’ academic weighted grades (WG). Student cognitive and emotional perceptions of the intervention were measured using the Credibility/Expectancy Questionnaire (CEQ). Results Data from 317 students, who completed the follow ups, were analysed across the three time periods (IG, n = 155; CG, n = 162). The baseline variables and demographic data of the IG and CG were not significantly different. The IG showed short-term significant reductions in depression and anxiety in compared to CG from T1 to T2. The short-term changes in stress, GSE and SWLS of the IG were not significantly different from those of the CG. While both groups showed a significant change on most of the psychological variables from T1 to T3, no significant differences were found between the groups in this period. In addition, no significant difference was found in WG between the IG and CG after the intervention. No harms relevant to the intervention were reported. Conclusion The investigated self-development coaching programme showed only a short-term improvement on depression and anxiety compared with an active control. There was no effect of the intervention on academic performance.

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An improved understanding of the characteristics of the pre-discharge current pulses in GIS will lead to improved analyses of the results from the UHF partial discharge detection method. This paper presents the characteristics of the first pre-discharge current pulses from a point-to-plain geometry at 1 bar absolute under both polarities of a 1.1/80 us lightning impulse. The analysis has shown that the pre-discharge current wave shape, peak current magnitude and charge is effected by the instantaneous voltage at which the pre- discharge took place as well as the polarity of the active electrode. The measured results show that protrusions on the electrodes have slower wave shape parameters than those reported for free conducting particles.

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Twenty-nine first-year pre-service teachers' perceptions of mentoring and primary science teaching were collected through a literature-based survey. Frequencies, means, and standard deviations of these responses provided data for analysis on these mentoring practices. Results indicated that even though mentors may provide feedback, the majority of mentors do not provide specific primary science mentoring in the areas of pedagogical knowledge, system requirements, and the modeling of teaching practice. It appears that the mentor's personal attributes may also influence the quality of mentoring. There were tentative conclusions that first-year pre-service teachers may not have strong beliefs about specific primary science mentoring practices, and possibly because of inexperience, may not be critical enough to analyse their mentoring in primary science teaching. Identifying specific mentoring for developing primary science teaching may assist mentors in their practices with pre-service teachers.

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Capstone units in higher education courses are learning experiences which are designed to bring reflection and focus to a whole course of study while, at the same time, leading students toward their entry into a new world of work (Humphrey, Brown, & Benson, 2005). The capstone experience described in this paper runs as a conference, called the Stepping Out Conference. The conference is delivered as one unit and is mandatory for all fourth year pre-service teachers. Participation in a capstone unit is an effective way for students to begin thinking of themselves as teaching professionals rather than as continuing students. Students engage in the assessment as part of their capstone experience. The assessment is designed to measure students’ knowledge and skills as they relate to ‘authentic’ real life situations (Darling-Hammond, 1991). This paper details pre-service teachers’ experiences of authentic learning through their participation in a capstone unit.

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The beliefs, attitudes and understandings of pre-service teachers towards bullying and more recently, cyberbullying remains unclear. Previous studies have found them to be generally lacking confidence to address bullying, which could impact negatively on school climate if, when they enter the profession, these beliefs undermine existing anti-bullying initiatives. This study explores Australian pre-service teachers' (N= 717) understanding and knowledge of traditional bullying and cyberbullying and their confidence and capacity to deal with it. Findings from self-report, anonymous questionnaires from students attending three universities in Australia indicated that two thirds (66%) of current pre-service teachers felt informed to very informed and capable to very capable (62%) of dealing with school bullying and 90% could discern cyber and traditional bullying behaviours from other online and offline aggressive acts. Gender and Year level differences were found. The potential impact of their knowledge and understanding of bullying and cyberbullying on school climate, and sustaining and maintaining anti-bullying interventions as they enter the profession is discussed.

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Purpose: To evaluate the efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis (nr-axSpA). Methods: Patients fulfilled Assessment of Spondyloarthritis international Society (ASAS) criteria for axial spondyloarthritis, had a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of ≥ 4, total back pain score of ≥ 4 (10 cm visual analogue scale) and inadequate response, intolerance or contraindication to non-steroidal anti-inflammatory drugs (NSAIDs); patients fulfilling modified New York criteria for ankylosing spondylitis were excluded. Patients were randomised to adalimumab (N=91) or placebo (N=94). The primary endpoint was the percentage of patients achieving ASAS40 at week 12. Efficacy assessments included BASDAI and Ankylosing Spondylitis Disease Activity Score (ASDAS). MRI was performed at baseline and week 12 and scored using the Spondyloarthritis Research Consortium of Canada (SPARCC) index. Results: Significantly more patients in the adalimumab group achieved ASAS40 at week 12 compared with patients in the placebo group (36% vs 15%, p<0.001). Significant clinical improvements based on other ASAS responses, ASDAS and BASDAI were also detected at week 12 with adalimumab treatment, as were improvements in quality of life measures. Inflammation in the spine and sacroiliac joints on MRI significantly decreased after 12 weeks of adalimumab treatment. Shorter disease duration, younger age, elevated baseline C-reactive protein or higher SPARCC MRI sacroiliac joint scores were associated with better week 12 responses to adalimumab. The safety profile was consistent with what is known for adalimumab in ankylosing spondylitis and other diseases. Conclusions: In patients with nr-axSpA, adalimumab treatment resulted in effective control of disease activity, decreased inflammation and improved quality of life compared with placebo. Results from ABILITY-1 suggest that adalimumab has a positive benefit-risk profile in active nr-axSpA patients with inadequate response to NSAIDs.

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This study proposes that the adoption process of complex-wide systems (e.g. cloud ERP) should be observed as multi-stage actions. Two theoretical lenses were utilised for this study with critical adoption factors identified through the theory of planned behaviour and the progression of each adoption factor observed through Ettlie's (1980) multi-stage adoption model. Together with a survey method, this study has employed data gathered from 162 decision-makers of small and medium-sized enterprises (SMEs). Using both linear and non-linear approaches for the data analysis, the study findings have shown that the level of importance for adoption factors changes across different adoption stages.

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The space and positioning of Indigenous knowledges (IK) within Australian curricula and pedagogy are often contentious, informed by the broader Australian socio-cultural, political and economic landscape. Against changing educational policy, historically based on the myth of terra nullius, we discuss the shifting priorities for embedding Indigenous knowledges in educational practice in university and school curricula and pedagogy. In this chapter, we argue that personal and professional commitment to social justice is an important starting point for embedding Indigenous knowledges in the Australian school curricula and pedagogy. Developing teacher knowledge around embedding IK is required to enable teachers’ preparedness to navigate a contested historical/colonising space in curriculum decision-making, teaching and learning. We draw one mpirical data from a recent research project on supporting pre-service teachers as future curriculum leaders; the project was funded by the Office of Learning and Teaching (OLT). This project aimed to support future curriculum leaders to develop their knowledge of embedding IK at one Australian university. We propose supporting the embedding of IK in situ with pre-service teachers and their supervising teachers on practicum in real, sustained and affirming ways that shifts the recognition of IK from personal commitment to social justice in education, to one that values Indigenous knowledges as content to educate (Connell, 1993). We argue that sustained engagement with and appreciation of IKhas the potential to decolonise Australian curricula, shift policy directions and enhance race relations between Indigenous and non-Indigenous Australians .