672 resultados para randomised control trial


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We conducted a systematic review of the literature on telemedicine use in long-term care facilities (LTCFs) and assessed the quality of the published evidence. A database search identified 22 papers which met the inclusion criteria. The quality of the studies was assessed and if they contained economic data, they were rated according to standard criteria. The clinical services provided by telemedicine included allied health (n = 5), dermatology (3), general practice (4), neurology (2), geriatrics (1), psychiatry (4) and multiple specialities (3). Most studies (17) employed real-time telemedicine using videoconferencing. The remaining five used store and forward telemedicine. The papers focused on economics (3), feasibility (9), stakeholder satisfaction (12), reliability (5) and service implementation (2). Overall, the quality of evidence for telemedicine in LTCFs was low. There was only one small randomised controlled trial (RCT). Most studies were observational and qualitative, and focused on utilisation. They were mainly based on surveys and interviews of stakeholders. A few studies evaluated the cost associated with implementing telemedicine services in LTCFs. The present review shows that there is evidence for feasibility and stakeholder satisfaction in using telemedicine in LTCFs in a number of clinical specialities.

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Parental reading to children from an early age has been shown to enhance children’s emergent literacy skills. A pragmatic randomized controlled trial (RCT) was used to investigate the effects of two forms of shared reading interventions on children’s language and literacy skills. Parents of 80 preparatory year children from outer suburban schools of an Australian metropolitan city were trained to use shared reading strategies in an eight-week home intervention. Families were assigned to one of three groups: Dialogic Reading (DR), Dialogic Reading with the addition of Print Referencing (DR + PR), or an attention-matched control group. The sample comprised 42 boys and 38 girls ranging in age from 4.9 years to 6.3 years (M = 5.5, SD = 0.3). Data were collected at pre, post, and at three months follow-up. Measures assessed children’s oral language (receptive and expressive vocabulary), phonological awareness (rhyme, word completion), alphabet knowledge, and concepts about print. Analyses of change from pre to post showed significant effects for the DR and DR + PR groups compared to the control group on three of the six measures: expressive language, rhyme, and concepts about print. At 3-month follow-up assessment, the two intervention groups maintained significantly better performance on the measure of concepts of print only. At both time points, there were no group differences between the DR and DR+PR conditions. These findings illustrate the potential of a brief home focused intervention on promoting children’s emergent literacy.

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Children and adolescents with intellectual disability have higher rates of mental health problems compared with there typically developing peers. Social support has been identified as an important protective factor for psychological well - being. In this paper we discuss the benefits of social support networks, and consider approaches for promoting children’s perceptions of the availability of social support. We describe an evidence-based intervention that has been specially adapted and implemented for students with intellectual disability in school settings. In a randomised controlled trial, the Aussie Optimism Resilience Skills Program was associated with improved perceptions of social support following a 10-week intervention. Educators need to be aware of the increased vulnerability of students with intellectual disability to the development mental health problems and the proactive ways in which they can promote psychological well - being within their classrooms.

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Background Lumbar Epidural Steroids Injections (ESI’s) have previously been shown to provide some degree of pain relief in sciatica. Number Needed To Treat (NNT) to achieve 50% pain relief has been estimated at 7 from the results of randomised controlled trials. Pain relief is temporary. They remain one of the most commonly provided procedures in the UK. It is unknown whether this pain relief represents good value for money. Methods 228 patients were randomised into a multi-centre Double Blind Randomised Controlled Trial. Subjects received up to 3 ESI’s or intra-spinous saline depending on response and fall off with the first injection. All other treatments were permitted. All received a review of analgesia, education and physical therapy. Quality of life was assessed using the SF36 at 6 points and compared using independent sample t-tests. Follow up was up to 1 yr. Missing data was imputed using last observation carried forward (LOCF). QALY’s (Quality of Life Years) were derived from preference based heath values (summary health utility score). SF-6D health state classification was derived from SF-36 raw score data. Standard gambles (SG) were calculated using Model 10. SG scores were calculated on trial results. LOCF was not used for this. Instead average SG were derived for a subset of patients with observations for all visits up to week 12. Incremental QALY’s were derived as the difference in the area between the SG curve for the active group and placebo group. Results SF36 domains showed a significant improvement in pain at week 3 but this was not sustained (mean 54 Active vs 61 Placebo P<0.05). Other domains did not show any significant gains compared with placebo. For derivation of SG the number in the sample in each period differed. In week 12, average SG scores for active and placebo converged. In other words, the health gain for the active group as measured by SG was achieved by the placebo group by week 12. The incremental QALY gained for a patient under the trial protocol compared with the standard care package was 0.0059350. This is equivalent to an additional 2.2 days of full health. The cost per QALY gained to the provider from a patient management strategy administering one epidural as suggested by results was £25 745.68. This result was derived assuming that the gain in QALY data calculated for patients under the trial protocol would approximate that under a patient management strategy based on the trial results (one ESI). This is above the threshold suggested by some as a cost effective treatment. Conclusions The transient benefit in pain relief afforded by ESI’s does not appear to be cost-effective. Further work is needed to develop more cost-effective conservative treatments for sciatica.

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This study explored the interaction between physical and psychosocial factors in the workplace on neck pain and disability in female computer users. A self-report survey was used to collect data on physical risk factors (monitor location, duration of time spent using the keyboard and mouse) and psychosocial domains (as assessed by the Job Content Questionnaire). The neck disability index was the outcome measure. Interactions among the physical and psychosocial factors were examined in analysis of covariance. High supervisor support, decision authority and skill discretion protect against the negative impact of (1) time spent on computer-based tasks, (2) non-optimal placement of the computer monitor, and; (3) long duration of mouse use. Office workers with greater neck pain experience a combination of high physical and low psychosocial stressors at work. Prevention and intervention strategies that target both sets of risk factors are likely to be more successful than single intervention programmes. Statement of Relevance The results of this study demonstrate that the interaction of physical and psychosocial factors in the workplace has a stronger association with neck pain and disability than the presence of either factor alone. This finding has important implications for strategies aimed at the prevention of musculoskeletal problems in office workers.

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Objective To summarise how costs and health benefits will change with the adoption of total laparoscopic hysterectomy compared to total abdominal hysterectomy for the treatment of early stage endometrial cancer. Design Cost-effectiveness modelling using the information from a randomised controlled trial. Participants Two hypothetical modelled cohorts of 1000 individuals undergoing total laparoscopic hysterectomy and total abdominal hysterectomy. Outcome measures Surgery costs; hospital bed days used; total healthcare costs; quality-adjusted life years; and net monetary benefits. Results For 1000 individuals receiving total laparoscopic hysterectomy surgery, the costs were $509 575 higher, 3548 hospital fewer bed days were used and total health services costs were reduced by $3 746 221. There were 39.13 more quality-adjusted life years for a 5 year period following surgery. Conclusions The adoption of total laparoscopic hysterectomy is almost certainly a good decision for health services policy makers. There is 100% probability that it will be cost saving to health services, a 86.8% probability that it will increase health benefits and a 99.5% chance that it returns net monetary benefits greater than zero.

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Objectives To evaluate relationships between self-reported physical activity, proportions of long-chain omega-3 polyunsaturated fatty acids (LCn3) in erythrocyte content (percentage of total fatty acids) and risk of mild cognitive impairment (MCI) in older adults. Method A cross-sectional study was conducted. Community-dwelling male and female (n = 84) participants over the age of 65 years with and without MCI were tested for erythrocyte proportions of the LCn3s eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). Physical activity was measured using a validated questionnaire. Results The interaction between erythrocyte EPA, but not DHA, and increased physical activity was associated with increased odds of a non-MCI classification. Conclusion An interaction between physical activity and erythrocyte EPA content (percentage of fatty acids) significantly predicted MCI status in older adults. Randomised control trials are needed to examine the potential for supplementation with EPA in combination with increased physical activity to mitigate the risk of MCI in ageing adults.

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A research protocol for our prospective study of research funding. How much research funding improves research productivity is a question that has relevance for all funding agencies and governments around the world. Previous studies have used observational data that compares productivity between winners of different amounts of funding, but researchers who win lots of funding are usually very different from those who win little or no funding. This difference creates potentially serious confounding which biases any estimate of the effect of funding based on observational data that simply compares research output for those who did and did not win funding. This means we do not currently know the return on investment for our research dollars, of which billions are invested around the world every year. By using a study design that incorporates randomisation this will be the world’s first unbiased study of the impact of researcher funding.

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Purpose To systematically review the Theory of Planned Behaviour studies predicting self-care intentions and behaviours in populations with and at-risk of diabetes. Methods A systematic review using six electronic databases was conducted in 2013. A standardised protocol was used for appraisal. Studies eligibility included a measure of behaviour for healthy eating, physical activity, glucose monitoring, medication use (ii) the TPB variables (iii) the TPB tested in populations with diabetes or at-risk. Results Sixteen studies were appraised for testing the utility of the TPB. Studies included cross-sectional (n=7); prospective (n=5) and randomised control trials (n=4). Intention (18% – 76%) was the most predictive construct for all behaviours. Explained variance for intentions were similar across cross-sectional (28 -76%); prospective (28 -73%); and RCT studies (18 - 63%). RCTs (18 - 43%) provided slightly stronger evidence for predicting behaviour. Conclusions Few studies tested predictability of the TPB in populations with or at-risk of diabetes. This review highlighted differences in the predictive utility of the TPB suggesting that the model is behaviour and population specific. Findings on key determinants of specific behaviours contribute to a better understanding of mechanisms of behaviour change and are useful in designing targeted behavioural interventions for different diabetes populations.

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There is considerable recognition that shared book reading helps develop young children's early reading and literacy skills. Home is an important context in which children first start to develop their early literacy skills. This paper reviews Australian and international literature of shared book-reading intervention pertaining to the effects of two different strategies (dialogic reading and print referencing) on young children's early literacy skills. Further, a brief summary of findings of a recent Australian study are presented that showed some significant effects of shared reading on children's early literacy skills. This research used a pragmatic RCT (randomised controlled trial) to investigate a combination of these two forms of shared book-reading home intervention with parents and their children enrolled in the Prep year of school in Queensland. The paper concludes with a discussion of the significance of the findings and implications for parents and teachers to use an evidence-based approach to help children develop early literacy skills.

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The thesis develops a summative evaluation framework of the NOURISH Randomised Controlled Trial, and applies this to a selection of maternal feeding choice outcomes of the programme. The research is based on an ecological model of the complex set of factors that need to be acted upon to address childhood obesity. The novel approach extends the standard RCT effect evaluation, while also conducting an in-depth evaluation of the process of programme development and implementation. Research findings identify adaptations of intervention delivery that could improve its effectiveness and translatability, in a new cycle of the programme.

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Background Feeding practices are commonly examined as potentially modifiable determinants of children’s eating behaviours and weight status. Although a variety of questionnaires exist to assess different feeding aspects, many lack thorough reliability and validity testing. The Feeding Practices and Structure Questionnaire (FPSQ) is a tool designed to measure early feeding practices related to non-responsive feeding and structure of the meal environment. Face validity, factorial validity, internal reliability and cross-sectional correlations with children’s eating behaviours have been established in mothers with 2-year-old children. The aim of the present study was to further extend the validity of the FPSQ by examining factorial, construct and predictive validity, and stability. Methods Participants were from the NOURISH randomised controlled trial which evaluated an intervention with first-time mothers designed to promote protective feeding practices. Maternal feeding practices (FP) and child eating behaviours were assessed when children were aged 2 years and 3.7 years (n=388). Confirmatory Factor analysis, group differences, predictive relationships, and stability were tested. Results The original 9-factor structure was confirmed when children were aged 3.7±0.3 years. Cronbach’s alpha was above the recommended 0.70 cut-off for all factors except Structured Meal Timing, Over Restriction and Distrust in Appetite which were 0.58, 0.67 and 0.66 respectively. Allocated group differences reflected behaviour consistent with intervention content and all feeding practices were stable across both time points (range of r= 0.45-0.70). There was some evidence for the predictive validity of factors with 2 FP showing expected relationships, 2 FP showing expected and unexpected relationships and 5 FP showing no relationship. Conclusions Reliability and validity was demonstrated for most subscales of the FPSQ. Future validation is warranted with culturally diverse samples and with fathers and other caregivers. The use of additional outcomes to further explore predictive validity is recommended as well as testing construct validity and test-retest reliability of the questionnaire.