657 resultados para cluster randomised control trial


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Objective: To assess whether a multifaceted intervention can reduce the number of prescriptions for antimicrobials for suspected urinary tract infections in residents of nursing homes. Design: Cluster randomised controlled trial. Setting: 24 nursing homes in Ontario, Canada, and Idaho, United States. Participants: 12 nursing homes allocated to a multifaceted intervention and 12 allocated to usual care. Outcomes were measured in 4217 residents. Interventions: Diagnostic and treatment algorithm for urinary tract infections implemented at the nursing home level using a multifaceted approach-small group interactive sessions for nurses, videotapes, written material, outreach visits, and one on one interviews with physicians. Main outcome measures: Number of antimicrobials prescribed for suspected urinary tract infections, total use of antimicrobials, admissions to hospital, and deaths. Results: Fewer courses of antimicrobials for suspected urinary tract infections per 1000 resident days were prescribed in the intervention nursing homes than in the usual care homes (1.17 v 1.59 courses; weighted mean difference -0.49, 95% confidence intervals -0.93 to -0.06). Antimicrobials for suspected urinary tract infection represented 28.4% of all courses of drugs prescribed in the intervention nursing homes compared with 38.6% prescribed in the usual care homes (weighted mean difference -9.6%, -16.9% to -2.4%). The difference in total antimicrobial use per 1000 resident days between intervention and usual care groups was not significantly different (3.52 v 3.93; weighed mean difference -0.37, -1.17 to 0.44). No significant difference was found in admissions to hospital or mortality between the study arms. Conclusion: A multifaceted intervention using algorithms can reduce the number of antimicrobial prescriptions for suspected urinary tract infections in residents of nursing homes.

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The paucity of training in physical activity (PA) promotion in UK medical schools is a barrier to health professionals' promotion of PA to their patients. Doctors who are more physically active are more likely to counsel patients in this regard. We used a randomised controlled trial (RCT) to examine the effect of an intervention which engaged students in goal-setting, using pedometer step counts, on their PA behaviour and intentions to promote PA in future practice.

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While there is evidence for effective in-school programmes
for struggling beginning readers, the evidence in relation to after-schools
interventions focusing on academic outcomes is particularly weak. This study
seeks to contribute to this body of evidence through a randomized trial (n=464)
of an after-school literacy programme (DoodleDen) for struggling beginning readers in a deprived area of Dublin, Ireland.

The programme based on a balanced literacy framework, was delivered in group
settings, and had a strong focus on staff development. Doodle Den was found to improve the children’s overall literacy (d=+0.17), teacher assessments of their literacy ability (d=+0.28) and to positively impact on problem behaviours in regular school class (d=-0.18). The implications for
the development of after-school programmes are discussed.









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Background There is growing evidence linking early social and emotional wellbeing to later academic performance and various health outcomes including mental health. An economic evaluation was designed alongside the Roots of Empathy cluster-randomised trial evaluation, which is a school-based intervention for improving pupils’ social and emotional wellbeing. Exploration of the relevance of the Strengths and Diffi culties Questionnaire (SDQ) and Child Health Utility 9D (CHU9D) in school-based health economic evaluations is warranted. The SDQ is a behavioural screening questionnaire for 4–17-year-old children, consisting of a total diffi culties score, and also prosocial behaviour,
which aims to identify positive aspects of behaviour. The CHU9D is a generic preference-based health-related quality of life instrument for 7–17-year-old children.

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A substantial body of evidence suggest that well designed school based prevention programmes can be effective in improving a variety of social, health and academic outcomes for children and young people. This poster presents the methodology for evaluating the Roots of Empathy (ROE) programme. ROE is a universal programme delivered on a whole-class basis for one academic year. It consists of 27 lessons that run over a school year and is based around a monthly classroom visit by an infant and parent, typically recruited from the local community, whom the class 'adopts' at the start of the school year. The evaluation aims to evaluate the immediate and longer term impact of ROE on social and emotional wellbeing outcomes among 8-9 year old pupils, as well as evaluate the cost-effectiveness of the programme.

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This paper reports the results from a cluster randomised controlled trial (RCT) and process evaluation of the Early Years DELTA Parenting Programme; a six-week, group based intervention. The evaluation was part funded by DELTA and involved 23 primary schools and 334 parents. Results showed that intervention parents reported increased parental self-efficacy in relation to: knowledge of their child’s development and needs; self-acceptance as a good parent, and; disciplining and setting boundaries. No change was observed in the remaining outcome areas. Parent interviews indicated a high level of programme satisfaction and the main benefits reflected the outcomes measured by the RCT. This small, robust evaluation is commensurate with other similar research demonstrating the effectiveness and reach of short-term, group-based parenting programmes.

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OBJECTIVES: There is previous epidemiological evidence that intake of polyphenol-rich foods has been associated with reduced cardiovascular disease risk. We aimed to investigate the effect of increasing dietary polyphenol intake on microvascular function in hypertensive participants.

METHODS: All participants completed a 4-week run-in phase, consuming <2 portions of fruit and vegetables (F&V) daily and avoiding berries and dark chocolate. Subjects were then randomised to continue with the low-polyphenol diet for 8 weeks or to consume a high-polyphenol diet of six portions F&V (including one portion of berries/day and 50 g of dark chocolate). Endothelium-dependent (acetylcholine, ACh) and endothelium-independent (sodium nitroprusside) vasodilator responses were assessed by venous occlusion plethysmography. Compliance with the intervention was measured using food diaries and biochemical markers.

RESULTS: Final analysis of the primary endpoint was conducted on 92 participants. Between-group comparison of change in maximum % response to ACh revealed a significant improvement in the high-polyphenol group (p=0.02). There was a significantly larger increase in vitamin C, carotenoids and epicatechin in the high-polyphenol group (between-group difference p<0.001; p<0.001; p=0.008, respectively).

CONCLUSIONS: This study has shown that increasing the polyphenol content of the diet via consumption of F&V, berries and dark chocolate results in a significant improvement in an established marker of cardiovascular risk in hypertensive participants.

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Objective To undertake a process evaluation of pharmacists' recommendations arising in the context of a complex IT-enabled pharmacist-delivered randomised controlled trial (PINCER trial) to reduce the risk of hazardous medicines management in general practices. Methods PINCER pharmacists manually recorded patients’ demographics, details of interventions recommended, actions undertaken by practice staff and time taken to manage individual cases of hazardous medicines management. Data were coded and double entered into SPSS v15, and then summarised using percentages for categorical data (with 95% CI) and, as appropriate, means (SD) or medians (IQR) for continuous data. Key findings Pharmacists spent a median of 20 minutes (IQR 10, 30) reviewing medical records, recommending interventions and completing actions in each case of hazardous medicines management. Pharmacists judged 72% (95%CI 70, 74) (1463/2026) of cases of hazardous medicines management to be clinically relevant. Pharmacists recommended 2105 interventions in 74% (95%CI 73, 76) (1516/2038) of cases and 1685 actions were taken in 61% (95%CI 59, 63) (1246/2038) of cases; 66% (95%CI 64, 68) (1383/2105) of interventions recommended by pharmacists were completed and 5% (95%CI 4, 6) (104/2105) of recommendations were accepted by general practitioners (GPs), but not completed at the end of the pharmacists’ placement; the remaining recommendations were rejected or considered not relevant by GPs. Conclusions The outcome measures were used to target pharmacist activity in general practice towards patients at risk from hazardous medicines management. Recommendations from trained PINCER pharmacists were found to be broadly acceptable to GPs and led to ameliorative action in the majority of cases. It seems likely that the approach used by the PINCER pharmacists could be employed by other practice pharmacists following appropriate training.

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The World Health Organisation suggests that simplification of the medical abortion regime will contribute to an increased acceptability of medical abortion, among women as well as providers. It is expected that a home-based follow-up after a medical abortion will increase the willingness to opt for medical abortion as well as decrease the workload and service costs in the clinic. Trial design The study is a randomised, controlled, non-superiority trial . Methods Women screened to participate in the study are those with unwanted pregnancies and gestational ages equal to or less than nine weeks. Eligible women randomised to the home-based assessment group will use a low-sensitivity pregnancy test and a pictorial instruction sheet at home, while the women in the clinic follow-up group will return to the clinic for routine follow-up carried out by a doctor. The primary objective of the study is to evaluate the effectiveness of home-based assessment using a low-sensitivity pregnancy test and a pictorial instruction sheet 10-14 days after an early medical abortion. Providers or research assistants will not be blinded during outcome assessment. To ensure feasibility of the self-assessment intervention an adaption phase took place at the selected study sites before study initiation. This was to optimise and tailor-make the intervention and the study procedures and resulted in the development of the pictorial instruction sheet for how to use the low-sensitivity pregnancy test and the danger signs after a medical abortion. Discussion In this paper, we will describe the study protocol for a randomised control trial investigating the efficacy of simplified follow-up in terms of home-based assessment, 10-14 days after a medical abortion. Moreover, a description of the adaptation phase is included for a better understanding of the implementation of the intervention in a setting where literacy is low and the road-connections are poor. Trial registration: Clinicaltrials.gov NCT01827995. Registered 04 May 2013