A randomized, controlled trial of an intervention promoting cataract surgery acceptance in Rural China:The Guangzhou uptake of surgery trial (GUSTO)

PURPOSE. To evaluate an educational intervention promoting acceptance of cataract surgery in rural China using a randomized controlled design. METHODS. Patients aged 50 years or older with presenting visual acuity (PVA) less than 6/18 in one or both eyes due to cataract were recruited from 26 screening sessions (13 intervention, 13 control) conducted by five rural hospitals in Guangdong, China. At intervention sessions, subjects were shown a 5- minute informational video, and counseled about cataract, surgery, and surgical cost. During screening, all subjects answered questionnaires on knowledge and attitudes about cataract, their finances, and transportation, and were referred for definitive examination if eligible. Study outcomes were acceptance of surgery (principal outcome) and hospital followup. RESULTS. Subjects in the intervention group were younger than controls (P = 0.01), but the groups did not otherwise differ. Among 212 intervention patients and 222 controls, no differences in knowledge and attitude regarding cataract were found. Surgery was accepted by 31.1% of intervention patients and 34.2% of controls (P > 0.50). Predictors of acceptance included younger age, worse logMAR PVA, knowing that cataract can be treated surgically only, greater anticipated loss in income from hospitalization, and greater house floor space per person. Membership in the intervention group was not associated with accepting surgery (odds ratio [OR]=1.11, 95% confidence interval [CI] 0.67-1.84) or hospital follow-up (OR= 1.03, 95% CI = 0.63-1.67). CONCLUSIONS. Educational interventions that successfully impart the knowledge that cataract can be only treated surgically may be more effective in increasing uptake in this setting. © 2012 The Association for Research in Vision and Ophthalmology, Inc.

Visual symptoms and retinal straylight after laser peripheral iridotomy: the Zhongshan Angle-Closure Prevention Trial.

OBJECTIVE: To assess the impact of laser peripheral iridotomy (LPI) on forward-scatter of light and subjective visual symptoms and to identify LPI parameters influencing these phenomena. DESIGN: Cohort study derived from a randomized trial, using an external control group. PARTICIPANTS: Chinese subjects initially aged 50 or older and 70 years or younger with bilateral narrow angles undergoing LPI in 1 eye selected at random, and age- and gender-matched controls. METHODS: Eighteen months after laser, LPI-treated subjects underwent digital iris photography and photogrammetry to characterize the size and location of the LPI, Lens Opacity Classification System III cataract grading, and measurement of retinal straylight (C-Quant; OCULUS, Wetzlar, Germany) in the treated and untreated eyes and completed a visual symptoms questionnaire. Controls answered the questionnaire and underwent straylight measurement and (in a random one-sixth sample) cataract grading. MAIN OUTCOME MEASURES: Retinal straylight levels and subjective visual symptoms. RESULTS: Among 230 LPI-treated subjects (121 [58.8%] with LPI totally covered by the lid, 43 [19.8%] with LPI partly covered by the lid, 53 [24.4%] with LPI uncovered by the lid), 217 (94.3%) completed all testing, as did 250 (93.3%) of 268 controls. Age, gender, and prevalence of visual symptoms did not differ between treated subjects and controls, although nuclear (P<0.01) and cortical (P = 0.03) cataract were less common among controls. Neither presenting visual acuity nor straylight score differed between the treated and untreated eyes among all treated persons, nor among those (n = 96) with LPI partially or totally uncovered. Prevalence of subjective glare did not differ significantly between participants with totally covered LPI (6.61%; 95% confidence interval [CI], 3.39%-12.5%), partially covered LPI (11.6%; 95% CI, 5.07%-24.5%), or totally uncovered LPI (9.43%; 95% CI, 4.10%-10.3%). In regression models, only worse cortical cataract grade (P = 0.01) was associated significantly with straylight score, and no predictors were associated with subjective glare. None of the LPI size or location parameters were associated with straylight or subjective symptoms. CONCLUSIONS: These results suggests that LPI is safe regarding measures of straylight and visual symptoms. This randomized design provides strong evidence that treatment programs for narrow angles would be unlikely to result in important medium-term visual disability.

Ophthalmology. 2011 Dec;118(12):2343-50. doi: 10.1016/j.ophtha.2011.06.016. Epub 2011 Sep 1. Randomized, controlled trial of an educational intervention to promote spectacle use in rural China: the see well to learn well study.

OBJECTIVE: To test an educational intervention promoting the purchase of spectacles among Chinese children. DESIGN: Randomized, controlled trial. PARTICIPANTS: Children in years 1 and 2 of all 20 junior and senior high schools (ages 12-17 years) in 3 rural townships in Guangdong, China. METHODS: Children underwent visual acuity (VA) testing, and parents of participants with presenting VA worse than 6/12 in either eye improving by more than 2 lines with cycloplegic refraction were recommended to purchase glasses. Children at 10 randomly selected schools received a lecture, video, and classroom demonstration promoting spectacle purchase. MAIN OUTCOME MEASURES: Self-reported purchase of spectacles (primary outcome) and observed wear or possession of newly purchased glasses (secondary outcome) at follow-up examinations (mean, 219 ± 87 days after the baseline visit). RESULTS: Among 15 404 eligible children, examinations were completed for 6379 (74.6%) at intervention schools and 5044 (73.6%) at control schools. Spectacles were recommended for 2236 (35.1%) children at intervention schools and for 2212 (43.9%) at control schools. Of these, 417 (25.7%) intervention schools children and 537 (34.0%, P = 0.45) control schools children reported buying glasses. Predictors of purchase in regression models included female gender (P = 0.02), worse uncorrected VA (P < 0.001), and higher absolute value of refractive error (P = 0.001). Neither the rate of self-reported purchase of glasses or observed wear or possession of newly purchased glasses differed between control schools and intervention schools in mixed-effect logistic regression models. Among children not purchasing glasses, 21.7% had better-eye VA of worse than 6/18. CONCLUSIONS: An intervention based on extensive pilot testing and focus groups in the area failed to promote spectacle purchase or wear. The high burden of remaining uncorrected poor vision underscores the need to develop better interventions. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Effects of a book gifting programme on literacy outcomes for foster children: A randomised controlled trial evaluation of the Letterbox Club in Northern Ireland

The poor educational outcomes of children in care is a significant concern internationally. Whilst there have been many interventions developed to address this problem, very few of these have been rigorously evaluated. This article presents the findings of a randomised controlled trial that sought to measure the effectiveness of a book gifting programme (the Letterbox Club) that aims to improve literacy skills amongst children aged 7-11 years in foster care. The programme involves children receiving six parcels of books sent through the post over a six-month period. The trial, which ran between April 2013 and June 2014, involved a sample of 116 children in Northern Ireland (56 randomly allocated to the intervention group and 60 to a waiting list control group). Outcome measures focused on reading skills (reading accuracy, comprehension and rate) and attitudes to reading and school. The trial found no evidence that the book-gifting programme had any effect on any of the outcomes measured. Drawing upon some of the emergent themes from the accompanying qualitative process evaluation that sought to determine foster carer/child attitude towards and engagement with the parcels, it is suggested that one plausible reason for the ineffectiveness of the Letterbox Club, as intimated by carers and children (rather than explicitly explored with them), is the lack of support provided to the carers/children in relation to the packs received. Reflective of an ecological model of children’s development, it is recommended that for book-gifting programmes to be effective they need to include a focus on encouraging the direct involvement of foster carers in shared literacy activities with the children using the books that are gifted.

Transfusion and Treatment of severe anaemia in African children (TRACT): a study protocol for a randomised controlled trial

BACKGROUND: In sub-Saharan Africa, where infectious diseases and nutritional deficiencies are common, severe anaemia is a common cause of paediatric hospital admission, yet the evidence to support current treatment recommendations is limited. To avert overuse of blood products, the World Health Organisation advocates a conservative transfusion policy and recommends iron, folate and anti-helminthics at discharge. Outcomes are unsatisfactory with high rates of in-hospital mortality (9-10 %), 6-month mortality and relapse (6 %). A definitive trial to establish best transfusion and treatment strategies to prevent both early and delayed mortality and relapse is warranted.

METHODS/DESIGN: TRACT is a multicentre randomised controlled trial of 3954 children aged 2 months to 12 years admitted to hospital with severe anaemia (haemoglobin < 6 g/dl). Children will be enrolled over 2 years in 4 centres in Uganda and Malawi and followed for 6 months. The trial will simultaneously evaluate (in a factorial trial with a 3 x 2 x 2 design) 3 ways to reduce short-term and longer-term mortality and morbidity following admission to hospital with severe anaemia in African children. The trial will compare: (i) R1: liberal transfusion (30 ml/kg whole blood) versus conservative transfusion (20 ml/kg) versus no transfusion (control). The control is only for children with uncomplicated severe anaemia (haemoglobin 4-6 g/dl); (ii) R2: post-discharge multi-vitamin multi-mineral supplementation (including folate and iron) versus routine care (folate and iron) for 3 months; (iii) R3: post-discharge cotrimoxazole prophylaxis for 3 months versus no prophylaxis. All randomisations are open. Enrolment to the trial started September 2014 and is currently ongoing. Primary outcome is cumulative mortality to 4 weeks for the transfusion strategy comparisons, and to 6 months for the nutritional support/antibiotic prophylaxis comparisons. Secondary outcomes include mortality, morbidity (haematological correction, nutritional and infectious), safety and cost-effectiveness.

DISCUSSION: If confirmed by the trial, a cheap and widely available 'bundle' of effective interventions, directed at immediate and downstream consequences of severe anaemia, could lead to substantial reductions in mortality in a substantial number of African children hospitalised with severe anaemia every year, if widely implemented.

Do Cochrane summaries help student midwives understand the findings of Cochrane systematic reviews: the BRIEF randomised trial

BACKGROUND: Abstracts and plain language summaries (PLS) are often the first, and sometimes the only, point of contact between readers and systematic reviews. It is important to identify how these summaries are used and to know the impact of different elements, including the authors' conclusions. The trial aims to assess whether (a) the abstract or the PLS of a Cochrane Review is a better aid for midwifery students in assessing the evidence, (b) inclusion of authors' conclusions helps them and (c) there is an interaction between the type of summary and the presence or absence of the conclusions.

METHODS: Eight hundred thirteen midwifery students from nine universities in the UK and Ireland were recruited to this 2 × 2 factorial trial (abstract versus PLS, conclusions versus no conclusions). They were randomly allocated to one of four groups and asked to recall knowledge after reading one of four summary formats of two Cochrane Reviews, one with clear findings and one with uncertain findings. The primary outcome was the proportion of students who identified the appropriate statement to describe the main findings of the two reviews as assessed by an expert panel.

RESULTS: There was no statistically significant difference in correct response between the abstract and PLS groups in the clear finding example (abstract, 59.6 %; PLS, 64.2 %; risk difference 4.6 %; CI -0.2 to 11.3) or the uncertain finding example (42.7 %, 39.3 %, -3.4 %, -10.1 to 3.4). There was no significant difference between the conclusion and no conclusion groups in the example with clear findings (conclusions, 63.3 %; no conclusions, 60.5 %; 2.8 %; -3.9 to 9.5), but there was a significant difference in the example with uncertain findings (44.7 %; 37.3 %; 7.3 %; 0.6 to 14.1, p = 0.03). PLS without conclusions in the uncertain finding review had the lowest proportion of correct responses (32.5 %). Prior knowledge and belief predicted student response to the clear finding review, while years of midwifery education predicted response to the uncertain finding review.

CONCLUSIONS: Abstracts with and without conclusions generated similar student responses. PLS with conclusions gave similar results to abstracts with and without conclusions. Removing the conclusions from a PLS with uncertain findings led to more problems with interpretation.

Impact of the Roots of Empathy Programme on Social-Emotional Learning: A Randomized Controlled Trial

Roots of Empathy (ROE) is a universal, school-based social and emotional learning programme aimed at increasing prosocial behaviour and reducing difficult behaviour. This paper reports the findings of a cluster randomized controlled trial of the effects of ROE on 8-9 year old children. 74 schools and 1,181 children took part. The findings provide evidence that ROE is effective in increasing prosocial behaviour (g=+.20, p=.043) and some potential evidence that it may reduce difficult behaviour (g=-.15, p=.070). While ROE was found to lead to improvements in positive behaviour, these were not associated with improvements in empathy or other social and emotional learning outcomes.

Beneficial effect of a polyphenol-rich diet on cardiovascular risk: a randomised control trial

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.

A randomized controlled trial on the effects of combined aerobic-resistance exercise on muscle strength and fatigue, glycemic control and health-related quality of life of type 2 diabetes patients

Aim: to evaluate the effects of a 12-weeks combined aerobic-resistance exercise therapy on fatigue and isokinetic muscle strength, glycemic control and health-related quality of life (HRQoL) in moderately affected type 2 diabetes (T2DM) patients. Methods: a randomized controlled trial design was employed. Forty-three T2DM patients were assigned to an exercise group (n = 22), performing 3 weekly sessions of 60 minutes of combined aerobic-resistance exercise for 12-weeks; or a no exercise control group (n = 21). Both groups were evaluated at a baseline and after 12-weeks of exercise therapy for: 1) muscle strength and fatigue by isokinetic dynamometry; 2) plasma glycated hemoglobin A1C (HbA1C); and 3) HRQoL utilizing the SF-36 questionnaire. Results: the exercise therapy led to improvements in muscle fatigue in knee extensors (-55%) and increased muscle strength in knee flexors and extensors (+15 to +30%), while HbA1C decreased (-18%). In addition, the exercising patients showed sizeable improvements in HRQoL: physical function (+53%), vitality (+21%) and mental health (+40%). Conclusion: 12-weeks of combined aerobic-resistance exercise was highly effective to improve muscle strength and fatigue, glycemic control and several aspects of HRQoL in T2DM patients. These data encourage the use of aerobic and resistance exercise in the good clinical care of T2DM.

The Well London program - a cluster randomized trial of community engagement for improving health behaviors and mental wellbeing: baseline survey results

Background The Well London programme used community engagement, complemented by changes to the physical and social neighbourhood environment, to improve physical activity levels, healthy eating and mental wellbeing in the most deprived communities in London. The effectiveness of Well London is being evaluated in a pair-matched cluster randomised trial (CRT). The baseline survey data are reported here. Methods The CRT involved 20 matched pairs of intervention and control communities (defined as UK census lower super output areas; ranked in the 11% most deprived LSOAs in London by Index of Multiple Deprivation) across 20 London boroughs. The primary trial outcomes, sociodemographic information and environmental neighbourhood characteristics were assessed in three quantitative components within the Well London CRT at baseline: a cross-sectional, interviewer-administered adult household survey; a self-completed, school-based adolescent questionnaire; a fieldworker completed neighbourhood environmental audit. Baseline data collection occurred in 2008. Physical activity, healthy eating and mental wellbeing were assessed using standardised, validated questionnaire tools. Multiple imputation was used to account for missing data in the outcomes and other variables in the adult and adolescent surveys. Results There were 4107 adults and 1214 adolescent respondents in the baseline surveys. The intervention and control areas were broadly comparable with respect to the primary outcomes and key sociodemographic characteristics. The environmental characteristics of the intervention and control neighbourhoods were broadly similar. There was greater between cluster variation in the primary outcomes in the adult population compared to the adolescent population. Levels of healthy eating, smoking and self-reported anxiety/depression were similar in the Well London population and the national Health Survey for England. Levels of physical activity were higher in the Well London population but this is likely to be due to the different measurement tools used in the two surveys. Conclusions Randomisation of social interventions such as Well London is acceptable and feasible and in this study the intervention and control arms are well balanced with respect to the primary outcomes and key sociodemographic characteristics. The matched design has improved the statistical efficiency of the study amongst adults but less so amongst adolescents. Follow-up data collection will be completed 2012.

South Carolina/common pleas court circuits meeting benchmark 80% of Pending Docket 365 Days or Less From Placement on the Trial Docket as of February 28, 2015

This is a list of the courts in all the circuits of South Carolina and the percentage of cases disposed of in 365 day or less. Only three courts met the 80% benchmark.

Detecting Adverse Events in Clinical Trial Free Text

Thesis (Master's)--University of Washington, 2013