1,022 research outputs found
Graphical sensitivity analysis with different methods of imputation for a trial with probable non-ignorable missing data
No full textGraphical sensitivity analyses have recently been recommended for clinical trials with non-ignorable missing binary outcome. We demonstrate an adaptation of this methodology for a continuous outcome of a trial of three cognitive-behavioural therapies for mild depression in primary care, in which one arm had unexpectedly high levels of missing data. Fixed value and multiple imputation from a normal distribution (assuming either varying mean and fixed SD, or fixed mean and varying SD) were used to obtain contour plots of the contrast estimates with their P values superimposed; their confidence interval; and the root mean square error. Imputation was based on both the outcome value alone, or on change from baseline. The plots showed fixed value imputation to be more sensitive than imputing from a normal distribution, but the normally distributed imputations were subject to sampling noise. The contours of the sensitivity plots were close to linear in appearance with the slope approximately equal to the ratio of the proportions of subjects with missing data in each trial arm
The influence of attention deficits on functional recovery post stroke during the first 12 months after discharge from hospital
No full textBackground: Attention deficits have been linked to poor recovery after stroke and may predict outcome. We explored the influence of attention on functional recovery post stroke in the first 12 months after discharge from hospital.Methods: People with stroke completed measures of attention, balance, mobility and activities of daily living (ADL) ability at the point of discharge from hospital, and 6 and 12 months later. We used correlational analysis and stepwise linear regression to explore potential predictors of outcome.Results: We recruited 122 men and women, mean age 70 years. At discharge, 56 (51%) had deficits of divided attention, 45 (37%) of sustained attention, 43 (36%) of auditory selective attention and 41 (37%) had visual selective attention deficits. Attention at discharge correlated with mobility, balance and ADL outcomes 12 months later. After controlling for the level of the outcome at discharge, correlations remained significant in only five of the 12 relationships. Stepwise linear regression revealed that the outcome measured at discharge, days until discharge and number of medications were better predictors of outcome: in no case was an attention variable at discharge selected as a predictor of outcome at 12 months.Conclusions: Although attention and function correlated significantly, this correlation was reduced after controlling for functional ability at discharge. Furthermore, side of lesion and the attention variables were not demonstrated as important predictors of outcome 12 months later.<br/
A systematic review of vanadium oral supplements for glycaemic control in type 2 diabetes mellitus
No full textObjective: To assess the effectiveness of oral vanadium supplementation for glycaemic control in type 2 diabetes by conducting a systematic review of the literature. Design and Methods: Eligible studies were identified by searching 14 databases using standardized terms. Experts, study authors and manufacturers were also contacted. Hand-searching was not undertaken. Selection criteria for inclusion in the review were controlled human trials of vanadium vs. placebo in adults with type 2 diabetes of minimum 2 months duration, and a minimum of 10 subjects per arm. Data extraction, assessment of study quality and outcome analysis were undertaken by two independent reviewers. Results: One hundred and fifty one studies were found but none met the inclusion criteria. We proceeded to summarize the state of existing evidence and plan for a future clinical trial by applying revised, less restrictive criteria to our search, for clinical trials of 30150 mg daily oral vanadium supplementation in diabetic humans. Only five were identified. These demonstrated significant treatment-effects, but due to poor study quality, must be interpreted with caution. Treatment with vanadium often results in gastrointestinal side-effects. Conclusion: There is no rigorous evidence that oral vanadium supplementation improves glycaemic control in type 2 diabetes. The routine use of vanadium for this purpose cannot be recommended. A large-scale randomized controlled trial is needed to address this clinical question
Graphical sensitivity analysis with different methods of imputation for a trial with probable non-ignorable missing data
No full textGraphical sensitivity analyses have recently been recommended for clinical trials with non-ignorable missing outcome. We demonstrate an adaptation of this methodology for a continuous outcome of a trial of three cognitive-behavioural therapies for mild depression in primary care, in which one arm had unexpectedly high levels of missing data. Fixed-value and multiple imputations from a normal distribution (assuming either varying mean and fixed standard deviation, or fixed mean and varying standard deviation) were used to obtain contour plots of the contrast estimates with their?P-values superimposed, their confidence intervals, and the root mean square errors. Imputation was based either on the outcome value alone, or on change from baseline. The plots showed fixed-value imputation to be more sensitive than imputing from a normal distribution, but the normally distributed imputations were subject to sampling noise. The contours of the sensitivity plots were close to linear in appearance, with the slope approximately equal to the ratio of the proportions of subjects with missing data in each trial arm
Comparison of retrospective interviews and prospective diaries to facilitate fall reports among people with stroke
No full textQuestions asked and answered in pilot and feasibility randomized controlled trials
No full textAbstract Background In the last decade several authors have reviewed the features of pilot and feasibility studies and advised on the issues that should be addressed within them. We extend this literature by examining published pilot/feasibility trials that incorporate random allocation, examining their stated objectives, results presented and conclusions drawn, and comparing drug and non-drug trials. Methods A search of EMBASE and MEDLINE databases for 2000 to 2009 revealed 3652 papers that met our search criteria. A random sample of 50 was selected for detailed review. Results Most of the papers focused on efficacy: those reporting drug trials additionally addressed safety/toxicity; while those reporting non-drug trials additionally addressed methodological issues. In only 56% (95% confidence intervals 41% to 70%) were methodological issues discussed in substantial depth, 18% (95% confidence interval 9% to 30%) discussed future trials and only 12% (95% confidence interval 5% to 24%) of authors were actually conducting one. Conclusions Despite recent advice on topics that can appropriately be described as pilot or feasibility studies the large majority of recently published papers where authors have described their trial as a pilot or addressing feasibility do not primarily address methodological issues preparatory to planning a subsequent study, and this is particularly so for papers reporting drug trials. Many journals remain willing to accept the pilot/feasibility designation for a trial, possibly as an indication of inconclusive results or lack of adequate sample size.</p
Impacts of hunter-gatherers on the vegetation history of the eastern vale of pickering, Yorkshire
No full textResearch is undertaken into the vegetation and human impact at three previously un-researched archaeological sites from the eastern Vale of Pickering. The vegetation history is reconstructed from the end of the Windermere Interstadial c. 13,000 (^14)C yr BP until the final Mesolithic c. 5100 (^14)C yr BP. The early Mesolithic human impact on the vegetation is assessed using a three stage statistical test to establish the internal variability in the data as well as background variations in pollen output. The results reveal that humans had a small but significant impact on the vegetation around two of the sites. Pollen preservation at the third site precluded analyses of the impacts of humans on the vegetation. The three-stage test used to test for human impact was quite successful but requires revision before any further use. On the whole the tests confirmed the findings of conventional human impact analyses. During the pre-Holocene fires occurred on a regular basis. These fires varied in location and intensity, suggesting that some of the fires were regional or large-scale, whilst others were small and very localized. A multi-causal explanation has been given for the fires. Later, during the early Mesolithic, human groups are thought to have burnt the reedswamp at the lake edges as part of an economic strategy. Star Carr is the only site that demonstrates clearance of significant areas of woodland. During the later Mesolithic the hunter-gatherers have a greater impact on the vegetation within the Vale. This is attributed to the need for more resources as a result of vegetation change and increased population levels. Unlike their counter-parts from the North York Moors, the occupants of the lowland Vale of Pickering cause no long-term change to their environment
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