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Cluster randomisation trials and their challenges

Ethical Challenges in Cluster Randomized Trials

Ethical Challenges in Cluster Randomized Trials

... Some data were missing for the independent variables describing journal impact factor and mean cluster sizes. Given the dichotomous nature of the variables, plausible values for each missing data point were easily ...

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A re-randomisation design for clinical trials

A re-randomisation design for clinical trials

... There are two options regarding the analysis in this situ- ation: the first is to exclude the patient from the analysis, and the second is to include them. Excluding patients from the analysis is generally an ...

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Cluster randomisation or randomised consent as an appropriate methodology for trials in palliative care: a feasibility study [ISRCTN60243484]

Cluster randomisation or randomised consent as an appropriate methodology for trials in palliative care: a feasibility study [ISRCTN60243484]

... Patients consenting to the trial treatment have the right to withdraw from the trial at any time. One of the main criticisms of Zelen's method is that a con- sideration of sample size needs to be undertaken if the study ...

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Researchers’ perceptions of ethical challenges in cluster randomized trials: a qualitative analysis

Researchers’ perceptions of ethical challenges in cluster randomized trials: a qualitative analysis

... Data collection A semi-structured telephone interview guide was devel- oped and pilot tested on colleagues. The interview guide included questions about informants’ experience with CRTs, ethical issues in CRTs, ethical ...

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Using re-randomisation to increase the recruitment rate in clinical trials

Using re-randomisation to increase the recruitment rate in clinical trials

... the cluster design may not be ...the cluster design is thought to be greater than the risk of bias from misspecification of the causal model for treatment history in the re-randomisation design; ...

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Are pilot trials useful for predicting randomisation and attrition rates in definitive studies: A review of publicly funded trials

Are pilot trials useful for predicting randomisation and attrition rates in definitive studies: A review of publicly funded trials

... from trials completed between 2004 and ...being cluster randomised controlled trials leaving 102 ...these trials 58 trials had no pilot ...a cluster RCT (n=1), did not conform to ...

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Community perspectives on randomisation and fairness in a cluster randomised controlled trial in Zambia

Community perspectives on randomisation and fairness in a cluster randomised controlled trial in Zambia

... following challenges: interviews were conducted 2 years after the randomisation process and some respondents did not attend the randomisation ...the randomisation procedures were influenced by ...

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The Method of Randomization for Cluster-Randomized Trials: Challenges of Including Patients with Multiple Chronic Conditions

The Method of Randomization for Cluster-Randomized Trials: Challenges of Including Patients with Multiple Chronic Conditions

... CHALLENGES TO DEVELOPING CRT AMONG POPULATIONS WITH MCC The overarching methodologic challenges inherent in CRT designs [9,15–17] may be exacerbated by the demands of the specific patient population under ...

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Reconstructing communities in cluster trials?

Reconstructing communities in cluster trials?

... representative of a political party located in a slum community. Results: Residents ’ sense of community largely matched the scientific notion of the cluster, defined by the investigators as a geographic area, but ...

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Placebo-controlled clinical trials: how trial documents justify the use of randomisation and placebo

Placebo-controlled clinical trials: how trial documents justify the use of randomisation and placebo

... the trials were clearly in- formed of the possibility of receiving a ...most trials the participants continued to receive standard care, with the study drug added to the existing ...

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Methodological bias in cluster randomised trials

Methodological bias in cluster randomised trials

... 36 trials we identified 14 that reported, either directly or indirectly, the mean age and standard deviation of the treatment ...14 trials that were included nine stated they had taken clustering into ...

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Missing Data in Cluster Randomised Trials

Missing Data in Cluster Randomised Trials

... Table 8.11: Average estimates of log(RaR) using gamma SFM, their average estimated standard errors (aveSE), empirical standard errors (empSE) and coverage (Cov) rates for nominal 95% CI [r] ...

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Spatial Analysis of Cluster Randomised Trials

Spatial Analysis of Cluster Randomised Trials

... I would like to thank my supervisors John Edmunds, Neal Alexander, and Daniel Lewis, for their support, feedback and critique. I thank my original supervisor Gian Luca Di Tanna for his supervision during the first year ...

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CRTs--cluster randomized trials or "courting real troubles": challenges of running a CRT in rural Gujarat, India.

CRTs--cluster randomized trials or "courting real troubles": challenges of running a CRT in rural Gujarat, India.

... controlled trials Arecent review concluded that research on alternative modes of health financing in developing countries is generally small scale, with findings of restricted applicability, and called for the use ...

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Choosing covariates in the analysis of cluster randomised trials.

Choosing covariates in the analysis of cluster randomised trials.

... 5.6 Conclusion Adjusted analyses are common in reports of CRTs. Further, adjusting for covariates other than baseline measure of outcome and covariates used in randomisation is pre- sented in almost half of the ...

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Biomarker-guided trials: Challenges in practice.

Biomarker-guided trials: Challenges in practice.

... in trials, where genetic markers are being assessed, and susceptibility to certain other diseases are uncovered – so-called ‘incidental’ findings, and this is a subject of much debate(16, ...

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The impact of varying cluster size in cross-sectional stepped-wedge cluster randomised trials

The impact of varying cluster size in cross-sectional stepped-wedge cluster randomised trials

... for cluster, as a framework for the design and analysis of a ...the cluster sizes to be equal, subsequent design ef- fects derived from this model make the assumption that there is no variation in ...

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Studying Group Behaviour: Cluster Randomized Clinical Trials

Studying Group Behaviour: Cluster Randomized Clinical Trials

... potential challenges and ethical issues involved with cluster trials may be managed ...within cluster correlation and between cluster variability, and adjustment for nonindependence of ...

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Heterogeneity issues in the meta-analysis of cluster randomization trials.

Heterogeneity issues in the meta-analysis of cluster randomization trials.

... from cluster randomization ...such trials is problematic because responses of subjects within clusters are likely ...randomized trials having a binary ...

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Randomization-Based Confidence Intervals for Cluster Randomized Trials

Randomization-Based Confidence Intervals for Cluster Randomized Trials

... words: Cluster randomized trial; Confidence interval; Correlated data; Interval-censored; Permuta- tion test; Randomization-based ...a cluster randomized trial (CRT), groups of people rather than ...

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