Special ethical issues in cluster randomized trials 117
Ethical issues posed by cluster randomized trials in health research
... in cluster trials when the intervention tar- gets the ...First, ethical and regulatory requirements for informed consent apply only to research ...to cluster trials requires further ...
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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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Ethical issues in the design and conduct of stepped wedge cluster randomized trials in low resource settings
... This cluster evaluation was necessary because it made study implementation logistically easier and pre- vented contamination from some components of the intervention that were delivered across wide areas ...fully ...
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Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study
... settings; cluster randomized trials in which entire medical practices or health care units are randomized, are ideal for this ...the ethical con- duct of research involving human beings ...
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Researchers’ perceptions of ethical challenges in cluster randomized trials: a qualitative analysis
... CRTs, ethical issues in CRTs, ethical challenges encoun- tered with particular CRTs and the ethics review process, and questions seeking input on the need for ethics guidelines for ...important ...
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Cluster randomized clinical trials in orthodontics: design, analysis and reporting issues
... SUMMARY Cluster randomized trials (CRTs) use as the unit of randomization clusters, which are usually defined as a collection of individuals sharing some common ...a cluster provides less ...
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Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation
... Given that pragmatic RCTs meet the definition of research involving human participants, we believe that the answer to this question must appeal to internation- ally accepted research ethics principles. Shifting discus- ...
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Clinical trials in neonates: ethical issues
... At least two studies have suggested that at least some of these problems do eventuate in practice. 13;14 There is also evidence that parents who give consent for a trial in the early neonatal period later forget having ...
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Statistical issues in randomized trials of cancer screening
... typical randomized trial of cancer screening, screen- ing is offered for a limited time and subjects are followed after screening has ...a special baseline variable B such that B = 1 if (i) the subject ...
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Studying Group Behaviour: Cluster Randomized Clinical Trials
... of ethical principles behind, Emanuel and Weijer[44] argued that a forth principle should be added to the Belmont trinity, 4 namely respect for communities, and thought that this principle “is reasonably ...
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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 ...completely randomized trials having a binary ...
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Imputation strategies for missing binary outcomes in cluster randomized trials
... Generally, the nature or type of missingness can fit into four categories: missing completely at random (MCAR), missing at random (MAR), covariate dependent (CD) missing, and missing not at random (MNAR) [6]. Under- ...
15
Who is the research subject in cluster randomized trials in health research?
... Example 3: A CRT comparing interventions to improve primary care prescribing Naughton and colleagues [6] report on a CRT designed to compare the effectiveness of two quality improvement interventions to increase ...
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Imputation strategies for missing binary outcomes in cluster randomized trials
... Generally, the nature or type of missingness can fit into four categories: missing completely at random (MCAR), missing at random (MAR), covariate dependent (CD) missing, and missing not at random (MNAR) [6]. Under- ...
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Sample size calculations for the design of cluster randomized trials: A summary of methodology.
... Abstract Cluster randomized trial designs are growing in popularity in, for example, cardiovascular medicine research and other clinical areas and parallel statistical developments concerned with the design ...
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Does clinical equipoise apply to cluster randomized trials in health research?
... individually randomized trials involving patients, similar questions are addressed by the concept of clinical equipoise, that is, the ethical requirement that, at the start of a trial, there be a ...
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Power and sample size determination for stepped wedge cluster randomized trials
... In Chapter 4, we studied several analytical issues for SWT designs through Monte Carlo simulations. Specifically, we studied choice of correlation structure and fitting the step effect as a random effect. For ...
128
When is informed consent required in cluster randomized trials in health research?
... It is a dictum in ethics that “ought implies can": ethi- cal obligations must be possible to fulfill. Given that it was impossible to approach prospective research sub- jects before randomization, researchers in this ...
13
Allocation techniques for balance at baseline in cluster randomized trials: a methodological review
... methodological issues in the conduct and reporting of cluster randomized controlled trials ...requiring special attention in C-RCTs is the risk for imbalance of covariates at ...to ...
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Intervention effect estimates in cluster randomized versus individually randomized trials: a meta-epidemiological study.
... because the abstracts of reports rarely specify the inclusion of both CRTs and IRTs. Restricting our study to Cochrane reviews may limit the generalizability of our results. This study was conducted using trial-level ...
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