[PDF] Top 20 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 ... See full document

... 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 ... See full document

... and cluster level; and details of the ethics review ...20 trials will be used for reviewer ...identified ethical issues such as informed consent procedures among study disciplines, types of ... See full document

... 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 ... See full document

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

... Naughton and colleagues [6] report on a CRT designed to compare the effectiveness of two quality improvement interventions to increase prescribing of antiplatelet and lipid lowering medications for patients with ... See full document

... explanatory trials are commonly sponsored by pharmaceutical companies, pragmatic RCTs are typically funded by government or public agencies [5]; in fact, facing rising health care costs, gov- ernments and public ... See full document

... The ethical principle of respect for persons implies that researchers are generally obligated to obtain the informed consent of research ...including cluster randomization, cluster level ... See full document

... the challenges posed by informed consent in CRTs without the need to invoke ...when cluster members are approached for consent at the earliest opportunity and before any study interventions or ... See full document

... which trials may be more explanatory or pragmatic ...identified trials as existing upon a multiaxial continuum, and pro- posed nine design features upon which trials could be more explanatory or more ... See full document

... a cluster-randomized design were approved with a waiver of the requirement for consent, then a study of the same in- terventions that employed randomization at the level of the individual should also ... See full document

... The ethical principle of respect for persons generally requires that researchers obtain the informed consent of research ...the cluster trials literature it is commonly claimed that the need for ... See full document

... the randomized evaluation by making the intervention available to all (either all clusters or all participants) at some ...Further ethical evaluation will be essential to provide a full solution to this ... See full document

... in trials with “ non-match ” sub-study without blinding of participants where everyone knows to which sub-trial they were ...these trials, subjects in arms that “ matched ” may be 100% confident that they ... See full document

... recruitment; cluster-level means (or medians) would be used to minimize participant-level covariates, such as the practice-level mean of patient blood pressure values ...of trials that use minimization ... See full document

... with cluster randomized trials, including text books ...of cluster trials [12], published subsequent to the 2004 extension of the CONSORT guidelines [13-14], concluded that the ... See full document

... We also define the probability that the intervention is cost effective (for a given willingness to pay, say λ ) as Pr(e λ – c > 0), where e is the effect and c is the difference in cost. In our example we shall ... See full document

... recent trials [27, 28] with lower risk of bias also found non-statistically significant benefit for persistent/recur- rent wheeze or asthma in the first 3 years of ... See full document

... in randomized trials of clusters compared with that of individuals, although this clustering effect is rarely taken into ...of cluster ran- domized trials in primary care, Eldridge et al [6] ... See full document

... Background: Infectious disease interventions are increasingly tested using cluster- randomised trials. These trial settings tend to involve a set of sampling units, such as villages, whose geographic ... See full document