Cluster randomized control trials
Who is the research subject in cluster randomized trials in health research?
... 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 ...
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Ethical issues posed by cluster randomized trials in health research
... of cluster trials in developing ...conducting cluster trials face ethical issues that flow from cultural differences and disparities in access to health care between host and sponsor ...the ...
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Studying Group Behaviour: Cluster Randomized Clinical Trials
... home. Control mothers were expected to follow the Tigray Community-Based Malaria Control Programme (TCBMCP), a program that relied on trained, volunteer community health workers to expeditiously point ...
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Reducing contamination risk in cluster randomized infectious disease intervention trials
... An additional option for modifying the inclusion criteria is aimed at potential social expectations of fairness, because in many cases, CRT interventions are perceived as benefits by the communities in the study region. ...
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Imputation strategies for missing binary outcomes in cluster randomized trials
... total, 28 FPs participated in the study. Fourteen were randomly allocated to the intervention (pharmacy BP clinics) and 14 to the control group (no BP clinics offered). Fifty-five patients were randomly selected ...
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Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study
... in trials of infectious disease interventions, a vaccine may be administered at the individual level but its effects observed among those in the wider community as a con- sequence of herd ...in trials of ...
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Intracluster correlation coefficients in cluster randomized trials: empirical insights into how should they be reported
... average cluster size [13]); • what data were used to calculate the ICC – for example whether the ICC was calculated from control data only, from both control and intervention data, using pre-inter- ...
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The use of the cluster randomized crossover design in clinical trials: protocol for a systematic review
... and control), characteris- tics, methods used in the trial (recruitment, randomization, allocation, and blinding), reporting of baseline characteris- tics of the trial design, and statistical analysis (methods to ...
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When is informed consent required in cluster randomized trials in health research?
... the control arm) were not in a position whereby their interests could plausibly be compromised in the context of a research study and, accordingly, they were not human research ...translation trials who are ...
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On the estimation of intracluster correlation for time-to-event outcomes in cluster randomized trials
... The purpose of this trial was to assess the impact of insecticide inpregnated bednets on child mortality in relation to the control group (Binka et al., 1996). This trial was conducted in Ghana (Africa) from July ...
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PubMedCentral-PMC5571824.pdf
... to control confounding in the ...or cluster-randomized trials (random assignment of identifiable groups to study conditions with observations on group members), 59–62 individually ...
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Methods for analyzing cost effectiveness data from cluster randomized trials
... clinics [16]. Forty clinics were randomized to intervention or control arms. In each clinic 50 patients were inter- viewed at baseline and 3 months later. The trial outcome, indicating appropriate care, was ...
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What is the role and authority of gatekeepers in cluster randomized trials in health research?
... were randomized to the intervention and control ...the control arm completed the task before the educational session, and those in the intervention arm completed it after the ...
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Choosing an imbalance metric for covariate constrained randomization in multiple arm cluster randomized trials
... In this article, we present a complex three-arm C-RCT case study that involved CCR, aiming to control imbal- ance for three continuous baseline variables. This case demonstrated two gaps in the literature ...
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Does clinical equipoise apply to cluster randomized trials in health research?
... Clinical equipoise helps to resolve the ethical tensions raised by harm-benefit assessments in RCTs by provid- ing a principled justification for the ethical permissibility of a trial. More specifically, it provides ...
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Ethical Challenges in Cluster Randomized Trials
... An example of such a study is a CRT conducted in Nepal that evaluated the comparative efficacy of three different strategies for umbilical stump cleansing on neonatal mortality and incidence of omphalitis (infection of ...
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Researchers’ perceptions of ethical challenges in cluster randomized trials: a qualitative analysis
... Informants described perceived challenges with the eth- ics review process, expressed concern over when informed consent is required from cluster members, and over the authority of cluster gatekeepers. ...
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Early life vitamin D status and asthma and wheeze: a systematic review and meta-analysis
... included randomized con- trolled trials (RCTs), quasi-randomized controlled trials, non-randomized controlled trials, prospective and retro- spective cohort studies that measured ...
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Allocation techniques for balance at baseline in cluster randomized trials: a methodological review
... The pharmaceutical industry [50] and other commen- tators [51] warn against the use of minimization mainly due to higher risk of selection bias that comes with pre- dictability of deterministic assignment. The extent of ...
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Pre pregnancy care for women with pre gestational diabetes mellitus : a systematic review and meta analysis
... however, randomized controlled trials to assess the effectiveness of PPC are neither ethical nor ...the control groups at different times during the course of the study (pre-pregnancy period and ...
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