A brief history of the cluster randomised trial design

Moberg, Jenny; Kramer, Michael S.

doi:10.1177/0141076815582303

Cited by 40 publications

(37 citation statements)

References 67 publications

(69 reference statements)

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“…Therefore, randomisation by day of recruitment was considered the best pragmatic alternative. Given the nature of the intervention, we identified a strong potential for contamination if randomisation was conducted at the patient‐level 23 . This study received ethical approval from the University of Newcastle Human Research and Ethics Committee (H‐2014‐0198).…”

Section: Methodsmentioning

confidence: 99%

Testing the effectiveness of a general practice intervention to improve uptake of colorectal cancer screening: a randomised controlled trial

Dodd

Carey

Mansfield

et al. 2019

Australian and New Zealand Journal of Public Health

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Objective: Uptake of screening through the Australian National Bowel Cancer Screening Program remains low. General practice guidelines support the general practitioners’ role to offer CRC screening. This study tests the effect that an intervention including point‐of‐care FOBT provision, printed screening advice and GP endorsement has on self‐reported FOBT uptake. Methods: A multisite, 1:1 parallel‐arm, cluster‐randomised controlled trial. Participants aged 50–74, at average risk of CRC and overdue for screening were recruited from four general practices in New South Wales, Australia, from September 2016 to May 2017. Self‐report of FOBT up to eight weeks post baseline. Results: A total of 336 participants consented to complete a baseline survey (64% consent rate), of which 123 were recruited into the trial (28 usual care days and 26 intervention days). Follow‐up data was collected for 114 participants (65 usual care and 49 intervention). Those receiving the intervention had ten times greater odds of completing screening compared to usual care (39% vs. 6%; OR 10.24; 95%CI 2.9‐36.6, p=0.0006). Conclusions: A multicomponent intervention delivered in general practice significantly increased self‐reported FOBT uptake in those at average risk of CRC. Implications for public health: General practice interventions could serve as an important adjunct to the Australian National Bowel Cancer Screening Program to boost plateauing screening rates.

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Section: Methodsmentioning

confidence: 99%

Testing the effectiveness of a general practice intervention to improve uptake of colorectal cancer screening: a randomised controlled trial

Dodd

Carey

Mansfield

et al. 2019

Australian and New Zealand Journal of Public Health

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“…It is defined as the ratio of the variance of the estimator, e.g., treatment effect, when the centre effect is taken into account and the variance of the estimator assuming a simple random sample. It has been shown [8] that in a multi-centre study with two treatment arms, the design effect can be approximated by Deff = 1 + (S − 1)ρ, where ρ represents the ICC as defined in [1] and S is defined as…”

Section: Methodsmentioning

confidence: 99%

“…The past decade has seen a steady increase in the use of the cluster randomised trial design [1]. In cluster-randomised trials, the unit of randomisation is the cluster, such as a hospital or school, rather than the individual participant.…”

Section: Introductionmentioning

confidence: 99%

Clustering of continuous and binary outcomes at the general practice level in individually randomised studies in primary care - a review of 10 years of primary care trials

Stuart

Becque

Moore

et al. 2020

BMC Med Res Methodol

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Background: In randomised controlled trials, the assumption of independence of individual observations is fundamental to the design, analysis and interpretation of studies. However, in individually randomised trials in primary care, this assumption may be violated because patients are naturally clustered within primary care practices. Ignoring clustering may lead to a loss of power or, in some cases, type I error. Methods: Clustering can be quantified by intra-cluster correlation (ICC), a measure of the similarity between individuals within a cluster with respect to a particular outcome. We reviewed 17 trials undertaken by the Department of Primary Care at the University of Southampton over the last ten years. We calculated the ICC for the primary and secondary outcomes in each trial at the practice level and determined whether ignoring practice-level clustering still gave valid inferences. Where multiple studies collected the same outcome measure, the median ICC was calculated for that outcome. Results: The median intra-cluster correlation (ICC) for all outcomes was 0.016, with interquartile range 0.00-0.03. The median ICC for symptom severity was 0.02 (interquartile range (IQR) 0.01 to 0.07) and for reconsultation with new or worsening symptoms was 0.01 (IQR 0.00, 0.07). For HADS anxiety the ICC was 0.04 (IQR 0.02, 0.05) and for HADS depression was 0.02 (IQR 0.00, 0.05). The median ICC for EQ. 5D-3 L was 0.01 (IQR 0.01, 0.04). Conclusions: There is evidence of clustering in individually randomised trials primary care. The non-zero ICC suggests that, depending on study design, clustering may not be ignorable. It is important that this is fully considered at the study design phase.

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“…The rationale for running trials is to determine the effectiveness or otherwise of new interventions or teaching methods by comparing an intervention group (receiving the programme or treatment) to the control group (not receiving the programme). In educational research, cluster designs are preferred to individual randomisation for reasons including efficiency, practicality and avoiding contamination effects (Torgerson, 2001;Hutchinson and Styles 2010;Moberg and Kramer 2015). The groups (be they school, classes or otherwise) will then be randomly assigned to either the intervention or control group.…”

Section: School-based Trials In Post-primary Settingsmentioning

confidence: 99%

Respecting and fulfilling the right of post-primary pupils to consent to participate in trials and evaluative research: a discussion paper

Maguire

Byrne

Kehoe³

2016

International Journal of Research & Method in Education

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This paper provides an introduction to issues surrounding the participation rights of young people in research and the implications of their growing involvement in research as well as providing a discourse on the ethical implications related to consent. The unique contribution of this paper is that it considers children's rights in respect to the increasing opportunities for young people to take part in evaluation research. The aim of this paper, therefore, is to acknowledge the growing involvement for young people in research and the implications of ensuring that their rights of participation are respected. Secondly we will consider the children's rights legislation and our obligations as researchers to implement this. Finally we will explore consent as an issue in its own right as well as the practicalities of accessing participants. This paper will postulate that any research about young people should involve and prioritise at all stages of the research process; including participation in decision-making.We conclude by identifying five key principles, which we believe can help to facilitate the fulfilment of post-primary pupils' ability to consent to participate in trials and evaluative research. evaluative research has brought with it increased opportunities for children and young people to be involved in research that will shape their future and that of their peers (Bourke and Loveridge 2014), through, for example, trials in socio-emotional learning, sex education, 2 literacy, numeracy, and physical activity. A systematic review conducted on the occurrence of trials in education since the 1980s has found a huge increase in published trials in the past ten years with around 100 educational trials published each year (Connolly 2015). Whilst the majority of these trials were conducted in North America, around 30% were based in Europe (Connolly 2015). School-based trials are accompanied by a range of general and specific ethical issues such as confidentiality, sampling, data storage, secondary data analysis and consent. These can take on added significance when children and young people are involved. IntroductionChildren and young people are, in legal terms, viewed as 'minors' who are 'vulnerable' and in need of safeguarding (Bos et al., 2013). In contrast to most research with adults, research with children and young people can be subject to multiple and hierarchical layers of consent in the form of school-based institutional gatekeepers and parental/guardian permissions (Gallagher et al., 2010). The extent to which children and young people can genuinely express willingness to take part and/or have the freedom to refuse to take part in evaluative research can thus risk becoming blurred.

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A brief history of the cluster randomised trial design

Cited by 40 publications

References 67 publications

Testing the effectiveness of a general practice intervention to improve uptake of colorectal cancer screening: a randomised controlled trial

Testing the effectiveness of a general practice intervention to improve uptake of colorectal cancer screening: a randomised controlled trial

Clustering of continuous and binary outcomes at the general practice level in individually randomised studies in primary care - a review of 10 years of primary care trials

Respecting and fulfilling the right of post-primary pupils to consent to participate in trials and evaluative research: a discussion paper

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