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However, as demonstrated by Weinstein's review [ 33], the challenges of implementing a randomised controlled study design of sufficient power, with long term follow-up is limited by both subject non-adherence to randomisation and the ethical considerations around use of a true control group.
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Thus we designed and implemented a randomised controlled education trial.
To obtain sound information, two principally different analytical models were tested; in one model, pre-selected groups of patients with established diagnosis were analysed, whereas the other implemented a randomised group of patients in which a positive ANA test was the only selection criterion.
The study was funded by the NIHR HTA programme as part of implementing a pilot pragmatic randomised trial for the comparative effectiveness of antibiotics in patients with an exacerbation of chronic obstructive pulmonary disease and non-purulent sputum.
The study will constitute a randomised controlled trial, implementing a between-subjects repeated measures design to compare intervention and control conditions over four key areas at three time points.
We are successfully implementing a multi-centre, community-based, randomised control trial in partnership with community agencies and primary health organisations to see whether an electricity voucher enables elderly people with COPD to better heat their homes, and in turn, whether this reduces exacerbations of COPD symptoms, and hospitalisation.
However, individualised care planning during the postnatal period which incorporates a high level of flexibility may be challenging for organisations to manage and implement, and a randomised controlled trial of such an approach may not be feasible.
We define MVHT as the extent to which a homeopathic intervention and the main measure of its outcome, as implemented in a randomised controlled trial (RCT), reflect 'state-of-the-art' homeopathic practice.
To enhance patient attendance in the cardiac rehabilitation programme, a patient-education strategy called "Learning and Coping (LC)" was implemented within a randomised controlled trial (RCT) at the Regional Hospitals West Jutland in Denmark.
This study expands on the work of Gagnon et al 7 8 by implementing a more rigorous study methodology using a two-group, prospective, randomised control design.
A critical part of this process was establishing whether it was feasible and ethical to implement a meaningful intervention within a randomised controlled trial (RCT) framework; key to gaining acceptance for the study was assuring stakeholders that the control arm would receive 'usual care' and that there was a prima facie case for equipoise.
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