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BACKGROUND Previous reviews of cluster randomised trials have been critical of the quality of the trials reviewed, but none has explored determinants of the quality of these trials in a specific field over an extended period of time. Recent work suggests that correct conduct and reporting of these trials may require more than published guidelines. In this(More)
BACKGROUND Depression is common and is associated with poor outcomes among elderly care-home residents. Exercise is a promising low-risk intervention for depression in this population. We tested the hypothesis that a moderate intensity exercise programme would reduce the burden of depressive symptoms in residents of care homes. METHODS We did a(More)
OBJECTIVE Proxy measures are an alternative source of data for care home residents who are unable to complete the health utility measure, but the agreement levels between residents and care home staff for the EQ-5D have not been investigated previously. The objective of the present study was to examine the inter-rater agreement levels for the reporting of(More)
BACKGROUND The Coping with Persistent Pain, Effectiveness Research into Self-management (COPERS) trial assessed whether a group-based self-management course is effective in reducing pain-related disability in participants with chronic musculoskeletal pain. This article describes the statistical analysis plan for the COPERS trial. METHODS AND DESIGN COPERS(More)
OBJECTIVE To assess the quality of reported consent processes of cluster-randomised trials conducted in residential facilities for older people and to explore whether the focus on improving the general conduct and reporting of cluster-randomised trials influenced the quality of conduct and reporting of ethical processes in these trials. DESIGN Systematic(More)
Missing observations are common in cluster randomised trials. The problem is exacerbated when modelling bivariate outcomes jointly, as the proportion of complete cases is often considerably smaller than the proportion having either of the outcomes fully observed. Approaches taken to handling such missing data include the following: complete case analysis,(More)
In randomised controlled trials that have non-compliance with the treatment assigned, policy makers require unbiased estimates of the causal effect of the treatment received. Instrumental variable (IV) approaches provide complier average causal effects (CACE) estimates. Common IV methods such as two-stage least squares (2SLS) have not been extended to(More)
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