BACKGROUND Randomized controlled trials (RCTs) that use the modified intention-to-treat (mITT) approach are increasingly being published. Such trials have a preponderance of post-randomization exclusions, industry sponsorship, and favourable findings, and little is known whether in terms of these items mITT trials are different with respect to trials that report a standard intention-to-treat. ...

BACKGROUND Depression is associated with physical inactivity, which may mediate the relationship between depression and a range of chronic physical health conditions. However, few interventions have combined a psychological intervention for depression with behaviour change techniques, such as behavioural activation (BA), to promote increased physical activity. METHODS To determine procedural ...

Results 125 clinical trials published in the HTA Journal Series met the inclusion. Five trials were reported to have been abandoned and were excluded from analyses. 72% of clinical trials achieved 50% or better of their original recruitment target. 90% of clinical trials recruited their targeted number of centres with 50% recruiting more than the initial number they expected. One third of trial...

BACKGROUND Randomized controlled trials (RCTs) are not always well reported, especially in terms of their methodological descriptions. This study aimed to investigate the adherence of methodological reporting complying with CONSORT and explore associated trial level variables in the Chinese nursing care field. METHODS In June 2012, we identified RCTs published in five leading Chinese nursing ...

BACKGROUND Ischemic preconditioning (IPC) of the heart is a protective strategy in which a brief ischemic stimulus immediately before a lethal ischemic episode potently limits infarct size. Although very promising in animal models of myocardial infarction, IPC has not yet been successfully translated to benefit for patients. OBJECTIVE To appraise all preclinical evidence on IPC for myocardial...

New randomised trials should be planned and reported taking account of knowledge from a systematic review of the existing research, but there is little empirical evidence to show how systematic reviews are used in the planning stages of new trials. A systematic review could be used to inform the design of a new trial in several ways: (1) to choose the most appropriate forms of the interventions...

PURPOSE To provide sample size calculation for the quantitative assessment of carotid atherosclerotic plaque using non-invasive magnetic resonance imaging in multi-center clinical trials. METHODS. As part of a broader double-blind randomized trial of an experimental pharmaceutical agent, 20 asymptomatic placebo-control subjects were recruited from 5 clinical sites for a multi-center study. Subj...

In clinical research, the occurrence of certain events (e.g., adverse events, disease progression, relapse, or death) is often of particular interest to the investigators, especially in the area of cancer trials. In most situations, these events are undesirable and unpreventable. In practice, it would be beneficial to patients if the test treatment could delay the occurrence of such events. As ...

BACKGROUND Non-inferiority (NI) trials in drug research are used to demonstrate that a new treatment is not less effective than an active comparator. Since phase IV trials typically aim at informing a clinical decision, the value of a phase IV non-inferiority trial hinges also on its clinical relevance. In such trials, clinical relevance would refer to the added benefit claims of a specific dru...

The use of routine datasets in the evaluation of interventions in clinical trials is increasing. Action to Support Practices Implementing Research Evidence (ASPIRE) is an NIHR Programme aiming to develop and test ways to support general practices in implementing key NICE recommendations. Multifaceted intervention packages have been developed to target four key clinical practice recommendations,...