BACKGROUND The Cochrane risk of bias (RoB) tool has been widely embraced by the systematic review community, but several studies have reported that its reliability is low. We aim to investigate whether training of raters, including objective and standardized instructions on how to assess risk of bias, can improve the reliability of this tool. We describe the methods that will be used in this in...

Because public health must operate at scale in widely diverse, complex situations, randomized controlled trials (RCTs) have limited utility for public health. Other methodologies are needed. A key conceptual backbone is a detailed "theory of change" to apply appropriate evidence for each operational component. Synthesizing patterns of findings across multiple methodologies provides key insights...

Bias affects the true intervention effect in randomized controlled trials (RCTs), making the results unreliable. We evaluated the risk of bias (ROB) of quasi-RCTs or RCTs reported in the Korean Journal of Anesthesiology (KJA) between 2010 and 2016. Six kinds of bias (selection, performance, detection, attrition, reporting, and other biases) were evaluated by determining low, unclear, or high RO...

Very-brief, web-based alcohol interventions have great potential due to their convenience, ease of dissemination, and college students' stated preference for this intervention modality. To address the efficacy of these interventions, we conducted a review of the literature to identify randomized controlled trials (RCTs). Fifteen published reports were included. All RCTs meeting criteria for inc...

Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public he...

OBJECTIVES To develop best practice guidance for the use of retention strategies in randomized clinical trials (RCTs). STUDY DESIGN AND SETTING Consensus development workshops conducted at two UK Clinical Trials Units. Sixty-six statisticians, clinicians, RCT coordinators, research scientists, research assistants, and data managers associated with RCTs participated. The consensus development ...

BACKGROUND Recent evidence has highlighted deficiencies in clinical trial protocols, having implications for many groups. Existing guidelines for randomized clinical trial (RCT) protocol content vary substantially and most do not describe systematic methodology for their development. As one of three prespecified steps for the systematic development of a guideline for trial protocol content, the...

In the present investigation the Randomized Clinical Trial (RCT) is the “gold standard” for evaluating new therapies or strategies in medicine [1]. A low quality in RCTs design or publication, it could lead to an underestimation of the risk or even false, using treatments that may be less or even harmful, and could produce daily clinical practice consequences [2]. So a higher quality in publish...

There is a general agreement that before a therapy can be accepted into widespread clinical use, demonstration of efficacy in randomized clinical trials (RCTs) is absolutely necessary. There are, however, a growing number of experts who believe that demonstration of RCT efficacy might not be a sufficient basis for widespread acceptance.1 RCTs may not enroll subjects representative of patients i...

In 2008, the National Institute for Health Research (NIHR) set up a new Public Health Research (PHR) programme. This aims to provide ‘new knowledge on the benefits, costs, acceptability and wider impacts of non-NHS interventions intended to improve the health of the public and reduce inequalities in health’. It has a budget of £10 m per annum. It will fund high-quality research to answer questi...