Patient relevant outcomes, measured using questionnaires, are becoming increasingly popular endpoints in randomized clinical trials (RCTs). Recently, interest in the use of item response theory (IRT) to analyze the responses to such questionnaires has increased. In this paper, we used a simulation study to examine the small sample behavior of a test statistic designed to examine the difference ...

OBJECTIVE Acupuncture is often used and frequently advocated for the symptomatic treatment of fibromyalgia. A systematic review has previously demonstrated encouraging findings. As it is now outdated, we wanted to update it. METHODS We searched seven electronic databases for relevant randomized clinical trials (RCTs). The data were extracted and validated independently by both authors. As no ...

O widely accepted definition of Evidence Based Practices (EBPs) is that they are interventions for which scientific evidence consistently shows that the practice improves client outcomes.1 EBPs rely on the classifications of research studies and findings according to a variety of evidence. In general, the highest standard requires evidence from several Randomized Clinical Trials (RCTs) by multi...

Events of the past decade or so argue that there is little support in the literature for much of the specialty's treatment portfolio. The resulting call for 'evidence-based' treatment (not to mention the obvious intellectual bankruptcy of much of the clinical literature) has prompted many to argue that the randomized clinical trial (RCT) represents the future of orthodontic clinical investigati...

OBJECTIVE Considering the importance of randomized clinical trials (RCTs) in the evidence-based approach, the objective of this study was critical appraisal of reporting RCTs in Iranian dental journals. MATERIALS AND METHODS After adequate searching, 113 RCT articles published during 2003-2010 were reviewed for quality of reporting with the CONSORT scale. The quality of each paper was assesse...

As randomized clinical trial (RCT) programs have increasingly become more global geographically, numerous challenges have resulted. One issue that arises with such global programs is the sometimes differing regulatory advice or requirements on primary or secondary endpoints. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use...

Randomized clinical trials (RCTs) not only are the gold standard for evaluating the efficacy and effectiveness of psychiatric treatments but also can be valuable in revealing moderators and mediators of therapeutic change. Conceptually, moderators identify on whom and under what circumstances treatments have different effects. Mediators identify why and how treatments have effects. We describe ...

This paper is a practical guide to the essentials of statistical analysis and reporting of randomized clinical trials (RCTs). It is the first in a series of 4 educational papers on statistical issues for RCTs, which will also include statistical controversies in RCT reporting and interpretation, the fundamentals of design for RCTs, and statistical challenges in the design and monitoring of RCTs...