The Collaborative Assessment and Management of Suicidality (CAMS) is an evidence-based clinical intervention that has significantly evolved over 25 years of clinical research. CAMS is best understood as a therapeutic framework that emphasizes a unique collaborative assessment and treatment planning process between the suicidal patient and clinician. This process is designed to enhance the thera...

BACKGROUND A number of papers have proposed or evaluated the delayed-start design as an alternative to the standard two-arm parallel group randomized clinical trial (RCT) design in the field of rare disease. However the discussion is felt to lack a sufficient degree of consideration devoted to the true virtues of the delayed start design and the implications either in terms of required sample-s...

BACKGROUND Some argue that by precluding individualized treatment, randomized clinical trials (RCTs) provide substandard medical care, while others claim that participation in clinical research is associated with improved patient outcomes. However, there are few data to assess the impact of random treatment assignment on RCT participants. We therefore performed a systematic review to quantify t...

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...

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 ...

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...

INTRODUCTION Although classical randomized clinical trials (RCTs) are the gold standard for proof of drug efficacy, randomized discontinuation trials (RDTs), sometimes called "enriched" trials, are used increasingly, especially in psychiatric maintenance studies. METHODS A narrative review of two decades of experience with RDTs. RESULTS RDTs in psychiatric maintenance trials tend to use a d...

OBJECTIVE Although prophylactic antibiotics have been shown by randomized clinical trials (RCTs) to help prevent deep infection after craniotomies, recent reports have suggested that antibiotics are not effective in preventing postcraniotomy meningitis. METHODS Data on meningitis as an end point from RCTs on prophylactic antibiotics for craniotomies were pooled in a random-effects meta-analys...

OBJECTIVE To determine how well therapeutic randomized controlled trials (RCTs) in the Journal of Pediatric Psychology (JPP) met the CONSORT criteria as compared to pediatric trials in the Journal of Clinical and Consulting Psychology (JCCP), which served as a control. METHODS Nine trials were found in JPP and 19 clinical trials were retrieved from JCCP. The modified Consort Checklist and Flo...