Targeted temperature management was adopted as part of the treatment of unconscious survivors of out-ofhospital cardiac arrest following the publication of two landmark studies [1,2] which concluded that mild induced hypothermia (32°C to 34°C) improved survival and neurological outcome, substantiating the neuroprotective effect of mild hypothermia described in experimental animal data [3]. Subs...

Randomized clinical trials (RCTs) are among the most rigorous ways to determine the causal relationship between an intervention and important clinical outcome. Their use in veterinary medicine has become increasingly common, and as is often the case, with progress comes new challenges. Randomized clinical trials yield important answers, but results from these studies can be unhelpful or even mi...

For too long children have received medicines not sufficiently studied for their needs and, in fact, being considered as small replicas of adults, it was deemed sufficient to adjust the dosage of a drug approved for adults. Together with the limited availability of appropriate drug formulations, especially for neonates and toddlers, this approach has caused increased iatrogenic risk and/or subo...

Although randomized clinical trials (RCTs) are universally regarded as the standard for establishing treatment efficacy (Shapiro and Louis 1983), relatively few RCTs have been attempted in the field of outpatient drug abuse treatment. Of those that have been attempted, most have reported subject recruitment and retention to be among the most pervasive problems encountered. Considerable attentio...

The role of real-world evidence (RWE) in regulatory, drug development, and healthcare decision-making is rapidly expanding. Recent advances have increased the complexity of cancer care and widened the gap between randomized clinical trial (RCT) results and the evidence needed for real-world clinical decisions. Instead of remaining invisible, data from the >95% of cancer patients treated outside...

PURPOSE To discuss the methodological considerations of a standard and applicable randomized clinical trial (RCT). MATERIALS AND METHODS Using a predefined strategy, we conducted systematic computerized search of the MEDLINE (1966 to 2011) and EMBASE (1980 to 2011) databases to identify all English language educational articles discussing the RCT methodological aspects. Full text versions of ...

leagues in the June 2004 Canadian Journal of Surgery (volume 47, pages 200–208) nicely takes readers through the process of assessing the value of a randomized clinical trial (RCT) in surgery. These steps are based on the invaluable work of the Evidence-Based Medicine Working Group (EBMWG). Considerable effort has also gone into standardizing reportage of RCTs. Thoma’s article has 35 references...

Several issues concerning stepped care are discussed: the constraints of using Diagnostic and Statistical Manual of Mental Disorders diagnoses in randomized clinical trials (RCTs), the importance of basic and process research, the unintended negative effects of exaggerated claims of effectiveness and efficiency, the limits of RCTs in evaluating improvement and deterioration, the self-correcting...

An intensive, 9-session motivational interviewing (IMI) intervention was assessed using a randomized clinical trial of 217 methamphetamine (MA) dependent individuals. Intensive motivational interviewing (IMI) was compared with a single standard session of MI (SMI) combined with eight nutrition education sessions. Interventions were delivered weekly over 2 months. All study participants also rec...

The practice of evidence-based medicine depends on several steps: a basic science derived understanding of disease pathophysiology, epidemiological research, and the results of well-conducted and appropriately analyzed randomized clinical trials (RCTs). The approval of new therapies by regulatory agencies is also based largely on RCT determination of the safety and therapeutic efficacy of drugs...