Clinical Trials

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No abstract text is available yet for this article.

No abstract text is available yet for this article.

No abstract text is available yet for this article.

The volume of clinical research is increasing exponentially-far beyond our ability to process and absorb the results. Given this situation, it may be beneficial to consider reducing the flow at its source. In what follows, I will motivate and critically evaluate the following proposal: researchers should conduct fewer clinical trials. More specifically, I c onsider whether researchers should be permitted to conduct only clinical research of very high quality and, in turn, whether research ethics committees (RECs) should prohibit all other, lower-quality research, even when it might appear to meet some minimal ethical standard...

The concept of a minimal clinically important difference (MCID) is well established. Here, we review the evidence base and methods used to define MCIDs as well as their strengths and limitations. Most MCIDs in chronic obstructive pulmonary disease (COPD) are empirically derived estimates applying to populations of patients. Validated MCIDs are available for many commonly used outcomes in COPD, including lung function (100 ml for trough FEV1), dyspnea (improvement of ≥ 1 unit in the Transition Dyspnea Index total score or 5 units in the University of California, San Diego Shortness of Breath Questionnaire), health status (reduction of 4 units in the St George's Respiratory Questionnaire total score), and exercise capacity (47...

Clinical research has evolved substantially over the last two decades, but industry-sponsored research is still substantially superior to academic research in preparing, organizing and monitoring studies. Academics have to realize that conducting clinical research has become a real job with professionalism requirements. The primary objectives of research and development clearly differ between industry and academics. In the first case, new drug development is expected to generate profit, whereas in the latter case, research is aimed at understanding mechanisms of disease, promoting evidence-based medicine, and improving public health and care...

The use of cardiac output monitoring to guide fluid and inotropic therapy in surgical patients has remained a controversial topic for more than 40 years. The reasons for this are numerous and complex, but key amongst them is the interplay between poor research methodology and the likely selective reporting of randomised trials. In this issue of Perioperative Medicine, we find a very unusual report, one which describes a randomised trial stopped for futility after the recruitment of only a small proportion of the target patient sample (Jammer et al...

This article analyzes the translation of research to clinical practice. Clinical practice is focused on a concrete context in which patients are encountered. This follows from the population under care in terms of their health status, socioeconomic circumstances, cultural and religious features, and social determinants of health but also from the actual function in which the encounter between patient and professional takes place. An understanding of this contextual complexity is as important in the translation of research into practice, as is an understanding of research...

Placebo effects are often considered the effects of an "inert substance," but that characterization is misleading. In a broad sense, placebo effects are improvements in patients' symptoms that are attributable to their participation in the therapeutic encounter, with its rituals, symbols, and..

No abstract text is available yet for this article.

No abstract text is available yet for this article.

No abstract text is available yet for this article.

OBJECTIVE: To estimate the proportion of participants in clinical trials who understand different components of informed consent. METHODS: Relevant studies were identified by a systematic review of PubMed, Scopus and Google Scholar and by manually reviewing reference lists for publications up to October 2013. A meta-analysis of study results was performed using a random-effects model to take account of heterogeneity. FINDINGS: The analysis included 103 studies evaluating 135 cohorts of participants...