Randomized Clinical Trials Design, Practice, and Reporting

Methodological Reporting of Randomized Clinical Trials

BACKGROUND: Although randomized controlled trials (RCTs) are considered the highest level of evidence, they are also subject to bias, due to a lack of adequately reported randomization, and therefore the reporting should be as explicit as possible for readers to determine the significance of the contents. We evaluated the methodological quality of RCTs in respiratory research in high ranking cl...

Cluster randomized clinical trials in orthodontics: design, analysis and reporting issues.

Cluster randomized trials (CRTs) use as the unit of randomization clusters, which are usually defined as a collection of individuals sharing some common characteristics. Common examples of clusters include entire dental practices, hospitals, schools, school classes, villages, and towns. Additionally, several measurements (repeated measurements) taken on the same individual at different time poi...

Clinical Trials A Practical Guide to Design , Analysis , and Reporting

Reporting the clinical importance of randomized controlled trials.

T implement bedside rationing as described in Peter Ubel’s Pricing Life: Why It’s Time for Health Care Rationing would most certainly set medical ethics back 2500 years by ignoring the issue of patient trust, which gave rise to the traditional Hippocratic oath. The fundamental unit of health care is the physician–patient relationship. For physicians to knowingly withhold beneficial services fro...

Safety reporting in randomized clinical trials - a need for improvement.

The reporting of adverse events (AEs) in randomized clinical trials (RCTs) is often lacking in the publication of trials. Part of the problem is the way safety data are reported in RCTs. Reporting of "time to event," use of standardized incidence ratios for comparison to normal population or disease controls, use of "patient years" when reporting AE, and adequate sample size and power calculati...