Biomedical subjects

ISAKOS Scientific Committee

Publications and source records attributed to ISAKOS Scientific Committee.

5 recordsLinked to original sources

PubMed2003

Considerations on sample size and power calculations in randomized clinical trials.

Many studies in orthopaedics and sports medicine have not considered sample size or statistical power as important issues in study design. This article addresses the importance of a sample size calculation in randomized clinical trials and the components of the calculations that researchers must consider in their preliminary planning of an investigation. The types of data being collected, level of significance, types I and II errors, and power are also addressed.

Humans↗

PubMed2003

Practical aspects of randomization and blinding in randomized clinical trials.

Randomization and blinding are important tools in determining the effectiveness of a new intervention and ensuring the validity of a clinical trial. However, randomness and haphazardness are not equivalent. Randomization cannot overcome poor experimental design or technique. Several types of randomization including historical controls and pseudorandomization are discussed, as well as methods of treatment allocation, stratification, and minimization techniques. The importance of decreasing bias and the advantages and disadvantages of blinding in randomized clinical trials are also covered.

Bias↗

PubMed2003

Research methodology.

Research aims to reach valid conclusions through scientific enquiry. Valid conclusions can only be reached if bias is minimized or eliminated. Bias can potentially take place in the design, implementation, or analysis of a study. Various study designs reduce bias, and this article reviews some of the more common study designs in orthopaedic sports medicine. We also discuss bias and confounding factors as they relate to these studies.

Bias↗

PubMed2003

A primer for statistical analysis of clinical trials.

Randomized controlled trials have become the cornerstone of current practice evidence-based medicine. In this article, we present concise descriptions of fundamental statistical concepts and methods frequently used in the analysis of randomized trials. These include descriptive statistics, statistical inferences, techniques for the comparison of means or proportions from two samples, correlation, and regression analysis methods. The uses of these methods are illustrated with a number of practical examples, and the pitfalls of these topics are also briefly discussed. Lastly, some frequently used statistical terms and their meanings are also provided. By the end of the article, the reader should have sufficient knowledge to appreciate the statistical aspects of most clinical trial reports.

Evidence-Based Medicine↗

PubMed2003

Factors to consider in determining the feasibility of randomized clinical trials.

This article briefly reviews some of the important feasibility issues to be considered, and often overlooked, prior to undertaking clinical research. Topics such as time requirements, the multidisciplinary approach, the importance of a Clinical Research Coordinator, training of personnel, enrollment issues, funding, and the intrinsic and extrinsic benefits of conducting clinical research are discussed.

Humans↗